Current Measures: NQF staff have compiled the program's measures in a spreadsheet organized according to concepts.

Program History and Structure: The Hospice Quality Reporting Program (HQRP) was established in accordance with section 1814(i) of the Social Security Act, as amended by section 3004(c) of the Affordable Care Act. The HQRP applies to all hospices, regardless of setting. Proposed data sources for future HQRP measures include the Hospice Item Set and the Hospice Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey. HQRP measure development and selection activities take into account established national priorities and input from multi-stakeholder groups. Beginning in FY 2014, Hospices that fail to submit quality data will be subject to a 2.0 percentage point reduction to their annual payment update.

High Priority Domains for Future Measure Consideration:

Current Measures: NQF staff have compiled the program's measures in a spreadsheet organized according to concepts.

Index of Measures (by Program)

General Comments

• General comments
  
  

• Transfer of Health Information to Provider—Post-Acute Care (Public comments received:11; MUC ID: MUC2018-131)
  
  
• Transfer of Health Information to Patient—Post-Acute Care (Public comments received:10; MUC ID: MUC2018-135)
  
  

• Cesarean Birth (Public comments received:18; MUC ID: MUC2018-052)
  
  
• Hospital Harm - Pressure Injury (Public comments received:17; MUC ID: MUC2018-107)
  
  
• Hospital Harm - Hypoglycemia (Public comments received:16; MUC ID: MUC2018-109)
  
  

• Transitions from Hospice Care, Followed by Death or Acute Care (Public comments received:12; MUC ID: MUC2018-101)
  
  

• Transfer of Health Information to Provider—Post-Acute Care (Public comments received:12; MUC ID: MUC2018-132)
  
  
• Transfer of Health Information to Patient—Post-Acute Care (Public comments received:11; MUC ID: MUC2018-139)
  
  

• Transfer of Health Information to Provider—Post-Acute Care (Public comments received:8; MUC ID: MUC2018-133)
  
  
• Transfer of Health Information to Patient—Post-Acute Care (Public comments received:8; MUC ID: MUC2018-141)
  
  

• Time to surgery for elderly hip fracture patients (Public comments received:2; MUC ID: MUC2018-031)
  
  
• Discouraging the routine use of occupational and/or physical therapy after carpal tunnel release (Public comments received:2; MUC ID: MUC2018-032)
  
  
• International Prostate Symptom Score (IPSS) or American Urological Association-Symptom Index (AUA-SI) change 6-12 months after diagnosis of Benign Prostatic Hyperplasia (Public comments received:4; MUC ID: MUC2018-038)
  
  
• Multimodal Pain Management (Public comments received:14; MUC ID: MUC2018-047)
  
  
• Potential Opioid Overuse (Public comments received:16; MUC ID: MUC2018-048)
  
  
• Annual Wellness Assessment: Preventive Care (Public comments received:15; MUC ID: MUC2018-057)
  
  
• Adult Immunization Status (Public comments received:14; MUC ID: MUC2018-062)
  
  
• Functional Status Change for Patients with Neck Impairments (Public comments received:2; MUC ID: MUC2018-063)
  
  
• Inpatient Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (Public comments received:5; MUC ID: MUC2018-115)
  
  
• Femoral or Inguinal Hernia Repair (Public comments received:5; MUC ID: MUC2018-116)
  
  
• Lumbar Spine Fusion for Degenerative Disease, 1-3 Levels (Public comments received:6; MUC ID: MUC2018-117)
  
  
• Psychoses/Related Conditions (Public comments received:7; MUC ID: MUC2018-119)
  
  
• Lumpectomy, Partial Mastectomy, Simple Mastectomy (Public comments received:5; MUC ID: MUC2018-120)
  
  
• Acute Kidney Injury Requiring New Inpatient Dialysis (Public comments received:7; MUC ID: MUC2018-121)
  
  
• Lower Gastrointestinal Hemorrhage (Public comments received:6; MUC ID: MUC2018-122)
  
  
• Renal or Ureteral Stone Surgical Treatment (Public comments received:5; MUC ID: MUC2018-123)
  
  
• Hemodialysis Access Creation (Public comments received:6; MUC ID: MUC2018-126)
  
  
• Elective Primary Hip Arthroplasty (Public comments received:5; MUC ID: MUC2018-137)
  
  
• Non-Emergent Coronary Artery Bypass Graft (CABG) (Public comments received:4; MUC ID: MUC2018-140)
  
  
• Medicare Spending Per Beneficiary (MSPB) clinician measure (Public comments received:14; MUC ID: MUC2018-148)
  
  
• Total Per Capita Cost (Public comments received:19; MUC ID: MUC2018-149)
  
  

• Adult Immunization Status (Public comments received:9; MUC ID: MUC2018-062)
  
  
• Use of Opioids from Multiple Providers in Persons Without Cancer (Public comments received:15; MUC ID: MUC2018-077)
  
  
• Use of Opioids at High Dosage in Persons Without Cancer (Public comments received:15; MUC ID: MUC2018-078)
  
  
• Use of Opioids from Multiple Providers and at High Dosage in Persons Without Cancer (Public comments received:14; MUC ID: MUC2018-079)
  
  
• Initial opioid prescription compliant with CDC recommendations (Public comments received:11; MUC ID: MUC2018-106)
  
  

• Surgical Treatment Complications for Localized Prostate Cancer (Public comments received:3; MUC ID: MUC2018-150)
  
  

• Transfer of Health Information to Provider—Post-Acute Care (Public comments received:9; MUC ID: MUC2018-136)
  
  
• Transfer of Health Information to Patient—Post-Acute Care (Public comments received:9; MUC ID: MUC2018-138)
  
  

Full Comments (Listed by Measure)

• January 10, 2019 RE: Recognition of malnutrition as a gap area for quality measurement and improvement in federal hospital programs. Dear MAP Hospital Workgroup and Coordinating Committee, Abbott welcomes the opportunity to provide feedback on the recently released Measures Under Consideration (MUC) List for the 2018-2019 review cycle, and the omission of measures that address hospital malnutrition from this list. Abbott has a long history of developing nutritional products, services and resources to help health professionals effectively address and manage those with, or at-risk for malnutrition in all care settings. We are committed to working with health professionals, providers and policy makers to raise awareness of malnutrition as a critical, costly, and largely under-appreciated health concern that is also an important determinant of health. We appreciate that CMS and the NQF MAP have both identified and recognized malnutrition as a significant gap area warranting attention. In the FY 2018 proposed IPPS rule, CMS included four de novo malnutrition electronic clinical quality measures (eCQMs) under consideration for a future Hospital IQR program and CMS EHR Incentive Programs, emphasizing that malnourished patients have an increased risk of complications, readmissions, and length of stay, resulting in increased costs. While no new quality measures were adopted in the final rule, CMS noted that it would consider the feasibility of implementing a composite malnutrition measure (when available), as the Agency believed there could be important benefits to patients by having malnutrition measures that quantify the degree to which established best practices are carried out, improve health outcomes, and reduce cost burdens to the healthcare systems. A global composite malnutrition measure was created and submitted in response to this request and the NQF MAP 2017 Considerations for Implementing Measures in Federal Programs: Hospitals. 3 We ask the MAP to acknowledge in the final report that malnutrition in hospitals remains a known gap area for quality measure implementation, and to recommend that CMS adopt a meaningful malnutrition-focused measure as soon as feasible, starting with the Hospital IQR. We believe clinically-relevant malnutrition electronic quality measures (eCQMs) measures strongly align with CMS’ Meaningful Measures Initiative intended to identify relevant high-priority areas for quality measurement and improvement that are closely linked to patient outcomes. Sincerely, Susan M. Drawert, MED, RDN Director, Government Affairs 1. 82 Fed. Reg. 19796 (April 28, 2017). Available at: https://www.gpo.gov/fdsys/pkg/FR-2017-04-28/pdf/2017-07800.pdf. 2. 82 Fed. Reg. 37990 (Aug. 14, 2017). Available at https://www.gpo.gov/fdsys/pkg/FR-2017-08-14/pdf/2017-16434.pdf. 3. MAP 2017 Considerations for Implementing Measures in Federal Programs: Hospitals, NQF HHSM-500-T0018, Feb 2017 (Submitted by: Abbott)
  
  
• Dear MAP Hospital Workgroup and Coordinating Committee, CMS has long recognized the prevalence of malnutrition, its negative impact on patient outcomes, and the persistent barriers to high-quality malnutrition care. In 2013 and 2014, CMS referenced that 20-50 percent of hospital inpatients are malnourished or at-risk of malnutrition depending on the patient population and the criteria for assessment and that approximately 20 percent of hospitalized patients require complex nutrition plans and dietary orders. Furthermore, recent comments by HHS Secretary Alex Azar to the Hatch Foundation for Civility and Solutions emphasized that malnutrition was “involved in up to 12 percent of non-maternal, non-neonatal hospital stays—$42 billion each year in healthcare spending” in 2013 (Azar, November 2018). Given acknowledgement by key stakeholders of the concern with the burden of malnutrition in the hospital, we urge that the MAP Hospital Workgroup and the MAP Coordinating Committee follow suit and acknowledge malnutrition as a persistent quality measurement gap area in federal programs for hospitals. The burden of malnutrition on patients in the hospital setting as detailed in a report published by the AHRQ Healthcare Cost and Utilization Project (HCUP) in 2018 demonstrates that malnutrition is a public health issue. The analysis reported that malnourished hospitalized patients are three to five times more likely to experience in-hospital death, and experience a 56 percent higher rate of hospital 30-day readmissions compared with non-malnourished patients. Furthermore, malnutrition is a key health disparity that HCUP data demonstrate is more likely to affect older adults (age =85 years), and African American patients. There are short-term, and readily supported options available to address malnutrition in the hospital. The Malnutrition Quality Improvement Initiative (MQii) Learning Collaborative of hospitals across the U.S. has demonstrated that there are existing malnutrition measures which are feasible, reliable and support improvements to quality of care. The MQii is based on the implementation of an interdisciplinary quality improvement toolkit along with four malnutrition eCQMs focused on malnutrition screening upon admission, nutrition assessment for those at-risk of malnutrition, a provider diagnosis of malnutrition for those assessed as malnourished, and the development of a nutrition care plan for those with malnutrition. Through this dual-pronged initiative, the MQii Toolkit and eCQMs are being disseminated to over 250 hospitals across the U.S. Their implementation has supported improvements to quality of care highly associated with outcomes such as 30-day readmissions and length of stay. These measures have already been reviewed by the Measures Application Partnership (MAP) which recommended that they be combined into a composite measure. In response, our organization developed one of the first ever e-specified composite measures, the Global Malnutrition Composite Measure, that reflects a combination of these individual measures and is closely linked to key outcomes such as patient length of stay and 30-day readmissions. In addition, the recognition of malnutrition as a critical issue presents an opportunity to better align with the Meaningful Measures Initiative, which strives to identify high priority areas for quality of care and ensure measurement is strongly linked to patient outcomes. CMS has an immediate opportunity to advance the objectives of the initiative by adopting existing inpatient malnutrition eCQMs and/or composite measure into hospital pay-for-reporting program(s). We ask that the MAP acknowledge this quality measurement opportunity for hospitals and request CMS to add the Global Malnutrition Composite Measure to the MAP’s docket for consideration in future years of the Hospital Inpatient Quality Reporting (HIQR) Program. Closing this gap in malnutrition quality measurement would support clinical practices that can improve patient safety, and care continuity, and lead to better patient outcomes; address a known clinical gap, and align closely with the core values of the Meaningful Measures Initiative. Sincerely, Sharon M. McCauley, MS, MBA, RDN, LDN, FADA, FAND Senior Director, Quality Management | Malnutrition Quality Improvement Initiative Academy of Nutrition and Dietetics 312-899-4823 | smccauley@eatright.org (Submitted by: Academy of Nutrition and Dietetics)
  
  
• MIPS Cost and Resource Use Measures In December 2018, the MAP conditionally supported 11 episode-based cost measures and two total cost measures for inclusion in the Merit-based Incentive Payment System (MIPS), pending NQF endorsement. Efficiency is an important component of overall hospital performance improvement; however, these cost measures lack appropriate risk adjustment and do not truly reflect hospital efficiency. Medicare payments are more reflective of a hospital’s services and patients, rather than its efficiency. Further, as raised by the MAP, we are concerned about double-counting clinician costs in the episode-based cost measures and total cost-of-care measures, as well as overlap within the total cost-of-care measures. It is critical that measures accurately assess the components of cost that a clinician or group can control and avoid unintended consequences such as double-counting. America’s Essential Hospitals supports the evolution of value-based purchasing as the health care market shifts from volume to value. Our members continuously work to optimize care by increasing coordination between hospitals and physicians. However, improving care coordination and quality while maintaining a mission to serve the most vulnerable is a delicate balance. The cost measures in the MIPS lack risk adjustment for factors outside the control of the hospital and might unfairly penalize clinicians that serve a disproportionate share of patients with complex and costly needs—both clinically and socially. We urge the MAP to ensure the validity and value of the MIPS cost measures and account for social risk factors to improve quality of care while not unduly penalizing essential hospitals. (Submitted by: America's Essential Hospitals)
  
  
• The American Medical Association (AMA) requests that the section on “Emphasizing Appropriate Attribution and Level of Analysis for Incorporated Measures” be further expanded. In particular, we believe that the last sentence in the first paragraph on page 4 which states “However, MAP discussed that the measures need both to assess high-priority topics and to demonstrate that they can evaluate performance at the appropriate level of analysis” does not adequately address the ongoing need to ensure that there must be sufficient evidence that the accountable unit (e.g., clinician) is able to meaningfully influence the outcome as outlined in the most recent National Quality Forum (NQF) report, Improving Attribution Models (2018). The AMA also urges that this section be expanded to align with the current evidence requirements for outcome measures in the NQF Consensus Development Process to further strengthen the report. Specifically, developers must demonstrate through empirical evidence that there is at least one structure or process that can influence the outcome. These relationships with the accountable unit must be demonstrated for all of the measures under consideration prior to implementing them in the Merit-Based Incentive Payment System (MIPS) or other federal programs. (Submitted by: American Medical Association)
  
  
• WellCare appreciates the opportunity to offer comment on the National Quality Forum’s Measure Applications Partnership (MAP) draft recommendations. WellCare remains supportive of CMS’s goal of aligning measures across programs and rewarding stakeholders for forward progress in quality. However, WellCare would ask that consideration be given to potential barriers that might be faced by key participants in implementing the measures under consideration. We expect that providers would need to make meaningful investments in their processes, technology, and infrastructure to enable their ability to capture and report the data required by each of the new measures. Such investments could introduce both financial and operational burden to providers that could potentially compete with the resources they currently deploy to drive patient outcomes. WellCare requests that consideration be given to incentives and/or supports that can be deployed to reward providers that successfully manage the outcomes of their patients while also implementing the structures needed to successfully integrate new measures. Likewise, health plans continue to partner closely with their provider networks to drive coordinated care for their enrollees and provide administrative and operational supports to provider offices that bolster their abilities to improve outcomes. We ask that CMS consider the role that the health plan could play in partnering with providers as they develop their capabilities and that such health plans be rewarded for this work to strengthen their ability to incentivize provider compliance with new measures. (Submitted by: WellCare Health Plans)
  
  

• Overall, we support the inclusion of this measure. However, we would like to suggest adding “Absolute Cardiovascular Contraindications for Surgery” to the exclusions based on American Heart Association/American College of Cardiology (AHA/ACC) recommendations. (Submitted by: American Geriatrics Society)
  
  
• Recommend adding Hospice Care as an exclusion before approving (Submitted by: Memorial Hermann Health System)
  
  

• (Early public comment)The American Occupational Therapy Association (AOTA) appreciates the opportunity to comment on this measure. While we agree with the AAOS recommendation that routine use of occupational therapy or physical therapy following carpal tunnel release (CTR) surgery is not recommended, we believe that the use of this measure as written is not ready for use in the MIPS program, especially because these MIPS measures are benchmarked for performance and can change eligible clinician’s reimbursement. We think that the measure specifications have several problems: (1) the measure may have low specificity: it could capture beneficiaries who receive therapy for unrelated reasons; (2) the measure contains no exclusions: the literature on which the rationale is based is primarily non-Medicare literature and does not consider the addition of complications or comorbidities. The measure may have the unintended consequence of limiting Medicare beneficiary access to needed services. The measure would capture beneficiaries who receive therapy for unrelated conditions or medical reasons. The measure includes all beneficiaries who receive any OT or PT evaluation within 6 weeks of the CTR date. A surgeon would be attributed an increased (worse) score on this measure if their patient received an OT or PT evaluation for any reason during this period of time. We would recommend considering a CPT and ICD combination in the numerator to reduce the likelihood of incorrectly counting a beneficiary in the numerator. The measure contains no exclusions. We believe that this may lead to limited access. While the AAOS recommendation is that OT and PT services should not be routine, the measure can be interpreted to mean that OT and PT services should be never events. Based on our discussions with AOTA subject matter experts, while OT and PT services should not be routine, there are instances in which the services are warranted (e.g., when an UE fracture is also present, the presence of severe arthritis, complications related to sensation or scar management). The measure as written could penalize surgeons for referring the beneficiary to therapy in these appropriate contexts. The literature provided in the rationale does not address these populations. Alves (2011), the high quality study, only addresses one specific modality (that is not recommended by AOTA) and includes a median age of 44 years compared to a median age of 52 years. Pomerance (2007) includes participants with a median age of 46 years. And, Provinciali (2000) includes participants with a mean age of 55 years. None of the studies discuss chronic or co-occurring conditions. Especially in the Medicare population, a surgeon may identify additional complications or conditions that could indicate a clinical need for OT or PT for optimal care following a CTR. This should be addressed before the measure is used in a pay for performance program like MIPS. Another potential solution could be a shorter time horizon for the measure. As an example, a 2 week horizon rather than a 6 week horizon would likely capture less beneficiaries evaluated by OT or PT for other reasons. It would also allow a follow up visit to the surgeon’s office to identify if there are potential complications that would warrant a therapy referral. And, it should still measure the routine post-operation referral. (Submitted by: American Occupational Therapy Association)
  
  
• This measure penalizes clinicians for ordering therapy that may be appropriate. There should be some exclusions for patients where it is definitely appropriate. I would encourage the submitting organization to propose a related Patient Reported Outcome that is more meaningful than one that encourages limiting treatments. (Submitted by: Memorial Hermann Health System)
  
  

• As IPSS is not utilized for other measures in the program today, this concept may not be available discretely today in all EHR systems.  We do agree there is value in capturing this information within the Electronic Health Record for public reporting. Due to the lack of specifications for this measure we cannot comment on the full development implications. (Submitted by: Cerner Corporation)
  
  
• We suggest adding “Advance Dementia” to the exclusion criteria. In the denominator, we recommend changing the timeframe from 6-12 months to 3-12 months. (Submitted by: American Geriatrics Society)
  
  
• Would recommend submission for NQF endorsement (Submitted by: Memorial Hermann Health System)
  
  
• Work required to assist patients to collect data for scoring is significant on providers, this may be a heavy lift/perception of burden in primary care. (Submitted by: OCHIN, Inc.)
  
  

• (Early public comment)NHPCO Comments: Not all chronically ill/seriously ill individuals have access to palliative care services. We recommend considering a broader group of diagnoses for “excludes” and/or use of the standard definition of serious illness: a health condition that carries a high risk of mortality AND either negatively impacts a person’s daily function or quality of life, OR excessively strains their caregivers (Kelley et al Journal of Palliative Medicine 2018). (Submitted by: National Hospice and Palliative Care Organization)
  
  
• (Early public comment)We support this measure as the evidence suggests multimodal pain management for acute pain is more effective than single agents alone and, in surgical patients, could achieve better pain control with less risk of potential overuse/abuse of opioids. (Submitted by: Coalition to Transform Advanced Care)
  
  
• With the ongoing opioid epidemic in the US coupled with the realization that many of those addicted to opiates (40%) occur after surgery a non-opiate based, multimodal analgesic regimen is urgently needed. A multimodal analgesic program has been shown to reduce costs by reducing length of stay as well as increasing patient satisfaction due to lack of untoward effects of excessive opidates. (Submitted by: NorthShore University HealthSystem)
  
  
• We believe that this measure is problematic. For older adults with complex, serious illness, performance status improvement often means staying on longer than 90 days. As a general comment, the AGS is concerned with CMS’ approach to promoting its goal of increased alignment of measures across programs. Specifically, we believe that “looking first to existing program measures for use in new programs” is problematic because these measures are often inadequate for older adults with complex, serious illness. We are concerned that many of the MUCs will continue to incentivize providers to care for younger, healthier patients as they are more likely to have better outcomes, without complications and lower costs. Appropriate risk adjustment will be critical. (Submitted by: American Geriatrics Society)
  
  
• While written comments were not provided, the commenter indicated their support for MAP's preliminary recommendation (Submitted by: American Psychiatric Association Foundation)
  
  
• The American Medical Association supports the preliminary recommendation and associated conditions. (Submitted by: American Medical Association)
  
  
• While written comments were not provided, the commenter indicated their support for MAP's preliminary recommendation (Submitted by: American Psychiatric Association Foundation )
  
  
• AdventHealth does not support the use of this measure because, from our understanding, there is no known benchmark for the appropriate use of the multimodal pain medication with elective surgical procedures. AdventHealth is unsure of how providers can be held accountable for this measure without a current benchmark. (Submitted by: AdventHealth)
  
  
• The American Society of Anesthesiologists (ASA) appreciates the Measure Applications Partnership (MAP) review and recommendation to conditionally recommend the Multimodal Pain Management measure (MUC18-47) for use in the Merit-based Incentive Payment System in future years. This important measure not only improves patient care, but contributes to a decrease in opioid use, opioid prescriptions and common opioid-related complications in several patient populations. We encourage the Centers for Medicare & Medicaid Services (CMS) to include this measure for MIPS Program Year 2020. We look forward to continued collaboration with the MAP and the National Quality Forum (NQF) as we work to improve health outcomes and patient safety and further address the opioid epidemic. (Submitted by: American Society of Anesthesiologists)
  
  
• The American Society of Anesthesiologists (ASA) appreciates the Measure Applications Partnership (MAP) review and recommendation to conditionally recommend the Multimodal Pain Management measure (MUC18-47) for use in the Merit-based Incentive Payment System in future years. This important measure not only improves patient care, but contributes to a decrease in opioid use, opioid prescriptions and common opioid-related complications in several patient populations. We encourage the Centers for Medicare & Medicaid Services (CMS) to include this measure for MIPS Program Year 2020. We look forward to continued collaboration with the MAP and the National Quality Forum (NQF) as we work to improve health outcomes and patient safety and further address the opioid epidemic. (Submitted by: American Society of Anesthesiologists)
  
  
• While we agree that this type of measurement is needed, there is not enough details to support this measure. For example, what are all the multimodal treatments that qualify? We recommend submission for NQF endorsement and including more details on the specifications and measure development test results before adding to the MUC (Submitted by: Memorial Hermann Health System)
  
  
• The MiraMed QCDR currently harmonized this measure with the AQI and support its inclusion in the MIPS measure set. (Submitted by: MiraMed QCDR)
  
  
• The MEDNAX appreciates the ASA/AQI's submission of this measure for 2020 MIPS. The anesthesiologists who participate in the MEDNAX QCDR find this measure clinically meaningful and supportive of effective, efficient patient care. The measure reflects the role that broad, strategic pain control plays in certain types of elective surgical procedures. Strongly supportive peer-reviewed literature validates the importance of the performance parameters embedded within this measure. (Submitted by: MEDNAX QCDR)
  
  
• Support this measure becoming a MIPS 2020 measure for anesthesiology. Keeping more patients opioid naive and utilizing opioid sparing techniques is not only good for our patients, its good for reducing opioids in the community that has contributed to our opioid abuse crisis.Our organization uses the ASA's QCDR for non-MIPS and has our own accredited QR for MIPS reporting. This is an impactful measure and should be accepted. (Submitted by: TeamHealth Anesthesiology)
  
  

• (Early public comment)NHPCO Comments: Not all chronically ill/seriously ill individuals have access to palliative care services. We recommend considering a broader group of diagnoses for “excludes” and/or use of the standard definition of serious illness: a health condition that carries a high risk of mortality AND either negatively impacts a person’s daily function or quality of life, OR excessively strains their caregivers (Kelley et al Journal of Palliative Medicine 2018). (Submitted by: National Hospice and Palliative Care Organization)
  
  
• (Early public comment)The AANS and CNS disagree with the fundamental premise of this measure that daily dose and duration of therapy involving prescription opioid analgesics can serve on its own as a measure of quality patient care. Instead, quality measurement needs to focus on how well patients’ pain is controlled, whether functional improvement goals are met, and what therapies are being used to manage pain. A reduction in opioid dose, in the absence of other findings, is not an appropriate goal and it is not consistent with the Centers for Disease Control & Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain, which allows for physicians to document a clinical rationale or justification for the clinical use of dosages exceeding a daily threshold of 90 morphine milligram equivalents (MME). If this measure does not adequately define the patients for whom higher doses of opioids may be appropriate, it will provide invalid representations of physician performance. There is also a risk that physicians may reduce opioid prescriptions to score well on this measure and harm patients for whom the benefits of opioid therapy exceed the risks. CMS should explore more appropriate methods to assess a patient’s chronic pain, including the use of patient-reported data as the basis for performance measures. CMS also should test this measure in different patient populations to understand whether differences in performance scores are due to the complexity of patients treated across various specialties and whether the measure as defined is actually appropriate for quality improvement and/or accountability purposes. In addition, understanding the feasibility of directly calculating the measure from the EHR is critical because it is not clear that EHRs uniformly capture MMEs, which is a necessary calculation to populate the measure's numerator. In light of these concerns, the AANS and CNS do NOT support MUC18-48 Potential Opioid Overuse for implementation in MIPS at this time. (Submitted by: American Association of Neurological Surgeons )
  
  
• (Early public comment)The AMA disagrees with the fundamental premise of this measure that daily dose and duration of therapy involving prescription opioid analgesics can serve on its own as a measure of quality patient care. Instead, quality measurement needs to focus on how well patients’ pain is controlled, whether functional improvement goals are met, and what therapies are being used to manage pain. A reduction in opioid dose, in the absence of other findings, is not an appropriate goal and it is not consistent with the Centers for Disease Control & Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain, which allows for physicians to document a clinical rationale or justification for the clinical use of dosages exceeding a daily threshold of 90 morphine milligram equivalents (MME). CMS should explore more appropriate methods to assess a patient’s chronic pain such as the Pain Assessment Screening Tool and Outcomes Registry (PASTOR) and use this patient-reported data as the basis for performance measures. This tool utilizes the Patient Reported Outcomes Measurement Information System (PROMIS) and through the use of Computer Adaptive Testing, key domains such as sleep disturbance and physical function can be assessed in a targeted and patient-directed way. During CMS’ public comment on this draft measure, the AMA raised significant concerns around the intent of the measure, with its broad denominator population and limited exclusions, and questioned whether the current specifications adequately captured the recommendations from the CDC such as acknowledging the ability to justify prescriptions exceeding 90 MME/day. The measure currently includes buprenorphine (for pain management) and it is not clear how the clinical indication for prescribing can be captured in an electronic health record (EHR). Because it is most often used for medication assisted treatment (MAT) of opioid use disorder, and existing MME calculators do not account for buprenorphine required for MAT, we believe that this drug should be removed. In addition, the unintended consequences of this measure must be clearly evaluated prior to moving forward. Specifically, if the measure does not adequately define the patients for whom higher doses of opioids may be appropriate, it will provide invalid representations of physician performance. There is also a risk that physicians may reduce opioid prescriptions to score well on this measure and harm patients for whom the benefits of opioid therapy exceed the risks. Prior to finalization of the measure, the AMA has already requested that it be tested in different patient populations and medical specialties to understand whether differences in performance scores are due to the complexity of patients treated across various specialties and whether the measure as defined is actually appropriate for quality improvement and/or accountability purposes. In addition, understanding the feasibility of directly calculating the measure from the EHR is critical because it is not clear that EHRs uniformly capture MMEs; this calculation is necessary to populate the measure's numerator. Therefore, in light of the multiple uncertainties and concerns with the measure, as well as the existence of proposed measures that are similar and overlapping, the AMA recommends that the highest level of MAP recommendation be “Do Not Support With Potential For Mitigation”. (Submitted by: American Medical Association)
  
  
• (Early public comment)The Renal Physicians Association (RPA) is the professional organization of nephrologists whose goals are to ensure optimal care under the highest standards of medical practice for patients with kidney disease and related disorders. RPA acts as the national representative for physicians engaged in the study and management of patients with kidney disease. RPA supports this measure. (Submitted by: Renal Physician Association )
  
  
• (Early public comment)We appreciate that this measure has exclusions for cancer/sickle cell, hospice, and palliative care. We urge CMS to closely monitor implementation for unintended consequences for patients with serious illness who don’t fall under these exclusions, but for whom higher doses of opioids are clinically indicated. (Submitted by: Center to Advance Palliative Care)
  
  
• (Early public comment)We support this but recognize other people with advanced illnesses outside of the excluded categories, including those with chronic pain, can also justifiably need opioids for longer and at higher doses (Submitted by: C-TAC)
  
  
• We do not support the MAP’s recommendation to not recommend the measure for inclusion in MIPS. We recommend the MAP change its recommendation to “support for rulemaking.” The measure’s current threshold for opioid overuse of 90 morphine milligram equivalent (MME) or greater daily is aligned with the Centers for Disease Prevention and Control (CDC) Guideline for Prescribing Opioids for Chronic Pain. It also aligns with AHIP’s recently launched Safe, Transparent, Opioid Prescribing (STOP) Measure – a robust, evidence-based methodology that health insurance providers can use to assess how provider practices compare to the federal recommendations for prescribing opioids. We also note that under MIPS, providers can choose which measures to report, and we feel this measure is a reasonable reporting option for this program. (Submitted by: America's Health Insurance Plans)
  
  
• On December 12, 2018 the National Quality Forum (NQF) Measure Applications Partnership (MAP) Clinician Workgroup reviewed the Potential Opioid Overuse measure (MUC18-048) electronic clinical quality measure (eCQM), under consideration for use in the Merit-based Incentive Payment System. On December 21, the MAP Coordinating Committee circulated the preliminary MAP Workgroup MUC recommendations and the draft Workgroup report. Please see our comment below related to the following language found on page 7 of the “2018-2019 Clinician Draft Report for Commenting “document: “MAP similarly did not support MUC18-048 Potential Opioid Overuse for rulemaking with the potential for mitigation. MAP identified distinctions in the morphine milligram equivalents dose between this measure and the related measures that MAP conditionally supported for inclusion in the SSP (MUC18-077 Use of Opioids from Multiple Providers in Persons without Cancer and MUC18-078 Use of Opioids at High Dosage in Persons without Cancer). MAP highlighted the potential reporting burden for physicians reporting under both SSP and MIPS and therefore recommended mitigation through harmonization with MUC18-077 and MUC18-078.” Comment 1: Our notes also included MAP recommending harmonization with MUC18-106 Initial opioid prescription compliant with CDC recommendations. (Submitted by: Mathematica Policy Research )
  
  
• We have been looking into the detail CQL measure specifications and have a follow-up meeting with Mathmatica January 22, 2019. At a high-level the consensus is that this measure logic and feasibility need additional evaluation. These are just a few notes: There are portions of the logic that can be optimized to reduce complexity. The maintenance and support of the measure with all the variables and functions should be simplified. Rather than manually including all the medications (100+ pages of static code), the value set data for medications should be expanded to allow for consistency and ease of implementation. There was discussion of potential APIs, but that would add new technology and need to evaluate that option. Date algorithms should be used for calculations. There are also concerns with the EHR support of the medication data elements needed to calculate the CMD/MME and the reliability. There is concern on the timing of the provider visit in relation to the opioid medication that should be considered when reporting (opioid should start before or during the visit). It has taken significant time to dig in and evaluate the measure. For the MIPS program, evaluation should be given to make sure that the population and outcome reflect value. (Submitted by: Cerner Corporation)
  
  
• On December 12, 2018 the National Quality Forum (NQF) Measure Applications Partnership (MAP) Clinician Workgroup reviewed the Potential Opioid Overuse (MUC18-48) electronic clinical quality measure (eCQM), under consideration for use in the Merit-based Incentive Payment System. The NQF MAP Clinician Workgroup voted to not support the eCQM for rulemaking, citing potential for mitigation and concern that the eCQM was not fully harmonized with four opioid measures reviewed by the Workgroup earlier in the day: (1) Use of Opioids at High Dosage in Persons Without Cancer (MUC18-78); (2) Use of Opioids from Multiple Providers in Persons Without Cancer (MUC18-77); (3) Use of Opioids from Multiple Providers and at High Dosage in Persons Without Cancer (MUC18-79); and (4) Initial Opioid Prescription Compliant with CDC Recommendations (MUC18-106). In response to questions raised by the Workgroup, under direction from the Centers for Medicare & Medicaid Services (CMS), the measure steward, Mathematica Policy Research, the CMS contractor leading development and implementation of the measure, reviewed each of the other opioid measures, analyzing the differences and similarities between these five measures. We concluded that the Potential Opioid Overuse measure is harmonized to the extent appropriate with the other four opioid measures and request the MAP reconsider its current recommendation of requiring further harmonization before proposing in rulemaking. In our analysis (presented below), we outline how the Potential Opioid Overuse and the Pharmacy Quality Alliance (PQA) measures (MUC18-78, MUC18-77, and MUC18-79) are harmonized in areas where the measures overlap, except for the dose threshold included in MUC18-78 and MUC18-79 as the Potential Opioid Overuse measure aligns with the CDC guidelines whereas PQA’s measures align with recent literature around dosing thresholds. The Potential Opioid Overuse measure and the OptumLabs measure (MUC18-106) focus on different intents and populations and as such it would not be appropriate for the measures to harmonize. As part of measure maintenance described in the Measures Management System Blueprint, CMS will continue to collaborate with measure developers to confirm the measure remains harmonized with other opioid measures, as appropriate. Pharmacy Quality Alliance (PQA) – Use of Opioids at High Dosage in Persons Without Cancer Measure (MUC18-78) Similarities: The Potential Opioid Overuse measure and MUC18-78 share a similar intent: to reduce the prescription of high-dose, long-term opioids to minimize the risk of adverse events. Given the two measure’s similarities, the measures are harmonized in the following ways: (1) both measure define “long term” as 90 days or more, (2) both measures exclude patients with cancer or those receiving palliative care, and (3) both measures include the same list of opioid medications. Differences: The Potential Opioid Overuse measure deviates from the MUC18-78 in the following ways and for the outlined reasons: 1. The Potential Opioid Overuse measure sets its high-dose threshold at 90 morphine milligram equivalents (MME) rather than 120 MME. - Reason for difference: The Potential Opioid Overuse measure aligns with the CDC’s guidance on prescribing high-dose opioids. MUC18-78 aligns with recent research that suggests an overdose mortality rate of 24.6 patients per 10,000 person-years among patients taking 200 to 250 MME per day; this rate declines to 8.3 deaths per 10,000 person-years for patients taking opioid doses of 100 to 120 MME per day (Dasgupta et al. 2016) . 2. The structure of the Potential Opioid Overuse and MUC18-78 measures are different—the Potential Opioid Overuse denominator includes patients taking an opioid for 90 days or longer, while MUC18-78 measure accounts for these long-term opioid users in their measure numerator (their denominator includes any member with two or more prescription claims for opioids filled on at least two separate days for which the sum of the days’ supply is greater than or equal to 15). - Reason for difference: The Potential Opioid Overuse measure informs stakeholders of the proportion of patients on high-dose opioids who are taking long-term opioids. Whereas the MUC18-78 measure informs stakeholders of those patients taking any opioids, how many are high-dose and long-term. 3. The Potential Opioid Overuse measure score will be reported as a percentage of the clinician’s total patients from the denominator, whereas the MUC18-78 measure is expressed as a proportion out of 1,000. - Reason for difference: The Potential Opioid Overuse measure is specified and tested as a clinician-level measure. The MUC18-78 measure is a health plan level measure. 4. The Potential Opioid Overuse measure also excludes patients with sickle cell disease (SCD), while MUC18-78 measure only excludes cancer and hospice or palliative care treatment. - Reason for difference: Through a review of the literature, discussions with the expert work group, and supported by testing data, we elected to exclude patients with SCD. Our primary rationale is due to the face validity of opioid use for management of pain crises within this population and based on guidance from the National Heart, Lung, and Blood Institute’s 2014 Evidence-Based Management of Sickle Cell Disease expert panel report . While the risk/benefit ratio for use of opioids as a pain-management tool is no different for patients with SCD than those with many other chronic diseases, there is strong face validity for using opioids for SCD during pain crises. Pharmacy Quality Alliance (PQA) – Use of Opioids from Multiple Providers in Persons Without Cancer (MUC18-77) Similarities: Both measures focus on opioid prescribing. Additionally, both measures exclude patients with cancer or those receiving palliative care, and both measures include the same list of opioid medications. Differences. MUC18-77 is in the same measure set as MUC18-78, therefore, the differences outlined in bullets number three and four above are relevant here as well. In addition, differences in measure intent between the Potential Opioid Overuse measure and the MUC18-77 cause additional appropriate difference between the measures. 1. The intent of the Potential Opioid Overuse measure is to reduce the prescription of high-dose, long-term opioids to minimize the risk of adverse events, whereas the intent of MUC18-77 is to reduce the prescription of opioids from multiple providers. - Due to the differences in measure intent, these two measures differ significantly and the specifications do not offer many opportunities to harmonize. Two examples of where these intent differences cause specification differences are in the strength and duration of the specified opioid prescription. The Potential Opioid Overuse measure specifies a specific opioid strength and a longer prescription duration due to the measure’s intent to reduce long-term, high-dose opioid use. Whereas the MUC18-77 measure does not specify the prescription strength and includes a shorter minimum prescription duration as its focus is to reduce patients from obtaining opioid prescriptions from multiple providers and multiple pharmacies regardless of prescription strength and duration. Pharmacy Quality Alliance (PQA) - Use of Opioids from Multiple Providers and at High Dosage in Persons Without Cancer (MUC18-79) Similarities: The Potential Opioid Overuse measure and MUC18-79 share a similar intent: to reduce the prescription of high-dose, long-term opioids to minimize the risk of adverse events. Therefore, the measures are harmonized in the following ways: (1) both measures define “long term” as 90 days or more, (2) both measures exclude patients with cancer or those receiving palliative care, and (3) both measures include the same list of opioid medications. However, MUC18-79 extends the measure intent to also reduce the number of patients who receive these high-dose, long-term opioids from multiple providers. Differences. MUC18-79 is in the same measure set as MUC18-77 and MUC18-78 and combines MUC18-77 and MUC18-78 together to assess high-dose opioid prescriptions from multiple providers. Therefore many of the differences noted in the two sections above apply to this measure and there are no unique differences to describe between the Potential Opioid Overuse measure and MUC18-79. OptumLabs – Initial Opioid Prescription Compliant with CDC Recommendations (MUC18-106) Similarities: Both measures focus on opioid prescribing. Differences. The differences outlined below demonstrate substantial differences in measure intent and patient population. The measures are currently harmonized to the extent possible given the key differences outlined below. 1. Measure intent. The intent of the Potential Opioid Overuse measure is to reduce the prescription of high-dose, long-term opioids to minimize the risk of adverse events. Whereas the intent of the MUC18-106 measure is to encourage providers to appropriately align with the 2016 CDC Guidelines for Prescribing Opioids for Chronic Pain (‘CDC guidelines’) when initiating a new opioid to an opioid-naïve patient. - Due to the differences in measure intent, the two measures have differing dose thresholds. The Potential Opioid Overuse measure sets its dose threshold at 90 MME, in line with the CDC guidelines. The MUC18-106 measure sets it’s dose threshold at 50 MME because, as recommended by the CDC guidelines, when opioids are started, clinicians should prescribe the lowest effective dosage and carefully reassess evidence of individual benefits and risks when considering increasing dosage to greater than 50 MME. Therefore although the measures have differing dose thresholds each measure’s threshold is appropriate given the measure’s specific intent. 2. Target population. The target population for the Potential Opioid Overuse is patients prescribed opioids chronically. Whereas the target population in the MUC18-106 measure is opioid-naïve patients. - Due to the difference in the measures’ target population, that is, patients who are already prescribed opioid therapy versus those who are newly prescribed opioids, the two measures have differing prescription lengths. The Potential Opioid Overuse measure encourages providers to prescribe high-dose opioids no more than 90 days, whereas the MUC18-106 measure intends to encourage providers to prescribe an opioid prescription for 7-day supply or less. - Due to the difference in the measures’ target population, the Potential Opioid Overuse measure does not specify the type of opioid, and takes into account the total MME for all prescribed opioids, given the complex medication regimen likely issued to the population targeted by the measure (for example, those with long-term chronic pain) that might require combinations of long-acting and short-acting opioids whereas the MUC18-106 measure encourages providers to use only short-acting opioids, as the CDC guidelines encourage providers to prescribe immediate-release opioids instead of extended-release/long-acting opioids when initiating opioid therapy. ---------- References: Dasgupta, N., M.J. Funk, S. Proescholdbell, A. Hirsch, K.M. Ribisl, and S. Marshall. “Cohort Study of the Impact of High-Dose Opioid Analgesics on Overdose Mortality.” Pain Medicine, vol. 17, no. 1, 2016. https://doi.org/10.1111/pme.12907. Epub January 14, 2016. National Heart, Lung, and Blood Institute. Evidence-Based Management of Sickle Cell Disease. 2014. https://www.nhlbi.nih.gov/sites/default/files/media/docs/Evd-Bsd_SickleCellDis_Rep2014.pdf. Accessed on December 21, 2018. Dowell, D., Haegerich, T., Chou, R. "CDC Guideline for Prescribing Opioids for Chronic Pain - United States, 2016". MMWR Recomm Rep 2016;65. https://www.cdc.gov/media/dpk/prescription-drug-overdose/opioid-prescription-guidelines/dpk-opioid-prescription-guidelines.html (Submitted by: Mathematica Policy Research )
  
  
• We believe that this measure is based on little evidence of a ceiling for opioids and we are concerned that it may have a negative impact on older adults who improve in function with opioids. Geriatricians caring for patients with complex serious illness may consider higher doses in select instances and prescriptions longer than 90 days when the use of these medications improve functional status. In these instances, one could argue that the use of these medications is palliative. The CDC opioid guideline specifically states that the guideline is not applicable to patients with cancer, hospice or palliative care. We agree that palliative care patients should be excluded from the denominator (neither pass nor fail) and believe that patients seeing a pain specialist should also be excluded. Further, patient prescribed methadone or suboxone should also qualify as passing the measure even if the equivalents exceed the limit (i.e. should be included in the denominator). (Submitted by: American Geriatrics Society)
  
  
• APAF agrees with MAP's preliminary recommendation comment that harmonizing this measure with similarly focused measures would make this measure more useful. However, we support the measures inclusion for future MIPS performance years, given the opportunity to view test data for use at the provider-level. (Submitted by: American Psychiatric Association Foundation)
  
  
• The American Medical Association (AMA) supports the preliminary recommendation but asks that additional conditions be placed on this measure, including clarification on whether buprenorphine is still included and further testing to determine if the measure could result in unintended consequences and feasibility testing across multiple electronic health record systems (EHRs). Specifically, the AMA is concerned with the lack of clarity on whether the measure continues to include buprenorphine (for pain management). Because it is most often used for medication assisted treatment (MAT) of opioid use disorder, and existing MME calculators do not account for buprenorphine required for MAT, we believe that this drug should be removed. The developer stated during the Clinician Workgroup meeting that it is no longer included but on review the most recent version of specifications endorsed by the National Quality Forum, this drug is still listed. In addition, the unintended consequences of this measure must be clearly evaluated prior to moving forward. Specifically, if the measure does not adequately define the patients for whom higher doses of opioids may be appropriate, it will provide invalid representations of physician performance. There is also a risk that physicians may reduce opioid prescriptions to score well on this measure and harm patients for whom the benefits of opioid therapy exceed the risks. Prior to finalization of the measure, the AMA has already requested that it be tested in different patient populations and medical specialties to understand whether differences in performance scores are due to the complexity of patients treated across various specialties and whether the measure as defined is actually appropriate for quality improvement and/or accountability purposes. In addition, understanding the feasibility of directly calculating the measure from the EHR is critical because it is not clear that EHRs uniformly capture MMEs; this calculation is necessary to populate the measure's numerator. (Submitted by: American Medical Association)
  
  
• AdventHealth supports this measure because it already aligns with the current Center for Disease Control’s (CDC) recommendations for prescribing opioids. These recommendations are currently in use by many health systems, including AdventHealth. (Submitted by: AdventHealth)
  
  
• The AANS disagrees with the fundamental premise of this measure that daily dose and duration of therapy involving prescription opioid analgesics can serve on its own as a measure of quality patient care. Instead, quality measurement needs to focus on how well patients’ pain is controlled, whether functional improvement goals are met, and what therapies are being used to manage pain. A reduction in opioid dose, in the absence of other findings, is not an appropriate goal and it is not consistent with the Centers for Disease Control & Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain, which allows for physicians to document a clinical rationale or justification for the clinical use of dosages exceeding a daily threshold of 90 morphine milligram equivalents (MME). If this measure does not adequately define the patients for whom higher doses of opioids may be appropriate, it will provide invalid representations of physician performance. There is also a risk that physicians may reduce opioid prescriptions to score well on this measure and harm patients for whom the benefits of opioid therapy exceed the risks. CMS should explore more appropriate methods to assess a patient’s chronic pain, including the use of patient-reported data as the basis for performance measures. CMS also should test this measure in different patient populations to understand whether differences in performance scores are due to the complexity of patients treated across various specialties and whether the measure as defined is actually appropriate for quality improvement and/or accountability purposes. In addition, understanding the feasibility of directly calculating the measure from the EHR is critical because it is not clear that EHRs uniformly capture MMEs, which is a necessary calculation to populate the measure's numerator. In light of these concerns, the AANS does NOT support MUC18-48 Potential Opioid Overuse for implementation in MIPS at this time. (Submitted by: American Association of Neurological Surgeons)
  
  
• This would be impactful to our patients and life-saving. (Submitted by: OCHIN, Inc.)
  
  

• (Early public comment)Lamaze International strongly promotes non-clinical interventions to lower the primary cesarean birth rate through evidence-based antenatal childbirth education and education of perinatal professionals. Tracking cesarean birth in nulliparous women with a term, singleton baby in the vertex position is critical to evaluating and sharing the effectiveness of such non-clinical antenatal interventions. These educational interventions may include informing women of the importance of provider and hospital selection, the benefits to low risk women of laboring at home until labor has progressed to the active phase, the importance of labor movement, support, avoiding unnecessary routine medical interventions and others. Most importantly, childbirth educators and others can use these data to help women and their partners engage in shared decision-making about practices that may increase their likelihood of undergoing cesarean birth. Likewise, perinatal professionals will benefit from evidence of measures that lower the primary cesarean birth rate. Lamaze currently provides an Evidence-Based Labor Support Workshop to help labor and delivery nurses engage in evidence-based practices that can help lower the rate of primary cesareans. Collection of this outcome measure will help to guide the efforts of perinatal professionals and pregnant women to safely avoid the first cesarean. Lamaze International strongly supports this proposed measure. (Submitted by: Lamaze International)
  
  
• (Early public comment)The Federation of American Hospitals supports the intent of the measure to decrease the rate of cesarean births but believes that examining the quality of care delivered to mothers and babies should be more holistic and balanced (e.g., ensure the delivery of healthy term newborns). Specifically, FAH does not believe that inclusion of a limited number of obstetric measures in the Inpatient Quality Reporting Program or Medicare and Medicaid EHR Incentive Program for Eligible Hospitals and Critical Access Hospitals (PC-1, Elective Delivery and Cesarean Birth) will provide a comprehensive picture of the desired outcomes. Neither measure can achieve optimal performance rates (i.e., 100% for Elective Delivery, 0% for Cesarean Birth) and CMS must ensure that their individual use does not create unintended consequences. Also, based on our review of the Quality Positioning System, it appears that this measure is currently endorsed (NQF #471), which is inconsistent with the failed endorsement status included in the current Measures Under Consideration materials. FAH requests that this information be clarified prior to the Hospital Workgroup meeting. (Submitted by: Federation of American Hospitals)
  
  
• (Early public comment)This measure should not be included in the HAI domain. The subject matter and goal of the measure is not related to healthcare-associated infections. The measure developer should provide further clarification on the intent of this measure as it relates to healthcare-associated infection rates as a measure of healthcare quality. In the absence of clarification or further explanation from the developer, SHEA recommends this measure be removed from the HAI domain and not be adopted as proposed. (Submitted by: The Society for Healthcare Epidemiology of America)
  
  
• Comments and Data to Support Measure MUC2018-052, Cesarean birth, nulliparous women with a term singleton baby in vertex position. Elliott Main, MD Professor of Obstetrics and Gynecology, Stanford University School of Medicine We have only recently become aware of the MAP Hospital Workgroup process that included discussion of this measure MUC18-52, also known as PC-02 for the Joint Commission. I submitted similar comments earlier but the formatting was distorted so i apologize for any repetition. This measure has been widely used by many organizations (Leapfrog Group, Joint Commission, CHIPRA and was the only Cesarean measure endorsed by American College of Obstetricians and Gynecologists) and has been part of the national Health Person 2010 and 2020 projects. Over the last 6 years, California has had extensive positive experience using this measure for both public reporting and quality improvement activities. We wish to share the highlights of our findings and the successes in reducing overall state rates and reducing the extraordinary hospital variation seen for this measure (2015: hospitals ranged from 11 to 77%!). Our findings strongly support the view that the vast majority of this variation is due to provider and unit practice styles and not to the hospital’s patient population characteristics. There is extraordinary variation in risk-adjusted cesarean rates California and national data show variation from 11-77% for PC-02 Are the important patient characteristics accounted for by this measure? We have explored the relative contributions of multiple patient characteristics as potential contributors for this variation using the concept of population attributable fraction. This can address questions like: “What proportion of the rate of Lung Cancer is due to smoking?” For us: “What proportion of the cesarean delivery rate is due to a given risk factor?” The Population Attributable Fraction analysis for primary cesarean section inlcuded in the NTSV CS includes ALL risk factors with a population attributable risk >1% (nulliparity is 59%, Breech is 12% prematurity is 11% and twins 7%). All medical risk factors not included in the measure specifications account for <1%. Conclusion: additional diagnosis codes do not add meaningful value. How do these specifications impact data collection? Limiting the measure to nulliparous term singleton women with a baby in head first position without a placenta previa allows for both standard data collection and an e-measure. The Joint Commission PC-02 specifications use ICD-10 codes for all but nulliparity which is now a structured mandatory data field in most electronic health records. Since PC-02 is now mandatory for all maternity hospitals reporting to the Joint Commission, electronic health record vendors have made great strides in the last 2 years to automate these processes. Conclusion: PC-02 is now a straightforward measure for e-measure collection. Are high risk centers disadvantaged by their patient populations? We looked specifically whether hospitals who cared for the highest risk patients are disadvantaged by this measure. The 2017 NTSV Cesarean Rate results for all 10 California university medical centers show 7 between 18% and 24% and 3 between 24% and 29%. 7 of 8 county hospitals that care for the most challenging patients range form 16% to 23% and 1 was 26%. Conclusion: high risk centers can do very well on this measure, particularly if they make an effort. What else can account for such variation? We are able to calculate provider-level rates in California and in the next figure we present examples from 4 large hospitals with multiple providers who do not have midwifery or hospitalist providers (which can complicate the calculation of provider-level rates). The variation within the same hospital for providers is dramatic. It ranges from 4 to as high as 10-fold within the same facility! In each of these hospitals, if the four providers with very highest rates were no longer in practice, the hospital rates would have been significantly lower. Conclusion: Provider variation in practice styles is the main driver for hospital variation. If the variation is due to practice variation and unit culture can it be affected by quality improvement projects? Provider and unit culture and practice styles suggest potential for quality improvement projects. If rates are due to patient characteristics, then high rates should not be able to be reduced significantly by QI projects. In California, we have demonstrated both the rapid success in lowering cesarean rates among a large number of hospitals in a quality improvement collaborative and the maternal and infant safety of doing so. Quality Collaborative Success 91 hospitals all with starting NTSV Cesarean rates above 24% were recruited to participate in the California Supporting Vaginal Birth/Reducing Primary Cesarean Collaborative. They joined as 3 separate cohorts and each cohort has shown significant reductions. Data are shown below for the first 3 quarters of 2018 compared to 2015. Fully 70% of hospitals have either dropped below target or lowered their cesarean rate by >5% points. Conclusion: The finding that 70% of hospitals show significant and meaningful reductions in their cesarean rate over a short period of time indicates that the cesarean rate is not fixed or based on patient characteristics but driven by unit and provider practice style. Safety of Lowering the Cesarean Rate: 7 maternal and neonatal safety measures were closely followed during the project in the 91 hospitals. None showed any worsening and there actually there was a small but statistically significant IMPROVEMENT in composite term neonatal outcomes. Hospitals with very large (>10% point drops) also showed no ill effects. (Paper in press, Obstetrics and Gynecology) Conclusion: Cesarean rates can be significantly lowered with safety for mother and infant. (Submitted by: California Maternal Quality Care Collaborative--Dr Elliott Main)
  
  
• We support the MAP’s recommendation to not consider the measure for inclusion in the HIQR and Promoting Interoperability programs at this time but consider the measure for future rulemaking after the developer has addressed their concerns. We note that the chart-abstracted version of this measure, NQF #0471, is currently included in the Core Quality Measures Collaborative (CQMC) OB/GYN Core Measure Set. As the CQMC has recently reconvened its OB/GYN workgroup, we recommend that the MAP re-consider this measure after CMS and the CQMC have had the opportunity to jointly evaluate both the chart abstracted and eCQM versions of this measure for the purposes of updating the OB/GYN Core Set. (Submitted by: America's Health Insurance Plans)
  
  
• We agree with MAPs initial recommendation to not support with potential mitigation due to the lack of risk adjustment and high-risk conditions in the exclusions. We would need to review detailed specifications, as were shared in the 2018 specification to fully understand the population and development criteria. (Submitted by: Cerner Corporation)
  
  
• The Maternal Safety Foundation, an NQF consumer member organization, supports the implementation of MUC18-52 Cesarean Birth (CB) in IQR and the CMS EHR Incentive Program. We are submitting this comment to address MAP’s concerns and fears of negative unintended consequences documented in the Hospital IQR Program final report. MUC18-52 (also called the NTSV Cesarean Birth Measure or PC-02) measures a specific subset of patients (nulliparous patients with term, singleton, vertex pregnancies without a placenta previa) whose outcomes are shown to be largely influenced by physician factors, rather than patient characteristics or obstetric diagnoses. Over 60% of hospital variation in NTSV patients can be attributed to first birth labor induction rates and first birth early labor admission rates. As a consumer/patient organization, we consider a robust measure that illuminates practice variation among providers and facilities to be very valuable for comparing hospitals and for holding providers accountable. The addition of Unexpected Newborn Complications (NQF #716) to The Joint Commission’s Perinatal Core Measure Set beginning January 1, 2019, will serve as a balancing measure to the current delivery measures. Whereas there is little further room for improvement in Early Elective Delivery rates, reducing unwarranted practice variation and curbing overuse of medically unnecessary cesarean births--both primary and repeat—as well as ensuring that patients have access to risk-appropriate care remain top public health priorities. MAP’s question about whether or not measuring CB rates directly relates to improved maternal health outcomes seems to originate from a discussion that “some states” have seen “unintended consequences that may arise such as increased maternal mortality with decreased CB rates.” Research shows that the NTSV cesarean rate can be quickly lowered with no adverse maternal or infant outcomes. In fact, they fared better in a 2015 California Maternal Quality Care Collaborative three-hospital pilot program. While implementing a quality improvement program to lower NTSV cesarean rates, data were collected for NTSV cesarean births and balancing measures, including the NQF Unexpected Newborn Complications measure (now TJC’s PC-06) and 3rd/4th degree maternal lacerations occurring in vaginal births. The hospitals in the pilot program averaged a 18.6% reduction in their NTSV. Newborn complications fell (significantly) by 24.5% and 3rd/4th degree lacerations dropped by 4.7%. With regards to MAP’s suggestion that the NQF Scientific Methods Panel and Perinatal Standing Committee pay special attention to risk adjustment, exclusions, and unintended consequences (full-disclosure: I am a new member of the Perinatal and Women’s Health Standing Committee), the cesarean birth measure in question was just re-endorsed as one of NQF’s Perinatal and Women’s Health measures in 2016 with 96% of the committee supporting the measure, and The Joint Commission is now the steward of the measure. This measure and its exclusions have already undergone recent rigorous review by the appropriate NQF committees. We apologize for late involvement with this, as we learned that CB was up for discussion by MAP just prior to the final meeting on December 11, 2018. In mid-2018, the same measure was being discussed by the MAP Rural Health Workgroup measure, with the committee recommending that it not be included due to concerns about low-volume in critical access and rural hospitals. We ran some numbers and found that the majority of rural hospitals with maternity services meet TJC’s reporting threshold of 300 births and asked that the committee please ensure that their decision was data-driven. PC-02 was changed to a “yes” for recommendation as a rural-relevant measure with a caveat that low volume should be taken into consideration. The cesarean section is the most commonly performed surgery in the United States, and pregnancy accounts for almost 25 percent of all hospitalizations. Overuse of cesarean births is a significant contributor to both short-term and long-term maternal morbidity as well as maternal mortality and we as consumer/patient advocates strongly recommend the implementation of MUC18-52 Cesarean Birth (CB) in IQR and the CMS EHR Incentive Program. Sincerely, Jill Arnold Executive Director, Maternal Safety Foundation (Submitted by: Maternal Safety Foundation)
  
  
• The Maternal Safety Foundation, an NQF consumer member organization, supports the implementation of MUC18-52 Cesarean Birth (CB) in IQR and the CMS EHR Incentive Program. We are submitting this comment to address MAP’s concerns and fears of negative unintended consequences documented in the Hospital IQR Program final report. MUC18-52 (also called the NTSV Cesarean Birth Measure or PC-02) measures a specific subset of patients (nulliparous patients with term, singleton, vertex pregnancies without a placenta previa) whose outcomes are shown to be largely influenced by physician factors, rather than patient characteristics or obstetric diagnoses. Over 60% of hospital variation in NTSV patients can be attributed to first birth labor induction rates and first birth early labor admission rates. As a consumer/patient organization, we consider a robust measure that illuminates practice variation among providers and facilities to be very valuable for comparing hospitals and for holding providers accountable. The addition of Unexpected Newborn Complications (NQF #716) to The Joint Commission’s Perinatal Core Measure Set beginning January 1, 2019, will serve as a balancing measure to the current delivery measures. Whereas there is little further room for improvement in Early Elective Delivery rates, reducing unwarranted practice variation and curbing overuse of medically unnecessary cesarean births--both primary and repeat—as well as ensuring that patients have access to risk-appropriate care remain top public health priorities. MAP’s question about whether or not measuring CB rates directly relates to improved maternal health outcomes seems to originate from a discussion that “some states” have seen “unintended consequences that may arise such as increased maternal mortality with decreased CB rates.” Research shows that the NTSV cesarean rate can be quickly lowered with no adverse maternal or infant outcomes. In fact, they fared better in a 2015 California Maternal Quality Care Collaborative three-hospital pilot program. While implementing a quality improvement program to lower NTSV cesarean rates, data were collected for NTSV cesarean births and balancing measures, including the NQF Unexpected Newborn Complications measure (now TJC’s PC-06) and 3rd/4th degree maternal lacerations occurring in vaginal births. The hospitals in the pilot program averaged a 18.6% reduction in their NTSV. Newborn complications fell (significantly) by 24.5% and 3rd/4th degree lacerations dropped by 4.7%. With regards to MAP’s suggestion that the NQF Scientific Methods Panel and Perinatal Standing Committee pay special attention to risk adjustment, exclusions, and unintended consequences (full-disclosure: I am a new member of the Perinatal and Women’s Health Standing Committee), the cesarean birth measure in question was just re-endorsed as one of NQF’s Perinatal and Women’s Health measures in 2016 with 96% of the committee supporting the measure, and The Joint Commission is now the steward of the measure. This measure and its exclusions have already undergone recent rigorous review by the appropriate NQF committees. We apologize for late involvement with this, as we learned that CB was up for discussion by MAP just prior to the final meeting on December 11, 2018. In mid-2018, the same measure was being discussed by the MAP Rural Health Workgroup measure, with the committee recommending that it not be included due to concerns about low-volume in critical access and rural hospitals. We ran some numbers and found that the majority of rural hospitals with maternity services meet TJC’s reporting threshold of 300 births and asked that the committee please ensure that their decision was data-driven. PC-02 was changed to a “yes” for recommendation as a rural-relevant measure with a caveat that low volume should be taken into consideration. The cesarean section is the most commonly performed surgery in the United States, and pregnancy accounts for almost 25 percent of all hospitalizations. Overuse of cesarean births is a significant contributor to both short-term and long-term maternal morbidity as well as maternal mortality and we as consumer/patient advocates strongly recommend the implementation of MUC18-52 Cesarean Birth (CB) in IQR and the CMS EHR Incentive Program. Sincerely, Jill Arnold Executive Director, Maternal Safety Foundation (Submitted by: Maternal Safety Foundation)
  
  
• Dear Mr. Kahn and Dr. Hall: The Association of American Medical Colleges (AAMC or Association) welcomes this opportunity to comment on the National Quality Forum (NQF) Measure Applications Partnership (MAP)’s 2019 Considerations for Implementing Measures in Federal Programs draft report. The AAMC is a not-for-profit association dedicated to transforming health care through innovative medical education, cutting-edge patient care, and groundbreaking medical research. Its members are all 152 accredited U.S. and 17 accredited Canadian medical schools; nearly 400 major teaching hospitals and health systems, including 51 Department of Veterans Affairs medical centers; and more than 80 academic societies. Through these institutions and organizations, the AAMC serves the leaders of America’s medical schools and teaching hospitals and their more than 173,000 full-time faculty members, 89,000 medical students, 129,000 resident physicians, and more than 60,000 graduate students and postdoctoral researchers in the biomedical sciences. The AAMC appreciates the MAP Workgroups’ thoughtful review and discussion of the measures under consideration (MUC). The following are the AAMC’s high-level comments on the MAP recommendations for both hospitals and clinicians: • Regarding the clinician measures under consideration, the AAMC strongly believes that providers should not be held accountable for activities outside their control. The 11 episode level cost measures must be appropriately risk adjusted, including for social risk factors, and the attribution methodology for episodes should clearly and accurately determine the relationship between patient and clinician before such episode-level cost measures are incorporated into the Quality Payment Program. The 2 re-evaluated total cost measures (Medicare Spending per Beneficiary (MSPB) and Total Per Capita Cost) must similarly be appropriately adjusted for both clinical and social risk factors before the measures are incorporated into the Quality Payment Program. • For the hospital measures, the AAMC continues to strongly believe that certain accountability measures must be adjusted for sociodemographic status (SDS) before being included in the Medicare quality reporting programs, be NQF-endorsed prior to MAP review, and be included in the Inpatient Quality Reporting (IQR) program for at least one year before being considered in a performance program by the Workgroup. Additionally, the AAMC recommends that the report appropriately distinguish the Medicare and Medicaid Promoting Interoperability Program for Eligible Hospitals and Critical Access Hospitals (Promoting Interoperability Program) as separate from the IQR. While electronic clinical quality measures are shared between the two programs, the programs have unique histories and different penalties on hospitals for failure to meet a given program’s distinct requirements and the report should appropriately reflect that. MAP Hospital Workgroup Comments Distinguish Differences Between Programs in the Draft Report The draft report for hospitals currently describes the IQR and Promoting Interoperability Programs as a single or joint program, which may mislead readers less familiar with these programs. The AAMC recommends that the two programs be described separately to better document their separate and unique histories and requirements for hospitals. An alternative would be to retain the joint write up acknowledging the programs’ similar goals and shared measures, and separately detail the incentive structures for each program. The AAMC believes it is important that the report note that the Promoting Interoperability Program has a separate 75 percent reduction of the annual payment update for hospitals that do not participate in or fail to meet the program’s requirements. As currently drafted, the report only describes the structure of the incentives for the IQR Program. Individual Measure Review Cesarean Birth (CB) The Hospital MAP did not support, with potential for mitigation, the Cesarean Birth (MUC18-52) electronic clinical quality measure (eCQM) for rulemaking. While the AAMC agrees with the importance of eliminating early deliveries and improving maternal health outcomes, we do not support this measure as currently specified and agree with MAP’s recommendation. The draft report accurately summarizes the MAP’s discussion, including concerns about the failure to exclude high-risk conditions such as pre-eclampsia/eclampsia from the measurement population and potential unintended consequences of increased maternal mortality in states that use the chart-abstracted version of the measure. The MAP also discussed concerns with the data collection process for this measure, cautioning that inclusion of a measure before the data collection process is ready may have the unintended consequence of stalling the improvement of data quality. (Submitted by: Association of American Medical Colleges)
  
  
• Support current MAP recommendation (Submitted by: Federation of American Hospitals)
  
  
• AdventHealth believes this measure has the ability to accurately track and improve the quality of care provided to first time mothers who are not giving birth to twins or are not in breech position. Additionally, quality data on cesarean births is already being collected by many private payors. Since the data for this measure is already being collected, we do not believe there will be a significant burden to report this measure to CMS. We believe that incorporating this measure into federal programs will help providers decrease the number of preventable cesarean sections nationwide and advance quality. (Submitted by: AdventHealth)
  
  
• Surgical birth has lifelong effect on a woman's health. This lifesaving technique is being grossly overused. (Submitted by: ICAN)
  
  
• It is important to add cesarean rate tracking to this measure because as a country our rates are astronomical. My experience is that what gets measured, gets monitored, and what is monitored is held accountable. Measuring csection rates will help patient outcomes by forcing hospitals and L&D practitioners to truly learn about all the nuances of natural birth and provide true informed consent and guidance to patients navigating the birthing experience. It would be important to gather data in a way that separates the type of csection (planned vs emergency); timing of decision making. I do not think "elective" is a proper term when I as a patient did not "elect" but was forced into my 2nd csection. I also think MAP's argument that measuring CB would distract hospitals from early deliveries and maternal mortality. I'm not sure how that is the case, but if it were true than, gathering data on maternal mortality ALONG with CB data is imperative. Lastly, CB impacts certain populations more than others and that in itself is a major reason to capture this information. Thank you for your time and consideration. (Submitted by: Patient, Individual, Mother)
  
  
• Tracking cesarean birth rates absolutely will improve outcomes. We've seen it happen in states like Indiana. We've seen hospitals that reduced cesarean rates just by publishing the physician rates. The competition alone made the rates decrease. We have a maternity care crisis in this country, and we aren't able to change it on our own. We need your help to hold hospitals accountable. Someone has to get the rates down if we are going to save women and babies. The vast majority of hospitals are not working to lower rates. Please help us! (Submitted by: International Cesarean Awareness Network)
  
  
• The AHA agrees with the MAP’s recommendation of Do Not Support- Potential for Mitigation. America’s hospitals must focus our attention on maternal health, but this measure would not capture important information that would help improve maternal outcomes, and might even distract from more important issues regarding early elective delivery and maternal mortality. Cesarean birth (CB) is a common procedure that can save the lives of mothers and babies. Given the potential risks of the procedure, the AHA certainly agrees that CBs should not be performed more than is medically necessary. Yet, as analysis by NQF’s scientific methods panel found, there is not a strong or convincing case that the measure addresses a real quality problem. The measure’s rationale cites the “skyrocketing” rates of CB, but presents no evidence that rates are rising solely because of hospital practice rather than changes in the underlying patient population factors (e.g., advancing maternal age) that might increase the need for CBs. Furthermore, the measure lacks risk adjustment, which could lead to inappropriate performance comparisons between referral centers for high risk deliveries and other hospitals. Finally, the measure fails to exclude patients with eclampsia or pre-eclampsia, for whom CB may be indicated. As specified, the measure likely is detecting differences in patient populations rather than differences in quality performance. In other words, the measure does not capture inappropriate or unnecessary procedures, and the use of the measure would go against optimal treatment for patients for whom CB is a protective option. Further, we question the feasibility of implementing MUC18-52 as an e-measure. The data elements necessary to calculate the measure are not available in a structured format within current EHRs, and it is unclear whether they would capture data as accurately as through chart-abstraction. We understand that hospitals can currently choose which eCQMs to report under the Promoting Interoperability (PI) Program; however, CMS could easily change this policy in the future, which would put providers in the difficult position of sacrificing accuracy for compliance. Because of these logistical and conceptual issues as well as the overall importance of measures regarding maternal health, the AHA recommends that the MAP and CMS seek other ways to surveil quality of care on this issue. (Submitted by: American Hospital Association)
  
  
• Comments and Data to Support Measure MUC2018-052, Cesarean birth, nulliparous women with a term singleton baby in vertex position. < >Elliott Main, MD Professor of Obstetrics and Gynecology, Stanford University School of Medicine Shen-Chih Chang, PhD California Maternal Quality Care Collaborative Stanford University We have only recently become aware of the MAP Hospital Workgroup process that included discussion of this measure MUC18-52, also known as PC-02 for the Joint Commission. This measure has been widely used by many organizations (Leapfrog Group, Joint Commission, CHIPRA and was the only Cesarean measure endorsed by American College of Obstetricians and Gynecologists) and has been part of the national Health Person 2010 and 2020 projects. Over the last 6 years, California has had extensive positive experience using this measure for both public reporting and quality improvement activities. We wish to share the highlights of our findings and the successes in reducing overall state rates and reducing the extraordinary hospital variation seen for this measure (2015: hospitals ranged from 11 to 77%!). Our findings strongly support the view that the vast majority of this variation is due to provider and unit practice styles and not to the hospital’s patient population characteristics. There is extraordinary variation in risk-adjusted cesarean rates California and national data show variation from 11-77% for PC-02 Are the important patient characteristics accounted for by this measure? We have explored the relative contributions of multiple patient characteristics as potential contributors for this variation using the concept of population attributable fraction. This can address questions like: “What proportion of the rate of Lung Cancer is due to smoking?” For us: “What proportion of the cesarean delivery rate is due to a given risk factor?” The Population Attributable Fraction analysis for primary cesarean section is shown below: Medical Risk Factor Population Attributable Fraction These code sets are included in the NTSV Cesarean measure Nulliparity 59.5% Non-Vertex Presentation 12.5% Preterm Birth 10.6% Multiple Gestation 7.4% Placenta Previa 2.5% These code sets have been suggested* as possible additional drivers of variation, but none have significant frequency even at tertiary centers to have an impact HIV 0.05% Eclampsia 0.15% Fetal CNS abnl (hydrocephalus) 0.16% Maternal Cardiovascular Disease 0.79% Population Frequency and Relative Risk were drawn from California data 2016-2017 (ICD-10) California Maternal Quality Care Collaborative, 2018 *these code sets were suggested as potential modifiers by a committee of the Society for Maternal Fetal Medicine based on expert opinion but not based on any data analysis Conclusion: This table shows that over 95% of the attributable fraction for cesarean birth is accounted for by the current PC-02 measure specifications and that additional diagnosis codes do not add meaningful value. How do these specifications impact data collection? Limiting the measure to nulliparous term singleton women with a baby in head first position without a placenta previa allows for both standard data collection and an e-measure. The Joint Commission PC-02 specifications use ICD-10 codes for all but nulliparity which is now a structured mandatory data field in most electronic health records. Since PC-02 is now mandatory for all maternity hospitals reporting to the Joint Commission, electronic health record vendors have made great strides in the last 2 years to automate these processes. Conclusion: PC-02 is now a straightforward measure for e-measure collection. Are high risk centers disadvantaged by their patient populations? We looked specifically whether hospitals who cared for the highest risk patients are disadvantaged by this measure. The 2017 NTSV Cesarean Rate results for all 10 California university medical centers and 8 county hospitals that care for the most challenging patients. University Medical Centers (10) County Hospitals (8) 18.0% 16.0% 19.5% 18.3% 20.0% 19.6% 20.1% 20.7% 21.1% 20.8% 21.5% 21.3% 22.6% 23.4% 24.5% 26.5% 25.9% 29.8% All but 4 were under the national target of 23.9% and none were over 30%. Conclusion: This table indicates that high risk centers can do very well on this measure, particularly if they make an effort. What else can account for such variation? We are able to calculate provider-level rates in California and in the next figure we present examples from 4 large hospitals with multiple providers who do not have midwifery or hospitalist providers (which can complicate the calculation of provider-level rates). The variation within the same hospital for providers is dramatic. It ranges from 4 to as high as 10-fold within the same facility! In each of these hospitals, if the four providers with very highest rates were no longer in practice, the hospital rates would have been significantly lower. Conclusion: Provider variation in practice styles is the main driver for hospital variation. If the variation is due to practice variation and unit culture can it be affected by quality improvement projects? Provider and unit culture and practice styles suggest potential for quality improvement projects. If rates are due to patient characteristics, then high rates should not be able to be reduced significantly by QI projects. In the next two figures, we illustrate both the rapid success in lowering cesarean rates among a large number of hospitals in a quality improvement collaborative and the maternal and infant safety of doing so. Quality Collaborative Success 91 hospitals all with starting NTSV Cesarean rates above 24% were recruited to participate in the California Supporting Vaginal Birth/Reducing Primary Cesarean Collaborative. They joined as 3 separate cohorts and each cohort has shown significant reductions. Data are shown below for the first 3 quarters of 2018 compared to 2015. Fully 70% of hospitals have either dropped below target or lowered their cesarean rate by >5% points. Cohort 1: Started May 2016 Ended Nov 2017 (N=24) (data thru September 2018) Cohort 2: Started Jan 2017 Ended Jun 2018 (N=42) (data thru September 2018) Cohort 3: Started Nov 2017 (N=25) (data thru September 2018) Dropped below target of 23.9% 38% 39% 24% Dropped >5% 33% 44% 36% No significant change (+-1%) 13% 12% 12% Increased >1% 4% 12% 20% Conclusion: The finding that 70% of hospitals show significant and meaningful reductions in their cesarean rate over a short period of time indicates that the cesarean rate is not fixed or based on patient characteristics but driven by unit and provider practice style. Safety of Lowering the Cesarean Rate: The top panel follows the decline of the Cesarean rate among the first two cohorts and the bottom panel demonstrates no change in any of the maternal or fetal safety measures (over 120,000 births total). Hospitals with >10% point drop also showed no ill effects. (Paper in press, Obstetrics and Gynecology) Conclusion: Cesarean rates can be significantly lowered with safety for mother and infant. (Submitted by: Stanford University and California Maternal Quality Care Collaborative)
  
  
• The National Partnership for Women & Families strongly supports inclusion of the Cesarean Birth Measure in both the Hospital IQR program and the Medicare and Medicaid EHR Incentive Program for Eligible Hospitals and Critical Access Hospitals. This would help address the limited measures in these programs relating to quality of care for the large population of childbearing women and newborns. This outcome measure is very important for appropriate care of childbearing women and newborns, together the nation's most common (23%) and costly reasons for hospitalization. Moreover, cesarean birth is the nation's most common operating room procedure. After a steep rise since the mid-1990s, the national cesarean birth rate has plateaued for about a decade at 1 in 3 births. This is widely understood to reflect substantial overuse. * The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) conclude that no discernible maternal and newborn benefits accompanied the steep rise. * High-performing pockets of care show that much lower rates are possible. For example, women beginning labor in the recent National Birth Center Study II had a 6% cesarean rate whereas the rate for comparable women in hospitals is above 20%. This overuse is problematic for many reasons: * In the shorter- and longer-term, both women and cesarean-born babies experience greater likelihood of many adverse outcomes. - For women, these include infection, anesthesia complications, blood clots, surgical adhesions, urgent hysterectomy, maternal death, longer hospital stay, hospital readmission, longer and more painful recovery, not breastfeeding. - For babies, these include newborn respiratory problems, not breastfeeding and increased likelihood of multiple childhood chronic conditions (e.g., type 2 diabetes, allergy, obesity, asthma, Crohn's disease). - In subsequent pregnancies, risk of serious problems increase, especially with repeated uterine scarring: e.g., ectopic cesarean scar pregnancy, placenta accreta, placenta previa, stillbirth, uterine rupture, intensive care, readmission. - While judicious use of this procedure can be beneficial and even life-saving, its overuse is associated with many conditions that contribute to the nation's rising rates of severe maternal morbidity and maternal mortality. * For both commercial and Medicaid payers, total payments made on behalf of the woman and baby across the entire prenatal through postpartum and newborn episode are about 50% higher when the birth is cesarean versus vaginal. * At this time, contrary to best evidence and clinical guidance, nearly nine in ten women with a past cesarean have a repeat cesarean, multiplying the harm and expense. Professional societies, advocates, state policymakers, QI leaders and others are calling for safely bringing down the cesarean rate via multiple evidence-based approaches: * The multi-professional AIM project (Alliance for Innovation on Maternal Health) has issued care bundles and guidance for Reduction of Low-Risk Primary Cesarean Births/Support for Intended Vaginal Births. * ACOG and SMFM issued guidance about safely reducing the first cesarean in 2014, and subsequently reaffirmed the guidance. * The American College of Nurse-Midwives is operating a collaborative in participating hospitals to reduce the cesarean rate. * Ariadne Labs has developed and is piloting a program to help hospitals bring down the cesarean rate. * The California Maternal Quality Care Collaborative makes available an excellent cesarean reduction toolkit. * Effective practices for cesarean reduction that could be widely adopted include: - Making wise choice of care providers and birth settings (which public reporting would facilitate) - Arranging for the labor support of a doula - Delaying hospital admission until labor is well established - Observing temporal guidelines (and exercising patience) in labor - Using handheld devices (Doppler or fetal stethoscope) to monitor fetus in labor versus continuous electronic fetal monitoring - Non-epidural pain relief measures (to impact cesareans due to concerns about fetal heart rate patterns) - Being up and around versus in bed during labor - Support for vaginal birth after cesarean - Support for vaginal twin and breech births - Payment reform, e.g., a pilot sponsored by the Pacific Business Group on Health led to rapid reduction in cesarean rates in the three participating hospitals The Cesarean Birth measure is widely respected and used * Because it is limited to first-time mothers with low-risk births, it is considered a fairer comparator than various other cesarean measures. * It is endorsed by the National Quality Forum; an exceptionally high 96% of members of the Perinatal and Reproductive Health Standing Committee voted for continued endorsement during the most recent NQF review. * It is include in The Joint Commission's Perinatal Care Core Set (PC-02), and hospitals with 300 or more births annually are required to collect it (but The Joint Commission does not publicly report hospital-level Cesarean Birth rates). * The Joint Commission has developed an e-measure version to enable multiple Cesarean Birth collection options. * It is included in the Medicaid Child Core Set (voluntary state-level reporting and use for QI). * It is a voluntary measure reported by The Leapfrog Group. * Multiple state-level perinatal quality collaboratives use this measure for QI. * Over 100 hospitals in California participate in a collaborative that has reduced the rate of Cesarean Birth. * Healthy People 2020 included this indicator and set a national goal of 23.9%; it is proposed for inclusion in Healthy People 2030. * An NQF-endorsed balancing measure is available to address/avert any overzealous cesarean reduction that might hurt newborns: Unexpected Newborn Complications. The Cesarean Birth measure is not currently publicly reported for all facilities. * Apart from the voluntary state-level reporting of Medicaid Child and Adult core sets, the federal measurement programs largely address common Medicare conditions. * The Leapfrog Group reports Cesarean Birth Rates for participating hospitals, but many hospitals do not participate in this voluntary program. * Greater uptake of maternal-newborn measures is needed to address the nation's maternal health crisis and persistent maternal-newborn care and outcome disparities. * Inclusion of Cesarean Birth in the Hospital IQR program would be of great value to consumers, purchasers, health plans and policymakers by making facility-level rates publicly available to anyone with Internet access. Adding this measure to the Hospital EHR Incentive program would further increase opportunities to engage in this quality measure. (Submitted by: National Partnership for Women & Families)
  
  
• SHEA previously submitted this comment on December 5, 2018. This measure should not be included in the HAI meaningful measure area of the "Make Care Safer by Reducing Harm Caused in the Delivery of Care" quality priority domain. According to the description, the subject matter and goal of the measure is not related to healthcare-associated infections. The measure developer should provide further clarification on the intent of this measure as it relates to healthcare-associated infection rates as a measure of healthcare quality. In the absence of clarification or further explanation from the developer, SHEA recommends this measure be removed from the HAI meaningful measure area and not be adopted as proposed. (Submitted by: The Society for Healthcare Epidemiology of America)
  
  

• (Early public comment)AVAC believes the MUC18- 57 Annual Wellness Assessment: Preventive Care satisfy many of the objectives of the Meaningful Measures Framework, including addressing high impact measure areas that safeguard public health, patient centered and meaningful to patients, minimize the level of burden for health care providers, significant opportunity for improvement, fulfill each program’s statutory requirements and align across programs and with other payers. The two measures also strongly align with the Meaningful Measure areas and overarching quality priorities outlined in the MUC announcement. MUC18-57 also address the cross-cutting measure criteria: eliminating disparities; tracking measurable outcomes and impact; safeguarding public health; achieving cost savings; improving access for rural communities and reducing burden. (Submitted by: Adult Vaccine Access Coalition)
  
  
• (Early public comment)BIO supports the inclusion of influenza and pneumococcal immunization as components of the Annual Wellness Assessment measure. Measures that monitor immunization status as well as reporting of immunizations offered and administered for beneficiaries represent critical preventative service benchmarks on the value of immunizations under new payment models and such measures help to identify where gaps in access remain. We applaud the measure for aligning with the Standards for Adult Immunization Practice [https://www.cdc.gov/vaccines/hcp/adults/for-practice/standards/index.html] and urging the assessment, recommendation, administration or referral, and documentation of immunization status of these serious diseases at each clinical encounter. Adult immunization rates lag behind childhood rates in the U.S. According to the 2016 National Health Interview Survey, 70.4% of adults age 65 years and older were vaccinated against influenza and 66.9% of adults age 65 years and older were vaccinated against pneumococcal disease. Additionally, stark racial and ethnic disparities for adult immunizations exist. [https://www.cdc.gov/vaccines/imz-managers/coverage/adultvaxview/pubs-resources/NHIS-2016.html] Adoption of MUC18-057 in the MIPS program will help to improve the consistency and reporting for adult immunization status for all Medicare beneficiaries. Increasing adult immunization rates will improve health outcomes and decrease healthcare usage from vaccine-preventable diseases. Annually, the U.S. spends nearly $26.5 billion treating influenza, pneumococcal, zoster, and pertussis among adults age 50 years and over. [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4486398/] Not preventing these vaccine-preventable diseases has a significant cost to the U.S. healthcare system; the Adult Immunization Status measure will help drive increases in adult immunization rates, leading to the dual benefits of improving patient health and lowering federal healthcare expenditures. To maximize the impact of the measure, MUC18-057 should include all ACIP-routinely recommended adult vaccines, including zoster and Td/Tdap. Influenza and pneumococcal represent a great burden among older adults, but inclusion of all recommended vaccines will encourage providers to offer and report all vaccines consistently, increasing the positive health impact for patients. (Submitted by: Biotechnology Innovation Organization (BIO))
  
  
• (Early public comment)In general the AAFP opposes the use of all-or-none composite measures in MIPS. All-or-none composite measures do not award partial credit. Thus, a physician/group that does well on 6/7 measures but poorly in one measure will be scored similarly to a physician that does poorly in all measures. At minimum the numerators of each measure could be summed, the denominators of each measure summed, and a composite score calculated by dividing numerator by denominator. Composite measures may be useful for internal quality improvement but not for accountability as in QPP. --While an exclusion exists for patient refusal for influenza and pneumococcal vaccination, there is no exclusion for the remaining measures in the AWV composite. Yet it is known that patients frequently refuse such procedures as mammograms and colorectal screenings, or simply do not follow-through with orders of their primary care physician. --The measure must represent indisputable basics of care, yet there is widespread disagreement among medical specialties in the mammography measure. --Errors in measurement are amplified by composite measures. Since 5/7 actions included in the AWV composite measure are frequently or exclusively performed outside the primary care office (e.g., mammograms, influenza vaccination, pneumococcal vaccination, colorectal cancer screenings, DXA scans) there is a high likelihood that lack of data sharing and interoperability, and lack of access to claims data from payers will lead to poor data accuracy for these measures, resulting in lower scores. --The scores from these measures are likely to reflect the extent of EHR documentation rather than performance of the action. (Submitted by: American Academy of Family Physicians)
  
  
• (Early public comment)While the AMA supports the individual components included in this composite, we are concerned that the complexity of the measure with seven numerators, denominators and exclusions/exceptions will directly impact the feasibility, reliability and validity of the measure. Several of the components require longitudinal data, which are likely not to be readily available in electronic health records (EHRs) and are often captured in physician notes or other unstructured fields. It is critical that the measure be tested across multiple EHR vendor systems to understand how well each captures the required data elements and the degree to which the data produced is valid. We also note that there are overlapping and inconsistent immunizations included in this measure as well as MUC18-62 Adult Immunization Status. For example, each measure examines the rate of influenza immunizations but uses a different timeframe (MUC18-57 is August 1 to March 31 and MUC18-62 requires it be given between July 1 and June 30) and MUC18-57 only requires only one of the two pneumococcal vaccines while MUC18-62 requires that both have been given at least 12 months apart with the first occurrence after the age of 60 years. Both measures as well as any current measures that capture the same immunizations must be harmonized before they are finalized for implementation in MIPS or MSSP. Therefore, the AMA recommends that the highest level of MAP recommendation be “Do Not Support With Potential For Mitigation”. (Submitted by: American Medical Association)
  
  
• (Early public comment)December 6, 2018 National Quality Forum 1030 15th Street, NW, Suite 800 Washington, DC 20005 RE: List of Measures under Consideration Dear Members of the Measure Applications Partnership, On behalf of the National Association of County and City Health Officials (NACCHO), I write to provide comments on the Centers for Medicare and Medicaid Services’ (CMS) List of Measures under Consideration (MUC) for December 1, 2018. NACCHO commends CMS for its consideration of adult immunization in two of the thirty-nine measures for use in Medicare programs: • MUC18- 57 Annual Wellness Assessment: Preventive Care --Percentage of patients 65 years of age and older with an Annual Wellness Visit who received age and sex-appropriate preventive services. This measure is a composite of seven component composite measures that are based on recommendations for preventive care by the US Preventive Services Task Force, Advisory Committee on Immunization Practices, and the American Geriatrics Society. Specifically, the measure is under consideration for use in the Merit-Based Incentive Payment System – Quality (MIPS-Quality). • MUC18- 62 Adult Immunization Status -- Percentage of members 19 years of age and older who are up-to-date on recommended routine vaccines for influenza; tetanus and diphtheria (Td) or tetanus, diphtheria and acellular pertussis (Tdap); zoster; and pneumococcal. This measure is under consideration for use in the Medicare Shared Savings Program and the Merit-Based Incentive Payment System – Quality (MIPS-Quality). NACCHO is the voice for nearly 3,000 local health departments across the country. These city, county, metropolitan, district, and tribal departments work daily to ensure that communities have access to vital public health programs and services such as adult immunizations. Notably, adult immunizations are the clinical service most often provided by local health departments (90%) , and it is estimated that 63% of the nation’s local health departments conduct targeted immunization and outreach efforts for adults . Given that local health departments are significant providers of adult immunization services and counseling, NACCHO appreciates the opportunity to provide the local health department perspective regarding measures that will improve the access and utilization of adult immunizations. Immunization has been one of the most successful and safest public health measures available to populations worldwide, with an unparalleled record of disease reduction and prevention. Despite the establishment and implementation of immunization recommendations by the Advisory Committee on Immunization Practices, Centers for Disease Control and Prevention, and many other professional organizations, adult immunization coverage rates are less than optimal for routinely recommended vaccines, and many rates remain below the Healthy People 2020 targets. Recognizing the need for improved quality measures that will facilitate the identification, implementation, and monitoring of adult vaccine improvement opportunities, NACCHO strongly supports CMS’ proposed measures as a means to increase adult immunization coverage rates. The inclusion of MUC 18- 57 Annual Wellness Assessment: Preventive Care and MUC 18- 62 Adult Immunization Status would address many of the Meaningful Measures Framework objectives and fulfill the cross-cutting measure criteria. Though MUC 18- 62 is under consideration for use in the Medicare Shared Savings Program and the Merit-Based Incentive Payment System – Quality (MIPS-Quality), NACCHO encourages CMS to also evaluate including the revised measure under several other quality and payment programs on the MUC list. The proposal would make MUC 18- 62 applicable to home health, inpatient rehabilitation, long-term care hospital, skilled nursing facility, ambulatory surgical center, hospital inpatient and outpatient, inpatient psychiatric facility, and PPS-exempt cancer hospital reporting programs. However, broader inclusion of MUC 18- 62 in other quality reporting and payment programs would further facilitate consistent monitoring and reporting of adult immunization status for Medicare beneficiaries. Widespread use of this new composite measure is particularly timely and important in settings where patients are especially susceptible and vulnerable to the negative health outcomes of a vaccine-preventable disease such as the flu or pneumonia. Inclusion of the composite measure under these additional programs would also update, streamline, and align the varied adult immunization measures presently being used to monitor influenza, pneumococcal, and zoster vaccination. Additionally, implementation of MUC 18- 62 across quality programs would substantially contribute to increasing adult immunization coverage rates. Local health departments across the nation play a vital role in providing immunizations, investigating cases of vaccine-preventable disease, and maintaining high immunization coverage rates. Local health departments are uniquely positioned to improve the capacity of the healthcare system for delivering immunizations and strengthening the coordination between public, professional, and private sector stakeholders. Given this, NACCHO champions efforts that can be instrumental in helping to achieve optimal immunization rates, and we look forward to further action to refine and implement the proposed measures under consideration. Should you have any questions, please contact Michelle Cantu, NACCHO’s Director for Infectious Disease and Immunization, at mcantu@naccho.org. Sincerely, Lori Tremmel Freeman, MBA Chief Executive Officer (Submitted by: National Association of County and City Health Officials)
  
  
• We agree with MAPs recommendations for NQF endorsement and harmonization of this measure with the existing subcomponent measures already in the program. For each sub-measure numerator we propose that measure timing and value sets should align with applicable measures (i.e. .Fall Risk, Depression Screening, Influenza Immunization, Pneumococcal Vaccination, Mammograms, Colorectal Screening, DXA Scan). In addition we would be interested in understanding how the sub-measures will be weighted and how the overall performance score for this measure will be calculated. (Submitted by: Cerner Corporation)
  
  
• AVAC appreciates the addition of an annual wellness assessment measure under the Preventive Care/MIPS domain. One of our key priorities is improved federal benchmarks and quality measures to encourage better tracking and reporting of adult immunization status that will result in increased adult immunization coverage rates. In 2016, AVAC released a White Paper outlining the value and imperative of quality measures for adult vaccines, highlighting the role of vaccine quality measures in preventing illness and death, reducing caregiving demands, avoiding unnecessary healthcare spending, and setting the foundation for healthy aging. Quality metrics in Medicare payment programs play a critical role in promoting improved quality, more consistent adherence to and utilization of recommended adult vaccines and, ultimately, better outcomes for patients. We are pleased that the annual wellness assessment includes influenza and pneumococcal vaccination screening as two of the 6 items in the numerator of the measure. We would urge the MAP to also consider including an assessment of zoster vaccination status in the annual wellness assessment measure since it is also an ACIP-recommended vaccine for patients ages 50 and older. (Submitted by: Adult Vaccine Access Coalition (AVAC) )
  
  
• • PhRMA supports the addition of guideline-recommended immunization measures, and therefore we support the inclusion of individual immunization measures are part of the overall Annual Wellness Assessment measure. Immunizations have long been a part of the CMS strategic goals, National Quality Strategy, and the Department of Health and Human Services (HHS) 2018-2022 Strategic Plan, which include components that address prevention of communicable and chronic diseases. Therefore it is appropriate to include them as a component of the measure. • We concur with the MAP’s conditional support pending NQF endorsement and the recommendation to ensure subcomponents of the measure are harmonized with existing measures in the program. (Submitted by: PhRMA)
  
  
• On December 12, 2018 the National Quality Forum (NQF) Measure Applications Partnership (MAP) Clinician Workgroup reviewed the Annual Wellness Assessment: Preventive Care measure (MUC18-057) electronic clinical quality measure (eCQM), under consideration for use in the Merit-based Incentive Payment System. On December 21, the MAP Coordinating Committee circulated the preliminary MAP Workgroup MUC recommendations and the draft Workgroup report. Please see our comments below related to the following language found on pages 6 and 7 of the “2018-2019 Clinician Draft Report for Commenting “document: “MAP also conditionally supported MUC18-057 Annual Wellness Assessment: Preventive Care with the condition of NQF endorsement and harmonization of subcomponents within the MIPS program. MAP was in favor of incorporating a composite measure of preventive care into the program. However, MAP members expressed concerns with the lack of complete specifications for the measure. MAP members found it difficult to determine how the composite measure was calculated for patients who only receive some of the recommended care. Additionally, MAP recommended that the exclusions be revisited to include cognitive impairment and limited life expectancy.” Comment 1: Regarding the sentence “MAP also conditionally supported MUC18-057 Annual Wellness Assessment: Preventive Care with the condition of NQF endorsement and harmonization of subcomponents within the MIPS program”, our notes state that the MAP committee voted 14 to 2 on “acceptance of the preliminary analysis decision [conditional support, with the condition of NQF endorsement]”. We did not have anything written down about on condition of harmonization of subcomponents within the MIPS program. During the discussion, the committee did comment on the need for harmonization and the measure developer addressed that concern stating the measures are harmonized already to the extent possible. Comment 2: Regarding the sentence “However, MAP members expressed concerns with the lack of complete specifications for the measure”, the MUC submission requirements do not ask for the measure developer to submit detailed composite methodology or measure calculation information and no additional detail on the specification was requested prior to the MAP meeting. Full detailed specifications exist. We suggest a small edit to help bridge that gap in communication: “However, MAP members expressed concerns with the lack of complete specifications for the measure within the materials provided to them.” Also, CMS can address this concern moving forward with E&O efforts centered on implementation of the first eCQM composite in the MIPS program. Comment 3: Regarding the sentence “Additionally, MAP recommended that the exclusions be revisited to include cognitive impairment and limited life expectancy”, this statement does not completely align with our notes. Additionally, revisiting exclusions on the component measures works against their recommendation to harmonize with the parent measures in the MIPS program. (Submitted by: Mathematica Policy Research )
  
  
• Amgen agrees with MAP’s recommendation of “conditional support” of the Annual Wellness Assessment: Preventive Care (MUC18-57) for inclusion in the Merit-based Incentive Payment System (MIPS). Specifically, Amgen supports the inclusion of the osteoporosis screening via central DXA (dual-energy X-ray absorptiometry) component of the composite measure. This component measures the number of female patients who have ever received a central (that is, hip or spine) DXA scan. Osteoporosis is a prevalent disease in the United States. Of the estimated 10 million Americans with osteoporosis, about eight million (80 percent) are women. Approximately one in two women over age 50 will break a bone because of osteoporosis. Suffering from fractures often results in significant morbidity, reductions in quality of life, loss of independence, and mortality. Given the prevalence and significant morbidity and mortality related to this disease, the U.S. Preventive Services Task Force recently updated their osteoporosis screening recommendations, concluding that “screening for osteoporosis with bone measurement testing to prevent osteoporotic fractures in women 65 years and older” is recommended (B recommendation). Amgen supports measures that encourage evaluating a patient’s bone health by identifying osteoporosis and fracture risk. The Medicare Annual Wellness Visit is an appropriate time for bone density testing to be conducted based on individual patient risk factors such as age, health and family history and lifestyle. Screening via DXA is the gold standard for determining risk of fracture due to low bone density. Unlike other diseases, where we are waiting to find an accurate screening test or cure, osteoporosis is a model for disease prevention with accurate, cost-effective diagnostic tools and inexpensive treatments that work at reducing fractures. Some of the anticipated economic and clinical burden of osteoporosis over the next two decades could be avoided with appropriate identification and treatment of high-risk women. Prevention of osteoporotic fractures is possible; diagnostic tools and effective treatments are available to help reduce the burden of disease, but they are underutilized. Although dual-energy X-ray absorptiometry (DXA) is highly effective at identifying at-risk individuals and recommended for all women age 65 years and older, its utilization is extremely low. Improving the quality of care for osteoporosis patients pre- and post-fracture must be a priority for the Medicare program due to known gaps in care, and the enormous impact on patient outcomes and costs to the program. The National Quality Forum (NQF) has highlighted osteoporosis in the past as a high-impact Medicare condition that has important quality measurement gaps, including screening, diagnosis, and therapy. Fractures caused by osteoporosis place an enormous medical burden on Medicare patients (most of whom are women) and have a significant economic impact on the Medicare system, as reported by the Surgeon General in 2012. Osteoporosis is an important chronic condition within the Medicare population. Medicare has committed to screening bone mass in appropriate patients at risk for osteoporosis. This composite measure honors that commitment and should be included in MIPS. (Submitted by: Amgen)
  
  
• We are not in favor of this being a composite measure as defined in CMS’ document because we are concerned that it will encourage overuse of preventive services, including colonoscopies and mammograms in 90 year olds. If not taken as a composite measure, we would suggest the addition of two screens: (1) Assessment of cognitive health. For example, the assessment could be that the patient is doing well cognitively with no red flags without a formal screening test, and on the other spectrum, a patient with dementia does not need a screening test but could be assessed overall on his/her dementia, safety and care. (2) Mobility screen beyond a fall risk assessment. Since a beneficiary may not screen for fall risk but a change in mobility can affect this as well as other health measures. (Submitted by: American Geriatrics Society)
  
  
• While written comments were not provided, the commenter indicated their support for MAP's preliminary recommendation (Submitted by: American Psychiatric Association Foundation)
  
  
• The American Medical Association supports the preliminary recommendation and associated conditions. (Submitted by: American Medical Association)
  
  
• Composite measures are difficult to calculate and utilize results to guide improvement. Performance on a composite measure of 7 individual measures does not differentiate between compliance with 1 of 7 and 6 of 7 components. Performance also does not indicate which component measures have the opportunity for improvement. It is difficult to trend performance of the individual component measures and would be much easier to report, understand, and track data on the measures if they continue to be used as individual measures instead of a composite measure. (Submitted by: Sanford Health)
  
  
• Request would be to align the measure definitions explicitly with existing measures already reported for the MIPS program (i.e.: CMS measures). For example: depression screens included in this measure will match the depression screens included in the depression measure (or guidance will be exactly the same so organizations can apply the same interpretations). This is the only way this composite measure could be considered as be linked with action-ability. Request would be to ensure this is evidence based, to support use of tools like PHQ-9 as a valid follow up to positive PHQ-2.   (Submitted by: OCHIN, Inc.)
  
  

• (Early public comment): In general, the AAFP opposes the use of all-or-none composite measures in QPP. All-or-none composite measures do not award partial credit. Thus, a physician/group that does very well in 6/7 measures but poorly in one measure will be scored similarly to a physician/group that does poorly in all measures. At minimum the numerators of each measure could be summed, the denominators of each measure summed, and a composite score calculated by dividing numerator by denominator. Composite measures may be useful for internal quality improvement but not for accountability as in MIPS. The numerators, denominators, and exclusions for the influenza and pneumococcal vaccine measures within this composite are not consistent with those in the AWV composite. NQF must make certain measures are aligned to the extent possible prior to endorsing any measure, and CMS must also make alignment a top priority for QPP. Errors in measurement are amplified by composite measures. Since 5/7 actions included in the AWV composite measure are frequently or exclusively performed outside the primary care office (e.g., mammograms, influenza vaccination, pneumococcal vaccination, colorectal cancer screenings, DXA scans) there is a high likelihood that lack of data sharing and interoperability and lack of access to claims data from payers will lead to poor data accuracy for these measures, resulting in lower scores. The scores from these measures are likely to reflect the extent of EHR documentation rather than performance of the action. Insurance coverage and expense of the vaccines may impact patient willingness to be vaccinated. (Submitted by: American Academy of Family Physicians)
  
  
• (Early public comment)BIO supports the development, endorsement, and CMS adoption of this composite adult immunization measure, which includes influenza; zoster; pneumococcal; and tetanus and diphtheria (Td) or tetanus, diphtheria, and acellular pertussis (Tdap) vaccination in both the CMS MIPS and MSSP programs. We applaud the measure for aligning with the Standards for Adult Immunization Practice [https://www.cdc.gov/vaccines/hcp/adults/for-practice/standards/index.html] and urging the assessment, recommendation, administration or referral, and documentation of immunization status of these serious diseases at each clinical encounter. Adult immunization rates lag behind childhood rates in the U.S. According to the 2016 National Health Interview Survey, 70.4% of adults age 65 years and older were vaccinated against influenza; 66.9% of adults age 65 years and older were vaccinated against pneumococcal; 33.4% of adults age 60 years and older were vaccinated against zoster; and 26.6% of adults age 19 years and older received a Tdap vaccine. Additionally, stark racial and ethnic disparities for adult immunizations exist. [https://www.cdc.gov/vaccines/imz-managers/coverage/adultvaxview/pubs-resources/NHIS-2016.html] Adoption of MUC18-062 in both the MIPS and MSSP programs will help to improve the consistency and reporting for adult immunization status for all Medicare beneficiaries. Increasing adult immunization rates will improve health outcomes and decrease healthcare usage from vaccine-preventable diseases. Annually, the U.S. spends nearly $26.5 billion treating influenza, pneumococcal, zoster, and pertussis among adults age 50 years and over. [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4486398/] Not preventing these vaccine-preventable diseases has a significant cost the U.S. healthcare system; the Adult Immunization Status measure will help drive increases in adult immunization rates, leading to the dual benefits of improving patient health and lowering federal healthcare expenditures. Additionally, the use of a composite measure such as MUC18-062 Adult Immunization Status can aid in the harmonization of adult immunization measures across Medicare programs. Currently, Medicare programs utilize a variety of disease-specific measures. The use of this composite measure may allow for efficiencies in monitoring and reporting, and the elimination of duplicative or outdated measures. For consistency and to have the greatest impact on patient outcomes, CMS should also consider including the measure in other quality and payment programs. (Submitted by: Biotechnology Innovation Organization (BIO))
  
  
• (Early public comment)December 6, 2018 National Quality Forum 1030 15th Street, NW, Suite 800 Washington, DC 20005 RE: List of Measures under Consideration Dear Members of the Measure Applications Partnership, On behalf of the National Association of County and City Health Officials (NACCHO), I write to provide comments on the Centers for Medicare and Medicaid Services’ (CMS) List of Measures under Consideration (MUC) for December 1, 2018. NACCHO commends CMS for its consideration of adult immunization in two of the thirty-nine measures for use in Medicare programs: • MUC18- 57 Annual Wellness Assessment: Preventive Care --Percentage of patients 65 years of age and older with an Annual Wellness Visit who received age and sex-appropriate preventive services. This measure is a composite of seven component composite measures that are based on recommendations for preventive care by the US Preventive Services Task Force, Advisory Committee on Immunization Practices, and the American Geriatrics Society. Specifically, the measure is under consideration for use in the Merit-Based Incentive Payment System – Quality (MIPS-Quality). • MUC18- 62 Adult Immunization Status -- Percentage of members 19 years of age and older who are up-to-date on recommended routine vaccines for influenza; tetanus and diphtheria (Td) or tetanus, diphtheria and acellular pertussis (Tdap); zoster; and pneumococcal. This measure is under consideration for use in the Medicare Shared Savings Program and the Merit-Based Incentive Payment System – Quality (MIPS-Quality). NACCHO is the voice for nearly 3,000 local health departments across the country. These city, county, metropolitan, district, and tribal departments work daily to ensure that communities have access to vital public health programs and services such as adult immunizations. Notably, adult immunizations are the clinical service most often provided by local health departments (90%) , and it is estimated that 63% of the nation’s local health departments conduct targeted immunization and outreach efforts for adults . Given that local health departments are significant providers of adult immunization services and counseling, NACCHO appreciates the opportunity to provide the local health department perspective regarding measures that will improve the access and utilization of adult immunizations. Immunization has been one of the most successful and safest public health measures available to populations worldwide, with an unparalleled record of disease reduction and prevention. Despite the establishment and implementation of immunization recommendations by the Advisory Committee on Immunization Practices, Centers for Disease Control and Prevention, and many other professional organizations, adult immunization coverage rates are less than optimal for routinely recommended vaccines, and many rates remain below the Healthy People 2020 targets. Recognizing the need for improved quality measures that will facilitate the identification, implementation, and monitoring of adult vaccine improvement opportunities, NACCHO strongly supports CMS’ proposed measures as a means to increase adult immunization coverage rates. The inclusion of MUC 18- 57 Annual Wellness Assessment: Preventive Care and MUC 18- 62 Adult Immunization Status would address many of the Meaningful Measures Framework objectives and fulfill the cross-cutting measure criteria. Though MUC 18- 62 is under consideration for use in the Medicare Shared Savings Program and the Merit-Based Incentive Payment System – Quality (MIPS-Quality), NACCHO encourages CMS to also evaluate including the revised measure under several other quality and payment programs on the MUC list. The proposal would make MUC 18- 62 applicable to home health, inpatient rehabilitation, long-term care hospital, skilled nursing facility, ambulatory surgical center, hospital inpatient and outpatient, inpatient psychiatric facility, and PPS-exempt cancer hospital reporting programs. However, broader inclusion of MUC 18- 62 in other quality reporting and payment programs would further facilitate consistent monitoring and reporting of adult immunization status for Medicare beneficiaries. Widespread use of this new composite measure is particularly timely and important in settings where patients are especially susceptible and vulnerable to the negative health outcomes of a vaccine-preventable disease such as the flu or pneumonia. Inclusion of the composite measure under these additional programs would also update, streamline, and align the varied adult immunization measures presently being used to monitor influenza, pneumococcal, and zoster vaccination. Additionally, implementation of MUC 18- 62 across quality programs would substantially contribute to increasing adult immunization coverage rates. Local health departments across the nation play a vital role in providing immunizations, investigating cases of vaccine-preventable disease, and maintaining high immunization coverage rates. Local health departments are uniquely positioned to improve the capacity of the healthcare system for delivering immunizations and strengthening the coordination between public, professional, and private sector stakeholders. Given this, NACCHO champions efforts that can be instrumental in helping to achieve optimal immunization rates, and we look forward to further action to refine and implement the proposed measures under consideration. Should you have any questions, please contact Michelle Cantu, NACCHO’s Director for Infectious Disease and Immunization, at mcantu@naccho.org. Sincerely, Lori Tremmel Freeman, MBA Chief Executive Officer (Submitted by: National Association of County and City Health Officials)
  
  
• (Early public comment)Sanofi supports the implementation of the Adult Immunization Status into the MIPS program. Immunizations play an important part in public health and prioritizing this measure can assist in improving the immunization rates and make progress on immunization goals stated in Healthy People 2020. (Submitted by: Sanofi)
  
  
• (Early public comment)The current MUC list has MUC18- 62 Adult Immunization Status only under consideration for use in the Medicare Shared Savings Program and the Merit-Based Incentive Payment System – Quality (MIPS-Quality). AVAC strongly supports its inclusion in both programs and urges CMS to consider also including the revised measure under several other quality and payment programs on the MUC, including: Home Health Quality Reporting Program Inpatient Rehabilitation Facility Quality Reporting Program Long-Term Care Hospital Quality Reporting Program Skilled Nursing Facility Quality Reporting Program Skilled Nursing Facility Value-Based Purchasing Program Ambulatory Surgical Center Quality Reporting Hospital Inpatient Quality Reporting Hospital Outpatient Quality Reporting Inpatient Psychiatric Facility Quality Reporting PPS-Exempt Cancer Hospital Quality Reporting (Submitted by: Adult Vaccine Access Coalition )
  
  
• (Early public comment)This measure appears to be developed and tested for use in health plans. Its unclear if the plan level measure can be adapted for use in ACOs given the differences in reporting mechanisms between ACOs and health plans. Additionally, the pneumoccocal vaccination measure was recently removed from MSSP because of measure reporting issues in the ACO program, this measure does not resolve those issues. (Submitted by: Premier, Inc.)
  
  
• (Early public comment)This measure proposal appears to combine three separate existing measures related to influenza, pneumonia and herpes zoster immunization status. Combining the separate measures into one single measure reduces the impact of each individual measure. The performance data would not be actionable, as it would combine immunization rates and would not provide specific data to allow clinicians to act upon any individual immunization rate. The Academy is concerned about the impact this would have on patients. If this is intended as a substitute for existing individual measures, the American Academy of Ophthalmology encourages MAP not to recommend this measure for inclusion in QPP. (Submitted by: American Academy of Ophthalmology)
  
  
• (Early public comment)While the AMA supports the individual components included in this composite, we are concerned that the complexity of the measure with five numerators, denominators and exclusions/exceptions will directly impact the feasibility, reliability and validity of the measure for use in MIPS. It is not clear at what data source the measure is specified but we anticipate that implementation will be challenging given that several of the components require longitudinal data. It is critical that the measure be tested at the clinician level to understand how well each of the required data elements are captured and the degree to which the data produced is valid. We also note that there are overlapping and inconsistent immunizations included in this measure as well as MUC18-62 Adult Immunization Status. For example, each measure examines the rate of influenza immunizations but uses a different timeframe (MUC18-57 is August 1 to March 31 and MUC18-62 requires it be given between July 1 and June 30) and MUC18-57 only requires only one of the two pneumococcal vaccines while MUC18-62 requires that both have been given at least 12 months apart with the first occurrence after the age of 60 years. Both measures as well as any current measures that capture the same immunizations must be harmonized before they are finalized for implementation in MIPS or MSSP. Therefore, the AMA recommends that the highest level of MAP recommendation be “Do Not Support With Potential For Mitigation”. (Submitted by: American Medical Association)
  
  
• We support the MAP’s recommendation to not consider this measure for inclusion in MIPS given that is has not been specified and tested at the clinician level. Additionally, we are concerned with the data collection burden associated with this measure. Immunization information is often not captured electronically, and measure data elements such as immunization status are not consistently or accurately coded. Data collection for this measure will be especially difficult for providers operating in states with limited or no immunization registries. We recommend that the measure developers address these feasibility concerns in addition to testing the measure at the clinician level during the NQF endorsement process. (Submitted by: America's Health Insurance Plans)
  
  
• AVAC appreciates the opportunity to offer our perspective on the Centers for Medicare and Medicaid Services (CMS) List of Measures under Consideration (MUC) MIPS measure. AVAC was delighted to see the inclusion of the MUC2018-062: Adult Immunization Status for MIPS but disappointed to see it not supported. We urge the Measure Applications Partnership to include MUC2018-062 as a measure under the MIP-Quality program. One of our key priorities is improved federal benchmarks and quality measures to encourage better tracking and reporting of adult immunization status that will result in increased adult immunization coverage rates. In 2016, AVAC released a White Paper outlining the value and imperative of quality measures for adult vaccines, highlighting the role of vaccine quality measures in preventing illness and death, reducing caregiving demands, avoiding unnecessary healthcare spending, and setting the foundation for healthy aging. Quality metrics in Medicare payment programs play a critical role in promoting improved quality, more consistent adherence to and utilization of recommended adult vaccines and, ultimately, better outcomes for patients. The HEDIS composite seeks to capture the percentage of members 19 years of age and older who are up-to-date on recommended routine vaccines for influenza; tetanus and diphtheria (Td) or tetanus, diphtheria and acellular pertussis (Tdap); zoster; and pneumococcal. the measure is under consideration for use in MIPS. The adult immunization composite measure is a status measure, and providers do not need to give all of the vaccines in office. We were deeply concerned that members of the MAP misunderstood that each of the immunizations included in the composite measure are independently considered and factored into the composite so a provider would still receive credit. The measure will lead to vaccination or referral, thereby ensuring that all patients are up-to-date with respect to recommended immunizations. The HEDIS composite is complementary to the National Vaccine Advisory Committee (NVAC) Standards for Adult Immunization Practice, which provide guidance to health care providers across the spectrum of health care. Primary care and certain specialty care providers have a fundamental responsibility. The standards urge all health care professionals who provide care to adults to: 1. ASSESS immunization status of all patients in every clinical encounter 2. SHARE a strong recommendation for vaccines that patients need 3. ADMINISTER needed vaccines or REFER to a provider who can immunize 4. DOCUMENT vaccines administered or received by their patients AVAC believes the MUC18- 62 Adult Immunization Status MIPS measure satisfies many of the objectives of the Meaningful Measures Framework, including addressing high impact measure areas that safeguard public health, patient centered and impactful on health outcomes, minimize the level of burden for health care providers, significant opportunity for improvement, fulfill each program’s statutory requirements and align across programs and with other payers. The measure also strongly aligns with the Meaningful Measure areas and overarching quality priorities outlined in the MUC announcement. At the same time, the MUC18-62 MIPS measure addresses the cross-cutting measure criteria: eliminating disparities; tracking measurable outcomes and impact; safeguarding public health; achieving cost savings; improving access for rural communities and reducing burden on providers. (Submitted by: Adult Vaccine Access Coalition (AVAC))
  
  
• • The MAP considered MUC18-062 for both the MIPS and MSSP programs, with differing recommedations. While the MAP recognizes the clinical importance of the measure, the Committee also identified some areas of measure improvement: such as strengthening measure specification and harmonization of the measure’s component parts that would require additional mitigation. While the MAP is supporting the measure for inclusion (pending NQF endorsement) in the Shared Savings Program, the Committee is not supporting for inclusion in MIPS without further measure refinement at the clinician level. • PhRMA is not in a position to comment on implementation or reporting challenges associated with this measure. However, we would like to take this opportunity to reiterate the importance of adherence to all Advisory Committee on Immunization Practices (ACIP)-recommended vaccinations, and the need for quality measures that are reflective of such guidelines. • Vaccination rates and adherence to guidelines are still not optimal, representing a clinical area for improvement and progress. The MAP has recognized the importance of adult immunizations, and emphasized the need for a broader composite measure that addresses all appropriate vaccines in the adult population. • There is strong alignment and clinical evidence that supports the need for quality measures that address adult immunization status, and therefore PhRMA supports the development, endorsement and adoption of such a composite measure. We support the inclusion of this measure in any quality and reporting program, and encourage the clinician work group, measure steward, and CMS thoughtfully consider how the measure could be modified to provide for appropriate attribution for clinician-level reporting. Data collection methods that do not support harmonization could further create inconsistencies and differing goals across payment programs. As an example, the misalignment of measures reported by providers in ACOs and MIPS could result in different incentives to improve immunization rates. (Submitted by: PhRMA)
  
  
• We are not in favor of this being a composite measure as defined in CMS’ document because the vaccinations all have different frequencies. If a patient refuses one vaccination, then there is little incentive to administer the rest. (Submitted by: American Geriatrics Society)
  
  
• The American Medical Association supports the preliminary recommendation and associated conditions. (Submitted by: American Medical Association)
  
  
• Preventative measures are important and immunization status should be measured, but doing so in a composite is too complicated. The number of doses and recommended age ranges for each vaccine is different, making it difficult to aggregate performance into a single composite metric. Performance does not differentiate between noncompliance with all vaccines and providing all but one. This makes it difficult to track improvement towards full compliance and to target areas of opportunity. Providers must try to deconstruct the measure back into individual measures in order to assess improvement needs and develop action plans. This is additional and unnecessary burden for the provider with little additional benefit gained by using a composite measure vs. individual measures. (Submitted by: Sanford Health)
  
  

• (Early public comment)BIO supports the development, endorsement, and CMS adoption of this composite adult immunization measure, which includes influenza; zoster; pneumococcal; and tetanus and diphtheria (Td) or tetanus, diphtheria, and acellular pertussis (Tdap) vaccination in both the CMS MIPS and MSSP programs. We applaud the measure for aligning with the Standards for Adult Immunization Practice [https://www.cdc.gov/vaccines/hcp/adults/for-practice/standards/index.html] and urging the assessment, recommendation, administration or referral, and documentation of immunization status of these serious diseases at each clinical encounter. Adult immunization rates lag behind childhood rates in the U.S. According to the 2016 National Health Interview Survey, 70.4% of adults age 65 years and older were vaccinated against influenza; 66.9% of adults age 65 years and older were vaccinated against pneumococcal; 33.4% of adults age 60 years and older were vaccinated against zoster; and 26.6% of adults age 19 years and older received a Tdap vaccine. Additionally, stark racial and ethnic disparities for adult immunizations exist. [https://www.cdc.gov/vaccines/imz-managers/coverage/adultvaxview/pubs-resources/NHIS-2016.html] Adoption of MUC18-062 in both the MIPS and MSSP programs will help to improve the consistency and reporting for adult immunization status for all Medicare beneficiaries. Increasing adult immunization rates will improve health outcomes and decrease healthcare usage from vaccine-preventable diseases. Annually, the U.S. spends nearly $26.5 billion treating influenza, pneumococcal, zoster, and pertussis among adults age 50 years and over. [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4486398/] Not preventing these vaccine-preventable diseases has a significant cost the U.S. healthcare system; the Adult Immunization Status measure will help drive increases in adult immunization rates, leading to the dual benefits of improving patient health and lowering federal healthcare expenditures. Additionally, the use of a composite measure such as MUC18-062 Adult Immunization Status can aid in the harmonization of adult immunization measures across Medicare programs. Currently, Medicare programs utilize a variety of disease-specific measures. The use of this composite measure may allow for efficiencies in monitoring and reporting, and the elimination of duplicative or outdated measures. For consistency and to have the greatest impact on patient outcomes, CMS should also consider including the measure in other quality and payment programs. (Submitted by: Biotechnology Innovation Organization (BIO))
  
  
• (Early public comment)Including MUC18- 62 Adult Immunization Status more broadly across quality reporting and payment programs is critically important for several reasons. First, it will ensure more consistent monitoring and reporting of adult immunization status for Medicare beneficiaries. Widespread use of this new composite measure is particularly timely and important in the hospital inpatient and outpatient settings, as well as in long-term care and skilled nursing facilities where patients are especially susceptible and vulnerable to the negative health outcomes of a vaccine-preventable illness such as the flu or pneumonia. Inclusion of the composite measure for additional consideration under these programs would also update, streamline and align the varied adult immunization measures presently being used to monitor influenza, pneumococcal and zoster vaccination. Additionally, implementation of MUC18- 62 Adult Immunization Status across quality programs would drive increases in adult immunization rates and would ultimately yield lower federal health care expenditures. Most importantly, beneficiaries would see improved health outcomes over the long-term as a result of fewer hospitalizations, provider visits and other ancillary services required in the treatment of a vaccine preventable illness. (Submitted by: Adult Vaccine Access Coalition )
  
  
• (Early public comment)Sanofi supports inclusion of the adult immunization status measure into the MSSP. Immunizations are an important part of public health and caring for populations. (Submitted by: Sanofi)
  
  
• (Early public comment)While the AMA supports the individual components included in this composite, we note that there are overlapping and inconsistent immunizations included in this measure as well as MUC18-62 Adult Immunization Status. For example, each measure examines the rate of influenza immunizations but uses a different timeframe (MUC18-57 is August 1 to March 31 and MUC18-62 requires it be given between July 1 and June 30) and MUC18-57 only requires only one of the two pneumococcal vaccines while MUC18-62 requires that both have been given at least 12 months apart with the first occurrence after the age of 60 years. Both measures as well as any current measures that capture the same immunizations must be harmonized before they are finalized for implementation in MIPS or MSSP. Therefore, the AMA recommends that the highest level of MAP recommendation be “Do Not Support With Potential For Mitigation”. (Submitted by: American Medical Association)
  
  
• (Early public comment)While written comments were not provided, the commenter indicated their support for MAP's preliminary recommendation (Submitted by: National Association of County and City Health Officials)
  
  
• We do not support the MAPs recommendation to re-consider this measure for inclusion in MSSP following NQF endorsement. We recommend that the MAP change its recommendation to “Do not support for rulemaking with the potential for mitigation.” We feel the measure should be specified and tested at the ACO level before being considered for MSSP. Additionally, we are concerned with the data collection burden associated with this measure. Immunization information is often not captured electronically, and measure data elements such as immunization status are not consistently or accurately coded. Data collection for this measure will be especially difficult for ACOs operating in states with limited or no immunization registries. We recommend that the measure developers address these feasibility concerns in addition to testing the measure at the ACO level during the NQF endorsement process. (Submitted by: America's Health Insurance Plans)
  
  
• AVAC appreciates the opportunity to offer our perspective on the Centers for Medicare and Medicaid Services (CMS) List of Measures under Consideration (MUC) MSSP measure. AVAC was delighted to see that the MAP voted 68% (15 supported 4 opposed) to go along with the initial recommendation to provide conditional support for the MUC18- 62 Adult Immunization Status measure. One of our key priorities is improved federal benchmarks and quality measures to encourage better tracking and reporting of adult immunization status that will result in increased adult immunization coverage rates. In 2016, AVAC released a White Paper outlining the value and imperative of quality measures for adult vaccines, highlighting the role of vaccine quality measures in preventing illness and death, reducing caregiving demands, avoiding unnecessary healthcare spending, and setting the foundation for healthy aging. Quality metrics in Medicare payment programs play a critical role in promoting improved quality, more consistent adherence to and utilization of recommended adult vaccines and, ultimately, better outcomes for patients. The HEDIS adult immunization composite seeks to capture the percentage of members 19 years of age and older who are up-to-date on recommended routine vaccines for influenza; tetanus and diphtheria (Td) or tetanus, diphtheria and acellular pertussis (Tdap); zoster; and pneumococcal. the measure is under consideration for use in the Medicare Shared Savings Program. The adult immunization composite measure is a status measure, and providers do not need to give all of the vaccines in office. The measure will lead to vaccination or referral, thereby ensuring that all patients are up-to-date with respect to recommended immunizations. The HEDIS composite is complementary to the National Vaccine Advisory Committee (NVAC) Standards for Adult Immunization Practice, which provide guidance to health care providers across the spectrum of health care. Primary care and certain specialty care providers have a fundamental responsibility The standards urge all health care professionals who provide care to adults to take steps to: 1. ASSESS immunization status of all patients in every clinical encounter 2. SHARE a strong recommendation for vaccines that patients need 3. ADMINISTER needed vaccines or REFER to a provider who can immunize 4. DOCUMENT vaccines administered or received by their patients AVAC believes the MUC18- 62 Adult Immunization Status measure satisfy many of the objectives of the Meaningful Measures Framework, including addressing high impact measure areas that safeguard public health, patient centered and meaningful to patients, minimize the level of burden for health care providers, significant opportunity for improvement, fulfill each program’s statutory requirements and align across programs and with other payers. The measure also strongly aligns with the Meaningful Measure areas and overarching quality priorities outlined in the MUC announcement. At the same time, the MUC18-62 MSSP measure addresses the cross-cutting measure criteria: eliminating disparities; tracking measurable outcomes and impact; safeguarding public health; achieving cost savings; improving access for rural communities and reducing reporting burden on providers. We also recommend including the revised measure under MIPS as well as several other quality and payment programs on the MUC, including the following:> Home Health Quality Reporting Program> Inpatient Rehabilitation Facility Quality Reporting Program> Long-Term Care Hospital Quality Reporting Program> Skilled Nursing Facility Quality Reporting Program> Skilled Nursing Facility Value-Based Purchasing Program> Ambulatory Surgical Center Quality Reporting> Hospital Inpatient Quality Reporting> Hospital Outpatient Quality Reporting> Inpatient Psychiatric Facility Quality Reporting> PPS-Exempt Cancer Hospital Quality Reporting Including MUC18- 62 Adult Immunization Status more broadly across quality reporting and payment programs is critically important for several reasons. First, it will ensure more consistent monitoring and reporting of adult immunization status for Medicare beneficiaries. Widespread use of this new composite measure is particularly timely and important in the hospital inpatient and outpatient settings, as well as in long-term care and skilled nursing facilities where patients are especially susceptible and vulnerable to the negative health outcomes of a vaccine-preventable illness such as the flu or pneumonia. Inclusion of the composite measure for additional consideration under these programs would also update, streamline and align the varied adult immunization measures presently being used to monitor influenza, pneumococcal and zoster vaccination. Additionally, implementation of MUC18- 62 Adult Immunization Status across quality programs would drive increases in adult immunization rates and would ultimately yield lower federal health care expenditures. Most importantly, beneficiaries would see improved health outcomes over the long-term as a result of fewer hospitalizations, provider visits and other ancillary services required in the treatment of a vaccine preventable illness. (Submitted by: Adult Vaccine Access Coalition )
  
  
• • The MAP considered MUC18-062 for both the MIPS and MSSP programs, with differing recommedations. While the MAP recognizes the clinical importance of the measure, the Committee also identified some areas of measure improvement: such as strengthening measure specification and harmonization of the measure’s component parts that would require additional mitigation. While the MAP is supporting the measure for inclusion (pending NQF endorsement) in the Shared Savings Program, the Committee is not supporting for inclusion in MIPS without further measure refinement at the clinician level. • PhRMA is not in a position to comment on implementation or reporting challenges associated with this measure. However, we would like to take this opportunity to reiterate the importance of adherence to all Advisory Committee on Immunization Practices (ACIP)-recommended vaccinations, and the need for quality measures that are reflective of such guidelines. • Vaccination rates and adherence to guidelines are still not optimal, representing a clinical area for improvement and progress. The MAP has recognized the importance of adult immunizations, and emphasized the need for a broader composite measure that addresses all appropriate vaccines in the adult population. • There is strong alignment and clinical evidence that supports the need for quality measures that address adult immunization status, and therefore PhRMA supports the development, endorsement and adoption of such a composite measure. We support the inclusion of this measure in any quality and reporting program, and encourage the clinician work group, measure steward, and CMS thoughtfully consider how the measure could be modified to provide for appropriate attribution for clinician-level reporting. Data collection methods that do not support harmonization could further create inconsistencies and differing goals across payment programs. As an example, the misalignment of measures reported by providers in ACOs and MIPS could result in different incentives to improve immunization rates. (Submitted by: PhRMA)
  
  
• The shortage of Shingix, if it continues will be problematic. We would not recommend this measure to be included in MSSP unless the shortage is addressed or the measure exclusion criteria includes system reasons for vaccine not administered(e.g. vaccine shortage) (Submitted by: Einstein Healthcare Netwrok)
  
  

• We would like to note that there is a lack of meaningful functional status measures in the list of MUCs. Despite its importance, functional status remains a big gap in the data collected, resulting in a big gap in quality measures. The American Geriatrics Society recently published a white paper calling for a greater focus on mobility as an outcome for hospitalized older adults and outlining key recommendations. The paper can be accessed here: https://onlinelibrary.wiley.com/doi/full/10.1111/jgs.15595 (Submitted by: American Geriatrics Society)
  
  
• Work required to assist patients to collect data for scoring is significant on providers, this may be a heavy lift/perception of burden in primary care. (Submitted by: OCHIN, Inc.)
  
  

• (Early public comment)NHPCO Comments: Include cancer patients receiving palliative care services in “excludes”. (Submitted by: National Hospice and Palliative Care Organization)
  
  
• (Early public comment)The AAN agrees with the need to measure and monitor cases where a patient may be receiving a prescription for an opiate from multiple providers and pharmacies. However, we believe that four different providers and four different pharmacies is too many. We suggest that anything above a prescription from one physician or one pharmacy should be of concern and therefore the numbers should in fact be reduced to one. A single physician can then properly monitor the patient through the use of an opiate contract, questionnaires and screening to ensure that the medications are being used appropriately. (Submitted by: American Academy of Neurology)
  
  
• (Early public comment)The AMA has significant concerns with the proposed inclusion of this measure in the MSSP because it was developed with the intention of determining the quality of care provided by prescription drug health plans, and not for ACOs. The measure as currently specified requires access to health plan medical and pharmacy claims and member enrollment information; such data may not be readily available across all ACOs given their varying composition and access to pharmacy claims data. Comprehensive assessment of the feasibility of collecting and reporting these data at the ACO level must be determined. For example, for those MSSP participants that provide care across state lines or have patients that receive care outside of the ACO, it is unclear whether they can access data to confirm that prescriptions were not received outside of the network. Ensuring that ACOs can collect the data needed to satisfy the measure requirements is necessary to inform and allow thorough evaluations of the reliability and the validity of the performance scores. For example, it is not clear what the minimum sample size is to ensure that performance scores are reliable across ACOs. The evaluation completed by the Pharmacy Quality Alliance included more than 700 Medicare Part D prescription drug plans, eight state-based Medicaid prescription drug plans, and one commercial health plan. In addition, the current measure specifications include buprenorphine, which is primarily used to treat opioid use disorder. We believe that its inclusion is not consistent with the intent of this measure and it should be removed. The AMA believes that this measure must be adequately specified and tested across ACOs prior to its implementation in MSSP and the MAP must address the number of proposed measures on opioid use that are similar and/or overlapping. Therefore, the AMA recommends that the highest level of MAP recommendation be “Do Not Support With Potential For Mitigation” for this measure. (Submitted by: American Medical Association)
  
  
• (Early public comment)The Federation of American Hospitals questions CMS’ rationale for submitting four similar and potentially competing measures for consideration in MSSP. These duplicative measures seem to be contradictory to recent CMS efforts to streamline the number of measures in response to the Patients Over Paperwork initiative. We request that the MAP thoughtfully consider whether all of these measures should be recommended for potential implementation. In addition, while it is difficult to determine the underlying data source that will be used for MUC18-106 Initial opioid prescription compliant with CDC recommendations, we assume that all four measures will be derived from claims data. As a result, FAH has significant concerns with recommending these measures at this time. Specifically, it is not clear that the developers have demonstrated how well any of these measures perform within an accountable care organization (ACO). ACOs currently receive prescription claims data from CMS, which is not as robust and accurate on opioid utilization as would be required to ensure that these measures represent reliable and valid performance and limits an ACO’s ability to impact clinical care in a timely way. Therefore, the FAH requests that the highest level of MAP recommendation be “Do Not Support With Potential For Mitigation” for all four opioid-related measures proposed for MSSP. (Submitted by: Federation of American Hospitals)
  
  
• (Early public comment)The Pharmacy Quality Alliance (PQA), the measure steward of three of the opioid-related quality measures (listed here) on the Measures Under Consideration (MUC) List, supports CMS’ consideration of the measures for adoption in the designated federal program of the Medicare Shared Savings Program (MSSP) through rulemaking under Medicare. The three related measures, developed by PQA, address safe and appropriate prescribing of opioids by identifying cases with high potential of misuse/abuse of opioid analgesics: 1. Use of Opioids from Multiple Providers in Persons Without Cancer (MUC18-77) 2. Use of Opioids at High Dosage in Persons Without Cancer (MUC18-78) 3. Use of Opioids from Multiple Providers and at High Dosage in Persons Without Cancer (MUC18-79) The designated Medicare program for consideration of these three measures, the MSSP, encourages health care provider groups to come together as an Accountable Care Organization (ACO) to give coordinated, high quality care to their Medicare patients. With the stated goals of MSSP to promote accountability for a patient population, coordinate items and services for beneficiaries, incentivize investment in high quality and cost-efficient services, in the presence of the ever-increasing challenge of the opioid crisis, the inclusion of performance measures in the program to support safe prescribing of opioids is an important program update. Reinforcingly, PQA has received several unsolicited requests from ACOs interested in using the PQA opioid measures, offering an early positive indication of interest by these alternative payment model entities to support achievement of quality and cost goals. Lastly, the three PQA opioid measures developed in 2015 have been updated to align with the CDC Guideline for Prescribing Opioids for Chronic Pain published in 2016. The revised specifications for 2019 (measurement year 2018) were provided to CMS for the purpose of informing pre-rule making and Measure Application Partnership stakeholders. (Submitted by: Pharmacy Quality Alliance)
  
  
• (Early public comment)This measure is developed and tested for assessing PBMs. It is unclear if the measure can readily apply to ACOs. Moreover, ACOs do not administer the Part D benefit and have less control over these measures. CMS has sought comment on providing additional information to ACOs on Part D claims and incorporating Part D into ACO models. In the absence of more data or managing the benefit, ACOs should not be held accountable for these measures. However, since these are claims-based measures CMS should calculate the measures and provide ACO with confidential performance information. (Submitted by: Premier, Inc.)
  
  
• (Early public comment)Updated PQA comment from what was sent yesterday The Pharmacy Quality Alliance (PQA), the measure steward of three of the opioid-related quality measures (listed here) on the Measures Under Consideration (MUC) List, supports CMS’ consideration of the measures for adoption in the designated federal program of the Medicare Shared Savings Program (MSSP) through rulemaking under Medicare. The three related PQA measures address safe prescribing of opioids by identifying prescribing patterns associated with increased risk of opioid overdose: 1. Use of Opioids from Multiple Providers in Persons Without Cancer (MUC18-77) 2. Use of Opioids at High Dosage in Persons Without Cancer (MUC18-78) 3. Use of Opioids from Multiple Providers and at High Dosage in Persons Without Cancer (MUC18-79) The designated Medicare program for consideration of these three measures, the MSSP, encourages health care provider groups to come together as an Accountable Care Organization (ACO) to give coordinated, high quality care to their Medicare patients. With the stated goals of MSSP to promote accountability for a patient population, coordinate items and services for beneficiaries, incentivize investment in high quality and cost-efficient services, in the presence of the ever-increasing challenge of the opioid crisis, the inclusion of performance measures in the program to support safe prescribing of opioids is an important program update. Reinforcingly, PQA has received several unsolicited requests from ACOs interested in using the PQA opioid measures, offering an early positive indication of interest by these alternative payment model entities to support achievement of quality and cost goals. Lastly, the three PQA opioid measures developed in 2015 have been updated to align with the CDC Guideline for Prescribing Opioids for Chronic Pain published in 2016. The revised specifications for 2019 (measurement year 2018) were provided to CMS for the purpose of informing pre-rule making and Measure Application Partnership stakeholders. (Submitted by: Pharmacy Quality Alliance)
  
  
• (Early public comment)We appreciate that this measure has exclusions for patients receiving hospice services, but suggest additional exclusions for palliative care. We note that this is consistent with the CDC Guideline that includes an exclusion for patients receiving palliative care. (Submitted by: Center to Advance Palliative Care)
  
  
• (Early public comment)We support this measure but it needs to exclude those receiving palliative care. We also have a concern that patients in hospice and palliative care programs with multiple providers may be inappropriately flagged by this aspect of this measure and urge that that be addressed. We do support monitoring the number of pharmacies dispensing opioids (Submitted by: CTAC)
  
  
• We do not support the MAPs recommendation to consider this measure for inclusion in MSSP. We recommend that the MAP change its recommendation to “Do not support for rulemaking with the potential for mitigation.” We feel the measure should be tested at the ACO level before being considered for MSSP. We echo the MAP’s recommendation that CMS should strive for alignment of opioid use disorder across programs. We also agree with the MAP that CMS will need to devise strategies to make pharmacy data more readily available to ACOs, as discussed in the 2019 Medicare Shared Savings Program Final Rule, to ensure successful reporting of this measure. (Submitted by: America's Health Insurance Plans)
  
  
• The Federation of American Hospitals (FAH) has significant concerns with the Conditional Support recommendation for these two measures at this time. Specifically, these measures are tested at the health plan level and the developers have not demonstrated how well any of these measures perform within an accountable care organization (ACO). ACOs currently receive prescription claims data from CMS, which is not as robust and accurate on opioid utilization as would be required to ensure that these measures represent reliable and valid performance and limits an ACO’s ability to impact clinical care in a timely way. In addition, the FAH supports the Clinician Workgroup’s concerns with the multiple measures across federal programs targeting this issue and alignment of these measures would be consistent with the goals of the Meaningful Measures Initiative. The FAH does not believe that these measures have met the level of testing required to achieve “Conditional Support” and requests that the highest level of MAP recommendation be “Do Not Support With Potential For Mitigation”. Do not support current recommendation. (Submitted by: Federation of American Hospitals)
  
  
• While written comments were not provided, the commenter indicated their support for MAP's preliminary recommendation (Submitted by: American Psychiatric Association Foundation)
  
  
• While written comments were not provided, the commenter indicated their support for MAP's preliminary recommendation (Submitted by: American Psychiatric Association Foundation )
  
  
• The American Medical Association (AMA) continues to have significant concerns with the proposed inclusion of this measure in the Medicare Shared Savings Program (MSSP) because it was developed with the intention of determining the quality of care provided by prescription drug health plans, not for Accountable Care Organizations (ACOs). As a result, we do not believe that the measure has been adequately tested in the setting in which it will be applied and therefore it cannot receive a Conditional Support recommendation. The measure as currently specified requires access to health plan medical and pharmacy claims and member enrollment information; such data may not be readily available across all ACOs given their varying composition and access to pharmacy claims data. We refer the Coordinating Committee to our comments submitted prior to the Clinician Workgroup meeting for additional details. In light of this lack of testing demonstrating reliability and validity at the ACO level, the AMA recommends that the highest level of MAP recommendation be “Do Not Support With Potential For Mitigation” for this measure. (Submitted by: American Medical Association)
  
  
• The opioid measures that involve prescriptions from multiple people sound challenging – I think that clinical teams may feel like that is hard for them to impact (Submitted by: OCHIN, Inc.)
  
  

• (Early public comment)NHPCO Comments: Include cancer patients receiving palliative care services in “excludes”. (Submitted by: National Hospice and Palliative Care Organization)
  
  
• (Early public comment)The AANS and CNS disagree with the fundamental premise of a measure that focuses only on daily dose and duration of therapy involving prescription opioid analgesics because on its own it is not a valid indicator of quality patient care. In fact, since the Centers for Disease Control & Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain was issued, there have been many reports of patients who have been successfully managed on opioid analgesics for long periods of time, and in whom the benefits of such therapy exceed the risks, of being forced to abruptly reduce or discontinue their medication regimens. Such involuntary tapers are associated with sometimes extremely adverse outcomes, including depression, anxiety and emergence of other mental health disorder, loss of function and the ability to perform daily activities, and even suicide. There has been considerable discussion of these unintended consequences at meetings of the HHS Interagency Pain Management Best Practices Task Force. Identifying those patients for whom the daily prescribed morphine milligram equivalents (MME) are considered high may serve as an indicator of whether a patient is at risk of overdose and should be co-prescribed naloxone, but it alone is not an appropriate marker of the quality of care provided. The CDC recommendations allow physicians to document a clinical rationale or justification when suggested dose levels are exceeded; yet, the existing measures that focus on MME do not capture if a justification exists nor do they provide a well-defined and targeted denominator. If CMS implements a measure that focuses on MME, it must adequately define the patients for whom higher doses of opioids may be appropriate. Otherwise, the measure will provide invalid representations of performance. In addition, the current measure specifications include buprenorphine, which is primarily used to treat opioid use disorder. CMS also should explore more appropriate methods to assess a patient’s chronic pain, including the use of patient-reported data as the basis for performance measures. Given these concerns, we do NOT recommend MUC18-78 Use of Opioids at High Dosage in Persons Without Cancer for implementation in the Medicare Shared Savings Program (MSSP) at this time. (Submitted by: American Association of Neurological Surgeons )
  
  
• (Early public comment)The AMA disagrees with the fundamental premise of a measure that focuses only on daily dose and duration of therapy involving prescription opioid analgesics because on its own it is not a valid indicator of quality patient care. In fact, since the Centers for Disease Control & Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain was issued, there have been many reports of patients who have been successfully managed on opioid analgesics for long periods of time, and in whom the benefits of such therapy exceed the risks, of being forced to abruptly reduce or discontinue their medication regimens. Such involuntary tapers are associated with sometimes extremely adverse outcomes, including depression, anxiety and emergence of other mental health disorder, loss of function and the ability to perform daily activities, and even suicide. There has been considerable discussion of these unintended consequences at meetings of the HHS Interagency Pain Management Best Practices Task Force. Identifying those patients for whom the daily prescribed morphine milligram equivalents (MME) are considered high may serve as an indicator of whether a patient is at risk of overdose and should be co-prescribed naloxone, but it alone is not an appropriate marker of the quality of care provided. The CDC recommendations allow physicians to document a clinical rationale or justification when suggested dose levels are exceeded; yet, the existing measures that focus on MME do not capture if a justification exists nor do they provide a well-defined and targeted denominator. CMS should explore more appropriate methods to assess a patient’s chronic pain such as the Pain Assessment Screening Tool and Outcomes Registry (PASTOR) and use this patient-reported data on areas as the basis for performance measures. This tool utilizes the Patient Reported Outcomes Measurement Information System (PROMIS) and through the use of Computer Adaptive Testing, key domains such as sleep disturbance and physical function can be assessed in a targeted and patient-directed way. If CMS implements a measure that focuses on MME, it must adequately define the patients for whom higher doses of opioids may be appropriate. Otherwise, the measure will provide invalid representations of performance. In addition, the current measure specifications include buprenorphine, which is primarily used to treat opioid use disorder. We believe that its inclusion is not consistent with the intent of this measure and it should be removed. CMS should consider and explore alternative measures or ones that provide complementary information on the quality of care in managing substance use disorders and/or pain, for example, NQF #2597 for assessing substance use screening and intervention. Given the ongoing concerns with this measure and the number of proposed measures on opioid use that are similar and/or overlapping, the AMA recommends that the highest level of MAP recommendation be “Do Not Support With Potential For Mitigation”. (Submitted by: American Medical Association)
  
  
• (Early public comment)The Federation of American Hospitals questions CMS’ rationale for submitting four similar and potentially competing measures for consideration in MSSP. These duplicative measures seem to be contradictory to recent CMS efforts to streamline the number of measures in response to the Patients Over Paperwork initiative. We request that the MAP thoughtfully consider whether all of these measures should be recommended for potential implementation. In addition, while it is difficult to determine the underlying data source that will be used for MUC18-106 Initial opioid prescription compliant with CDC recommendations, we assume that all four measures will be derived from claims data. As a result, FAH has significant concerns with recommending these measures at this time. Specifically, it is not clear that the developers have demonstrated how well any of these measures perform within an accountable care organization (ACO). ACOs currently receive prescription claims data from CMS, which is not as robust and accurate on opioid utilization as would be required to ensure that these measures represent reliable and valid performance and limits an ACO’s ability to impact clinical care in a timely way. Therefore, the FAH requests that the highest level of MAP recommendation be “Do Not Support With Potential For Mitigation” for all four opioid-related measures proposed for MSSP. (Submitted by: Federation of American Hospitals)
  
  
• (Early public comment)The Pharmacy Quality Alliance (PQA), the measure steward of three of the opioid-related quality measures (listed here) on the Measures Under Consideration (MUC) List, supports CMS’ consideration of the measures for adoption in the designated federal program of the Medicare Shared Savings Program (MSSP) through rulemaking under Medicare. The three related measures, developed by PQA, address safe and appropriate prescribing of opioids by identifying cases with high potential of misuse/abuse of opioid analgesics: 1. Use of Opioids from Multiple Providers in Persons Without Cancer (MUC18-77) 2. Use of Opioids at High Dosage in Persons Without Cancer (MUC18-78) 3. Use of Opioids from Multiple Providers and at High Dosage in Persons Without Cancer (MUC18-79) The designated Medicare program for consideration of these three measures, the MSSP, encourages health care provider groups to come together as an Accountable Care Organization (ACO) to give coordinated, high quality care to their Medicare patients. With the stated goals of MSSP to promote accountability for a patient population, coordinate items and services for beneficiaries, incentivize investment in high quality and cost-efficient services, in the presence of the ever-increasing challenge of the opioid crisis, the inclusion of performance measures in the program to support safe prescribing of opioids is an important program update. Reinforcingly, PQA has received several unsolicited requests from ACOs interested in using the PQA opioid measures, offering an early positive indication of interest by these alternative payment model entities to support achievement of quality and cost goals. Lastly, the three PQA opioid measures developed in 2015 have been updated to align with the CDC Guideline for Prescribing Opioids for Chronic Pain published in 2016. The revised specifications for 2019 (measurement year 2018) were provided to CMS for the purpose of informing pre-rule making and Measure Application Partnership stakeholders. (Submitted by: Pharmacy Quality Alliance)
  
  
• (Early public comment)This measure is developed and tested for assessing PBMs. It is unclear if the measure can readily apply to ACOs. Moreover, ACOs do not administer the Part D benefit and have less control over these measures. CMS has sought comment on providing additional information to ACOs on Part D claims and incorporating Part D into ACO models. In the absence of more data or managing the benefit, ACOs should not be held accountable for these measures. However, since these are claims-based measures CMS should calculate the measures and provide ACO with confidential performance information. (Submitted by: Premier, Inc.)
  
  
• (Early public comment)This needs the CDC guideline exclusion of those receiving: palliative care. We would also note that others with serious illness or chronic pain may justifiably need these medications at higher/longer doses (Submitted by: CTAC)
  
  
• (Early public comment)Updated PQA comment from what was sent yesterday The Pharmacy Quality Alliance (PQA), the measure steward of three of the opioid-related quality measures (listed here) on the Measures Under Consideration (MUC) List, supports CMS’ consideration of the measures for adoption in the designated federal program of the Medicare Shared Savings Program (MSSP) through rulemaking under Medicare. The three related PQA measures address safe prescribing of opioids by identifying prescribing patterns associated with increased risk of opioid overdose: 1. Use of Opioids from Multiple Providers in Persons Without Cancer (MUC18-77) 2. Use of Opioids at High Dosage in Persons Without Cancer (MUC18-78) 3. Use of Opioids from Multiple Providers and at High Dosage in Persons Without Cancer (MUC18-79) The designated Medicare program for consideration of these three measures, the MSSP, encourages health care provider groups to come together as an Accountable Care Organization (ACO) to give coordinated, high quality care to their Medicare patients. With the stated goals of MSSP to promote accountability for a patient population, coordinate items and services for beneficiaries, incentivize investment in high quality and cost-efficient services, in the presence of the ever-increasing challenge of the opioid crisis, the inclusion of performance measures in the program to support safe prescribing of opioids is an important program update. Reinforcingly, PQA has received several unsolicited requests from ACOs interested in using the PQA opioid measures, offering an early positive indication of interest by these alternative payment model entities to support achievement of quality and cost goals. Lastly, the three PQA opioid measures developed in 2015 have been updated to align with the CDC Guideline for Prescribing Opioids for Chronic Pain published in 2016. The revised specifications for 2019 (measurement year 2018) were provided to CMS for the purpose of informing pre-rule making and Measure Application Partnership stakeholders. (Submitted by: Pharmacy Quality Alliance)
  
  
• (Early public comment)We appreciate that this measure has exclusions for patients receiving hospice services, but suggest additional exclusions for palliative care. We note that this is consistent with the CDC Guideline that includes an exclusion for patients receiving palliative care. (Submitted by: Center to Advance Palliative Care)
  
  
• We do not support the MAPs recommendation to consider this measure for inclusion in MSSP. We recommend that the MAP change its recommendation to “Do not support for rulemaking with the potential for mitigation.” We feel the measure should be tested at the ACO level before being considered for MSSP. We echo the MAP’s recommendation that CMS should strive for alignment of opioid use disorder across programs. We also agree with the MAP that CMS will need to devise strategies to make pharmacy data more readily available to ACOs, as discussed in the 2019 Medicare Shared Savings Program Final Rule, to ensure successful reporting of this measure. (Submitted by: America's Health Insurance Plans)
  
  
• The Federation of American Hospitals (FAH) has significant concerns with the Conditional Support recommendation for these two measures at this time. Specifically, these measures are tested at the health plan level and the developers have not demonstrated how well any of these measures perform within an accountable care organization (ACO). ACOs currently receive prescription claims data from CMS, which is not as robust and accurate on opioid utilization as would be required to ensure that these measures represent reliable and valid performance and limits an ACO’s ability to impact clinical care in a timely way. In addition, the FAH supports the Clinician Workgroup’s concerns with the multiple measures across federal programs targeting this issue and alignment of these measures would be consistent with the goals of the Meaningful Measures Initiative. The FAH does not believe that these measures have met the level of testing required to achieve “Conditional Support” and requests that the highest level of MAP recommendation be “Do Not Support With Potential For Mitigation”. Do not support current recommendation. (Submitted by: Federation of American Hospitals)
  
  
• While written comments were not provided, the commenter indicated their support for MAP's preliminary recommendation (Submitted by: American Psychiatric Association Foundation)
  
  
• The American Medical Association (AMA) continues to have significant concerns with the proposed inclusion of this measure in the Medicare Shared Savings Program (MSSP) because it was developed with the intention of determining the quality of care provided by prescription drug health plans, not for Accountable Care Organizations (ACOs). As a result, we do not believe that the measure has been adequately tested in the setting in which it will be applied and therefore it cannot receive a Conditional Support recommendation. The measure as currently specified requires access to health plan medical and pharmacy claims and member enrollment information; such data may not be readily available across all ACOs given their varying composition and access to pharmacy claims data. We refer the Coordinating Committee to our comments submitted prior to the Clinician Workgroup meeting for additional details. In light of this lack of testing demonstrating reliability and validity at the ACO level, the AMA recommends that the highest level of MAP recommendation be “Do Not Support With Potential For Mitigation” for this measure. (Submitted by: American Medical Association)
  
  
• The AANS disagrees with the fundamental premise of a measure that focuses only on daily dose and duration of therapy involving prescription opioid analgesics because on its own it is not a valid indicator of quality patient care. In fact, since the Centers for Disease Control & Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain was issued, there have been many reports of patients who have been successfully managed on opioid analgesics for long periods of time, and in whom the benefits of such therapy exceed the risks, of being forced to abruptly reduce or discontinue their medication regimens. Such involuntary tapers are associated with sometimes extremely adverse outcomes, including depression, anxiety and emergence of other mental health disorder, loss of function and the ability to perform daily activities, and even suicide. There has been considerable discussion of these unintended consequences at meetings of the HHS Interagency Pain Management Best Practices Task Force. Identifying those patients for whom the daily prescribed morphine milligram equivalents (MME) are considered high may serve as an indicator of whether a patient is at risk of overdose and should be co-prescribed naloxone, but it alone is not an appropriate marker of the quality of care provided. The CDC recommendations allow physicians to document a clinical rationale or justification when suggested dose levels are exceeded; yet, the existing measures that focus on MME do not capture if a justification exists nor do they provide a well-defined and targeted denominator. If CMS implements a measure that focuses on MME, it must adequately define the patients for whom higher doses of opioids may be appropriate. Otherwise, the measure will provide invalid representations of performance. In addition, the current measure specifications include buprenorphine, which is primarily used to treat opioid use disorder. CMS also should explore more appropriate methods to assess a patient’s chronic pain, including the use of patient-reported data as the basis for performance measures. Given these concerns, we do NOT recommend MUC18-78 Use of Opioids at High Dosage in Persons Without Cancer for implementation in the Medicare Shared Savings Program (MSSP) at this time. (Submitted by: American Association of Neurological Surgeons)
  
  
• the high dose measures (>90, >120) look impactful in terms of safety, and possible for our members to report on (Submitted by: OCHIN, Inc.)
  
  

• (Early public comment)NHPCO Comments: Include cancer patients receiving palliative care services in “excludes”. (Submitted by: National Hospice and Palliative Care Organization)
  
  
• (Early public comment)The AMA has the significant concerns with the proposed inclusion of this measure in MSSP, given the dearth of information on the feasibility of collecting and reporting pharmacy claims data and the lack of specifications and testing for the intended level of analysis (ACO). In addition, the current measure specifications include buprenorphine, which is primarily used to treat opioid use disorder. We believe that its inclusion is not consistent with the intent of this measure and it should be removed. After reviewing the performance scores provided during the NQF endorsement, we questioned whether this measure has adequate variation in scores to enable meaningful comparisons in performance because the testing results showed that less than a 2.5 percent difference existed between the minimum and maximum rates for the Medicare population and less than 5.5 percent difference existed for the Medicaid population. If similar rates were to be found when applied to ACOs, we believe that it will be difficult to distinguish better versus worse care; additionally, this measure must be adequately specified and tested across ACOs prior to its implementation in MSSP. Given the ongoing concerns with this measure and the number of proposed measures on opioid use that are similar and overlapping, the AMA recommends that the highest level of MAP recommendation be “Do Not Support With Potential For Mitigation”. (Submitted by: American Medical Association)
  
  
• (Early public comment)The Federation of American Hospitals questions CMS’ rationale for submitting four similar and potentially competing measures for consideration in MSSP. These duplicative measures seem to be contradictory to recent CMS efforts to streamline the number of measures in response to the Patients Over Paperwork initiative. We request that the MAP thoughtfully consider whether all of these measures should be recommended for potential implementation. In addition, while it is difficult to determine the underlying data source that will be used for MUC18-106 Initial opioid prescription compliant with CDC recommendations, we assume that all four measures will be derived from claims data. As a result, FAH has significant concerns with recommending these measures at this time. Specifically, it is not clear that the developers have demonstrated how well any of these measures perform within an accountable care organization (ACO). ACOs currently receive prescription claims data from CMS, which is not as robust and accurate on opioid utilization as would be required to ensure that these measures represent reliable and valid performance and limits an ACO’s ability to impact clinical care in a timely way. Therefore, the FAH requests that the highest level of MAP recommendation be “Do Not Support With Potential For Mitigation” for all four opioid-related measures proposed for MSSP. (Submitted by: Federation of American Hospitals)
  
  
• (Early public comment)The Pharmacy Quality Alliance (PQA), the measure steward of three of the opioid-related quality measures (listed here) on the Measures Under Consideration (MUC) List, supports CMS’ consideration of the measures for adoption in the designated federal program of the Medicare Shared Savings Program (MSSP) through rulemaking under Medicare. The three related measures, developed by PQA, address safe and appropriate prescribing of opioids by identifying cases with high potential of misuse/abuse of opioid analgesics: 1. Use of Opioids from Multiple Providers in Persons Without Cancer (MUC18-77) 2. Use of Opioids at High Dosage in Persons Without Cancer (MUC18-78) 3. Use of Opioids from Multiple Providers and at High Dosage in Persons Without Cancer (MUC18-79) The designated Medicare program for consideration of these three measures, the MSSP, encourages health care provider groups to come together as an Accountable Care Organization (ACO) to give coordinated, high quality care to their Medicare patients. With the stated goals of MSSP to promote accountability for a patient population, coordinate items and services for beneficiaries, incentivize investment in high quality and cost-efficient services, in the presence of the ever-increasing challenge of the opioid crisis, the inclusion of performance measures in the program to support safe prescribing of opioids is an important program update. Reinforcingly, PQA has received several unsolicited requests from ACOs interested in using the PQA opioid measures, offering an early positive indication of interest by these alternative payment model entities to support achievement of quality and cost goals. Lastly, the three PQA opioid measures developed in 2015 have been updated to align with the CDC Guideline for Prescribing Opioids for Chronic Pain published in 2016. The revised specifications for 2019 (measurement year 2018) were provided to CMS for the purpose of informing pre-rule making and Measure Application Partnership stakeholders. (Submitted by: Pharmacy Quality Alliance)
  
  
• (Early public comment)This measure is developed and tested for assessing PBMs. It is unclear if the measure can readily apply to ACOs. Moreover, ACOs do not administer the Part D benefit and have less control over these measures. CMS has sought comment on providing additional information to ACOs on Part D claims and incorporating Part D into ACO models. In the absence of more data or managing the benefit, ACOs should not be held accountable for these measures. However, since these are claims-based measures CMS should calculate the measures and provide ACO with confidential performance information. (Submitted by: Premier, Inc.)
  
  
• (Early public comment)This needs the CDC guideline exclusion of those receiving: palliative care. We would also note that others with serious illness or chronic pain may justifiably need these medications at higher/longer doses (Submitted by: CTAC)
  
  
• (Early public comment)To reduce provider burden, we recommend that 18-79 be computed by CMS from agency reporting on measures 18-77 and 18-78, and that 18-79 be eliminated as a measure. (Submitted by: National Assn for Behavioral Healthcare)
  
  
• (Early public comment)Updated PQA comment from what was sent yesterday The Pharmacy Quality Alliance (PQA), the measure steward of three of the opioid-related quality measures (listed here) on the Measures Under Consideration (MUC) List, supports CMS’ consideration of the measures for adoption in the designated federal program of the Medicare Shared Savings Program (MSSP) through rulemaking under Medicare. The three related PQA measures address safe prescribing of opioids by identifying prescribing patterns associated with increased risk of opioid overdose: 1. Use of Opioids from Multiple Providers in Persons Without Cancer (MUC18-77) 2. Use of Opioids at High Dosage in Persons Without Cancer (MUC18-78) 3. Use of Opioids from Multiple Providers and at High Dosage in Persons Without Cancer (MUC18-79) The designated Medicare program for consideration of these three measures, the MSSP, encourages health care provider groups to come together as an Accountable Care Organization (ACO) to give coordinated, high quality care to their Medicare patients. With the stated goals of MSSP to promote accountability for a patient population, coordinate items and services for beneficiaries, incentivize investment in high quality and cost-efficient services, in the presence of the ever-increasing challenge of the opioid crisis, the inclusion of performance measures in the program to support safe prescribing of opioids is an important program update. Reinforcingly, PQA has received several unsolicited requests from ACOs interested in using the PQA opioid measures, offering an early positive indication of interest by these alternative payment model entities to support achievement of quality and cost goals. Lastly, the three PQA opioid measures developed in 2015 have been updated to align with the CDC Guideline for Prescribing Opioids for Chronic Pain published in 2016. The revised specifications for 2019 (measurement year 2018) were provided to CMS for the purpose of informing pre-rule making and Measure Application Partnership stakeholders. (Submitted by: Pharmacy Quality Alliance)
  
  
• (Early public comment)We appreciate that this measure has exclusions for patients receiving hospice services, but suggest additional exclusions for palliative care. We note that this is consistent with the CDC Guideline that includes an exclusion for patients receiving palliative care. (Submitted by: Center to Advance Palliative Care)
  
  
• We support the MAP’s recommendation to not include this measure in MSSP. We echo the MAP’s desire to create parsimony in the MSSP measure set and agree that this measure is redundant with MUC18-77 and MUC18-78. (Submitted by: America's Health Insurance Plans)
  
  
• Support current MAP recommendation (Submitted by: Federation of American Hospitals)
  
  
• While written comments were not provided, the commenter indicated their support for MAP's preliminary recommendation (Submitted by: American Psychiatric Association Foundation)
  
  
• The American Medical Association supports the preliminary recommendation and associated conditions. (Submitted by: American Medical Association)
  
  
• the high dose measures (>90, >120) look impactful in terms of safety, and possible for our members to report on, but measures that involve prescriptions from multiple people sound challenging –clinical teams may feel like that is hard for them to impact (Submitted by: OCHIN, Inc.)
  
  

• (Early public comment) VIA: http://www.qualityforum.org/map/ December 6, 2018 Public Comment 2018 Measures Under Consideration Submitted via: Since 1982, the National Association for Home Care & Hospice (NAHC) has been the leading association representing the interests of hospices, home health, and home care providers across the nation, including the home caregiving staff and the patients and families they serve. Our members are providers of all sizes and types -- from small rural agencies to large national companies -- and include government-based providers, nonprofit voluntary hospices, privately-owned companies and public corporations. As such, we welcome the opportunity to comment on the CMS List of Measures Under Consideration for December 1, 2018. We are commenting on the following three measures: MUC18- 101 Transitions from Hospice Care, Followed by Death or Acute Care MUC18- 131 Transfer of Health Information to Patient—PostAcute Care MUC18- 135 Transfer of Health Information to Provider—PostAcute Care MUC18- 101 Transitions from Hospice Care, Followed by Death or Acute Care As we commented to CMS directly in 2018, we believe this measure falls short of providing a direct indicator of quality of care, has significant potential unintended consequences the least of which is confusion about a hospice’s performance amongst consumers. This raises concern, particularly relative to use of this measure for public reporting. We appreciate and understand the intent of this measure which is to assess negative outcomes following hospice live discharge, including acute care use shortly after discharge, as these outcomes represent potentially burdensome transitions to patients and families. We also appreciate the considerable expansion by CMS of the risk adjustment factors, based on previous public comment, to include a patient’s prior use of acute care services, social risk factors, setting of care while receiving hospice care, etc. We further appreciate that CMS would potentially plan a dry run of this measure, as indicated in its public comment summary report for this measure (August 2018), to determine if the measure is appropriate for public reporting. There is considerable potential for misunderstanding of this measure, and consequent unintended negative consequences. This was emphasized in the comments CMS received, and in its response, CMS stated “Finally, additional measure testing and refinement, including a potential measure dry run will aim to further address the potential unintended consequences of the measure.” We believe this additional measure testing and refinement is crucial to making the measure meaningful to providers and for providers to utilize the measure to inform improvement actions. The current measure specifications exclude the following types of patients: 1. Patients not continuously enrolled in Part A Medicare FFS in the 12 months prior to the hospice admission date, during the hospice stay, or at least 7 days following the hospice discharge date 2. Patients enrolled in Medicare Advantage in the 12 months prior to the hospice admission date, during the hospice stay, or in the 7 days following the hospice discharge date. 3. Patients who are under 18 years old at hospice admission. The most current data shows that in 2016 51.9% of Medicare Advantage (MA) beneficiaries utilized hospice care. There is currently no way for CMS to capture the necessary claims data to include MA beneficiaries in the measure calculation. We believe that leaving these patients out of the measure reduces its usefulness. Additionally, in hospice care there are various discharge codes depending on the reason that the patient is leaving service and the measure specifications include all of them. Patients may revoke service or be discharged or transferred because they have moved out of the area or gone for an extended stay with family members. Patients may be discharged because they (without knowledge of the hospice) admitted themselves to a hospital at which the hospice may not have a contract and cannot continue to treat the patient. Veterans may decide to be served at a VA facility, which requires discharge from hospice care. Patients may also be discharged because they are determined to be no longer be eligible for hospice services. Further, cause for discharge may vary widely depending on market and/or geographic factors. These factors have the potential to dramatically impact some hospices while having little to no impact on others in a different area of a state, region or the country. CMS should consider excluding certain types of live discharges and circumstances surrounding them, including discharges for cause, revocations, transfers, and discharges due to the patient moving out of the service. All of these are, in large part, beyond a hospice’s control. In its review of comments submitted to CMS on this measure, CMS addressed the ways it would intend to handle these types of discharges. Even with some of the risk adjustments CMS intends to make, it appears that CMS would retain a significant number of reasons for live discharge reflecting situations that are out of the hospice’s control and for which they could be penalized. This is especially true of transfer situations. In looking at this proposed measure, it is notable that there is not a consideration of whether the acute care a patient may seek after hospice care is aligned with the patient’s goals. We believe that measures assessing goal attainment and specifically whether a patient’s goals of care align with the care received are more meaningful and could be utilized for hospice performance improvement and consumer education much more efficiently and effectively than the proposed transitions of care measure. If the measure is used in the hospice quality reporting program it is critical that a dry run be implemented and results critically analyzed before any public reporting. If this measure is used for public reporting there must be a clear explanation of the measure, in layman’s terms, that accompanies the posting. MUC18- 131 Transfer of Health Information to Patient—PostAcute Care, and MUC18- 135 Transfer of Health Information to Provider—PostAcute Care In both of these measures under consideration, the assessment items used to record the data have not been finalized and thus are not available for review nor is a draft version showing how the measures might be revised in light of the feedback CMS received from its request for public comment. These are necessary for full consideration of the measure especially since many of the comments submitted by stakeholders on these measures were related to the data source (assessment items) directly. One of the assessment items in particular, Route of Transmission, is of particular concern. NAHC does not support including this question as part of the comprehensive assessment. There is no correlation between the route of transmission and quality of care provided by post-acute care providers and home health in particular. It is unclear why it is important for providers or the public to have this information or what might be gained from having the information . It cannot be assumed that one route is preferred above another, and therefore, reporting the route of transmission without context is not meaningful for utilization by providers in performance improvement or for patients/caregivers/consumers. In fact, there was disagreement within the Technical Expert Panel (TEP) convened by CMS on the route of transmission assessment item. The only exclusion for these measures is patients who died. In the comments provided to CMS when stakeholder input was solicited on this measure, NAHC recommended the exclusion of any patient from the measure calculation where the home health agency assessment data identifies that the HHA was not made of a transfer timely. NAHC is concerned that if untimely transfers are not accounted for in the measure calculation, the measure rate for HHAs could be artificially low. Unlike the facility-based providers, some portion of HHA patients and the providers to which they transfer might not receive a medication profile at transfer for reasons out of the home health agency’s control. This could have unintended consequences for HHAs when used as a cross setting measure with other post- acute care providers. The second of these measures, MUC18- 135, includes the transfer of medication information when a patient is being transferred to settings including: • Private home/ apartment (apt.), • Board/care, • Assisted living, • Group home, • Transitional living or • Home under care of organized home health service organization or hospice It is unclear as to why a home health agency would need to provide a medication profile to the patient, family and/or caregiver in a transfer to another home health service organization or hospice as the patient would continue to receive care by the other home health service organization or hospice and the medication profile would be shared with this provider as a matter of practice. Thank you for this opportunity to provide input on these measures under consideration. We recognize the MAP’s overall timeframe for reviewing these measures is tight and appreciate having the opportunity to provide feedback. However, the timeframe given for public commenting is limited to five business days which makes it somewhat difficult to review the measures in context and formulate comments. If there is any way in the future to extend this review period it would be much appreciated. Please do not hesitate to contact us if our comments require clarification in any way. Sincerely, Katie Wehri Katie Wehri Director, Home Care & Hospice Regulatory Affairs (Submitted by: National Association for Home Care & Hospice (NAHC))
  
  
• (Early public comment)Live discharges that are the result of a patient revoking his or her election of the hospice benefit, or moving out of the hospice’s service area, should not be included in the proposed measure. The Medicare hospice regulations are clear that “an individual or representative may revoke the individual’s election of hospice care at any time during an election period.” (42 CFR §418.28(a)) Despite counseling and recommendations from the hospice, patients continue to have a right to revert to the traditional Medicare benefit at any time. Their choosing to exercise that right should not be a direct reflection on the quality of care provided by the hospice. Similarly, when a patient is discharged after they choose to move outside a hospice’s service area, those discharges also should be excluded from the measure. Discharges from hospice followed by an inpatient hospital admission may occur for a variety of reasons, some of which may be related to the hospice’s quality and some of which may be due to factors beyond their control, such as the refusal of hospitals in their service area to contract with them for beds to provide General Inpatient Care (GIP). One way to focus the measure on factors closer to a hospice provider’s control would be to reduce from 7 days to 1 day the period during which an inpatient hospital admission, ED visit, or observation stay would be counted in the measure numerator. This approach still would not completely account for the contracting practices of the hospitals in a hospice’s service area. This issue underscores the point that the proposed measure is at best a crude measure of care quality because it will be next to impossible to adjust for all the factors that are beyond a hospice’s control. Hospices must carefully evaluate their patients’ clinical conditions when deciding whether to admit them and periodically thereafter to make sure they continue to meet the benefit’s eligibility criteria. Some patients’ conditions improve while they are receiving hospice care to the point where they no longer meet the eligibility criteria but are still severely ill and medically fragile. Our members’ experience is that a significant portion of their patients appear to be relatively stable, are therefore discharged from hospice for no longer meeting the eligibility criteria, and then die within a matter of a few weeks. Many of these patients would be captured in the 30-day post-discharge period of the current measure specifications, which does not seem to be a fair measure of the hospice’s quality of care. This is particularly true in the current regulatory environment, in which Medicare contractors’ erroneous interpretation that patients must be experiencing continuous decline in order to be hospice eligible is forcing live discharges from hospice that are not consistent with the intent or letter of the law or regulations. A shorter period, such as 7 or 14 days, to observe post-discharge deaths would still capture inappropriate discharges of medically unstable patients, while excluding patients who are discharged in relatively stable condition but still seriously ill and facing imminent end of life. Certain discharges from hospice to an inpatient hospital followed by death may be planned and in accordance with the patient’s plan of care. One of our member hospices is a preferred provider for the local Veterans Administration health system, and many patients referred by the VA are admitted to this hospice with a plan for the hospice agency to care for them at home for as long as possible and then to transfer them to the palliative care unit of a local inpatient VA facility for their final days. This would of course appear to Medicare as a live discharge followed by death within 30 days. We recommend excluding patients discharged to palliative care unit of an inpatient VA hospital so as not to penalize hospices who have a relationship with their local VAs and would be more likely to admit patients with this sort of plan for end of life. State CON laws can affect whether a hospice provider must discharge a patient who has been admitted to a nearby inpatient hospital that is outside of the hospice’s service area. We suggest exploring the impact of adding a binary (yes/no) variable to the risk adjustment algorithm reflecting the presence of a State CON law that includes hospice providers. The presence of a “Do Not Resuscitate” (DNR) code for a hospice patient is another variable beyond a hospice’s control that should be included in the risk adjustment methodology. All else being equal, a patient’s DNR code would affect a hospice’s rate of deaths within 30 days following discharge. It is our understanding that DNR codes are not included in Medicare claims data, but we urge RTI to investigate if other Medicare data sources that capture whether a beneficiary had a DNR code could be added to the measure’s risk adjustment formula. (Submitted by: National Partnership for Hospice Innovation)
  
  
• (Early public comment)NHPCO Comments: NHPCO shares the concern about hospices with higher rates of live discharges and higher rates of negative outcomes after live discharge. While we have concerns about live discharges, the measure should recognize that there will always be live discharges in hospice – either by patient choice to revoke or transfer or by a hospice-initiated discharge for patients whose condition has stabilized, have moved out of the hospice’s service area or for whom the discharge is for cause. As NHPCO commented on the draft measure specifications for this measure in April 2018, we continue to be concerned that there is no mention in the rationale or in the documentation provided with this MUC list that shares the measure’s intent to include all live discharges, regardless of reason. While the measure is targeting hospices with very high rates of live discharge, this broad-based, all reasons for live discharge inclusion may cause concern among providers about live-discharging patients when a live discharge is appropriate. Some language in the rationale or background on this measure must address that issue. The rationale states that ” [2] Measuring transitions among hospice patients and assessing outcomes following transitions from hospice care can therefore provide valuable information about hospices’ quality of care.” NHPCO’s ongoing concern is that by only using claims data, there will be no opportunity to assess the patient’s individual circumstances and reasons for live discharge. How can the hospice’s quality of care be determined by claims data and coded reasons for discharge? The exclusions list for this measure does not include patients who were discharged alive or transferred, receiving care continuously but from another hospice provider. Would this live discharge or transfer count as a discharge in the numerator? We continue to be concerned that this quality measure is derived from claims information only. The claims data will be able to determine the reason for the live discharge, but no other details about the care or the reasons for the discharge. NHPCO strongly urges NQF to investigate additional ways to gather information on live discharge and subsequent Medicare services. (Submitted by: National Hospice and Palliative Care Organization)
  
  
• (Early public comment)This measure will provide more information to examine outcomes post hospice discharge, and could inform improvements in care and future policy changes. (Submitted by: Center to Advance Palliative Care)
  
  
• (Early public comment)We support this measure although urge NQF and CMS to find further ways to dimensionalize why some patients may justifiable leave hospice care before death. (Submitted by: CTAC)
  
  
• The National Coalition for Hospice and Palliative Care appreciates the Clinician Workgroup’s deliberation on this measure. After reviewing the Workgroup’s proceedings, we agree with the MAP’s preliminary decision “Do Not Support with Potential for Mitigation.” While this measure has potential to improve care transitions for patients nearing the end of life, we are concerned that the measure does not fully consider the reasons why a patient may be discharged from hospice, including the patient’s culture and/or beliefs or the patient’s own stated goals of care within a disease process. Cultural factors may include the delay of hospice election and the belief that death at home may not be culturally acceptable. This should not be considered a failure, but rather respect for cultural beliefs. In addition, clarity about the reasons for live discharge must be explored fully, including the patient’s choice to either revoke their hospice benefit or transfer to another hospice. We also agree with the assessment that the metric is trying to capture too many points of information. Therefore, we agree with the Workgroup’s recommendations to: 1. Reconsider the exclusion criteria to add Medicare Advantage patients and allow for patient choice 2. Conduct further analysis to determine the measure’s impact on small hospices 3. Separate concepts addressed within the measure (death within 30 days, admission to acute care within 7 days), so that it does not attempt to measure multiple issues at the same time. 4. Shorten the timeframe for the measure 5. Consider a dry run of the measure before publicly reporting results 6. Explore conducting a survey of patients with live discharge from hospice to better understand this phenomenon (and how it relates to patients’ needs and reasons for discharge.) (Submitted by: National Coalition for Hospice and Palliative Care)
  
  
• The Center to Advance Palliative Care appreciates the Clinician Workgroup’s deliberation on this measure. After reviewing the Workgroup’s proceedings, we agree with the MAP’s preliminary decision “Do Not Support with Potential for Mitigation.” While this measure has potential to improve care transitions for patients nearing the end of life, we are concerned that the measure does not fully consider the reasons why a patient may be discharged from hospice, including the patient’s culture and/or beliefs or the patient’s own stated goals of care within a disease process. Cultural factors may include the delay of hospice election and the belief that death at home may not be culturally acceptable. This should not be considered a failure, but rather respect for cultural beliefs. In addition, clarity about the reasons for live discharge must be explored fully, including the patient’s choice to either revoke their hospice benefit or transfer to another hospice. We also agree with the assessment that the metric is trying to capture too many points of information. Therefore, we agree with the Workgroup’s recommendations to: 1. Reconsider the exclusion criteria to add Medicare Advantage patients and allow for patient choice 2. Conduct further analysis to determine the measure’s impact on small hospices 3. Separate concepts addressed within the measure (death within 30 days, admission to acute care within 7 days), so that it does not attempt to measure multiple issues at the same time. 4. Shorten the timeframe for the measure 5. Consider a dry run of the measure before publicly reporting results 6. Explore conducting a survey of patients with live discharge from hospice to better understand this phenomenon (and how it relates to patients’ needs and reasons for discharge.) (Submitted by: Center to Advance Palliative Care)
  
  
• Since 1982, the National Association for Home Care & Hospice (NAHC) has been the leading association representing the interests of hospices, home health, and home care providers across the nation, including the home caregiving staff and the patients and families they serve. Our members are providers of all sizes and types -- from small rural agencies to large national companies -- and include government-based providers, nonprofit voluntary hospices, privately-owned companies and public corporations. As such, we welcome the opportunity to comment on the MAP’s Draft Recommendations of the CMS List of Measures Under Consideration for December 1, 2018. We are commenting on the following three measures: MUC18- 101 Transitions from Hospice Care, Followed by Death or Acute Care MUC18- 131 Transfer of Health Information to Patient—PostAcute Care MUC18- 135 Transfer of Health Information to Provider—PostAcute Care MUC18- 101 Transitions from Hospice Care, Followed by Death or Acute Care As we commented to CMS directly in 2018 and again in our comments dated December 6, 2018 on the CMS List of Measures Under Consideration, we believe this measure falls short of providing a direct indicator of quality of care, has significant potential unintended consequences the least of which is confusion about a hospice’s performance amongst consumers. This raises concern, particularly relative to use of this measure for public reporting. We appreciate and understand the intent of this measure which is to assess negative outcomes following hospice live discharge, including acute care use shortly after discharge, as these outcomes represent potentially burdensome transitions to patients and families. We appreciate the MAP’s preliminary decision of “Do Not Support With Potential For Mitigation”. The MAP rationale for this decision brings forth many of the concerns NAHC and its members have with this measure. As we stated previously, there is considerable potential for misunderstanding of this measure, and consequent unintended negative consequences. We especially agree with the MAP’s recommendation that CMS reconsider exclusions for the measure and the MAP suggestion that there be a dry run of the measure before public reporting. There are many types of live discharges and circumstances surrounding them, including discharges for cause, revocations, transfers, discharges due to the patient moving out of the service area and discharges for patients determined to not be terminally ill. Most all of these, in large part, are beyond a hospice’s control. In its review of comments submitted to CMS on this measure, CMS addressed the ways it would intend to handle these types of discharges. Even with some of the risk adjustments CMS intends to make, it appears that CMS would retain a significant number of reasons for live discharge reflecting situations that are out of the hospice’s control and for which they could be penalized. If the measure is used in the hospice quality reporting program it is critical that a dry run be implemented and results critically analyzed before any public reporting. If this measure is used for public reporting there must be a clear explanation of the measure, in layman’s terms, that accompanies the posting. MUC18- 131 Transfer of Health Information to Patient—PostAcute Care, and MUC18- 135 Transfer of Health Information to Provider—PostAcute Care NAHC is pleased that the MAP has not wholeheartedly given a preliminary approval of these measures. We appreciate that the MAP recognizes the importance of the ability to transfer certain health information to the next provider of care. However, in both of these measures under consideration, the assessment items used to record the data have not been finalized and thus are not available for review nor is a draft version showing how the measures might be revised in light of the feedback CMS received from its request for public comment. These are necessary for full consideration of the measure especially since many of the comments submitted by stakeholders on these measures were related to the data source (assessment items) directly. One of the assessment items in particular, Route of Transmission, is of particular concern. The MAP appreciates the ability to utilize different modes of transmission and NAHC acknowledges this ability as beneficial as well. However, NAHC does not support including this question as part of the comprehensive assessment. There is no correlation between the route of transmission and quality of care provided by post-acute care providers and home health in particular. It is unclear why it is important for providers or the public to have this information or what might be gained from having the information . It cannot be assumed that one route is preferred above another, and therefore, reporting the route of transmission without context is not meaningful for utilization by providers in performance improvement or for patients/caregivers/consumers. In fact, there was disagreement within the Technical Expert Panel (TEP) convened by CMS on the route of transmission assessment item. The only exclusion for these measures is patients who died. In the comments provided to CMS when stakeholder input was solicited on this measure, NAHC recommended the exclusion of any patient from the measure calculation where the home health agency assessment data identifies that the HHA was not made aware of a transfer timely. NAHC is concerned that if untimely transfers are not accounted for in the measure calculation, the measure rate for HHAs could be artificially low. Unlike the facility-based providers, some portion of HHA patients and the providers to which they transfer might not receive a medication profile at transfer for reasons out of the home health agency’s control including the agency not being made aware of the transfer timely. This could have unintended consequences for HHAs when used as a cross setting measure with other post- acute care providers. The MAP made a preliminary recommendation of “Conditional Support for Rulemaking” for the second of these measures, MUC18- 135. This measure includes the transfer of medication information when a patient is being transferred to settings including: • Private home/ apartment (apt.), • Board/care, • Assisted living, • Group home, • Transitional living or • Home under care of organized home health service organization or hospice It is unclear as to why a home health agency would need to provide a medication profile to the patient, family and/or caregiver in a transfer to another home health service organization or hospice as the patient would continue to receive care by the other home health service organization or hospice and the medication profile would be shared with this provider as a matter of practice. Thank you for this opportunity to provide input on these preliminary recommendations. Please do not hesitate to contact us if our comments require clarification in any way. Sincerely, Katie Wehri Director, Home Care & Hospice Regulatory Affairs (Submitted by: National Association for Home Care & Hospice)
  
  
• We believe that this measure has too many and often unclear objectives. While difficult transitions occur, the measure approach risks too many unintended consequences. Specifically, revocation impact is a big concern. (Submitted by: American Geriatrics Society)
  
  
• The National Hospice and Palliative Care Organization appreciates the opportunity to be a part of the Clinician Workgroup’s deliberation on this measure. As we indicated in the discussions, we agree with the MAP’s preliminary decision “Do Not Support with Potential for Mitigation.” We support measures that will improve care transitions for patients nearing the end of life. However, we believe that the design of this measure is too broad and is trying to address disparate concepts in one measure, specifically by including both death within 30 days and admission to an acute care facility within seven days. In addition, we continue to be concerned that the measure, as currently written, does not differentiate between the reasons for a patient’s choice to revoke or transfer to another hospice and the hospice’s responsibility for making the decision to discharge a patient alive. A patient always has the right to revoke their hospice election, whether it is to pursue one last aggressive treatment, cultural beliefs that influence the definition of a good death or the location of death, or the need to revoke the hospice benefit to avoid a financial penalty for seeking more acute care. The hospice has the decision to live discharge a patient whose disease process has slowed or stabilized, who has moved out of the service area, or is discharged for cause. We agree with the Workgroup’s recommendations to: 1. Reconsider the exclusion criteria for Medicare Advantage patients as it may exclude too many patients 2. Consider adding an exclusion to allow for patient choice, as there are valid reasons why a patient may choose to transition from hospice 3. Conduct further analysis and provide guidance to determine the measure’s impact on hospices with a low volume of patients 4. Examine the use of a predicted to expected ratio 5. Separate concepts addressed within the measure (death within 30 days, admission to acute care within 7 days) 6. Shorten the timeframe for the measure, including admission to acute care within 1-2 days and death within 7-14 days as an option 7. Consider a dry run or pilot test of the measure before considering public reporting of results 8. Explore conducting a survey of patients who have revoked their hospice benefit, transferred to another hospice or who have been discharged alive by the hospice to better understand this phenomenon and how it relates to patients’ needs and reasons for revocation, transfer or discharge. (Submitted by: NHPCO)
  
  
• The AHA agrees with the MAP recommendation of Do Not Support- Potential for Mitigation. We understand that transitions from hospice are associated with adverse health outcomes, higher costs, fragmentation of care delivery, and lower patient and family satisfaction; however, we have both conceptual and logistical concerns with this measure that should preclude it from inclusion in the Hospice Quality Reporting Program. Conceptually, it is unclear what the goal of this measure is. There will never be zero hospice discharges, as there are valid reasons for patient transitions including patient preferences. It is our impression that patients commonly choose to be discharged from the hospice to go home for their final days; this measure might create incentives for hospices to act against patient wishes. Logistically, we are concerned about using claims data to inform quality measures. Claims data, specifically codes for reason for discharge, does not adequately capture patient-level factors including preferences. Further, the 30-day window is too long for the purposes of this measure; including deaths within this window would not accurately capture only patients whose care would have been better managed within the hospice. This measure could potentially be useful if it were stratified or specified around specific types of discharges and a narrower timeframe to better capture inappropriate transitions, but currently this measure is not appropriate for inclusion in a CMS program. (Submitted by: American Hospital Association)
  
  
• When a patient enters hospice, their goals and treatment plan change. When a patient is discharged from hospice, their goals of care and treatment plan may shift again. While in hospice care, the treatment goals are not to avoid death, but to maintain comfort and quality of life. Since the goal of care and outcome of death do not align, it does not make sense to hold hospice providers responsible for outcomes of care that happen after discharge. On the other hand, patients who were recently discharged from hospice are different than those who have continually been under a more aggressive treatment plan. The CMS mortality measures excludes patients who were enrolled in hospice anytime in the 12 months prior to hospitalization for this reason. This proposed measure seems to be an indirect method for detecting potential early and/or inappropriate discharge from hospice care. This measure may not be the best way to assess that and other measures should be explored. (Submitted by: Sanford Health)
  
  

• (Early public comment)The AANS and CNS do not believe that the measure accurately reflects the recommendations outlined in the Centers for Disease Control & Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain, such as the numerator’s requirement for a daily dose and duration of therapy without the ability to capture instances where it may be clinically appropriate to exceed 90 morphine milligram equivalents (MME) per day. In addition, we question the limit of 50 morphine milligram equivalents (MME) per day for an initial dose, as it is not specifically recommended in the guideline and the numerator requirement that the “initial opioid prescription is not for methadone” appears intended to further refine the patient population and may be better suited as an exclusion. Given these concerns, we do NOT recommend MUC 18–106 Initial Opioid Prescription Compliant with CDC Recommendations for implementation in the Medicare Shared Savings Program (MSSP) at this time. (Submitted by: American Association of Neurological Surgeons )
  
  
• (Early public comment)The CDC recommendations, known as the CDC Guideline for Prescribing Opioids for Chronic Pain, are meant to guide primary care physicians prescribing opioids for chronic pain. As crafted, this measure suggests that the CDC Guideline should be applied to all care providers, regardless of practice setting and across the board for all patients, including those with acute pain following a procedure or surgery and those suffering from a chronic pain condition. ASA cautions against improperly applying the CDC Guideline; a one-size fits all policy does not work for all patients and can have unintended consequences. For example, mandating that a patient experiencing acute pain following surgery be subject to the CDC Guideline could result in that patient experiencing chronic pain down the road, as untreated acute pain is a risk factor for developing chronic pain. Additionally, limiting prescriptions to 7-days for acute pain is especially problematic for patients undergoing certain invasive surgeries, such as amputation, thoracotomy, total knee replacement or hernia. We are concerned about how pain medicine specialists and anesthesiologists would be impacted by this measure. Pain medicine specialists and anesthesiologists have additional training, education and board certification that enable them to treat patients suffering from acute pain to complex chronic pain conditions. Anesthesiologists, treating acute pain, can best determine the appropriate pain treatment following surgery. (Submitted by: American Society of Anesthesiologists (ASA))
  
  
• (Early public comment)The Federation of American Hospitals questions CMS’ rationale for submitting four similar and potentially competing measures for consideration in MSSP. These duplicative measures seem to be contradictory to recent CMS efforts to streamline the number of measures in response to the Patients Over Paperwork initiative. We request that the MAP thoughtfully consider whether all of these measures should be recommended for potential implementation. In addition, while it is difficult to determine the underlying data source that will be used for MUC18-106 Initial opioid prescription compliant with CDC recommendations, we assume that all four measures will be derived from claims data. As a result, FAH has significant concerns with recommending these measures at this time. Specifically, it is not clear that the developers have demonstrated how well any of these measures perform within an accountable care organization (ACO). ACOs currently receive prescription claims data from CMS, which is not as robust and accurate on opioid utilization as would be required to ensure that these measures represent reliable and valid performance and limits an ACO’s ability to impact clinical care in a timely way. Therefore, the FAH requests that the highest level of MAP recommendation be “Do Not Support With Potential For Mitigation” for all four opioid-related measures proposed for MSSP. (Submitted by: Federation of American Hospitals)
  
  
• (Early public comment)We do not support this measure. It is based on CDC guidelines, which are for chronic pain only so don’t apply to initial prescription. It is good that this includes all the populations excluded in the CDC guidelines but, again, there are others for whom doses for acute pain may be outside of CDC recommendations, for instance if they have a higher opioid tolerance from a previous history of substance use but are in active treatment for it. (Submitted by: CTAC)
  
  
• (Early public comment)While it is difficult to adequately assess the appropriateness of this measure for the MSSP given the limited information available for public comment, the AMA has significant concerns with many of the components included in this composite and the lack of precision in the measure specifications. Specifically, we do not believe that the measure accurately reflects the recommendations outlined in the Centers for Disease Control & Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain, such as the numerator’s requirement for a daily dose and duration of therapy without the ability to capture instances where it may be clinically appropriate to exceed 90 morphine milligram equivalents (MME) per day. In addition, we question the limit of 50 morphine milligram equivalents (MME) per day for an initial dose, as it is not specifically recommended in the guideline and the numerator requirement that the “initial opioid prescription is not for methadone” appears intended to further refine the patient population and may be better suited as an exclusion. Given the significant concerns with this measure and the number of similar and overlapping measures on opioid use proposed, the AMA recommends that the highest level of MAP recommendation be “Do Not Support”. (Submitted by: American Medical Association)
  
  
• (Early public comment)While we appreciate that this measure has exclusions for malignant cancer, chemotherapy, or radiation in the measurement year, hospice, palliative care, and those in LTC, nursing homes, and SNFs in the measurement year, there is more work to be done before it is ready for use in the MSSP. The CDC Guideline was developed for chronic pain and not for newly diagnosed pain. Furthermore, we urge the measure steward to consider additional exclusions, since other conditions, including non-malignant cancer, can still result in significant pain. (Submitted by: Center to Advance Palliative Care)
  
  
• We support the MAP’s recommendation to not include this measure in MSSP but consider the measure for future rulemaking. We recommend that, in addition to testing the measure at the ACO level, the measure developers work to harmonize the measure with other opioid use disorder measures being considered for use in this program. (Submitted by: America's Health Insurance Plans)
  
  
• Support current MAP recommendation (Submitted by: Federation of American Hospitals)
  
  
• APAF agrees this measure domain is necessary. However, we would request to see the test data that demonstrates its use for the specified measurement-level. (Submitted by: American Psychiatric Association Foundation)
  
  
• The American Medical Association supports the preliminary recommendation and associated conditions. (Submitted by: American Medical Association)
  
  
• The AANS does not believe that the measure accurately reflects the recommendations outlined in the Centers for Disease Control & Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain, such as the numerator’s requirement for a daily dose and duration of therapy without the ability to capture instances where it may be clinically appropriate to exceed 90 morphine milligram equivalents (MME) per day. In addition, we question the limit of 50 morphine milligram equivalents (MME) per day for an initial dose, as it is not specifically recommended in the guideline and the numerator requirement that the “initial opioid prescription is not for methadone” appears intended to further refine the patient population and may be better suited as an exclusion. Given these concerns, we do NOT recommend MUC 18–106 Initial Opioid Prescription Compliant with CDC Recommendations for implementation in the Medicare Shared Savings Program (MSSP) at this time. (Submitted by: American Association of Neurological Surgeons)
  
  

• (Early public comment)American Association for Homecare, the national organization representing home medical equipment (HME) suppliers, manufacturers, and other HME stakeholders, would like to submit comments in support for the quality measure concept referenced in MUC 2018-107 - Hospital Harm - Pressure Injury. We believe this measure will improve patient care and reduce costs by encouraging hospitals to adopt evidence-driven procedures. (Submitted by: American Association for Homecare)
  
  
• (Early public comment)December 5, 2018 National Quality Forum Submission of Open Comment for Measures Under Consideration December 1st, 2018 Weblink: http://www.qualityforum.org/map/ As the Public Policy Committee of NPUAP, and the Board of Directors we are reaching out to you to respond to the open comment period for Measures Under Consideration dated 12/1/18. The National Pressure Ulcer Advisory Panel (NPUAP) is an independent, not-for-profit professional organization dedicated to the prevention and management of pressure injuries. Formed in 1987, the NPUAP Board of Directors is composed of leading experts from different health care disciplines—all of whom share a commitment to the prevention and management of pressure injuries. The NPUAP serves as a resource to health care professionals, government, the public, and health care agencies; and welcomes and encourages the participation of those interested in pressure injury issues through utilization of NPUAP educational materials, participation at national conferences, and support of efforts in public policy, education and research. The NPUAP supports MUC18-107 Hospital Harm – Pressure Injury, page 18. NPUAP is pleased to see the adoption of terminology consistent with the 2016 NPUAP Pressure Injury Staging System. We would strongly recommend that any supporting materials produced in relation to this measure are consistent with the definitions proposed by NPUAP for pressure injury, Stage 2, Stage 3, Stage 4, deep tissue pressure injury (DTPI) and unstageable pressure injury. (Edsberg, 2017 and http://www.npuap.org/resources/educational-and-clinical-resources/npuap-pressure-injury-stages/ NPUAP Position on Staging, 2017) NPUAP realizes that coding of DTPI using the ICD-10 classification system requires “work-arounds”. The NPUAP has worked with its international guideline partners (European Pressure Ulcer Advisory Panel – EPUAP and Pan Pacific Pressure Injury Alliance -PPPIA) to ensure there are ICD-11 codes for Stage 1, Stage 2, Stage 3, Stage 4, DTPI and unstageable pressure injuries. Pressure injury is listed as a synonym for “pressure ulceration” in ICD-11. There has been some debate within the health care community regarding which stages/categories of pressure injuries should be reported as measures of quality. The NPUAP believes that that 5 stages/categories selected for this measure are appropriate choices. Pressure injury rates are often reported under a general category of “Stage 2 and greater”. While this measure provides a gross measure of hospital acquired pressure injury (HAPI) rates; it can be somewhat misleading. During the 2017 NPUAP Annual Conference, data from National Database of Nursing Quality Indicators (NDNQI) were presented indicating that, although the rate of “Stage 2 and greater” HAPI had been declining for over a decade, the proportions of more severe pressure injuries (Stage 3, Stage 4, DTPI and Unstageable Pressure Injuries) were increasing. (Cuddigan, 2017). This trend has been recently verified using data from multiple national databases (Kayser, et al, 2018; Smith, et al., 2018). When possible, we encourage facilities to analyze HAPI data by stage/category for a better understanding of the data and a more focused approach to quality improvement initiatives. NPUAP has a few points of clarification and would welcome further discussion: 1. In Measures Under Consideration, page 18, Appendix A: Measure Specifications, page 39 Measure Title “Hospital Harm-Pressure Injury” with further discussion in Appendix B: Measure Rationale, page 70: ? “This measure assesses the rate at which new hospital acquired pressure injuries occur during an acute care hospitalization.” Obviously, this includes patients who are pressure injury free on admission and develop a “new” pressure injury 24 or more hours after admission. Will it include patients with pressure injury(ies) on admission who develop additional “new” pressure injuries? ? No exclusions are listed. In the absence of exclusion criteria, will there be opportunities for risk adjustment? ? Is there any provision for measuring “worsening” of existing pressure injuries? If yes, how would “worsening” be operationally defined? ? “Newly developed” is operationally defined as “not documented within the first 24 hours of arrival at the hospital”. This provides important written clarification. ? Some have suggested that the timeframe for determining “Present on Admission – POA” status for Deep Tissue Pressure Injury (DTPI), be extended to 48 hours. Descriptive studies of the natural history of DTPI indicate that deep tissue injury may occur 48 hours or more before it can be detected by clinicians through visual inspection or palpation. (Black, et al, 2015; Honaker, et al. 2014). As part of their revision of the 2019 International Guideline on Pressure Injury/Ulcer Prevention and Treatment, the NPUAP, EPUAP and PPPIA are reviewing the evidence on the natural history DTPI and the reliability and validity of technologies designed to detect DTPI at earlier stages. After the international guideline is released in November 2019, the NPUAP would be happy to discuss whether the evidence justifies extension of the POA timeframe for DTPI. NPUAP would be happy to continue our ongoing collaboration with NQF and CMS to support the educational needs associated with the full understanding of these terms necessary for accurate clinical classification/staging. Thank you for the opportunity to comment Sincerely, Sarah Holden-Mount, PT, CWS Public Policy Chair Mary Litchford, PhD, RDN, LDN President Janet Cuddigan, PhD, RN, CWCN, FAAN President-Elect References: 1. Black, J.M., C.T. Brindle, and J.S. Honaker, Differential diagnosis of suspected deep tissue injury. Int Wound J, 2015. 2. Cuddigan, J., NDNQI: Getting the Numbers --- Pressure Injuries Across the U.S., in NPUAP 2017 Biennial Conference -- Pressure Injury: Advancing the Vision. 2017, National Pressure Ulcer Advisory Panel: New Orleans, LA. 3. Edsberg, L.E., et al., Revised National Pressure Ulcer Advisory Panel Pressure Injury Staging System: Revised Pressure Injury Staging System. J Wound Ostomy Continence Nurs, 2016. 43(6): p. 585-597. 4. Honaker, J., D. Brockopp, and K. Moe, Suspected deep tissue injury profile: a pilot study. Adv Skin Wound Care, 2014. 27(3): p. 133-40; quiz 141-2. 5. Kayser, S.A., C.A. VanGilder, and C. Lachenbruch, Predictors of superficial and severe hospital-acquired pressure injuries: A cross-sectional study using the international pressure ulcer prevalence survey. Int J Nurs Stud, 2018. 89: p. 46-52. 6. National Pressure Ulcer Advisory Panel. National Pressure Ulcer Advisory Panel (NPUAP) announces a change in terminology from pressure ulcer to pressure injury and updates the stages of pressure injury. 2016 June 14, 2016]; Available from: http://www.npuap.org/resources/educational-and-clinical-resources/npuap-pressure-injury-stages/. 7. National Pressure Ulcer Advisory Panel. NPUAP Position Statement on Staging - 2017 Clarifications 2017 January 24, 2017; Available from: http://www.npuap.org/wp-content/uploads/2012/01/NPUAP-Position-Statement-on-Staging-Jan-2017.pdf. 8. Smith, S., et al., Success In Hospital-Acquired Pressure Ulcer Prevention: A Tale In Two Data Sets. Health Aff (Millwood), 2018. 37(11): p. 1787-1796. (Submitted by: National Pressure Ulcer Advisory Panel)
  
  
• (Early public comment)Measure: MUC18-107 - Hospital Harm - Pressure Injury (For CMS Programs: HIQR; EHR Incentive/EH/CAH) The Advanced Medical Technology Association (AdvaMed) would like to express support for the quality measure concept referenced in MUC18-107 - Hospital Harm - Pressure Injury (For CMS Programs: HIQR; EHR Incentive/EH/CAH). Capturing the wide array of pressure injury types (newly developed stage 2, stage 3, stage 4, deep tissue pressure injury or unstageable pressure injury) will focus hospital efforts on reducing the risk of these hospital-acquired conditions (HAC), which according to the Agency for Healthcare Research and Quality (AHRQ) National Scorecard on Hospital-Acquired Conditions (June 2018), are on the rise (https://www.ahrq.gov/sites/default/files/wysiwyg/data/infographics/hac-rates-decline.pdf). This measure should help to encourage hospitals to employ evidence-driven protocols, thereby improving patient care and reducing healthcare costs. (Submitted by: Advanced Medical Technology Association (AdvaMed))
  
  
• (Early public comment)On behalf of Smith & Nephew, Inc., I would like to express support for the quality measure concept referenced in MUC18-107 - Hospital Harm - Pressure Injury (For CMS Programs: HIQR; EHR Incentive/EH/CAH). Capturing the wide array of pressure injury types (newly developed stage 2, stage 3, stage 4, deep tissue pressure injury or unstageable pressure injury) will focus hospital efforts on reducing the risk of these hospital-acquired conditions (HAC), which according to the Agency for Healthcare Research and Quality (AHRQ) National Scorecard on Hospital-Acquired Conditions (June 2018), are on the rise https://www.ahrq.gov/sites/default/files/wysiwyg/data/infographics/hac-rates-decline.pdf). This measure should help to encourage hospitals to employ evidence-driven protocols, thereby improving patient care and reducing healthcare costs. (Submitted by: Smith & Nephew, Inc.)
  
  
• (Early public comment)Smith & Nephew strongly supports the quality measure referenced above. Capturing the wide array of pressure injury types (newly developed stage 2, stage 3, stage 4, deep tissue pressure injury or unstageable pressure injury) will focus hospital efforts on reducing the risk of these hospital-acquired conditions. This measure will encourage hospitals to employ evidence-driven protocols, thereby improving patient care and reducing healthcare costs. (Submitted by: Smith&Nephew)
  
  
• (Early public comment)The AAMC does not recommend this measure for the IQR and Promoting Interoperability Programs because the measure as developed does not appropriately narrow the scope of measurement to avoidable pressure injuries. This is in part because the measure presupposes that all pressure injuries are preventable and ignores a recent systematic review that various interventions, including nutrition, skin-care regimen, positioning and re-positioning routines, and education in prevention of hospital-acquired pressure ulcers, do not yield a statistically significant benefit to preventing pressure ulcers (see Tayyib, N et al. Effectiveness of Pressure Ulcer Prevention Strategies for Adult Patients in Intensive Care Units: A Systematic Review. Worldview Evidence Based Nursing. December 2016). There must be greater consensus on actionability of pressure ulcer prevention strategies before the measure is implemented. Additionally, the measure fails to appropriately exclude pressure injuries incurred prior to hospitalization from measurement, which is necessary for determining hospital harm. The 24-hour timeframe to document all pre-existing pressure ulcers is insufficient because some injuries take days to manifest. The measure should not be included in CMS programs until there is a more accurate ability to track delayed presentation of pressure injury for more precise measurement. Including all pressure injuries will unfairly inflate the incidence despite the provision of optimal care rather than accounting for avoidable hospital harm. The AAMC advises that the measure should demonstrate reliability and validity in the acute care setting and this measure should be submitted to National Quality (NQF) for review and endorsement. Additionally, CMS should vet new eCQMs across a selection of vendors and hospitals prior to considering the measures for addition to the IQR and Promoting Interoperability Program for implementation. The AAMC urges CMS to continue outreach to EHR vendors, hospital quality staff, and other affected stakeholders to identify underlying structural problems and barriers to successful reporting of eCQMs. With this in mind, the Association continues to have concerns that hospitals and vendors may not be adequately prepared to fully report eCQMs, and asks CMS to focus resources on sufficiently addressing current concerns with eCQM reporting rather than on developing additional eCQMs for inclusion in hospital reporting programs for the future. Focusing on the inclusion of a small number of measures in the eCQM program that are meaningful and not overly burdensome will provide hospitals with additional time and bandwidth to address the considerable challenges of electronic data reporting. (Submitted by: Association of American Medical Colleges)
  
  
• (Early public comment)The Alliance of Wound Care Stakeholders would like to express our strong support for the quality measure referenced above. Capturing the wide array of pressure injury types (newly developed stage 2, stage 3, stage 4, deep tissue pressure injury or unstageable pressure injury) will focus hospital efforts on reducing the risk of these hospital-acquired conditions, which according to AHRQ (2014-2016 HAC data below) are on the rise. This measure will encourage hospitals to employ evidence-driven protocols, thereby improving patient care and reducing healthcare costs We are a NQF member and would be pleased to discuss this with you if you have any questions. Sincerely, Marcia Nusgart, Executive Director (Submitted by: Alliance of Wound Care Stakeholders)
  
  
• (Early public comment)The Alliance of Wound Care Stakeholders would like to express our strong support for the quality measure referenced above. Capturing the wide array of pressure injury types (newly developed stage 2, stage 3, stage 4, deep tissue pressure injury or unstageable pressure injury) will focus hospital efforts on reducing the risk of these hospital-acquired conditions, which according to AHRQ (2014-2016 HAC data below) are on the rise. This measure will encourage hospitals to employ evidence-driven protocols, thereby improving patient care and reducing healthcare costs. We are members of NQF and happy to speak with you about this if you have any questions. Sincerely,Marcia Nusgart, Executive Director (Submitted by: Alliance of Wound Care Stakeholders)
  
  
• (Early public comment)The Federation of American Hospitals (FAH) recognizes the need to address this important patient safety event but encourages the MAP to conditionally recommend this measure given that it is still in field testing. Specifically, FAH is concerned that the differences in performance scores may be minimal and may not yield reliable and valid representations of performance across the hospitals. In addition, FAH also strongly encourages CMS to assess the feasibility of collecting the required data elements from electronic health record systems (EHRs) and determine if the measure is reliable and valid. FAH is concerned that the complexity of the measure and, particularly the complexity of the numerator, may significantly impact an individual hospital’s ability to successfully collect and report on the measure. (Submitted by: Federation of American Hospitals)
  
  
• We agree with MAPS preliminary decision for condition support for rulemaking, pending NQF review/endorsement. (Submitted by: Cerner Corporation)
  
  
• Thank you for the opportunity to comment on the Measure Application Partnership’s (MAP’s) draft report of pre-rulemaking recommendations for the federal hospital programs. America’s Essential Hospitals appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS’) Measures Under Consideration (MUC) list for 2019. However, we are concerned that the two harm measures under consideration could have unintended consequences if adopted into CMS programs. We respectfully submit our comments to the MAP for consideration during this pre-rulemaking process. America’s Essential Hospitals is the leading champion for hospitals and health systems dedicated to high-quality care for all. Filling a vital role in their communities, our more than 320 members provide a disproportionate share of the nation’s uncompensated care and devote more than 75 percent of their inpatient care and nearly 70 percent of their outpatient care to the uninsured and to patients receiving insurance through public programs. Through their integrated health systems, members of America’s Essential Hospitals offer primary care through quaternary care, including trauma care, outpatient care in ambulatory clinics, public health services, mental health and substance abuse services, and wraparound services vital to disadvantaged patients. Feasibility of Proposed Hospital Harm Measures America’s Essential Hospitals supports the development of electronic clinical quality measures (eCQMs) for harm events in hospitals. However, we are concerned the two harm measures under consideration could have unintended consequences if adopted into CMS programs. The hospital harm-hypoglycemia measure (MUC18-109) assesses the rate at which severe hypoglycemia events caused by hospital administration of medications occur in the acute-care hospital setting. The hospital harm-pressure injury measure (MUC18-107) assesses the rate at which new hospital-acquired pressure injuries occur during an acute-care hospitalization. We support CMS’ development of measures to assess critical patient safety issues, such as severe hypoglycemia and pressure injury. However, as noted in the MAP’s conditional support, CMS should not include these measures in public reporting programs until they are reviewed by NQF and receive endorsement. In particular, the MAP raised concerns about the feasibility of a subsequent lab test for glucose within five minutes of a low glucose reading, as well as the lack of risk adjustment and/or stratification, where appropriate. We encourage further development and field testing of these measures, with input from stakeholders, to ensure the information collected accurately reflects quality of care. Additionally, before introducing more measures, it is necessary to balance the usefulness of information reported through electronic health records (EHRs) with the challenges of extracting such data and the accuracy of the information captured. Providers still are working to incorporate EHR data entry into their workflows; it is premature to incorporate measures into reporting programs until there is enough evidence of their validity across the field to justify inclusion. We urge the MAP to examine whether these eCQMs are a viable option for all hospitals and to vet new eCQMs across EHR vendors and hospitals before considering the measures for program inclusion. CMS should not require electronic reporting before these measures are fully electronically specified and field tested. Electronic measures have specific requirements for the type of information to document; they require more standardization than non-electronic measures. Required electronic specifications are unclear at this point in the development of the hospital harm measures. If detailed specifications are not provided far enough in advance, many providers will not have enough time to update their reporting systems. The validity of the eCQM depends on the accuracy of this information. While providers are adapting their workflows to ensure meticulous entry of standardized data into EHRs, essential hospitals still face obstacles to the meaningful use of health information technology. In addition, adoption requires extensive training and resources. We urge MAP to ensure the hospital harm eCQMs are administratively simple to collect and report. Risk Adjustment It is important that the MAP appropriately assess the impact of sociodemographic factors, including socioeconomic status, and risk adjust when warranted. Essential hospitals serve many of the most complex patients, many of whom have low incomes and other compounding sociodemographic factors. Without proper risk adjustment, these hospitals might appear, through public reporting, to have poorer outcomes than other hospitals. But this is an inaccurate and misleading picture created by factors outside the control of the hospital and its providers. The current specifications for the hospital harm eCQMs do not include risk adjustment for sociodemographic factors or stratification. When developing quality measures, developers should account for the socioeconomic and sociodemographic complexities of vulnerable populations to ensure the measures reflect quality of care, rather than factors outside of hospitals’ control. For example, the hospital harm measure assessing pressure injury does not consider factors that might influence the likelihood of a patient developing pressure injury, such as lack of nutrition due to food insecurity. We urge NQF to continue testing these measures and fully vet them through the endorsement process, including review by the NQF Disparities Committee. America’s Essential Hospitals supports the stratification of quality measurement data to discern potential disparities and support active improvement. We encourage the MAP to consider various risk adjustment and stratification approaches and refine measures to account for differences, unrelated to quality of care, among hospitals. Additionally, America’s Essential Hospitals encourages CMS to limit the use of these hospital harm measures, once fully vetted, to public reporting and quality improvement programs, rather than value-based purchasing programs. (Submitted by: America's Essential Hospitals)
  
  
• Dear MAP Hospital Workgroup and Coordinating Committee, CMS has long recognized the prevalence of malnutrition, its negative impact on patient outcomes, and the persistent barriers to high-quality malnutrition care. In 2013 and 2014, CMS referenced that 20-50 percent of hospital inpatients are malnourished or at-risk of malnutrition depending on the patient population and the criteria for assessment and that approximately 20 percent of hospitalized patients require complex nutrition plans and dietary orders. Furthermore, recent comments by HHS Secretary Alex Azar to the Hatch Foundation for Civility and Solutions emphasized that malnutrition was “involved in up to 12 percent of non-maternal, non-neonatal hospital stays—$42 billion each year in healthcare spending” in 2013 (Azar, November 2018). Given acknowledgement by key stakeholders of the concern with the burden of malnutrition in the hospital, we urge that the MAP Hospital Workgroup and the MAP Coordinating Committee follow suit and acknowledge malnutrition as a persistent quality measurement gap area in federal programs for hospitals. The burden of malnutrition on patients in the hospital setting as detailed in a report published by the AHRQ Healthcare Cost and Utilization Project (HCUP) in 2018 demonstrates that malnutrition is a public health issue. The analysis reported that malnourished hospitalized patients are three to five times more likely to experience in-hospital death, and experience a 56 percent higher rate of hospital 30-day readmissions compared with non-malnourished patients. Furthermore, malnutrition is a key health disparity that HCUP data demonstrate is more likely to affect older adults (age =85 years), and African American patients. There are short-term, and readily supported options available to address malnutrition in the hospital. The Malnutrition Quality Improvement Initiative (MQii) Learning Collaborative of hospitals across the U.S. has demonstrated that there are existing malnutrition measures which are feasible, reliable and support improvements to quality of care. The MQii is based on the implementation of an interdisciplinary quality improvement toolkit along with four malnutrition eCQMs focused on malnutrition screening upon admission, nutrition assessment for those at-risk of malnutrition, a provider diagnosis of malnutrition for those assessed as malnourished, and the development of a nutrition care plan for those with malnutrition. Through this dual-pronged initiative, the MQii Toolkit and eCQMs are being disseminated to over 250 hospitals across the U.S. Their implementation has supported improvements to quality of care highly associated with outcomes such as 30-day readmissions and length of stay. These measures have already been reviewed by the Measures Application Partnership (MAP) which recommended that they be combined into a composite measure. In response, our organization developed one of the first ever e-specified composite measures, the Global Malnutrition Composite Measure, that reflects a combination of these individual measures and is closely linked to key outcomes such as patient length of stay and 30-day readmissions. In addition, the recognition of malnutrition as a critical issue presents an opportunity to better align with the Meaningful Measures Initiative, which strives to identify high priority areas for quality of care and ensure measurement is strongly linked to patient outcomes. CMS has an immediate opportunity to advance the objectives of the initiative by adopting existing inpatient malnutrition eCQMs and/or composite measure into hospital pay-for-reporting program(s). We ask that the MAP acknowledge this quality measurement opportunity for hospitals and request CMS to add the Global Malnutrition Composite Measure to the MAP’s docket for consideration in future years of the Hospital Inpatient Quality Reporting (HIQR) Program. Closing this gap in malnutrition quality measurement would support clinical practices that can improve patient safety, and care continuity, and lead to better patient outcomes; address a known clinical gap, and align closely with the core values of the Meaningful Measures Initiative. Sincerely, Sharon M. McCauley, MS, MBA, RDN, LDN, FADA, FAND Senior Director, Quality Management | Malnutrition Quality Improvement Initiative Academy of Nutrition and Dietetics 312-899-4823 | smccauley@eatright.org (Submitted by: Academy of Nutrition and Dietetics)
  
  
• Dear Mr. Kahn and Dr. Hall: The Association of American Medical Colleges (AAMC or Association) welcomes this opportunity to comment on the National Quality Forum (NQF) Measure Applications Partnership (MAP)’s 2019 Considerations for Implementing Measures in Federal Programs draft report. The AAMC is a not-for-profit association dedicated to transforming health care through innovative medical education, cutting-edge patient care, and groundbreaking medical research. Its members are all 152 accredited U.S. and 17 accredited Canadian medical schools; nearly 400 major teaching hospitals and health systems, including 51 Department of Veterans Affairs medical centers; and more than 80 academic societies. Through these institutions and organizations, the AAMC serves the leaders of America’s medical schools and teaching hospitals and their more than 173,000 full-time faculty members, 89,000 medical students, 129,000 resident physicians, and more than 60,000 graduate students and postdoctoral researchers in the biomedical sciences. The AAMC appreciates the MAP Workgroups’ thoughtful review and discussion of the measures under consideration (MUC). The following are the AAMC’s high-level comments on the MAP recommendations for both hospitals and clinicians: • Regarding the clinician measures under consideration, the AAMC strongly believes that providers should not be held accountable for activities outside their control. The 11 episode level cost measures must be appropriately risk adjusted, including for social risk factors, and the attribution methodology for episodes should clearly and accurately determine the relationship between patient and clinician before such episode-level cost measures are incorporated into the Quality Payment Program. The 2 re-evaluated total cost measures (Medicare Spending per Beneficiary (MSPB) and Total Per Capita Cost) must similarly be appropriately adjusted for both clinical and social risk factors before the measures are incorporated into the Quality Payment Program. • For the hospital measures, the AAMC continues to strongly believe that certain accountability measures must be adjusted for sociodemographic status (SDS) before being included in the Medicare quality reporting programs, be NQF-endorsed prior to MAP review, and be included in the Inpatient Quality Reporting (IQR) program for at least one year before being considered in a performance program by the Workgroup. Additionally, the AAMC recommends that the report appropriately distinguish the Medicare and Medicaid Promoting Interoperability Program for Eligible Hospitals and Critical Access Hospitals (Promoting Interoperability Program) as separate from the IQR. While electronic clinical quality measures are shared between the two programs, the programs have unique histories and different penalties on hospitals for failure to meet a given program’s distinct requirements and the report should appropriately reflect that. MAP Hospital Workgroup Comments Distinguish Differences Between Programs in the Draft Report The draft report for hospitals currently describes the IQR and Promoting Interoperability Programs as a single or joint program, which may mislead readers less familiar with these programs. The AAMC recommends that the two programs be described separately to better document their separate and unique histories and requirements for hospitals. An alternative would be to retain the joint write up acknowledging the programs’ similar goals and shared measures, and separately detail the incentive structures for each program. The AAMC believes it is important that the report note that the Promoting Interoperability Program has a separate 75 percent reduction of the annual payment update for hospitals that do not participate in or fail to meet the program’s requirements. As currently drafted, the report only describes the structure of the incentives for the IQR Program. Individual Measure Review Hospital Harm – Pressure Injury The Hospital MAP conditionally supported the pressure injury eCQM (MUC18-107) pending review and endorsement once the measure is fully tested. The AAMC believes that pressure injuries are important to measure and can reduce patient harm, and agrees with the MAP that the measure should be vetted further before its inclusion in Medicare quality reporting programs. Specifically, CMS should complete testing and submit the measure for NQF endorsement, with a recommendation that the NQF Disparities Committee review and provide input on adjusting for social risk factors. The AAMC is concerned that implementation of the measure without appropriate risk adjustment is likely to disproportionately impact academic medical centers and safety net providers who treat more complex patients. The AAMC agrees with the MAP’s suggestion that the measure exclude patients with certain conditions or undergoing certain types of treatments that may not be appropriate to receive the evidence-based pressure injury reducing interventions (e.g., extracorporeal membrane oxygenation [ECMO]). (Submitted by: Association of American Medical Colleges)
  
  
• Support current MAP recommendation (Submitted by: Federation of American Hospitals)
  
  
• AdventHealth does not support the adoption of this measure because there is a lack of standardization on who determines staging, which creates challenges in comparing the data for this measure across the country. According to the National Database of Nursing Quality Indicator (NDNQI) Guidelines for Data Collection and Submission on Pressure Injury Indicators, the staging of a pressure injury is complex and has a wide variation depending on who is making the determination of such stage (the size, depth and extent of the pressure injury). There is also little standardization in the reporting of what is present on admission and the duration of time for the discovery of an injury before it is deemed hospital-acquired. AdventHealth would be more supportive of this measure if there was a standard for who stages a pressure injury and the length of time it takes for an injury to be discovered before it is deemed hospital-acquired. For example, in some facilities, it is a physician who determines the stage or a nurse. In other facilities, an RN who specializes in pressure injuries would perform the staging for the entire hospital. The different practitioners staging the pressure injuries create discrepancies in how the injuries are documented. (Submitted by: AdventHealth)
  
  
• The AHA agrees that pressure injuries are an important harm that should be the focus of improvement efforts. However, we disagree with the MAP’s recommendation of Conditional Support for this particular measure at this time and would recommend a position of Do Not Support with Potential for Mitigation. This measure as currently specified does not capture important information around how injuries are detected and recorded and thus would not provide valuable insight to improve quality of care. For all other measures that received a recommendation of Conditional Support, the condition was usually solely NQF endorsement; there are too many outstanding questions and additional considerations to be investigated for this measure for it to be ready for the endorsement process, let alone inclusion in CMS programs. This measure is similar to that recently implemented in the various post-acute care quality reporting programs. In the notice and comment cycles in which that measure was proposed and finalized, several organizations raised issues with the measure that are also apparent in this inpatient measure. First, this measure relies heavily on documentation of injuries within the first 24 hours of arrive at the hospital, which is a major challenge. Documentation of injuries of the various stages during this very busy period is extremely difficult, and it is unclear whether this measure relies upon physician documentation alone or whether nurse notes would also contribute to identification of these injuries. Even though there are guidelines on how to determine the stage of pressure injuries, there is still room for subjectivity. Performance on quality measures should only be influenced by the care provided, not on the variable documentation of that care. Second, the measure does not adequately adjust for the various risk factors associated with pressure injuries, including proportion of ICU patients, frailty, nutrition, ECMO patients, and multiple injuries. Academic medical centers and safety net hospitals care for patients more susceptible to pressure injuries, so their performance on this measure would likely be comparably low through no fault of the providers. We urge the MAP to wait until the developers have further investigated how feasibly and accurately this measure can capture performance regarding prevention of pressure injuries and gone through the NQF endorsement process before considering this measure for inclusion in the IQR. (Submitted by: American Hospital Association)
  
  
• The issue on avoidable harm is what should be addressed. Not all hospital acquired pressure injuries are avoidable. Some Deep Tissue Pressure Injuries start before the patient is admitted and do not present for 48 hours. The current coding guidelines allow for hospitals to consider conditions as present on admission if they are suspicious that the condition was evolving at the time of admission. For example, not all cases of pneumonia are detectable at the time of admission, nor are all fractures visible on x-ray. The addition of the word "Avoidable" stage 2, 3 etc is recommended. (Submitted by: UNMC)
  
  

• (Early public comment)We agree with the critical importance of this measure. We also recognize that non-hospital levels of care typically function on a M-Fri, 9-5 work week. This does not provide hospitals with sufficient time to contact and receive a response from external entities to meet the standard, especially with the inevitability of Friday afternoon admissions. As such, we would we suggest a 72-hour time frame. (Submitted by: National Assn for Behavioral Healthcare)
  
  
• APAF agrees that medication reconciliation on admission is a critical safety component but recognize that the Joint Commission also requires the capture of these data components. As such, we felt it important to prevent duplicative data collection to avoid burden. (Submitted by: American Psychiatric Association Foundation)
  
  

• (Early public comment)Novo Nordisk is pleased to provide the following comments on CMS’ list of measures under consideration. Headquartered in Denmark, and with U.S. headquarters in New Jersey and production and research facilities in four states, Novo Nordisk employs approximately 5,000 people throughout the country. Novo Nordisk is a global healthcare company with 95 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: rare bleeding disorders, growth hormone-related disorders, and obesity. Novo Nordisk is committed to the goal of ensuring patients have access to high-quality, affordable health care. As a life sciences company with a focus on diabetes care, we support the Agency’s continued efforts to focus on regulatory reform and reducing regulatory burden. Furthermore, we applaud the Agency’s efforts on the Meaningful Measures Initiative to identify the highest priority areas for quality measurement and quality improvement to improve patient outcomes. Novo Nordisk is pleased to see the inclusion of a hypoglycemia outcome measure (Hospital Harm- Hypoglycemia: MUC18-109) and we strongly support the addition of the measure in the Hospital Inpatient Quality Reporting Program (HIQR), and the Medicare and Medicaid EHR Incentive Program for Eligible Hospitals (EH) and Critical Access Hospitals (CAH). The measure fits into the Meaningful Measures framework quality priority to Make Care Safer by Reducing Harm Caused in the Delivery of Care. We are concerned that the proposed lab glucose value of <40mg/dL for hypoglycemia is at such a low value that it could potentially miss many clinically significant hypoglycemic events. We recommend Level 2 hypoglycemia as the most appropriate measure to assess meaningful hypoglycemia in this and other settings. The updated 2018 Level 2 value is <54mg/dL. With the American Diabetes Association and the International Hypoglycaemia Working Group working collaboratively to standardize the definition of hypoglycemia, we strongly believe it is important that this standardization happens across all stakeholders engaged in delivering and measuring quality care. In addition, the choice of medications to treat diabetes is critically important in impacting the important safety outcome of hypoglycemia. FDA-approved medications are available that have lower rates of severe hypoglycemia and should be considered for patients at high risk for these events as part of delivering quality care. We’d also like to note that there remain opportunities to prevent instances of hypoglycemia by considering patient-reported outcome measures (PROMs) that increase shared-decision making and patient engagement, as well as outcome measures for primary care providers in clinical settings that assess adherence to diabetes medications. Thank you for this opportunity to comment on the 2018 CMS’ List of Measures Under Consideration. If you have any questions about the comments included here, please do not hesitate to reach out to me at TDDH@novonordisk.com. Sincerely, Todd M. Hobbs, MD Vice President, Chief Medical Officer – Diabetes & Obesity (Submitted by: Novo Nordisk Inc.)
  
  
• (Early public comment)Please consider the following Does the measure consider only a lab measured blood glucose and not a point of care check? If it is for a lab draw only, is it 5 minutes after result is ready or 5 minutes after blood is drawn? Either way, it is extremely difficult to logistically respond to a lab draw in 5 minutes. There is a window of about an hour or so to get the result of a stat draw sent to lab. After result is read, it takes some time to treat the patient and reorder and draw blood for the follow up BG which then goes back to the lab. If the measure also considers a point of care blood glucose, then what is the aim of the measure? Is it to eliminate a false reading or to document recovery from hypoglycemia. If it is to eliminate a false low and just gather data on how many true low BG are present, then it makes sense to have a 5 minute recheck. If it is to document recovery from hypoglycemia, 5 minutes is still too short. The most immediate task for nurse is to respond to the low reading in the first few minutes, get juice, dextrose etc. This itself takes more than 5 minutes. Patient then drinks juice, etc which also takes a few minutes. A recheck POC then follows. This takes about 20- 30 minutes which is probably the appropriate time-frame with the tightest being a recheck at 15 minutes. The Society of Hospital Medicine benchmarking group uses a measure for documenting BG by POC within 30 minutes of the initial episode. Something within that ballpark would be a fair and useful measure which hospitals could adopt easily and would benefit outcomes. (Submitted by: Endocrine Society)
  
  
• (Early public comment)Support the measure Sanofi encourages categorizing as Hospital-Harm - Severe Hypoglycemia given Hypoglycemia is defined as blood glucose less than 70mg/dL. (Submitted by: Sanofi)
  
  
• (Early public comment)The Federation of American Hospitals (FAH) recognizes the need to address this important patient safety event but encourages the MAP to conditionally recommend this measure given that they are still in field testing. Specifically, FAH is concerned that the differences in performance scores may be minimal and may not yield reliable and valid representations of performance across the hospitals. In addition, FAH also strongly encourages CMS to assess the feasibility of collecting the required data elements from electronic health record systems (EHRs) and determine if the measure is reliable and valid. FAH is concerned that the complexity of the measure and, particularly the complexity of the numerator, may significantly impact an individual hospital’s ability to successfully collect and report on the measure. Additionally, the FAH has concerns that the measure only counts one sever hypoglycemic event per patient admission. Patients that experience 1 hypoglycemic event are at the highest risk of experiencing another hypoglycemic event unless there is an intervention. Type 1 diabetic patients are often seen with 4 to 6 episodes per admission. The FAH would like further clarity around whether there would be consideration to assess events during a 24-hour period. As an example we request clarity on, if there is at least one severe event during each 24-hour period, whether it would be counted as 1 episode per day. The FAH recommends that this measure be reported together with the Hospital Harm – Severe Hyperglycemia measure that is under development. This pairing will minimize the risk of increasing either event, which might occur if the focus is solely on one or the other outcome. The FAH also requests clarification on whether this proposed measure is the current measure endorsed by NQF (NQF #2363). Previous documents when the measure concept was released for comment stated that NQF #2363 was a different measure. It would be helpful if this information was clarified prior to the Hospital Workgroup meeting. (Submitted by: Federation of American Hospitals)
  
  
• (Early public comment)While the AAMC agrees that it is important to develop measures that focus on reducing the most common adverse drug events, and that hospitals should implement protocols to manage hypoglycemia for critically ill patients, the AAMC does not recommend this measure for the IQR and Promoting Interoperability Programs. The measure as developed does not appear to be useful in assessing and improving the care of patients because of the timing and manner of the glucose measurement. The majority of tests for monitoring blood glucose levels are done with a glucometer at the bedside (point-of-care testing) because it is cost effective and expedient and not from a drawn blood sample that goes to the lab. In the event that a drawn blood sample goes to the lab and comes back as less than 40 mg/dL there is no immediate course to provide the sugar and 5-minute glucose measure follow-up because the lab test was often done hours before. By measuring only lab tests, and not including point-of-care testing, the measure removes the majority of blood glucose testing from measure. It should also be noted that administering an anti-hyperglycemic is the standard of care to lower the glucose for a patient that is hyperglycemic and that a measure to incentivize management of hypoglycemia should not have the indirect potential to cause second guessing of that standard of care. Instead, it should incent care workflows to ensure that there is appropriate glucose monitoring after the administration of the anti-hyperglycemic. The AAMC advises that the measure should demonstrate reliability and validity in the acute care setting and this measure should be submitted to National Quality (NQF) for review and endorsement. Additionally, CMS should vet new eCQMs across a selection of vendors and hospitals prior to considering the measures for addition to the IQR and Promoting Interoperability Program for implementation. The AAMC urges CMS to continue outreach to EHR vendors, hospital quality staff, and other affected stakeholders to identify underlying structural problems and barriers to successful reporting of eCQMs. With this in mind, the Association continues to have concerns that hospitals and vendors may not be adequately prepared to fully report eCQMs, and asks CMS to focus resources on sufficiently addressing current concerns with eCQM reporting rather than on developing additional eCQMs for inclusion in hospital reporting programs for the future. Focusing on the inclusion of a small number of measures in the eCQM program that are meaningful and not overly burdensome will provide hospitals with additional time and bandwidth to address the considerable challenges of electronic data reporting. (Submitted by: Association of American Medical Colleges)
  
  
• We agree with MAPs preliminary decision for condition support for rulemaking, pending NQF review/endorsement. (Submitted by: Cerner Corporation)
  
  
• AdvaMed applauds CMS for addressing potential hospital harm by developing a measure to assess the rate at which severe hypoglycemia events caused by hospital administration of medications occur in the acute care hospital setting. We believe that there are additional opportunities to address additional gap measurement areas related to patients specifically with diabetes requiring insulin therapy. This is addressed in the 2017 Discern Health White Paper entitled: Medical Technology in the Value-Based Environment: An Assessment of Quality Measure Gaps (http://discernhealth.com/wp-content/uploads/2018/01/medical_technology_in_the_value_based_environment_-_assessment_of_quality_measure_gaps.pdf). While diabetes has been a significant area of focus for quality measurement, gaps in measures and measure sets remain. This report discusses available measures not used in Medicare VBP models, and measure concepts identified by Discern that, if used in VBP models, would help guide appropriate care of patients with Type 1 diabetes. This paper identified several opportunities for measurement within the Type 1 diabetes care episode. These included opportunities for diagnosis (collection of family history, assessment of body mass index (BMI), and timely testing (HbA1c, LDL-C, and blood pressure)), treatment (delivery of education and lifestyle counseling, prescribing intensive insulin regimens, timely prescribing and treatment of hypoglycemia with glucagon), monitoring (assessing blood glucose monitoring, performing HbA1c tests, monitoring BMI, monitoring long-term issues (nephropathy, neuropathy, etc.)), outcomes (complication rates including hypo- and hyperglycemia events, patient-reported quality of life, glycemic control and time in range (TIR)), and structural improvements (testing and maintaining device competency, collecting device-reported patient data). For example, these include the development of patient-reported outcome (PRO) performance measures, including quality of life and patient-reported change in less severe hypoglycemic event incidence, which does not always result in hospital admission and may be underreported. Quality of life measures are particularly important where the stress of managing insulin injections and monitoring can be alleviated using Continuous Glucose Monitoring (CGM) and/or Sensor-Augmented Insulin Pumps (SAP) (“Patient-Reported T1D Quality of Life” and “Patient-Reported Incidence of Hypoglycemia”). (Submitted by: AdvaMed)
  
  
• Thank you for the opportunity to comment on the Measure Application Partnership’s (MAP’s) draft report of pre-rulemaking recommendations for the federal hospital programs. America’s Essential Hospitals appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS’) Measures Under Consideration (MUC) list for 2019. However, we are concerned that the two harm measures under consideration could have unintended consequences if adopted into CMS programs. We respectfully submit our comments to the MAP for consideration during this pre-rulemaking process. Feasibility of Proposed Hospital Harm Measures America’s Essential Hospitals supports the development of electronic clinical quality measures (eCQMs) for harm events in hospitals. However, we are concerned the two harm measures under consideration could have unintended consequences if adopted into CMS programs. The hospital harm-hypoglycemia measure (MUC18-109) assesses the rate at which severe hypoglycemia events caused by hospital administration of medications occur in the acute-care hospital setting. The hospital harm-pressure injury measure (MUC18-107) assesses the rate at which new hospital-acquired pressure injuries occur during an acute-care hospitalization. We support CMS’ development of measures to assess critical patient safety issues, such as severe hypoglycemia and pressure injury. However, as noted in the MAP’s conditional support, CMS should not include these measures in public reporting programs until they are reviewed by NQF and receive endorsement. In particular, the MAP raised concerns about the feasibility of a subsequent lab test for glucose within five minutes of a low glucose reading, as well as the lack of risk adjustment and/or stratification, where appropriate. We encourage further development and field testing of these measures, with input from stakeholders, to ensure the information collected accurately reflects quality of care. Additionally, before introducing more measures, it is necessary to balance the usefulness of information reported through electronic health records (EHRs) with the challenges of extracting such data and the accuracy of the information captured. Providers still are working to incorporate EHR data entry into their workflows; it is premature to incorporate measures into reporting programs until there is enough evidence of their validity across the field to justify inclusion. We urge the MAP to examine whether these eCQMs are a viable option for all hospitals and to vet new eCQMs across EHR vendors and hospitals before considering the measures for program inclusion. CMS should not require electronic reporting before these measures are fully electronically specified and field tested. Electronic measures have specific requirements for the type of information to document; they require more standardization than non-electronic measures. Required electronic specifications are unclear at this point in the development of the hospital harm measures. If detailed specifications are not provided far enough in advance, many providers will not have enough time to update their reporting systems. The validity of the eCQM depends on the accuracy of this information. While providers are adapting their workflows to ensure meticulous entry of standardized data into EHRs, essential hospitals still face obstacles to the meaningful use of health information technology. In addition, adoption requires extensive training and resources. We urge MAP to ensure the hospital harm eCQMs are administratively simple to collect and report. Risk Adjustment It is important that the MAP appropriately assess the impact of sociodemographic factors, including socioeconomic status, and risk adjust when warranted. Essential hospitals serve many of the most complex patients, many of whom have low incomes and other compounding sociodemographic factors. Without proper risk adjustment, these hospitals might appear, through public reporting, to have poorer outcomes than other hospitals. But this is an inaccurate and misleading picture created by factors outside the control of the hospital and its providers. The current specifications for the hospital harm eCQMs do not include risk adjustment for sociodemographic factors or stratification. When developing quality measures, developers should account for the socioeconomic and sociodemographic complexities of vulnerable populations to ensure the measures reflect quality of care, rather than factors outside of hospitals’ control. For example, the hospital harm measure assessing pressure injury does not consider factors that might influence the likelihood of a patient developing pressure injury, such as lack of nutrition due to food insecurity. We urge NQF to continue testing these measures and fully vet them through the endorsement process, including review by the NQF Disparities Committee. America’s Essential Hospitals supports the stratification of quality measurement data to discern potential disparities and support active improvement. We encourage the MAP to consider various risk adjustment and stratification approaches and refine measures to account for differences, unrelated to quality of care, among hospitals. Additionally, America’s Essential Hospitals encourages CMS to limit the use of these hospital harm measures, once fully vetted, to public reporting and quality improvement programs, rather than value-based purchasing programs. (Submitted by: America's Essential Hospitals)
  
  
• Dear Mr. Kahn and Dr. Hall: The Association of American Medical Colleges (AAMC or Association) welcomes this opportunity to comment on the National Quality Forum (NQF) Measure Applications Partnership (MAP)’s 2019 Considerations for Implementing Measures in Federal Programs draft report. The AAMC is a not-for-profit association dedicated to transforming health care through innovative medical education, cutting-edge patient care, and groundbreaking medical research. Its members are all 152 accredited U.S. and 17 accredited Canadian medical schools; nearly 400 major teaching hospitals and health systems, including 51 Department of Veterans Affairs medical centers; and more than 80 academic societies. Through these institutions and organizations, the AAMC serves the leaders of America’s medical schools and teaching hospitals and their more than 173,000 full-time faculty members, 89,000 medical students, 129,000 resident physicians, and more than 60,000 graduate students and postdoctoral researchers in the biomedical sciences. The AAMC appreciates the MAP Workgroups’ thoughtful review and discussion of the measures under consideration (MUC). The following are the AAMC’s high-level comments on the MAP recommendations for both hospitals and clinicians: • Regarding the clinician measures under consideration, the AAMC strongly believes that providers should not be held accountable for activities outside their control. The 11 episode level cost measures must be appropriately risk adjusted, including for social risk factors, and the attribution methodology for episodes should clearly and accurately determine the relationship between patient and clinician before such episode-level cost measures are incorporated into the Quality Payment Program. The 2 re-evaluated total cost measures (Medicare Spending per Beneficiary (MSPB) and Total Per Capita Cost) must similarly be appropriately adjusted for both clinical and social risk factors before the measures are incorporated into the Quality Payment Program. • For the hospital measures, the AAMC continues to strongly believe that certain accountability measures must be adjusted for sociodemographic status (SDS) before being included in the Medicare quality reporting programs, be NQF-endorsed prior to MAP review, and be included in the Inpatient Quality Reporting (IQR) program for at least one year before being considered in a performance program by the Workgroup. Additionally, the AAMC recommends that the report appropriately distinguish the Medicare and Medicaid Promoting Interoperability Program for Eligible Hospitals and Critical Access Hospitals (Promoting Interoperability Program) as separate from the IQR. While electronic clinical quality measures are shared between the two programs, the programs have unique histories and different penalties on hospitals for failure to meet a given program’s distinct requirements and the report should appropriately reflect that. MAP Hospital Workgroup Comments Distinguish Differences Between Programs in the Draft Report The draft report for hospitals currently describes the IQR and Promoting Interoperability Programs as a single or joint program, which may mislead readers less familiar with these programs. The AAMC recommends that the two programs be described separately to better document their separate and unique histories and requirements for hospitals. An alternative would be to retain the joint write up acknowledging the programs’ similar goals and shared measures, and separately detail the incentive structures for each program. The AAMC believes it is important that the report note that the Promoting Interoperability Program has a separate 75 percent reduction of the annual payment update for hospitals that do not participate in or fail to meet the program’s requirements. As currently drafted, the report only describes the structure of the incentives for the IQR Program. Individual Measure Review Hospital Harm- Hypoglycemia The Hospital MAP conditionally supported the hypoglycemia eCQM (MUC1-109) pending review and re-endorsement once the measure is fully tested. The AAMC agrees that measurement of hypoglycemic events is important to prevent avoidable harm from use of antihyperglycemic medications, and that the revised measure should be re-endorsed prior to inclusion in future rulemaking. The AAMC’s concerns with the revised measure include consideration of appropriate risk adjustment. Process measures do not generally need risk adjustment, but in the case of glucose monitoring it is important to note that some procedures may warrant exclusion due to glucose measurement swings outside of the hospital’s control (e.g., coronary artery bypass surgery [CABG] and sepsis) and should be measured separately from broader hospital measurement. The AAMC also questions the use of lab testing to measure glucose levels rather than point of care testing using blood glucose monitors and asks that the measure developer more clearly denote that point of care testing is included in measurement. We also support the MAP’s recommendation to monitor the potential impact of the recent guidance from the FDA that could impact the tools available to hospitals for blood glucose monitoring and thus implementation of the measure. (Submitted by: Association of American Medical Colleges)
  
  
• Support current MAP recommendation (Submitted by: Federation of American Hospitals)
  
  
• We believe that this is a reasonable measure. (Submitted by: American Geriatrics Society)
  
  
• AdventHealth does not support this measure because it provides no clear guidance on the medications to monitor for this measure and the types of glucose tests that would apply. Without such guidance, it would be difficult to implement this measure. In addition, where this measure would be abstracted from the EHR component would also need to be clarified. (Submitted by: AdventHealth)
  
  
• Thank you for the opportunity to share comments and considerations regarding MUC18-109. We have two comments about the measure’s ability to capture clinically meaningful information. 1. We are seeking rationale for the low threshold of 40 mg/dL to identify a hypoglycemic event. Based on a publication by the International Hypoglycemia Study Group* (joint position statement of ADA and EASD), hypoglycemia as determined by a blood glucose measurement is defined as <70 mg/dL for level 1 and <54 mg/dL for level 2. When trying to determine the appropriate threshold for level 2 hypoglycemia, levels of <54 mg/dL and <50 mg/dL were initially evaluated by the study group, but they ultimately recommended use of <54 mg/dL. When evaluating these levels, they stated “Both of these levels are distinctly low glucose concentrations that do not occur under physiological conditions in nondiabetic individuals. Thus, they are unequivocally hypoglycemic values.” They also stated that “a glucose concentration <54 mg/dL is sufficiently low to indicate serious, clinically important hypoglycemia.” Using the low threshold of <40 mg/dL could lead to underestimating hospital harm from hypoglycemia. 2. Since this measure only counts one severe hypoglycemia event per patient admission, it could be missing multiple events for patients admitted to the hospital for an extended duration. * International Hypoglycemia Study Group. Glucose Concentrations of Less Than 3.0 mmol/L (54 mg/dL) Should Be Reported in Clinical Trials: A Joint Position Statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2017;40:155–157. (Submitted by: Merck & Co.)
  
  
• Thank you for the opportunity to share comments and considerations regarding MUC18-109. We have two comments about the measure’s ability to capture clinically meaningful information. 1. We are seeking rationale for the low threshold of 40 mg/dL to identify a hypoglycemic event. Based on a publication by the International Hypoglycemia Study Group* (joint position statement of ADA and EASD), hypoglycemia as determined by a blood glucose measurement is defined as <70 mg/dL for level 1 and <54 mg/dL for level 2. When trying to determine the appropriate threshold for level 2 hypoglycemia, levels of <54 mg/dL and <50 mg/dL were initially evaluated by the study group, but they ultimately recommended use of <54 mg/dL. When evaluating these levels, they stated “Both of these levels are distinctly low glucose concentrations that do not occur under physiological conditions in nondiabetic individuals. Thus, they are unequivocally hypoglycemic values.” They also stated that “a glucose concentration <54 mg/dL is sufficiently low to indicate serious, clinically important hypoglycemia.” Using the low threshold of <40 mg/dL could lead to underestimating hospital harm from hypoglycemia. 2. Since this measure only counts one severe hypoglycemia event per patient admission, it could be missing multiple events for patients admitted to the hospital for an extended duration. * International Hypoglycemia Study Group. Glucose Concentrations of Less Than 3.0 mmol/L (54 mg/dL) Should Be Reported in Clinical Trials: A Joint Position Statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2017;40:155–157. (Submitted by: Merck & Co.)
  
  
• The AHA disagrees with the MAP’s recommendation of Conditional Support for this measure and instead suggests a recommendation of Do Not Support- Potential for Mitigation. We question the usefulness of this measure as well as certain specifications. First, it is unclear from the supporting data in the specifications and maintenance documents whether hypoglycemia is a widespread issue. The AHA agrees that hypoglycemic events should certainly be avoided, but as CMS engages in its Meaningful Measures initiative we wonder whether a streamlined measure set would include a measure so narrowly focused unless there is evidence that it is a frequent source of harm to hospitalized patients. Second, during the MAP meeting, several panelists raised issues with the timing of the actions specified in the measure. Specifically, the measure assesses lab tests “within five minutes of the low glucose result.” A panelist stated that if low glucose is identified, clinicians should be tending to the patient rather than performing further tests. There was also some disagreement about the definition of “low glucose”—whether the level should be 40 mg/dL or 70 mg/dL. While the AHA questions the overall usefulness of this measure, we at least recommend that these issues be addressed before the measure moves forward. (Submitted by: American Hospital Association)
  
  
• This measure would be burdensome as either a chart abstracted measure or eCQM. A measure that involves multiple events occurring during specific time periods is complicated for calculations of a single measure. The burden for this measure outweighs the benefit. An unintended consequence could result from the exclusion afforded for glucose greater than 80 mg/dL within 5 minutes as providers aggressively treat low levels, especially if treating a falsely low result. (Submitted by: Sanford Health)
  
  

• (Early public comment)Cost measures have been identified as a priority, and CMS addressed this priority through the inclusion of additional episode-based cost measures on the MUC list. The cost measures risk-adjust based on variables, such as age, and comorbidities by using HCC data and other clinical characteristics. However, we are concerned that the measures are not adjusted to account for socio-demographic status. In addition to differences in patient clinical complexity, socio-demographic status can drive differences in average episode costs. In particular, physicians at academic medical centers (AMCs) care for vulnerable populations of patients who are sicker, poorer, and more complex than patients treated elsewhere. Recent reports from the National Academies of Science, Engineering and Medicine and Assistant Secretary for Planning and Evaluation (ASPE) have clearly acknowledged that SDS variables (such as low income and education) may explain adverse outcomes and higher costs. Differences in patient severity, rates of patient compliance with treatment, sociodemographic status, patient engagement, patient preferences for treatment approaches, and sites of care, can all drive differences in average costs. Appropriate risk adjustment is essential so that differences in patient characteristics that are behind a health care provider’s control do not have an unfair impact on a provider’s resource use performance score. CMS should look at alternative sources of data to obtain information about risk adjustment. In regard to attribution – AAMC believes that attribution methods used should be clear and transparent to clinicians and that it is critical that there be an accurate determination of the relationship between a patient and a clinician to ensure that the correct clinician is held responsible for the patient’s outcomes and costs. This is complicated given that most patients receive care from numerous clinicians across several facilities. In the 2019 physician fee schedule final rule CMS changed the attribution methodology for the inpatient episode measures to measure more physicians on episode-based cost measures. We are concerned about the impact of this change and the need for more analysis and opportunity to provide feedback on this new attribution approach. Attribution is complicated, given that most patients receive care from numerous clinicians across several facilities. The AAMC believes that better data sources and analytic techniques should be explored in the future to support more accurate attribution. (Submitted by: Association of American Medical Colleges)
  
  
• (Early public comment)NHPCO Comments: NHPCO appreciates this measure and recognizes that high quality community-based palliative care services could potentially have a positive impact on this measure. This may be a secondary outcome of comprehensive assessment, symptom and medication management, advance care planning and goals of care conversations, patient and family education, and care coordination by an interdisciplinary team. (Submitted by: National Hospice and Palliative Care Organization)
  
  
• (Early public comment)Overall, the AMA supports the episode-based measure development process and movement to episode based measures over broad cost measures. However, we cannot endorse any of the specific measures due to the paucity of analytic information such as the measures’ mean made available prior to the deadline for comments. We request further refinements to the process to ensure the cost measures are accurate and fair when used in the Merit-based Incentive Payment System and, ultimately, publicly reported. In general, we urge the MAP to make “Conditional Support” its highest level of recommendation and to recommend “Do Not Support with Potential for Mitigation” for any measures where relevant specialties have raised serious concerns. Our rationale for these recommendations is as follows: Prior to implementation of any measure, CMS should seek and share more information on the impact the measures and the surrounding methodological structure across different types of practices and situations. The findings should be shared with stakeholders soon enough to be considered in their comments on the measure. As noted above, this information has not been made available on the new measures. We have serious concerns with the attribution method that CMS has adopted for the acute inpatient condition measures. This method was adopted for the three acute inpatient condition measures that will take effect in 2019 and is proposed to be continued in the inpatient condition measures now before the MAP. First, the modifications were made without adequate transparency and input from the expert panels and stakeholders. As originally designed and pilot tested, these episodes would have only been attributed to individual physicians if they were responsible for at least 30 percent of the inpatient evaluation and management (E/M) services in the episode. Under the revised methodology, the 30 percent threshold will be applied at the TIN level (i.e., if members of the TIN participated as individuals rather than a group and the group as a whole met the 30 percent threshold, the full Part A and Part B expenditures associated with the episode would be attributed to any physician who provided even one inpatient E/M service during the episode). If physicians participate as a group, an episode could be attributed to multiple groups but no episode will be attributed to a particular group more than once. However, if a group’s members report as individuals, all members who bill for at least one inpatient E/M service would be assigned the cost of the same episode and have it counted in their cost score if they have at least 19 other episodes for the same inpatient condition. The agency did not field test the 2019 measures based on the revised attribution methodology, nor did CMS release information about the anticipated impact of its revisions as compared to the initial methodology. What we do know is that CMS has repeatedly stated its desire to increase the number of clinicians that are counted in the cost category and the number of attributed episodes for the three inpatient measures was 3% to 12% higher after the revision than before. We do not know if this change increased or decreased the reliability of the acute inpatient condition measures but we do know that reliability was less than CMS’s modest 0.4 reliability standard for a significant number of individually participating MIPS clinicians. Specifically, 25% of clinicians who would have been subject to the intracranial hemorrhage/cerebral infarction measure and 68% of those subject to the simple pneumonia measure were below the 0.4 threshold. We are troubled about the lack of transparency surrounding this change and its potential to undercut the work of the clinical panels in developing these models. Second, we are increasingly concerned that in its desire to fold more physicians into the cost category, CMS is compromising the reliability of the measures. For example, even though CMS considered addressing the simple pneumonia measure’s “somewhat lower” reliability by increasing the minimum threshold for scoring a measure from 20 episodes to 30, the agency ultimately rejected this solution because it would have decreased the number of physicians and groups who met the case minimum and were attributed a cost measure. The AMA believes this choice ignores the impact of unreliable measures on real physicians and their patients in order to increase the number of physicians who are subject to a measure that is likely to trigger inappropriate payment adjustments for a significant number of physicians. We urge the MAP to recommend a higher reliability threshold for the episode measures. Alternatively, the case minimum could be increased, the measure could be treated as optional or its results could be provided for information only while improvements were developed and implemented. Third, while the AMA is very appreciative of the process that CMS and Acumen, LLP have created to obtain clinical input on the cost episodes, we believe that the CMS timelines and certain administrative obstacles have created several shortcomings throughout the cost measure development and field testing process. These include: • The continued reliance on administrative claims data, which limits risk adjustment and exclusion criteria. CMS should allow for use of alternative sources of data, such as clinical data registries. • The timeline for development and testing was rushed and limited the ability of practicing physicians to engage. • Stakeholder input was hampered by the complexity of the field testing reports and challenges accessing the reports. Fourth, due to their unfamiliarity with the measures and the complexity of the attribution method for the acute inpatient condition measures, many physicians found it very difficult to glean useful and actionable information from the reports. Even physicians who were actively engaged in the development process had difficulty navigating the reports, interpreting the data and determining whether the workgroup’s decisions were accurately reflected in the draft measure. Physicians who were not part of the development process reported challenges understanding basic aspects of the methodology, including the time interval for eligibility, how risk adjustment was done, and whether the cost measures apply to Medicare or all-payers. For the acute condition measures—where there is the potential for assignment of the same costs to up to three different groups and more than one physician in each of those groups—tracking costs and taking action to improve care and reduce costs will be extremely difficult. Therefore, we are concerned about the actionability of the measures when implemented in MIPS and physicians’ ability to make changes that could improve their scores in the future. We would be more comfortable moving forward with the new episode measures if CMS put in place safeguards against unintended consequences, especially if a measure does not meet a 0.7 or higher mean reliability for a significant percentage of groups or individuals. These include: • Phasing in new measures over several performance periods to give physicians an opportunity to understand how they will be evaluated on their resource utilization during episodes; • Increasing the case minimums for new measures while they are being introduced into the program to create better physician buy-in, identify potential issues, and ensure that individual physicians and small groups are not disadvantaged by a small number of outliers; • Maintaining the current cost category weight at 15% for the next three years while new episode measures are developed, tested, and used in MIPS; • Releasing more detailed analyses about how the new measures will impact physicians and groups, particularly based on group size, practice composition and specialty. • Conducting extensive education and outreach about the new measures. (Submitted by: American Medical Association)
  
  
• (Early public comment)ASCO supports the episode-based measure development process, as episode-based measures can provide a more appropriate and meaningful assessment of care costs than extremely broad cost measures that also lack clarity in attribution. We appreciate the opportunity to participate in the development of those measures and look forward to working on measures related to oncology care, in addition to oncology surgical procedures. However, as we have stated before in numerous comment letters to CMS, the reliance on administrative claims with the failure to consider other important sources of data leads to a crude measure of true cost, and limits both risk adjustment and exclusion criteria. Section 105(b) of the MACRA statute specifically allows for the sharing of data by CMS with qualified clinical data registries; to date, CMS has not provided a process to make this data accessible to clinical registries, instead implementing a “quasi-qualified entity” pathway that is onerous, time-consuming, and may provide access to the data for a limited period. We continue to urge CMS to make this data available, as clearly intended by the MACRA statute, and to work with stakeholders including professional societies to assess how the potential linkage of administrative claims data and clinical registry data could improve existing and new cost measures. We thank NQF for this opportunity to submit comments and look forward to engaging further in the measure development process timeline. (Submitted by: American Society of Clinical Oncology (ASCO) )
  
  
• The American Medical Association (AMA) supports the preliminary recommendation of “Conditional Support” for these measures unless a relevant specialty society raises serious concerns with one of these measures during the public comment period. If serious concerns are raised, we ask that the highest recommendation be “Do Not Support with Potential for Mitigation”. In addition, the AMA requests that additional conditions be placed on each of these measures. Specifically, on review of the supplemental materials provided by Acumen for the Clinician Workgroup meeting, we note that only reliability testing was provided and the validity of the measures have not yet been demonstrated. This testing, which is a requirement for NQF endorsement and inclusion in the MIPS program, must be completed prior to implementation in MIPS. In addition, we question whether any of the proposed cost measures have had sufficient feedback from clinicians given the limited timeframe and challenges accessing the reports. The supplemental materials indicate that more than 78,000 field test reports were distributed; yet, feedback was received from only 67 stakeholders. We do not believe that such a low response rate should necessarily lead to conclusions that these measures are generally supported and do not require ongoing refinements. We refer the Coordination Committee to the substantive feedback provided by the AMA and others during the pre-workgroup comment period and ask that the MAP include the additional conditions requesting that additional feedback and input from clinicians be sought and validity testing be completed prior to implementation in MIPS. (Submitted by: American Medical Association)
  
  

• (Early public comment)Cost measures have been identified as a priority, and CMS addressed this priority through the inclusion of additional episode-based cost measures on the MUC list. The cost measures risk-adjust based on variables, such as age, and comorbidities by using HCC data and other clinical characteristics. However, we are concerned that the measures are not adjusted to account for socio-demographic status. In addition to differences in patient clinical complexity, socio-demographic status can drive differences in average episode costs. In particular, physicians at academic medical centers (AMCs) care for vulnerable populations of patients who are sicker, poorer, and more complex than patients treated elsewhere. Recent reports from the National Academies of Science, Engineering and Medicine and Assistant Secretary for Planning and Evaluation (ASPE) have clearly acknowledged that SDS variables (such as low income and education) may explain adverse outcomes and higher costs. Differences in patient severity, rates of patient compliance with treatment, sociodemographic status, patient engagement, patient preferences for treatment approaches, and sites of care, can all drive differences in average costs. Appropriate risk adjustment is essential so that differences in patient characteristics that are behind a health care provider’s control do not have an unfair impact on a provider’s resource use performance score. CMS should look at alternative sources of data to obtain information about risk adjustment. In regard to attribution – AAMC believes that attribution methods used should be clear and transparent to clinicians and that it is critical that there be an accurate determination of the relationship between a patient and a clinician to ensure that the correct clinician is held responsible for the patient’s outcomes and costs. This is complicated given that most patients receive care from numerous clinicians across several facilities. In the 2019 physician fee schedule final rule CMS changed the attribution methodology for the inpatient episode measures to measure more physicians on episode-based cost measures. We are concerned about the impact of this change and the need for more analysis and opportunity to provide feedback on this new attribution approach. Attribution is complicated, given that most patients receive care from numerous clinicians across several facilities. The AAMC believes that better data sources and analytic techniques should be explored in the future to support more accurate attribution. (Submitted by: Association of American Medical Colleges)
  
  
• (Early public comment)Overall, the AMA supports the episode-based measure development process and movement to episode based measures over broad cost measures. However, we cannot endorse any of the specific measures due to the paucity of analytic information, such as the measures’ mean, made available prior to the deadline for comments. We request further refinements to the process to ensure the cost measures are accurate and fair when used in the Merit-based Incentive Payment System and, ultimately, publicly reported. In general, we urge the MAP to make “Conditional Support” its highest level of recommendation and to recommend “Do Not Support with Potential for Mitigation” for any measures where relevant specialties have raised serious concerns. Please see additional comments submitted earlier regarding the MUC18-115 Inpatient Chronic Obstructive Pulmonary Disease (COPD) Exacerbation. (Submitted by: American Medical Association)
  
  
• (Early public comment)ASCO supports the episode-based measure development process, as episode-based measures can provide a more appropriate and meaningful assessment of care costs than extremely broad cost measures that also lack clarity in attribution. We appreciate the opportunity to participate in the development of those measures and look forward to working on measures related to oncology care, in addition to oncology surgical procedures. However, as we have stated before in numerous comment letters to CMS, the reliance on administrative claims with the failure to consider other important sources of data leads to a crude measure of true cost, and limits both risk adjustment and exclusion criteria. Section 105(b) of the MACRA statute specifically allows for the sharing of data by CMS with qualified clinical data registries; to date, CMS has not provided a process to make this data accessible to clinical registries, instead implementing a “quasi-qualified entity” pathway that is onerous, time-consuming, and may provide access to the data for a limited period. We continue to urge CMS to make this data available, as clearly intended by the MACRA statute, and to work with stakeholders including professional societies to assess how the potential linkage of administrative claims data and clinical registry data could improve existing and new cost measures. We thank NQF for this opportunity to submit comments and look forward to engaging further in the measure development process timeline. (Submitted by: American Society of Clinical Oncology (ASCO) )
  
  
• MUC18-116: Femoral or Inguinal Hernia Repair is one of eleven (11) episode-based cost measures that CMS submitted to the MAP as Measures Under Consideration for this cycle for potential use in MIPS. It is important to note that the cost measures field testing took place during a time period of October 3 to November 5, 2018; a brief period just prior to deliberation by the MAP workgroups. Although AdvaMed supports the collaborative process used by CMS to develop the episode-based cost measures, it appears that the recent field-testing process experienced a number of challenges. Advamed shares many of the concerns already mentioned by others in their comments — before and during the MAP workgroup meetings — regarding these issues and questions. In the end, we question whether physicians had sufficient time and information to provide complete reviews of the test reports. It is concerning that many physicians may not have had the opportunity to understand the basic aspects of the methodology of these complex measures, especially if they were not actively engaged in the development process. We are especially concerned about the potential unintended consequences of implementing cost-related measures in the CMS reporting programs without rigorous testing in the field, such as pushing providers to utilize the least costly alternative without consideration for patient outcomes. MUC18-116: Femoral or Inguinal Hernia Repair measure is a good example of this. MUC18-116 examines femoral or inguinal hernia repair 30-days out from diagnosis, but seems to fail to take into account the potential for post-operative soft tissue adhesions that may be prevented through a slightly more costly upfront procedure and/or supplies that could require significant additional costs after that window. This seems to be a common problem among many of the proposed cost efficacy measures and, without proper testing and additional research around the conditions being included in this group, there is a high risk of providers engaging in least costly alternative methodology that could become a barrier to optimal patient care. AdvaMed agrees with the MAP’s guidance to CMS on these episode-based measures, which included recommendations for: continued evaluation of risk-adjustment models and the potential use of social risk adjustment; incorporating balancing measures into the program (e.g. quality, efficiency, access, and appropriate use measures); consistent surveillance for unintended consequences such as stinting of care and reduced quality of care; evaluation of attribution models; continuous feedback and testing of measures; providing education and transparency to the measure specifications and rationale; and ensuring a strong link between clinician behavior and cost. (Submitted by: Advanced Medical Technology Association (AdvaMed))
  
  
• The American Medical Association (AMA) supports the preliminary recommendation of “Conditional Support” for these measures unless a relevant specialty society raises serious concerns with one of these measures during the public comment period. If serious concerns are raised, we ask that the highest recommendation be “Do Not Support with Potential for Mitigation”. In addition, the AMA requests that additional conditions be placed on each of these measures. Specifically, on review of the supplemental materials provided by Acumen for the Clinician Workgroup meeting, we note that only reliability testing was provided and the validity of the measures have not yet been demonstrated. This testing, which is a requirement for NQF endorsement and inclusion in the MIPS program, must be completed prior to implementation in MIPS. In addition, we question whether any of the proposed cost measures have had sufficient feedback from clinicians given the limited timeframe and challenges accessing the reports. The supplemental materials indicate that more than 78,000 field test reports were distributed; yet, feedback was received from only 67 stakeholders. We do not believe that such a low response rate should necessarily lead to conclusions that these measures are generally supported and do not require ongoing refinements. We refer the Coordination Committee to the substantive feedback provided by the AMA and others during the pre-workgroup comment period and ask that the MAP include the additional conditions requesting that additional feedback and input from clinicians be sought and validity testing be completed prior to implementation in MIPS. (Submitted by: American Medical Association)
  
  

• (Early public comment)Cost measures have been identified as a priority, and CMS addressed this priority through the inclusion of additional episode-based cost measures on the MUC list. The cost measures risk-adjust based on variables, such as age, and comorbidities by using HCC data and other clinical characteristics. However, we are concerned that the measures are not adjusted to account for socio-demographic status. In addition to differences in patient clinical complexity, socio-demographic status can drive differences in average episode costs. In particular, physicians at academic medical centers (AMCs) care for vulnerable populations of patients who are sicker, poorer, and more complex than patients treated elsewhere. Recent reports from the National Academies of Science, Engineering and Medicine and Assistant Secretary for Planning and Evaluation (ASPE) have clearly acknowledged that SDS variables (such as low income and education) may explain adverse outcomes and higher costs. Differences in patient severity, rates of patient compliance with treatment, sociodemographic status, patient engagement, patient preferences for treatment approaches, and sites of care, can all drive differences in average costs. Appropriate risk adjustment is essential so that differences in patient characteristics that are behind a health care provider’s control do not have an unfair impact on a provider’s resource use performance score. CMS should look at alternative sources of data to obtain information about risk adjustment. In regard to attribution – AAMC believes that attribution methods used should be clear and transparent to clinicians and that it is critical that there be an accurate determination of the relationship between a patient and a clinician to ensure that the correct clinician is held responsible for the patient’s outcomes and costs. This is complicated given that most patients receive care from numerous clinicians across several facilities. In the 2019 physician fee schedule final rule CMS changed the attribution methodology for the inpatient episode measures to measure more physicians on episode-based cost measures. We are concerned about the impact of this change and the need for more analysis and opportunity to provide feedback on this new attribution approach. Attribution is complicated, given that most patients receive care from numerous clinicians across several facilities. The AAMC believes that better data sources and analytic techniques should be explored in the future to support more accurate attribution. (Submitted by: Association of American Medical Colleges)
  
  
• (Early public comment)Multiple neurosurgeons contributed their time and expertise to the development of this measure. While they felt that their input was taken seriously and appreciated the flexibility to define certain aspects of the measure, such as trigger codes and risk adjustment factors, they continue to believe there are multiple critical deficiencies in the underlying measure development process that limit the measures readiness for implementation. These include: • Adherence to a uniform measure development framework that fails to account for uniqueness of each clinical scenario. It is not necessarily appropriate for the Lumbar Fusion Workgroup to adhere to the same standardized measure constructs as the Hernia Repair or the COPD Exacerbation Workgroups. Procedures and patient populations are vastly different and cannot be evaluated for appropriateness using a one-size-fits-all approach. • Exclusive reliance on administrative claims data. The limitations of claims data impact the effectiveness and accuracy of risk stratification, subgrouping, and inclusion and exclusion criteria. In order to achieve the most accurate assessment of cost, CMS must look beyond administrative billing data and make use of clinical data from registries and other sources. • The ongoing absence of a direct link to quality. By focusing simply on cost, this process fails to account for the impact that cost reduction (or spending) may have on patient outcomes; provides clinicians with virtually meaningless and unactionable data in a clinical context; and belies the value-driven goals of the Medicare Access and CHIP Reauthorization Act (MACRA). • Rushed timeline. One of the biggest limiting factors to the utility and credibility of this exercise has been the rushed timeline. This process was driven by a rapid and arbitrary timeline that focused exclusively on the goal of measure implementation, rather than actually getting the measure right. Very few members of the Lumbar Fusion Workgroup were able to access their performance reports during the short Field Testing period and even if they could, they found it very difficult to decipher the reports and provide meaningful feedback. If clinicians who were most involved in this process encountered such problems, there is a low likelihood that Acumen collected valid and useful feedback from the general public. In fact, Acumen informed us that the Field Testing response rates were very low. The Lumbar Fusion measure should not be implemented until relevant stakeholders are given a more reasonable opportunity to review, understand, and comment on the confidential performance reports. In light of these unresolved concerns, the AANS and CNS and the neurosurgical representatives that served on the development Workgroup do NOT endorse the MUC18-117: Lumbar Spine Fusion for Degenerative Disease, 1-3 Levels, Episode-Based Cost Measure and do NOT believe it is ready for implementation in MIPS at this time or any other program with public accountability and payment implications. For these same reasons, we recommend that the MAP NOT support this measure for use in MIPS. (Submitted by: American Association of Neurological Surgeons)
  
  
• (Early public comment)Overall, the AMA supports the episode-based measure development process and movement to episode based measures over broad cost measures. However, we cannot endorse any of the specific measures due to the paucity of analytic information such as the measures’ mean made available prior to the deadline for comments. We request further refinements to the process to ensure the cost measures are accurate and fair when used in the Merit-based Incentive Payment System and, ultimately, publicly reported. In general, we urge the MAP to make “Conditional Support” its highest level of recommendation and to recommend “Do Not Support with Potential for Mitigation” for any measures where relevant specialties have raised serious concerns. Please see additional comments submitted earlier in response to MUC18-115 Inpatient Chronic Obstructive Pulmonary Disease (COPD) Exacerbation. (Submitted by: American Medical Association)
  
  
• (Early public comment)ASCO supports the episode-based measure development process, as episode-based measures can provide a more appropriate and meaningful assessment of care costs than extremely broad cost measures that also lack clarity in attribution. We appreciate the opportunity to participate in the development of those measures and look forward to working on measures related to oncology care, in addition to oncology surgical procedures. However, as we have stated before in numerous comment letters to CMS, the reliance on administrative claims with the failure to consider other important sources of data leads to a crude measure of true cost, and limits both risk adjustment and exclusion criteria. Section 105(b) of the MACRA statute specifically allows for the sharing of data by CMS with qualified clinical data registries; to date, CMS has not provided a process to make this data accessible to clinical registries, instead implementing a “quasi-qualified entity” pathway that is onerous, time-consuming, and may provide access to the data for a limited period. We continue to urge CMS to make this data available, as clearly intended by the MACRA statute, and to work with stakeholders including professional societies to assess how the potential linkage of administrative claims data and clinical registry data could improve existing and new cost measures. We thank NQF for this opportunity to submit comments and look forward to engaging further in the measure development process timeline. (Submitted by: American Society of Clinical Oncology (ASCO) )
  
  
• The American Medical Association (AMA) supports the preliminary recommendation of “Conditional Support” for these measures unless a relevant specialty society raises serious concerns with one of these measures during the public comment period. If serious concerns are raised, we ask that the highest recommendation be “Do Not Support with Potential for Mitigation”. In addition, the AMA requests that additional conditions be placed on each of these measures. Specifically, on review of the supplemental materials provided by Acumen for the Clinician Workgroup meeting, we note that only reliability testing was provided and the validity of the measures have not yet been demonstrated. This testing, which is a requirement for NQF endorsement and inclusion in the MIPS program, must be completed prior to implementation in MIPS. In addition, we question whether any of the proposed cost measures have had sufficient feedback from clinicians given the limited timeframe and challenges accessing the reports. The supplemental materials indicate that more than 78,000 field test reports were distributed; yet, feedback was received from only 67 stakeholders. We do not believe that such a low response rate should necessarily lead to conclusions that these measures are generally supported and do not require ongoing refinements. We refer the Coordination Committee to the substantive feedback provided by the AMA and others during the pre-workgroup comment period and ask that the MAP include the additional conditions requesting that additional feedback and input from clinicians be sought and validity testing be completed prior to implementation in MIPS. (Submitted by: American Medical Association)
  
  
• Multiple neurosurgeons contributed their time and expertise to the development of this measure. While they felt that their input was taken seriously and appreciated the flexibility to define certain aspects of the measure, such as trigger codes and risk adjustment factors, they continue to believe there are multiple critical deficiencies in the underlying measure development process that limit the measures readiness for implementation. These include: • Adherence to a uniform measure development framework that fails to account for uniqueness of each clinical scenario. It is not necessarily appropriate for the Lumbar Fusion Workgroup to adhere to the same standardized measure constructs as the Hernia Repair or the COPD Exacerbation Workgroups. Procedures and patient populations are vastly different and cannot be evaluated for appropriateness using a one-size-fits-all approach. • Exclusive reliance on administrative claims data. The limitations of claims data impact the effectiveness and accuracy of risk stratification, subgrouping, and inclusion and exclusion criteria. In order to achieve the most accurate assessment of cost, CMS must look beyond administrative billing data and make use of clinical data from registries and other sources. • The ongoing absence of a direct link to quality. By focusing simply on cost, this process fails to account for the impact that cost reduction (or spending) may have on patient outcomes; provides clinicians with virtually meaningless and unactionable data in a clinical context; and belies the value-driven goals of the Medicare Access and CHIP Reauthorization Act (MACRA). • Rushed timeline. One of the biggest limiting factors to the utility and credibility of this exercise has been the rushed timeline. This process was driven by a rapid and arbitrary timeline that focused exclusively on the goal of measure implementation, rather than actually getting the measure right. Very few members of the Lumbar Fusion Workgroup were able to access their performance reports during the short Field Testing period and even if they could, they found it very difficult to decipher the reports and provide meaningful feedback. If clinicians who were most involved in this process encountered such problems, there is a low likelihood that Acumen collected valid and useful feedback from the general public. In fact, Acumen informed us that the Field Testing response rates were very low. The Lumbar Fusion measure should not be implemented until relevant stakeholders are given a more reasonable opportunity to review, understand, and comment on the confidential performance reports. In light of these unresolved concerns, the AANS and the neurosurgical representatives that served on the development Workgroup do NOT endorse the MUC18-117: Lumbar Spine Fusion for Degenerative Disease, 1-3 Levels, Episode-Based Cost Measure and do NOT believe it is ready for implementation in MIPS at this time or any other program with public accountability and payment implications. For these same reasons, we recommend that the MAP NOT support this measure for use in MIPS. (Submitted by: American Association of Neurological Surgeons)
  
  

• (Early public comment)Cost measures have been identified as a priority, and CMS addressed this priority through the inclusion of additional episode-based cost measures on the MUC list. The cost measures risk-adjust based on variables, such as age, and comorbidities by using HCC data and other clinical characteristics. However, we are concerned that the measures are not adjusted to account for socio-demographic status. In addition to differences in patient clinical complexity, socio-demographic status can drive differences in average episode costs. In particular, physicians at academic medical centers (AMCs) care for vulnerable populations of patients who are sicker, poorer, and more complex than patients treated elsewhere. Recent reports from the National Academies of Science, Engineering and Medicine and Assistant Secretary for Planning and Evaluation (ASPE) have clearly acknowledged that SDS variables (such as low income and education) may explain adverse outcomes and higher costs. Differences in patient severity, rates of patient compliance with treatment, sociodemographic status, patient engagement, patient preferences for treatment approaches, and sites of care, can all drive differences in average costs. Appropriate risk adjustment is essential so that differences in patient characteristics that are behind a health care provider’s control do not have an unfair impact on a provider’s resource use performance score. CMS should look at alternative sources of data to obtain information about risk adjustment. In regard to attribution – AAMC believes that attribution methods used should be clear and transparent to clinicians and that it is critical that there be an accurate determination of the relationship between a patient and a clinician to ensure that the correct clinician is held responsible for the patient’s outcomes and costs. This is complicated given that most patients receive care from numerous clinicians across several facilities. In the 2019 physician fee schedule final rule CMS changed the attribution methodology for the inpatient episode measures to measure more physicians on episode-based cost measures. We are concerned about the impact of this change and the need for more analysis and opportunity to provide feedback on this new attribution approach. Attribution is complicated, given that most patients receive care from numerous clinicians across several facilities. The AAMC believes that better data sources and analytic techniques should be explored in the future to support more accurate attribution. (Submitted by: Association of American Medical Colleges)
  
  
• (Early public comment)o We do not understand how this measure is intended to improve the quality of provided healthcare, and request it be withdrawn, or better connected/associated or proven to be indicative of some improvement in the quality of delivered (Submitted by: National Assn for Behavioral Healthcare)
  
  
• (Early public comment)Overall, the AMA supports the episode-based measure development process and movement to episode based measures over broad cost measures. However, we cannot endorse any of the specific measures due to the paucity of analytic information such as the measures’ mean made available prior to the deadline for comments. We request further refinements to the process to ensure the cost measures are accurate and fair when used in the Merit-based Incentive Payment System and, ultimately, publicly reported. In general, we urge the MAP to make “Conditional Support” its highest level of recommendation and to recommend “Do Not Support with Potential for Mitigation” for any measures where relevant specialties have raised serious concerns. Please see additional comments submitted earlier in response to MUC18-115 Inpatient Chronic Obstructive Pulmonary Disease (COPD) Exacerbation. (Submitted by: American Medical Association)
  
  
• (Early public comment)ASCO supports the episode-based measure development process, as episode-based measures can provide a more appropriate and meaningful assessment of care costs than extremely broad cost measures that also lack clarity in attribution. We appreciate the opportunity to participate in the development of those measures and look forward to working on measures related to oncology care, in addition to oncology surgical procedures. However, as we have stated before in numerous comment letters to CMS, the reliance on administrative claims with the failure to consider other important sources of data leads to a crude measure of true cost, and limits both risk adjustment and exclusion criteria. Section 105(b) of the MACRA statute specifically allows for the sharing of data by CMS with qualified clinical data registries; to date, CMS has not provided a process to make this data accessible to clinical registries, instead implementing a “quasi-qualified entity” pathway that is onerous, time-consuming, and may provide access to the data for a limited period. We continue to urge CMS to make this data available, as clearly intended by the MACRA statute, and to work with stakeholders including professional societies to assess how the potential linkage of administrative claims data and clinical registry data could improve existing and new cost measures. We thank NQF for this opportunity to submit comments and look forward to engaging further in the measure development process timeline. (Submitted by: American Society of Clinical Oncology (ASCO) )
  
  
• The American Psychiatric Association is concerned about the lack of robust feedback during the field testing phase of this measure set and asks that the NQF recommendation be revised to “Do Not Support with Potential for Mitigation.” While the development process put in place by CMS and Acumen, LLP to define the measure set has been collaborative and inclusive of appropriate expertise, the ability to validate the measure set was hampered by scant data received through the field testing phase. We believe the robustness of the feedback was inadequate to set policy that has tremendous implications. Longer timelines with greater scrutiny of the set may lead to a different outcome; it assures we are heading in the right direction. Policy based on limited data could be particularly problematic given this patient population and the known barriers (inadequate insurance coverage, fragmented system of care, and lack of access to specialty care) that have an impact on the cost of care. We ask that the MAP include the additional conditions requesting that additional feedback and input from clinicians be sought and validity testing be completed prior to implementation in MIPS. (Submitted by: American Psychiatric Association)
  
  
• We are concerned that this measure would drive systems to dump their psychiatric patients or figure out a way to code them as delirium, rather than result in the intended outcome which is to control cost. Creating better systems to provide psychiatric care would be better for patients regardless of cost. (Submitted by: American Geriatrics Society)
  
  
• The American Medical Association (AMA) supports the preliminary recommendation of “Conditional Support” for these measures unless a relevant specialty society raises serious concerns with one of these measures during the public comment period. If serious concerns are raised, we ask that the highest recommendation be “Do Not Support with Potential for Mitigation”. In addition, the AMA requests that additional conditions be placed on each of these measures. Specifically, on review of the supplemental materials provided by Acumen for the Clinician Workgroup meeting, we note that only reliability testing was provided and the validity of the measures have not yet been demonstrated. This testing, which is a requirement for NQF endorsement and inclusion in the MIPS program, must be completed prior to implementation in MIPS. In addition, we question whether any of the proposed cost measures have had sufficient feedback from clinicians given the limited timeframe and challenges accessing the reports. The supplemental materials indicate that more than 78,000 field test reports were distributed; yet, feedback was received from only 67 stakeholders. We do not believe that such a low response rate should necessarily lead to conclusions that these measures are generally supported and do not require ongoing refinements. We refer the Coordination Committee to the substantive feedback provided by the AMA and others during the pre-workgroup comment period and ask that the MAP include the additional conditions requesting that additional feedback and input from clinicians be sought and validity testing be completed prior to implementation in MIPS. (Submitted by: American Medical Association)
  
  

• (Early public comment)Cost measures have been identified as a priority, and CMS addressed this priority through the inclusion of additional episode-based cost measures on the MUC list. The cost measures risk-adjust based on variables, such as age, and comorbidities by using HCC data and other clinical characteristics. However, we are concerned that the measures are not adjusted to account for socio-demographic status. In addition to differences in patient clinical complexity, socio-demographic status can drive differences in average episode costs. In particular, physicians at academic medical centers (AMCs) care for vulnerable populations of patients who are sicker, poorer, and more complex than patients treated elsewhere. Recent reports from the National Academies of Science, Engineering and Medicine and Assistant Secretary for Planning and Evaluation (ASPE) have clearly acknowledged that SDS variables (such as low income and education) may explain adverse outcomes and higher costs. Differences in patient severity, rates of patient compliance with treatment, sociodemographic status, patient engagement, patient preferences for treatment approaches, and sites of care, can all drive differences in average costs. Appropriate risk adjustment is essential so that differences in patient characteristics that are behind a health care provider’s control do not have an unfair impact on a provider’s resource use performance score. CMS should look at alternative sources of data to obtain information about risk adjustment. In regard to attribution – AAMC believes that attribution methods used should be clear and transparent to clinicians and that it is critical that there be an accurate determination of the relationship between a patient and a clinician to ensure that the correct clinician is held responsible for the patient’s outcomes and costs. This is complicated given that most patients receive care from numerous clinicians across several facilities. In the 2019 physician fee schedule final rule CMS changed the attribution methodology for the inpatient episode measures to measure more physicians on episode-based cost measures. We are concerned about the impact of this change and the need for more analysis and opportunity to provide feedback on this new attribution approach. Attribution is complicated, given that most patients receive care from numerous clinicians across several facilities. The AAMC believes that better data sources and analytic techniques should be explored in the future to support more accurate attribution. (Submitted by: Association of American Medical Colleges)
  
  
• (Early public comment)Overall, the AMA supports the episode-based measure development process and movement to episode based measures over broad cost measures. However, we cannot endorse any of the specific measures due to the paucity of analytic information such as the measures’ mean made available prior to the deadline for comments. We request further refinements to the process to ensure the cost measures are accurate and fair when used in the Merit-based Incentive Payment System and, ultimately, publicly reported. In general, we urge the MAP to make “Conditional Support” its highest level of recommendation and to recommend “Do Not Support with Potential for Mitigation” for any measures where relevant specialties have raised serious concerns. Please see additional comments submitted earlier in response to MUC18-115 Inpatient Chronic Obstructive Pulmonary Disease (COPD) Exacerbation. (Submitted by: American Medical Association)
  
  
• (Early public comment)The American Society of Breast Surgeons (ASBrS) would like to express its ongoing concerns with the episode-based cost measure “Lumpectomy, Partial Mastectomy, Simple Mastectomy,” which is under consideration for inclusion in the 2020 Merit-Based Incentive Payment System (MIPS). While one of our breast surgeon members served on the Clinical Subcommittee and several members served on the smaller workgroup that helped to develop this measure, neither the ASBrS nor our clinical expert volunteers endorse the measure or believe it is ready for implementation in a program with public accountability and payment implications. Our concerns with this measure center on the fundamentally flawed process under which it was developed. Although workgroup members had the flexibility to define many elements of the episode, there was little flexibility to stray from the overall measure framework, which relied on a one-size-fits-all-approach to measuring cost across diverse conditions, procedures, and patient populations. This standardized process failed to adequately account for the complexities of oncologic care and made it challenging to measure cost variation in a meaningful and clinically relevant manner. This project also continues to focus exclusively on cost without evaluating what impact cost reduction (or spending) has on quality. As a result, it fails to provide a meaningful picture of healthcare value and what is truly best for the patient. The project also suffers from its exclusive reliance on claims data, which impacts the accuracy of risk adjustments and performance evaluations, overall. Finally, this project was driven by a rushed and arbitrary timeline, which seemed to be more focused on measure implementation than actually getting the measure right. We strongly urge the MAP to recommend that CMS not implement this measure at this time and that it give relevant clinical stakeholders the opportunity to more carefully craft and test a breast surgery cost measure under a more flexible framework and more reasonable timeline. (Submitted by: The American Society of Breast Surgeons)
  
  
• (Early public comment)ASCO supports the episode-based measure development process, as episode-based measures can provide a more appropriate and meaningful assessment of care costs than extremely broad cost measures that also lack clarity in attribution. We appreciate the opportunity to participate in the development of those measures and look forward to working on measures related to oncology care, in addition to oncology surgical procedures. However, as we have stated before in numerous comment letters to CMS, the reliance on administrative claims with the failure to consider other important sources of data leads to a crude measure of true cost, and limits both risk adjustment and exclusion criteria. Section 105(b) of the MACRA statute specifically allows for the sharing of data by CMS with qualified clinical data registries; to date, CMS has not provided a process to make this data accessible to clinical registries, instead implementing a “quasi-qualified entity” pathway that is onerous, time-consuming, and may provide access to the data for a limited period. We continue to urge CMS to make this data available, as clearly intended by the MACRA statute, and to work with stakeholders including professional societies to assess how the potential linkage of administrative claims data and clinical registry data could improve existing and new cost measures. We thank NQF for this opportunity to submit comments and look forward to engaging further in the measure development process timeline. (Submitted by: American Society of Clinical Oncology (ASCO) )
  
  
• The American Medical Association (AMA) supports the preliminary recommendation of “Conditional Support” for these measures unless a relevant specialty society raises serious concerns with one of these measures during the public comment period. If serious concerns are raised, we ask that the highest recommendation be “Do Not Support with Potential for Mitigation”. In addition, the AMA requests that additional conditions be placed on each of these measures. Specifically, on review of the supplemental materials provided by Acumen for the Clinician Workgroup meeting, we note that only reliability testing was provided and the validity of the measures have not yet been demonstrated. This testing, which is a requirement for NQF endorsement and inclusion in the MIPS program, must be completed prior to implementation in MIPS. In addition, we question whether any of the proposed cost measures have had sufficient feedback from clinicians given the limited timeframe and challenges accessing the reports. The supplemental materials indicate that more than 78,000 field test reports were distributed; yet, feedback was received from only 67 stakeholders. We do not believe that such a low response rate should necessarily lead to conclusions that these measures are generally supported and do not require ongoing refinements. We refer the Coordination Committee to the substantive feedback provided by the AMA and others during the pre-workgroup comment period and ask that the MAP include the additional conditions requesting that additional feedback and input from clinicians be sought and validity testing be completed prior to implementation in MIPS. (Submitted by: American Medical Association)
  
  

• (Early public comment)Cost measures have been identified as a priority, and CMS addressed this priority through the inclusion of additional episode-based cost measures on the MUC list. The cost measures risk-adjust based on variables, such as age, and comorbidities by using HCC data and other clinical characteristics. However, we are concerned that the measures are not adjusted to account for socio-demographic status. In addition to differences in patient clinical complexity, socio-demographic status can drive differences in average episode costs. In particular, physicians at academic medical centers (AMCs) care for vulnerable populations of patients who are sicker, poorer, and more complex than patients treated elsewhere. Recent reports from the National Academies of Science, Engineering and Medicine and Assistant Secretary for Planning and Evaluation (ASPE) have clearly acknowledged that SDS variables (such as low income and education) may explain adverse outcomes and higher costs. Differences in patient severity, rates of patient compliance with treatment, sociodemographic status, patient engagement, patient preferences for treatment approaches, and sites of care, can all drive differences in average costs. Appropriate risk adjustment is essential so that differences in patient characteristics that are behind a health care provider’s control do not have an unfair impact on a provider’s resource use performance score. CMS should look at alternative sources of data to obtain information about risk adjustment. In regard to attribution – AAMC believes that attribution methods used should be clear and transparent to clinicians and that it is critical that there be an accurate determination of the relationship between a patient and a clinician to ensure that the correct clinician is held responsible for the patient’s outcomes and costs. This is complicated given that most patients receive care from numerous clinicians across several facilities. In the 2019 physician fee schedule final rule CMS changed the attribution methodology for the inpatient episode measures to measure more physicians on episode-based cost measures. We are concerned about the impact of this change and the need for more analysis and opportunity to provide feedback on this new attribution approach. Attribution is complicated, given that most patients receive care from numerous clinicians across several facilities. The AAMC believes that better data sources and analytic techniques should be explored in the future to support more accurate attribution. (Submitted by: Association of American Medical Colleges)
  
  
• (Early public comment)Overall, the AMA supports the episode-based measure development process and movement to episode based measures over broad cost measures. However, we cannot endorse any of the specific measures due to the paucity of analytic information such as the measures’ mean made available prior to the deadline for comments. We request further refinements to the process to ensure the cost measures are accurate and fair when used in the Merit-based Incentive Payment System and, ultimately, publicly reported. In general, we urge the MAP to make “Conditional Support” its highest level of recommendation and to recommend “Do Not Support with Potential for Mitigation” for any measures where relevant specialties have raised serious concerns. Please see additional comments submitted earlier in response to MUC18-115 Inpatient Chronic Obstructive Pulmonary Disease (COPD) Exacerbation. (Submitted by: American Medical Association)
  
  
• (Early public comment)The Renal Physicians Association (RPA) is the professional organization of nephrologists whose goals are to ensure optimal care under the highest standards of medical practice for patients with kidney disease and related disorders. RPA acts as the national representative for physicians engaged in the study and management of patients with kidney disease. The RPA opposes the proposed measure. First, we believe that appropriate clinician attribution is problematic. Patients requiring dialysis for AKI usually have multiple medical problems and complications, and multiple providers and consultants. For the vast majority of patients, the management of AKI accounts for only a small fraction of the inpatient cost of care. It is rare that the nephrologist has any substantial control over the total cost. Similarly, for outpatient care, AKI patients often require multiple non-renal services which are outside the control of the nephrologist. Finally, RPA is concerned that holding nephrologists responsible and accountable for these costs may have the unintended consequence that will result in nephrologists unwilling to initiate dialysis in AKI patients. (Submitted by: Renal Physicians Association )
  
  
• (Early public comment)ASCO supports the episode-based measure development process, as episode-based measures can provide a more appropriate and meaningful assessment of care costs than extremely broad cost measures that also lack clarity in attribution. We appreciate the opportunity to participate in the development of those measures and look forward to working on measures related to oncology care, in addition to oncology surgical procedures. However, as we have stated before in numerous comment letters to CMS, the reliance on administrative claims with the failure to consider other important sources of data leads to a crude measure of true cost, and limits both risk adjustment and exclusion criteria. Section 105(b) of the MACRA statute specifically allows for the sharing of data by CMS with qualified clinical data registries; to date, CMS has not provided a process to make this data accessible to clinical registries, instead implementing a “quasi-qualified entity” pathway that is onerous, time-consuming, and may provide access to the data for a limited period. We continue to urge CMS to make this data available, as clearly intended by the MACRA statute, and to work with stakeholders including professional societies to assess how the potential linkage of administrative claims data and clinical registry data could improve existing and new cost measures. We thank NQF for this opportunity to submit comments and look forward to engaging further in the measure development process timeline. (Submitted by: American Society of Clinical Oncology (ASCO) )
  
  
• MUC18-121: Acute Kidney Injury Requiring New Inpatient Dialysis is one of eleven (11) episode-based cost measures that CMS submitted to the MAP as Measures Under Consideration for this cycle for potential use in MIPS. . It is important to note that the cost measures field testing took place during a time period of October 3 to November 5, 2018; a brief period just prior to deliberation by the MAP workgroups. Although AdvaMed supports the collaborative process used by CMS to develop the episode-based cost measures, it appears that the recent field-testing process experienced a number of challenges. Advamed shares many of the concerns already mentioned by others in their comments — before and during the MAP workgroup meetings — regarding these issues and questions. In the end, we question whether physicians had sufficient time and information to provide complete reviews of the test reports. It is concerning that many physicians may not have had the opportunity to understand the basic aspects of the methodology of these complex measures, especially if they were not actively engaged in the development process. We are especially concerned about the potential unintended consequences of implementing cost-related measures in the CMS reporting programs without rigorous testing in the field, such as pushing providers to utilize the least costly alternative without consideration for patient outcomes. AdvaMed agrees with the MAP’s guidance to CMS, which included recommendations for: continued evaluation of risk-adjustment models and the potential use of social risk adjustment; incorporating balancing measures into the program (e.g. quality, efficiency, access, and appropriate use measures); consistent surveillance for unintended consequences such as stinting of care and reduced quality of care; evaluation of attribution models; continuous feedback and testing of measures; providing education and transparency to the measure specifications and rationale; and ensuring a strong link between clinician behavior and cost. AKI is a prevalent and costly disease state that is often unrecognized and presents a therapeutic area where improved care can dramatically impact patients’ lives, health system outcomes performance and reduce costs to payers. Each year an estimated 300,000 people die in the United States from AKI and up to 50% of critically ill patients develop some stage of AKI. Patients with a documented event with AKI have a 9-times higher risk of developing Chronic Kidney Disease and double the risk of premature death. We express general support for the quality measure concept referenced in MUC18-121: Acute Kidney Injury (AKI) Requiring New Patient Inpatient Dialysis measure, however it is important to note that this measure assigns cost considerations to multiple types of renal replacement therapies with upfront cost differences that have not had sufficient comparative studies for outcomes in certain patient populations, longer-term outcomes, and downstream cost savings. This seems to be a common problem among many of the proposed cost efficacy measures and, without proper testing and additional research around the conditions being included in this group, there is a high risk of providers engaging in least costly alternative methodology that could become a barrier to optimal patient care. Given the high prevalence of AKI, its impact on patients and the healthcare system, and the increasing evidence demonstrating that improved outcomes are possible, we believe that developing AKI quality measures are extremely worthwhile. We encourage CMS to continue to push for additional measures in AKI to encourage not just economical dialysis treatment, but prevention of severe AKI (Stages 2 + 3) requiring dialysis. Through improved assessment of patients at high-risk of AKI, as well as nephro-protective strategies as directed in the Kidney Disease Improving Global Outcomes (KDIGO) guidelines, effective AKI prevention will improve outcomes, such as lengths of stay, 30-day readmissions, as well as hospital costs. (Submitted by: AdvaMed )
  
  
• The American Medical Association (AMA) supports the preliminary recommendation of “Conditional Support” for these measures unless a relevant specialty society raises serious concerns with one of these measures during the public comment period. If serious concerns are raised, we ask that the highest recommendation be “Do Not Support with Potential for Mitigation”. In addition, the AMA requests that additional conditions be placed on each of these measures. Specifically, on review of the supplemental materials provided by Acumen for the Clinician Workgroup meeting, we note that only reliability testing was provided and the validity of the measures have not yet been demonstrated. This testing, which is a requirement for NQF endorsement and inclusion in the MIPS program, must be completed prior to implementation in MIPS. In addition, we question whether any of the proposed cost measures have had sufficient feedback from clinicians given the limited timeframe and challenges accessing the reports. The supplemental materials indicate that more than 78,000 field test reports were distributed; yet, feedback was received from only 67 stakeholders. We do not believe that such a low response rate should necessarily lead to conclusions that these measures are generally supported and do not require ongoing refinements. We refer the Coordination Committee to the substantive feedback provided by the AMA and others during the pre-workgroup comment period and ask that the MAP include the additional conditions requesting that additional feedback and input from clinicians be sought and validity testing be completed prior to implementation in MIPS. (Submitted by: American Medical Association)
  
  
• The Renal Physicians Association (RPA) is the professional organization of nephrologists whose goals are to ensure optimal care under the highest standards of medical practice for patients with kidney disease and related disorders. RPA acts as the national representative for physicians engaged in the study and management of patients with kidney disease. The RPA opposes the proposed measure. First, we believe that appropriate clinician attribution is problematic. Patients requiring dialysis for AKI usually have multiple medical problems and complications, and multiple providers and consultants. For the vast majority of patients, the management of AKI accounts for only a small fraction of the inpatient cost of care. It is rare that the nephrologist has any substantial control over the total cost. Similarly, for outpatient care, AKI patients often require multiple non-renal services which are outside the control of the nephrologist. Finally, RPA is concerned that holding nephrologists responsible and accountable for these costs may have the unintended consequence that will result in nephrologists unwilling to initiate dialysis in AKI patients. (Submitted by: Renal Physicians Association )
  
  

• (Early public comment)Cost measures have been identified as a priority, and CMS addressed this priority through the inclusion of additional episode-based cost measures on the MUC list. The cost measures risk-adjust based on variables, such as age, and comorbidities by using HCC data and other clinical characteristics. However, we are concerned that the measures are not adjusted to account for socio-demographic status. In addition to differences in patient clinical complexity, socio-demographic status can drive differences in average episode costs. In particular, physicians at academic medical centers (AMCs) care for vulnerable populations of patients who are sicker, poorer, and more complex than patients treated elsewhere. Recent reports from the National Academies of Science, Engineering and Medicine and Assistant Secretary for Planning and Evaluation (ASPE) have clearly acknowledged that SDS variables (such as low income and education) may explain adverse outcomes and higher costs. Differences in patient severity, rates of patient compliance with treatment, sociodemographic status, patient engagement, patient preferences for treatment approaches, and sites of care, can all drive differences in average costs. Appropriate risk adjustment is essential so that differences in patient characteristics that are behind a health care provider’s control do not have an unfair impact on a provider’s resource use performance score. CMS should look at alternative sources of data to obtain information about risk adjustment. In regard to attribution – AAMC believes that attribution methods used should be clear and transparent to clinicians and that it is critical that there be an accurate determination of the relationship between a patient and a clinician to ensure that the correct clinician is held responsible for the patient’s outcomes and costs. This is complicated given that most patients receive care from numerous clinicians across several facilities. In the 2019 physician fee schedule final rule CMS changed the attribution methodology for the inpatient episode measures to measure more physicians on episode-based cost measures. We are concerned about the impact of this change and the need for more analysis and opportunity to provide feedback on this new attribution approach. Attribution is complicated, given that most patients receive care from numerous clinicians across several facilities. The AAMC believes that better data sources and analytic techniques should be explored in the future to support more accurate attribution. (Submitted by: Association of American Medical Colleges)
  
  
• (Early public comment)Overall, the AMA supports the episode-based measure development process and movement to episode based measures over broad cost measures. However, we cannot endorse any of the specific measures due to the paucity of analytic information such as the measures’ mean made available prior to the deadline for comments. We request further refinements to the process to ensure the cost measures are accurate and fair when used in the Merit-based Incentive Payment System and, ultimately, publicly reported. In general, we urge the MAP to make “Conditional Support” its highest level of recommendation and to recommend “Do Not Support with Potential for Mitigation” for any measures where relevant specialties have raised serious concerns. Please see additional comments submitted earlier in response to MUC18-115 Inpatient Chronic Obstructive Pulmonary Disease (COPD) Exacerbation. (Submitted by: American Medical Association)
  
  
• (Early public comment)The American College of Gastroenterology (ACG) supports the collaborative process used by the Centers for Medicare and Medicaid Services (CMS) to develop the episode-based cost measures but found that the recent field-testing process was rife with challenges. We question whether physicians had adequate time and information to complete comprehensive reviews of the test reports and are concerned that many physicians may not understand the basic aspects of the methodology of these complex measures, particularly if they were not actively engaged in the development process. ACG provided detailed comments on measure attribution methodology, construction including triggers and assigned services, and specifications during the recent comment period. We ask that the MAP specifically recommend that CMS incorporate the specialty societies and technical experts’ feedback provided prior to implementation to ensure that the measures are reliable and valid representations of the costs attributed to physicians. (Submitted by: American College of Gastroenterology)
  
  
• (Early public comment)ASCO supports the episode-based measure development process, as episode-based measures can provide a more appropriate and meaningful assessment of care costs than extremely broad cost measures that also lack clarity in attribution. We appreciate the opportunity to participate in the development of those measures and look forward to working on measures related to oncology care, in addition to oncology surgical procedures. However, as we have stated before in numerous comment letters to CMS, the reliance on administrative claims with the failure to consider other important sources of data leads to a crude measure of true cost, and limits both risk adjustment and exclusion criteria. Section 105(b) of the MACRA statute specifically allows for the sharing of data by CMS with qualified clinical data registries; to date, CMS has not provided a process to make this data accessible to clinical registries, instead implementing a “quasi-qualified entity” pathway that is onerous, time-consuming, and may provide access to the data for a limited period. We continue to urge CMS to make this data available, as clearly intended by the MACRA statute, and to work with stakeholders including professional societies to assess how the potential linkage of administrative claims data and clinical registry data could improve existing and new cost measures. We thank NQF for this opportunity to submit comments and look forward to engaging further in the measure development process timeline. (Submitted by: American Society of Clinical Oncology (ASCO) )
  
  
• We believe that attribution to a single responsible provider is an issue here as care for such patients starts often immediately on arrival in the ER and then can transitions across different settings in the hospital (ICU, surgery, medicine) with decisions on modalities of care made collaboratively by multiple disciplines of providers rather than by one provider. It may make more sense to make the hospital facility the unit of responsibility here. (Submitted by: American Geriatrics Society)
  
  
• The American Medical Association (AMA) supports the preliminary recommendation of “Conditional Support” for these measures unless a relevant specialty society raises serious concerns with one of these measures during the public comment period. If serious concerns are raised, we ask that the highest recommendation be “Do Not Support with Potential for Mitigation”. In addition, the AMA requests that additional conditions be placed on each of these measures. Specifically, on review of the supplemental materials provided by Acumen for the Clinician Workgroup meeting, we note that only reliability testing was provided and the validity of the measures have not yet been demonstrated. This testing, which is a requirement for NQF endorsement and inclusion in the MIPS program, must be completed prior to implementation in MIPS. In addition, we question whether any of the proposed cost measures have had sufficient feedback from clinicians given the limited timeframe and challenges accessing the reports. The supplemental materials indicate that more than 78,000 field test reports were distributed; yet, feedback was received from only 67 stakeholders. We do not believe that such a low response rate should necessarily lead to conclusions that these measures are generally supported and do not require ongoing refinements. We refer the Coordination Committee to the substantive feedback provided by the AMA and others during the pre-workgroup comment period and ask that the MAP include the additional conditions requesting that additional feedback and input from clinicians be sought and validity testing be completed prior to implementation in MIPS. (Submitted by: American Medical Association)
  
  

• (Early public comment)Cost measures have been identified as a priority, and CMS addressed this priority through the inclusion of additional episode-based cost measures on the MUC list. The cost measures risk-adjust based on variables, such as age, and comorbidities by using HCC data and other clinical characteristics. However, we are concerned that the measures are not adjusted to account for socio-demographic status. In addition to differences in patient clinical complexity, socio-demographic status can drive differences in average episode costs. In particular, physicians at academic medical centers (AMCs) care for vulnerable populations of patients who are sicker, poorer, and more complex than patients treated elsewhere. Recent reports from the National Academies of Science, Engineering and Medicine and Assistant Secretary for Planning and Evaluation (ASPE) have clearly acknowledged that SDS variables (such as low income and education) may explain adverse outcomes and higher costs. Differences in patient severity, rates of patient compliance with treatment, sociodemographic status, patient engagement, patient preferences for treatment approaches, and sites of care, can all drive differences in average costs. Appropriate risk adjustment is essential so that differences in patient characteristics that are behind a health care provider’s control do not have an unfair impact on a provider’s resource use performance score. CMS should look at alternative sources of data to obtain information about risk adjustment. In regard to attribution – AAMC believes that attribution methods used should be clear and transparent to clinicians and that it is critical that there be an accurate determination of the relationship between a patient and a clinician to ensure that the correct clinician is held responsible for the patient’s outcomes and costs. This is complicated given that most patients receive care from numerous clinicians across several facilities. In the 2019 physician fee schedule final rule CMS changed the attribution methodology for the inpatient episode measures to measure more physicians on episode-based cost measures. We are concerned about the impact of this change and the need for more analysis and opportunity to provide feedback on this new attribution approach. Attribution is complicated, given that most patients receive care from numerous clinicians across several facilities. The AAMC believes that better data sources and analytic techniques should be explored in the future to support more accurate attribution. (Submitted by: Association of American Medical Colleges)
  
  
• (Early public comment)Overall, the AMA supports the episode-based measure development process and movement to episode based measures over broad cost measures. However, we cannot endorse any of the specific measures due to the paucity of analytic information such as the measures’ mean made available prior to the deadline for comments. We request further refinements to the process to ensure the cost measures are accurate and fair when used in the Merit-based Incentive Payment System and, ultimately, publicly reported. In general, we urge the MAP to make “Conditional Support” its highest level of recommendation and to recommend “Do Not Support with Potential for Mitigation” for any measures where relevant specialties have raised serious concerns. Please see additional comments submitted earlier in response to MUC18-115 Inpatient Chronic Obstructive Pulmonary Disease (COPD) Exacerbation. (Submitted by: American Medical Association)
  
  
• (Early public comment)ASCO supports the episode-based measure development process, as episode-based measures can provide a more appropriate and meaningful assessment of care costs than extremely broad cost measures that also lack clarity in attribution. We appreciate the opportunity to participate in the development of those measures and look forward to working on measures related to oncology care, in addition to oncology surgical procedures. However, as we have stated before in numerous comment letters to CMS, the reliance on administrative claims with the failure to consider other important sources of data leads to a crude measure of true cost, and limits both risk adjustment and exclusion criteria. Section 105(b) of the MACRA statute specifically allows for the sharing of data by CMS with qualified clinical data registries; to date, CMS has not provided a process to make this data accessible to clinical registries, instead implementing a “quasi-qualified entity” pathway that is onerous, time-consuming, and may provide access to the data for a limited period. We continue to urge CMS to make this data available, as clearly intended by the MACRA statute, and to work with stakeholders including professional societies to assess how the potential linkage of administrative claims data and clinical registry data could improve existing and new cost measures. We thank NQF for this opportunity to submit comments and look forward to engaging further in the measure development process timeline. (Submitted by: American Society of Clinical Oncology (ASCO) )
  
  
• The American Medical Association (AMA) supports the preliminary recommendation of “Conditional Support” for these measures unless a relevant specialty society raises serious concerns with one of these measures during the public comment period. If serious concerns are raised, we ask that the highest recommendation be “Do Not Support with Potential for Mitigation”. In addition, the AMA requests that additional conditions be placed on each of these measures. Specifically, on review of the supplemental materials provided by Acumen for the Clinician Workgroup meeting, we note that only reliability testing was provided and the validity of the measures have not yet been demonstrated. This testing, which is a requirement for NQF endorsement and inclusion in the MIPS program, must be completed prior to implementation in MIPS. In addition, we question whether any of the proposed cost measures have had sufficient feedback from clinicians given the limited timeframe and challenges accessing the reports. The supplemental materials indicate that more than 78,000 field test reports were distributed; yet, feedback was received from only 67 stakeholders. We do not believe that such a low response rate should necessarily lead to conclusions that these measures are generally supported and do not require ongoing refinements. We refer the Coordination Committee to the substantive feedback provided by the AMA and others during the pre-workgroup comment period and ask that the MAP include the additional conditions requesting that additional feedback and input from clinicians be sought and validity testing be completed prior to implementation in MIPS. (Submitted by: American Medical Association)
  
  
• The American Medical Association (AMA) supports the preliminary recommendation of “Conditional Support” for these measures unless a relevant specialty society raises serious concerns with one of these measures during the public comment period. If serious concerns are raised, we ask that the highest recommendation be “Do Not Support with Potential for Mitigation”. In addition, the AMA requests that additional conditions be placed on each of these measures. Specifically, on review of the supplemental materials provided by Acumen for the Clinician Workgroup meeting, we note that only reliability testing was provided and the validity of the measures have not yet been demonstrated. This testing, which is a requirement for NQF endorsement and inclusion in the MIPS program, must be completed prior to implementation in MIPS. In addition, we question whether any of the proposed cost measures have had sufficient feedback from clinicians given the limited timeframe and challenges accessing the reports. The supplemental materials indicate that more than 78,000 field test reports were distributed; yet, feedback was received from only 67 stakeholders. We do not believe that such a low response rate should necessarily lead to conclusions that these measures are generally supported and do not require ongoing refinements. We refer the Coordination Committee to the substantive feedback provided by the AMA and others during the pre-workgroup comment period and ask that the MAP include the additional conditions requesting that additional feedback and input from clinicians be sought and validity testing be completed prior to implementation in MIPS. (Submitted by: American Medical Association)
  
  

• (Early public comment)Cost measures have been identified as a priority, and CMS addressed this priority through the inclusion of additional episode-based cost measures on the MUC list. The cost measures risk-adjust based on variables, such as age, and comorbidities by using HCC data and other clinical characteristics. However, we are concerned that the measures are not adjusted to account for socio-demographic status. In addition to differences in patient clinical complexity, socio-demographic status can drive differences in average episode costs. In particular, physicians at academic medical centers (AMCs) care for vulnerable populations of patients who are sicker, poorer, and more complex than patients treated elsewhere. Recent reports from the National Academies of Science, Engineering and Medicine and Assistant Secretary for Planning and Evaluation (ASPE) have clearly acknowledged that SDS variables (such as low income and education) may explain adverse outcomes and higher costs. Differences in patient severity, rates of patient compliance with treatment, sociodemographic status, patient engagement, patient preferences for treatment approaches, and sites of care, can all drive differences in average costs. Appropriate risk adjustment is essential so that differences in patient characteristics that are behind a health care provider’s control do not have an unfair impact on a provider’s resource use performance score. CMS should look at alternative sources of data to obtain information about risk adjustment. In regard to attribution – AAMC believes that attribution methods used should be clear and transparent to clinicians and that it is critical that there be an accurate determination of the relationship between a patient and a clinician to ensure that the correct clinician is held responsible for the patient’s outcomes and costs. This is complicated given that most patients receive care from numerous clinicians across several facilities. In the 2019 physician fee schedule final rule CMS changed the attribution methodology for the inpatient episode measures to measure more physicians on episode-based cost measures. We are concerned about the impact of this change and the need for more analysis and opportunity to provide feedback on this new attribution approach. Attribution is complicated, given that most patients receive care from numerous clinicians across several facilities. The AAMC believes that better data sources and analytic techniques should be explored in the future to support more accurate attribution. (Submitted by: Association of American Medical Colleges)
  
  
• (Early public comment)Overall, the AMA supports the episode-based measure development process and movement to episode based measures over broad cost measures. However, we cannot endorse any of the specific measures due to the paucity of analytic information such as the measures’ mean made available prior to the deadline for comments. We request further refinements to the process to ensure the cost measures are accurate and fair when used in the Merit-based Incentive Payment System and, ultimately, publicly reported. In general, we urge the MAP to make “Conditional Support” its highest level of recommendation and to recommend “Do Not Support with Potential for Mitigation” for any measures where relevant specialties have raised serious concerns. Please see additional comments submitted earlier in response to MUC18-115 Inpatient Chronic Obstructive Pulmonary Disease (COPD) Exacerbation. (Submitted by: American Medical Association)
  
  
• (Early public comment)The Renal Physicians Association (RPA) is the professional organization of nephrologists whose goals are to ensure optimal care under the highest standards of medical practice for patients with kidney disease and related disorders. RPA acts as the national representative for physicians engaged in the study and management of patients with kidney disease. RPA believes more information is needed regarding attribution model for this measure. (Submitted by: Renal Physicians Association )
  
  
• (Early public comment)ASCO supports the episode-based measure development process, as episode-based measures can provide a more appropriate and meaningful assessment of care costs than extremely broad cost measures that also lack clarity in attribution. We appreciate the opportunity to participate in the development of those measures and look forward to working on measures related to oncology care, in addition to oncology surgical procedures. However, as we have stated before in numerous comment letters to CMS, the reliance on administrative claims with the failure to consider other important sources of data leads to a crude measure of true cost, and limits both risk adjustment and exclusion criteria. Section 105(b) of the MACRA statute specifically allows for the sharing of data by CMS with qualified clinical data registries; to date, CMS has not provided a process to make this data accessible to clinical registries, instead implementing a “quasi-qualified entity” pathway that is onerous, time-consuming, and may provide access to the data for a limited period. We continue to urge CMS to make this data available, as clearly intended by the MACRA statute, and to work with stakeholders including professional societies to assess how the potential linkage of administrative claims data and clinical registry data could improve existing and new cost measures. We thank NQF for this opportunity to submit comments and look forward to engaging further in the measure development process timeline. (Submitted by: American Society of Clinical Oncology (ASCO) )
  
  
• The Renal Physicians Association (RPA) is the professional organization of nephrologists whose goals are to ensure optimal care under the highest standards of medical practice for patients with kidney disease and related disorders. RPA acts as the national representative for physicians engaged in the study and management of patients with kidney disease. RPA believes more information is needed regarding attribution model for this measure and that the measure is immature at this time. (Submitted by: Renal Physicians Association )
  
  
• As a nephrologist who is interested in researching patient-reported outcomes and who is a member of the Acute Kidney Injury requiring New Dialysis work group, I do favor the inclusion of the "Hemodialysis Access Creation" measure. The number of individuals who present to the emergency department in acute on chronic renal failure with no form of permanent access is far too high and results in both higher costs, higher morbidity (infections) and ultimately, higher mortality. I think this measure can be made more useful by including the measurement of known barriers to hemodialysis access creation that can drive better policy. This includes race/ethnicity, length of time in nephrology care, and insurance status. I would love to be a part of this committee to assist in further measure refinement. (Submitted by: Vanderbilt University)
  
  

• (Early public comment) VIA: http://www.qualityforum.org/map/ December 6, 2018 Public Comment 2018 Measures Under Consideration Submitted via: Since 1982, the National Association for Home Care & Hospice (NAHC) has been the leading association representing the interests of hospices, home health, and home care providers across the nation, including the home caregiving staff and the patients and families they serve. Our members are providers of all sizes and types -- from small rural agencies to large national companies -- and include government-based providers, nonprofit voluntary hospices, privately-owned companies and public corporations. As such, we welcome the opportunity to comment on the CMS List of Measures Under Consideration for December 1, 2018. We are commenting on the following three measures: MUC18- 101 Transitions from Hospice Care, Followed by Death or Acute Care MUC18- 131 Transfer of Health Information to Patient—PostAcute Care MUC18- 135 Transfer of Health Information to Provider—PostAcute Care MUC18- 101 Transitions from Hospice Care, Followed by Death or Acute Care As we commented to CMS directly in 2018, we believe this measure falls short of providing a direct indicator of quality of care, has significant potential unintended consequences the least of which is confusion about a hospice’s performance amongst consumers. This raises concern, particularly relative to use of this measure for public reporting. We appreciate and understand the intent of this measure which is to assess negative outcomes following hospice live discharge, including acute care use shortly after discharge, as these outcomes represent potentially burdensome transitions to patients and families. We also appreciate the considerable expansion by CMS of the risk adjustment factors, based on previous public comment, to include a patient’s prior use of acute care services, social risk factors, setting of care while receiving hospice care, etc. We further appreciate that CMS would potentially plan a dry run of this measure, as indicated in its public comment summary report for this measure (August 2018), to determine if the measure is appropriate for public reporting. There is considerable potential for misunderstanding of this measure, and consequent unintended negative consequences. This was emphasized in the comments CMS received, and in its response, CMS stated “Finally, additional measure testing and refinement, including a potential measure dry run will aim to further address the potential unintended consequences of the measure.” We believe this additional measure testing and refinement is crucial to making the measure meaningful to providers and for providers to utilize the measure to inform improvement actions. The current measure specifications exclude the following types of patients: 1. Patients not continuously enrolled in Part A Medicare FFS in the 12 months prior to the hospice admission date, during the hospice stay, or at least 7 days following the hospice discharge date 2. Patients enrolled in Medicare Advantage in the 12 months prior to the hospice admission date, during the hospice stay, or in the 7 days following the hospice discharge date. 3. Patients who are under 18 years old at hospice admission. The most current data shows that in 2016 51.9% of Medicare Advantage (MA) beneficiaries utilized hospice care. There is currently no way for CMS to capture the necessary claims data to include MA beneficiaries in the measure calculation. We believe that leaving these patients out of the measure reduces its usefulness. Additionally, in hospice care there are various discharge codes depending on the reason that the patient is leaving service and the measure specifications include all of them. Patients may revoke service or be discharged or transferred because they have moved out of the area or gone for an extended stay with family members. Patients may be discharged because they (without knowledge of the hospice) admitted themselves to a hospital at which the hospice may not have a contract and cannot continue to treat the patient. Veterans may decide to be served at a VA facility, which requires discharge from hospice care. Patients may also be discharged because they are determined to be no longer be eligible for hospice services. Further, cause for discharge may vary widely depending on market and/or geographic factors. These factors have the potential to dramatically impact some hospices while having little to no impact on others in a different area of a state, region or the country. CMS should consider excluding certain types of live discharges and circumstances surrounding them, including discharges for cause, revocations, transfers, and discharges due to the patient moving out of the service. All of these are, in large part, beyond a hospice’s control. In its review of comments submitted to CMS on this measure, CMS addressed the ways it would intend to handle these types of discharges. Even with some of the risk adjustments CMS intends to make, it appears that CMS would retain a significant number of reasons for live discharge reflecting situations that are out of the hospice’s control and for which they could be penalized. This is especially true of transfer situations. In looking at this proposed measure, it is notable that there is not a consideration of whether the acute care a patient may seek after hospice care is aligned with the patient’s goals. We believe that measures assessing goal attainment and specifically whether a patient’s goals of care align with the care received are more meaningful and could be utilized for hospice performance improvement and consumer education much more efficiently and effectively than the proposed transitions of care measure. If the measure is used in the hospice quality reporting program it is critical that a dry run be implemented and results critically analyzed before any public reporting. If this measure is used for public reporting there must be a clear explanation of the measure, in layman’s terms, that accompanies the posting. MUC18- 131 Transfer of Health Information to Patient—PostAcute Care, and MUC18- 135 Transfer of Health Information to Provider—PostAcute Care In both of these measures under consideration, the assessment items used to record the data have not been finalized and thus are not available for review nor is a draft version showing how the measures might be revised in light of the feedback CMS received from its request for public comment. These are necessary for full consideration of the measure especially since many of the comments submitted by stakeholders on these measures were related to the data source (assessment items) directly. One of the assessment items in particular, Route of Transmission, is of particular concern. NAHC does not support including this question as part of the comprehensive assessment. There is no correlation between the route of transmission and quality of care provided by post-acute care providers and home health in particular. It is unclear why it is important for providers or the public to have this information or what might be gained from having the information . It cannot be assumed that one route is preferred above another, and therefore, reporting the route of transmission without context is not meaningful for utilization by providers in performance improvement or for patients/caregivers/consumers. In fact, there was disagreement within the Technical Expert Panel (TEP) convened by CMS on the route of transmission assessment item. The only exclusion for these measures is patients who died. In the comments provided to CMS when stakeholder input was solicited on this measure, NAHC recommended the exclusion of any patient from the measure calculation where the home health agency assessment data identifies that the HHA was not made of a transfer timely. NAHC is concerned that if untimely transfers are not accounted for in the measure calculation, the measure rate for HHAs could be artificially low. Unlike the facility-based providers, some portion of HHA patients and the providers to which they transfer might not receive a medication profile at transfer for reasons out of the home health agency’s control. This could have unintended consequences for HHAs when used as a cross setting measure with other post- acute care providers. The second of these measures, MUC18- 135, includes the transfer of medication information when a patient is being transferred to settings including: • Private home/ apartment (apt.), • Board/care, • Assisted living, • Group home, • Transitional living or • Home under care of organized home health service organization or hospice It is unclear as to why a home health agency would need to provide a medication profile to the patient, family and/or caregiver in a transfer to another home health service organization or hospice as the patient would continue to receive care by the other home health service organization or hospice and the medication profile would be shared with this provider as a matter of practice. Thank you for this opportunity to provide input on these measures under consideration. We recognize the MAP’s overall timeframe for reviewing these measures is tight and appreciate having the opportunity to provide feedback. However, the timeframe given for public commenting is limited to five business days which makes it somewhat difficult to review the measures in context and formulate comments. If there is any way in the future to extend this review period it would be much appreciated. Please do not hesitate to contact us if our comments require clarification in any way. Sincerely, Katie Wehri Katie Wehri Director, Home Care & Hospice Regulatory Affairs (Submitted by: National Association for Home Care & Hospice (NAHC))
  
  
• (Early public comment)ARN supports the measures under consideration for Post Acute care settings (Home health, SNF, LTCH and IRF) with regard to medication reconciliation and sharing patient health information to 1) providers and 2) patients, families and / or caregivers. We believe these measures demonstrate a commitment to quality thereby ensuring that important medication information is shared and communicated at transitions. Accurate medication profile information helps keep a patient medication compliant, thereby potentially reducing 30-day re-admission rates. (Submitted by: Association of Rehabilitation Nurses)
  
  
• (Early public comment)Confirmed transfer of a reconciled medication list to providers is a critical component to improving care for people with serious illness; this is a good measure to include in this quality reporting program. (Submitted by: Center to Advance Palliative Care)
  
  
• (Early public comment)NHPCO Comments: NHPCO supports this measure as a patient safety and quality of care issue, especially for seriously ill individuals. (Submitted by: National Hospice and Palliative Care Organization)
  
  
• (Early public comment)The Federation of American Hospitals notes that this measure includes language requiring a “reconciled medication list”, which differs from the draft specification released for comment earlier this year. FAH requests that information on what constitutes a “reconciled medication list” be provided during the MAP review to enable a thorough assessment of whether these refinements have made data collection more feasible and less subjective. (Submitted by: Federation of American Hospitals)
  
  
• (Early public comment)These comments apply to MUC 18-131, 132, 133, 135, 136, 138, 139, 141. AOTA appreciates the opportunity to comment on the Transfer of Health Information PAC measures. We agree that a reconciled medication list is a logical first measure to implement in the transfer of health information in these settings. (Submitted by: American Occupational Therapy Association)
  
  
• (Early public comment)We request an operationalization or definition of the phrase “at the time of discharge/transfer.” This applies to the other 'Transfer' measures #131-136. (Submitted by: National Assn for Behavioral Healthcare)
  
  
• Since 1982, the National Association for Home Care & Hospice (NAHC) has been the leading association representing the interests of hospices, home health, and home care providers across the nation, including the home caregiving staff and the patients and families they serve. Our members are providers of all sizes and types -- from small rural agencies to large national companies -- and include government-based providers, nonprofit voluntary hospices, privately-owned companies and public corporations. As such, we welcome the opportunity to comment on the MAP’s Draft Recommendations of the CMS List of Measures Under Consideration for December 1, 2018. We are commenting on the following three measures: MUC18- 101 Transitions from Hospice Care, Followed by Death or Acute Care MUC18- 131 Transfer of Health Information to Patient—PostAcute Care MUC18- 135 Transfer of Health Information to Provider—PostAcute Care MUC18- 101 Transitions from Hospice Care, Followed by Death or Acute Care As we commented to CMS directly in 2018 and again in our comments dated December 6, 2018 on the CMS List of Measures Under Consideration, we believe this measure falls short of providing a direct indicator of quality of care, has significant potential unintended consequences the least of which is confusion about a hospice’s performance amongst consumers. This raises concern, particularly relative to use of this measure for public reporting. We appreciate and understand the intent of this measure which is to assess negative outcomes following hospice live discharge, including acute care use shortly after discharge, as these outcomes represent potentially burdensome transitions to patients and families. We appreciate the MAP’s preliminary decision of “Do Not Support With Potential For Mitigation”. The MAP rationale for this decision brings forth many of the concerns NAHC and its members have with this measure. As we stated previously, there is considerable potential for misunderstanding of this measure, and consequent unintended negative consequences. We especially agree with the MAP’s recommendation that CMS reconsider exclusions for the measure and the MAP suggestion that there be a dry run of the measure before public reporting. There are many types of live discharges and circumstances surrounding them, including discharges for cause, revocations, transfers, discharges due to the patient moving out of the service area and discharges for patients determined to not be terminally ill. Most all of these, in large part, are beyond a hospice’s control. In its review of comments submitted to CMS on this measure, CMS addressed the ways it would intend to handle these types of discharges. Even with some of the risk adjustments CMS intends to make, it appears that CMS would retain a significant number of reasons for live discharge reflecting situations that are out of the hospice’s control and for which they could be penalized. If the measure is used in the hospice quality reporting program it is critical that a dry run be implemented and results critically analyzed before any public reporting. If this measure is used for public reporting there must be a clear explanation of the measure, in layman’s terms, that accompanies the posting. MUC18- 131 Transfer of Health Information to Patient—PostAcute Care, and MUC18- 135 Transfer of Health Information to Provider—PostAcute Care NAHC is pleased that the MAP has not wholeheartedly given a preliminary approval of these measures. We appreciate that the MAP recognizes the importance of the ability to transfer certain health information to the next provider of care. However, in both of these measures under consideration, the assessment items used to record the data have not been finalized and thus are not available for review nor is a draft version showing how the measures might be revised in light of the feedback CMS received from its request for public comment. These are necessary for full consideration of the measure especially since many of the comments submitted by stakeholders on these measures were related to the data source (assessment items) directly. One of the assessment items in particular, Route of Transmission, is of particular concern. The MAP appreciates the ability to utilize different modes of transmission and NAHC acknowledges this ability as beneficial as well. However, NAHC does not support including this question as part of the comprehensive assessment. There is no correlation between the route of transmission and quality of care provided by post-acute care providers and home health in particular. It is unclear why it is important for providers or the public to have this information or what might be gained from having the information . It cannot be assumed that one route is preferred above another, and therefore, reporting the route of transmission without context is not meaningful for utilization by providers in performance improvement or for patients/caregivers/consumers. In fact, there was disagreement within the Technical Expert Panel (TEP) convened by CMS on the route of transmission assessment item. The only exclusion for these measures is patients who died. In the comments provided to CMS when stakeholder input was solicited on this measure, NAHC recommended the exclusion of any patient from the measure calculation where the home health agency assessment data identifies that the HHA was not made aware of a transfer timely. NAHC is concerned that if untimely transfers are not accounted for in the measure calculation, the measure rate for HHAs could be artificially low. Unlike the facility-based providers, some portion of HHA patients and the providers to which they transfer might not receive a medication profile at transfer for reasons out of the home health agency’s control including the agency not being made aware of the transfer timely. This could have unintended consequences for HHAs when used as a cross setting measure with other post- acute care providers. The MAP made a preliminary recommendation of “Conditional Support for Rulemaking” for the second of these measures, MUC18- 135. This measure includes the transfer of medication information when a patient is being transferred to settings including: • Private home/ apartment (apt.), • Board/care, • Assisted living, • Group home, • Transitional living or • Home under care of organized home health service organization or hospice It is unclear as to why a home health agency would need to provide a medication profile to the patient, family and/or caregiver in a transfer to another home health service organization or hospice as the patient would continue to receive care by the other home health service organization or hospice and the medication profile would be shared with this provider as a matter of practice. Thank you for this opportunity to provide input on these preliminary recommendations. Please do not hesitate to contact us if our comments require clarification in any way. Sincerely, Katie Wehri Director, Home Care & Hospice Regulatory Affairs (Submitted by: National Association for Home Care & Hospice)
  
  
• While the Federation of American Hospitals (FAH) supports the current recommendation, we note that this measure includes language requiring a “reconciled medication list”, which differs from the draft specification released for comment earlier this year. This omission was identified by members of the Post-Acute Care/Long-Term Care Workgroup and FAH requests that information on what constitutes a “reconciled medication list” be provided during the MAP Coordinating Committee review to enable a thorough assessment of whether these refinements have made data collection more feasible and less subjective. Support current MAP recommendation (Submitted by: Federation of American Hospitals)
  
  
• AdventHealth supports the adoption of this measure and believes that it will improve care coordination and communication between health care providers. Additionally, we believe this measure could be improved by capturing the amount of time the transmission of records takes to get to another provider. The best clinical decisions can only be made if providers have access to the most relevant and timely data. Although the measure requires post-acute providers to send the medication profile at the time a patient is discharged or transferred to another facility, the route of transmission will affect the timeliness of the transfer. As the measure is currently written, a provider will be scored as successful for transferring the information, regardless of whether the records are delivered in a day or week. We recommend that this measure uses a mechanism to track the timeliness of the transmission of records. Doing so will allow this measure to be more meaningful and better aligned with its purpose—to improve the timely transfer of a medication profile. (Submitted by: AdventHealth)
  
  
• The AHA agrees with the MAP’s recommendation of Conditional Support. Accurate and timely transfer of medication information is key to ensuring high-quality and seamless care transitions in post-acute care, but this measure must complete field testing and go through the NQF endorsement process to ensure that it actually captures the intended information before CMS adopts it for use in long-term care programs. Conceptually, the measure is a better version of what CMS released for public comment in May of 2018. Rather than requiring a long and arbitrary list of medication profile elements to meet the measure criteria, the items to be included would be informed by guidance. In addition, the developers assured the MAP that providers would have an option to note when a patient has no medication to list (a not applicable option) or ends care against medical advice. Logistically, there are still a few issues that must be resolved before this measure is proposed for inclusion in any CMS programs. First, we request clarification on who compiles the medication list—is a physician required to compile the list, or can a licensed nurse or pharmacist (or other medical professional in charge of the patient’s care) perform this task? We also question whether the specifications for the measure can be adjusted for each post-acute care setting; for example, requiring the list to be transferred “at the time of discharge” is not appropriate for all settings. In skilled nursing, this time is used to ensure that necessary medical equipment is available at the patient’s next setting, so requiring the medication list to be transferred at that point would be burdensome. The NQF endorsement process would shed light on whether this measure would actually result in improvements in care, which is unclear from the information provided to the MAP. Medication errors and other events are a serious issue in post-acute care, and while this measure may address one aspect of the issue, transferring the list does not ensure that the subsequent provider received, acknowledged, or used the medication list. Also, as with any process measure, we worry that without specific requirements around what is included on the medication list—while making the task less burdensome to complete—might result in this becoming a mere check-box assessment. (Submitted by: American Hospital Association)
  
  

• (Early public comment)AMRPA appreciates the opportunities to provide input to the NQF Measures Application Partnership regarding the Transfer of Health Information measures under consideration for the Inpatient Rehabilitation Facility Quality Reporting Program (IRF QRP) in the 2019 pre-rulemaking cycle. AMRPA is the national trade association representing more than 600 freestanding inpatient rehabilitation hospitals and rehabilitation units of general hospitals (referred to as inpatient rehabilitation facilities (IRFs) by Medicare) and outpatient rehabilitation service providers. Inpatient rehabilitation hospitals and units (IRH/Us) provide hospital-level care, which is significantly different in intensity, capacity, and outcomes from care provided in non-hospital post-acute settings. AMRPA remains supportive of the intent of the Transfer of Health Information measures which fulfill a domain required by the IMPACT Act. It it is critical to ensure that clinically relevant, valuable, and actionable patient information is transferred to the patient/family or to a downstream provider at discharge from PAC. Nonetheless, AMRPA is unable to fully support the quality measures because stakeholders have not been afforded an opportunity to the full extent of the measures; specifically, the technical specifications for these measures as they are characterized in the 2019 MUC List. CMS appears to have altered the scope of these measures since draft specifications were last made public in spring 2018. At that time, these measures were titled Transfer of Info: Medication Profile and the specification report proposed a list of patient data items for providers to report. However, in this 2019 MUC list, the measures description has been revised and is as follows: “For this measure, the timely transfer of health information specifically assesses for the transfer of the patient’s current reconciled medication list.” There is minimal information beyond that. Without seeing details as to what constitutes a “reconciled medication list” or how CMS would implement reporting, we are unable to comment on how the measures would add value to the IRF QRP and improve patient outcomes, or assess if measure benefits would outweigh the burden of data collection/reporting. In short, we are not able to substantively respond to the questions NQF is asking stakeholders. We respectfully request CMS provide the technical specifications for both Transfer of Health Information Measures Under Considerations for PAC so that stakeholders can review the measures in full and provide considered and meaningful input. AMRPA commented on the TOH: Medication Profile draft specifications this past spring. AMRPA’s comments reflected feedback from our Quality Committee with input from pharmacists, administrators, physicians and other clinicians at inpatient rehabilitation hospitals and units. Our members agree that the accurate and successful transfer of essential medication information at PAC discharge/transfer is critical to ensuring that patient safety and quality of care are not compromised once a patient leaves a particular setting. While we supported the measures’ intent, at that time, many aspects of the measures are yet to be specified such as: the data elements required for reporting, the process by which they would be reported, whether changes need to be made to the mandatory IRF Patient Assessment Instrument (IRF PAI) to accommodate measure reporting, and how CMS would ensure measure validity for these process-based measures, among other questions. As CMS continues to develop the Transfer of Health Information measures, we urge it to do so in a practical and minimally burdensome manner that adds value beyond rehabilitation hospitals’ current medication reconciliation and/or discharge planning practices. This would be consistent with CMS’ Patients over Paperwork and Meaningful Measures initiatives which aim to reduce providers’ administrative burden, and specifically with regard to burden from quality measures. (Submitted by: American Medical Rehabilitation Providers Association (AMRPA))
  
  
• (Early public comment)ARN supports the measures under consideration for Post Acute care settings (Home health, SNF, LTCH and IRF) with regard to medication reconciliation and sharing patient health information to 1) providers and 2) patients, families and / or caregivers. We believe these measures demonstrate a commitment to quality thereby ensuring that important medication information is shared and communicated at transitions. Accurate medication profile information helps keep a patient medication compliant, thereby potentially reducing 30-day re-admission rates. (Submitted by: Association of Rehabilitation Nurses)
  
  
• (Early public comment)Confirmed transfer of a reconciled medication list to providers is a critical component to improving care for people with serious illness; this is a good measure to include in this quality reporting program. (Submitted by: Center to Advance Palliative Care)
  
  
• (Early public comment)NHPCO Comments: NHPCO supports this measure as a patient safety and quality of care issue, especially for seriously ill individuals. (Submitted by: National Hospice and Palliative Care Organization)
  
  
• (Early public comment)The Federation of American Hospitals notes that this measure includes language requiring a “reconciled medication list”, which differs from the draft specification released for comment earlier this year. FAH requests that information on what constitutes a “reconciled medication list” be provided during the MAP review to enable a thorough assessment of whether these refinements have made data collection more feasible and less subjective. (Submitted by: Federation of American Hospitals)
  
  
• (Early public comment)We are unable to comment on MUC2018-132 Transfer of Health Information to Provider without measure specifications. The 2018 Measures Under Consideration List, Program Specific Measure Needs and Priorities (May 29, 2018) states under section 3. Candidate Measure Submission Guidance, "In an effort to provide a more meaningful List of Measures under Consideration, CMS included only measures that contain adequate specifications." However, for measure 2018-132, only a numerator and denominator were supplied on the MUC. While a similar transfer of health information measure and measure specifications were released for public comment in the spring of 2018, CMS has noted the measure on the MUC list has been modified and does not therefore use the same specifications. Given the potential of this measure to be comprehensive in scope, without understanding the elements included in the numerator, it is not possible to meaningfully comment on the measure proposed on the MUC list. Since the measure is not defined beyond a numerator and denominator, we cannot support its consideration into the IRF QRP. (Submitted by: Encompass Health)
  
  
• (Early public comment)We support this measure although find the name confusion and so recommend renaming it to: be “Transfer of a “reconciled” medication list” from hospital to post-hospital care provider. We also suggest it would be useful to also include/transfer a statement about the likely course and the patient’s situation with regard to social supports and personal care. (Submitted by: CTAC)
  
  
• Measure specifications should be made publicly available PRIOR to CMS or NQF MAP asking for comments. We believe the current draft definition of medication profile, as outlined on pp. 9-10 of the measure specification, is overly burdensome and too prescriptive, making it inconsistent with the Patients over Paperwork and Meaningful Measure initiatives, both of which emphasize reducing provider burden in the interest of increasing quality time with the patient. For example, requiring a clinician to collect and summarize a patient’s adherence to each individual medication, while also providing a more general summary for the patient’s overall medication adherence, is duplicative, particularly if it must be done for medications that will be discontinued at discharge. If CMS, via the 25-item checklist proposed in the draft specification, intends to require all post-acute providers to undertake these highly specific steps regarding the transfer of medication information, we believe the agency should propose formal regulations requiring these actions instead of wrapping them into a quality measure. We suggest replacing the proposed lengthy checklist-based definition regarding the necessary components of a qualifying medication profile with a more flexible narrative definition that permits those post-acute providers that already have medication communication procedures in place to maintain their practices while simultaneously requiring other post-acute providers that do not have medication communication capacity to implement one. Such an alternative definitional approach would preserve the best-practices that are already in place within sophisticated care environments, such as IRFs, while also offering opportunities for improvement in other care settings where medication information collection and transfer is less consistent or robust. This definitional approach would be sensitive to what already works, but would also create an important standard for other providers to aspire to. The proposed checklist of 25 items is too long and too subjective to be considered practical for all post-acute providers. Collecting all of this information for each medication for each patient would drastically increase the amount of time required to prepare a patient for discharge and also overlaps in large part with information already contained and prepared in pre-existing discharge summaries of many post-acute providers. Furthermore, many of the items in draft measure released in March, 2018 are highly subjective and potentially situation-specific, and are therefore less useful to subsequent caregivers for whom the patient’s status or clinical profile may be different than in the prior post-acute stay/episode. (Submitted by: Encompass Health)
  
  
• While the Federation of American Hospitals (FAH) supports the current recommendation, we note that this measure includes language requiring a “reconciled medication list”, which differs from the draft specification released for comment earlier this year. This omission was identified by members of the Post-Acute Care/Long-Term Care Workgroup and FAH requests that information on what constitutes a “reconciled medication list” be provided during the MAP Coordinating Committee review to enable a thorough assessment of whether these refinements have made data collection more feasible and less subjective. Support current MAP recommendation (Submitted by: Federation of American Hospitals)
  
  
• AdventHealth supports the adoption of this measure and believes that it will improve care coordination and communication between health care providers. Additionally, we believe this measure could be improved by capturing the amount of time the transmission of records takes to get to another provider. The best clinical decisions can only be made if providers have access to the most relevant and timely data. Although the measure requires post-acute providers to send the medication profile at the time a patient is discharged or transferred to another facility, the route of transmission will affect the timeliness of the transfer. As the measure is currently written, a provider will be scored as successful for transferring the information, regardless of whether the records are delivered in a day or week. We recommend that this measure uses a mechanism to track the timeliness of the transmission of records. Doing so will allow this measure to be more meaningful and better aligned with its purpose—to improve the timely transfer of a medication profile. (Submitted by: AdventHealth)
  
  
• AMRPA appreciates the opportunity to provide input on the National Quality Forum (NQF) Measure Application Partnership’s (MAP) draft recommendations regarding the Transfer of Health Information Measures Under Consideration for the Inpatient Rehabilitation Facility Quality Reporting Program (IRF QRP) in the 2019 pre-rulemaking cycle. AMRPA is the national trade association representing more than 625 freestanding inpatient rehabilitation hospitals and rehabilitation units of general hospitals (referred to as inpatient rehabilitation facilities (IRFs) by Medicare) and outpatient rehabilitation service providers. Inpatient rehabilitation hospitals and units (IRH/Us) provide hospital-level care, which is significantly different in intensity, capacity, and outcomes from care provided in non-hospital post-acute settings. AMRPA supports the intent of the Transfer of Health Information measures and appreciates the additional information and clarifications provided by CMS staff during the December 10th NQF PAC/LTC MAP public meeting. Notably, CMS clarified that the differences between these Measures Under Consideration and the prior versions of the measures (made publicly available in spring 2018) are nominal in nature: The term “medication profile” was changed to “reconciled medication list” and the formal name of the measure was changed. With regard to the underlying technical measure specifications, CMS indicated that they are the same as the prior draft measure specifications, although she additionally noted that CMS’ guidance for what constitutes a medication list has been “pared down.” AMRPA appreciates CMS’ responsiveness to our and other stakeholders’ requests to scale back the measures and be less prescriptive in how providers reconcile medications and transfer that information for which IRFs, as hospitals, already have standard practices. Additionally, we are pleased to hear that CMS is incorporating certain beneficiary exclusions in the measure denominator for hospital-based PAC settings, such as excluding those patients discharged against medical advice (AMA). CMS staff also stated that they are developing additional measure guidance, such as the types of medications/interventions that define a reconciled medication list, that will be more granular than the technical measure specifications. If there have been changes made to the measures’ *guidance* (if not to the technical specifications), AMRPA respectfully requests that CMS make this information available to stakeholders as part of the NQF MAP process. We echo comments made by MAP members during the December meeting that there is still a need to resolve questions about the specific medication information the measures are intended to encompass and how providers would be expected to implement the measures. Needless to say, this guidance will shape the medication information transmitted at discharge/transfer and ultimately would impact how these measures will be operationalized across PAC settings. We impress upon NQF the importance of having this type of information available during the MAP public comment process. Without it, neither the MAP nor public stakeholders are able to truly respond to MAP’s questions for this comment opportunity, including “Do the potential benefits of the measure outweigh the burden of data collection or reporting?” or “What, if any, implementation challenges have you encountered for this measure?” Finally, because these measures are process measures, it is important for NQF and CMS to evaluate how provider performance would be validated. While some PAC settings are accredited by the Joint Commission and already adhere to medication reconciliation requirements, this is not standard practice across PAC settings. The Transfer of Health Information measures will be implemented across PAC settings and could potentially be viewed as a quality indicator to compare PAC settings. As such, it is critical for CMS to validate the reported data. In summary, while we support the non-prescriptive nature of these measures, we think CMS should still provide NQF and stakeholders more information about how the measures will be implemented and operationalized by PAC providers, and how CMS intends to validate the reported data. (Submitted by: American Medical Rehabilitation Providers Association)
  
  
• The AHA agrees with the MAP’s recommendation of Conditional Support. Accurate and timely transfer of medication information is key to ensuring high-quality and seamless care transitions in post-acute care, but this measure must complete field testing and go through the NQF endorsement process to ensure that it actually captures the intended information before CMS adopts it for use in long-term care programs. Conceptually, the measure is a better version of what CMS released for public comment in May of 2018. Rather than requiring a long and arbitrary list of medication profile elements to meet the measure criteria, the items to be included would be informed by guidance. In addition, the developers assured the MAP that providers would have an option to note when a patient has no medication to list (a not applicable option) or ends care against medical advice. Logistically, there are still a few issues that must be resolved before this measure is proposed for inclusion in any CMS programs. First, we request clarification on who compiles the medication list—is a physician required to compile the list, or can a licensed nurse or pharmacist (or other medical professional in charge of the patient’s care) perform this task? We also question whether the specifications for the measure can be adjusted for each post-acute care setting; for example, requiring the list to be transferred “at the time of discharge” is not appropriate for all settings. In skilled nursing, this time is used to ensure that necessary medical equipment is available at the patient’s next setting, so requiring the medication list to be transferred at that point would be burdensome. The NQF endorsement process would shed light on whether this measure would actually result in improvements in care, which is unclear from the information provided to the MAP. Medication errors and other events are a serious issue in post-acute care, and while this measure may address one aspect of the issue, transferring the list does not ensure that the subsequent provider received, acknowledged, or used the medication list. Also, as with any process measure, we worry that without specific requirements around what is included on the medication list—while making the task less burdensome to complete—might result in this becoming a mere check-box assessment. (Submitted by: American Hospital Association)
  
  

• (Early public comment)ARN supports the measures under consideration for Post Acute care settings (Home health, SNF, LTCH and IRF) with regard to medication reconciliation and sharing patient health information to 1) providers and 2) patients, families and / or caregivers. We believe these measures demonstrate a commitment to quality thereby ensuring that important medication information is shared and communicated at transitions. Accurate medication profile information helps keep a patient medication compliant, thereby potentially reducing 30-day re-admission rates. (Submitted by: Association of Rehabilitation Nurses)
  
  
• (Early public comment)Confirmed transfer of a reconciled medication list to providers is a critical component to improving care for people with serious illness; this is a good measure to include in this quality reporting program. (Submitted by: Center to Advance Palliative Care)
  
  
• (Early public comment)NHPCO Comments: NHPCO supports this measure as a patient safety and quality of care issue, especially for seriously ill individuals. (Submitted by: National Hospice and Palliative Care Organization)
  
  
• (Early public comment)The Federation of American Hospitals notes that this measure includes language requiring a “reconciled medication list”, which differs from the draft specification released for comment earlier this year. FAH requests that information on what constitutes a “reconciled medication list” be provided during the MAP review to enable a thorough assessment of whether these refinements have made data collection more feasible and less subjective. (Submitted by: Federation of American Hospitals)
  
  
• (Early public comment)We support this measure although find the name confusion and so recommend renaming it to: be “Transfer of a “reconciled” medication list” from hospital to post-hospital care provider. We also suggest it would be useful to also include/transfer a statement about the likely course and the patient’s situation with regard to social supports and personal care. (Submitted by: CTAC)
  
  
• While the Federation of American Hospitals (FAH) supports the current recommendation, we note that this measure includes language requiring a “reconciled medication list”, which differs from the draft specification released for comment earlier this year. This omission was identified by members of the Post-Acute Care/Long-Term Care Workgroup and FAH requests that information on what constitutes a “reconciled medication list” be provided during the MAP Coordinating Committee review to enable a thorough assessment of whether these refinements have made data collection more feasible and less subjective. Support current MAP recommendation (Submitted by: Federation of American Hospitals)
  
  
• AdventHealth supports the adoption of this measure and believes that it will improve care coordination and communication between health care providers. Additionally, we believe this measure could be improved by capturing the amount of time the transmission of records takes to get to another provider. The best clinical decisions can only be made if providers have access to the most relevant and timely data. Although the measure requires post-acute providers to send the medication profile at the time a patient is discharged or transferred to another facility, the route of transmission will affect the timeliness of the transfer. As the measure is currently written, a provider will be scored as successful for transferring the information, regardless of whether the records are delivered in a day or week. We recommend that this measure uses a mechanism to track the timeliness of the transmission of records. Doing so will allow this measure to be more meaningful and better aligned with its purpose—to improve the timely transfer of a medication profile. (Submitted by: AdventHealth)
  
  
• The AHA agrees with the MAP’s recommendation of Conditional Support. Accurate and timely transfer of medication information is key to ensuring high-quality and seamless care transitions in post-acute care, but this measure must complete field testing and go through the NQF endorsement process to ensure that it actually captures the intended information before CMS adopts it for use in long-term care programs. Conceptually, the measure is a better version of what CMS released for public comment in May of 2018. Rather than requiring a long and arbitrary list of medication profile elements to meet the measure criteria, the items to be included would be informed by guidance. In addition, the developers assured the MAP that providers would have an option to note when a patient has no medication to list (a not applicable option) or ends care against medical advice. Logistically, there are still a few issues that must be resolved before this measure is proposed for inclusion in any CMS programs. First, we request clarification on who compiles the medication list—is a physician required to compile the list, or can a licensed nurse or pharmacist (or other medical professional in charge of the patient’s care) perform this task? We also question whether the specifications for the measure can be adjusted for each post-acute care setting; for example, requiring the list to be transferred “at the time of discharge” is not appropriate for all settings. In skilled nursing, this time is used to ensure that necessary medical equipment is available at the patient’s next setting, so requiring the medication list to be transferred at that point would be burdensome. The NQF endorsement process would shed light on whether this measure would actually result in improvements in care, which is unclear from the information provided to the MAP. Medication errors and other events are a serious issue in post-acute care, and while this measure may address one aspect of the issue, transferring the list does not ensure that the subsequent provider received, acknowledged, or used the medication list. Also, as with any process measure, we worry that without specific requirements around what is included on the medication list—while making the task less burdensome to complete—might result in this becoming a mere check-box assessment. (Submitted by: American Hospital Association)
  
  

• (Early public comment) VIA: http://www.qualityforum.org/map/ December 6, 2018 Public Comment 2018 Measures Under Consideration Submitted via: Since 1982, the National Association for Home Care & Hospice (NAHC) has been the leading association representing the interests of hospices, home health, and home care providers across the nation, including the home caregiving staff and the patients and families they serve. Our members are providers of all sizes and types -- from small rural agencies to large national companies -- and include government-based providers, nonprofit voluntary hospices, privately-owned companies and public corporations. As such, we welcome the opportunity to comment on the CMS List of Measures Under Consideration for December 1, 2018. We are commenting on the following three measures: MUC18- 101 Transitions from Hospice Care, Followed by Death or Acute Care MUC18- 131 Transfer of Health Information to Patient—PostAcute Care MUC18- 135 Transfer of Health Information to Provider—PostAcute Care MUC18- 101 Transitions from Hospice Care, Followed by Death or Acute Care As we commented to CMS directly in 2018, we believe this measure falls short of providing a direct indicator of quality of care, has significant potential unintended consequences the least of which is confusion about a hospice’s performance amongst consumers. This raises concern, particularly relative to use of this measure for public reporting. We appreciate and understand the intent of this measure which is to assess negative outcomes following hospice live discharge, including acute care use shortly after discharge, as these outcomes represent potentially burdensome transitions to patients and families. We also appreciate the considerable expansion by CMS of the risk adjustment factors, based on previous public comment, to include a patient’s prior use of acute care services, social risk factors, setting of care while receiving hospice care, etc. We further appreciate that CMS would potentially plan a dry run of this measure, as indicated in its public comment summary report for this measure (August 2018), to determine if the measure is appropriate for public reporting. There is considerable potential for misunderstanding of this measure, and consequent unintended negative consequences. This was emphasized in the comments CMS received, and in its response, CMS stated “Finally, additional measure testing and refinement, including a potential measure dry run will aim to further address the potential unintended consequences of the measure.” We believe this additional measure testing and refinement is crucial to making the measure meaningful to providers and for providers to utilize the measure to inform improvement actions. The current measure specifications exclude the following types of patients: 1. Patients not continuously enrolled in Part A Medicare FFS in the 12 months prior to the hospice admission date, during the hospice stay, or at least 7 days following the hospice discharge date 2. Patients enrolled in Medicare Advantage in the 12 months prior to the hospice admission date, during the hospice stay, or in the 7 days following the hospice discharge date. 3. Patients who are under 18 years old at hospice admission. The most current data shows that in 2016 51.9% of Medicare Advantage (MA) beneficiaries utilized hospice care. There is currently no way for CMS to capture the necessary claims data to include MA beneficiaries in the measure calculation. We believe that leaving these patients out of the measure reduces its usefulness. Additionally, in hospice care there are various discharge codes depending on the reason that the patient is leaving service and the measure specifications include all of them. Patients may revoke service or be discharged or transferred because they have moved out of the area or gone for an extended stay with family members. Patients may be discharged because they (without knowledge of the hospice) admitted themselves to a hospital at which the hospice may not have a contract and cannot continue to treat the patient. Veterans may decide to be served at a VA facility, which requires discharge from hospice care. Patients may also be discharged because they are determined to be no longer be eligible for hospice services. Further, cause for discharge may vary widely depending on market and/or geographic factors. These factors have the potential to dramatically impact some hospices while having little to no impact on others in a different area of a state, region or the country. CMS should consider excluding certain types of live discharges and circumstances surrounding them, including discharges for cause, revocations, transfers, and discharges due to the patient moving out of the service. All of these are, in large part, beyond a hospice’s control. In its review of comments submitted to CMS on this measure, CMS addressed the ways it would intend to handle these types of discharges. Even with some of the risk adjustments CMS intends to make, it appears that CMS would retain a significant number of reasons for live discharge reflecting situations that are out of the hospice’s control and for which they could be penalized. This is especially true of transfer situations. In looking at this proposed measure, it is notable that there is not a consideration of whether the acute care a patient may seek after hospice care is aligned with the patient’s goals. We believe that measures assessing goal attainment and specifically whether a patient’s goals of care align with the care received are more meaningful and could be utilized for hospice performance improvement and consumer education much more efficiently and effectively than the proposed transitions of care measure. If the measure is used in the hospice quality reporting program it is critical that a dry run be implemented and results critically analyzed before any public reporting. If this measure is used for public reporting there must be a clear explanation of the measure, in layman’s terms, that accompanies the posting. MUC18- 131 Transfer of Health Information to Patient—PostAcute Care, and MUC18- 135 Transfer of Health Information to Provider—PostAcute Care In both of these measures under consideration, the assessment items used to record the data have not been finalized and thus are not available for review nor is a draft version showing how the measures might be revised in light of the feedback CMS received from its request for public comment. These are necessary for full consideration of the measure especially since many of the comments submitted by stakeholders on these measures were related to the data source (assessment items) directly. One of the assessment items in particular, Route of Transmission, is of particular concern. NAHC does not support including this question as part of the comprehensive assessment. There is no correlation between the route of transmission and quality of care provided by post-acute care providers and home health in particular. It is unclear why it is important for providers or the public to have this information or what might be gained from having the information . It cannot be assumed that one route is preferred above another, and therefore, reporting the route of transmission without context is not meaningful for utilization by providers in performance improvement or for patients/caregivers/consumers. In fact, there was disagreement within the Technical Expert Panel (TEP) convened by CMS on the route of transmission assessment item. The only exclusion for these measures is patients who died. In the comments provided to CMS when stakeholder input was solicited on this measure, NAHC recommended the exclusion of any patient from the measure calculation where the home health agency assessment data identifies that the HHA was not made of a transfer timely. NAHC is concerned that if untimely transfers are not accounted for in the measure calculation, the measure rate for HHAs could be artificially low. Unlike the facility-based providers, some portion of HHA patients and the providers to which they transfer might not receive a medication profile at transfer for reasons out of the home health agency’s control. This could have unintended consequences for HHAs when used as a cross setting measure with other post- acute care providers. The second of these measures, MUC18- 135, includes the transfer of medication information when a patient is being transferred to settings including: • Private home/ apartment (apt.), • Board/care, • Assisted living, • Group home, • Transitional living or • Home under care of organized home health service organization or hospice It is unclear as to why a home health agency would need to provide a medication profile to the patient, family and/or caregiver in a transfer to another home health service organization or hospice as the patient would continue to receive care by the other home health service organization or hospice and the medication profile would be shared with this provider as a matter of practice. Thank you for this opportunity to provide input on these measures under consideration. We recognize the MAP’s overall timeframe for reviewing these measures is tight and appreciate having the opportunity to provide feedback. However, the timeframe given for public commenting is limited to five business days which makes it somewhat difficult to review the measures in context and formulate comments. If there is any way in the future to extend this review period it would be much appreciated. Please do not hesitate to contact us if our comments require clarification in any way. Sincerely, Katie Wehri Katie Wehri Director, Home Care & Hospice Regulatory Affairs (Submitted by: National Association for Home Care & Hospice)
  
  
• (Early public comment)ARN supports the measures under consideration for Post Acute care settings (Home health, SNF, LTCH and IRF) with regard to medication reconciliation and sharing patient health information to 1) providers and 2) patients, families and / or caregivers. We believe these measures demonstrate a commitment to quality thereby ensuring that important medication information is shared and communicated at transitions. Accurate medication profile information helps keep a patient medication compliant, thereby potentially reducing 30-day re-admission rates. (Submitted by: Association of Rehabilitation Nurses)
  
  
• (Early public comment)Confirmed provision of a reconciled medication list to the patient, family, and/or caregiver is a critical component to improving care for people with serious illness, and can help empower them to better manage their own care. This is a good measure to include in this quality reporting program. (Submitted by: Center to Advance Palliative Care)
  
  
• (Early public comment)NHPCO Comments: NHPCO supports this measure as a patient safety and quality of care issue, especially for seriously ill individuals. (Submitted by: National Hospice and Palliative Care Organization)
  
  
• (Early public comment)The Federation of American Hospitals notes that this measure includes language requiring a “reconciled medication list”, which differs from the draft specification released for comment earlier this year. FAH requests that information on what constitutes a “reconciled medication list” be provided during the MAP review to enable a thorough assessment of whether these refinements have made data collection more feasible and less subjective. (Submitted by: Federation of American Hospitals)
  
  
• (Early public comment)We support this measure although recommend renaming it to: be “Transfer of a “reconciled” medication list” from hospital to post-hospital care provider. We also suggest it would be useful to also include/transfer a statement about the likely course and the patient’s situation with regard to social supports and personal care. (Submitted by: CTAC)
  
  
• Since 1982, the National Association for Home Care & Hospice (NAHC) has been the leading association representing the interests of hospices, home health, and home care providers across the nation, including the home caregiving staff and the patients and families they serve. Our members are providers of all sizes and types -- from small rural agencies to large national companies -- and include government-based providers, nonprofit voluntary hospices, privately-owned companies and public corporations. As such, we welcome the opportunity to comment on the MAP’s Draft Recommendations of the CMS List of Measures Under Consideration for December 1, 2018. We are commenting on the following three measures: MUC18- 101 Transitions from Hospice Care, Followed by Death or Acute Care MUC18- 131 Transfer of Health Information to Patient—PostAcute Care MUC18- 135 Transfer of Health Information to Provider—PostAcute Care MUC18- 101 Transitions from Hospice Care, Followed by Death or Acute Care As we commented to CMS directly in 2018 and again in our comments dated December 6, 2018 on the CMS List of Measures Under Consideration, we believe this measure falls short of providing a direct indicator of quality of care, has significant potential unintended consequences the least of which is confusion about a hospice’s performance amongst consumers. This raises concern, particularly relative to use of this measure for public reporting. We appreciate and understand the intent of this measure which is to assess negative outcomes following hospice live discharge, including acute care use shortly after discharge, as these outcomes represent potentially burdensome transitions to patients and families. We appreciate the MAP’s preliminary decision of “Do Not Support With Potential For Mitigation”. The MAP rationale for this decision brings forth many of the concerns NAHC and its members have with this measure. As we stated previously, there is considerable potential for misunderstanding of this measure, and consequent unintended negative consequences. We especially agree with the MAP’s recommendation that CMS reconsider exclusions for the measure and the MAP suggestion that there be a dry run of the measure before public reporting. There are many types of live discharges and circumstances surrounding them, including discharges for cause, revocations, transfers, discharges due to the patient moving out of the service area and discharges for patients determined to not be terminally ill. Most all of these, in large part, are beyond a hospice’s control. In its review of comments submitted to CMS on this measure, CMS addressed the ways it would intend to handle these types of discharges. Even with some of the risk adjustments CMS intends to make, it appears that CMS would retain a significant number of reasons for live discharge reflecting situations that are out of the hospice’s control and for which they could be penalized. If the measure is used in the hospice quality reporting program it is critical that a dry run be implemented and results critically analyzed before any public reporting. If this measure is used for public reporting there must be a clear explanation of the measure, in layman’s terms, that accompanies the posting. MUC18- 131 Transfer of Health Information to Patient—PostAcute Care, and MUC18- 135 Transfer of Health Information to Provider—PostAcute Care NAHC is pleased that the MAP has not wholeheartedly given a preliminary approval of these measures. We appreciate that the MAP recognizes the importance of the ability to transfer certain health information to the next provider of care. However, in both of these measures under consideration, the assessment items used to record the data have not been finalized and thus are not available for review nor is a draft version showing how the measures might be revised in light of the feedback CMS received from its request for public comment. These are necessary for full consideration of the measure especially since many of the comments submitted by stakeholders on these measures were related to the data source (assessment items) directly. One of the assessment items in particular, Route of Transmission, is of particular concern. The MAP appreciates the ability to utilize different modes of transmission and NAHC acknowledges this ability as beneficial as well. However, NAHC does not support including this question as part of the comprehensive assessment. There is no correlation between the route of transmission and quality of care provided by post-acute care providers and home health in particular. It is unclear why it is important for providers or the public to have this information or what might be gained from having the information . It cannot be assumed that one route is preferred above another, and therefore, reporting the route of transmission without context is not meaningful for utilization by providers in performance improvement or for patients/caregivers/consumers. In fact, there was disagreement within the Technical Expert Panel (TEP) convened by CMS on the route of transmission assessment item. The only exclusion for these measures is patients who died. In the comments provided to CMS when stakeholder input was solicited on this measure, NAHC recommended the exclusion of any patient from the measure calculation where the home health agency assessment data identifies that the HHA was not made aware of a transfer timely. NAHC is concerned that if untimely transfers are not accounted for in the measure calculation, the measure rate for HHAs could be artificially low. Unlike the facility-based providers, some portion of HHA patients and the providers to which they transfer might not receive a medication profile at transfer for reasons out of the home health agency’s control including the agency not being made aware of the transfer timely. This could have unintended consequences for HHAs when used as a cross setting measure with other post- acute care providers. The MAP made a preliminary recommendation of “Conditional Support for Rulemaking” for the second of these measures, MUC18- 135. This measure includes the transfer of medication information when a patient is being transferred to settings including: • Private home/ apartment (apt.), • Board/care, • Assisted living, • Group home, • Transitional living or • Home under care of organized home health service organization or hospice It is unclear as to why a home health agency would need to provide a medication profile to the patient, family and/or caregiver in a transfer to another home health service organization or hospice as the patient would continue to receive care by the other home health service organization or hospice and the medication profile would be shared with this provider as a matter of practice. Thank you for this opportunity to provide input on these preliminary recommendations. Please do not hesitate to contact us if our comments require clarification in any way. Sincerely, Katie Wehri Director, Home Care & Hospice Regulatory Affairs (Submitted by: National Association for Home Care & Hospice)
  
  
• While the Federation of American Hospitals (FAH) supports the current recommendation, we note that this measure includes language requiring a “reconciled medication list”, which differs from the draft specification released for comment earlier this year. This omission was identified by members of the Post-Acute Care/Long-Term Care Workgroup and FAH requests that information on what constitutes a “reconciled medication list” be provided during the MAP Coordinating Committee review to enable a thorough assessment of whether these refinements have made data collection more feasible and less subjective. Support current MAP recommendation (Submitted by: Federation of American Hospitals)
  
  
• AdventHealth supports the adoption of this measure because it will give patients and their families better access and control over their medical records. To ensure the meaningfulness of this measure, AdventHealth recommends that this measure considers the routes of transmission allowed. Many post-acute patients are seniors who do not have the sufficient computer literacy to access an Electronic Health Record (EHR). In addition, many have a variety of mental health illnesses, such as dementia or Alzheimer’s, that may limit their ability to retrieve the medication profile electronically. We recommend that the options for the route of transmission be modified to consider the previously mentioned limitations. For example, the EHR option should either be excluded or used in combination with another route. (Submitted by: AdventHealth)
  
  
• The AHA agrees with the MAP’s recommendation of Conditional Support. Accurate and timely transfer of medication information is key to ensuring high-quality and seamless care transitions in post-acute care, but this measure must complete field testing and go through the NQF endorsement process to ensure that it actually captures the intended information before CMS adopts it for use in long-term care programs. While similar to MUC18-131, 132, 133, and 136 (Transfer of Health Information to Provider), this measure evokes additional concerns because of the inclusion of the patient. We worry that, because the measures are specified similarly, the patient is likely to receive the same medication list as that which is transferred to the subsequent provider. Such a list—which would likely include a long medication history and complex medical information—could potentially be confusing to a patient. Additionally, the specifications should require the medication list to be provided to the patient in the language and format of his/her choice. The NQF endorsement process would shed light on whether this measure would actually result in improvements in care, including in patient experience. Without information from that process, this measure is not ready for inclusion in any CMS programs. (Submitted by: American Hospital Association)
  
  

• (Early public comment)ARN supports the measures under consideration for Post Acute care settings (Home health, SNF, LTCH and IRF) with regard to medication reconciliation and sharing patient health information to 1) providers and 2) patients, families and / or caregivers. We believe these measures demonstrate a commitment to quality thereby ensuring that important medication information is shared and communicated at transitions. Accurate medication profile information helps keep a patient medication compliant, thereby potentially reducing 30-day re-admission rates. (Submitted by: Association of Rehabilitation Nurses)
  
  
• (Early public comment)Confirmed transfer of a reconciled medication list to providers is a critical component to improving care for people with serious illness; this is a good measure to include in this quality reporting program. (Submitted by: Center to Advance Palliative Care)
  
  
• (Early public comment)NHPCO Comments: NHPCO supports this measure as a patient safety and quality of care issue, especially for seriously ill individuals. (Submitted by: National Hospice and Palliative Care Organization)
  
  
• (Early public comment)We support this measure although find the name confusion and so recommend renaming it to: be “Transfer of a “reconciled” medication list” from hospital to post-hospital care provider. We also suggest it would be useful to also include/transfer a statement about the likely course and the patient’s situation with regard to social supports and personal care. (Submitted by: CTAC)
  
  
• MUC18-136: Transfer of Health Information to Provider—Post-Acute Care is intended to promote the exchange of health information electronically. The December 21, 2018 NQF MAP Post-Acute Care and Long-Term Care Draft Report for Comment had the following statement regarding overarching themes for improving care coordination and care transitions: “MAP noted that CMS should continue to work to improve standardization and promote interoperability and recognized that the CMS Data Element Library is an important tool to promote data exchange. MAP also recommended that CMS work with vendors to improve EHR interoperability.” It is our understanding that CMS is not the agency responsible for standardizing and promoting interoperability, and therefore, may have minimal impact on the promotion of EHR improvement. Instead, we believe that CMS should coordinate with the Office of Interoperability and Standards (OIS), a division within the Office of the National Coordinator for Health IT (ONC), to promote the standards & interoperability framework to develop the standards that will enable the secure exchange of healthcare information. The measure, without the standards, will not accomplish the goal of promoting interoperability. It also is our understanding that the CMS Data Element Library was launched in June 2018 and has not been validated in the exchange of specific health data that would support this quality measure. We believe that additional research should be conducted prior to recommending this as a source to promote interoperability (Submitted by: AdvaMed)
  
  
• While the Federation of American Hospitals (FAH) supports the current recommendation, we note that this measure includes language requiring a “reconciled medication list”, which differs from the draft specification released for comment earlier this year. This omission was identified by members of the Post-Acute Care/Long-Term Care Workgroup and FAH requests that information on what constitutes a “reconciled medication list” be provided during the MAP Coordinating Committee review to enable a thorough assessment of whether these refinements have made data collection more feasible and less subjective. Support current MAP recommendation (Submitted by: Federation of American Hospitals)
  
  
• While the Federation of American Hospitals (FAH) supports the current recommendation, we note that this measure includes language requiring a “reconciled medication list”, which differs from the draft specification released for comment earlier this year. This omission was identified by members of the Post-Acute Care/Long-Term Care Workgroup and FAH requests that information on what constitutes a “reconciled medication list” be provided during the MAP Coordinating Committee review to enable a thorough assessment of whether these refinements have made data collection more feasible and less subjective. Support current MAP recommendation (Submitted by: Federation of American Hospitals)
  
  
• AdventHealth supports the adoption of this measure and believes that it will improve care coordination and communication between health care providers. Additionally, we believe this measure could be improved by capturing the amount of time the transmission of records takes to get to another provider. The best clinical decisions can only be made if providers have access to the most relevant and timely data. Although the measure requires post-acute providers to send the medication profile at the time a patient is discharged or transferred to another facility, the route of transmission will affect the timeliness of the transfer. As the measure is currently written, a provider will be scored as successful for transferring the information, regardless of whether the records are delivered in a day or week. We recommend that this measure uses a mechanism to track the timeliness of the transmission of records. Doing so will allow this measure to be more meaningful and better aligned with its purpose—to improve the timely transfer of a medication profile. (Submitted by: AdventHealth)
  
  
• The AHA agrees with the MAP’s recommendation of Conditional Support. Accurate and timely transfer of medication information is key to ensuring high-quality and seamless care transitions in post-acute care, but this measure must complete field testing and go through the NQF endorsement process to ensure that it actually captures the intended information before CMS adopts it for use in long-term care programs. Conceptually, the measure is a better version of what CMS released for public comment in May of 2018. Rather than requiring a long and arbitrary list of medication profile elements to meet the measure criteria, the items to be included would be informed by guidance. In addition, the developers assured the MAP that providers would have an option to note when a patient has no medication to list (a not applicable option) or ends care against medical advice. Logistically, there are still a few issues that must be resolved before this measure is proposed for inclusion in any CMS programs. First, we request clarification on who compiles the medication list—is a physician required to compile the list, or can a licensed nurse or pharmacist (or other medical professional in charge of the patient’s care) perform this task? We also question whether the specifications for the measure can be adjusted for each post-acute care setting; for example, requiring the list to be transferred “at the time of discharge” is not appropriate for all settings. In skilled nursing, this time is used to ensure that necessary medical equipment is available at the patient’s next setting, so requiring the medication list to be transferred at that point would be burdensome. The NQF endorsement process would shed light on whether this measure would actually result in improvements in care, which is unclear from the information provided to the MAP. Medication errors and other events are a serious issue in post-acute care, and while this measure may address one aspect of the issue, transferring the list does not ensure that the subsequent provider received, acknowledged, or used the medication list. Also, as with any process measure, we worry that without specific requirements around what is included on the medication list—while making the task less burdensome to complete—might result in this becoming a mere check-box assessment. (Submitted by: American Hospital Association)
  
  

• (Early public comment)Overall, the AMA supports the episode-based measure development process and movement to episode based measures over broad cost measures. However, we cannot endorse any of the specific measures due to the paucity of analytic information such as the measures’ mean made available prior to the deadline for comments. We request further refinements to the process to ensure the cost measures are accurate and fair when used in the Merit-based Incentive Payment System and, ultimately, publicly reported. In general, we urge the MAP to make “Conditional Support” its highest level of recommendation and to recommend “Do Not Support with Potential for Mitigation” for any measures where relevant specialties have raised serious concerns. Please see additional comments submitted earlier in response to MUC18-115 Inpatient Chronic Obstructive Pulmonary Disease (COPD) Exacerbation. (Submitted by: American Medical Association)
  
  
• (Early public comment)ASCO supports the episode-based measure development process, as episode-based measures can provide a more appropriate and meaningful assessment of care costs than extremely broad cost measures that also lack clarity in attribution. We appreciate the opportunity to participate in the development of those measures and look forward to working on measures related to oncology care, in addition to oncology surgical procedures. However, as we have stated before in numerous comment letters to CMS, the reliance on administrative claims with the failure to consider other important sources of data leads to a crude measure of true cost, and limits both risk adjustment and exclusion criteria. Section 105(b) of the MACRA statute specifically allows for the sharing of data by CMS with qualified clinical data registries; to date, CMS has not provided a process to make this data accessible to clinical registries, instead implementing a “quasi-qualified entity” pathway that is onerous, time-consuming, and may provide access to the data for a limited period. We continue to urge CMS to make this data available, as clearly intended by the MACRA statute, and to work with stakeholders including professional societies to assess how the potential linkage of administrative claims data and clinical registry data could improve existing and new cost measures. We thank NQF for this opportunity to submit comments and look forward to engaging further in the measure development process timeline. (Submitted by: American Society of Clinical Oncology (ASCO) )
  
  
• We believe that in addition to episode-based measures in this area, there remains a measure gap in the assessment of revision rates regarding joint replacement. This is addressed in the 2017 Discern Health White Paper entitled: Medical Technology in the Value-Based Environment: An Assessment of Quality Measure Gaps (http://discernhealth.com/wp-content/uploads/2018/01/medical_technology_in_the_value_based_environment_-_assessment_of_quality_measure_gaps.pdf). This paper identified potential measurement opportunities within the THA/TKA care episode. These included opportunities around diagnosis and assessment (physical examinations, risk and functional assessments, and imaging); treatment (patient education, referrals for physical therapy, timely initiation of medical therapy or surgery, selection of surgery based on patient need); monitoring (imaging and referrals for physical therapy and rehabilitation); and outcomes (post-surgical complication rates, patient-reported change in function or quality of life, and revision rates). An important finding of this paper was that important gaps remain between the measurement opportunities identified and the available THA/TKA measures. Specifically, the paper noted that a priority THA/TKA measure gap would be the development of an outcome measure to assess multi-year revision rates (“Risk-Adjusted Multi-Year Revision Rate”). While VBP programs do use some outcome measures, such as readmissions, complications and infections, these are all short-term in nature and are not sufficient to fully determine the adequacy and appropriateness of the implant and the intermediate and long-term clinical benefit of the surgery. Discern Health noted that there is a gap in multi-year assessments of revision rates and implant failures. Policymakers must consider the application of such measures in population- or episode-based payment models to assess quality across performance periods. These revisions rates can be easily captured using Medicare claims data and measuring quality of hospitals beyond the 90-day episode would organize care around use of implants best-suited for the patient, with greater awareness of interim and longer-term rates of revision surgery. Capturing these measures would also assist patients and enable them to act as informed consumers of care, a key policy objective of the administration. (Submitted by: AdvaMed)
  
  
• The American Medical Association (AMA) supports the preliminary recommendation of “Conditional Support” for these measures unless a relevant specialty society raises serious concerns with one of these measures during the public comment period. If serious concerns are raised, we ask that the highest recommendation be “Do Not Support with Potential for Mitigation”. In addition, the AMA requests that additional conditions be placed on each of these measures. Specifically, on review of the supplemental materials provided by Acumen for the Clinician Workgroup meeting, we note that only reliability testing was provided and the validity of the measures have not yet been demonstrated. This testing, which is a requirement for NQF endorsement and inclusion in the MIPS program, must be completed prior to implementation in MIPS. In addition, we question whether any of the proposed cost measures have had sufficient feedback from clinicians given the limited timeframe and challenges accessing the reports. The supplemental materials indicate that more than 78,000 field test reports were distributed; yet, feedback was received from only 67 stakeholders. We do not believe that such a low response rate should necessarily lead to conclusions that these measures are generally supported and do not require ongoing refinements. We refer the Coordination Committee to the substantive feedback provided by the AMA and others during the pre-workgroup comment period and ask that the MAP include the additional conditions requesting that additional feedback and input from clinicians be sought and validity testing be completed prior to implementation in MIPS. (Submitted by: American Medical Association)
  
  
• Smith & Nephew strongly supports this episode-based measure, which would complement the existing episode-based measure for elective primary knee arthroplasty. Still, we are concerned that a significant measure gap remains in the assessment of revision rates regarding joint replacement. In a 2017 Discern Health White Paper entitled: Medical Technology in the Value-Based Environment: An Assessment of Quality Measure Gaps, potential measurement opportunities were noted, with the chief gap for joint replacement being the need to develop an outcome measure to assess multi-year revision rates (“Risk-Adjusted Multi-Year Revision Rate”). While Medicare’s Value-Based Purchasing (VBP) programs do use some claims-based outcome measures for total joint arthroplasty, such as readmissions and complications, these capture short-term adverse events and do not convey the potentially more clinically relevant outcome of revision rates. Joint replacement registries across the world track patient care and implant performance in this way, gauging quality through the lens of interim and long-term clinical benefits of the surgery. Discern Health noted this gap in multi-year assessments of revision rates and implant performance. We urge policymakers to consider the application of such measures in population- or episode-based payment models to assess quality across performance periods. Revision rates can be easily captured using Medicare claims, and measuring quality beyond 90-day episodes would organize provider care around the best techniques, protocols and implants matched to individual patient needs, and would boost quality efforts in the interim and long-term. Capturing these measures and posting provider performance on Hospital Compare or other CMS site would also empower patients to act as informed consumers of care, a key policy objective of the administration. (Submitted by: Smith & Nephew)
  
  

• (Early public comment)ARN supports the measures under consideration for Post Acute care settings (Home health, SNF, LTCH and IRF) with regard to medication reconciliation and sharing patient health information to 1) providers and 2) patients, families and / or caregivers. We believe these measures demonstrate a commitment to quality thereby ensuring that important medication information is shared and communicated at transitions. Accurate medication profile information helps keep a patient medication compliant, thereby potentially reducing 30-day re-admission rates. (Submitted by: Association of Rehabilitation Nurses)
  
  
• (Early public comment)Confirmed provision of a reconciled medication list to the patient, family, and/or caregiver is a critical component to improving care for people with serious illness, and can help empower them to better manage their own care. This is a good measure to include in this quality reporting program. (Submitted by: Center to Advance Palliative Care)
  
  
• (Early public comment)NHPCO Comments: NHPCO supports this measure as a patient safety and quality of care issue, especially for seriously ill individuals. (Submitted by: National Hospice and Palliative Care Organization)
  
  
• (Early public comment)The Federation of American Hospitals notes that this measure includes language requiring a “reconciled medication list”, which differs from the draft specification released for comment earlier this year. FAH requests that information on what constitutes a “reconciled medication list” be provided during the MAP review to enable a thorough assessment of whether these refinements have made data collection more feasible and less subjective. (Submitted by: Federation of American Hospitals)
  
  
• (Early public comment)These comments apply to MUC 18-131, 132, 133, 135, 136, 138, 139, 141. AOTA appreciates the opportunity to comment on the Transfer of Health Information PAC measures. We agree that a reconciled medication list is a logical first measure to implement in the transfer of health information in these settings. (Submitted by: American Occupational Therapy Association)
  
  
• (Early public comment)We support this measure although recommend renaming it to: be “Transfer of a “reconciled” medication list” from hospital to post-hospital care provider. We also suggest it would be useful to also include/transfer a statement about the likely course and the patient’s situation with regard to social supports and personal care. (Submitted by: CTAC)
  
  
• While the Federation of American Hospitals (FAH) supports the current recommendation, we note that this measure includes language requiring a “reconciled medication list”, which differs from the draft specification released for comment earlier this year. This omission was identified by members of the Post-Acute Care/Long-Term Care Workgroup and FAH requests that information on what constitutes a “reconciled medication list” be provided during the MAP Coordinating Committee review to enable a thorough assessment of whether these refinements have made data collection more feasible and less subjective. Support current MAP recommendation (Submitted by: Federation of American Hospitals)
  
  
• AdventHealth supports the adoption of this measure because it will give patients and their families better access and control over their medical records. To ensure the meaningfulness of this measure, AdventHealth recommends that this measure considers the routes of transmission allowed. Many post-acute patients are seniors who do not have the sufficient computer literacy to access an Electronic Health Record (EHR). In addition, many have a variety of mental health illnesses, such as dementia or Alzheimer’s, that may limit their ability to retrieve the medication profile electronically. We recommend that the options for the route of transmission be modified to consider the previously mentioned limitations. For example, the EHR option should either be excluded or used in combination with another route. (Submitted by: AdventHealth)
  
  
• The AHA agrees with the MAP’s recommendation of Conditional Support. Accurate and timely transfer of medication information is key to ensuring high-quality and seamless care transitions in post-acute care, but this measure must complete field testing and go through the NQF endorsement process to ensure that it actually captures the intended information before CMS adopts it for use in long-term care programs. While similar to MUC18-131, 132, 133, and 136 (Transfer of Health Information to Provider), this measure evokes additional concerns because of the inclusion of the patient. We worry that, because the measures are specified similarly, the patient is likely to receive the same medication list as that which is transferred to the subsequent provider. Such a list—which would likely include a long medication history and complex medical information—could potentially be confusing to a patient. Additionally, the specifications should require the medication list to be provided to the patient in the language and format of his/her choice. The NQF endorsement process would shed light on whether this measure would actually result in improvements in care, including in patient experience. Without information from that process, this measure is not ready for inclusion in any CMS programs. (Submitted by: American Hospital Association)
  
  

• (Early public comment)AMRPA appreciates the opportunities to provide input to the NQF Measures Application Partnership regarding the Transfer of Health Information measures under consideration for the Inpatient Rehabilitation Facility Quality Reporting Program (IRF QRP) in the 2019 pre-rulemaking cycle. AMRPA is the national trade association representing more than 600 freestanding inpatient rehabilitation hospitals and rehabilitation units of general hospitals (referred to as inpatient rehabilitation facilities (IRFs) by Medicare) and outpatient rehabilitation service providers. Inpatient rehabilitation hospitals and units (IRH/Us) provide hospital-level care, which is significantly different in intensity, capacity, and outcomes from care provided in non-hospital post-acute settings. AMRPA remains supportive of the intent of the Transfer of Health Information measures which fulfill a domain required by the IMPACT Act. It it is critical to ensure that clinically relevant, valuable, and actionable patient information is transferred to the patient/family or to a downstream provider at discharge from PAC. Nonetheless, AMRPA is unable to fully support the quality measures because stakeholders have not been afforded an opportunity to the full extent of the measures; specifically, the technical specifications for these measures as they are characterized in the 2019 MUC List. CMS appears to have altered the scope of these measures since draft specifications were last made public in spring 2018. At that time, these measures were titled Transfer of Info: Medication Profile and the specification report proposed a list of patient data items for providers to report. However, in this 2019 MUC list, the measures description has been revised and is as follows: “For this measure, the timely transfer of health information specifically assesses for the transfer of the patient’s current reconciled medication list.” There is minimal information beyond that. Without seeing details as to what constitutes a “reconciled medication list” or how CMS would implement reporting, we are unable to comment on how the measures would add value to the IRF QRP and improve patient outcomes, or assess if measure benefits would outweigh the burden of data collection/reporting. In short, we are not able to substantively respond to the questions NQF is asking stakeholders. We respectfully request CMS provide the technical specifications for both Transfer of Health Information Measures Under Considerations for PAC so that stakeholders can review the measures in full and provide considered and meaningful input. AMRPA commented on the TOH: Medication Profile draft specifications this past spring. AMRPA’s comments reflected feedback from our Quality Committee with input from pharmacists, administrators, physicians and other clinicians at inpatient rehabilitation hospitals and units. Our members agree that the accurate and successful transfer of essential medication information at PAC discharge/transfer is critical to ensuring that patient safety and quality of care are not compromised once a patient leaves a particular setting. While we supported the measures’ intent, at that time, many aspects of the measures are yet to be specified such as: the data elements required for reporting, the process by which they would be reported, whether changes need to be made to the mandatory IRF Patient Assessment Instrument (IRF PAI) to accommodate measure reporting, and how CMS would ensure measure validity for these process-based measures, among other questions. As CMS continues to develop the Transfer of Health Information measures, we urge it to do so in a practical and minimally burdensome manner that adds value beyond rehabilitation hospitals’ current medication reconciliation and/or discharge planning practices. This would be consistent with CMS’ Patients over Paperwork and Meaningful Measures initiatives which aim to reduce providers’ administrative burden, and specifically with regard to burden from quality measures. (Submitted by: American Medical Rehabilitation Providers Association (AMRPA))
  
  
• (Early public comment)ARN supports the measures under consideration for Post Acute care settings (Home health, SNF, LTCH and IRF) with regard to medication reconciliation and sharing patient health information to 1) providers and 2) patients, families and / or caregivers. We believe these measures demonstrate a commitment to quality thereby ensuring that important medication information is shared and communicated at transitions. Accurate medication profile information helps keep a patient medication compliant, thereby potentially reducing 30-day re-admission rates. (Submitted by: Association of Rehabilitation Nurses)
  
  
• (Early public comment)Confirmed provision of a reconciled medication list to the patient, family, and/or caregiver is a critical component to improving care for people with serious illness, and can help empower them to better manage their own care. This is a good measure to include in this quality reporting program. (Submitted by: Center to Advance Palliative Care)
  
  
• (Early public comment)NHPCO Comments: NHPCO supports this measure as a patient safety and quality of care issue, especially for seriously ill individuals. (Submitted by: National Hospice and Palliative Care Organization)
  
  
• (Early public comment)We are unable to comment on MUC2018-132 Transfer of Health Information to Patient without measure specifications. The 2018 Measures Under Consideration List, Program Specific Measure Needs and Priorities (May 29, 2018) states under section 3. Candidate Measure Submission Guidance, "In an effort to provide a more meaningful List of Measures under Consideration, CMS included only measures that contain adequate specifications." However, for measure 2018-139, only a numerator and denominator were supplied on the MUC. While a similar transfer of health information measure and measure specifications were released for public comment in the spring of 2018, CMS has noted the measure on the MUC list has been modified and does not reflect those measure specifications. Given the potential of this measure to be comprehensive in scope, without understanding the elements included in the numerator, it is not possible to meaningfully comment on the measure proposed on the MUC list. Since the measure is not defined, we cannot support its consideration into the IRF QRP. (Submitted by: Encompass Health)
  
  
• (Early public comment)We support this measure although recommend renaming it to: be “Transfer of a “reconciled” medication list” from hospital to post-hospital care provider. We also suggest it would be useful to also include/transfer a statement about the likely course and the patient’s situation with regard to social supports and personal care. (Submitted by: CTAC)
  
  
• Measure specifications should be made publicly available PRIOR to CMS or NQF MAP asking for comments. We believe the current draft definition of medication profile, as outlined on pp. 9-10 of the measure specification, is overly burdensome and too prescriptive, making it inconsistent with the Patients over Paperwork and Meaningful Measure initiatives, both of which emphasize reducing provider burden in the interest of increasing quality time with the patient. For example, requiring a clinician to collect and summarize a patient’s adherence to each individual medication, while also providing a more general summary for the patient’s overall medication adherence, is duplicative, particularly if it must be done for medications that will be discontinued at discharge. If CMS, via the 25-item checklist proposed in the draft specification, intends to require all post-acute providers to undertake these highly specific steps regarding the transfer of medication information, we believe the agency should propose formal regulations requiring these actions instead of wrapping them into a quality measure. We suggest replacing the proposed lengthy checklist-based definition regarding the necessary components of a qualifying medication profile with a more flexible narrative definition that permits those post-acute providers that already have medication communication procedures in place to maintain their practices while simultaneously requiring other post-acute providers that do not have medication communication capacity to implement one. Such an alternative definitional approach would preserve the best-practices that are already in place within sophisticated care environments, such as IRFs, while also offering opportunities for improvement in other care settings where medication information collection and transfer is less consistent or robust. This definitional approach would be sensitive to what already works, but would also create an important standard for other providers to aspire to. We believe medication profiles should cover a broad range of medications, whether prescribed or over-the-counter (“OTC”), but raise a concern with the proposal’s assumption that the same medication information that should be prepared for and transferred to subsequent providers should also be given to patients. Specifically, including all the proposed information items for discontinued medications would create so much clinical material for a patient that the patient would be inundated with unnecessary material that could cloud the actual educational goals of pre-existing discharge documentation, thereby increasing the risk of confusion about what medications should be continued. We therefore suggest using our singular narrative definition above because it is patient-centered and avoids such a risk by allowing a care team to exclude those discontinued medications that are not relevant to a patient’s continued care and instead focuses on medications that should be continued after discharge. Our suggested definition would cover most if not all of the types of medications in the RTI-proposed definition, and would help clarify that the medication profile should focus on medications that are to be continued post-discharge. In the alternative, if CMS is not comfortable with the suggested single definition that emphasizes the appropriate information for the patient, then we believe two distinct definitions of “medication profile” should be pursued and utilized simultaneously – one which details the information that should go to the patient when he/she is discharged home (excluding discontinued medications), and a separate definition for when a patient is discharged to a subsequent care setting (including discontinued medications). These patient and provider definitions could also be conveyed as flexible narrative definitions, similar to that suggested above. The rationale for this dual approach is that the information for discontinued medications is indeed important and valuable for medical professionals in subsequent care settings, but could actually increase the risk of confusion, and therefore of patient harm, when given directly to a patient. (Submitted by: Encompass Health)
  
  
• While the Federation of American Hospitals (FAH) supports the current recommendation, we note that this measure includes language requiring a “reconciled medication list”, which differs from the draft specification released for comment earlier this year. This omission was identified by members of the Post-Acute Care/Long-Term Care Workgroup and FAH requests that information on what constitutes a “reconciled medication list” be provided during the MAP Coordinating Committee review to enable a thorough assessment of whether these refinements have made data collection more feasible and less subjective. Support current MAP recommendation (Submitted by: Federation of American Hospitals)
  
  
• AdventHealth supports the adoption of this measure because it will give patients and their families better access and control over their medical records. To ensure the meaningfulness of this measure, AdventHealth recommends that this measure considers the routes of transmission allowed. Many post-acute patients are seniors who do not have the sufficient computer literacy to access an Electronic Health Record (EHR). In addition, many have a variety of mental health illnesses, such as dementia or Alzheimer’s, that may limit their ability to retrieve the medication profile electronically. We recommend that the options for the route of transmission be modified to consider the previously mentioned limitations. For example, the EHR option should either be excluded or used in combination with another route. (Submitted by: AdventHealth)
  
  
• AMRPA appreciates the opportunity to provide input on the National Quality Forum (NQF) Measure Application Partnership’s (MAP) draft recommendations regarding the Transfer of Health Information Measures Under Consideration for the Inpatient Rehabilitation Facility Quality Reporting Program (IRF QRP) in the 2019 pre-rulemaking cycle. AMRPA is the national trade association representing more than 625 freestanding inpatient rehabilitation hospitals and rehabilitation units of general hospitals (referred to as inpatient rehabilitation facilities (IRFs) by Medicare) and outpatient rehabilitation service providers. Inpatient rehabilitation hospitals and units (IRH/Us) provide hospital-level care, which is significantly different in intensity, capacity, and outcomes from care provided in non-hospital post-acute settings. AMRPA supports the intent of the Transfer of Health Information measures and appreciates the additional information and clarifications provided by CMS staff during the December 10th NQF PAC/LTC MAP public meeting. Notably, CMS clarified that the differences between these Measures Under Consideration and the prior versions of the measures (made publicly available in spring 2018) are nominal in nature: The term “medication profile” was changed to “reconciled medication list” and the formal name of the measure was changed. With regard to the underlying technical measure specifications, CMS indicated that they are the same as the prior draft measure specifications, although she additionally noted that CMS’ guidance for what constitutes a medication list has been “pared down.” AMRPA appreciates CMS’ responsiveness to our and other stakeholders’ requests to scale back the measures and be less prescriptive in how providers reconcile medications and transfer that information for which IRFs, as hospitals, already have standard practices. Additionally, we are pleased to hear that CMS is incorporating certain beneficiary exclusions in the measure denominator for hospital-based PAC settings, such as excluding those patients discharged against medical advice (AMA). CMS staff also stated that they are developing additional measure guidance, such as the types of medications/interventions that define a reconciled medication list, that will be more granular than the technical measure specifications. If there have been changes made to the measures’ *guidance* (if not to the technical specifications), AMRPA respectfully requests that CMS make this information available to stakeholders as part of the NQF MAP process. We echo comments made by MAP members during the December meeting that there is still a need to resolve questions about the specific medication information the measures are intended to encompass and how providers would be expected to implement the measures. Needless to say, this guidance will shape the medication information transmitted at discharge/transfer and ultimately would impact how these measures will be operationalized across PAC settings. We impress upon NQF the importance of having this type of information available during the MAP public comment process. Without it, neither the MAP nor public stakeholders are able to truly respond to MAP’s questions for this comment opportunity, including “Do the potential benefits of the measure outweigh the burden of data collection or reporting?” or “What, if any, implementation challenges have you encountered for this measure?” Finally, because these measures are process measures, it is important for NQF and CMS to evaluate how provider performance would be validated. While some PAC settings are accredited by the Joint Commission and already adhere to medication reconciliation requirements, this is not standard practice across PAC settings. The Transfer of Health Information measures will be implemented across PAC settings and could potentially be viewed as a quality indicator to compare PAC settings. As such, it is critical for CMS to validate the reported data. In summary, while we support the non-prescriptive nature of these measures, we think CMS should still provide NQF and stakeholders more information about how the measures will be implemented and operationalized by PAC providers, and how CMS intends to validate the reported data. (Submitted by: American Medical Rehabilitation Providers Association (AMRPA))
  
  
• The AHA agrees with the MAP’s recommendation of Conditional Support. Accurate and timely transfer of medication information is key to ensuring high-quality and seamless care transitions in post-acute care, but this measure must complete field testing and go through the NQF endorsement process to ensure that it actually captures the intended information before CMS adopts it for use in long-term care programs. While similar to MUC18-131, 132, 133, and 136 (Transfer of Health Information to Provider), this measure evokes additional concerns because of the inclusion of the patient. We worry that, because the measures are specified similarly, the patient is likely to receive the same medication list as that which is transferred to the subsequent provider. Such a list—which would likely include a long medication history and complex medical information—could potentially be confusing to a patient. Additionally, the specifications should require the medication list to be provided to the patient in the language and format of his/her choice. The NQF endorsement process would shed light on whether this measure would actually result in improvements in care, including in patient experience. Without information from that process, this measure is not ready for inclusion in any CMS programs. (Submitted by: American Hospital Association)
  
  

• (Early public comment)Overall, the AMA supports the episode-based measure development process and movement to episode based measures over broad cost measures. However, we cannot endorse any of the specific measures due to the paucity of analytic information such as the measures’ mean made available prior to the deadline for comments. We request further refinements to the process to ensure the cost measures are accurate and fair when used in the Merit-based Incentive Payment System and, ultimately, publicly reported. In general, we urge the MAP to make “Conditional Support” its highest level of recommendation and to recommend “Do Not Support with Potential for Mitigation” for any measures where relevant specialties have raised serious concerns. Please see additional comments submitted earlier in response to MUC18-115 Inpatient Chronic Obstructive Pulmonary Disease (COPD) Exacerbation. (Submitted by: American Medical Association)
  
  
• (Early public comment)ASCO supports the episode-based measure development process, as episode-based measures can provide a more appropriate and meaningful assessment of care costs than extremely broad cost measures that also lack clarity in attribution. We appreciate the opportunity to participate in the development of those measures and look forward to working on measures related to oncology care, in addition to oncology surgical procedures. However, as we have stated before in numerous comment letters to CMS, the reliance on administrative claims with the failure to consider other important sources of data leads to a crude measure of true cost, and limits both risk adjustment and exclusion criteria. Section 105(b) of the MACRA statute specifically allows for the sharing of data by CMS with qualified clinical data registries; to date, CMS has not provided a process to make this data accessible to clinical registries, instead implementing a “quasi-qualified entity” pathway that is onerous, time-consuming, and may provide access to the data for a limited period. We continue to urge CMS to make this data available, as clearly intended by the MACRA statute, and to work with stakeholders including professional societies to assess how the potential linkage of administrative claims data and clinical registry data could improve existing and new cost measures. We thank NQF for this opportunity to submit comments and look forward to engaging further in the measure development process timeline. (Submitted by: American Society of Clinical Oncology (ASCO) )
  
  
• This appears to be a directly relevant measure to target. The details of this measure should be aligned with those used in the BPCI-Advanced CABG bundle. The draft recommendation document has very little detail, so it is possible that this is already planned. There is simply not enough detail to know. (Submitted by: Cerner Corporation)
  
  
• The American Medical Association (AMA) supports the preliminary recommendation of “Conditional Support” for these measures unless a relevant specialty society raises serious concerns with one of these measures during the public comment period. If serious concerns are raised, we ask that the highest recommendation be “Do Not Support with Potential for Mitigation”. In addition, the AMA requests that additional conditions be placed on each of these measures. Specifically, on review of the supplemental materials provided by Acumen for the Clinician Workgroup meeting, we note that only reliability testing was provided and the validity of the measures have not yet been demonstrated. This testing, which is a requirement for NQF endorsement and inclusion in the MIPS program, must be completed prior to implementation in MIPS. In addition, we question whether any of the proposed cost measures have had sufficient feedback from clinicians given the limited timeframe and challenges accessing the reports. The supplemental materials indicate that more than 78,000 field test reports were distributed; yet, feedback was received from only 67 stakeholders. We do not believe that such a low response rate should necessarily lead to conclusions that these measures are generally supported and do not require ongoing refinements. We refer the Coordination Committee to the substantive feedback provided by the AMA and others during the pre-workgroup comment period and ask that the MAP include the additional conditions requesting that additional feedback and input from clinicians be sought and validity testing be completed prior to implementation in MIPS. (Submitted by: American Medical Association)
  
  

• (Early public comment)ARN supports the measures under consideration for Post Acute care settings (Home health, SNF, LTCH and IRF) with regard to medication reconciliation and sharing patient health information to 1) providers and 2) patients, families and / or caregivers. We believe these measures demonstrate a commitment to quality thereby ensuring that important medication information is shared and communicated at transitions. Accurate medication profile information helps keep a patient medication compliant, thereby potentially reducing 30-day re-admission rates. (Submitted by: Association of Rehabilitation Nurses)
  
  
• (Early public comment)Confirmed provision of a reconciled medication list to the patient, family, and/or caregiver is a critical component to improving care for people with serious illness, and can help empower them to better manage their own care. This is a good measure to include in this quality reporting program. (Submitted by: Center to Advance Palliative Care)
  
  
• (Early public comment)NHPCO Comments: NHPCO supports this measure as a patient safety and quality of care issue, especially for seriously ill individuals. (Submitted by: National Hospice and Palliative Care Organization)
  
  
• (Early public comment)The Federation of American Hospitals notes that this measure includes language requiring a “reconciled medication list”, which differs from the draft specification released for comment earlier this year. FAH requests that information on what constitutes a “reconciled medication list” be provided during the MAP review to enable a thorough assessment of whether these refinements have made data collection more feasible and less subjective. (Submitted by: Federation of American Hospitals)
  
  
• (Early public comment)Commenter did not submit written comments (Submitted by: CTAC)
  
  
• While the Federation of American Hospitals (FAH) supports the current recommendation, we note that this measure includes language requiring a “reconciled medication list”, which differs from the draft specification released for comment earlier this year. This omission was identified by members of the Post-Acute Care/Long-Term Care Workgroup and FAH requests that information on what constitutes a “reconciled medication list” be provided during the MAP Coordinating Committee review to enable a thorough assessment of whether these refinements have made data collection more feasible and less subjective. Support current MAP recommendation (Submitted by: Federation of American Hospitals)
  
  
• AdventHealth supports the adoption of this measure because it will give patients and their families better access and control over their medical records. To ensure the meaningfulness of this measure, AdventHealth recommends that this measure considers the routes of transmission allowed. Many post-acute patients are seniors who do not have the sufficient computer literacy to access an Electronic Health Record (EHR). In addition, many have a variety of mental health illnesses, such as dementia or Alzheimer’s, that may limit their ability to retrieve the medication profile electronically. We recommend that the options for the route of transmission be modified to consider the previously mentioned limitations. For example, the EHR option should either be excluded or used in combination with another route. (Submitted by: AdventHealth)
  
  
• The AHA agrees with the MAP’s recommendation of Conditional Support. Accurate and timely transfer of medication information is key to ensuring high-quality and seamless care transitions in post-acute care, but this measure must complete field testing and go through the NQF endorsement process to ensure that it actually captures the intended information before CMS adopts it for use in long-term care programs. While similar to MUC18-131, 132, 133, and 136 (Transfer of Health Information to Provider), this measure evokes additional concerns because of the inclusion of the patient. We worry that, because the measures are specified similarly, the patient is likely to receive the same medication list as that which is transferred to the subsequent provider. Such a list—which would likely include a long medication history and complex medical information—could potentially be confusing to a patient. Additionally, the specifications should require the medication list to be provided to the patient in the language and format of his/her choice. The NQF endorsement process would shed light on whether this measure would actually result in improvements in care, including in patient experience. Without information from that process, this measure is not ready for inclusion in any CMS programs. (Submitted by: American Hospital Association)
  
  

• (Early public comment)CMS is proposing a revised MSPB measure developed and field tested by Acumen, LLP. The AMA greatly appreciates the efforts of CMS and Acumen, LLP to improve on this measure carried over from the Value-Based Payment Modifier. Conceptually, we believe that the exclusion of unrelated services from costs counted in the measure and the use of MS-DRGs to define severity are promising changes. On the other hand, we have concerns about the medical DRG attribution method which is essentially the same as the method employed for acute inpatient condition episodes and could hold individual physicians accountable for costs of a patient that they saw only once. At this time, however, we are unable to make a definitive recommendation on this measure because information on the validity and impact of the attribution methodology is not publicly available nor has data on the reliability and validity of the measure itself been released. As a result, the AMA recommends that the highest level of MAP recommendation be “Conditional Support” for this measure. The AMA also encourages the Measures Application Partnership (MAP) to carefully consider whether inclusion of the MSPB and Total Per Capita Cost (TPCC) in MIPS should be continued as the number of episode-based cost measures increases. Many of the same beneficiaries captured in the episode-based cost measures will also be included in one or both of the broader population measures and this “double counting” could have negative unintended consequences because costs attributed to a clinician for a particular beneficiary will likely differ between measures. These differences could occur simply because of the construction of the measures because the episode-based measures are more precise--and likely more reflective of care that is actually within the physician’s sphere of influence—than the broader MSPB and TPC measures even where there is no true difference in performance. The impact that the attribution of one beneficiary for the same episode to multiple measures will have on the overall cost category in MIPS is not known. Generally, we can assume that the results will be inconsistent across clinicians. CMS has removed measures from other federal programs due to the issue of “double counting”, and we believe this principle should also apply to the cost category of MIPS. For instance, physicians in MIPS APMs, such as those in the Medicare Shared Savings Program (MSSP), are not measured on cost in MIPS to avoid conflicts between the shared savings/losses calculations in MSSP and the MIPS cost measures. Physicians may face similar conflicts when measured on episode-based cost measures, as well as TPCC and MSPB. (Submitted by: American Medical Association)
  
  
• (Early public comment)General Cost Measure Comments • The AANS and CNS oppose the continued inclusion of the Total Per Capita Cost (TPCC) and Medicare Spending Per Beneficiary (MSPB) in MIPS given the substantial issues with these measures, their inappropriateness for physician-level measurements, and in light of the growing number of episode-based cost measures. In general, the TPCC and MSPB lack the precision in representing costs that are truly within the control of the physician related to a condition or procedure that is most likely better represented in those that are episode-based. • Many of the same beneficiaries captured in the episode-based cost measures will also be included in one or both of the broader population measures, resulting in “double counting” for purposes of MIPS scoring and payment adjustments. CMS has removed measures from other federal programs, such as the Medicare Shared Savings Program (MSSP) and the Impatient Quality Reporting Program (IQR), due to the issue of “double counting”, which we believe also applies to the cost category of MIPS. • For all cost measures currently under consideration, information on the validity and impact of the attribution methodology is not publicly available nor has data on the reliability and validity of the measure itself been released. (Submitted by: American Association of Neurological Surgeons)
  
  
• (Early public comment)NHPCO Comments: NHPCO appreciates this measure and recognizes that high quality inpatient palliative care services could potentially have a positive impact on this measure, as a secondary outcome of comprehensive assessment, symptom and medication management, advance care planning and goals of care conversations, patient and family education, and care coordination by an interdisciplinary team. (Submitted by: National Hospice and Palliative Care Organization)
  
  
• (Early public comment)The AAFP does not support inclusion of the MSPB and TPCC measures in MIPS for the following reasons: • These measures were developed for use at the TIN level, and their validity at the solo/small practice level is questionable. We reiterate that a measure may be considered reliable, but can still lack validity. The National Quality Forum (NQF) did not endorse CMS’ total per capita cost measure (CMS Measure #2165). NQF questioned the utility of the measure to improve cost performance due to concerns with its attribution method. NQF noted that primary care providers may have limited ability to meaningfully influence the cost of specialists, inpatient care, and post-acute care, but would ultimately be held responsible for these costs. The AAFP encourages CMS to explore alternatives to these measures and offers the two utilization measures of the Comprehensive Primary Care Plus (CPC+) program (inpatient hospital utilization and emergency department utilization) as such alternatives. • Many of the same beneficiaries captured in the episode-based cost measures will also be included in one or both of the broader population measures, resulting in double counting and potential negative unintended consequences. • First, the costs attributed to a clinician for one beneficiary will likely differ between an episode-based measure versus TPCC or MSPB for the same episode. These differences are due to how each measure is constructed and less likely to represent true differences in performance. Also, the TPCC and MSPB lack the precision in representing costs that are truly within the control of the physician related to a condition or procedure that is most likely better represented in those that are episode-based. • Second, the impact that the attribution of one beneficiary for the same episode to multiple measures will have on the overall cost category in MIPS is not known. Generally, we can assume that the results will be inconsistent across clinicians. • CMS has removed measures from other federal programs due to the issue of “double counting”, which we believe also applies to the cost category of MIPS. For instance, physicians in MIPS APMs, such as those in the Medicare Shared Savings Program (MSSP), are not measured on cost in MIPS to avoid conflicts between the shared savings/losses calculations in MSSP and the MIPS cost measures. Physicians may face similar conflicts when measured on episode-based cost measures, as well as TPCC and MSPB. The AAFP requests that the MAP recommend discontinuing use of the TPCC and MSPB measures in light of the increasing number of episode-based cost measures being proposed and finalized. (Submitted by: American Academy of Family Physicians)
  
  
• (Early public comment)The AAMC has concerns with the use of the total per capita cost measure in the MIPS program. Specifically, we are concerned that the risk adjustment model for the MSPB measure does not adequately address patient complexity and the impact of socio-demographic factors. Vulnerable populations generally require higher resource utilization. Appropriate risk adjustment is essential so that differences in patient characteristics that are beyond a health care provider’s control do not have an unfair impact on a provider’s cost performance score. CMS should look at alternative sources of data to obtain information about risk adjustment. In addition, many of the same beneficiaries captured in the episode-based cost measures will also be included in the MSPB measure and therefore it is duplicative to assess performance on both these measures. CMS recently changed the attribution methodology and conducted field testing on the revised MSPB measure. At this time, information on the validity of the revised attribution methodology is not available. Given these concerns, this measure should receive no more than “conditional support.” (Submitted by: The Association of American Medical Colleges)
  
  
• (Early public comment)The American College of Gastroenterology (ACG) encourages the MAP to carefully consider the continued inclusion of the Medicare Spending Per Beneficiary (MSPB) in MIPS considering the growing number of episode-based cost measures. With the introduction of the Screening/Surveillance Colonoscopy cost measure and the development of the Lower GI hemorrhage cost measure, there are now two specialty-specific cost measures for gastroenterology. Specialty-specific measures are better suited to evaluate how gastroenterologists perform on costs. However, their introduction creates the potential for the same cost episodes to be captured by multiple cost measures. For example, episodes captured by the Lower GI Hemorrhage cost measure are also likely to be captured by the MSPB measure. ACG is concerned about this overlap and the potential for lower GI bleeding episodes to be “double counted.” The Lower GI Hemorrhage measure better captures the costs specific to these episodes and those costs should count towards that measure alone. It is also unclear at this time what the impact of one beneficiary may have on multiple cost measures and the overall cost category in MIPS. Generally, we can assume that the results will be inconsistent across physicians. Thus, ACG requests that MAP recommend that CMS develop a methodology that allows episodes or beneficiaries captured in an episode-based cost measure to be excluded from the MSPB measure for the same attributed physician or remove the MSPB from future MIPS program years. (Submitted by: American College of Gastroneterology)
  
  
• (Early public comment)The workgroup must confirm that risk adjustment methodologies are sufficient to capture the true costs of patients with serious illness (i.e., explore ways to incorporate function); otherwise the measure could unfairly penalize clinicians caring for this population. (Submitted by: Center to Advance Palliative Care)
  
  
• (Early public comment)Given the growing number of episode-based cost measures, and continued work on their development, ASCO would encourage the MAP to consider whether the TPCC and MSPB measures still serve a purpose, as many of the beneficiaries captured in the episode-based measures will also be included in either or both the MSPB and TPCC measures. With the measures as proposed, a beneficiary could potentially be attributed to multiple providers within and across multiple measures. First, this could magnify the impact on cost measures of any individual beneficiary and second, could complicate any true differences in cost and value. CMS has proposed a revised attribution methodology and conducted field testing for both of these measures. While a version of the proposed revised measure specifications for both measures is available on the CMS public website (for example see https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-Feedback.html), currently we are not aware of publicly available information on the validity and reliability of the measure. It is also currently unknown what the impact of these measures would be compared to earlier versions. Specifically, for the TPCC measure, ASCO is supportive of attempts to remove certain specialty physicians such as oncologists from the measure, as its intent is to capture overall costs of care and encourage coordination of care by primary care providers. While the methodology does exclude chemotherapy and radiation therapy, there is the potential for providers such as physician assistants, nurse practitioners, and other advanced practice professionals who work with oncologists or radiation oncologists to have beneficiaries attributed to them, which would seem to defeat the purpose of the revised measure. In addition, if the exclusion relies on the provider billing for chemotherapy administration or radiation therapy under the Medicare Physician Fee Schedule, it would fail to consider clinicians who order therapy to be delivered in the hospital outpatient department under the Hospital Outpatient Prospective Payment System. ASCO would therefore recommend that the MAP also consider the following exclusion criteria: oncologists delivering primary care services to a patient with a principle diagnosis of cancer. More generally, the proposed attribution method for the TPCC measure will likely cause confusion, as it relies on a complex combination of “events” and services linked to the care of all individual physicians in a TIN, rather than just one. Further confusion will be caused by the timing of episodes: the episode itself consists of a month, yet the attribution period continues for a full year; it is therefore possible for a clinician to have more than one “episode” existing concurrently for the same beneficiary. CMS has also proposed removal of the specialty adjustment without explicitly stating that the new attribution methodology compensates for that removal. The specialty adjustment was used as an attempt to overcome an inherent flaw in the TPCC, i.e. the combination of prospective risk adjustment with retrospective attribution. That methodology can lead to scenarios where a patient in good health in the prior year (e.g. 10% risk quartile for Hierarchical Condition Categories) presents with acute leukemia in the current year, leading to huge differences in observed versus expected costs. In contrast, the MSPB measure considers diagnoses up to and during the trigger event. In sum, the existing specialty adjustment worked to mitigate this inherent flaw in the TPCC by adjusting those specialties most likely to suffer adverse selection under the measure, but ultimately failed to address the root of the problem. (Submitted by: American Society of Clinical Oncology (ASCO) )
  
  
• Dear Mr. Kahn and Dr. Hall: The Association of American Medical Colleges (AAMC or Association) welcomes this opportunity to comment on the National Quality Forum (NQF) Measure Applications Partnership (MAP)’s 2019 Considerations for Implementing Measures in Federal Programs draft report. The AAMC is a not-for-profit association dedicated to transforming health care through innovative medical education, cutting-edge patient care, and groundbreaking medical research. Its members are all 152 accredited U.S. and 17 accredited Canadian medical schools; nearly 400 major teaching hospitals and health systems, including 51 Department of Veterans Affairs medical centers; and more than 80 academic societies. Through these institutions and organizations, the AAMC serves the leaders of America’s medical schools and teaching hospitals and their more than 173,000 full-time faculty members, 89,000 medical students, 129,000 resident physicians, and more than 60,000 graduate students and postdoctoral researchers in the biomedical sciences. The AAMC appreciates the MAP Workgroups’ thoughtful review and discussion of the measures under consideration (MUC). The following are the AAMC’s high-level comments on the MAP recommendations for both hospitals and clinicians: • Regarding the clinician measures under consideration, the AAMC strongly believes that providers should not be held accountable for activities outside their control. The 11 episode level cost measures must be appropriately risk adjusted, including for social risk factors, and the attribution methodology for episodes should clearly and accurately determine the relationship between patient and clinician before such episode-level cost measures are incorporated into the Quality Payment Program. The 2 re-evaluated total cost measures (Medicare Spending per Beneficiary (MSPB) and Total Per Capita Cost) must similarly be appropriately adjusted for both clinical and social risk factors before the measures are incorporated into the Quality Payment Program. • For the hospital measures, the AAMC continues to strongly believe that certain accountability measures must be adjusted for sociodemographic status (SDS) before being included in the Medicare quality reporting programs, be NQF-endorsed prior to MAP review, and be included in the Inpatient Quality Reporting (IQR) program for at least one year before being considered in a performance program by the Workgroup. Additionally, the AAMC recommends that the report appropriately distinguish the Medicare and Medicaid Promoting Interoperability Program for Eligible Hospitals and Critical Access Hospitals (Promoting Interoperability Program) as separate from the IQR. While electronic clinical quality measures are shared between the two programs, the programs have unique histories and different penalties on hospitals for failure to meet a given program’s distinct requirements and the report should appropriately reflect that. MAP Clinician Workgroup Comments Cost Measures Should be Appropriately Risk-Adjusted and the Attribution Methodology Should be Clear and Accurately Determine Patient/Clinician Relationship Cost measures have been identified as a priority, and CMS addressed this priority through the inclusion of 13 cost measures for the MIPS program on the MUC list for discussion during the MAP Clinician Workgroup meeting. The AAMC remains concerned that none of the 13 cost measures are adjusted to account for socio-demographic status (SDS). In addition to patient clinical complexity, SDS factors can drive differences in average costs. In particular, physicians at academic medical centers (AMCs) care for vulnerable populations of patients who are sicker, poorer, and more complex than patients treated elsewhere. In regard to attribution – AAMC has previously commented that attribution methods used should be clear and transparent to clinicians and that it is critical that there be an accurate determination of the relationship between a patient and a clinician to ensure that the correct clinician is held responsible for the patient’s outcomes and costs. Attribution is complicated, given that most patients receive care from numerous clinicians across several facilities, and AAMC has urged CMS to explore better data sources and analytic techniques to support more accurate attribution. In addition, the movement in medicine has been to team-based care. The MAP, through its recommendations, and CMS should be careful not to incent patterns of care that are outdated. The AAMC recommends that: (1) cost measures include risk-adjustment for SDS factors, (2) the attribution methodology is transparent, and (3) the appropriate clinician is held responsible for the patient’s outcomes and costs. Individual Measure Comments Medicare Spending Per Beneficiary Clinician Measure The AAMC has concerns with the use of the total per capita cost measure in the MIPS program. Many of the same beneficiaries captured in the episode-based cost measures will also be included in the MSPB measure and therefore it is duplicative to assess performance on both these measures. CMS recently changed the attribution methodology and conducted field testing on the revised MSPB measure. At this time, information on the validity of the revised attribution methodology is not available. (Submitted by: Association of American Medical Colleges)
  
  
• • On behalf of the members of the American Podiatric Medical Association (APMA), the national organization representing the vast majority of the estimated 15,000 doctors of podiatric medicine (DPMs), also known as podiatric physicians and surgeons, in the country, we appreciate the opportunity to comment on the Medicare Spending Per Beneficiary (MSPB) clinician measure for the MIPS program. We would like to comment specifically on the impact and potential negative unintended consequence this measure may have on surgeons. A surgeon may perform the core procedure (the procedure that initiates/triggers the episode window) but that surgeon may not have input or control over other events that occur, during the hospital admission or during the 30-days after discharge, that will be attributed to them. An example would be when a diabetic patient is admitted to a hospitalist service for an inpatient stay and a podiatric surgeon is consulted to perform an amputation. The potential unintended consequence is that the episode window will be attributed to the podiatric surgeon for performing the core procedure but the hospitalization was being managed by a different provider (one who did not trigger the episode window with the core procedure but made, potentially, many more decisions driving the cost of the hospitalization/episode in question). We could see this happening to other surgeons if their patients are being cared for by a primary team while an inpatient and they are consulted to perform a specific procedure. (Submitted by: American Podiatric Medical Association)
  
  
• We are concerned that this measure will have severe consequences on patients with functional and cognitive impairments, i.e. disincentive to care for complex older patients. (Submitted by: American Geriatrics Society)
  
  
• The American Medical Association (AMA) supports the preliminary recommendation of “Conditional Support” for this measure but requests that additional conditions be placed on this measure. Specifically, on review of the supplemental materials provided by Acumen for the Clinician Workgroup meeting, we note that only reliability testing was provided and the validity of the measure has not yet been demonstrated. This testing, which is a requirement for NQF endorsement and inclusion in the MIPS program, must be completed prior to implementation in MIPS. In addition, we question whether this revised measure has had sufficient feedback from clinicians given the limited timeframe and challenges accessing the reports. The supplemental materials indicate that more than 148,000 field test reports were distributed; yet, feedback was received from only 67 stakeholders. We do not believe that such a low response rate should necessarily lead to conclusions that this measure is generally supported and does not require ongoing refinements. We refer the Coordination Committee to the substantive feedback provided by the AMA and others during the pre-workgroup comment period and ask that the MAP include the additional conditions requesting that additional feedback and input from clinicians be sought and validity testing be completed prior to implementation in MIPS. (Submitted by: American Medical Association)
  
  
• CMS is proposing a revised MSPB measure developed and field tested by Acumen, LLP. ASTRO greatly appreciates the efforts of CMS and Acumen, LLP to improve on this measure carried over from the Value Modifier Program. At this time, we are unable to support this measure because information on the validity and impact of the attribution methodology is not publicly available nor has data on the reliability and validity of the measure itself been released. Additionally, we are concerned about the lack of transparency in reporting data since beneficiary level data was only presented in the field report using the proposed methodology, not in the MIPS feedback data for the current measures. We are also concerned that the MSPB measure unfairly attributes patients for radiation oncology services. Most radiation oncology services are provided in the outpatient setting and are planned prior to beginning treatment delivery. While the patient could be treated with radiation therapy within the 3 days prior to and 30 days after an admission, if the reason for the admission is not related to radiation oncology services, then the radiation oncologist should not be scored on this measure. We therefore believe that the MSPB measure should be tied to the admitting physician and the services related to the ICD-10 code that generated the admission. (Submitted by: American Society for Radiation Oncology)
  
  
• • The AANS opposes the continued inclusion of the Total Per Capita Cost (TPCC) and Medicare Spending Per Beneficiary (MSPB) measures in MIPS given the substantial issues with these measures, their inappropriateness for physician-level measurements, and in light of the growing number of episode-based cost measures. In general, the TPCC and MSPB lack the precision in representing costs that are truly within the control of the physician related to a condition or procedure that is most likely better represented in those that are episode-based. • Many of the same beneficiaries captured in the episode-based cost measures will also be included in one or both of the broader population measures, resulting in “double counting” for purposes of MIPS scoring and payment adjustments. CMS has removed measures from other federal programs, such as the Medicare Shared Savings Program (MSSP) and the Impatient Quality Reporting Program (IQR), due to the issue of “double counting”, which we believe also applies to the cost category of MIPS. • For all cost measures currently under consideration, information on the validity and impact of the attribution methodology is not publicly available nor has data on the reliability and validity of the measure itself been released. (Submitted by: American Association of Neurological Surgeons)
  
  

• (Early public comment)AOTA appreciates the effort of Acumen and CMS to make this measure more meaningful. We believe the reports provide more actionable feedback than they have in the past. We encourage Acumen to continue exploring ways to make this information available to ECs who are involved in the downstream costs. (Submitted by: American Occupational Therapy Association)
  
  
• (Early public comment)ASGE encourages the Measures Application Partnership to carefully consider the continued inclusion of the Total Per Capita Cost and Medicare Spending Per Beneficiary in MIPS in light of the growing number of episode-based cost measures as many of the same beneficiaries captured in the episode-based cost measures will also be included in one or both of the broader population measures. “Double counting” could lead to several potentially negative unintended consequences. The attribution methodology for the Total Per Capita Cost was recently revised and there remains unanswered questions and significant concerns relative to these revisions. Notably, the specialty adjustment was removed, which will present problems since it is not clear that the revised attribution methodology addresses all the reasons why it was needed previously. Information on the validity and impact of the attribution methodology has not been made publicly available nor has data from the field testing of the measure on the reliability and validity of the measure itself been released. As such, ASGE suggests this measure meets the rationale of the new category of “Do Not Support With Potential For Mitigation”. Specifically, we do not believe that the measure is ready for use at this time as it likely requires substantive changes. (Submitted by: American Society for Gastrointestinal Endoscopy)
  
  
• (Early public comment)CMS is proposing to replace the TPCC measure carried over from the VBM with a revised measure developed and field tested by Acumen, LLP. The AMA greatly appreciates the efforts of CMS and Acumen, LLP to improve this measure. However, we are concerned that due to time constraints and a less open development process, the revised TPCC measure needs more work and testing. Additionally, we are troubled that comments on the proposed revisions are due prior to any public release of information on the reliability, validity and impact of the revised attribution methodology or the measure itself. The proposed revision is extremely complex. We do not believe that it is reasonable or realistic to expect physicians to pore through and understand how the new measure would work. Tracking a patient and determining how care might be improved will be nearly impossible because: • Attribution relies on a combination of events and services/costs. The list of services that can contribute to attribution is long and not easily described. • The same month-long episode of care can be attributed to multiple groups or individual physicians; • Attribution of the month-long episode will make all these groups/physicians responsible for total Part A and B costs for an entire year; • A new service in a following month could trigger a new episode making the same or additional physicians responsible for a year of costs that overlaps with the annual costs reflected in an earlier episode. • While certain specialties would be exempt from this measure, the services they provide would not be exempt. Therefore, a practice comprised of exempted specialists might still be subject to the measure if it also uses a physician assistant or nurse practitioner who provides an E/M visit. A goal of the revised TPCC was to eliminate the possibility that physicians could be held responsible for care that occurred even before they saw the patient. The AMA supports this goal but notes that physicians could still be held responsible for costs that occurred long after they saw the patient and potentially even after the patient had moved to another city or state. We also have concerns about the equity of the revised measure. Elimination of the specialty adjustment is premature. We also question the decision to make exemptions at the specialty level rather than the service level. As noted, this will make it hard to determine which practices are likely to be subject to the TPCC measure. It also creates a fairness issue by exempting certain specialties regarded as not providing primary care but it then holds primary care physicians responsible for the costs of these non-primary-care services that they do not provide and cannot control. If this measure is adopted, we urge the MAP and CMS to develop an exclusion based on service, rather than specialty. Finally, we wish to reiterate our position that measures should only cover costs that physicians can reasonably be considered to control. Measures that hold individual physicians or practices responsible for the entire year of all Part A and B costs will never meet that criteria. Given these significant concerns, we do not believe that the measure is ready for use at this time and requires substantive changes. As a result, the AMA recommends that the highest level of MAP recommendation be “Do Not Support With Potential For Mitigation” for this measure. Also, as noted in our earlier comments on the MSPB measure the AMA encourages the Measures Application Partnership (MAP) to consider eliminating the Total Per Capita Cost (TPCC) and Medicare Spending Per Beneficiary (MSPB) in MIPS in light of the growing number of episode-based cost measures. As also noted earlier, we believe the MSPB and TPCC measure lead to double-counting of many beneficiaries and will produce inconsistent results that will lead to confusion in their use and inequities in the payment adjustments that result. (Submitted by: American Medical Association)
  
  
• (Early public comment)NHPCO Comments: NHPCO appreciates this measure and recognizes that high quality community-based palliative care services could potentially have a positive impact on this measure, as a secondary outcome of comprehensive assessment, symptom and medication management, advance care planning and goals of care conversations, patient and family education, and care coordination by an interdisciplinary team. (Submitted by: National Hospice and Palliative Care Organization)
  
  
• (Early public comment)The AAFP does not support inclusion of the MSPB and TPCC measures in MIPS for the following reasons: • These measures were developed for use at the TIN level, and their validity at the solo/small practice level is questionable. We reiterate that a measure may be considered reliable, but can still lack validity. The National Quality Forum (NQF) did not endorse CMS’ total per capita cost measure (CMS Measure #2165). NQF questioned the utility of the measure to improve cost performance due to concerns with its attribution method. NQF noted that primary care providers may have limited ability to meaningfully influence the cost of specialists, inpatient care, and post-acute care, but would ultimately be held responsible for these costs. The AAFP encourages CMS to explore alternatives to these measures and offers the two utilization measures of the Comprehensive Primary Care Plus (CPC+) program (inpatient hospital utilization and emergency department utilization) as such alternatives. • Many of the same beneficiaries captured in the episode-based cost measures will also be included in one or both of the broader population measures, resulting in double counting and potential negative unintended consequences. • First, the costs attributed to a clinician for one beneficiary will likely differ between an episode-based measure versus TPCC or MSPB for the same episode. These differences are due to how each measure is constructed and less likely to represent true differences in performance. Also, the TPCC and MSPB lack the precision in representing costs that are truly within the control of the physician related to a condition or procedure that is most likely better represented in those that are episode-based. • Second, the impact that the attribution of one beneficiary for the same episode to multiple measures will have on the overall cost category in MIPS is not known. Generally, we can assume that the results will be inconsistent across clinicians. • CMS has removed measures from other federal programs due to the issue of “double counting”, which we believe also applies to the cost category of MIPS. For instance, physicians in MIPS APMs, such as those in the Medicare Shared Savings Program (MSSP), are not measured on cost in MIPS to avoid conflicts between the shared savings/losses calculations in MSSP and the MIPS cost measures. Physicians may face similar conflicts when measured on episode-based cost measures, as well as TPCC and MSPB. The AAFP requests that the MAP recommend discontinuing use of the TPCC and MSPB measures in light of the increasing number of episode-based cost measures being proposed and finalized. (Submitted by: American Academy of Family Physicians)
  
  
• (Early public comment)The AAMC has concerns with the use of the total per capita cost measure in the MIPS program. The total per capita cost measure is a global measure of all Part A and Part B resources used during the performance period. The measure itself would be inclusive of a number of the episode condition measures that are also included in the MIPS program. It is duplicative to assess performance in the cost performance category on both the per capita cost measures and episode condition measures. The AAMC is concerned that the risk adjustment model for the total per capita cost measure does not adequately address patient complexity and the impact of socio-demographic factors. Vulnerable populations generally require higher resource utilization. Appropriate risk adjustment is essential so that differences in patient characteristics that are beyond a health care provider’s control do not have an unfair impact on a provider’s cost performance score. CMS should look at alternative sources of data to obtain information about risk adjustment. CMS recently changed the attribution methodology and conducted field testing on the revised total per capita cost measure. At this time, information on the validity of the revised attribution methodology is not available. Without this information, it is challenging to assess the validity of this measure. Given these concerns, the MAP should evaluate and question whether it is appropriate to include this measure in the MIPS program in the future (Submitted by: Association of American Medical Colleges)
  
  
• (Early public comment)The AAN is concerned about how the patient attribution is done as some patients use their specialist as a PCP and the impact this could have on specialists. (Submitted by: American Academy of Neurology)
  
  
• (Early public comment)The American Academy of Ophthalmology has reviewed the most recent iteration of the re-evaluated Total Per Capita Cost measure (TPCC) and is writing to share our ongoing concerns. In our evaluation of the TPCC field test, we find no improvement and in fact see an exacerbation of the same attribution problems that we saw and previously commented on with the Value-based Modifier (VBM). Accountability for costs and quality that are within the physician’s control is an important and achievable goal, but it cannot come at the expense of providing medically necessary services, emergent care or alternative treatment when initial options are failing. Measuring clinicians on costs that are entirely out of their control has not and will not create change or accountability. For example, ophthalmologists do not and never will have control over the costs incurred by a skilled nursing facility or a nephrologist. Despite this, we continue to see these costs attributed to ophthalmologists under this latest version of TPCC. Worse, this re-evaluated TPCC measure attributes all costs to nearly all treating clinicians. These continued and exacerbated attribution issues, particularly in the absence of more reliable risk adjustment than the current HCC, not only create an arbitrary and capricious basis for the MIPS Cost score, but also may create an incentive for physicians to refer more complex/sicker patients out of their practice. In the current MIPS TPCC measure, an ophthalmologist is attributed a patient if the patient does not receive services from a primary care provider and bills the plurality of a patient’s evaluation and management codes during the performance year. In this new, re-evaluated, TPCC field test measure, patients are attributed to all clinicians that provide an E&M service to that patient within three days before or after any non-E&M service provided by any TIN to the same patient or if the patient sees another clinician from that TIN within 90 days afterward. This means that, if a patient is seen for one follow up exam or comes in for a blood test, a clinician that saw the patient one or two times will be attributed that patient’s cost for 12 months. This also means that a patient who clusters their doctor visits into the span of a few days will cause every doctor they see to be attributed that patient, even if they only see the patient one time. The re-evaluated measure does have an exclusion for surgeons that meet certain criteria, but this does not capture many subspecialists. For instance, a glaucoma physician does provide management of a chronic condition, glaucoma, but has no control over how other, entirely unrelated, chronic conditions, such as systemic hypertension or diabetes mellitus, are managed for that patient. The 12-month “risk window,” or attribution period, is also confusing as it does not align with the performance period and can make it even more difficult for clinicians to anticipate which patients will be attributed to them. Attribution methods such as who submits claims at what time are arbitrary and have no relevance to actual patient care. Finally, the re-evaluated TPCC measure does not take into account clinician specialty or subspecialty. We strongly urge CMS to compare clinicians to their peers using taxonomy codes rather than the two-digit specialty codes that are currently being used. In light of the substantial attribution changes that Acumen has indicated that they made after the field test, we strongly believe that this measure needs to be field tested again, with these changes, before it can be supported. (Submitted by: American Academy of Ophthalmology)
  
  
• (Early public comment)The American College of Gastroenterology (ACG) and its members found it very difficult to understand this measure during the recent comment period in light of the numerous questions on attribution, and how costs are assigned to physicians or groups with the revised methodology. On review of the feedback reports, our members were often unable to identify which event led to a beneficiary attribution. In addition, there are many unanswered questions and concerns related to these revisions including the complexity of the new attribution method, which is not easily described in a simple sentence. Given these significant concerns, we believe that this measure meets the rationale provided for the new category of “Do Not Support With Potential For Mitigation.” Specifically, we do not believe that the measure is ready for use at this time and requires substantive changes. As a result, the ACG asks that the highest level of MAP recommendation be “Do Not Support With Potential For Mitigation” for this measure. ACG also encourages the MAP to carefully consider the continued inclusion of the Total Per Capita Cost (TPCC) in MIPS considering the growing number of episode-based cost measures. Many of the same beneficiaries captured in the episode-based cost measures will also be included in one or both of the broader population measures (TPCC or MSPB). This “double counting” could lead to several potentially negative and unintended consequences such as attributing costs to a physician for one beneficiary that will likely differ between an episode-based measure versus TPCC for the same episode. The results will likely reflect differences in how each measure is constructed, versus actual performance. In addition, the impact that the attribution of one beneficiary for the same episode to multiple measures will have on the overall cost category in MIPS is unknown. Generally, we can assume that the results will be inconsistent across physicians. We ask that the MAP recommend that CMS evaluate whether all the measures, and specifically the TPCC, should be included in future MIPS program years, particularly as an increasing number of episode-based measures are proposed and finalized. (Submitted by: American College of Gastroenterology)
  
  
• (Early public comment)The American Society of Cataract and Refractive Surgery (ASCRS) is a member of the cost measure technical expert panel (TEP) convened by Acumen that has been tasked with refining the TPCC measure. ASCRS appreciates the efforts Acumen and CMS have made to ensure that this measure, which we do not support, is not attributed to specialists, such as ophthalmologists. Following our recommendation, the measure will now exclude ophthalmologists, optometrists, and other specialties from attribution because they cannot control the total patient health care costs. Previously, Acumen had developed a proposed attribution methodology that would have excluded surgeons who bill 10- or 90-day global codes, which would have excluded most ophthalmologists, but would have included most optometrists because it attributed the measure if a physician billed two E/M services to the same patient within 90 days. Following our feedback that this new attribution methodology would attribute total costs to optometrists, Acumen and CMS modified their proposed methodology. Instead, the measure will only be attributed to a group of HCFA primary care and internal medicine sub-specialties that frequently manage chronic patients with significant conditions in their areas of specialty along with other medical comorbidities. We thank CMS and Acumen for this change which ensures that eye care providers, who do not treat the whole patient, are not held responsible for the total cost of care for a patient. Despite this change, ASCRS still objects to the fundamental premise of the TPCC measure that attempts to hold a single physician responsible for all a particular patient’s healthcare costs and does not recommend the MAP approve the measure for inclusion in MIPS. While we understand that CMS is attempting to encourage efficient resource use and care coordination in the Medicare program, the TPCC measure is not an effective tool to meet those goals. Because no physician, regardless of specialty, can reasonably be expected to control all the costs for a single patient, we continue to support development of episode-based cost measures that seek to measure the costs of care within an individual physician’s control. We do not support population measures, such as TPCC, that hold physicians responsible for the cost of care they did not provide, and recommend they be removed from the MIPS program. (Submitted by: American Society of Cataract and Refractive Surgery)
  
  
• (Early public comment)workgroup must confirm that risk adjustment methodologies are sufficient to capture the true costs of patients with serious illness (i.e., explore ways to incorporate function); otherwise the measure could unfairly penalize clinicians caring for this population. (Submitted by: Center to Advance Palliative Care)
  
  
• (Early public comment)Given the growing number of episode-based cost measures, and continued work on their development, ASCO would encourage the MAP to consider whether the TPCC and MSPB measures still serve a purpose, as many of the beneficiaries captured in the episode-based measures will also be included in either or both the MSPB and TPCC measures. With the measures as proposed, a beneficiary could potentially be attributed to multiple providers within and across multiple measures. First, this could magnify the impact on cost measures of any individual beneficiary and second, could complicate any true differences in cost and value. CMS has proposed a revised attribution methodology and conducted field testing for both of these measures. While a version of the proposed revised measure specifications for both measures is available on the CMS public website (for example see https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-Feedback.html), currently we are not aware of publicly available information on the validity and reliability of the measure. It is also currently unknown what the impact of these measures would be compared to earlier versions. Specifically, for the TPCC measure, ASCO is supportive of attempts to remove certain specialty physicians such as oncologists from the measure, as its intent is to capture overall costs of care and encourage coordination of care by primary care providers. While the methodology does exclude chemotherapy and radiation therapy, there is the potential for providers such as physician assistants, nurse practitioners, and other advanced practice professionals who work with oncologists or radiation oncologists to have beneficiaries attributed to them, which would seem to defeat the purpose of the revised measure. In addition, if the exclusion relies on the provider billing for chemotherapy administration or radiation therapy under the Medicare Physician Fee Schedule, it would fail to consider clinicians who order therapy to be delivered in the hospital outpatient department under the Hospital Outpatient Prospective Payment System. ASCO would therefore recommend that the MAP also consider the following exclusion criteria: oncologists delivering primary care services to a patient with a principle diagnosis of cancer. More generally, the proposed attribution method for the TPCC measure will likely cause confusion, as it relies on a complex combination of “events” and services linked to the care of all individual physicians in a TIN, rather than just one. Further confusion will be caused by the timing of episodes: the episode itself consists of a month, yet the attribution period continues for a full year; it is therefore possible for a clinician to have more than one “episode” existing concurrently for the same beneficiary. CMS has also proposed removal of the specialty adjustment without explicitly stating that the new attribution methodology compensates for that removal. The specialty adjustment was used as an attempt to overcome an inherent flaw in the TPCC, i.e. the combination of prospective risk adjustment with retrospective attribution. That methodology can lead to scenarios where a patient in good health in the prior year (e.g. 10% risk quartile for Hierarchical Condition Categories) presents with acute leukemia in the current year, leading to huge differences in observed versus expected costs. In contrast, the MSPB measure considers diagnoses up to and during the trigger event. In sum, the existing specialty adjustment worked to mitigate this inherent flaw in the TPCC by adjusting those specialties most likely to suffer adverse selection under the measure, but ultimately failed to address the root of the problem. (Submitted by: American Society of Clinical Oncology (ASCO) )
  
  
• The American College of Cardiology has several concerns with the proposed submission of the TPCC measure for use in the MIPS/QPP Program. Attribution of services remains an issue and it is not clear from the measure specifications how costs will be attributed to participating clinicians. The attribution method evaluates the services and costs associated with care of all physicians in a TIN. Since the episode covers a month but the measurement period continues for a year, it may be difficult to tease out costs if a patient sees a physician in another TIN during this timeframe. Particularly for specialist clinicians, this measure may be suboptimal for helping to drive meaningful improvements in care efficiency. “Double-counting” remains an issue as beneficiaries may be counted in both the episode-based cost-measures and population-based measures. Clinicians may also be accountable for costs that are beyond their control and after they are no longer under the clinician’s care. Additionally, the measure does not adequately account for social risk factors which have previously been shown to be associated with higher costs of care, such as poverty. As a result, some clinicians may be held responsible for care and conditions that are outside of their control. The ACC recommends the TPCC measure be considered instead as a measure for refinement and not for consideration at this time for implementation. We encourage the development of new measures that are designed for practice-level measurement that adequately account for differences in patient conditions and complexity. (Submitted by: American College of Cardiology)
  
  
• Dear Mr. Kahn and Dr. Hall: The Association of American Medical Colleges (AAMC or Association) welcomes this opportunity to comment on the National Quality Forum (NQF) Measure Applications Partnership (MAP)’s 2019 Considerations for Implementing Measures in Federal Programs draft report. The AAMC is a not-for-profit association dedicated to transforming health care through innovative medical education, cutting-edge patient care, and groundbreaking medical research. Its members are all 152 accredited U.S. and 17 accredited Canadian medical schools; nearly 400 major teaching hospitals and health systems, including 51 Department of Veterans Affairs medical centers; and more than 80 academic societies. Through these institutions and organizations, the AAMC serves the leaders of America’s medical schools and teaching hospitals and their more than 173,000 full-time faculty members, 89,000 medical students, 129,000 resident physicians, and more than 60,000 graduate students and postdoctoral researchers in the biomedical sciences. The AAMC appreciates the MAP Workgroups’ thoughtful review and discussion of the measures under consideration (MUC). The following are the AAMC’s high-level comments on the MAP recommendations for both hospitals and clinicians: • Regarding the clinician measures under consideration, the AAMC strongly believes that providers should not be held accountable for activities outside their control. The 11 episode level cost measures must be appropriately risk adjusted, including for social risk factors, and the attribution methodology for episodes should clearly and accurately determine the relationship between patient and clinician before such episode-level cost measures are incorporated into the Quality Payment Program. The 2 re-evaluated total cost measures (Medicare Spending per Beneficiary (MSPB) and Total Per Capita Cost) must similarly be appropriately adjusted for both clinical and social risk factors before the measures are incorporated into the Quality Payment Program. • For the hospital measures, the AAMC continues to strongly believe that certain accountability measures must be adjusted for sociodemographic status (SDS) before being included in the Medicare quality reporting programs, be NQF-endorsed prior to MAP review, and be included in the Inpatient Quality Reporting (IQR) program for at least one year before being considered in a performance program by the Workgroup. Additionally, the AAMC recommends that the report appropriately distinguish the Medicare and Medicaid Promoting Interoperability Program for Eligible Hospitals and Critical Access Hospitals (Promoting Interoperability Program) as separate from the IQR. While electronic clinical quality measures are shared between the two programs, the programs have unique histories and different penalties on hospitals for failure to meet a given program’s distinct requirements and the report should appropriately reflect that. MAP Clinician Workgroup Comments Cost Measures Should be Appropriately Risk-Adjusted and the Attribution Methodology Should be Clear and Accurately Determine Patient/Clinician Relationship Cost measures have been identified as a priority, and CMS addressed this priority through the inclusion of 13 cost measures for the MIPS program on the MUC list for discussion during the MAP Clinician Workgroup meeting. The AAMC remains concerned that none of the 13 cost measures are adjusted to account for socio-demographic status (SDS). In addition to patient clinical complexity, SDS factors can drive differences in average costs. In particular, physicians at academic medical centers (AMCs) care for vulnerable populations of patients who are sicker, poorer, and more complex than patients treated elsewhere. In regard to attribution – AAMC has previously commented that attribution methods used should be clear and transparent to clinicians and that it is critical that there be an accurate determination of the relationship between a patient and a clinician to ensure that the correct clinician is held responsible for the patient’s outcomes and costs. Attribution is complicated, given that most patients receive care from numerous clinicians across several facilities, and AAMC has urged CMS to explore better data sources and analytic techniques to support more accurate attribution. In addition, the movement in medicine has been to team-based care. The MAP, through its recommendations, and CMS should be careful not to incent patterns of care that are outdated. The AAMC recommends that: (1) cost measures include risk-adjustment for SDS factors, (2) the attribution methodology is transparent, and (3) the appropriate clinician is held responsible for the patient’s outcomes and costs. Individual Measure Comments Total Per Capita Cost Measure The AAMC has concerns with the use of the total per capita cost measure in the MIPS program. The total per capita cost measure is a global measure of all Part A and Part B resources used during the performance period. The measure itself would be inclusive of a number of the episode condition measures that are also included in the MIPS program. It is duplicative to assess performance in the cost performance category on both the per capita cost measures and episode condition measures. CMS recently changed the attribution methodology and conducted field testing on the revised total per capita cost measure. At this time, information on the validity of the revised attribution methodology is not available. Without this information, it is challenging to assess the validity of this measure. Given these concerns, the MAP should question whether it is appropriate to include this measure in the MIPS program in the future. (Submitted by: Association of American Medical Colleges)
  
  
• On behalf of the members of the American Podiatric Medical Association (APMA), the national organization representing the vast majority of the estimated 15,000 doctors of podiatric medicine (DPMs), also known as podiatric physicians and surgeons, in the country, we appreciate the opportunity to comment on the Total Per Capita Cost measure for the MIPS program. We would like to speak to the measure specifications and ask for clarification and a specific definition of what a “primary care service” is (i.e. E/M (in general or specific codes, provider type code, etc.). A doctor of podiatric medicine may be performing services that could be considered primary care-like services (routine care, preventative services) but it currently is unclear as to what services are considered “primary care services” for the TPCC measure. A patient may see their podiatrist for routine foot care or preventative services more times per year than the patient sees their primary care provider. But, without clarification as to what services are considered “primary care services,” there is no way to know, at this time, if a podiatrist could even be under consideration for attribution of this measure. As indicated on page 115 of the Draft List of Measures Under Consideration for December 1, 2018, there was a statement in the discussion around reduction of the total cost of care for patients in a Patient-Centered Medical Home: “Primary care management can lead to such savings in various ways, including by improving the treatment of chronic conditions, obviating the need for high-cost hospital or emergency department services.” If E/M services are broadly considered “primary care services” and a podiatrist could be attributed the TPCC measure, consideration should be given to establishing a model such as a “Lower Extremity Medical Home” as this could reduce costs and make care more affordable as a provider, such as a doctor of podiatric medicine, is providing care to patients related to their chronic conditions (such as diabetes) and reducing the need for hospitalizations and emergency department visits. (Submitted by: American Podiatric Medical Association)
  
  
• We are concerned that this measure will have severe consequences on patient with functional and cognitive impairments, i.e. disincentive to care for complex older patients. (Submitted by: American Geriatrics Society)
  
  
• The American Medical Association (AMA) continues to be extremely concerned with the overall complexity of the proposed revisions and lack of clarity regarding those changes and as a result requests that the MAP revise the recommendation to be “Do Not Support with Potential for Mitigation”. Specifically, this measure received the most comments of all of the measures reviewed by the Clinician Workgroup. The vast majority of comments voiced concerns with the lack of clear specifications and revised attribution methodology, and most did not support its inclusion in the MIPS at this time. These same concerns were raised by many of the Clinician Workgroup members who did not have the revised attribution methodology or specifications available to them at the meeting and we believe that the close vote (67% voted for Conditional Support) demonstrates the degree of concern over these revisions. In addition, on review of the supplemental materials provided by Acumen for the Clinician Workgroup meeting, we note that only reliability testing was provided and the validity of the measure has not yet been demonstrated. This testing, which is a requirement for NQF endorsement and inclusion in the MIPS program, must be completed prior to implementation in MIPS. In addition, we question whether this revised measure has had sufficient feedback from clinicians given the limited timeframe and challenges accessing the reports. The supplemental materials indicate that more than 567,000 field test reports were distributed; yet, feedback was received from only 67 stakeholders. We do not believe that such a low response rate should necessarily lead to conclusions that this measure is generally supported and does not require ongoing refinements. We refer the Coordination Committee to the substantive feedback provided by the AMA and others during the pre-workgroup comment period and ask that the MAP change its recommendation to “Do Not Support with Potential for Mitigation” in light of these ongoing concerns. (Submitted by: American Medical Association)
  
  
• CMS is proposing to replace the TPCC measure carried over from the VBM with a revised measure developed and field tested by Acumen, LLP. ASTRO appreciates the efforts of CMS and Acumen, LLP to improve this measure. However, we are concerned that due to time constraints and a less open development process, the revised TPCC measure needs more work and testing. Additionally, we are troubled that comments on the proposed revisions are due prior to any public release of information on the reliability, validity and impact of the revised attribution methodology or the measure itself. Radiation oncologists generally do not provide primary care services; however, they may have non-physician clinicians in their practice who do. Several ASTRO members received feedback on the TPCC measure in their 2017 MIPS Performance Feedback Reports, which we believe is because a non-physician clinician working in a radiation oncology practice billed for primary care services. So even if radiation oncology as a specialty is exempted, the services provided are not. In addition, we are concerned that because the same month-long episode of care can be attributed to multiple groups or individual physicians, it will be difficult to track a patient and determine how care might be improved. ASTRO encourages the Measures Application Partnership (MAP) to consider eliminating the Total Per Capita Cost (TPCC) and Medicare Spending Per Beneficiary (MSPB) in MIPS in light of the growing number of episode-based cost measures. As also noted earlier, we believe the MSPB and TPCC measure lead to double-counting of many beneficiaries and will produce inconsistent results that will lead to confusion in their use and inequities in the payment adjustments that result. (Submitted by: American Society for Radiation Oncology)
  
  
• • The AANS opposes the continued inclusion of the Total Per Capita Cost (TPCC) and Medicare Spending Per Beneficiary (MSPB) measures in MIPS given the substantial issues with these measures, their inappropriateness for physician-level measurements, and in light of the growing number of episode-based cost measures. In general, the TPCC and MSPB lack the precision in representing costs that are truly within the control of the physician related to a condition or procedure that is most likely better represented in those that are episode-based. • Many of the same beneficiaries captured in the episode-based cost measures will also be included in one or both of the broader population measures, resulting in “double counting” for purposes of MIPS scoring and payment adjustments. CMS has removed measures from other federal programs, such as the Medicare Shared Savings Program (MSSP) and the Impatient Quality Reporting Program (IQR), due to the issue of “double counting”, which we believe also applies to the cost category of MIPS. • For all cost measures currently under consideration, information on the validity and impact of the attribution methodology is not publicly available nor has data on the reliability and validity of the measure itself been released. (Submitted by: American Association of Neurological Surgeons)
  
  

• (Early public comment)The Alliance of Dedicated Cancer Centers (ADCC), comprised of eleven of the nation’s premier cancer hospitals, recommends the inclusion of MUC2018-150: Surgical Treatment Complications for Localized Prostate Cancer in the PPS-Exempt Cancer Hospital Quality Reporting (PCHQR Program). Prostate cancer is the second most common cancer in the U.S. (rates of new cancer cases) and the third leading cause of cancer death (CDC Leading Cancer Cases and Deaths, Male and Female, 2015 https://gis.cdc.gov/Cancer/USCS/DataViz.html). With the removal of two PCHQR Program measures related to prostate cancer in the FY 2019 IPPS/LTCH Final Rule, inclusion of this measure is an important addition to the PCHQR Program. The measure analyzes hospital/facility-level variation in patient-relevant outcomes during the year after prostate-directed surgery. Specifically, the measure developers were able to use claims to identify urinary incontinence and erectile dysfunction among patients undergoing localized prostate cancer surgery and use this information to derive hospital-specific rates. As such, it provides hospitals with a means to benchmark their performance against other hospitals and use the information for the purpose of decreasing the occurrence of procedure-related urinary incontinence and erectile dysfunction. Moreover, the public display of the overall results will allow patients to compare rates of surgical complications associated with prostate cancer surgery among hospitals. It is also important to note that because this measure is claims-based, there is no administrative or data collection burden to hospitals. In fact, this measure is proof of concept that claims data can be used to detect complications. We are not aware of any current use of the measure as the development work was just completed this year; however, several of the ADCCs were involved in the identification of adverse events and associated codes, data analysis, method refinement, and in assessment of the reliability and validity of the measure. The results are presented on a 0-100 scale, with 0=worst and 100=best, to facilitate interpretation of performance. Lastly, there are no negative unintended consequences anticipated with this measure. (Submitted by: Alliance of Dedicated Cancer Centers)
  
  
• The AHA agrees with the MAP’s recommendation of Do Not Support- Potential for Mitigation. This measure addresses issues that are more relevant to individual practitioners/surgeons rather than cancer hospital/system performance, and thus would not provide actionable information as part of the PCHQR program. While many surgical and post-surgical complications and other healthcare-associated conditions are related to systematic lapses in care, urinary incontinence and ED among patients who have undergone localized prostate cancer surgery are complications that arise specifically due to the performance of the surgeon. Additionally, these complications can develop over a long period of time, and in the relevant patient population (male patients over 66 years of age) can develop regardless of surgery. Thus it is difficult to attribute these patient outcomes to surgery in general or a hospital specifically. In addition, the measure uses claims to identify incidences of these complications and a confusing scaling methodology to derive hospital-specific rates. We question whether claims would accurately capture these complications, since it is hard to imagine a patient would visit the cancer hospital for a visit specifically for ED or incontinence. Post-surgical complications and functional status are important aspects of care, but this measure would be better suited as a patient-reported outcome measure than a claims-based performance measure. (Submitted by: American Hospital Association)
  
  
• The Alliance of Dedicated Cancer Centers (ADCC), comprised of 11 of the nation’s premier cancer hospitals, strongly recommends the inclusion of MUC18-150: Surgical Treatment Complications for Localized Prostate Cancer in the PPS-Exempt Cancer Hospital Quality Reporting (PCHQR Program). Prostate cancer is the second most common cancer in the U.S. (rates of new cancer cases) and the third leading cause of cancer death (CDC Leading Cancer Cases and Deaths, Male and Female, 2015 https://gis.cdc.gov/Cancer/USCS/DataViz.html). With the removal of two PCHQR Program measures related to prostate cancer in the FY 2019 IPPS/LTCH Final Rule, inclusion of this measure is an important addition to the PCHQR Program. The measure analyzes hospital/facility-level variation in patient-relevant outcomes during the year after prostate-directed surgery. Specifically, the measure developers were able to use claims to identify urinary incontinence and erectile dysfunction among patients undergoing localized prostate cancer surgery and use this information to derive hospital-specific rates. As such, it provides hospitals with a means to benchmark their performance against other hospitals and use the information for the purpose of decreasing the occurrence of procedure-related urinary incontinence and erectile dysfunction. Moreover, the public display of the overall results will allow patients to compare rates of surgical complications associated with prostate cancer surgery among hospitals. It is also important to note that because this measure is claims-based, there is no administrative or data collection burden to hospitals. In fact, this measure is proof of concept that claims data can be used to detect complications. We are not aware of any current use of the measure as the development work was just completed this year; however, members of all of the ADCCs contributed to the identification of adverse events and associated codes, data analysis, method refinement, and in assessment of the reliability and validity of the measure. The results are presented on a 0-100 scale, with 0=worst and 100=best, to facilitate interpretation of performance. Lastly, there are no negative unintended consequences anticipated with this measure. We thank the Hospital Workgroup of the MAP for their thoughtful and complete review of this measure during the meeting of December 11, 2018. We are especially appreciative of the opportunity to respond during the meeting to comments made by the Workgroup. We wish to take the opportunity to address the comments cited in the MAP’s preliminary decision of, “Do Not Support for Rulemaking with Potential for Mitigation”. • We strongly agree that measurement of outcomes for patients who have undergone surgical intervention for prostate cancer is important. • We respectfully disagree that this measure is better suited at the clinician level of analysis, believing that this measure is reflective of hospital/facility-level quality. While the individual clinician’s operative skill and technique are significant factors in the rate of adverse events, the hospital/facility is ultimately responsible for training and evaluating the medical staffs’ performance, supplying the optimal equipment and environment, and in having the appropriate systems and multidisciplinary team to support the clinician and patient. Furthermore, as noted in the MAP comments, there would likely be a limited number of individual surgeons who would perform enough cases to qualify for inclusion if this were a clinician-level measure. However, in the future, we have no objection to the measure being tested at the clinician level as well. Several Hospital Workgroup members concurred that this is an appropriate hospital/facility measure. In addition, it is in alignment with CMS Conditions of Participation and Joint Commission accreditation standards. Hospital Workgroup members also applauded the fact that the measure assesses adverse events over one year after the surgical intervention. • Because this claims-based measure uses the Medicare dataset, it includes patients 66 years or older. Medicare patients under 66 years of age were excluded because they oftentimes have this coverage due to a chronic disease (e.g. end stage renal disease), which could impact the outcomes unfairly. • The Workgroup questioned the lack of risk adjustment. Risk adjustment was carefully evaluated for this measure, including key clinical covariates obtained from the linked SEER-Medicare files. Statistical analysis demonstrated that several patient and hospital characteristics were associated with patient-level complications scores; however, an analysis of the correlation between unadjusted and adjusted hospital-level performance revealed correlations above 95%. Thus, risk adjustment is not required for these measures. • The Workgroup also considered whether patient-reported outcomes (PRO) performance measures (PRO-PMs) would be a better measurement option. The ADCC concurs that PRO-PMs are an increasingly important source of outcome measurement, and we are in the process of collecting data on PROs for early stage prostate cancer; however, analysis of this claims-based measure indicates it captures complications reasonably accurately with no data collection burden to providers. Perhaps most important, it provides valuable information to patients and caregivers as well as hospitals/facilities for identifying potential performance improvement opportunities. Therefore, at this time we advocate for use of the claims-based measure, at least until a PRO-PM is tested and available for implementation. • Lastly, the MAP commented that stratification by type of surgical procedure may be beneficial. We concur; however, the data available at the time of this analysis do not contain the code specificity to allow for this level of analytical granularity, and raises concerns regarding low numbers. We agree this is an area for future development. In conclusion, in concordance with the MAP’s recommendation, we plan to resubmit this measure to the NQF for consideration for endorsement for the Fall 2019 cycle. We will work proactively with NQF staff to address the aforementioned concerns voiced by the Scientific Methods Panel. As these issues are clarified and resolved, we are confident this measure will be endorsed by the MAP as a measure for the PCHQR Program in 2019. We thank you for the constructive feedback and dialogue, including this opportunity to respond to your comments. (Submitted by: Alliance of Dedicated Cancer Centers)
  
  

Navigating the Discussion Guide

• How do I get back to the section I was just looking at?
  The easiest way is to use the back button on your browser. Other options are using your backspace button (which works for many browsers on laptops), or using the permanent links at the upper right hand corner of the discussion guide. But the back button is the best choice in most situations.
  
  
• Can I print the discussion guide out?
  You can, but we don't recommend it. Besides using a lot of paper (probably a couple hundred pages at least), you'll lose all the links that allow you to move around the document. For instance, if you're scrolling through the agenda and want to see more information about a particular measure, the electronic format will allow you to click a link, read more, and then bo back. If you're on paper, there will be a lot of flipping through paper.
  
  
• If I can't print this out, how can I read it on the plane?
  Although the Discussion Guide opens in a web browser, it does not require an internet connection if you have downloaded and saved the HTML file to your hard drive.
  
  
• How do I know that I'm looking at the most recent version?
  At the top left corner of the discussion guide is a version number. At the beginning of the in person meetings, the NQF staff will ask everyone to load the most recent discussion guide version and will check that everyone has the same version loaded.
  
  
• What electronic devices can I use to view the discussion guide?
  We tried to make this as universal as possible, so it should work on your laptop (PC, Mac, Linux), your tablet (iPad, Android), or your phone (iPhone, Android). It should also work on many types of browsers (IE, Firefox, Chrome, Safari, Opera, Dolphin,....). Please let us know if you have any problems, and we'll troubleshoot with you (and improve the discussion guide for the next go around).
  
  
• Why do I see weird characters in some places?
  Because we're joining data from many different sources, we do find some technical challenges. This generally shows up as strange characters--extra question marks, accented characters, or otherwise unusual items. We've been able to fix many of these problems, but not all. We ask that you bear with us as we improve this over time!
  
  

Content

• What is included in the discussion guide?
  There are four sections within this document:
  • Agenda, with summaries of each measure under consideration
  • Full information about each measure, including its specifications, preliminary analysis of how this measure can advance the program's goals, and the rationale by HHS for being included in the list
  • Summaries for each federal health program being considered
  • Public comments that have been received to date (Note that the discussion guide may be released before the public comment period is finished, in which case there will just be a placeholder for where comments will go)
  
  
• How are the meeting discussions organized?
  The meeting sessions are organized around consent calendars, which are groups of measures being considered for a particular program or groups of measures for a particular condition or topic area. For each measure being discussed, this document will show you the description, the public comments (if any), the summary of the preliminary analysis, and the result of the preliminary analysis algorithm.

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