NQF

Agenda Synopsis

Full Agenda

Measure Index

• Time to surgery for elderly hip fracture patients (Public comments received: 0; MUC ID: MUC2018-031)
  
  
• Discouraging the routine use of occupational and/or physical therapy after carpal tunnel release (Public comments received:1; 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: 0; MUC ID: MUC2018-038)
  
  
• Multimodal Pain Management (Public comments received:2; MUC ID: MUC2018-047)
  
  
• Potential Opioid Overuse (Public comments received:6; MUC ID: MUC2018-048)
  
  
• Annual Wellness Assessment: Preventive Care (Public comments received:5; MUC ID: MUC2018-057)
  
  
• Adult Immunization Status (Public comments received:8; MUC ID: MUC2018-062)
  
  
• Functional Status Change for Patients with Neck Impairments (Public comments received: 0; MUC ID: MUC2018-063)
  
  
• Inpatient Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (Public comments received:4; MUC ID: MUC2018-115)
  
  
• Femoral or Inguinal Hernia Repair (Public comments received:3; MUC ID: MUC2018-116)
  
  
• Lumbar Spine Fusion for Degenerative Disease, 1-3 Levels (Public comments received:4; MUC ID: MUC2018-117)
  
  
• Psychoses/Related Conditions (Public comments received:4; MUC ID: MUC2018-119)
  
  
• Lumpectomy, Partial Mastectomy, Simple Mastectomy (Public comments received:4; MUC ID: MUC2018-120)
  
  
• Acute Kidney Injury Requiring New Inpatient Dialysis (Public comments received:4; MUC ID: MUC2018-121)
  
  
• Lower Gastrointestinal Hemorrhage (Public comments received:4; MUC ID: MUC2018-122)
  
  
• Renal or Ureteral Stone Surgical Treatment (Public comments received:3; MUC ID: MUC2018-123)
  
  
• Hemodialysis Access Creation (Public comments received:2; MUC ID: MUC2018-126)
  
  
• Elective Primary Hip Arthroplasty (Public comments received:2; MUC ID: MUC2018-137)
  
  
• Non-Emergent Coronary Artery Bypass Graft (CABG) (Public comments received:2; MUC ID: MUC2018-140)
  
  
• Medicare Spending Per Beneficiary (MSPB) clinician measure (Public comments received:8; MUC ID: MUC2018-148)
  
  
• Total Per Capita Cost (Public comments received:12; MUC ID: MUC2018-149)
  
  

• Adult Immunization Status (Public comments received:5; MUC ID: MUC2018-062)
  
  
• Use of Opioids from Multiple Providers in Persons Without Cancer (Public comments received:9; MUC ID: MUC2018-077)
  
  
• Use of Opioids at High Dosage in Persons Without Cancer (Public comments received:9; MUC ID: MUC2018-078)
  
  
• Use of Opioids from Multiple Providers and at High Dosage in Persons Without Cancer (Public comments received:9; MUC ID: MUC2018-079)
  
  
• Initial opioid prescription compliant with CDC recommendations (Public comments received:6; MUC ID: MUC2018-106)
  
  

Full Measure Information

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of patients (65 years and older) who present to the emergency department with a hip fracture receive surgical intervention within 48 hours of admission to the hospital.
  
  
• Numerator: Number of patients in the denominator who are operated on within 48 hours of admission to the hospital. Numerator Criteria (Eligible Cases): CPT: 27235, 27236, 27244, 27245, 27248, 27254, 27269
  
  
• Denominator: Number of patients age 65 or older admitted to the hospital with a low energy hip fracture Denominator Criteria (Eligible Cases): ICD-10-CM: S72.00, S72.001, S72.002, S72.009, S72.01, S72.011, S72.012, S72.019, S72.02, S72.03, S72.032, S72.033, S72.034, S72.035, S72.036, S72.04, S72.041, S72.042, S72.043, S72.044, S72.045, S72.046, S72.05, S72.051, S72.052, S72.059, S72.060, S72.09, S72.091, S72.092, S72.099, S72.136, S72.14, S72.141, S72.143, S72.144, S72.145, S72.1346, S72.2, S72.21, S72.22, S72.23, S72.24, S72.25, S72.26 OR ICD-9-CM: 820.8, 820, 820.02, 820.03, 820.09, 820.2, 820.21, 820.22
  
  
• Exclusions: Patients that can be classified as having the following: non-operative fractures, multiple injuries, periprosthetic fracture, high energy trauma, and or meet local criteria for multiple trauma designation
  
  
• HHS NQS Priority: Make Care Safer by Reducing Harm Caused in the Delivery of Care
  
  
• HHS Data Source: Administrative claims, administrative clinical data, claims, EHR, Record
  
  
• Measure Type: Process
  
  
• Steward: American Academy of Orthopaedic Surgeons
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Preventable Healthcare Harm
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support for rulemaking with the condition of NQF endorsement
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure could incentivize clinicians to ensure that elderly patients receive necessary intervention for hip fracture within the time frame as defined by the evidence. This offers the opportunity to improve patient care, facilitate cost-savings, and appropriately allocate resources.
  • Impact on quality of care for patients:This measure is fully developed. This measure would help reducing preventable healthcare harm.
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority of making care safer by reducing harm caused in the delivery of care and specifically addresses preventable healthcare harm.
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. This is a process measure. The measure is based on the American Academy of Orthopaedic Surgeons Management of Hip Fractures in the Elderly Clinical Practice Guideline, published in 2014. There is moderate strength evidence to support that hip fracture surgery within 48 hours of admission is associated with better outcomes.
  
  
• Does the measure address a quality challenge? Yes. This measure addresses a guideline with a performance gap of 89-94% that is more pronounced (75-81%) when evaluating those practitioners who are not 100% compliant.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative of existing measures within the program.
  
  
• Can the measure can be feasibly reported? Yes. This measure was fully tested using Cleveland Clinic data. However, no further feasibility analysis is available for other datasets.
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? Yes. This measure is specified and tested at the clinician level.
  
  
• Measure development status: Fully Developed
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a. This measure is not currently in use.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a. This measure is not currently in use.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Nine moderate strength studies evaluated patient outcomes in relation to timing of hip fracture surgery (Elliot et al 25, Fox et al 26, McGuire et al 27, Moran et al 28, Novack et al 29, Orosz et al 30, Parker et al 31, Radcliff et al 32, Siegmeth et al 33). In many of these studies the presence of increased comorbidities represented a confounding effect, and therefore delays for medical reasons were often excluded. The majority of studies favored improved outcomes in regards to mortality, pain, complications, or length of stay (Elliot et al 25, McGuire et al 27, Novack et al 29, Orosz et al 30, Parker et al 31, and Siegmeth et al 33). Although several studies showed a benefit of surgery within 48 hours, one study showed no harm with a delay up to four days for patients fit for surgery who were not delayed for medical reasons (Moran et al 28). Patients delayed due to medical reasons had the highest mortality and it is this subset of patients that could potentially benefit the most from earlier surgery. Prior to performing the literature search for this guideline, both patients and clinicians were surveyed for topics of interest related to the management of hip fractures in the elderly. These responses helped inform the PICO development by the workgroup. All PICO questions and inclusion criteria were developed a priori. AAOS staff trained in research methodology conducted a comprehensive systematic literature review, and final recommendations were developed by a multidisciplinary panel of experts. The workgroup that created these final recommendations is separate from the one that evaluated these quality measures. All included articles underwent study design quality appraisal, which assessed risks of bias/confounders that may skew the study’s results. Only the best available evidence was considered for inclusion in recommendations.

Measure Specifications

• NQF Number (if applicable): 3430
  
  
• Description: Percentage of patients who underwent carpal tunnel release surgery who were not prescribed postoperative hand, occupational, or physical therapy within 6 weeks of surgery
  
  
• Numerator: Number of patients who underwent carpal tunnel release and did not receive postoperative hand, physical therapy (low, moderate, or high complexity) or occupational therapy (low, moderate, or high complexity) within 6 weeks (42 days) of carpal tunnel release Numerator Criteria (Eligible Cases): Patient encounter (CPT): 64721 or 29848 AND No patient encounter for postoperative hand, physical therapy (low, moderate, or high complexity) within 6 weeks (42 days) of carpal tunnel release (CPT): 97161, 97162, 97163 AND No patient encounter for postoperative hand occupational therapy (low, moderate, or high complexity) within 6 weeks (42 days) of carpal tunnel release (CPT): 97165, 97166, 97167 Note: Code change implemented 2015, for data prior to 2015 CPT codes for 97161, 97162, 97163 is equivalent to 97001 (PT) and codes 97165, 97166, 97167 is equivalent to 97003 (OT).
  
  
• Denominator: Number of patients who underwent carpal tunnel release Denominator Criteria (Eligible Cases): Patient encounter (CPT): 64721 or 29848
  
  
• Exclusions: None
  
  
• HHS NQS Priority: Make Care Affordable
  
  
• HHS Data Source: Administrative claims, Claims, Administrative Clinical Data, EHR
  
  
• Measure Type: Process
  
  
• Steward: American Academy of Orthopaedic Surgeons
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Appropriate Use of Healthcare
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Do not support for rulemaking with the potential for mitigation. Mitigation would include specifying the measure at the clinician level.
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure assesses the appropriate use of healthcare services.
  • Impact on quality of care for patients:This measure is an appropriate use process measure. However, the measure is not specified or tested at the clinician level. Testing results should demonstrate reliability and validity at the clinician level. This measure should be submitted to NQF for review and endorsement.
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority of making care affordable and specifically addresses the appropriate use of healthcare
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. This measure is a process measure. This measure was developed directly from the American Academy of Orthopaedic Surgeons Management of Carpal Tunnel Syndrome Evidence-based Clinical Practice Guideline. The recommendation shows moderate evidence supports no additional benefit to routine supervised therapy over home programs in the immediate postoperative period.
  
  
• Does the measure address a quality challenge? Yes. The developer states that data from three years examined shows a consistent variability or gap in care.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This is an appropriate use, process measure. There are no competing measures in the program.
  
  
• Can the measure can be feasibly reported? No. Current specifications are at metropolitan statistical area and have not yet demonstrated feasibility at the clinician level.
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? No. Current specifications are at metropolitan statistical area and has not yet completed testing at the clinician level.
  
  
• Measure development status: Fully Developed
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a. This is a new measure and is not currently in use.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a. This is a new measure and is not currently in use.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Submitted.
  
  

Rationale for measure provided by HHS
Routine post-operative therapy after carpal tunnel release was examined in 6 high quality studies. From these, two studies (Hochberg 2001 and Jerosch-Herold 2012) addressed interventions not relevant to current core practices of postoperative rehabilitation. The remaining four studies (Alves 2011, Fagan 2004, Pomerance 2007, and Provinciali 2000) addressed the need for supervised therapy in addition to a home program in the early postoperative period, the early use of laser, or the role of sensory reeducation in the later stages of recovery. One high quality study (Alves 2011) evaluated the use of laser administered to the carpal tunnel in 10 daily consecutive sessions at a 3J dosage and found no difference in pain/symptom reoccurrence in comparison to placebo. Two moderate quality studies (Pomerance 2007 and Provinciali 2000) compared in-clinic or therapist supervised exercise programs in addition to a home program to a home program alone. The studies were somewhat limited by an incomplete description of who delivered home programs, exercise/education content and dosage, and treatment progression. Pomerance (2007) compared a two week program directed by a therapist combined with a home program alone and found no additional benefit in terms of grip or pinch strength in comparison to the home program alone. Provinciali (2000) compared one hour sessions over 10 consecutive days of in-clinic physiotherapy comprising a multimodal program with a home program that was progressed in terms of strength/endurance. No benefit was found in outcome when measured by a CTS-specific patient reported instrument.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of patients with an office visit within the measurement period and with a new diagnosis of clinically significant Benign Prostatic Hyperplasia who have International Prostate Symptoms Score (IPSS) or American Urological Association Symptom Index (AUA-SI) documented at time of diagnosis and again 6-12 months later with an improvement of 3 points.
  
  
• Numerator: Patients with a documented improvement of at least 3 points in their urinary symptom score during the measurement period.
  
  
• Denominator: Equals Initial Population. Initial population is: Male patients newly diagnosed with benign prostatic hyperplasia, that have a urinary symptom score (USS) within 1 month of initial diagnosis. If more than one USS in the initial one month, then the first USS counts. The patient must have a USS again at 6-12 months and if more than on USS in this time frame, then the last USS counts. The patient must have an office visit during the measurement period.
  
  
• Exclusions: Urinary retention within 1 year of BPH diagnosis BPH diagnosis during hospitalization or within 30 days of hospitalization Morbid obesity (BMI>40) during measurement period
  
  
• HHS NQS Priority: Strengthen Person & Family Engagement as Partners in their Care
  
  
• HHS Data Source: EHR
  
  
• Measure Type: Patient Reported Outcome
  
  
• Steward: Large Urology Group Practice Association and Oregon Urology Institute
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Patient Reported Functional Outcomes
  
  
• Is the measure specified as an electronic clinical quality measure? Yes
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support for rulemaking with the condition of NQF endorsement
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure would encourage the utilization of the American Urological Association Symptom Index (AUA-SI) and the International Prostate Symptom Score (IPSS) to measure outcomes for treatments of BPH
  • Impact on quality of care for patients:This measure is a patient reported outcome performance measure (PRO-PM). It would strengthen the program by adding a PRO-PM for benign prostatic hyperplasia (BPH),which is one of the most common conditions affecting older men, with a prevalence of 50% by age 60 years and 90% by the ninth decade of life (Medina,1999).
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure addresses the priority of strengthening person and family engagement as partners in their care and specifically addresses patient reported functional outcomes
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. The developer notes the evidence based guideline of using the American Urological Association Symptom Index (AUA-SI) or the International Prostate Symptom Score (IPSS) to measure outcomes associated with BPH
  
  
• Does the measure address a quality challenge? Yes. The measure monitors patient reported outcomes using a standard questionanaire. The developer states that many urologists who have a referral from a family practitioner or internist do not have an accompanying urology symptom score, even when an initial treatment was already started. The AUA Aqua Registry has a non QPP list for specialty reporting and understanding their benchmarks. The registry average for IPSS or AUASI is 2%.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative of existing measures in the program.
  
  
• Can the measure can be feasibly reported? Yes. Alpha and beta testing demonstrated feasibility in one EHR. However, per the NQF endorsement submission, not all EHRs contain these questionnaires.
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? Yes. The measure is specified at the clinician level.
  
  
• Measure development status: Fully Developed
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a. The measure is not currently in use
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a. The measure is not currently in use
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
The symptoms of BPH are LUTS symptoms. There are other disorders with similar symptoms and need to be excluded. History, physical examination, and testing are required prior to a diagnosis of BPH. IPSS by itself is not a reliable diagnostic tool for LUTS suggestive of BPH but serves as a quantitative measure of LUTS after the diagnosis is established (DSilva,2014). Medical and surgical interventions for BPH recommend a follow up IPSS evaluation to determine effectiveness of treatment. IPSS should be evaluated at the time of diagnosis and after definitive treatment.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of patients, regardless of age, undergoing selected elective surgical procedures that were managed with multimodal pain medicine.
  
  
• Numerator: Patients for whom multimodal pain management is administered in the perioperative period from six hours prior to anesthesia start time until discharged from the postanesthesia care unit. Numerator Definition: Multimodal pain management is defined as the use of two or more drugs and/or interventions, NOT including systemic opioids, that act by different mechanisms for providing analgesia. These drugs and/or interventions can be administered via the same route or by different routes. Opioids may be administered for pain relief when indicated but will not count towards this measure. Numerator note: Documentation of qualifying medications or interventions provided from six hours prior to anesthesia start time through PACU discharge count toward meeting the numerator.
  
  
• Denominator: Patients, regardless of age, who undergo selected elective surgical procedures
  
  
• Exclusions: Denominator Exception: Documented allergy to multiple classes of analgesics
  
  
• HHS NQS Priority: Promote Effective Prevention & Treatment of Chronic Disease
  
  
• HHS Data Source: Registry
  
  
• Measure Type: Process
  
  
• Steward: American Society of Anesthesiologists
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Prevention and Treatment of Opioid and Substance Use Disorders
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional Support for Rulemaking with the condition of NQF endorsement.
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure would encourage the use of multimodal pain interventions, which have shown to be more effective in pain control. This would also reduce the reliance on opioids as the primary means of pain control for patients.
  • Impact on quality of care for patients:This measure is fully developed and tested at the clinician level. It is available for use within registries. This measure would strengthen the program by giving additional measures around alternatives for opioids for pain management.
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority of promoting effective prevention and treatment of chronic disease and specifically addresses the prevention and treatment of opioid and substance use disorders.
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. This is a process measure. This measure follows evidence from the American Society of Anestehesiologists Task Force on Acute Pain Management, which recommends that clinicians use multi-modal pain management therapy in the perioperative period and offer multi-modal analgesia in the postoperative period. A randomized control trial found that patient who receive multi-modal pain interventions had lower pain scores, fewer adverse outcomes, higher satisfaction and fewer narcotics used than the cohort that received patient-controlled analgesia.
  
  
• Does the measure address a quality challenge? Yes. This measure addresses a critical topic of pain control. The developer presents data that demonstrates a 74.24% performance of using multimodal pain interventions with a range of 0.00 to 100.00.Additionally, in a preliminary sample of 2018 QCDR data, available as of October 31, 2018, including 1,526 clinicians there was a mean performance rate of 86.4% with performance rates ranging from 36% to 100%.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative of existing measures in the program.
  
  
• Can the measure can be feasibly reported? Yes. The developer states that the measure has been available for reporting via approved qualified clinical data registries since the beginning of 2018. However, the developer does not provide data regarding feasibility.
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? Yes. The measure has been specified at the clinician level.
  
  
• Measure development status: Fully Developed
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a. The measure is not in use in federal programs. The develper states that they are unaware of any unintended consequences at this time, however registry participants are able to share measure feedback through several avenues in the registry.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a. The measure is not in use in federal programs. The develper states that they are unaware of any unintended consequences at this time, however registry participants are able to share measure feedback through several avenues in the registry.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Lamplot, Wagner and Manning conducted a randomized control trial (RCT) that found patients that receive multimodal pain interventions had lower pain scores, fewer adverse outcomes, higher satisfaction and fewer narcotics used than the cohort that received patient-controlled analgesia. Another study from Memtsoudis et al. found that hip/knee arthroplasty patients receiving two modes of non-opioid analgesia experienced almost 20% fewer respiratory complications and 26% fewer gastrointestinal complications compared to those who received opioids only. Clinical guidelines support the use of multimodal pain management strategies to manage postoperative pain based on strong evidence. They suggest use of multimodal techniques whenever possible and consideration of regional anesthesia when appropriate to the reduce need for opioids to manage postoperative pain. Citations: Lamplot, J D et al. Multimodal pain management in total knee arthroplasty. J Arthroplasty 2014, 29(2): 329-334. Memtsoudis, S G et al. Association of multimodal pain management strategies with perioperative outcomes and resource utilization: A population-based study. Anesthesiology 2018, 128(5): 891-902. American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting. An updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology.2012;116(2):248-273. Chou R, Gordon DB, de Leon-Casasola O, et al. Management of postoperative pain: a clinical practice guideline from the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists’ Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain.2016;17(2):131-157.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of patients aged 18 years or older who receive opioid therapy for 90 days or longer and are prescribed a 90 milligram or larger morphine equivalent daily dose
  
  
• Numerator: Patients with an average daily dosage of 90 morphine milligram equivalents (MME) or greater, prescribed during the measurement period
  
  
• Denominator: Patients 18 years of age and older prescribed a 90 day or longer supply of opioids and who have a visit during the measurement period
  
  
• Exclusions: Patients with an active diagnosis of cancer or sickle cell disease, or who have an order for hospice or palliative care treatment during the measurement period
  
  
• HHS NQS Priority: Make Care Safer by Reducing Harm Caused in the Delivery of Care
  
  
• HHS Data Source: EHR
  
  
• Measure Type: Process
  
  
• Steward: Centers for Medicare & Medicaid Services
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Preventable Healthcare Harm
  
  
• Is the measure specified as an electronic clinical quality measure? Yes
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support for rulemaking with the condition NQF endorsement.
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This clinical quality measure would encourage providers to wean patients on high-dose opioids to lower doses, when medically appropriate, or to consider alternative approaches to pain management.
  • Impact on quality of care for patients:This measure is fully developed. This measure could strengthen the program measure set by reducing potential opioid overuse.
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority of promoting effective prevention and treatment of chronic disease and specifically addresses the prevention and treatment of opioid and substance use disorders
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. This is a process measure. CDC guidelines state that when opioids are started, clinicians should prescribe the lowest effective dosage.
  
  
• Does the measure address a quality challenge? Yes. This measure addresses a critical population at increased risk of morbidity and mortality. Recent research 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). The same study also noted that only 2.8 percent of patients were prescribed an opioid at doses greater than 150 MME per day, suggesting that this measure will target a small, but very high risk, patient population.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative of measures in the program.
  
  
• Can the measure can be feasibly reported? Yes. The developer states that while the measure is currently feasible to implement, CMS may need to assess the availability of data necessary for measure calculation using values from structured fields, as the measure team had to undertake significant post-extraction processing and creation of decision rules to clean the analytic files used for measure calculation.Additionally, this measure is similar to an existing NQF endorsed measure, Use of Opioids at High Dosage in Persons Without Cancer (NQF 2940). This NQF measure is not in MIPS. NQF 2940 currently targets individuals with greater than 120mg morphine equivalent dose (MED) as opposed to the 90mg MED in this measure.
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? Yes. The measure has been specified at the clinician level
  
  
• Measure development status: Fully Developed
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a. The developer states that during the semi-structured clinician interviews, some providers to whom we spoke were concerned that the Potential Opioid Overuse measure could unfairly punish those clinicians who are willing to treat patients already on a long-term, high-dose opioid and cannot easily be weaned down to a lower dose.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a. The measure team received feedback on potential negative unintended consequences from our project patient and family advisory board (PFAB). The PFAB is composed of patients, family members, and patient advocates who can speak about their experiences on a variety of clinical topics (rather than focusing on a single area). While PFAB members acknowledged that the issue of opioid overuse is important, some expressed concern that, if the measure was implemented, patients may be unable to access effective and necessary treatment for their chronic pain.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Improvement in provider performance on this measure will benefit patients primarily by reducing opioid-related morbidity and mortality. Recent research 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). The same study also noted that only 2.8 percent of patients were prescribed an opioid at doses greater than 150 MME per day, suggesting that this measure will target a small, but very high risk, patient population. Several peer-reviewed studies have estimated the costs associated with opioid use disorders, abuse, and dependence. In 2001, Americans lost more than $11.8 billion in societal costs because of opioid abuse (Birnbaum et al. 2011). For non-medical opioid use, this estimate rose to $53.4 billion in 2006, including $42.0 billion in lost productivity, $2.2 billion in treatment for opioid misuse, $8.2 billion in criminal justice expenses, and $944 million in medical care (Hansen et al. 2010). Lost productivity and healthcare expenditures associated with opioid abuse continue to rise; using 2007 data, Birnbaum et al. (2011) estimated lost productivity (including premature death, loss of employment, and presenteeism) cost society $25.6 billion, whereas healthcare costs rose to $25 billion (of which excess medical and drug use were the primary contributors). Estimates using 2013 data suggest total costs to society from opioid abuse and dependence exceeded $78 billion, including costs for health care, substance abuse treatment, criminal justice expenses, and lost productivity (Florence et al. 2016). Patients prescribed high-dose opioids have an approximately 10-fold increase in risk of overdose compared with those prescribed low-doses (Edlund et al. 2014). Patients on high-dose opioids are less likely to receive care consistent with guidelines and appropriate monitoring (Morasco et al. 2010). High daily dose is the most common indicator of potential opioid misuse or inappropriate prescription practices for opioids (Liu et al. 2013). Payers, providers, and patients will all benefit from the reduction of excess health care utilization associated with potential opioid overuse.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: 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 measures that are based on recommendations for preventive care by the USPSTF, ACIP, and AGS.
  
  
• Numerator: Numerator 1: Patients who were screened for fall risk at least once in the 12 months before or during a Medicare Annual Wellness Visit (AWV) Numerator 2: Patients who were screened for depression during the AWV or in the 12 months before (during an encounter) using an age-appropriate standardized tool Numerator 3: Patients who received an influenza immunization OR who reported previous receipt of an influenza immunization in the 153 days before the start of the measurement period (August 1) to the end of the most recent flu season (March 31) Numerator 4: Patients who have ever received a pneumococcal vaccination before the end of the measurement period Numerator 5: Women who had one or more mammograms during the measurement period, or in the 15 months prior to the measurement period Numerator 6: Patients with one or more screenings for colorectal cancer. Appropriate screenings are defined by any one of the following criteria: - Colonoscopy during the measurement period or the nine years prior to the measurement period - Flexible sigmoidoscopy during the measurement period or the four years prior to the measurement period - Fecal occult blood test (FOBT) during the measurement period - FIT-DNA during the measurement period or the two years prior to the measurement period - CT colonography during the measurement period or the four years prior to the measurement period Numerator 7: Female patients who have ever received a central (that is, hip or spine) DXA scan before the end of the measurement period
  
  
• Denominator: Denominator 1: Patients 65 years of age and older with an AWV during the measurement period. Denominator 2: Patients 65 years of age and older with an AWV during the measurement period. Denominator 3: Patients 65 years of age and older with an AWV during the measurement period, with an encounter from October 1 of the year before the measurement period to March 31 of the measurement period. Denominator 4: Patients 65 years of age and older with an AWV during the measurement period. Denominator 5: Female patients 65 to 74 years of age during the measurement period, with an AWV during the measurement period. Denominator 6: Patients age 65 to 75 years of age, with an AWV during the measurement period. Denominator 7: Female patients 65 to 85 years of age, with an AWV during the measurement period.
  
  
• Exclusions: Denominator Exclusion Population 1: Patients whose hospice care overlaps the 12 months before or during the AWV. Patients who were assessed to be non-ambulatory in the 12 months before or during the AWV. Denominator Exclusion Population 2: Patients with an active diagnosis of depression or bipolar disorder that starts before start of and overlaps the AWV. Denominator Exception Population 2: Patient refusal or medical reasons for not completing a depression screening in the 12 months before or during the AWV. Denominator Exclusion Population 3: None Denominator Exceptions Population 3: Documentation of medical reasons (e.g., patient allergy, other medical reasons), patient reasons (e.g., patient declined, other patient reasons), and system reasons (e.g., vaccine not available, other system reasons) for not receiving influenza immunization in the 153 days before the start of the measurement period (August 1) to the end of the most recent flu season (March 31). Documentation of an active allergy any time before the end of the most recent flu season. Denominator Exclusion Population 4: Patients whose hospice care overlaps the measurement period. Denominator Exclusion Population 5: Patients who had a bilateral mastectomy or who have a history of a bilateral mastectomy or for whom there is evidence of a right and a left unilateral mastectomy. Patients whose hospice care overlaps the measurement period. Denominator Exclusion Population 6: Patients with a diagnosis or past history of total colectomy or colorectal cancer. Patients whose hospice care overlaps the measurement period. Denominator Exclusion Population 7: Patients with a diagnosis of osteoporosis at the time of the AWV. Patients whose hospice care overlaps the measurement period.
  
  
• HHS NQS Priority: Promote Effective Prevention & Treatment of Chronic Disease
  
  
• HHS Data Source: EHR
  
  
• Measure Type: Composite
  
  
• Steward: Centers for Medicare & Medicaid Services
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Preventive Care
  
  
• Is the measure specified as an electronic clinical quality measure? Yes
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support for rulemaking with the condition for NQF endorsement and harmonization of this measure with the existing subcomponent measures already in the MIPS program.
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure is would encourage the providers to identify and manage a patien’s health risks for many preventable conditions. This measure evaluates whether clinicians ensure that patients receive key recommended preventive services.
  • Impact on quality of care for patients:This measure is fully developed at the clinician level. It is a composite measure of several evidenced based, recommended screening and immunizations.
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority of promoting effective prevention and treatment of chronic disease and specifically addresses preventive care.
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. This is a composite measure. This measure is based upon evidence for services (screenings and immunizations) the United States Preventive Services Task Force, the American Geriatrics Society, or the Advisory Committee on Immunization Practices recommended for the general older adult population.
  
  
• Does the measure address a quality challenge? Yes. This measure addresses the important issue of preventive care. The develpoer states that the median performance on the composite measure was 85 percent, with an interquartile range of 78 percent to 88 percent.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative of existing measures in the program. However, the subcomponents of the measure overlap with measures currently in the program. The following measures are represented in the composite: NQF 0101: Falls: Screening for Future Fall RiskNQF 0418: Preventive Care and Screening: Screening for Depression and Follow-Up PlanNQF 0041: Preventive Care and Screening: Influenza Immunization NQF 0043: Pneumococcal Vaccination Status for Older Adults (no longer endorsed)NQF 2372: Breast Cancer Screening NQF 0034: Colorectal Cancer ScreeningNQF 0037: Osteoporosis Testing in Older WomenNQF 0046: Screening for Osteoporosis for Women 65-85 Years of Age
  
  
• Can the measure can be feasibly reported? Yes. All of the component measures are based on measures currently implemented in MIPS.
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? Yes. The measure is specified at the clinician level.
  
  
• Measure development status: Fully Developed
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a. The developer notes that some clinicians mentioned general concerns the impact on scores from patients who refuse services, or among clinicians who serve end-of-life patients who might not benefit from preventive services. The developer states that they do not expect these concerns to bias results, because the patients who refuse services are likely to be sparse and distributed evenly across clinicians. Furthermore, this measure is in alignment with existing NQF measures that it is based on, which have individual exclusion criteria for patients.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a. The measures is not currently in use in a program.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Each component measure corresponds to an NQF-endorsed measure, meaning the evidence for each measure has been evaluated by an NQF committee and determined to have enough evidence to support the measure intent.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: 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.
  
  
• Numerator: Numerator 1 (N1): Members in Denominator 1 (D1) who received an influenza vaccine on or between July 1 of the year prior to the measurement period and June 30 of the measurement period. N2: Members in D2 who received at least 1 Td vaccine or 1 Tdap vaccine between 9 years prior to the start of the measurement period and the end of the measurement period. N3: Members in D3 who received at least 1 dose of the herpes zoster live vaccine or 2 doses of the herpes zoster recombinant vaccine anytime on or after the members 50th birthday. N4: Members in D4 who were administered both the 13-valent pneumococcal conjugate vaccine and the 23-valent pneumococcal polysaccharide vaccine at least 12 months apart, with the first occurrence after the age of 60. N5: The actual number of required immunizations administered to members in D5.
  
  
• Denominator: Denominator 1: Members age 19 and older at the start of the measurement period. Denominator 2: Members age 19 and older at the start of the measurement period. Denominator 3: Members age 50 and older at the start of the measurement period. Denominator 4: Members age 66 and older at the start of the measurement period. Denominator 5: The total number of possible immunizations required for members age 19 and older determined by their age at the start of the measurement period.
  
  
• Exclusions: Members with any of the following: - Prior anaphylactic reaction to the vaccine or its components any time during or before the measurement period. - History of encephalopathy within seven days after a previous dose of a Td-containing vaccine. - Active chemotherapy during the measurement period. - Bone marrow transplant during the measurement period. - History of immunocompromising conditions, cochlear implants, anatomic or functional asplenia, sickle cell anemia & HB-S disease or cerebrospinal fluid leaks any time during the member’s history prior to or during the measurement period. - In hospice or using hospice services during the measurement period.
  
  
• HHS NQS Priority: Promote Effective Prevention & Treatment of Chronic Disease
  
  
• HHS Data Source: Administrative clinical data, Claims, EHR, Facility Discharge Data, Other, Registry
  
  
• Measure Type: Composite
  
  
• Steward: National Committee for Quality Assurance
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Preventive Care
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Do not support for rulemaking with the potential for mitigation. Mitigation would include specifying the measure at the clinician level.
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure would encourage the use of evidence based practices to improve adult vaccination coverage. These vaccines can improve health and decrease health care costs by preventing severe disease and hospitalization.
  • Impact on quality of care for patients:This measure is a composite measure that evaluates receipt of all routine vaccines for the adult population.
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority of promoting effective prevention and treatment of chronic disease and specifically addresses preventative care.
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. This measure is a process measure. It is a composite measure that includes NQF endorsed measures, 1653, 0043, 0682, 0683, 0039, 0041, 1659, 0680, 0681, and 0431. The Advisory Committee on Immunization Practices (ACIP) recommends annual influenza vaccination; and tetanus, diphtheria and acellular pertussis (Tdap) and/or tetanus and diphtheria (Td) vaccine; herpes zoster vaccine; and the 13-valent pneumococcal conjugate vaccine (PCV13) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23) for adults at various ages.
  
  
• Does the measure address a quality challenge? Yes. This measure assesses the immuzations for all routine vaccines recommended for adults.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is the only measure that assesses receipt of all routine vaccines for the adult population. However, sub components of this measure could be related or competing measures.
  
  
• Can the measure can be feasibly reported? Yes. The developer states that in field testing, three health plans each with commercial, Medicaid and Medicare lines of business reported data for approximately 6.6 million enrolled adults ages 19 and older.
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? Yes. The measure was tested at the health plan level.
  
  
• Measure development status: Field Testing; Fully Developed
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Vaccines are recommended for adults to prevent serious diseases. Routine vaccination against influenza, tetanus, diphtheria and pertussis is recommended for all adults, while vaccines for herpes zoster and pneumococcal disease are recommended for older adults (Kim et al. 2017). Administration of the influenza, Tdap/Td, herpes zoster and pneumococcal vaccines can improve health and decrease health care costs by preventing severe disease and hospitalization. Evidence supporting administration of each individual vaccine follows. Influenza The influenza vaccine protects against influenza, a serious disease that can lead to hospitalization and death (Centers for Disease Control and Prevention [CDC] 2016a), particularly among older adults and vulnerable populations. It is characterized by a variety of symptoms related to the nose, throat and lungs that can range in severity (CDC 2015a), and it is easily spread (CDC 2016a). Although anyone can get the flu, people 65 and older, pregnant women, young children and those with chronic conditions are at higher risk of developing serious complications (CDC 2016a). Influenza can have severe consequences. The CDC estimates that since 2010, yearly influenza cases have ranged from 9.2-35.6 million; influenza-related hospitalizations, from 140,000-710,000; and influenza-related deaths, from 12,000-56,000 (CDC 2017a). Deaths associated with influenza are typically higher in older adults. In an analysis based on the 2010-2011 and 2012-2013 flu seasons, 71 percent-85 percent of deaths from influenza were among adults 65 and older (Grohskopf et al. 2016). Influenza is a leading cause of outpatient medical visits and worker absenteeism among adults. The average annual burden of seasonal influenza among adults 18-49 includes approximately 5 million illnesses, 2.4 million outpatient visits, 32,000 hospitalizations and 680 deaths (Grohskopf et al. 2016). A study in 2016 estimated that the cost-effectiveness ratio of the influenza vaccine was approximately $100,000 per quality-adjusted life year (Xu et al 2016). ACIP recommends routine annual influenza vaccination for all people 6 months of age and older (Grohskopf et al. 2017). For people 19 and older, any age-appropriate inactivated influenza vaccine (IIV) formulation or recombinant influenza vaccine (RIV) formulation are acceptable options. ACIP notes that live attenuated influenza vaccine (LAIV) should not be used during the 2017-2018 season for any population. Vaccination should occur before the onset of influenza activity in the community, ideally by the end of October; however, vaccination efforts should continue throughout flu season into February and March (Grohskopf et al. 2017). People who have a history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine should not receive the influenza vaccine (CDC 2017b). Td/Tdap vaccine Tetanus, diphtheria and pertussis can have serious health effects. Tetanus results in painful muscle spasms that can cause fractures, difficulty breathing, arrhythmia and death (CDC 2015b). Complications from diphtheria include myocarditis, which can lead to heart failure, and neuritis, which may temporarily paralyze motor nerves. Death occurs in 5-10 percent of cases (CDC 2015c). Pertussis, also known as whooping cough, is a respiratory infection characterized by a prolonged cough; it is highly communicable, and infection can lead to secondary pneumonia, the most common cause of pertussis-related deaths (CDC 2015d). Due to vaccines, tetanus and diphtheria are now uncommon. On average, there were 29 reported cases of tetanus per year from 1996-2009, and nearly all were among people who had never received a tetanus vaccine or were not up to date on their booster shots (CDC 2013). In the past decade, fewer than 5 diphtheria cases were reported to the CDC, although the disease is more prevalent in other countries: In 2014, 7,321 cases of diphtheria were reported to the World Health Organization, and there are likely many more unreported cases (CDC 2016b). Pertussis is much more prevalent today than tetanus and diphtheria, even though vaccines offer protection against the disease. Before the vaccine was introduced in the 1940s, there were about 200,000 cases of pertussis annually (CDC 2015d). Since widespread use of the vaccine, pertussis cases have decreased by 80 percent (CDC 2015d). However, pertussis cases have been increasing since the 1980s; currently, there are 10,000-40,000 pertussis cases and up to 20 deaths reported each year (CDC 2015d). Pertussis is usually milder in children, adolescents and adults than in infants and young children who may not be fully immunized. Older adults are often the source of infection for infants and children (CDC 2015d). Administering the Tdap vaccine to adults helps prevent the spread of pertussis to infants and prevents such hospitalizations; in 2010, the average cost of hospitalizing an infant with pertussis was $16,339, an increase from $12,377 in 2000 (Davis 2014). Because there has been a rise in pertussis over the past several decades in the U.S., studies have evaluated the cost-effectiveness of providing Tdap immunizations to adults. One study found that providing a dose of Tdap to people at age 11 or 12, as currently recommended, and again at age 21, could reduce outpatient visits for pertussis by 4 percent and hospitalizations for pertussis by 5 percent; costs per quality-adjusted life years saved would be $204,556 (Kamiya et al. 2016). Another study found that vaccinating all adults 2-64 at least once with Tdap is cost-effective (<$50,000 per quality-adjusted life years) if pertussis incidence in adults is greater than 120 cases per 100,000 people (Lee et al. 2007). McGarry et al. found that vaccinating all adults ages 65 and older with Tdap is a cost-effective intervention and would prevent 97,000 cases of pertussis annually—from the payer perspective, it would provide a net cost savings of $44.8 million (2014). ACIP recommends that all adults 19 and older who have not yet received a dose of Tdap receive a single dose (ACIP 2012; ACIP 2011). Tdap should be administered regardless of the interval since the last tetanus or diphtheria toxoid-containing vaccine. Adults 19 and older should receive a decennial Td vaccine booster, beginning 10 years after receipt of the Tdap vaccine (Kretsinger et al. 2006). People who have a history of severe allergic reaction (e.g., anaphylaxis) to any component of the Tdap or Td vaccine should not receive it. Tdap is contraindicated for adults with a history of encephalopathy (e.g., coma or prolonged seizures) not attributable to an identifiable cause within seven days of administration of a vaccine with pertussis components (CDC 2017b). Herpes zoster vaccine The herpes zoster vaccine protects against herpes zoster, commonly known as shingles. Herpes zoster is a painful skin rash caused by reactivation of the varicella zoster virus (CDC 2016c). After a person recovers from primary infection of varicella (chickenpox), the virus stays inactive in the body and can reactivate years later. Most people typically only have one episode of herpes zoster, but second or third episodes are possible. People with compromised immune systems are at higher risk of developing herpes zoster (CDC 2016c). The most common complication of herpes zoster is post-herpetic neuralgia (PHN) (CDC 2016c), which is severe, debilitating pain at the site of the rash that has no treatment or cure. Herpes zoster can also lead to serious complications of the eye, pneumonia, hearing problems, blindness, encephalitis or death (CDC 2016d). In the U.S., there are 1 million new cases of herpes zoster each year; 1 of every 3 people will be diagnosed with herpes zoster in their lifetime (CDC 2016c). A person’s risk for developing herpes zoster increases sharply after age 50 (CDC 2016c). As people age, they are more likely to develop PHN; it rarely occurs in people under 40, but can be seen in a third of untreated adults 60 and older (CDC 2016c). Between 1 and 4 percent of adults with herpes zoster are hospitalized for complications, and an estimated 96 deaths each year are directly caused by the virus (CDC 2016c). The vaccine can reduce the risk of developing herpes zoster and PHN. In 2011, total annual direct medical costs in the U.S. from herpes zoster were estimated to be $1.9 million; costs are expected to rise as the population ages (Friesen et al. 2017). A study of the cost-effectiveness of the herpes zoster vaccine among people at 50, 60 and 70 years found that vaccination at age 60 would prevent the most cases (26,147 cases per 1 million people), compared with vaccination at 50 or 70 (Hales et al. 2014). It also found that vaccination at 60 costs $86,000 per quality-adjusted life year, compared with $37,000 at 70 and $287,000 at 50 (Hales et a. 2014). There are currently two types of zoster vaccines recommended for older adults: the zoster vaccine live (ZVL) and a recombinant zoster vaccine (RZV). The ZVL is a 1-dose vaccine licensed for immunocompetent adults 50 and older; ACIP recommends ZVL for immunocompetent adults 60 and older. ZVL vaccine coverage for adults 60 and older has increased each year since ACIP first recommended it in 2008 (Dooling et al. 2018). In October 2017, the Food and Drug Administration approved the RZV for adults 50 and older. In January 2018, ACIP published a guideline recommending RZV for immunocompetent adults 50 and older, irrespective of prior receipt of varicella vaccine or ZVL (Dooling et al. 2018). RZV is a two-dose series; the second dose should be given 2-6 months after the first dose. If the second dose of RZV is given less than four weeks after the first, the second dose should be repeated; if the second dose is more than six months after the first dose, the vaccine series need not be restarted although individuals may be at higher risk for zoster. ZVL remains a recommended vaccine for immunocompetent adults 60 and older (Dooling et al. 2018). Patients with a severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component should not receive either zoster vaccine (Dooling et al. 2018). Pneumococcal vaccine Vaccines protect against pneumococcal disease, which is a common cause of illness and death in older adults and in persons with certain underlying conditions. The major clinical syndromes of pneumococcal disease include pneumonia, bacteremia and meningitis, with pneumonia being the most common (CDC 2015e). Pneumonia symptoms generally include fever, chills, pleuritic chest pain, cough with sputum, dyspnea, tachypnea, hypoxia tachycardia, malaise and weakness. There are an estimated 400,000 cases of pneumonia in the U.S. each year and a 5-7 percent mortality rate, although it may be higher among older adults and adults in nursing homes (CDC 2015f; Janssens and Krause 2004). Bacteremia, a blood infection, is another complication of pneumococcal disease (CDC 2015f). Approximately 30 percent of patients with pneumonia also have bacteremia, and 12,000 patients have bacteremia without pneumonia each year (CDC 2015f). Bacteremia has a 20 percent mortality rate among all adults and a 60 percent mortality rate among older adults. Pneumococcal disease causes 3,000-6,000 cases of meningitis each year (CDC 2015f). Meningitis symptoms may include headache, lethargy, vomiting, irritability, fever, nuchal rigidity, cranial nerve signs, seizures and coma. Meningitis has a 22 percent mortality rate among adults (CDC 2015f). Pneumococcal infections result in significant health care costs each year. Geriatric patients with pneumonia require hospitalization in nearly 90 percent of cases, and their average length of stay is twice that of younger adults (Janssens and Krause 2004). Pneumonia in the older adult population is associated with high acute-care costs and an overall impact on total direct medical costs and mortality during and after an acute episode (Thomas et al. 2012). Total medical costs for Medicare beneficiaries during and one year following a hospitalization for pneumonia were found to be $15,682 higher than matched beneficiaries without pneumonia (Thomas et al. 2012). It was estimated that in 2010, the total annual excess cost of hospital-treated pneumonia in the fee-for-service Medicare population was approximately $7 billion (Thomas et al. 2012). Pneumococcal vaccines have been shown to be highly effective in preventing invasive pneumococcal disease. When comparing costs, outcomes and quality adjusted life years, immunization with the two recommended pneumococcal vaccines was found to be more economically efficient than no vaccination, with an incremental cost-effectiveness ratio of $25,841 per quality-adjusted life year gained (Chen et al. 2014). There currently are two licensed pneumococcal vaccines in the U.S.: the 13-valent pneumococcal conjugate vaccine (PCV13) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23) (Kobayashi et al. 2015). For immunocompetent adults 65 and older who have not previously received pneumococcal vaccination, ACIP recommends a dose of PCV13, followed by a dose of PPSV23 one or more years later (Kobayashi et al. 2015). Immunocompetent adults 65 and older who received a dose of PPSV23 at younger than 65 should also receive a dose of PCV13 at least one year after the initial dose of PPSV23, and then another dose of PPSV23 at least 1 year after PCV13 and at least 5 years after the most recent dose of PPSV23 (Kobayashi et al. 2015). Adults should not receive either vaccine if they have had a severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component. Adults should not receive the PCV13 vaccine if they have had severe allergic reaction after any diphtheria-toxoid-containing vaccine (CDC 2017b).

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: This is a patient-reported outcome performance measure (PRO-PM) consisting of a patient-reported outcome measure (PROM) of risk-adjusted change in functional status (FS) for patients aged 14+ with neck impairments. The change in FS is assessed using the Neck FS PROM.* The measure is risk-adjusted to patient characteristics known to be associated with FS outcomes. It is used as a performance measure at the patient, individual clinician, and clinic levels to assess quality. *The Neck FS PROM is an item-response theory-based computer adaptive test (CAT). In addition to the CAT version, which provides for reduced patient response burden, it is available as a 10-item short form (static/paper-pencil).
  
  
• Numerator: The proportion of a provider’s (clinic’s or clinician’s) patient care episodes that met or exceeded the risk-adjusted predicted Residual Change Score. The Residual Change Score is defined as the difference between the Actual and Predicted Change Scores where - The Actual Score is the patient’s Functional Status (FS) Score, - The Actual Change Score is the change in the patient’s FS score from Admission to Discharge, and - The Predicted Change Score is the risk-adjusted prediction of FS change. (Please see the Comments section of JIRA submission for details of the Risk-adjustment component.) Calculating the Residual - Example Actual Score at Admission 45 Actual Score at Discharge 60 Actual Change Score (Discharge minus Admission) +15 Predicted Change Score +10 Residual (Actual Change minus Predicted) +5 Numerator Options Performance Met The Residual Change Score is equal to or greater than 0 Performance Not Met The Residual Change Score is less than 0 Performance may be calculated on 3 levels: 1. Patient Level: For the individual patient episode, the patient’s Actual FS scores relative to the risk-adjusted predicted. This level should be used for optimizing care as described below.* 2. Clinician Level: The average of the Residuals for patient care episodes managed by a clinician (individual provider) over a 12 month time period. 3. Clinic Level: The average of the Residuals for patient care episodes managed by a group of clinicians within a clinic over a 12 month time period. * A provider’s (clinician’s or clinic’s) performance must be assessed based on an average all of the provider’s patient episodes. On the level of the individual patient, variation is expected. When an individual episode does not result in meeting or exceeding the performance standard, the functional data should be useful to the provider in optimizing the balance of effectiveness/efficiency for that particular care episode. For example, if patient-perceived function is not improving, or has plateaued in progress, that data may be a component of provider-patient communication and care decision-making such as the following examples: 1) does the provider understand the patient’s perception of his/her current level of function? 2) should the treatment plan be modified? 3) should the patient be discharged sooner than later? 4) should the patient be referred to a different care provider?
  
  
• Denominator: Patients aged 14+ who initiated rehabilitation therapy, chiropractic, or medical episodes of care for neck impairments including but not limited to cervical (neck) pain, radiculopathy, strain, sprain, stenosis, myelopathy, spondylosis or disc disorders
  
  
• Exclusions: Denominator Exceptions - Patient refused to participate at admission and/or discharge - Patient unable to complete the Neck FS PROM at admission or discharge due to cognitive deficit, visual deficit, motor deficit, language barrier, or low reading level, and a suitable proxy/recorder is not available. - Patient self-discharged early (e.g., financial or insurance reasons, transportation problems, or reason unknown) - Medical reasons (e.g., scheduled for surgery or hospitalized) Denominator Exclusions - Patients with diagnosis of a degenerative neurological condition such as ALS, MS, Parkinson’s diagnosed at any time before or during the episode of care - Ongoing care not indicated, patient seen only 1-2 visits (e.g., home program only, referred to another provider or facility, consultation only)
  
  
• HHS NQS Priority: Strengthen Person & Family Engagement as Partners in their Care
  
  
• HHS Data Source: Registry
  
  
• Measure Type: Patient Reported Outcome
  
  
• Steward: Focus on Therapeutic Outcomes
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Patient Reported Functional Outcomes
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional Support for rulemaking with the condition of NQF endorsement.
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure would encourage providers to monitor functional status for patients with neck pain.
  • Impact on quality of care for patients:This measure is fully developed at the clinician level. This measure would add a PRO-PM measure, which are relatively lacking in the program.
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority area of strengthening person and family engagement as partners in their care and specifically addresses patient reported functional outcomes.
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. This is a patient reported outcome performance measure (PRO-PM). This measure is evidence based, and notes research to suppport the the use of neck functional status questionnaires.
  
  
• Does the measure address a quality challenge? Yes. This measure addresses a relative deficiency in PRO-PMs in the program. The developer states that 24.24% of clinics were classified as Low Performers, 60.01% as Average, and 15.75% as High performers.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative of existing measures in the program. It is related to the existing measure QPP #223 (NQF 0428): Functional Status Change for Patients with General Orthopaedic Impairments. However, this measure uses specific questions around neck pain and functional status.
  
  
• Can the measure can be feasibly reported? Yes. The FOTO measurement system and database has existed since 1994 and consists of approximately 21 million patient assessments. The FOTO Registry has functioned in CMS payment programs (PQRS and MIPS) since 2009. The Neck FS PROM is widely used throughout the U.S., being completed by patients in rehabilitation settings 414,436 times during 2017 alone. The Neck FS PROM and risk adjustment components needed to calculate all of the NQF endorsed PRO-PM measures stewarded by FOTO are freely available for use by patient care providers at https://www.fotoinc.com/science-of-foto/nqf-measure-specifications. However, the in-house resources required for a provider to administer, score, report for individual patient-provider communication, aggregate, risk adjust and report on aggregate levels are extensive and more cost-efficiently served for providers who opt to subscribe to the services provided by the FOTO measurement system (www.fotoinc.com).
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? Yes. This measure is specified at the clinician level.
  
  
• Measure development status: Fully Developed
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a. This measure is not in the program. The developer did not provide any information regarding implementation challenges.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a. This measure is not in the program. The developer did not provide any information regarding unintended consequences to the patient.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Wang YC, Cook KF, Deutscher D, Werneke MW, Hayes D, Mioduski JE. The development and psychometric properties of the patient self-report Neck Functional Status Questionnaire. J Orthop Sports Phys Ther. 2015;45(9):683-692. The findings by Wang and colleagues supported the uni-dimensionality and local independence of responses to the Neck FS PROM CAT. The items were found to have negligible differential item functioning and no ceiling or floor effects. The CAT-based measure yielded precision equal to fixed measure that included all items. N=439, age 48.4 +/- 13.8, 59% female. Deutscher D, Werneke MW, Hayes D, Mioduski JE, Cook KF, Fritz J, Woodhouse LJ, Stratford PW. Impact of risk-adjustment on provider ranking for patients with low back pain receiving physical therapy. J Orthop Sports Phys Ther. 2018 May 22:1-35 [Epub ahead of print]. https://www.ncbi.nlm.nih.gov/pubmed/29787696 The primary sample in the study by Deutscher et al. included 250,741 patients, ages 14-89, who completed the Neck FS PROM CAT at admission (age/SD=54/16; 65% women). Of these, 169,039 patients completed the Neck FS CAT at discharge, resulting in a completion rate of 67%. The scale-level reliability of the Neck FS CAT was 0.91. Standard Errors of Measurement (SEMs) were stable across the measurement continuum ranging from 3.7 to 3.9 points (range = 0 to 100), which corresponds to 6.1 to 6.4 points at the 90% confidence interval (CI). Minimal Detectable Improvement (MDI) at the 90% CI ranged between 6.6 to 7.0 points. A half standard deviation of baseline scores was 6.2 points. Minimal clinically important improvement (MCII) estimates ranged from 15 to 4 points from 1st to 4th quartile of baseline Neck FS CAT scores, respectively. Thus, greater change was needed to achieve MCII for patients with lower baseline functional status. The majority of patients (61%) demonstrated functional staging change during treatment.

Measure Specifications This measure's specifications have been modified. Please consult this Document for more information.

• NQF Number (if applicable):
  
  
• Description: The Inpatient Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Measure is meant to apply to clinicians who manage the inpatient care of Medicare beneficiaries hospitalized for exacerbation of COPD. This acute episode captures patients hospitalized for an exacerbation of COPD. The measure evaluates a clinician’s risk-adjusted cost for the episode group by averaging it across all episodes attributed to the clinician during the performance period. The cost of each episode is the sum of the cost to Medicare for assigned services performed by the attributed clinician and other healthcare providers during the episode window.
  
  
• Numerator: The numerator for the Inpatient Chronic Obstructive Pulmonary Disease (COPD) Exacerbation measure is the sum of the ratio of observed to expected payment-standardized cost to Medicare for all episodes attributed to a clinician. This sum is then multiplied by the national average observed episode cost to generate a dollar figure. Mathematically, this is represented as: sum of (observed episode cost/expected episode cost) * national average observed cost.
  
  
• Denominator: The denominator for the Inpatient Chronic Obstructive Pulmonary Disease (COPD) Exacerbation measure is the total number of episodes from this episode group attributed to a clinician.
  
  
• Exclusions: The following episode-level exclusions apply: (a) The beneficiary has a primary payer other than Medicare for any amount of time overlapping the episode window or in the lookback period. (b) No attributed clinician is found for the episode. (c) The beneficiary’s date of birth is missing. (d) The beneficiary’s death date occurred before the episode ended. (e) The beneficiary was not enrolled in Medicare Part A and B for the entirety of the lookback period plus episode window, or is enrolled in Part C for any part of the lookback period plus episode window. (f) The episode trigger claim was not performed in an office, IP, OP, or ASC setting based on its place of service. Exclusions specific to the Inpatient COPD Exacerbation measure are developed with input from the Pulmonary Disease Management Clinical Subcommittee.
  
  
• HHS NQS Priority: Make Care Affordable
  
  
• HHS Data Source: Claims
  
  
• Measure Type: Cost/Resource Use
  
  
• Steward: Centers for Medicare & Medicaid Services
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Patient-focused Episode of Care
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support with the condition of NQF endorsement.
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure assesses the cost of services performed by providers during the patient-focused episode of care.
  • Impact on quality of care for patients:This measure is a cost and resource use measure. This measure should be submitted to NQF for review and endorsement .
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority of making care affordable and specifically addresses a patient-focused episode of care.
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. The measure is a newly developed cost measure. Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending, which is still predominantly paid on a fee-for-service (FFS) basis, also grew 3.6 percent, reaching $672.1 billion (CMS, 2018)
  
  
• Does the measure address a quality challenge? Yes. Policymakers contend that an estimated 80 percent of overall health care costs are attributable to decisions made by clinicians (Fred, 2016). However, these same clinicians are often unaware of how their care decisions influence the overall costs of care. One of the goals for using cost measures is to help inform clinicians on the costs attributable to their decision making, as well as the total cost of their patient’s care.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative of other measures in the program and the measure captures a broad population. This measure is new and is not in use in any program.
  
  
• Can the measure can be feasibly reported? Yes. This is a claims-based measure.
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? No. This measure is fully developed and has completed field testing (see supplemental document with updates to the MUC list)This is a new measure that has not been submitted for NQF endorsement.
  
  
• Measure development status: Early Development; Field Testing
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a. The measure is not in current use. The developer considered the potential adverse effects of making unfair comparisons among certain types of clinicians in assessing cost measure performance, and/or rewarding lower costs without appropriately balancing performance on quality.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a. The measure is not in use. During development, the developer considered the potential adverse events of reducing access to care and stinting care.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending, which is still predominantly paid on a fee-for-service (FFS) basis, also grew by 3.6 percent, reaching $672.1 billion (CMS, 2018). However, this growth is slower than the previous two years due to a slowed growth in spending for both Medicare FFS and Medicare Advantage. In the United States, Medicare is the largest single purchaser of health care, and successfully establishing payment models under MIPS can have significant impacts on reducing costs and making care more affordable (MedPAC, 2017). COPD is a serious condition defined as the “physiologic finding of nonreversible pulmonary function impairment,” and includes chronic bronchitis and emphysema (NHLBI, 2012). In the United States, COPD is the third leading cause of death, affecting approximately 24 million Americans, accounting for more than 56 percent of deaths from lung disease, and representing over 700,000 hospital admissions in 2010 (CDC, 2017). In addition, evidence from the 1988 -1994 National Health and Nutrition Examination Survey suggests that as many as 12 million people in the United States may have undiagnosed COPD (NHLBI, 2012). Exacerbation of COPD and subsequent complications lead to a large majority of COPD costs. Studies in 2008 found Medicare beneficiaries with COPD incur annual health care costs $15,000 to $20,000 greater than costs for beneficiaries without COPD, with the majority of this cost resulting from inpatient hospitalizations for COPD (Menzin, 2008). Approximately 56 percent of patients with COPD were hospitalized in 2004 compared to 14 percent for patients without COPD (Vogelmeier 2017). Hospitalization for an acute exacerbation of COPD (AECOPD) is a known cause and predictor of COPD progression (Vogelmeier, 2017). In one study, hospitalizations due to COPD cost over $19,000 on average whereas hospitalizations unrelated to COPD had an average cost below $4,000 (Menzin, 2008). Mitigation of COPD readmissions and subsequent complications therefore has potential for substantial improvement in patients’ quality of life, care quality, as well as cost savings to Medicare. CDC. "Faststats: Chronic Obstructive Pulmonary Disease (COPD) Includes: Chronic Bronchitis and Emphysema." Centers for Disease Control and Prevention, 2017 https://www.cdc.gov/nchs/fastats/copd.htm. “Data Book: Health Care Spending and the Medicare Program.” MedPAC, 2017 Menzin, J., L. Boulanger, J. Marton, L. Guadagno, H. Dastani, R. Dirani, A. Phillips, and H. Shah. "The Economic Burden of Chronic Obstructive Pulmonary Disease (COPD) in a U.S. Medicare Population." [In Eng]. Respir Med 102, no. 9 (Sep 2008): 1248-56. “National Health Expenditure Projections, 2017-2026.” US Centers for Medicare & Medicaid Services, 2018. NHLBI. Morbidity & Mortality: 2012 Chart Book on Cardiovascular, Lung, and Blood Diseases. Edited by National Institutes of Health: National Heart, Lung, and Blood Institute, 2012. Vogelmeier, C. F., G. J. Criner, F. J. Martinez, A. Anzueto, P. J. Barnes, J. Bourbeau, B. R. Celli, et al. "Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report. Gold Executive Summary." [In Eng]. Am J Respir Crit Care Med 195, no. 5 (Mar 01 2017): 557-82.

Measure Specifications This measure's specifications have been modified. Please consult this Document for more information.

• NQF Number (if applicable):
  
  
• Description: The Femoral or Inguinal Hernia Repair Measure is meant to apply to clinicians who perform this procedure for Medicare beneficiaries. This procedural episode captures patients who undergo a femoral or inguinal hernia repair procedure. The measure evaluates a clinician’s risk-adjusted cost for the episode group by averaging it across all episodes attributed to the clinician during the performance period. The cost of each episode is the sum of the cost to Medicare for assigned services performed by the attributed clinician and other healthcare providers during the episode window.
  
  
• Numerator: The numerator for the Femoral or Inguinal Hernia Repair measure is the sum of the ratio of observed to expected payment-standardized cost to Medicare for all episodes attributed to a clinician. This sum is then multiplied by the national average observed episode cost to generate a dollar figure. Mathematically, this is represented as: sum of (observed episode cost/expected episode cost) * national average observed cost.
  
  
• Denominator: The denominator for the Femoral or Inguinal Hernia Repair measure is the total number of episodes from this episode group attributed to a clinician.
  
  
• Exclusions: The following episode-level exclusions apply: (a) The beneficiary has a primary payer other than Medicare for any amount of time overlapping the episode window or in the lookback period. (b) No attributed clinician is found for the episode. (c) The beneficiary’s date of birth is missing. (d) The beneficiary’s death date occurred before the episode ended. (e) The beneficiary was not enrolled in Medicare Part A and B for the entirety of the lookback period plus episode window, or is enrolled in Part C for any part of the lookback period plus episode window. (f) The episode trigger claim was not performed in an office, IP, OP, or ASC setting based on its place of service. Exclusions specific to the Femoral or Inguinal Hernia Repair measure are developed with input from the Gastrointestinal Disease Management Clinical Subcommittee.
  
  
• HHS NQS Priority: Make Care Affordable
  
  
• HHS Data Source: Claims
  
  
• Measure Type: Cost/Resource Use
  
  
• Steward: Centers for Medicare & Medicaid Services
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Patient-focused Episode of Care
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support with the condition of NQF endorsement.
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure assesses the cost of services performed by providers during the patient-focused episode of care.
  • Impact on quality of care for patients:This measure is a cost and resource use measure. This measure should be submitted to NQF for review and endorsement .
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority of making care affordable and specifically addresses a patient-focused episode of care.
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. The measure is a newly developed cost measure. Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending, which is still predominantly paid on a fee-for-service (FFS) basis, also grew 3.6 percent, reaching $672.1 billion (CMS, 2018)
  
  
• Does the measure address a quality challenge? Yes. Policymakers contend that an estimated 80 percent of overall health care costs are attributable to decisions made by clinicians (Fred, 2016). However, these same clinicians are often unaware of how their care decisions influence the overall costs of care. One of the goals for using cost measures is to help inform clinicians on the costs attributable to their decision making, as well as the total cost of their patient’s care.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative of other measures in the program and the measure captures a broad population. This measure is new and is not in use in any program.
  
  
• Can the measure can be feasibly reported? Yes. This is a claims-based measure.
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? No. This measure is fully developed and has completed field testing (see supplemental document with updates to the MUC list)This is a new measure that has not been submitted for NQF endorsement.
  
  
• Measure development status: Early Development; Field Testing
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a. The measure is not in current use. The developer considered the potential adverse effects of making unfair comparisons among certain types of clinicians in assessing cost measure performance, and/or rewarding lower costs without appropriately balancing performance on quality.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a. The measure is not in use. During development, the developer considered the potential adverse events of reducing access to care and stinting care.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending, which is still predominantly paid on a fee-for-service (FFS) basis, also grew 3.6 percent, reaching $672.1 billion (CMS, 2018). However, this growth is slower than the previous two years due to a slow growth in spending for both Medicare FFS and Medicare Advantage. In the United States, Medicare is the largest single purchaser of health care, and successfully establishing payment models under MIPS can have significant impacts on reducing costs and making care more affordable (MedPAC, 2017). Treating abdominal wall hernias, including femoral and inguinal hernias, is a common procedure. In the US, more than 1 million abdominal wall hernias are treated and or repaired annually, the majority of which are inguinal hernias (Matthews & Neumayer, 2008). On average, these hernia repair procedures cost approximately $2000 to $2500, representing nearly $2.5 billion in annual health care costs (Rutkow, 2003). Inguinal hernia repair remains one of the most performed surgical operations around the world and is a common surgical problem for older patients (Sanjay et al., 2011). Femoral or inguinal hernia repair has been shown to be safe for elderly patients, despite some surgeon reluctance to offer the procedure to elderly patients due to concerns of increased risk (Kurzer et al., 2009; Sinha et al., 2017; Wu et al., 2017). Cost calculations for hernia are confounded by the many surgical and anesthesia treatment options available, according to the International Guidelines for Groin Hernia Management (2018). Open procedures have been found to be less costly than laparoscopic procedures in some instances (Smink et al., 2009) “Data Book: Health Care Spending and the Medicare Program.” MedPAC, 2017 "International Guidelines for Groin Hernia Management." Hernia: The Journal Of Hernias And Abdominal Wall Surgery 22, no. 1 (2018): 1-165. Kurzer, M., A. Kark, and S. T. Hussain. "Day-Case Inguinal Hernia Repair in the Elderly: A Surgical Priority." Hernia: The Journal Of Hernias And Abdominal Wall Surgery 13, no. 2 (2009): 131-36. Matthews, R. Douglas and Leigh Neumayer. "Inguinal Hernia in the 21st Century: An Evidence-Based Review." Current Problems In Surgery 45, no. 4 (2008): 257-59. “National Health Expenditure Projections, 2017-2026.” US Centers for Medicare & Medicaid Services, 2018. Rutkow, Ira M. "Demographic and Socioeconomic Aspects of Hernia Repair in the United States in 2003." The Surgical Clinics Of North America 83, no. 5 (2003): 1045. Sanjay, Pandanaboyana, Heather Leaver, Irshad Shaikh, and Alan Woodward. "Lichtenstein Hernia Repair under Different Anaesthetic Techniques with Special Emphasis on Outcomes in Older People." Australasian Journal on Ageing 30, no. 2 (2011): 93-97. Sinha, Surajit, G. Srinivas, J. Montgomery, and D. DeFriend. "Outcome of Day-Case Inguinal Hernia in Elderly Patients: How Safe Is It?". Hernia: The Journal Of Hernias And Abdominal Wall Surgery 11, no. 3 (2007): 253-56. Smink, Douglas S., Ian M. Paquette, and Samuel R. G. Finlayson. "Utilization of Laparoscopic and Open Inguinal Hernia Repair: A Population-Based Analysis." Journal Of Laparoendoscopic & Advanced Surgical Techniques. Part A 19, no. 6 (2009): 745-48. Wu, J. J., B. C. Baldwin, E. Goldwater, and T. C. Counihan. "Should We Perform Elective Inguinal Hernia Repair in the Elderly?". Hernia: The Journal Of Hernias And Abdominal Wall Surgery 21, no. 1 (2017): 51-57.

Measure Specifications This measure's specifications have been modified. Please consult this Document for more information.

• NQF Number (if applicable):
  
  
• Description: The Lumbar Spine Fusion for Degenerative Disease, 1-3 Levels Measure is meant to apply to clinicians who perform this procedure for Medicare beneficiaries. This procedural episode captures patients who undergo a lumbar spinal fusion surgery. The measure evaluates a clinician’s risk-adjusted cost for the episode group by averaging it across all episodes attributed to the clinician during the performance period. The cost of each episode is the sum of the cost to Medicare for assigned services performed by the attributed clinician and other healthcare providers during the episode window.
  
  
• Numerator: The numerator for the Lumbar Spine Fusion for Degenerative Disease, 1-3 Levels measure is the sum of the ratio of observed to expected payment-standardized cost to Medicare for all episodes attributed to a clinician. This sum is then multiplied by the national average observed episode cost to generate a dollar figure. Mathematically, this is represented as: sum of (observed episode cost/expected episode cost) * national average observed cost.
  
  
• Denominator: The denominator for the Lumbar Spine Fusion for Degenerative Disease, 1-3 Levels measure is the total number of episodes from this episode group attributed to a clinician.
  
  
• Exclusions: The following episode-level exclusions apply: (a) The beneficiary has a primary payer other than Medicare for any amount of time overlapping the episode window or in the lookback period. (b) No attributed clinician is found for the episode. (c) The beneficiary’s date of birth is missing. (d) The beneficiary’s death date occurred before the episode ended. (e) The beneficiary was not enrolled in Medicare Part A and B for the entirety of the lookback period plus episode window, or is enrolled in Part C for any part of the lookback period plus episode window. (f) The episode trigger claim was not performed in an office, IP, OP, or ASC setting based on its place of service. Exclusions specific to the Lumbar Spine Fusion for Degenerative Disease, 1-3 Levels measure are developed with input from the Musculoskeletal Disease Management - Spine Clinical Subcommittee.
  
  
• HHS NQS Priority: Make Care Affordable
  
  
• HHS Data Source: Claims
  
  
• Measure Type: Cost/Resource Use
  
  
• Steward: Centers for Medicare & Medicaid Services
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Patient-focused Episode of Care
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support with the condition of NQF endorsement.
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure assesses the cost of services performed by providers during the patient-focused episode of care.
  • Impact on quality of care for patients:This measure is a cost and resource use measure. This measure should be submitted to NQF for review and endorsement .
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority of making care affordable and specifically addresses a patient-focused episode of care.
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. The measure is a newly developed cost measure. Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending, which is still predominantly paid on a fee-for-service (FFS) basis, also grew 3.6 percent, reaching $672.1 billion (CMS, 2018)
  
  
• Does the measure address a quality challenge? Yes. Policymakers contend that an estimated 80 percent of overall health care costs are attributable to decisions made by clinicians (Fred, 2016). However, these same clinicians are often unaware of how their care decisions influence the overall costs of care. One of the goals for using cost measures is to help inform clinicians on the costs attributable to their decision making, as well as the total cost of their patient’s care.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative of other measures in the program and the measure captures a broad population. This measure is new and is not in use in any program.
  
  
• Can the measure can be feasibly reported? Yes. This is a claims-based measure.
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? No. This measure is fully developed and has completed field testing (see supplemental document with updates to the MUC list)This is a new measure that has not been submitted for NQF endorsement.
  
  
• Measure development status: Early Development; Field Testing
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a. The measure is not in current use. The developer considered the potential adverse effects of making unfair comparisons among certain types of clinicians in assessing cost measure performance, and/or rewarding lower costs without appropriately balancing performance on quality.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a. The measure is not in use. During development, the developer considered the potential adverse events of reducing access to care and stinting care.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending, which is still predominantly paid on a fee-for-service (FFS) basis, also grew by 3.6 percent, reaching $672.1 billion (CMS, 2018). However, this growth is slower than the previous two years due to a slow growth in spending for both Medicare FFS and Medicare Advantage. In the United States, Medicare is the largest single purchaser of health care, and successfully establishing payment models under MIPS can have significant impacts on reducing costs and making care more affordable (MedPAC, 2017). Lower back pain is the most common medical problem worldwide and the top cause of years lived with disability, with over 600,000 cases in 2013, a 56.75 percent increase from 1990 (Global Burden of Disease, 2015). Common conditions responsible for lower back pain include: degenerative disk disease, spondylolysis, spondylolisthesis, trauma and spinal stenosis. Surgery is one of several options to consider for older patients with symptomatic lumbar spine disease that causes lower back pain. Between 2006 and 2012, over 6 million Medicare patients were diagnosed with lumbar degenerative conditions (Buser et al., 2017), and lumbar spine procedures are increasingly used in elderly patients to treat these conditions. For example, lumbar fusion rates have increased from 0.3 per 1000 Medicare beneficiaries in 1992 to 1.1 per 1000 in 2003 (Puvanesarajah, 2016). One study found that 5.9 per 100 patients progressed to lumbar fusion within 1 year, and there was an increase of 18.5 percent in the incidence of fusion procedures within 1 year of diagnosis between 2006 and 2011, with the age group 65 to 69 having the highest incidence (Buser et al., 2017). Furthermore, the 65 to 69 years age group also had the highest incidence of patients that underwent fusion within 1 year of diagnosis, while patients 80 to 84 and greater than 85 years of age had the greatest relative increase in fusion incidence between 2008 and 2011 (Buser et al., 2017). The cost of lumbar fusion has also increased, as noted by a 2012 study looking at the trends in spinal fusion from 1998 to 2008, where the cost per case increased from $24,676 to $81,960 (Rajaee et al., 2012). Based on a review of the Medicare Provider Analysis and Review file, total spending on lumbar spinal fusion surgery is also one of the highest admission outlays in the Medicare program, costing over $3.6 billion dollars in 2013 (Culler et al., 2016). Buser, Z., B. Ortega, A. D'Oro, W. Pannell, J. R. Cohen, J. Wang, R. Golish, M. Reed, and J. C. Wang. "Spine Degenerative Conditions and Their Treatments: National Trends in the United States of America." [In eng]. Global Spine J 8, no. 1 (Feb 2018): 57-67. Culler, S. D., D. S. Jevsevar, K. G. Shea, K. J. McGuire, M. Schlosser, K. K. Wright, and A. W. Simon. "Incremental Hospital Cost and Length-of-Stay Associated with Treating Adverse Events among Medicare Beneficiaries Undergoing Lumbar Spinal Fusion During Fiscal Year 2013." [In eng]. Spine (Phila Pa 1976) 41, no. 20 (Oct 15 2016): 1613-20. “Data Book: Health Care Spending and the Medicare Program.” MedPAC, 2017. "Global, Regional, and National Incidence, Prevalence, and Years Lived with Disability for 301 Acute and Chronic Diseases and Injuries in 188 Countries, 1990-2013: A Systematic Analysis for the Global Burden of Disease Study 2013." [In eng]. Lancet 386, no. 9995 (Aug 22 2015): 743-800. “National Health Expenditure Projections, 2017-2026.” US Centers for Medicare & Medicaid Services, 2018. Puvanesarajah, V., B. C. Werner, J. M. Cancienne, A. Jain, H. Pehlivan, A. L. Shimer, A. Singla, F. Shen, and H. Hassanzadeh. "Morbid Obesity and Lumbar Fusion in Patients Older Than 65 Years: Complications, Readmissions, Costs, and Length of Stay." [In eng]. Spine (Phila Pa 1976) 42, no. 2 (Jan 15 2017): 122-27. Rajaee, S. S., H. W. Bae, L. E. Kanim, and R. B. Delamarter. "Spinal Fusion in the United States: Analysis of Trends from 1998 to 2008." [In eng]. Spine (Phila Pa 1976) 37, no. 1 (Jan 1 2012): 67-76.

Measure Specifications This measure's specifications have been modified. Please consult this Document for more information.

• NQF Number (if applicable):
  
  
• Description: The Psychoses/Related Conditions Measure is meant to apply to clinicians who manage the inpatient care of Medicare beneficiaries hospitalized with these conditions. This acute episode captures patients who are treated for psychoses and related conditions. The measure evaluates a clinician’s risk-adjusted cost for the episode group by averaging it across all episodes attributed to the clinician during the performance period. The cost of each episode is the sum of the cost to Medicare for assigned services performed by the attributed clinician and other healthcare providers during the episode window.
  
  
• Numerator: The numerator for the Psychoses/Related Conditions measure is the sum of the ratio of observed to expected payment-standardized cost to Medicare for all episodes attributed to a clinician. This sum is then multiplied by the national average observed episode cost to generate a dollar figure. Mathematically, this is represented as: sum of (observed episode cost/expected episode cost) * national average observed cost.
  
  
• Denominator: The denominator for the Psychoses/Related Conditions measure is the total number of episodes from this episode group attributed to a clinician.
  
  
• Exclusions: The following episode-level exclusions apply: (a) The beneficiary has a primary payer other than Medicare for any amount of time overlapping the episode window or in the lookback period. (b) No attributed clinician is found for the episode. (c) The beneficiary’s date of birth is missing. (d) The beneficiary’s death date occurred before the episode ended. (e) The beneficiary was not enrolled in Medicare Part A and B for the entirety of the lookback period plus episode window, or is enrolled in Part C for any part of the lookback period plus episode window. (f) The episode trigger claim was not performed in an office, IP, OP, or ASC setting based on its place of service. Exclusions specific to the Psychoses/Related Conditions measure are developed with input from the Neuropsychiatric Disease Management Clinical Subcommittee.
  
  
• HHS NQS Priority: Make Care Affordable
  
  
• HHS Data Source: Claims
  
  
• Measure Type: Cost/Resource Use
  
  
• Steward: Centers for Medicare & Medicaid Services
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Patient-focused Episode of Care
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support with the condition of NQF endorsement.
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure assesses the cost of services performed by providers during the patient-focused episode of care.
  • Impact on quality of care for patients:This measure is a cost and resource use measure. This measure should be submitted to NQF for review and endorsement .
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority of making care affordable and specifically addresses a patient-focused episode of care.
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. The measure is a newly developed cost measure. Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending, which is still predominantly paid on a fee-for-service (FFS) basis, also grew 3.6 percent, reaching $672.1 billion (CMS, 2018)
  
  
• Does the measure address a quality challenge? Yes. Policymakers contend that an estimated 80 percent of overall health care costs are attributable to decisions made by clinicians (Fred, 2016). However, these same clinicians are often unaware of how their care decisions influence the overall costs of care. One of the goals for using cost measures is to help inform clinicians on the costs attributable to their decision making, as well as the total cost of their patient’s care.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative of other measures in the program and the measure captures a broad population. This measure is new and is not in use in any program.
  
  
• Can the measure can be feasibly reported? Yes. This is a claims-based measure.
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? No. This measure is fully developed and has completed field testing (see supplemental document with updates to the MUC list)This is a new measure that has not been submitted for NQF endorsement.
  
  
• Measure development status: Early Development; Field Testing
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a. The measure is not in current use. The developer considered the potential adverse effects of making unfair comparisons among certain types of clinicians in assessing cost measure performance, and/or rewarding lower costs without appropriately balancing performance on quality.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a. The measure is not in use. During development, the developer considered the potential adverse events of reducing access to care and stinting care.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending, which is still predominantly paid on a fee-for-service (FFS) basis, also grew 3.6 percent, reaching $672.1 billion (CMS, 2018). However, this growth is slower than the previous two years due to a slow growth in spending for both Medicare FFS and Medicare Advantage. In the United States, Medicare is the largest single purchaser of health care, and successfully establishing payment models under MIPS can have significant impacts on reducing costs and making care more affordable (MedPAC, 2017). Psychotic disorders, which are associated with disturbances in thought processing and behaviors that result in a loss of contact with reality, occur throughout the lifespan. Chronic psychotic disorders, including schizophrenia spectrum disorders, cause impairment in social, self-care and/or occupational functioning, and are among the most disabling disorders worldwide. Data from the 2010 Global Burden of Diseases, Injuries, and Risk Factors Study shows that mental and substance use disorders are the leading cause of years lived with disability. Despite being less prevalent than other disorders, schizophrenia accounted for 7.4 percent of disability-adjusted life years worldwide (Whiteford et al., 2013). Schizophrenia is diagnosed in between 0.3 percent and 1.6 percent of the US population and is one of the costliest mental illnesses, with treatment costs approximately double than that for major depression disorder and quadruple that for anxiety disorders (Desai et al., 2013; Zhu et al., 2008). Additionally, adults with schizophrenia represent a greater percent of Medicare beneficiaries than the general adult US population (approximately 1.5 percent and 1 percent, respectively) (Feldman et al., 2014). The direct costs of treating schizophrenia in the US are estimated to be between $33 and $65 billion annually, with inpatient services and medication representing the largest proportion of the costs (Wilson et al., 2011). Indirect costs represent a large cost burden as well and are estimated to cost $18.68 billion annually, which includes costs associated with lost productivity due to missed work, reduced employment and employability, premature death, and caregivers’ costs (Desai et al., 2013). “Data Book: Health Care Spending and the Medicare Program.” MedPAC, 2017 Desai, Pooja R., Kenneth A. Lawson, Jamie C. Barner, and Karen L. Rascati. "Estimating the Direct and Indirect Costs for Community-Dwelling Patients with Schizophrenia." Journal of Pharmaceutical Health Services Research 4, no. 4 (2013): 187-94. Feldman, Rachel, Robert A. Bailey, James Muller, Jennifer Le, and Riad Dirani. "Cost of Schizophrenia in the Medicare Program." Population Health Management 17, no. 3 (2014): 190-96. “National Health Expenditure Projections, 2017-2026.” US Centers for Medicare & Medicaid Services, 2018. Whiteford, Harvey A., Louisa Degenhardt, Jürgen Rehm, Amanda J. Baxter, Alize J. Ferrari, Holly E. Erskine, Fiona J. Charlson, et al. "Global Burden of Disease Attributable to Mental and Substance Use Disorders: Findings from the Global Burden of Disease Study 2010." The Lancet 382, no. 9904 (2013): 1575-86. Wilson, Leslie S., Gitlin, Matthew, Lightwood, Jim. "Schizophrenia Costs for Newly Diagnosed Versus Previously Diagnosed Patients." The American Journal of Pharmacy Benefits, vol. 3, no. 2, 2011, pp. 107-115. Zhu, Baojin, Haya Ascher-Svanum, Douglas E. Faries, Xiaomei Peng, David Salkever, and Eric P. Slade. "Costs of Treating Patients with Schizophrenia Who Have Illness-Related Crisis Events." BMC Psychiatry 8 (2008): 72-72.

Measure Specifications This measure's specifications have been modified. Please consult this Document for more information.

• NQF Number (if applicable):
  
  
• Description: The Lumpectomy, Partial Mastectomy, Simple Mastectomy Measure is meant to apply to clinicians who perform these procedures for Medicare beneficiaries. This procedural episode captures patients who receive surgical treatment for breast cancer. The measure evaluates a clinician’s risk-adjusted cost for the episode group by averaging it across all episodes attributed to the clinician during the performance period. The cost of each episode is the sum of the cost to Medicare for assigned services performed by the attributed clinician and other healthcare providers during the episode window.
  
  
• Numerator: The numerator for the Lumpectomy, Partial Mastectomy, Simple Mastectomy measure is the sum of the ratio of observed to expected payment-standardized cost to Medicare for all episodes attributed to a clinician. This sum is then multiplied by the national average observed episode cost to generate a dollar figure. Mathematically, this is represented as: sum of (observed episode cost/expected episode cost) * national average observed cost.
  
  
• Denominator: The denominator for the Lumpectomy, Partial Mastectomy, Simple Mastectomy measure is the total number of episodes from this episode group attributed to a clinician.
  
  
• Exclusions: The following episode-level exclusions apply: (a) The beneficiary has a primary payer other than Medicare for any amount of time overlapping the episode window or in the lookback period. (b) No attributed clinician is found for the episode. (c) The beneficiary’s date of birth is missing. (d) The beneficiary’s death date occurred before the episode ended. (e) The beneficiary was not enrolled in Medicare Part A and B for the entirety of the lookback period plus episode window, or is enrolled in Part C for any part of the lookback period plus episode window. (f) The episode trigger claim was not performed in an office, IP, OP, or ASC setting based on its place of service. Exclusions specific to the Lumpectomy, Partial Mastectomy, Simple Mastectomy measure are developed with input from the Oncologic Disease Management - Medical, Radiation, and Surgical Clinical Subcommittee.
  
  
• HHS NQS Priority: Make Care Affordable
  
  
• HHS Data Source: Claims
  
  
• Measure Type: Cost/Resource Use
  
  
• Steward: Centers for Medicare & Medicaid Services
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Patient-focused Episode of Care
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support with the condition of NQF endorsement.
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure assesses the cost of services performed by providers during the patient-focused episode of care.
  • Impact on quality of care for patients:This measure is a cost and resource use measure. This measure should be submitted to NQF for review and endorsement .
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority of making care affordable and specifically addresses a patient-focused episode of care.
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. The measure is a newly developed cost measure. Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending, which is still predominantly paid on a fee-for-service (FFS) basis, also grew 3.6 percent, reaching $672.1 billion (CMS, 2018)
  
  
• Does the measure address a quality challenge? Yes. Policymakers contend that an estimated 80 percent of overall health care costs are attributable to decisions made by clinicians (Fred, 2016). However, these same clinicians are often unaware of how their care decisions influence the overall costs of care. One of the goals for using cost measures is to help inform clinicians on the costs attributable to their decision making, as well as the total cost of their patient’s care.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative of other measures in the program and the measure captures a broad population. This measure is new and is not in use in any program.
  
  
• Can the measure can be feasibly reported? Yes. This is a claims-based measure.
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? No. This measure is fully developed and has completed field testing (see supplemental document with updates to the MUC list)This is a new measure that has not been submitted for NQF endorsement.
  
  
• Measure development status: Early Development; Field Testing
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a. The measure is not in current use. The developer considered the potential adverse effects of making unfair comparisons among certain types of clinicians in assessing cost measure performance, and/or rewarding lower costs without appropriately balancing performance on quality.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a. The measure is not in use. During development, the developer considered the potential adverse events of reducing access to care and stinting care.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending, which is still predominantly paid on a fee-for-service (FFS) basis, also grew 3.6 percent, reaching $672.1 billion (CMS, 2018). However, this growth is slower than the previous two years due to a slow growth in spending for both Medicare FFS and Medicare Advantage. In the United States, Medicare is the largest single purchaser of health care, and successfully establishing payment models under MIPS can have significant impacts on reducing costs and making care more affordable (MedPAC, 2017). The American Cancer Society estimates that breast cancer accounts for 29 percent of all new cancer diagnoses in women and has the highest treatment costs among all cancer types; estimated at $16.5 billion in 2010 (Siegel et al., 2016, Greenup et al., 2017). Breast cancer is the second most common cause of cancer mortality for women and surgery remains the primary treatment modality. Furthermore, the adoption and use of screening mammography has resulted in increased rates of detection of early-stage breast cancer and increased demand for surgical intervention (Helvie et al., 2014). As such, the surgical treatment of breast cancer including lumpectomy, partial mastectomy, and simple mastectomy represent a significant economic burden (Al-Hilli et al., 2015). Al-Hilli, Zahraa, Kristine M. Thomsen, Elizabeth B. Habermann, James W. Jakub, and Judy C. Boughey. "Reoperation for Complications after Lumpectomy and Mastectomy for Breast Cancer from the 2012 National Surgical Quality Improvement Program (Acs-Nsqip)." Annals Of Surgical Oncology 22 Suppl 3 (2015): S459-S69. “Data Book: Health Care Spending and the Medicare Program.” MedPAC, 2017. Greenup, Rachel A., Rachel C. Blitzblau, Kevin L. Houck, Julie Ann Sosa, Janet Horton, Jeffrey M. Peppercorn, Alphonse G. Taghian, Barbara L. Smith, and E. Shelley Hwang. "Cost Implications of an Evidence-Based Approach to Radiation Treatment after Lumpectomy for Early-Stage Breast Cancer." Journal Of Oncology Practice 13, no. 4 (2017): e283-e90. Helvie, Mark A., Joanne T. Chang, R. Edward Hendrick, and Mousumi Banerjee. "Reduction in Late-Stage Breast Cancer Incidence in the Mammography Era: Implications for Overdiagnosis of Invasive Cancer." Cancer 120, no. 17 (2014): 2649-56. “National Health Expenditure Projections, 2017-2026.” US Centers for Medicare & Medicaid Services, 2018. Siegel, Rebecca L., Kimberly D. Miller, and Ahmedin Jemal. "Cancer Statistics, 2016." CA: A Cancer Journal For Clinicians 66, no. 1 (2016): 7-30.

Measure Specifications This measure's specifications have been modified. Please consult this Document for more information.

• NQF Number (if applicable):
  
  
• Description: The Acute Kidney Injury (AKI) Requiring New Inpatient Dialysis Measure is meant to apply to clinicians who supervise dialysis procedures for AKI Medicare beneficiaries. This acute episode captures patients previously not dependent on dialysis who undergo AKI dialysis. The measure evaluates a clinician’s risk-adjusted cost for the episode group by averaging it across all episodes attributed to the clinician during the performance period. The cost of each episode is the sum of the cost to Medicare for assigned services performed by the attributed clinician and other healthcare providers during the episode window.
  
  
• Numerator: The numerator for the Acute Kidney Injury Requiring New Inpatient Dialysis measure is the sum of the ratio of observed to expected payment-standardized cost to Medicare for all episodes attributed to a clinician. This sum is then multiplied by the national average observed episode cost to generate a dollar figure. Mathematically, this is represented as: sum of (observed episode cost/expected episode cost) * national average observed cost.
  
  
• Denominator: The denominator for the Acute Kidney Injury Requiring New Inpatient Dialysis measure is the total number of episodes from this episode group attributed to a clinician.
  
  
• Exclusions: The following episode-level exclusions apply: (a) The beneficiary has a primary payer other than Medicare for any amount of time overlapping the episode window or in the lookback period. (b) No attributed clinician is found for the episode. (c) The beneficiary’s date of birth is missing. (d) The beneficiary’s death date occurred before the episode ended. (e) The beneficiary was not enrolled in Medicare Part A and B for the entirety of the lookback period plus episode window, or is enrolled in Part C for any part of the lookback period plus episode window. (f) The episode trigger claim was not performed in an office, IP, OP, or ASC setting based on its place of service. Exclusions specific to the AKI Requiring New Inpatient Dialysis measure are developed with input from the Renal Disease Management Clinical Subcommittee.
  
  
• HHS NQS Priority: Make Care Affordable
  
  
• HHS Data Source: Claims
  
  
• Measure Type: Cost/Resource Use
  
  
• Steward: Centers for Medicare & Medicaid Services
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Patient-focused Episode of Care
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support with the condition of NQF endorsement.
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure assesses the cost of services performed by providers during the patient-focused episode of care.
  • Impact on quality of care for patients:This measure is a cost and resource use measure. This measure should be submitted to NQF for review and endorsement .
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority of making care affordable and specifically addresses a patient-focused episode of care.
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. The measure is a newly developed cost measure. Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending, which is still predominantly paid on a fee-for-service (FFS) basis, also grew 3.6 percent, reaching $672.1 billion (CMS, 2018)
  
  
• Does the measure address a quality challenge? Yes. Policymakers contend that an estimated 80 percent of overall health care costs are attributable to decisions made by clinicians (Fred, 2016). However, these same clinicians are often unaware of how their care decisions influence the overall costs of care. One of the goals for using cost measures is to help inform clinicians on the costs attributable to their decision making, as well as the total cost of their patient’s care.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative of other measures in the program and the measure captures a broad population. This measure is new and is not in use in any program.
  
  
• Can the measure can be feasibly reported? Yes. This is a claims-based measure.
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? No. This measure is fully developed and has completed field testing (see supplemental document with updates to the MUC list)This is a new measure that has not been submitted for NQF endorsement.
  
  
• Measure development status: Early Development; Field Testing
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a. The measure is not in current use. The developer considered the potential adverse effects of making unfair comparisons among certain types of clinicians in assessing cost measure performance, and/or rewarding lower costs without appropriately balancing performance on quality.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a. The measure is not in use. During development, the developer considered the potential adverse events of reducing access to care and stinting care.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending, which is still predominantly paid on a fee-for-service (FFS) basis, also grew 3.6 percent, reaching $672.1 billion (CMS, 2018). However, this growth is slower than the previous two years due to a slow growth in spending for both Medicare FFS and Medicare Advantage. In the United States, Medicare is the largest single purchaser of health care, and successfully establishing payment models under MIPS can have significant impacts on reducing costs and making care more affordable (MedPAC, 2017). AKI is one of the most serious complications among hospitalized patients. It is associated with a significant number of acute and chronic conditions, worse operative outcomes, increased mortality, and high resource utilization (Lysak et al., 2017; Hsu et al., 2016). The severity of AKI is associated with worse outcomes, and negatively affects length of stay, resource use, and in-hospital and post-discharge costs. The annual expenditure of hospital-based AKI exceeds $10 billion, and each year there is approximately 600,000 cases of AKI (Lysak et al., 2017; Chawla et al., 2011). From 2000 to 2014, hospitalization rates for dialysis-requiring AKI increased by 57% among adults with diagnosed diabetes and by 64% among adults without diagnosed diabetes (Pavkov et al., 2018). In 2015, 4.3 percent of Medicare beneficiaries experienced a hospitalization complicated by AKI (USRDS, 2017). Older patients in particular have higher rates for poor outcomes, including a greater chance of nonrecovery renal function upon discharge after treatment (Coca et al., 2011). In 2009, the inpatient case fatality rate for a single episode of AKI-D was 23.5 percent (Hsu et al., 2012). Therefore, developing a measure that leads to improved care for, or prevention of, AKI-D could lead to significant cost savings. Chawla, Lakhmir S, Richard L Amdur, Susan Amodeo, Paul L Kimmel, and Carlos E Palant. “The Severity of Acute Kidney Injury Predicts Progression to Chronic Kidney Disease.” Kidney International, vol. 79, no. 12, 2011, pp. 1361-1369. Coca, Steven G, Kerry C Cho, and Chi-yuan Hsu. “Acute Kidney Injury in the Elderly: Predisposition to Chronic Kidney Diseases and Vice Versa.” Nephron Clinical Practice, vol. 119, 2011, pp. c19-c24. “Data Book: Health Care Spending and the Medicare Program.” MedPAC, 2017 Hsu, Raymond K, Charles E McCulloch, Michael Heung, Rajiv Saran, Vahakn B Shahinian, Meda E Pavkov, Nilka Ríos Burrows, Neil R Powe, and Chi-yuan Hsu, for the Centers for Disease Control and Prevention Chronic Kidney Disease Surveillance Team. “Exploring Potential Reasons for the Temporal Trend in Dialysis-Requiring AKI in the United States.” The Clinical Journal of the American Society of Nephrology, vol. 11, no. 1, 2016, pp. 14-20. Hsu, Raymond K, Charles E McCulloch, R Adams Dudley, Lowell J Lo, and Chi-yuan Hsu. “Temporal Changes in incidence of Dialysis-Requiring AKI.” Journal of the American Society of Nephrology, vol. 24, no. 1, 2012, pp. 37-42 Lysak, Nicholas, Azra Bihorac, and Charles Hobson. “Mortality and Cost of Acute and Chronic Kidney Disease After Cardiac Surgery.” Current Opinion in Anesthesiology, vol. 30, no. 1, 2017, pp. 113-117. “National Health Expenditure Projections, 2017-2026.” US Centers for Medicare & Medicaid Services, 2018. Pavkov, Meda E, Jessica L. Harding, and Nilka Ríos Burrows. “Trends in Hospitalizations for Acute Kidney Injury — United States, 2000–2014.” MMWR Morb Mortal Wkly Rep, vol. 67, no. 10, 2018, pp. 289–293. United States Renal Data System. 2017 USRDS annual data report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2017.

Measure Specifications This measure's specifications have been modified. Please consult this Document for more information.

• NQF Number (if applicable):
  
  
• Description: The Lower Gastrointestinal Hemorrhage Measure is meant to apply to clinicians who manage the inpatient care of Medicare beneficiaries hospitalized for acute lower gastrointestinal hemorrhage. This acute episode captures patients hospitalized for acute lower gastrointestinal hemorrhage. The measure evaluates a clinician’s risk-adjusted cost for the episode group by averaging it across all episodes attributed to the clinician during the performance period. The cost of each episode is the sum of the cost to Medicare for assigned services performed by the attributed clinician and other healthcare providers during the episode window.
  
  
• Numerator: The numerator for the Lower Gastrointestinal Hemorrhage measure is the sum of the ratio of observed to expected payment-standardized cost to Medicare for all episodes attributed to a clinician. This sum is then multiplied by the national average observed episode cost to generate a dollar figure. Mathematically, this is represented as: sum of (observed episode cost/expected episode cost) * national average observed cost.
  
  
• Denominator: The denominator for the Lower Gastrointestinal Hemorrhage measure is the total number of episodes from this episode group attributed to a clinician.
  
  
• Exclusions: The following episode-level exclusions apply: (a) The beneficiary has a primary payer other than Medicare for any amount of time overlapping the episode window or in the lookback period. (b) No attributed clinician is found for the episode. (c) The beneficiary’s date of birth is missing. (d) The beneficiary’s death date occurred before the episode ended. (e) The beneficiary was not enrolled in Medicare Part A and B for the entirety of the lookback period plus episode window, or is enrolled in Part C for any part of the lookback period plus episode window. (f) The episode trigger claim was not performed in an office, IP, OP, or ASC setting based on its place of service. Exclusions specific to the Lower Gastrointestinal Hemorrhage measure are developed with input from the Gastrointestinal Disease Management Clinical Subcommittee.
  
  
• HHS NQS Priority: Make Care Affordable
  
  
• HHS Data Source: Claims
  
  
• Measure Type: Cost/Resource Use
  
  
• Steward: Centers for Medicare & Medicaid Services
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Patient-focused Episode of Care
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support with the condition of NQF endorsement.
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure assesses the cost of services performed by providers during the patient-focused episode of care.
  • Impact on quality of care for patients:This measure is a cost and resource use measure. This measure should be submitted to NQF for review and endorsement .
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority of making care affordable and specifically addresses a patient-focused episode of care.
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. The measure is a newly developed cost measure. Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending, which is still predominantly paid on a fee-for-service (FFS) basis, also grew 3.6 percent, reaching $672.1 billion (CMS, 2018)
  
  
• Does the measure address a quality challenge? Yes. Policymakers contend that an estimated 80 percent of overall health care costs are attributable to decisions made by clinicians (Fred, 2016). However, these same clinicians are often unaware of how their care decisions influence the overall costs of care. One of the goals for using cost measures is to help inform clinicians on the costs attributable to their decision making, as well as the total cost of their patient’s care.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative of other measures in the program and the measure captures a broad population. This measure is new and is not in use in any program.
  
  
• Can the measure can be feasibly reported? Yes. This is a claims-based measure.
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? No. This measure is fully developed and has completed field testing (see supplemental document with updates to the MUC list)This is a new measure that has not been submitted for NQF endorsement.
  
  
• Measure development status: Early Development; Field Testing
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a. The measure is not in current use. The developer considered the potential adverse effects of making unfair comparisons among certain types of clinicians in assessing cost measure performance, and/or rewarding lower costs without appropriately balancing performance on quality.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a. The measure is not in use. During development, the developer considered the potential adverse events of reducing access to care and stinting care.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending, which is still predominantly paid on a fee-for-service (FFS) basis, also grew 3.6 percent, reaching $672.1 billion (CMS, 2018). However, this growth is slower than the previous two years due to a slow growth in spending for both Medicare FFS and Medicare Advantage. In the United States, Medicare is the largest single purchaser of health care, and successfully establishing payment models under MIPS can have significant impacts on reducing costs and making care more affordable (MedPAC, 2017). Gastrointestinal (GI) diseases are highly prevalent, costly, and utilize a significant amount of health care resources, especially in the Medicare population (Peery et al., 2015). Gastrointestinal bleeding is the most common cause of hospitalizations for gastrointestinal diseases, and over 500,000 patients are hospitalized annually for GI bleeds (Gralnek & Strate, 2017; Strate & Gralnek, 2016). Lower gastrointestinal bleeding (LGIB) is responsible for approximately 30-40 percent of all GI bleeding cases, with an incidence of around 36 per 100,000 persons (Gralnek & Strate, 2016; Parekh et al., 2014). Typically, bleeding resolves spontaneously for most patients with LGIB. However, tests and procedures to determine the bleeding source, as well as preventative treatments, may still be initiated to mitigate the risk for future catastrophic bleeding episodes (Gralnek & Strate, 2016). Patients who experience LGIB without spontaneous resolution are at risk for significant complications, including severe hemodynamic compromise, which may necessitate urgent and aggressive resuscitation and intervention measures. Morbidity and mortality also increase significantly for patients who are older and for those with preexisting medical conditions, leading to higher costs and resource use, particularly for Medicare patients (Jansen et al, 2009). The three most common causes of LGIB are diverticulosis, vascular ectasia, and hemorrhoids (Ghassemi & Jensen, 2013). On average, $33,630 is spent per Medicare patient for further evaluation of obscure GI bleeding (OGIB) (Parekh et al., 2014). Diverticular disease as a whole is responsible for around 300,000 hospitalizations annually, costing the United States approximately 2.6 billion dollars per year (Papageorge et al., 2016). Ghassemi, Kevin A and Dennis M Jensen. “Lower GI Bleeding: Epidemiology and Management.” Current Gastroenterology Reports vol. 15, no. 7, 2013. Gralnek, Ian M, Ziv Neeman, and Lisa L Strate. “Acute Lower Gastrointestinal Bleeding.” The New England Journal of Medicine, no. 376, 2017, pp. 1054-1063. “Data Book: Health Care Spending and the Medicare Program.” MedPAC, 2017 Jansen, Antje, Sabine Harenberg, Uwe Grenda, and Christoph Elsing. “Risk Factors for Colonic Diverticular Bleeding: A Westernized Community Based Hospital Study.” World Journal of Gastroenterology, vol. 15, no. 4, 2009, pp. 457-461. Papageorge, Christina M, Gregory D Kennedy, and Evie H Carchman. “National Trends in Short-term Outcomes Following Non-emergent Surgery for Diverticular Disease.” Journal of Gastrointestinal Surgery, vol. 20, 2016, pp. 1376-1387. Parekh, Parth J, Ross C Buerlein, Rouzbeh Shams, Harlan Vingan, and David A Johnson. “Evaluation of Gastrointestinal Bleeding: Update of Current Radiologic Strategies.” World Journal of Gastrointestinal Pharmacology and Therapeutics, vol. 5, no. 4, 2014, pp. 200-208. Peery, Ann F, Seth D Crockett, Alfred S Barrit, Evan S Dellon, Swathi Eluri, Lisa M Gangarosa, Elizabeth T Jensen, Jennifer L Lund, Sarina Pasricha, Thomas Runge, Monica Schmidt, Nicholas J Shaheen, and Robert S Sandler. “Burden of Gastrointestinal, Liver, and Pancreatic Diseases in the United States.” Gastroenterology, vol. 149, no. 7, 2015, pp. 1731-1741. “National Health Expenditure Projections, 2017-2026.” US Centers for Medicare & Medicaid Services, 2018. Strate, Lisa L and Ian M Gralnek. “ACG Clinical Guideline: Management of Patients with Acute Lower Gastrointestinal Bleeding.” The American Journal of Gastroenterology, vol. 111, 2016, pp. 459-474.

Measure Specifications This measure's specifications have been modified. Please consult this Document for more information.

• NQF Number (if applicable):
  
  
• Description: The Renal or Ureteral Stone Surgical Treatment Measure is meant to apply to clinicians who perform this procedure for Medicare beneficiaries. This procedural episode captures patients who receive surgical treatment for renal or ureteral stones. The measure evaluates a clinician’s risk-adjusted cost for the episode group by averaging it across all episodes attributed to the clinician during the performance period. The cost of each episode is the sum of the cost to Medicare for assigned services performed by the attributed clinician and other healthcare providers during the episode window.
  
  
• Numerator: The numerator for the Renal or Ureteral Stone Surgical Treatment measure is the sum of the ratio of observed to expected payment-standardized cost to Medicare for all episodes attributed to a clinician. This sum is then multiplied by the national average observed episode cost to generate a dollar figure. Mathematically, this is represented as: sum of (observed episode cost/expected episode cost) * national average observed cost.
  
  
• Denominator: The denominator for the Renal or Ureteral Stone Surgical Treatment measure is the total number of episodes from this episode group attributed to a clinician.
  
  
• Exclusions: The following episode-level exclusions apply: (a) The beneficiary has a primary payer other than Medicare for any amount of time overlapping the episode window or in the lookback period. (b) No attributed clinician is found for the episode. (c) The beneficiary’s date of birth is missing. (d) The beneficiary’s death date occurred before the episode ended. (e) The beneficiary was not enrolled in Medicare Part A and B for the entirety of the lookback period plus episode window, or is enrolled in Part C for any part of the lookback period plus episode window. (f) The episode trigger claim was not performed in an office, IP, OP, or ASC setting based on its place of service. Exclusions specific to the Renal or Ureteral Stone Surgical Treatment measure are developed with input from the Urologic Disease Management Clinical Subcommittee.
  
  
• HHS NQS Priority: Make Care Affordable
  
  
• HHS Data Source: Claims
  
  
• Measure Type: Cost/Resource Use
  
  
• Steward: Centers for Medicare & Medicaid Services
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Patient-focused Episode of Care
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support with the condition of NQF endorsement.
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure assesses the cost of services performed by providers during the patient-focused episode of care.
  • Impact on quality of care for patients:This measure is a cost and resource use measure. This measure should be submitted to NQF for review and endorsement .
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority of making care affordable and specifically addresses a patient-focused episode of care.
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. The measure is a newly developed cost measure. Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending, which is still predominantly paid on a fee-for-service (FFS) basis, also grew 3.6 percent, reaching $672.1 billion (CMS, 2018)
  
  
• Does the measure address a quality challenge? Yes. Policymakers contend that an estimated 80 percent of overall health care costs are attributable to decisions made by clinicians (Fred, 2016). However, these same clinicians are often unaware of how their care decisions influence the overall costs of care. One of the goals for using cost measures is to help inform clinicians on the costs attributable to their decision making, as well as the total cost of their patient’s care.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative of other measures in the program and the measure captures a broad population. This measure is new and is not in use in any program.
  
  
• Can the measure can be feasibly reported? Yes. This is a claims-based measure.
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? No. This measure is fully developed and has completed field testing (see supplemental document with updates to the MUC list)This is a new measure that has not been submitted for NQF endorsement.
  
  
• Measure development status: Early Development; Field Testing
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a. The measure is not in current use. The developer considered the potential adverse effects of making unfair comparisons among certain types of clinicians in assessing cost measure performance, and/or rewarding lower costs without appropriately balancing performance on quality.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a. The measure is not in use. During development, the developer considered the potential adverse events of reducing access to care and stinting care.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending, which is still predominantly paid on a fee-for-service (FFS) basis, also grew 3.6 percent, reaching $672.1 billion (CMS, 2018). However, this growth is slower than the previous two years due to a slow growth in spending for both Medicare FFS and Medicare Advantage. In the United States, Medicare is the largest single purchaser of health care, and successfully establishing payment models under MIPS can have significant impacts on reducing costs and making care more affordable (MedPAC, 2017). Urinary stone disease, or urolithiasis, is one of the most common and expensive urologic conditions. In the United States, one in 11 people will have a history of urinary stones in their lifetime, and approximately 50 percent of patients will experience a recurrence within 5 years of their first urinary stone (Scales et al., 2012). Urolithiasis is the second most expensive urologic problem, accounting for $2.1 billion of $11 billion spent annually on urologic diseases (NIH, 2007). From 2003 to 2007, the total expenditure among Medicare beneficiaries 65 and older for treatment of urinary tract stones exceeded $1.04 billion each year (HHS, 2012). Urolithiasis tends to be more severe in geriatric patients, who also have a two-fold increase risk of being hospitalized for treatment (Arampatzis et al., 2012). The treatment of urinary stones has a significant economic impact on health care spending, making this an important measure to establish to reduce costs related to renal and ureteral stone surgical treatment. Arampatzis, Spyridon, Gregor Lindner, Filiz Irmak, Georg-Christian Funk, Heinz Zimmermann, and Aristomenis K Exadaktylos. “Geriatric Urolithiasis in the Emergency Department: Risk Factors for Hospitalization and Emergency Management Patterns of Acute Urolithiasis.” BMC Nephrology, no.13, 2012, pp. 117. “Data Book: Health Care Spending and the Medicare Program.” MedPAC, 2017 Table 14-46. Economic Impact of Urologic Disease. In:Chapter 14. Litwin MS, Saigal CS, editors. Urologic Diseases in America. US Department of Health and Human Services, Public Health Service, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. Washington, DC: US Government Printing Office, 2012; NIH Publication No. 12-7865 pp. 486. “National Health Expenditure Projections, 2017-2026.” US Centers for Medicare & Medicaid Services, 2018. “Urologic Diseases Cost Americans $11 Billion a Year.” National Institutes of Health, 2007. Scales, Jr. Charles D, Alexandria C Smith, Janet M Hanley, Christopher S Saigal, and Urologic Diseases in America Project. “Prevalence of Kidney Stones in the United States.” European Urology, vol. 62, no. 1, 2012, pp. 160-165.

Measure Specifications This measure's specifications have been modified. Please consult this Document for more information.

• NQF Number (if applicable):
  
  
• Description: The Hemodialysis Access Creation Measure is meant to apply to clinicians who perform this procedure for Medicare beneficiaries. This procedural episode captures patients who undergo a procedure for the creation of access for long-term hemodialysis. The measure evaluates a clinician’s risk-adjusted cost for the episode group by averaging it across all episodes attributed to the clinician during the performance period. The cost of each episode is the sum of the cost to Medicare for assigned services performed by the attributed clinician and other healthcare providers during the episode window.
  
  
• Numerator: The numerator for the Hemodialysis Access Creation measure is the sum of the ratio of observed to expected payment-standardized cost to Medicare for all episodes attributed to a clinician. This sum is then multiplied by the national average observed episode cost to generate a dollar figure. Mathematically, this is represented as: sum of (observed episode cost/expected episode cost) * national average observed cost.
  
  
• Denominator: The denominator for the Hemodialysis Access Creation measure is the total number of episodes from this episode group attributed to a clinician.
  
  
• Exclusions: The following episode-level exclusions apply: (a) The beneficiary has a primary payer other than Medicare for any amount of time overlapping the episode window or in the lookback period. (b) No attributed clinician is found for the episode. (c) The beneficiary’s date of birth is missing. (d) The beneficiary’s death date occurred before the episode ended. (e) The beneficiary was not enrolled in Medicare Part A and B for the entirety of the lookback period plus episode window, or is enrolled in Part C for any part of the lookback period plus episode window. (f) The episode trigger claim was not performed in an office, IP, OP, or ASC setting based on its place of service. Exclusions specific to the Hemodialysis Access Creation measure are developed with input from the Peripheral Vascular Disease Management Clinical Subcommittee.
  
  
• HHS NQS Priority: Make Care Affordable
  
  
• HHS Data Source: Claims
  
  
• Measure Type: Cost/Resource Use
  
  
• Steward: Centers for Medicare & Medicaid Services
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Patient-focused Episode of Care
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support with the condition of NQF endorsement.
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure assesses the cost of services performed by providers during the patient-focused episode of care.
  • Impact on quality of care for patients:This measure is a cost and resource use measure. This measure should be submitted to NQF for review and endorsement .
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority of making care affordable and specifically addresses a patient-focused episode of care.
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. The measure is a newly developed cost measure. Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending, which is still predominantly paid on a fee-for-service (FFS) basis, also grew 3.6 percent, reaching $672.1 billion (CMS, 2018)
  
  
• Does the measure address a quality challenge? Yes. Policymakers contend that an estimated 80 percent of overall health care costs are attributable to decisions made by clinicians (Fred, 2016). However, these same clinicians are often unaware of how their care decisions influence the overall costs of care. One of the goals for using cost measures is to help inform clinicians on the costs attributable to their decision making, as well as the total cost of their patient’s care.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative of other measures in the program and the measure captures a broad population. This measure is new and is not in use in any program.
  
  
• Can the measure can be feasibly reported? Yes. This is a claims-based measure.
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? No. This measure is fully developed and has completed field testing (see supplemental document with updates to the MUC list)This is a new measure that has not been submitted for NQF endorsement.
  
  
• Measure development status: Early Development; Field Testing
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a. The measure is not in current use. The developer considered the potential adverse effects of making unfair comparisons among certain types of clinicians in assessing cost measure performance, and/or rewarding lower costs without appropriately balancing performance on quality.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a. The measure is not in use. During development, the developer considered the potential adverse events of reducing access to care and stinting care.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending, which is still predominantly paid on a fee-for-service (FFS) basis, also grew 3.6 percent, reaching $672.1 billion (CMS, 2018). However, this growth is slower than the previous two years due to a slow growth in spending for both Medicare FFS and Medicare Advantage. In the United States, Medicare is the largest single purchaser of health care, and successfully establishing payment models under MIPS can have significant impacts on reducing costs and making care more affordable (MedPAC, 2017). Because of a growing and aging population, the prevalence of beneficiaries with end-stage renal disease (ESRD) and enrollment for dialysis is rising (Ahmed et al., 2018). In 2015, there were 124,114 newly reported cases of ESRD, reaching a total of 703,243 people with ESRD for the year (NIH, 2017). Over 207,000 of those individuals were aged 65 and older, and accounted for approximately half of all individuals who received hemodialysis access for that year, which is a 22 percent increase from 2010 (NIH, 2017). The number ESRD cases increases by approximately 20,000 per year, with individuals aged 65 to 75 having the highest prevalence of ESRD and individuals aged 75 and older having the highest rate of new ESRD cases (NIH, 2017). Though the ESRD population is less than 1 percent of the total Medicare population, they accounted for 7.1 percent of Medicare spending in 2015. The United States Renal Data System (USRDS) 2017 Annual Data Report found that Medicare spent $33.9 billion on beneficiaries with ESRD, and when combined with the cost of Chronic Kidney Disease (CKD), a total of over $98 billion. For hemodialysis care, Medicare spent a total of $88,750 per patient per year, excluding unknown modalities, and $1,677 for vascular access procedures (procedures to place or create vascular accesses and procedures to maintain them) (NIH, 2017). Ahmed, Osman, Ketan Patel, Rana Rabei, Mikin V Patel, Michael Ginsburg, Bishir Clayton, and Bulent Arslan. "Hemodialysis Access Maintenance in the Medicare Population: An Analysis Over a Decade of Trends by Provider Specialty and Site of Service." Journal Of Vascular And Interventional Radiology, JVIR vol. 29, no. 2, 2018, pp. 159-169 “Data Book: Health Care Spending and the Medicare Program.” MedPAC, 2017 “National Health Expenditure Projections, 2017-2026.” US Centers for Medicare & Medicaid Services, 2018. United States Renal Data System, 2017 Annual Data Report: Epidemiology of Kidney Disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2017.

Measure Specifications This measure's specifications have been modified. Please consult this Document for more information.

• NQF Number (if applicable):
  
  
• Description: The Elective Primary Hip Arthroplasty Measure is meant to apply to clinicians who perform this procedure for Medicare beneficiaries. This procedural episode captures patients who undergo elective primary hip arthroplasty. The measure evaluates a clinician’s risk-adjusted cost for the episode group by averaging it across all episodes attributed to the clinician during the performance period. The cost of each episode is the sum of the cost to Medicare for assigned services performed by the attributed clinician and other healthcare providers during the episode window.
  
  
• Numerator: The numerator for the Elective Primary Hip Arthroplasty measure is the sum of the ratio of observed to expected payment-standardized cost to Medicare for all episodes attributed to a clinician. This sum is then multiplied by the national average observed episode cost to generate a dollar figure. Mathematically, this is represented as: sum of (observed episode cost/expected episode cost) * national average observed cost.
  
  
• Denominator: The denominator for the Elective Primary Hip Arthroplasty measure is the total number of episodes from this episode group attributed to a clinician.
  
  
• Exclusions: The following episode-level exclusions apply: (a) The beneficiary has a primary payer other than Medicare for any amount of time overlapping the episode window or in the lookback period. (b) No attributed clinician is found for the episode. (c) The beneficiary’s date of birth is missing. (d) The beneficiary’s death date occurred before the episode ended. (e) The beneficiary was not enrolled in Medicare Part A and B for the entirety of the lookback period plus episode window, or is enrolled in Part C for any part of the lookback period plus episode window. (f) The episode trigger claim was not performed in an office, IP, OP, or ASC setting based on its place of service. Exclusions specific to the Elective Primary Hip Arthroplasty measure are developed with input from the Musculoskeletal Disease Management - Non-Spine Clinical Subcommittee.
  
  
• HHS NQS Priority: Make Care Affordable
  
  
• HHS Data Source: Claims
  
  
• Measure Type: Cost/Resource Use
  
  
• Steward: Centers for Medicare & Medicaid Services
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Patient-focused Episode of Care
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support with the condition of NQF endorsement.
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure assesses the cost of services performed by providers during the patient-focused episode of care.
  • Impact on quality of care for patients:This measure is a cost and resource use measure. This measure should be submitted to NQF for review and endorsement .
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority of making care affordable and specifically addresses a patient-focused episode of care.
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. The measure is a newly developed cost measure. Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending, which is still predominantly paid on a fee-for-service (FFS) basis, also grew 3.6 percent, reaching $672.1 billion (CMS, 2018)
  
  
• Does the measure address a quality challenge? Yes. Policymakers contend that an estimated 80 percent of overall health care costs are attributable to decisions made by clinicians (Fred, 2016). However, these same clinicians are often unaware of how their care decisions influence the overall costs of care. One of the goals for using cost measures is to help inform clinicians on the costs attributable to their decision making, as well as the total cost of their patient’s care.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative of other measures in the program and the measure captures a broad population. This measure is new and is not in use in any program.
  
  
• Can the measure can be feasibly reported? Yes. This is a claims-based measure.
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? No. This measure is fully developed and has completed field testing (see supplemental document with updates to the MUC list)This is a new measure that has not been submitted for NQF endorsement.
  
  
• Measure development status: Early Development; Field Testing
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a. The measure is not in current use. The developer considered the potential adverse effects of making unfair comparisons among certain types of clinicians in assessing cost measure performance, and/or rewarding lower costs without appropriately balancing performance on quality.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a. The measure is not in use. During development, the developer considered the potential adverse events of reducing access to care and stinting care.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending, which is still predominantly paid on a fee-for-service (FFS) basis, also grew 3.6 percent, reaching $672.1 billion (CMS, 2018). However, this growth is slower than the previous two years due to a slow growth in spending for both Medicare FFS and Medicare Advantage. In the United States, Medicare is the largest single purchaser of health care, and successfully establishing payment models under MIPS can have significant impacts on reducing costs and making care more affordable (MedPAC, 2017). Joint replacement surgery is a common procedure in the older population. According to a 2015 study, the 2010 prevalence of total hip replacement in the United States population was 0.83 percent, and increased with age, reaching 1.49 percent at sixty years, and 5.87 percent at ninety years of age. There were an estimated 2.5 million individuals with total hip replacement in 2010, and the demand for primary Total Hip Arthroplasties (THAs) is estimated to grow by 174 percent between 2005 and 2030 (Kremers et al., 2015; Kurtz et al., 2007). Studies also suggest that hip arthroplasty accounts for a significant share of Medicare spending. A 2008 study found that the utilization of elective joint arthroplasty increases and Medicare becomes the primary payer after age 65 for these arthroplasties (Matlock, 2008). A 2016 study estimated that CMS payments per episode totaled between $18,030 and $21,661, depending on the presence of obesity (Meller et al., 2016). Hospital reimbursement for total hip replacement and knee replacement represented the largest payment group for CMS in 2008, combining for 4.6% of total payments (AHD, 2013). American Hospital Directory (AHD). American Hospital Directory, 2013. Available at: http://www.ahd.com/ip_ipps08.html. Accessed January 29, 2014. “Data Book: Health Care Spending and the Medicare Program.” MedPAC, 2017 Kremers et al. (2015). “Prevalence of Total Hip and Knee Replacement in the United States.” Journal of Bone and Joint Surgery 97(17):1386-97. Kurtz et al. (2007). “Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030.” Journal of Bone and Joint Surgery 89(4):780-5. Matlock, Dan. (2008). “Utilization of Elective Hip and Knee Arthroplasty by Age and Payer.” Clinical Orthopaedics and Related Research 466(4): 914-919. Meller, M. M., et al. (2016). "Surgical Risks and Costs of Care are Greater in Patients Who Are Super Obese and Undergoing THA." Clinical Orthopaedics and Related Research 474(11): 2472-2481. “National Health Expenditure Projections, 2017-2026.” US Centers for Medicare & Medicaid Services, 2018.

Measure Specifications This measure's specifications have been modified. Please consult this Document for more information.

• NQF Number (if applicable):
  
  
• Description: The Non-Emergent Coronary Artery Bypass Graft (CABG) Measure is meant to apply to clinicians who perform this procedure for Medicare beneficiaries. This procedural episode captures patients who undergo a CABG procedure. The measure evaluates a clinician’s risk-adjusted cost for the episode group by averaging it across all episodes attributed to the clinician during the performance period. The cost of each episode is the sum of the cost to Medicare for assigned services performed by the attributed clinician and other healthcare providers during the episode window.
  
  
• Numerator: The numerator for the Non-Emergent Coronary Artery Bypass Graft (CABG) measure is the sum of the ratio of observed to expected payment-standardized cost to Medicare for all episodes attributed to a clinician. This sum is then multiplied by the national average observed episode cost to generate a dollar figure. Mathematically, this is represented as: sum of (observed episode cost/expected episode cost) * national average observed cost.
  
  
• Denominator: The denominator for the Non-Emergent Coronary Artery Bypass Graft (CABG) measure is the total number of episodes from this episode group attributed to a clinician.
  
  
• Exclusions: The following episode-level exclusions apply: (a) The beneficiary has a primary payer other than Medicare for any amount of time overlapping the episode window or in the lookback period. (b) No attributed clinician is found for the episode. (c) The beneficiary’s date of birth is missing. (d) The beneficiary’s death date occurred before the episode ended. (e) The beneficiary was not enrolled in Medicare Part A and B for the entirety of the lookback period plus episode window, or is enrolled in Part C for any part of the lookback period plus episode window. (f) The episode trigger claim was not performed in an office, IP, OP, or ASC setting based on its place of service. Exclusions specific to the Non-Emergent CABG measure are developed with input from the Cardiovascular Disease Management Clinical Subcommittee.
  
  
• HHS NQS Priority: Make Care Affordable
  
  
• HHS Data Source: Claims
  
  
• Measure Type: Cost/Resource Use
  
  
• Steward: Centers for Medicare & Medicaid Services
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Patient-focused Episode of Care
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support with the condition of NQF endorsement.
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure assesses the cost of services performed by providers during the patient-focused episode of care.
  • Impact on quality of care for patients:This measure is a cost and resource use measure. This measure should be submitted to NQF for review and endorsement .
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority of making care affordable and specifically addresses a patient-focused episode of care.
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. The measure is a newly developed cost measure. Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending, which is still predominantly paid on a fee-for-service (FFS) basis, also grew 3.6 percent, reaching $672.1 billion (CMS, 2018)
  
  
• Does the measure address a quality challenge? Yes. Policymakers contend that an estimated 80 percent of overall health care costs are attributable to decisions made by clinicians (Fred, 2016). However, these same clinicians are often unaware of how their care decisions influence the overall costs of care. One of the goals for using cost measures is to help inform clinicians on the costs attributable to their decision making, as well as the total cost of their patient’s care.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative of other measures in the program and the measure captures a broad population. This measure is new and is not in use in any program.
  
  
• Can the measure can be feasibly reported? Yes. This is a claims-based measure.
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? No. This measure is fully developed and has completed field testing (see supplemental document with updates to the MUC list)This is a new measure that has not been submitted for NQF endorsement.
  
  
• Measure development status: Early Development; Field Testing
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a. The measure is not in current use. The developer considered the potential adverse effects of making unfair comparisons among certain types of clinicians in assessing cost measure performance, and/or rewarding lower costs without appropriately balancing performance on quality.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a. The measure is not in use. During development, the developer considered the potential adverse events of reducing access to care and stinting care.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending, which is still predominantly paid on a fee-for-service (FFS) basis, also grew by 3.6 percent, reaching $672.1 billion (CMS, 2018). However, this growth is slower than the previous two years due to a slow growth in spending for both Medicare FFS and Medicare Advantage. In the United States, Medicare is the largest single purchaser of health care, and successfully establishing payment models under MIPS can have significant impacts on reducing costs and making care more affordable (MedPAC, 2017). CABG is a major component of the management of advanced coronary artery disease (CAD), although its use has decreased since 2000. According to a 2016 study, an average of approximately 100,000 Medicare beneficiaries underwent CABG surgery annually between 2000 and 2012 with a steady decline in the number of procedures performed from 131,385 in 2000 to 71,086 in 2012 (McNeely et al., 2016). A 2011 study using Medicare outpatient hospital claims and the Healthcare Cost and Utilization Project’s Nationwide Inpatient Sample for data between 2001 and 2008 found that the annual CABG surgery rate in the United States decreased from about 17 per 10,000 adults in 2001 to about 11 per 10,000 adults in 2008 (Epstein et al., 2011). This decline is due in part to changes in patient populations and treatment options, including wider use of coronary stenting. Still, CABG remains a standard therapy and one of the most commonly used treatment options for CAD in patients with multi-vessel disease or diabetes (ElBardissi et al., 2012). ElBardissi, Andrew W., Sary F. Aranki, Shubin Sheng, Sean M. O'Brien, Caprice C. Greenberg, and James S. Gammie. "Trends in Isolated Coronary Artery Bypass Grafting: An Analysis of the Society of Thoracic Surgeons Adult Cardiac Surgery Database." The Journal of Thoracic and Cardiovascular Surgery 143, no. 2 (2012): 273-81. Epstein, Andrew J., Daniel Polsky, Feifei Yang, Lin Yang, and Peter W. Groeneveld. "Coronary Revascularization Trends in the United States, 2001-2008." JAMA 305, no. 17 (2011): 1769-76. “Data Book: Health Care Spending and the Medicare Program.” MedPAC, 2017 McNeely, Christian, Stephen Markwell, and Christina Vassileva. "Trends in Patient Characteristics and Outcomes of Coronary Artery Bypass Grafting in the 2000 to 2012 Medicare Population." The Annals Of Thoracic Surgery 102, no. 1 (2016): 132-38. “National Health Expenditure Projections, 2017-2026.” US Centers for Medicare & Medicaid Services, 2018.

Measure Specifications This measure's specifications have been modified. Please consult this Document for more information.

• NQF Number (if applicable):
  
  
• Description: MSPB is a payment-standardized, risk-adjusted cost measure focused on clinicians (TIN-NPIs) / clinician groups (TINs) providing care at acute inpatient hospitals. The measure is an average of risk-adjusted costs across all episodes. Each MSPB episode has a window spanning from three days prior to the index inpatient admission through 30 days after discharge. The measure attributes all Medicare Part A and B costs occurring in the episode window to the clinician(s) responsible for care, as identified for medical MS-DRGs through the use of an E&M threshold and for surgical MS-DRGs by identification of the physician performing the core procedure of the stay.
  
  
• Numerator: The numerator for the measure is the sum of the ratio of payment-standardized observed to expected MSPB episode costs for all MSPB episodes for the TIN-NPI or TIN. The sum of the ratios is then multiplied by the national average payment-standardized observed episode cost, to convert the ratio to a dollar amount.
  
  
• Denominator: The denominator for the MSPB measure is the total number of MSPB episodes for the TIN-NPI or TIN.
  
  
• Exclusions: The MSPB measure assesses costs during episodes of care initiated by acute inpatient hospital stays. Episodes for a beneficiary are excluded from the MSPB measure if they meet any of the following conditions: - the beneficiary was not continuously enrolled in both Medicare Parts A and B from 93 days prior to the index admission through 30 days after discharge. - the beneficiary’s death occurred during the episode - the beneficiary is enrolled in a Medicare Advantage plan or Medicare is the secondary payer at any time during the episode window or 90-day lookback period. - the index admission for the episode did not occur in a subsection (d) hospital paid under the Inpatient Prospective Payment System (IPPS) or an acute hospital in Maryland. - the discharge of the index admission occurred in the last 30 days of the performance period - the index admission for the episode is involved in an acute-to-acute hospital transfer (i.e., the admission ends in a hospital transfer or begins because of a hospital transfer) - the index admission inpatient claim indicates a $0 actual payment or a $0 standardized payment After applying the exclusions outlined above, all remaining episodes are included in the calculation of the MSPB measure.
  
  
• HHS NQS Priority: Make Care Affordable
  
  
• HHS Data Source: Claims
  
  
• Measure Type: Cost/Resource Use
  
  
• Steward: Centers for Medicare & Medicaid Services
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Patient-focused Episode of Care
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support for rulemaking with the condition of NQF endorsement.
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure assesses the risk adjusted total total cost of care.
  • Impact on quality of care for patients:This measure is a cost and resource use measure. This measure should be submitted to NQF for review and endorsement.
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority of making care affordable and specifically addresses a risk-adjusted total cost of care.
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. The measure is a newly developed cost measure. Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending, which is still predominantly paid on a fee-for-service (FFS) basis, also grew 3.6 percent, reaching $672.1 billion (CMS, 2018)
  
  
• Does the measure address a quality challenge? Yes. Policymakers contend that an estimated 80 percent of overall health care costs are attributable to decisions made by clinicians (Fred, 2016). However, these same clinicians are often unaware of how their care decisions influence the overall costs of care. One of the goals for using cost measures is to help inform clinicians on the costs attributable to their decision making, as well as the total cost of their patient’s care.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative of other measures in the program and the measure captures a broad population. This measure is new and is not in use in any program.
  
  
• Can the measure can be feasibly reported? Yes. This is a claims-based measure.
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? No. This measure is undergoing substantial changes. The version of this measure under consideration has not been submitted for NQF endorsement.In addition, the developer notes attribution concerns that all-cost measures such as MSPB and TPCC could be holding providers accountable for costs that they may not have had the opportunity to influence.
  
  
• Measure development status: Early Development; Field Testing
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a. This version of the measure is not in current use. The developer considered the potential adverse effects of making unfair comparisons among certain types of clinicians in assessing cost measure performance, and/or rewarding lower costs without appropriately balancing performance on quality.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a. The measure is currently in use, but is undergoing substantial changes. During development, the developer considered the potential adverse events of reducing access to care and stinting care.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
CMS and Acumen, LLC are undertaking a re-evaluation of the MSPB clinician measure. The Blueprint for the CMS Measure Management System (V 13.0, May 2017) provides a basis for measure re-evaluation. This document describes a “CMS ad hoc review” as a “limited examination of the measure based on new information” (CMS 2017). This new information can come from a variety of sources including ongoing surveillance of the scientific literature or from stakeholders. In this case, the motivation for CMS and Acumen to pursue re-evaluation is to address stakeholder feedback received via public comment in 2016. As discussed further in the Recommendation for the Measure section, stakeholders expressed a desire for the measure to be more actionable for clinicians and more statistically reliable. Aside from these particular stakeholder concerns, the MSPB clinician measure continues to be important as a means of measuring Medicare spending. Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending is estimated to have increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending grew more slowly in 2017 than in the previous two years due to slowed growth in spending for both Medicare FFS and Medicare Advantage. Nonetheless, spending for Medicare, which is still predominantly paid on a fee-for-service (FFS) basis, still grew by 3.6 percent, reaching $672.1 billion (CMS, 2018). In 2016, Medicare FFS paid $183 billion for approximately 10 million Medicare inpatient admissions and 200 million outpatient services, which reflects a 2.3 percent increase in hospital spending per FFS beneficiary between 2015 and 2016 (MedPAC, 2018). In the United States, Medicare is the largest single purchaser of health care, and successfully establishing payment models under MIPS can have significant impacts on reducing costs and making care more affordable (MedPAC, 2017). “Blueprint for the CMS Measures Management System. Version 13.0.” US Centers for Medicare & Medicaid Services, 2017. “Data Book: Health Care Spending and the Medicare Program.” MedPAC, 2017. “National Health Expenditure Projections, 2017-2026.” US Centers for Medicare & Medicaid Services, 2018. “Report to the Congress: Medicare Payment Policy.” MedPAC, 2018.

Measure Specifications This measure's specifications have been modified. Please consult this Document for more information.

• NQF Number (if applicable): 2165
  
  
• Description: The Total Per Capita Cost (TPCC) measure is a payment-standardized, risk-adjusted, and specialty-adjusted cost measure focused on clinicians/clinician groups performing primary care services. The measure is an average of per capita costs (with the previously mentioned adjustments applied) across all attributed beneficiaries. The measure includes all Medicare Part A and B costs across all attributed beneficiaries.
  
  
• Numerator: The numerator for the measure is the sum of the risk-adjusted, specialty-adjusted Medicare Part A and Part B costs across all beneficiaries’ episodes of care attributed to a TIN or TIN-NPI.
  
  
• Denominator: The denominator for the measure is the number of all Medicare beneficiaries’ episodes of care who received Medicare-covered services and are attributed to a TIN or TIN-NPI during the performance period.
  
  
• Exclusions: Beneficiaries are excluded from the population measured if they meet any of the following conditions: - were not enrolled in both Medicare Part A and Part B for every month during the performance period, unless part year enrollment was the result of new enrollment or death - were enrolled in a private Medicare health plan (for example, a Medicare Advantage HMO/PPO or a Medicare private FFS plan) for any month during the performance period - resided outside the United States, its territories, and its possessions during any month of the performance period.
  
  
• HHS NQS Priority: Make Care Affordable
  
  
• HHS Data Source: Claims
  
  
• Measure Type: Cost/Resource Use
  
  
• Steward: Centers for Medicare & Medicaid Services
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Risk adjusted total cost of care
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support for rulemaking with the condition of NQF endorsement.
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure assesses the risk adjusted total total cost of care .
  • Impact on quality of care for patients:This measure is a cost and resource use measure. This version of the measure should be submitted to NQF for review and endorsement.
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority of making care affordable and specifically addresses a risk-adjusted total cost of care.
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. The measure is a newly developed cost measure. Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending, which is still predominantly paid on a fee-for-service (FFS) basis, also grew 3.6 percent, reaching $672.1 billion (CMS, 2018)
  
  
• Does the measure address a quality challenge? Yes. Policymakers contend that an estimated 80 percent of overall health care costs are attributable to decisions made by clinicians (Fred, 2016). However, these same clinicians are often unaware of how their care decisions influence the overall costs of care. One of the goals for using cost measures is to help inform clinicians on the costs attributable to their decision making, as well as the total cost of their patient’s care.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative of other measures in the program and the measure captures a broad population. This measure is new and is not in use in any program.
  
  
• Can the measure can be feasibly reported? Yes. This is a claims-based measure.
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? No. This measure is undergoing substantial changes. The version of this measure under consideration has not been submitted for NQF endorsement.In addition, the developer notes attribution concerns that all-cost measures such as MSPB and TPCC could be holding providers accountable for costs that they may not have had the opportunity to influence.
  
  
• Measure development status: Early Development; Field Testing
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a. This version of the measure is not in current use. The developer considered the potential adverse effects of making unfair comparisons among certain types of clinicians in assessing cost measure performance, and/or rewarding lower costs without appropriately balancing performance on quality.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a. The measure is currently in use but is undergoing substantial changes. During development, the developer considered the potential adverse events of reducing access to care and stinting care.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Failed Endorsement.
  
  

Rationale for measure provided by HHS
CMS and Acumen, LLC are undertaking a re-evaluation of the TPCC measure. The Blueprint for the CMS Measure Management System (V 13.0, May 2017) provides a basis for measure re-evaluation. This document describes a “CMS ad hoc review” as a “limited examination of the measure based on new information” (CMS 2017). This new information can come from a variety of sources including ongoing surveillance of the scientific literature or from stakeholders. In this case, the motivation for CMS and Acumen to pursue re-evaluation is to address stakeholder feedback received via public comment in 2016. As discussed further in the Recommendation for the Measure section, stakeholders expressed a desire for the measure to be more actionable for clinicians. Aside from these particular stakeholder concerns, the TPCC measure continues to be important as a means of measuring Medicare spending. Health expenditures continue to increase in the United States. According to the National Health Expenditure Accounts, total health care spending is estimated to have increased by 4.6 percent in 2017, reaching $3.5 trillion (CMS, 2018). Medicare spending grew more slowly in 2017 than in the previous two years due to slowed growth in spending for both Medicare FFS and Medicare Advantage. Nonetheless, spending for Medicare, which is still predominantly paid on a fee-for-service (FFS) basis, still grew by 3.6 percent, reaching $672.1 billion (CMS, 2018). Spending on services for physicians and other health professionals totaled $69.9 billion and accounted for 15 percent of Medicare FFS spending in 2016 (MedPAC, 2018). In the United States, Medicare is the largest single purchaser of health care, and successfully establishing payment models under MIPS can have significant impacts on reducing costs and making care more affordable (MedPAC, 2017). Given the focus of the TPCC measure, it is also worth focusing more specifically on the importance of establishing successful payment models for primary care management. The American Academy of Family Physicians (AAFP) notes that numerous studies have found reductions to the total cost of care for patients in a Patient-Centered Medical Home (PCMH), brought about by the provision of primary care management services, and ranging from 4.4% to 11.2% for especially high-cost, elderly patients (AAFP, 2018). 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. Another impact that primary care management can have is directing patients to lower cost hospitals for the provision of necessary inpatient services. Given these potential linkages between primary care management and cost savings, it is critical to measure the costs of primary care management in a manner that captures broader healthcare costs influenced by primary care. “Blueprint for the CMS Measures Management System. Version 13.0.” US Centers for Medicare & Medicaid Services, 2017. “Data Book: Health Care Spending and the Medicare Program.” MedPAC, 2017. “National Health Expenditure Projections, 2017-2026.” US Centers for Medicare & Medicaid Services, 2018. “Report to the Congress: Medicare Payment Policy.” MedPAC, 2018. “Valuation of Care Management Performed by Primary Care Services: An Issue Brief.” American Academy of Family Physicians, 2018.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: 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.
  
  
• Numerator: Numerator 1 (N1): Members in Denominator 1 (D1) who received an influenza vaccine on or between July 1 of the year prior to the measurement period and June 30 of the measurement period. N2: Members in D2 who received at least 1 Td vaccine or 1 Tdap vaccine between 9 years prior to the start of the measurement period and the end of the measurement period. N3: Members in D3 who received at least 1 dose of the herpes zoster live vaccine or 2 doses of the herpes zoster recombinant vaccine anytime on or after the members 50th birthday. N4: Members in D4 who were administered both the 13-valent pneumococcal conjugate vaccine and the 23-valent pneumococcal polysaccharide vaccine at least 12 months apart, with the first occurrence after the age of 60. N5: The actual number of required immunizations administered to members in D5.
  
  
• Denominator: Denominator 1: Members age 19 and older at the start of the measurement period. Denominator 2: Members age 19 and older at the start of the measurement period. Denominator 3: Members age 50 and older at the start of the measurement period. Denominator 4: Members age 66 and older at the start of the measurement period. Denominator 5: The total number of possible immunizations required for members age 19 and older determined by their age at the start of the measurement period.
  
  
• Exclusions: Members with any of the following: - Prior anaphylactic reaction to the vaccine or its components any time during or before the measurement period. - History of encephalopathy within seven days after a previous dose of a Td-containing vaccine. - Active chemotherapy during the measurement period. - Bone marrow transplant during the measurement period. - History of immunocompromising conditions, cochlear implants, anatomic or functional asplenia, sickle cell anemia & HB-S disease or cerebrospinal fluid leaks any time during the member’s history prior to or during the measurement period. - In hospice or using hospice services during the measurement period.
  
  
• HHS NQS Priority: Promote Effective Prevention & Treatment of Chronic Disease
  
  
• HHS Data Source: Administrative clinical data, Claims, EHR, Facility Discharge Data, Other, Registry
  
  
• Measure Type: Composite
  
  
• Steward: National Committee for Quality Assurance
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Preventive Care
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional Support with the Condition of NQF Endorsement
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure would encourage the use of evidence based practices to improve adult vaccination coverage. These vaccines can improve health and decrease health care costs by preventing severe disease and hospitalization.
  • Impact on quality of care for patients:This measure is a composite measure that evaluates receipt of all routine vaccines for the adult population.
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority of promoting effective prevention and treatment of chronic disease and specifically addresses preventative care.
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. This measure is a process measure. It is a composite measure that includes NQF endorsed measures, 1653, 0043, 0682, 0683, 0039, 0041, 1659, 0680, 0681, and 0431. The Advisory Committee on Immunization Practices (ACIP) recommends annual influenza vaccination; and tetanus, diphtheria and acellular pertussis (Tdap) and/or tetanus and diphtheria (Td) vaccine; herpes zoster vaccine; and the 13-valent pneumococcal conjugate vaccine (PCV13) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23) for adults at various ages.
  
  
• Does the measure address a quality challenge? Yes. This measure assesses the immuzations for all routine vaccines recommended for adults.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is the only measure that assesses receipt of all routine vaccines for the adult population. However, sub components of this measure could be related or competing measures.
  
  
• Can the measure can be feasibly reported? Yes. The developer states that in field testing, three health plans each with commercial, Medicaid and Medicare lines of business reported data for approximately 6.6 million enrolled adults ages 19 and older.
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? No. The measure was tested at the health plan level.
  
  
• Measure development status: Field Testing; Fully Developed
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Vaccines are recommended for adults to prevent serious diseases. Routine vaccination against influenza, tetanus, diphtheria and pertussis is recommended for all adults, while vaccines for herpes zoster and pneumococcal disease are recommended for older adults (Kim et al. 2017). Administration of the influenza, Tdap/Td, herpes zoster and pneumococcal vaccines can improve health and decrease health care costs by preventing severe disease and hospitalization. Evidence supporting administration of each individual vaccine follows. Influenza The influenza vaccine protects against influenza, a serious disease that can lead to hospitalization and death (Centers for Disease Control and Prevention [CDC] 2016a), particularly among older adults and vulnerable populations. It is characterized by a variety of symptoms related to the nose, throat and lungs that can range in severity (CDC 2015a), and it is easily spread (CDC 2016a). Although anyone can get the flu, people 65 and older, pregnant women, young children and those with chronic conditions are at higher risk of developing serious complications (CDC 2016a). Influenza can have severe consequences. The CDC estimates that since 2010, yearly influenza cases have ranged from 9.2-35.6 million; influenza-related hospitalizations, from 140,000-710,000; and influenza-related deaths, from 12,000-56,000 (CDC 2017a). Deaths associated with influenza are typically higher in older adults. In an analysis based on the 2010-2011 and 2012-2013 flu seasons, 71 percent-85 percent of deaths from influenza were among adults 65 and older (Grohskopf et al. 2016). Influenza is a leading cause of outpatient medical visits and worker absenteeism among adults. The average annual burden of seasonal influenza among adults 18-49 includes approximately 5 million illnesses, 2.4 million outpatient visits, 32,000 hospitalizations and 680 deaths (Grohskopf et al. 2016). A study in 2016 estimated that the cost-effectiveness ratio of the influenza vaccine was approximately $100,000 per quality-adjusted life year (Xu et al 2016). ACIP recommends routine annual influenza vaccination for all people 6 months of age and older (Grohskopf et al. 2017). For people 19 and older, any age-appropriate inactivated influenza vaccine (IIV) formulation or recombinant influenza vaccine (RIV) formulation are acceptable options. ACIP notes that live attenuated influenza vaccine (LAIV) should not be used during the 2017-2018 season for any population. Vaccination should occur before the onset of influenza activity in the community, ideally by the end of October; however, vaccination efforts should continue throughout flu season into February and March (Grohskopf et al. 2017). People who have a history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine should not receive the influenza vaccine (CDC 2017b). Td/Tdap vaccine Tetanus, diphtheria and pertussis can have serious health effects. Tetanus results in painful muscle spasms that can cause fractures, difficulty breathing, arrhythmia and death (CDC 2015b). Complications from diphtheria include myocarditis, which can lead to heart failure, and neuritis, which may temporarily paralyze motor nerves. Death occurs in 5-10 percent of cases (CDC 2015c). Pertussis, also known as whooping cough, is a respiratory infection characterized by a prolonged cough; it is highly communicable, and infection can lead to secondary pneumonia, the most common cause of pertussis-related deaths (CDC 2015d). Due to vaccines, tetanus and diphtheria are now uncommon. On average, there were 29 reported cases of tetanus per year from 1996-2009, and nearly all were among people who had never received a tetanus vaccine or were not up to date on their booster shots (CDC 2013). In the past decade, fewer than 5 diphtheria cases were reported to the CDC, although the disease is more prevalent in other countries: In 2014, 7,321 cases of diphtheria were reported to the World Health Organization, and there are likely many more unreported cases (CDC 2016b). Pertussis is much more prevalent today than tetanus and diphtheria, even though vaccines offer protection against the disease. Before the vaccine was introduced in the 1940s, there were about 200,000 cases of pertussis annually (CDC 2015d). Since widespread use of the vaccine, pertussis cases have decreased by 80 percent (CDC 2015d). However, pertussis cases have been increasing since the 1980s; currently, there are 10,000-40,000 pertussis cases and up to 20 deaths reported each year (CDC 2015d). Pertussis is usually milder in children, adolescents and adults than in infants and young children who may not be fully immunized. Older adults are often the source of infection for infants and children (CDC 2015d). Administering the Tdap vaccine to adults helps prevent the spread of pertussis to infants and prevents such hospitalizations; in 2010, the average cost of hospitalizing an infant with pertussis was $16,339, an increase from $12,377 in 2000 (Davis 2014). Because there has been a rise in pertussis over the past several decades in the U.S., studies have evaluated the cost-effectiveness of providing Tdap immunizations to adults. One study found that providing a dose of Tdap to people at age 11 or 12, as currently recommended, and again at age 21, could reduce outpatient visits for pertussis by 4 percent and hospitalizations for pertussis by 5 percent; costs per quality-adjusted life years saved would be $204,556 (Kamiya et al. 2016). Another study found that vaccinating all adults 2-64 at least once with Tdap is cost-effective (<$50,000 per quality-adjusted life years) if pertussis incidence in adults is greater than 120 cases per 100,000 people (Lee et al. 2007). McGarry et al. found that vaccinating all adults ages 65 and older with Tdap is a cost-effective intervention and would prevent 97,000 cases of pertussis annually—from the payer perspective, it would provide a net cost savings of $44.8 million (2014). ACIP recommends that all adults 19 and older who have not yet received a dose of Tdap receive a single dose (ACIP 2012; ACIP 2011). Tdap should be administered regardless of the interval since the last tetanus or diphtheria toxoid-containing vaccine. Adults 19 and older should receive a decennial Td vaccine booster, beginning 10 years after receipt of the Tdap vaccine (Kretsinger et al. 2006). People who have a history of severe allergic reaction (e.g., anaphylaxis) to any component of the Tdap or Td vaccine should not receive it. Tdap is contraindicated for adults with a history of encephalopathy (e.g., coma or prolonged seizures) not attributable to an identifiable cause within seven days of administration of a vaccine with pertussis components (CDC 2017b). Herpes zoster vaccine The herpes zoster vaccine protects against herpes zoster, commonly known as shingles. Herpes zoster is a painful skin rash caused by reactivation of the varicella zoster virus (CDC 2016c). After a person recovers from primary infection of varicella (chickenpox), the virus stays inactive in the body and can reactivate years later. Most people typically only have one episode of herpes zoster, but second or third episodes are possible. People with compromised immune systems are at higher risk of developing herpes zoster (CDC 2016c). The most common complication of herpes zoster is post-herpetic neuralgia (PHN) (CDC 2016c), which is severe, debilitating pain at the site of the rash that has no treatment or cure. Herpes zoster can also lead to serious complications of the eye, pneumonia, hearing problems, blindness, encephalitis or death (CDC 2016d). In the U.S., there are 1 million new cases of herpes zoster each year; 1 of every 3 people will be diagnosed with herpes zoster in their lifetime (CDC 2016c). A person’s risk for developing herpes zoster increases sharply after age 50 (CDC 2016c). As people age, they are more likely to develop PHN; it rarely occurs in people under 40, but can be seen in a third of untreated adults 60 and older (CDC 2016c). Between 1 and 4 percent of adults with herpes zoster are hospitalized for complications, and an estimated 96 deaths each year are directly caused by the virus (CDC 2016c). The vaccine can reduce the risk of developing herpes zoster and PHN. In 2011, total annual direct medical costs in the U.S. from herpes zoster were estimated to be $1.9 million; costs are expected to rise as the population ages (Friesen et al. 2017). A study of the cost-effectiveness of the herpes zoster vaccine among people at 50, 60 and 70 years found that vaccination at age 60 would prevent the most cases (26,147 cases per 1 million people), compared with vaccination at 50 or 70 (Hales et al. 2014). It also found that vaccination at 60 costs $86,000 per quality-adjusted life year, compared with $37,000 at 70 and $287,000 at 50 (Hales et a. 2014). There are currently two types of zoster vaccines recommended for older adults: the zoster vaccine live (ZVL) and a recombinant zoster vaccine (RZV). The ZVL is a 1-dose vaccine licensed for immunocompetent adults 50 and older; ACIP recommends ZVL for immunocompetent adults 60 and older. ZVL vaccine coverage for adults 60 and older has increased each year since ACIP first recommended it in 2008 (Dooling et al. 2018). In October 2017, the Food and Drug Administration approved the RZV for adults 50 and older. In January 2018, ACIP published a guideline recommending RZV for immunocompetent adults 50 and older, irrespective of prior receipt of varicella vaccine or ZVL (Dooling et al. 2018). RZV is a two-dose series; the second dose should be given 2-6 months after the first dose. If the second dose of RZV is given less than four weeks after the first, the second dose should be repeated; if the second dose is more than six months after the first dose, the vaccine series need not be restarted although individuals may be at higher risk for zoster. ZVL remains a recommended vaccine for immunocompetent adults 60 and older (Dooling et al. 2018). Patients with a severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component should not receive either zoster vaccine (Dooling et al. 2018). Pneumococcal vaccine Vaccines protect against pneumococcal disease, which is a common cause of illness and death in older adults and in persons with certain underlying conditions. The major clinical syndromes of pneumococcal disease include pneumonia, bacteremia and meningitis, with pneumonia being the most common (CDC 2015e). Pneumonia symptoms generally include fever, chills, pleuritic chest pain, cough with sputum, dyspnea, tachypnea, hypoxia tachycardia, malaise and weakness. There are an estimated 400,000 cases of pneumonia in the U.S. each year and a 5-7 percent mortality rate, although it may be higher among older adults and adults in nursing homes (CDC 2015f; Janssens and Krause 2004). Bacteremia, a blood infection, is another complication of pneumococcal disease (CDC 2015f). Approximately 30 percent of patients with pneumonia also have bacteremia, and 12,000 patients have bacteremia without pneumonia each year (CDC 2015f). Bacteremia has a 20 percent mortality rate among all adults and a 60 percent mortality rate among older adults. Pneumococcal disease causes 3,000-6,000 cases of meningitis each year (CDC 2015f). Meningitis symptoms may include headache, lethargy, vomiting, irritability, fever, nuchal rigidity, cranial nerve signs, seizures and coma. Meningitis has a 22 percent mortality rate among adults (CDC 2015f). Pneumococcal infections result in significant health care costs each year. Geriatric patients with pneumonia require hospitalization in nearly 90 percent of cases, and their average length of stay is twice that of younger adults (Janssens and Krause 2004). Pneumonia in the older adult population is associated with high acute-care costs and an overall impact on total direct medical costs and mortality during and after an acute episode (Thomas et al. 2012). Total medical costs for Medicare beneficiaries during and one year following a hospitalization for pneumonia were found to be $15,682 higher than matched beneficiaries without pneumonia (Thomas et al. 2012). It was estimated that in 2010, the total annual excess cost of hospital-treated pneumonia in the fee-for-service Medicare population was approximately $7 billion (Thomas et al. 2012). Pneumococcal vaccines have been shown to be highly effective in preventing invasive pneumococcal disease. When comparing costs, outcomes and quality adjusted life years, immunization with the two recommended pneumococcal vaccines was found to be more economically efficient than no vaccination, with an incremental cost-effectiveness ratio of $25,841 per quality-adjusted life year gained (Chen et al. 2014). There currently are two licensed pneumococcal vaccines in the U.S.: the 13-valent pneumococcal conjugate vaccine (PCV13) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23) (Kobayashi et al. 2015). For immunocompetent adults 65 and older who have not previously received pneumococcal vaccination, ACIP recommends a dose of PCV13, followed by a dose of PPSV23 one or more years later (Kobayashi et al. 2015). Immunocompetent adults 65 and older who received a dose of PPSV23 at younger than 65 should also receive a dose of PCV13 at least one year after the initial dose of PPSV23, and then another dose of PPSV23 at least 1 year after PCV13 and at least 5 years after the most recent dose of PPSV23 (Kobayashi et al. 2015). Adults should not receive either vaccine if they have had a severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component. Adults should not receive the PCV13 vaccine if they have had severe allergic reaction after any diphtheria-toxoid-containing vaccine (CDC 2017b).

Measure Specifications

• NQF Number (if applicable): 2950
  
  
• Description: The rate (XX out of 1,000) of individuals without cancer receiving prescriptions for opioids from four (4) or more prescribers AND four (4) or more pharmacies.
  
  
• Numerator: Any member in the denominator who received opioid prescription claims from 4 or more prescribers AND 4 or more pharmacies.
  
  
• Denominator: 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.
  
  
• Exclusions: Any member with a diagnosis for Cancer or a Prescription Drug Hierarchical Condition Category (RxHCC) 8, 9, 10, 11 for Payment Year 2015; or RxHCC 15, 16, 17, 18, or 19 for Payment Year 2016, or a hospice indicator from the enrollment database.
  
  
• HHS NQS Priority: Promote Effective Prevention & Treatment of Chronic Disease
  
  
• HHS Data Source: Administrative claims
  
  
• Measure Type: Process
  
  
• Steward: Pharmacy Quality Alliance
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Prevention and Treatment of Opioid and Substance Use Disorders
  
  
• Changes to Endorsed Measure Specifications?: The MUC list indicates the measure has not been modified from its endorsed version.
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support for rulemaking with the condition that duplication is considered between this measure and MUC2018-079
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure would encourage the monitoring of opioid prescription patterns as studies have shown that people who see multiple providers or use multiple pharmacies are more likely to die of drug overdoses.
  • Impact on quality of care for patients:This measure is fully developed, tested, and NQF endorsed. This measure would strengthen and diversify the SSP program measure set by addressing opioid use disorder treatment.
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority of promoting effective prevention and treatment of chronic disease and specifically addresses the prevention and treatment of opioid and substance use disorders
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. This is an NQF endorsed process measure. Evidence shows that abuse and overdose of prescription drugs is a major public health issue in the United States. Studies have shown that people who see multiple providers or use multiple pharmacies are more likely to die of drug overdoses. Clinical guidelines from the Centers for Disease Control and Prevention (CDC) encourage clinicians to use state prescription drug monitoring program (PDMP) data to determine whether their patient is receiving opioid dosages or combinations that put them at risk for overdose.
  
  
• Does the measure address a quality challenge? Yes. This measure addresses a critical population at increased risk of morbidity and mortality. According to the CDC, overdose involving opioid analgesics killed nearly 17,000 persons in 2010 and the number of people with opioid analgesic use disorders increased to nearly 2 million.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative of existing measures in the SSP. It should be noted; however, that this measure is a subcomponent of MUC2018-079, which is also under consideration by the MAP this year.
  
  
• Can the measure can be feasibly reported? Yes. Pilot test sites indicated the measure was feasible and results were able to be reported efficiently and accurately. CMS calculates the measure for Part D plans. The data is readily available (prescription claims data and medical data).
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? Yes. The measure has been endorsed at the health plan level.
  
  
• Measure development status: Fully Developed
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a. The measure is not in use in a federal program. However, it is currently being used by the CMS Medicare Part D Drug Benefit and Medicare Part D Overutilization Monitoring System to monitor the utilization of opioids for members with the Medicare drug benefit. No implementation issues have been noted by the developer.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a. The developer considered concerns have been that prescribing changes such as dose reduction (without offering or arranging evidence-based treatment for patients with opioid use disorder) might be associated with unintended negative consequences, such as patients seeking heroin or other illicitly obtained opioids (1,2) or interference with appropriate pain treatment. These were taken into consideration with the balance of the damages from the opioid epidemic.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Endorsed.
  
  

Rationale for measure provided by HHS
A PubMed search was conducted using combinations of the following search terms: opioid, overdose, doctor shopping, pharmacy shopping, multiple prescribers, multiple pharmacies. Articles referenced in the identified articles were scanned for relevance. The CDC Guideline and Clinical and Contextual Evidence Reviews were also reviewed for relevant references (CDC Guideline: Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain - United States, 2016. MMWR Recomm Rep. 2016 Mar 18;65(1):1-49. doi: 10.15585/mmwr.rr6501e1. Available at: http://www.cdc.gov/drugoverdose/prescribing/guideline.html.; CDC Clinical Evidence Review. Available at: http://stacks.cdc.gov/view/cdc/38026; CDC Contextual Evidence Review. Available at: http://stacks.cdc.gov/view/cdc/38027). Further information on evidence for the measure can be found on the “National Quality Forum - Measure Testing” document in Section 1a.8.2. (National Quality Forum - Measure Testing; Section 1a.8.1.)

Summary of NQF Endorsement Review

• Year of Most Recent Endorsement Review: 2017
  
  
• Project for Most Recent Endorsement Review: Patient Safety 2016
  
  
• Review for Importance: 1. Importance to Measure and Report: The measure meets the Importance criteria(1a. Evidence, 1b. Performance Gap)1a. Evidence: 0-H; 20-M; 0-L; 0-I 1b. Performance Gap: 13-H; 7-M; 0-L; 0-IRationale:• The evidence suggests that prescriptions for opioids from multiple prescribers and pharmaciescorrelate with undesired health outcomes. The use of multiple prescribers and pharmacies are 35associated with increased risks for opioid overdose. The Committee noted this is highlyimportant to measure given the current national opioid overuse problem.• The measure was tested in three different health plan data sources – the Medicare population(mean was 23.31 per 1,000 and the median was 26.12 per 1,000), one commercial heath plan(rate for this plan was 20.57 per 1,000), and the Medicaid population (mean was 72.28 per 1,000and the median was 69.93 per 1,000). The Committee noted that these rates demonstrate asignificant performance gap.
  
  
• Review for Scientific Acceptability: 2. Scientific Acceptability of Measure Properties: The measure meets the Scientific Acceptabilitycriteria(2a. Reliability - precise specifications, testing; 2b. Validity - testing, threats to validity)2a. Reliability: 9-H; 11-M; 0-L;0-I 2b. Validity: 19-M; 0-L; 1-IRationale:• The developer tested the measure at the score level using several data sets for reliability testing:o For Medicare testing, the analysis included a convenience sample of over 700 MedicarePart D prescription drug plans (comprising a total of 7,067,445 individuals aged 18 andolder)o Testing was also conducted in one Commercial health plan (comprising a total of209,191 individuals age 18 and older)o For Medicaid testing, the analysis included 8 state-based prescription drug planscovering 6 states (comprising a total of 1,437,410 individuals age 18 and older)• To demonstrate reliability, the developer conducted a signal-to-noise analysis of the computedmeasure score using a beta-binomial model.• The mean reliability score across all plans is 0.9355.• The developer assessed the face validity (only) of the measure using a technical expert panelfrom the Pharmacy Quality Alliance (PQA). 67 percent strongly agreed that the measure resultsreflected quality of care. Five PQA member organizations also tested the measure using theirown data, and all strongly agreed that the measure reflected the quality of care provided fortheir populations.
  
  
• Review for Feasibility: 3. Feasibility: 18-H; 2-M; 0-L; 0-I(3a. Clinical data generated during care delivery; 3b. Electronic sources; 3c.Susceptibility to inaccuracies/unintended consequences identified 3d. Data collection strategy can be implemented)Rationale:• All data elements are in defined field in electronic claims.• Pilot test sites indicated the measure was feasible and results were able to be reportedefficiently and accurately.
  
  
• Review for Usability: 4. Usability and Use: 10-H; 9-M; 1-L; 0-I(Used and useful to the intended audiences for 4a. Accountability and Transparency; 4b. Improvement;and 4c. Benefits outweigh evidence of unintended consequences)Rationale:• The measure is currently being used in the Medicare Part D Overutilization Monitoring Systemto monitor the utilization of opioids for members with the Medicare drug benefit.36• Although no unintended negative consequences to individuals or populations were identifiedduring testing, , concerns have been raised that prescribing changes such as dose reduction(without offering or arranging evidence-based treatment for patients with opioid use disorder)might be associated with unintended negative consequences, such as patients seeking heroin orother illicitly obtained opioids (1,2) or interference with appropriate pain treatment
  
  
• Review for Related and Competing Measures: 5. Related and Competing Measures• Measure 2940: Use of Opioids at high Dosage in Persons without Cancer- The proportion (XX outof 1,000) of individuals without cancer receiving prescriptions for opioids with a daily dosagegreater than 120mg morphine equivalent dose (MED) for 90 consecutive days or longer.• Measure 2951: Use of Opioids from Multiple Providers and at High Dosage in Persons withoutCancer- The proportion (XX out of 1,000) of individuals without cancer receiving prescriptionsfor opioids with a daily dosage greater than 120mg morphine equivalent dose (MED) for 90consecutive days or longer, AND who received opioid prescriptions from four (4) or moreprescribers AND four (4) or more pharmacies.• These measures are also being considered for endorsement. The Committee determined thatthey are related but not competing
  
  
• Endorsement Public Comments: 6. Public and Member CommentComment:The measure received 1 comment in support of the measure with a few recommendations for how themeasure could be improved.Developer Response:The recommendations in the 2015 American Geriatrics Society Beers Criteria are based on a systematicevidence review conducted by American Geriatrics Society Beers Criteria Expert Panel. The review isfocused on the evidence for potential harms of medications in older adults. Medications then includedin the Beers Criteria recommendations are those that the panel found evidence indicating that themedications should in general be avoided in all older adults or avoided in older adults with certainconditions or diseases, due to their associated risks for these populations. The Beers Criteria is updatedregularly based on currently available literature. We believe it's important for this quality measure to bebased on the systematic evidence review that is conducted by the Beers Criteria Expert Panel. Thecomplete evidence tables for the systematic review can be accessed on the American Geriatrics Society'swebsite here: http://geriatricscareonline.org/toc/american-geriatrics-society-updated-beers-criteria-forpotentially-inappropriate-medication-use-in-older-adults/CL001NCQA recognizes that some of the medications that are most attributable to adverse drug events inolder adults that result in ED visits and hospitalizations are not included in the Beers Criteria asmedications to be generally avoided (e.g., warfarin, antidiabetics and oral antiplatelets - although someoral antiplatelets are in fact included in the Beers Criteria and this measure: Dipyridamole, Ticlopidine).These other high-risk medications should be addressed in separate quality measures that focus on safeprescribing and appropriate monitoring, rather than this measure which focuses on medications thatshould be generally avoided. We agree with the need for such quality measures to improve safeprescribing of anticoagulants, antidiabetics, and opioids and have current work underway at NCQA to 37explore development of measures in these areas. Of note, the Pharmacy Quality Alliance has severalmeasures addressing opioid prescribing that are currently being considered for NQF endorsement aspart of this Patient Safety project. NCQA supports the endorsement of these measures and has plans toadapt them for health plan reporting in the near future.In terms of the way this measure is currently specified to include a number of different medications, webelieve that creating separate quality measures or indicators for all the specific medications in the BeersCriteria, or for each drug-disease interaction, would be burdensome for measurement and reporting byhealth plans. Plans can look at medications on an individual basis to see where improvements andinterventions are needed, however we do not think this level of detail would be desirable for nationalreporting by health plans.As a measure of potentially inappropriate medication use, NCQA does not expect this measure'sperformance to ever reach 0% (i.e., no prescribing of high-risk medications). There will always be caseswhere the benefits of prescribing a high-risk medication may outweigh the risks for certain patients.Clinicians should take into account various factors when considering the risk-benefit ratio of prescribinga high-risk medication to an individual. A companion paper to the Beers Criteria was published by theAmerican Geriatrics Society Workgroup on Improving Use of the Beers Criteria in 2015. The paperspecifically states "the AGS 2015 Beers Criteria are reasonable to use for performance measurementacross large groups of patients and providers but should not be used to judge care for any individual"(Steinman et al., 2015, JAGS). We believe measuring this concept of potentially inappropriatemedication use among elderly at the health plan (i.e., population) level is an important and usefulmedication safety measure that health plans can use to identify high-risk medication prescribing.Committee Response:The Committee agrees with the developer response and maintains their decision to recommend thismeasure for continued endorsement.
  
  
• Endorsement Committee Recommendation: Steering Committee Recommendation for Endorsement: 20-Y; 0-N
  
  

Measure Specifications

• NQF Number (if applicable): 2940
  
  
• Description: The rate (XX out of 1,000) of individuals without cancer receiving prescriptions for opioids with a daily dosage greater than 120 mg morphine equivalent dose (MED) for 90 consecutive days or longer.
  
  
• Numerator: Any member in the denominator with opioid prescription claims where the MED is greater than 120mg for 90 consecutive days or longer.
  
  
• Denominator: 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.
  
  
• Exclusions: Any member with a diagnosis for Cancer or a Prescription Drug Hierarchical Condition Category (RxHCC) 8, 9, 10, or 11 for Payment Year 2015; or RxHCC 15, 16, 17, 18, 19 for Payment Year 2016; or a hospice indicator (Medicare Part D) from the enrollment database.
  
  
• HHS NQS Priority: Promote Effective Prevention & Treatment of Chronic Disease
  
  
• HHS Data Source: Administrative claims
  
  
• Measure Type: Process
  
  
• Steward: Pharmacy Quality Alliance
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Prevention and Treatment of Opioid and Substance Use Disorders
  
  
• Changes to Endorsed Measure Specifications?: The MUC list indicates the measure has not been modified from its endorsed version.
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support for rulemaking with the condition that duplication is considered between this measure and MUC2018-079
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure would encourage the monitoring of opioid prescription patterns as studies have determined that patient populations taking high opioid doses for prolonged periods are often characterized by high rates of psychiatric and substance abuse disorders, frequently do not receive care consistent with clinical guidelines, and have higher death rates.
  • Impact on quality of care for patients:This measure is fully developed, tested, and NQF endorsed. This measure would strengthen and diversify the SSP program measure set by addressing opioid use disorder treatment.
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority of promoting effective prevention and treatment of chronic disease and specifically addresses the prevention and treatment of opioid and substance use disorders
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. This is an NQF endorsed process measure. Evidence shows that abuse and overdose of prescription drugs is a major public health issue in the United States. Studies have determined that patient populations taking high opioid doses for prolonged periods are often characterized by high rates of psychiatric and substance abuse disorders, frequently do not receive care consistent with clinical guidelines, and have higher death rates.
  
  
• Does the measure address a quality challenge? Yes. This measure addresses a critical population at increased risk of morbidity and mortality. According to the CDC, overdose involving opioid analgesics killed nearly 17,000 persons in 2010 and the number of people with opioid analgesic use disorders increased to nearly 2 million.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative of existing measures in the SSP. It should be noted; however, that this measure is a subcomponent of MUC2018-079, which is also under consideration by the MAP this year.
  
  
• Can the measure can be feasibly reported? Yes. Pilot test sites indicated the measure was feasible and results were able to be reported efficiently and accurately. CMS calculates the measure for Part D plans. The data is readily available (prescription claims data and medical data).
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? Yes. The measure has been endorsed at the health plan level.
  
  
• Measure development status: Fully Developed
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a. The measure is not in use in a federal program. However, it is currently being used by the CMS Medicare Part D Drug Benefit and Medicare Part D Overutilization Monitoring System to monitor the utilization of opioids for members with the Medicare drug benefit. No implementation issues have been noted by the developer.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a. The developer considered concerns have been that prescribing changes such as dose reduction (without offering or arranging evidence-based treatment for patients with opioid use disorder) might be associated with unintended negative consequences, such as patients seeking heroin or other illicitly obtained opioids (1,2) or interference with appropriate pain treatment. These were taken into consideration with the balance of the damages from the opioid epidemic.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Endorsed.
  
  

Rationale for measure provided by HHS
This measure received systematic review by Clinical Practice Guideline recommendation, other systematic review and grading of the body of evidence, and review by The Centers for Medicare and Medicaid (CMS) Part D Overutilization Monitoring System (OMS) and PubMed. Further information on evidence for the measure can be found on the “National Quality Forum - Measure Testing” document in Section 1a.8.2. (National Quality Forum - Measure Testing; Section 1a.8.1.)

Summary of NQF Endorsement Review

• Year of Most Recent Endorsement Review: 2017
  
  
• Project for Most Recent Endorsement Review: Patient Safety 2016
  
  
• Review for Importance: 1. Importance to Measure and Report: The measure meets the Importance criteria(1a. Evidence, 1b. Performance Gap)1a. Evidence: 16-H; 3-M; 0-L; 0-I; 1b. Performance Gap: 13-H; 7-M; 0-L; 0-IRationale:• The developer provided a systematic review of the evidence demonstrating the benefits of highdoseopioids for chronic pain are not established and the risks for serious harm related to opioidtherapy increases at higher doses.• Lower dosages of opioids reduce the risk for overdose, but a single dosage threshold for safeopioid use has not been identified.• The measure was tested in three different health plan data sources – the Medicare population(mean rate=39.27 per 1,000), one commercial heath plan (mean rate= 32.003 per 1,000), andthe Medicaid population (mean rate =34.04 per 1,000). The Committee noted that these ratesdemonstrate a significant performance gap.• The Committee noted this is highly important to measure given the current national opioidoveruse problem.
  
  
• Review for Scientific Acceptability: 2. Scientific Acceptability of Measure Properties: The measure meets the Scientific Acceptabilitycriteria(2a. Reliability - precise specifications, testing; 2b. Validity - testing, threats to validity)2a. Reliability: 13-H; 7-M; 0-L; 0-I 2b. Validity: 14-M; 7-L; 0-IRationale:• The developer used several data sets for reliability testing:o For Medicare testing, the analysis included a convenience sample of over 700 MedicarePart D prescription drug plans (comprising a total of 7,067,445 individuals aged 18 andolder)o Testing was also conducted in one Commercial health plan (comprising a total of209,191 individuals age 18 and older)o For Medicaid testing, the analysis included 8 state-based prescription drug planscovering 6 states (comprising a total of 1,437,410 individuals age 18 and older)32• The mean reliability score across all plans is 0.9938.• The developer assessed the face validity (only) of the measure using a technical expert panelfrom the Pharmacy Quality Alliance (PQA). 67 percent strongly agreed that the measure resultsreflected quality of care. Five PQA member organizations also tested the measure using theirown data, and all strongly agreed that the measure reflected the quality of care provided fortheir populations.
  
  
• Review for Feasibility: 3. Feasibility: 13-H; 8-M; 0-L; 0-I(3a. Clinical data generated during care delivery; 3b. Electronic sources; 3c.Susceptibility to inaccuracies/unintended consequences identified 3d. Data collection strategy can be implemented)Rationale:• Pilot test sites indicated the measure was feasible and results were able to be reportedefficiently and accurately.• All the data elements are in defined fields in electronic claims
  
  
• Review for Usability: 4. Usability and Use: 11-H; 9-M; 1-L; 0-I(Used and useful to the intended audiences for 4a. Accountability and Transparency; 4b. Improvement;and 4c. Benefits outweigh evidence of unintended consequences)Rationale:• The measure is currently being used in the Medicare Part D Overutilization Monitoring Systemto monitor the utilization of opioids for members with the Medicare drug benefit.• Although no unintended negative consequences to individuals or populations were identifiedduring testing, concerns have been raised that prescribing changes such as dose reduction(without offering or arranging evidence-based treatment for patients with opioid use disorder)might be associated with unintended negative consequences, such as patients seeking heroin orother illicitly obtained opioids (1,2) or interference with appropriate pain treatment.
  
  
• Review for Related and Competing Measures: 5. Related and Competing MeasuresRelated measures:• Measure 2950: Use of Opioids from Multiple Providers in Persons without Cancer- Theproportion (XX out of 1,000) of individuals without cancer receiving prescriptions for opioidsfrom four (4) or more prescribers AND four (4) or more pharmacies.• Measure 2951: Use of Opioids from Multiple Providers and at High Dosage in Persons withoutCancer- The proportion (XX out of 1,000) of individuals without cancer receiving prescriptionsfor opioids with a daily dosage greater than 120mg morphine equivalent dose (MED) for 90consecutive days or longer, AND who received opioid prescriptions from four (4) or moreprescribers AND four (4) or more pharmacies.• These measures are also being considered for endorsement. The Committee determined thatthey are related but not competing.
  
  
• Endorsement Public Comments: 6. Public and Member CommentComments:This measure received 3 comments. The commenters noted that the measure may be too inclusive andthe developer should consider narrowing the measure to specific chronic conditions or diagnoses to bemore meaningful.Developers Response:The recommendations in the 2015 American Geriatrics Society Beers Criteria are based on a systematicevidence review conducted by American Geriatrics Society Beers Criteria Expert Panel. The review isfocused on the evidence for potential harms of medications in older adults. Medications then includedin the Beers Criteria recommendations are those that the panel found evidence indicating that themedications should in general be avoided in all older adults or avoided in older adults with certainconditions or diseases, due to their associated risks for these populations. The Beers Criteria is updatedregularly based on currently available literature. We believe it's important for this quality measure to bebased on the systematic evidence review that is conducted by the Beers Criteria Expert Panel. Thecomplete evidence tables for the systematic review can be accessed on the American Geriatrics Society'swebsite here: http://geriatricscareonline.org/toc/american-geriatrics-society-updated-beers-criteria-forpotentially-inappropriate-medication-use-in-older-adults/CL001NCQA recognizes that some of the medications that are most attributable to adverse drug events inolder adults that result in ED visits and hospitalizations are not included in the Beers Criteria asmedications to be generally avoided (e.g., warfarin, antidiabetics and oral antiplatelets - although someoral antiplatelets are in fact included in the Beers Criteria and this measure: Dipyridamole, Ticlopidine).These other high-risk medications should be addressed in separate quality measures that focus on safeprescribing and appropriate monitoring, rather than this measure which focuses on medications thatshould be generally avoided. We agree with the need for such quality measures to improve safeprescribing of anticoagulants, antidiabetics, and opioids and have current work underway at NCQA toexplore development of measures in these areas. Of note, the Pharmacy Quality Alliance has severalmeasures addressing opioid prescribing that are currently being considered for NQF endorsement aspart of this Patient Safety project. NCQA supports the endorsement of these measures and has plans toadapt them for health plan reporting in the near future.In terms of the way this measure is currently specified to include a number of different medications, webelieve that creating separate quality measures or indicators for all the specific medications in the BeersCriteria, or for each drug-disease interaction, would be burdensome for measurement and reporting byhealth plans. Plans can look at medications on an individual basis to see where improvements andinterventions are needed, however we do not think this level of detail would be desirable for nationalreporting by health plans.As a measure of potentially inappropriate medication use, NCQA does not expect this measure'sperformance to ever reach 0% (i.e., no prescribing of high-risk medications). There will always be caseswhere the benefits of prescribing a high-risk medication may outweigh the risks for certain patients.Clinicians should take into account various factors when considering the risk-benefit ratio of prescribinga high-risk medication to an individual. A companion paper to the Beers Criteria was published by theAmerican Geriatrics Society Workgroup on Improving Use of the Beers Criteria in 2015. The paperspecifically states "the AGS 2015 Beers Criteria are reasonable to use for performance measurementacross large groups of patients and providers but should not be used to judge care for any individual"(Steinman et al., 2015, JAGS). We believe measuring this concept of potentially inappropriatemedication use among elderly at the health plan (i.e., population) level is an important and usefulmedication safety measure that health plans can use to identify high-risk medication prescribing.
  
  
• Endorsement Committee Recommendation: Steering Committee Recommendation for Endorsement: 21-Y; 0-N
  
  

Measure Specifications

• NQF Number (if applicable): 2951
  
  
• Description: The rate (XX of 1,000) of individuals without cancer receiving prescriptions for opioids with a daily dosage greater than 120 mg morphine equivalent dose (MED) for 90 consecutive days or longer, AND who received opioid prescriptions from four (4) or more prescribers AND four (4) or more pharmacies.
  
  
• Numerator: Any member in the denominator with opioid prescription claims where the MED is greater than 120 mg for 90 consecutive days or longer AND who received opioid prescriptions from 4 or more prescribers AND 4 or more pharmacies.
  
  
• Denominator: 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.
  
  
• Exclusions: Any member with a diagnosis for Cancer or Prescription Drug Hierarchical Condition Category (RxHCC) 8, 9, 10, or 11 for Payment Year 2015; or RxHCC 15, 16, 17, 18, or 19 for Payment Year 2016; or a hospice indicator (Medicare Part D) from the enrollment database.
  
  
• HHS NQS Priority: Promote Effective Prevention & Treatment of Chronic Disease
  
  
• HHS Data Source: Administrative claims
  
  
• Measure Type: Process
  
  
• Steward: Pharmacy Quality Alliance
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Prevention and Treatment of Opioid and Substance Use Disorders
  
  
• Changes to Endorsed Measure Specifications?: The MUC list indicates the measure has not been modified from its endorsed version.
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support for rulemaking with the condition potential duplication between this measure and MUC2018-077 & 078 is considered.
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure would encourage the monitoring of opioid prescription patterns as studies have shown that people who see multiple providers or use multiple pharmacies are more likely to die of drug overdoses and that patient populations taking high opioid doses for prolonged periods are often characterized by high rates of psychiatric and substance abuse disorders, frequently do not receive care consistent with clinical guidelines, and have higher death rates.
  • Impact on quality of care for patients:This measure is fully developed, tested, and NQF endorsed. This measure would strengthen and diversify the SSP program measure set by addressing opioid use disorder treatment.
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority of promoting effective prevention and treatment of chronic disease and specifically addresses the prevention and treatment of opioid and substance use disorders
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. This is an NQF endorsed process measure. Evidence shows that abuse and overdose of prescription drugs is a major public health issue in the United States. Studies have determined that patient populations taking high opioid doses for prolonged periods are often characterized by high rates of psychiatric and substance abuse disorders, frequently do not receive care consistent with clinical guidelines, and have higher death rates.
  
  
• Does the measure address a quality challenge? Yes. This measure addresses a critical population at increased risk of morbidity and mortality. According to the CDC, overdose involving opioid analgesics killed nearly 17,000 persons in 2010 and the number of people with opioid analgesic use disorders increased to nearly 2 million.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative of existing measures in the SSP. It should be noted; however, that measures MUC2018-077 and MUC2018-078, which are also under consideration by MAP this year, are subcomponents of MUC2018-079.
  
  
• Can the measure can be feasibly reported? Yes. Pilot test sites indicated the measure was feasible and results were able to be reported efficiently and accurately. CMS calculates the measure for Part D plans. The data is readily available (prescription claims data and medical data).
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? Yes. The measure has been endorsed at the health plan level.
  
  
• Measure development status: Fully Developed
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a. The measure is not in use in a federal program. However, it is currently being used by the CMS Medicare Part D Drug Benefit and Medicare Part D Overutilization Monitoring System to monitor the utilization of opioids for members with the Medicare drug benefit. No implementation issues have been noted by the developer.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a. The developer considered concerns have been that prescribing changes such as dose reduction (without offering or arranging evidence-based treatment for patients with opioid use disorder) might be associated with unintended negative consequences, such as patients seeking heroin or other illicitly obtained opioids (1,2) or interference with appropriate pain treatment. These were taken into consideration with the balance of the damages from the opioid epidemic.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Endorsed.
  
  

Rationale for measure provided by HHS
This measure received systematic review by Clinical Practice Guideline recommendation, other systematic review and grading of the body of evidence, and review by The Centers for Medicare and Medicaid (CMS) Part D Overutilization Monitoring System (OMS) and PubMed. Further information on evidence for the measure can be found on the “National Quality Forum - Measure Testing” document in Section 1a.8.2. (National Quality Forum - Measure Testing; Section 1a.8.1.)

Summary of NQF Endorsement Review

• Year of Most Recent Endorsement Review: 2017
  
  
• Project for Most Recent Endorsement Review: Patient Safety 2016
  
  
• Review for Importance: 1. Importance to Measure and Report: The measure meets the Importance criteria(1a. Evidence, 1b. Performance Gap)1a. Evidence: 0-H;17-M; 1-L; 0-I; 1b. Performance Gap: 10-H; 6-M; 0-L; 0-IRationale:• The benefits for high dose opioids for chronic pain are not established and the risks for seriousharms related to opioid therapy increase at higher opioid dosage. The use of multipleprescribers and pharmacies are associated with increased risks for opioid overdose. The risk foroverdose increases with the number of prescribers and pharmacies.• The measure’s performance was tested in three different health plan data sources – theMedicare population (mean was 3.03 per 1,000 and the median was 2.89 per 1,000), onecommercial heath plan (mean rate 1.45 per 1,000), and the Medicaid population (mean was2.68 per 1,000 and the median was 2.38 per 1,000).
  
  
• Review for Scientific Acceptability: 2. Scientific Acceptability of Measure Properties: The measure meets the Scientific Acceptabilitycriteria(2a. Reliability - precise specifications, testing; 2b. Validity - testing, threats to validity)2a. Reliability: 11-H; 5-M; 0-L;0-I 2b. Validity: 16-M; 2-L; 0-IRationale:• The measure was tested at the score level. The developer used several data sets for reliabilitytesting:• For Medicare testing, the analysis included a convenience sample of over 700 Medicare Part Dprescription drug plans (comprising a total of 7,067,445 individuals aged 18 and older)• Testing was also conducted in one Commercial health plan (comprising a total of 209,191individuals age 18 and older)39• For Medicaid testing, the analysis included 8 state-based prescription drug plans covering 6states (comprising a total of 1,437,410 individuals age 18 and older)• The mean reliability score across all plans is 0.9208.• The developer assessed the face validity (only) of the measure using a technical expert panelfrom the Pharmacy Quality Alliance (PQA). 83.3 percent strongly agreed that the measureresults reflected quality of care. Five PQA member organizations also tested the measure usingtheir own data, and all strongly agreed that the measure reflected the quality of care providedfor their populations.
  
  
• Review for Feasibility: 3. Feasibility: 15-H; 2-M; 0-L; 0-I(3a. Clinical data generated during care delivery; 3b. Electronic sources; 3c.Susceptibility to inaccuracies/unintended consequences identified 3d. Data collection strategy can be implemented)Rationale:• All data elements are defined in field in electronic claims• Pilot test sites indicated the measure was feasible and results were able to be reportedefficiently and accurately.
  
  
• Review for Usability: 4. Usability and Use: 10-H; 9-M; 1-L; 0-I(Used and useful to the intended audiences for 4a. Accountability and Transparency; 4b. Improvement;and 4c. Benefits outweigh evidence of unintended consequences)Rationale:• The measure is currently being used in the Medicare Part D Overutilization Monitoring Systemto monitor the utilization of opioids for members with the Medicare drug benefit.• Although no unintended negative consequences to individuals or populations were identifiedduring testing, , concerns have been raised that prescribing changes such as dose reduction(without offering or arranging evidence-based treatment for patients with opioid use disorder)might be associated with unintended negative consequences, such as patients seeking heroin orother illicitly obtained opioids (1,2) or interference with appropriate pain treatment.(3) Dataindicate that if access to prescription opioids is limited, some users of opioid analgesics willtransition to heroin or other illicitly obtained opioids, leading to increased overdose deathcoincident with prescribing restrictions.(
  
  
• Review for Related and Competing Measures: 5. Related and Competing Measures• Measure 2950: Use of Opioids from Multiple Providers in Persons without Cancer- Theproportion (XX out of 1,000) of individuals without cancer receiving prescriptions for opioidsfrom four (4) or more prescribers AND four (4) or more pharmacies.• Measure 2940: Use of Opioids at high Dosage in Persons without Cancer- The proportion (XX outof 1,000) of individuals without cancer receiving prescriptions for opioids with a daily dosagegreater than 120mg morphine equivalent dose (MED) for 90 consecutive days or longer.• These measures are also being considered for endorsement. The Committee determined thatthey are related but not competing.
  
  
• Endorsement Public Comments: None
  
  
• Endorsement Committee Recommendation: Steering Committee Recommendation for Endorsement: 18-Y; 0-N
  
  

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Composite score indicating compliance with five measurable CDC opioid prescribing guidelines. The denominator includes new opioid prescriptions in the measurement year. The numerator includes new opioid prescriptions that are compliant on all 5 CDC indicators. Higher is better on this measure.
  
  
• Numerator: Individuals in the denominator whose new opioid medication meets all of the following CDC guidelines: 1. Initial opioid prescription is prescribed while patient is not exposed to benzodiazepines 2. Initial opioid prescription is not for methadone 3. Initial opioid prescription is for short acting formulation 4. Initial opioid prescription is for less than 50 MME/day 5. Initial opioid prescription is for a 7-day supply or less
  
  
• Denominator: All new opioid prescriptions in the measurement year (a new opioid prescription is defined as no evidence of an opioid prescription 12 months prior to the earliest detected claim in the measurement year).
  
  
• Exclusions: Denominator exclusions include: Evidence of malignant cancer, chemotherapy, or radiation in the measurement year. Patients in hospice or palliative care. Patients in long term care, nursing home, or skilled nursing facility for >=90 days at any time during the measurement year.
  
  
• HHS NQS Priority: Promote Effective Prevention and Treatment of Chronic Disease
  
  
• HHS Data Source:
  
  
• Measure Type: Composite
  
  
• Steward: OptumLabs
  
  
• Endorsement Status:
  
  
• Meaningful Measure Area: Prevention and Treatment of Opioid and Substance Use Disorders
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Do not support for rulemaking with the potential for mitigation. Mitigation would include specifying the measure at the health plan level.
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure would encourage the monitoring of opioid prescription patterns as studies have shown that people who see multiple providers or use multiple pharmacies are more likely to die of drug overdoses.
  • Impact on quality of care for patients:This composite measure would help monitor and improve guideline compliance of opioid prescriptions.
  
  
  
• Does the measure address a critical quality objective not currently adequately addressed by the measures in the program set? Yes. This measure meets the priority of promoting effective prevention and treatment of chronic disease and specifically addresses the prevention and treatment of opioid and substance use disorders.
  
  
• Is the measure evidence-based and either strongly linked to outcomes or an outcome measure? Yes. Evidence shows that abuse and overdose of prescription drugs is a major public health issue in the United States. Studies have determined that patient populations taking high opioid doses for prolonged periods are often characterized by high rates of psychiatric and substance abuse disorders, frequently do not receive care consistent with clinical guidelines, and have higher death rates.
  
  
• Does the measure address a quality challenge? Yes. This measure addresses a critical population at increased risk of morbidity and mortality. According to the CDC, overdose involving opioid analgesics killed nearly 17,000 persons in 2010 and the number of people with opioid analgesic use disorders increased to nearly 2 million.
  
  
• Does the measure contribute to efficient use of measurement resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative of existing measures in the SSP.
  
  
• Can the measure can be feasibly reported? Yes. This measure was developed using standard administrative claims and enrollment data for Medicare Advantage and commercial health plan participants. Similar data are currently available to CMS and may be feasibly shared with ACOs.
  
  
• Is the measure applicable to and appropriately specified for the program's intended care setting(s), level(s) of analysis, and population(s)? Yes. The measure was tested at the county level.
  
  
• Measure development status: Field Testing
  
  
• If the measure is in current use, have negative unintended issues to the patient been identified? n/a.
  
  
• If the measure is in current use, have implementation challenges outweighing the benefits of the measure have been identified? n/a.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
This measure was developed using the CDC Guideline for Prescribing Opioids for Chronic Pain – United States, 2016 (https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm), and the Surgeon General’s Report on Alcohol, Drugs, and Health (https://addiction.surgeongeneral.gov/) and is therefore based on scientific evidence consistent with establishing each of the 5 components that comprise the composite. The CDC Guideline provides clarity on opioid prescribing recommendations based on the most recent scientific evidence, informed by expert opinion and stakeholder and public input. A large body of research has identified high-risk prescribing practices that contribute to the overdose epidemic (e.g., high-dose and duration prescribing, overlapping opioid and benzodiazepine prescriptions, and extended-release/long-acting [ER/LA] opioids for acute pain). This composite measure, derived from the CDC Guideline, is aimed at addressing problematic initial prescribing. It has the potential to optimize treatment and improve patient safety using evidence-based, best practices, as well as mitigate opioid pain medication misuse that contributes to the opioid overdose epidemic. CDC Guideline References 24.Bohnert AS, Valenstein M, Bair MJ, et al. Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA 2011;305:1315–21. 26.Jamison RN, Sheehan KA, Scanlan E, Matthews M, Ross EL. Beliefs and attitudes about opioid prescribing and chronic pain management: survey of primary care providers. J Opioid Manag 2014;10:375–82. 27.Wilson HD, Dansie EJ, Kim MS, Moskovitz BL, Chow W, Turk DC. Clinicians’ attitudes and beliefs about opioids survey (CAOS): instrument development and results of a national physician survey. J Pain 2013;14:613–27. 28.Haegerich TM, Paulozzi LJ, Manns BJ, Jones CM. What we know, and don’t know, about the impact of state policy and systems-level interventions on prescription drug overdose. Drug Alcohol Depend 2014;145:34–47. 33.Liu Y, Logan JE, Paulozzi LJ, Zhang K, Jones CM. Potential misuse and inappropriate prescription practices involving opioid analgesics. Am J Manag Care 2013;19:648–65. 34.Mack KA, Zhang K, Paulozzi L, Jones C. Prescription practices involving opioid analgesics among Americans with Medicaid, 2010. J Health Care Poor Underserved 2015;26:182–98. 77.Miller M, Barber CW, Leatherman S, et al. Prescription opioid duration of action and the risk of unintentional overdose among patients receiving opioid therapy. JAMA Intern Med 2015;175:608–15 191.Chou R, Cruciani RA, Fiellin DA, et al. ; American Pain Society; Heart Rhythm Society. Methadone safety: a clinical practice guideline from the American Pain Society and College on Problems of Drug Dependence, in collaboration with the Heart Rhythm Society. J Pain 2014;15:321–37 127.Bohnert ASB, Logan JE, Ganoczy D, Dowell D. A detailed exploration into the association of prescribed opioid dosage and prescription opioid overdose deaths among patients with chronic pain. Med Care 2016. Epub ahead of print. http://journals.lww.com/lww-medicalcare/Abstract/publishahead/A_Detailed_Exploration_Into_the_Association_of.98952.aspx 192.Chu J, Farmer B, Ginsburg B, Hernandez S, Kenny J, Majlesi N. New York City emergency department discharge opioid prescribing guidelines. New York, NY: New York City Department of Health and Mental Hygiene; 2013. https://www1.nyc.gov/assets/doh/downloads/pdf/basas/opioid-prescribing-guidelines.pdf 193.Cheng D, Majlesi N. Clinical practice statement: emergency department opioid prescribing guidelines for the treatment of non-cancer related pain. Milwaukee, WI: American Academy of Emergency Medicine; 2013. 194.American College of Emergency Physicians. Maryland emergency department and acute care facility guidelines for prescribing opioids. Baltimore, MD: Maryland Chapter, American College of Emergency Physicians; 2014. http://www.mdacep.org/MD%20ACEP%20Pamphlet%20FINAL_April%202014.pdf 195.Paone D, Dowell D, Heller D. Preventing misuse of prescription opioid drugs. City Health Information 2011;30:23–30. 196.Thorson D, Biewen P, Bonte B, et al. Acute pain assessment and opioid prescribing protocol. Bloomington, MN: Institute for Clinical Systems Improvement; 2014. https://crh.arizona.edu/sites/default/files/u35/Opioids.pdf 197.Cantrill SV, Brown MD, Carlisle RJ, et al. ; American College of Emergency Physicians Opioid Guideline Writing Panel. Clinical policy: critical issues in the prescribing of opioids for adult patients in the emergency department. Ann Emerg Med 2012;60:499–525 212.Park TW, Saitz R, Ganoczy D, Ilgen MA, Bohnert AS. Benzodiazepine prescribing patterns and deaths from drug overdose among US veterans receiving opioid analgesics: case-cohort study. BMJ 2015;350:h2698. 213.Paquin AM, Zimmerman K, Rudolph JL. Risk versus risk: a review of benzodiazepine reduction in older adults. Expert Opin Drug Saf 2014;13:919–34. 214.Schweizer E, Case WG, Rickels K. Benzodiazepine dependence and withdrawal in elderly patients. Am J Psychiatry 1989;146:529–31.

Program Index

• Merit-Based Incentive Payment System 
  
  
• Medicare Shared Savings Program 
  
  

Full Program Summaries

Program History and Structure: The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) ended the Sustainable Growth Rate (SGR) formula, which would have resulted in a significant cut to payment rates for clinicians participating in Medicare. MACRA requires CMS by law to implement an incentive program for clinicians. This program, referred to as the Quality Payment Program, provides two participation pathways for clinicians: (1) The Merit-based Incentive Payment System (MIPS), and (2) Advanced Alternative Payment Models (Advanced APMs). MIPS combines three Medicare “legacy” programs – the Physician Quality Reporting System (PQRS), Value-based Payment Modifier (VM), and the Medicare EHR Incentive Program for Eligible Professionals – into a single program. Under MIPS, there are four connected performance categories that will affect a clinician’s future Medicare payments. Each performance category is scored independently and has a specific weight, indicating its contribution towards the MIPS Final Score. The MIPS performance categories and their 2018 weights towards the final score are: Quality (50%); Advancing Care information (25%); Improvement Activities (15%); and Cost (10%). The final score (100%) will be the basis for the MIPS payment adjustment assessed for MIPS eligible clinicians.

High Priority Domains for Future Measure Consideration:

CMS identified the following five domains as high-priority for future measure consideration:

1.Person and Family Engagement (Care is Personalized and Aligned with Patient's Goals, End of Life Care According to Preferences, Patient’s Experience and Functional Outcomes): This means that the measure should address the experience of each person and their family; and the extent to which they are engaged as partners in their care. a. CMS wants to specifically focus on patient reported outcome measures (PROMs). Person or family-reported experiences of being engaged as active members of the health care team and in collaborative partnerships with providers and provider organizations.

2. Communication and Coordination of Care (Medication Management, Admissions and Readmissions to Hospitals, Seamless Transfer of Health Information): This means that the measure must address the promotion of effective communication and coordination of care; and coordination of care and treatment with other providers.

3. Making Care Affordable (Appropriate Use of Healthcare, Patient-focused Episode of Care, Risk Adjusted Total Cost of Care): This means that the measure must address the affordability of health care including unnecessary health services, inefficiencies in health care delivery, high prices, or fraud. Measures should cause change in efficiency and reward value over volume.

4. Making Care Safer (Healthcare-Associated Infections, Preventable Healthcare Harm): This means that the measure must address either an explicit structure or process intended to make care safer, or the outcome of the presence or absence of such a structure or process; and harm caused in the delivery of care. This means that the structure, process or outcome described in “a” must occur as a part of or as a result of the delivery of care.

5. Appropriate Use: CMS wants to specifically focus on appropriate use measures. This means that the measure must address appropriate use of services, including measures of over use.

Measure Requirements: CMS applies criteria for measures that may be considered for potential inclusion in the MIPS. At a minimum, the following criteria and requirements must be met for selection in the MIPS: CMS is statutorily required to select measures that reflect consensus among affected parties, and to the extent feasible, include measures set forth by one or more national consensus building entities. To the extent practicable, quality measures selected for inclusion on the final list will address at least one of the following quality domains: Effective Prevention and Treatment, Making Care Safer, Communication and Coordination of Care, Best Practices of Healthy Living, Making Care Affordable or Person and Family Engagement. In addition, before including a new measure in MIPS, CMS is required to submit for publication in an applicable specialty-appropriate, peer-reviewed journal the measure and the method for developing the measure, including clinical and other data supporting the measure. Measures implemented in MIPS may be available for public reporting on Physician Compare. Measures must be fully developed, with completed testing results at the clinician level and ready for implementation at the time of submission (CMS’ internal evaluation). Preference will be given to measures that are endorsed by the National Quality Forum (NQF). Measures should not duplicate other measures currently in the MIPS. Duplicative measures are assessed to see which would be the better measure for the MIPS measure set. Measure performance and evidence should identify opportunities for improvement. CMS does not intend to implement measures in which evidence identifies high levels of performance with little variation or opportunity for improvement, e.g., measures that are “topped out.” Claims measures must also be reportable via another data submission mechanism (e.g. registry, eCQM). MIPS is not accepting claims only measures. Section 101(c)(1) of the MACRA requires submission of new measures for publication in applicable specialty-appropriate, peer-reviewed journals prior to implementing in MIPS. The Peer-Review Journal template provided by CMS, must accompany each measures submission. Please see the template for additional information. eCQMs must meet EHR system infrastructure requirements, as defined by MIPS regulation. Beginning with calendar year 2019, eCQMs will use clinical quality language (CQL) as the expression logic used in the Health Quality Measure Format (HQMF). CQL replaces the logic expressions currently defined in the Quality Data Model (QDM). The data collection mechanisms must be able to transmit and receive requirements as identified in MIPS regulation. For example, eCQMs being submitted as Quality Reporting Data Architecture (QRDA) III must meet QRDA – III standards as defined in the CMS QRDA III Implementation Guide. eCQMs must have HQMF output from the Measure Authoring Tool (MAT), using MAT v5.4, or more recent, with implementation of the clinical quality language logic. Additional information on the MAT can be found at https://ecqi.healthit.gov/ecqm-tools/tool-library/measure-authoring-tool Bonnie test cases must accompany each measure submission. Additional information on eCQM Tools and resources can be found at https://ecqi.healthit.gov/ecqm-tools-key-resources. Reliability and validity testing must be conducted for measures. In addition to the above, feasibility testing must be conducted for eCQMs. Testing data must accompany submission. For example, if a measure is being reported as registry and eCQM, testing data for both versions must be submitted.

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

Program History and Structure: Section 3022 of the Affordable Care Act (ACA) requires the Centers for Medicare & Medicaid Services (CMS) to establish a Shared Savings Program that promotes accountability for a patient population, coordinates items and services under Medicare Parts A and B, and encourages investment in infrastructure and redesigned care processes for high-quality and efficient service delivery. The Medicare Shared Savings Program (Shared Savings Program) was designed to facilitate coordination and cooperation among providers to improve the quality of care for Medicare Fee-For-Service (FFS) beneficiaries and reduce the rate of growth in health care costs. Eligible providers, hospitals, and suppliers may voluntarily participate in the Shared Savings Program by creating or participating in an Accountable Care Organization (ACO). If ACOs meet program requirements and the ACO quality performance standard, they are eligible to share in savings, if earned. There are four shared savings options: 1) one- sided risk model (Track 1 ACOs do not assume downside risk (shared losses) if they do not lower growth in Medicare expenditures), Medicare ACO Track 1+ Model (Medicare ACO Track 1+ Model (Track 1+ Model) ACOs assume limited downside risk (less than Track 2 or Track 3); 2) two-sided risk model (Track 2 ACOs may share in savings or repay Medicare losses depending on performance. Track 2 ACOs may share in a greater portion of savings than Track 1 ACOs); and, 3) two-sided risk model (Track 3 ACOs may share in savings or repay Medicare losses depending on performance. Track 3 ACOs take on the greatest amount of risk, but may share in the greatest portion of savings if successful)

Measure Requirements: Specific measure requirements include: Outcome measures that address conditions that are high-cost and affect a high volumeof Medicare patients. Measures that are targeted to the needs and gaps in care of Medicare fee-for-service patients and their caregivers. Measures that align with CMS quality reporting initiatives, such as the Quality Payment Program. Measures that support improved individual and population health. Measures addressing high-priority healthcare issues, such as opioid use. Measures that align with recommendations from the Core Quality Measures Collaborative.

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

Index of Measures (by Program)

• Time to surgery for elderly hip fracture patients (No public comments received; MUC ID: MUC2018-031)
  
  
• Discouraging the routine use of occupational and/or physical therapy after carpal tunnel release (Public comments received:1; 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 (No public comments received; MUC ID: MUC2018-038)
  
  
• Multimodal Pain Management (Public comments received:2; MUC ID: MUC2018-047)
  
  
• Potential Opioid Overuse (Public comments received:6; MUC ID: MUC2018-048)
  
  
• Annual Wellness Assessment: Preventive Care (Public comments received:5; MUC ID: MUC2018-057)
  
  
• Adult Immunization Status (Public comments received:8; MUC ID: MUC2018-062)
  
  
• Functional Status Change for Patients with Neck Impairments (No public comments received; MUC ID: MUC2018-063)
  
  
• Inpatient Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (Public comments received:4; MUC ID: MUC2018-115)
  
  
• Femoral or Inguinal Hernia Repair (Public comments received:3; MUC ID: MUC2018-116)
  
  
• Lumbar Spine Fusion for Degenerative Disease, 1-3 Levels (Public comments received:4; MUC ID: MUC2018-117)
  
  
• Psychoses/Related Conditions (Public comments received:4; MUC ID: MUC2018-119)
  
  
• Lumpectomy, Partial Mastectomy, Simple Mastectomy (Public comments received:4; MUC ID: MUC2018-120)
  
  
• Acute Kidney Injury Requiring New Inpatient Dialysis (Public comments received:4; MUC ID: MUC2018-121)
  
  
• Lower Gastrointestinal Hemorrhage (Public comments received:4; MUC ID: MUC2018-122)
  
  
• Renal or Ureteral Stone Surgical Treatment (Public comments received:3; MUC ID: MUC2018-123)
  
  
• Hemodialysis Access Creation (Public comments received:2; MUC ID: MUC2018-126)
  
  
• Elective Primary Hip Arthroplasty (Public comments received:2; MUC ID: MUC2018-137)
  
  
• Non-Emergent Coronary Artery Bypass Graft (CABG) (Public comments received:2; MUC ID: MUC2018-140)
  
  
• Medicare Spending Per Beneficiary (MSPB) clinician measure (Public comments received:8; MUC ID: MUC2018-148)
  
  
• Total Per Capita Cost (Public comments received:12; MUC ID: MUC2018-149)
  
  

• Adult Immunization Status (Public comments received:5; MUC ID: MUC2018-062)
  
  
• Use of Opioids from Multiple Providers in Persons Without Cancer (Public comments received:9; MUC ID: MUC2018-077)
  
  
• Use of Opioids at High Dosage in Persons Without Cancer (Public comments received:9; MUC ID: MUC2018-078)
  
  
• Use of Opioids from Multiple Providers and at High Dosage in Persons Without Cancer (Public comments received:9; MUC ID: MUC2018-079)
  
  
• Initial opioid prescription compliant with CDC recommendations (Public comments received:6; MUC ID: MUC2018-106)
  
  

Full Comments (Listed by Measure)

• 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)
  
  

• 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)
  
  
• 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)
  
  

• 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)
  
  
• 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 )
  
  
• 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)
  
  
• 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 )
  
  
• 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)
  
  
• 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)
  
  

• 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)
  
  
• 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))
  
  
• 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)
  
  
• 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)
  
  
• 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)
  
  

• : 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)
  
  
• 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))
  
  
• 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)
  
  
• 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)
  
  
• 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 )
  
  
• 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.)
  
  
• 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)
  
  
• 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)
  
  

• 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))
  
  
• 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 )
  
  
• 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)
  
  
• 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)
  
  
• While written comments were not provided, the commenter indicated their support for this measure in this program (Submitted by: National Association of County and City Health Officials)
  
  

• NHPCO Comments: Include cancer patients receiving palliative care services in “excludes”. (Submitted by: National Hospice and Palliative Care Organization)
  
  
• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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.)
  
  
• 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)
  
  
• 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 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)
  
  

• NHPCO Comments: Include cancer patients receiving palliative care services in “excludes”. (Submitted by: National Hospice and Palliative Care Organization)
  
  
• 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 )
  
  
• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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.)
  
  
• 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)
  
  
• 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)
  
  
• 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)
  
  

• NHPCO Comments: Include cancer patients receiving palliative care services in “excludes”. (Submitted by: National Hospice and Palliative Care Organization)
  
  
• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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.)
  
  
• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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)
  
  

• 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 )
  
  
• 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))
  
  
• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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)
  
  

• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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) )
  
  

• 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)
  
  
• 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)
  
  
• 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) )
  
  

• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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) )
  
  

• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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) )
  
  

• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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) )
  
  

• 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)
  
  
• 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)
  
  
• 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 )
  
  
• 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) )
  
  

• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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) )
  
  

• 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)
  
  
• 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)
  
  
• 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) )
  
  

• 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)
  
  
• 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)
  
  
• 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 )
  
  
• 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) )
  
  

• 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)
  
  
• 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) )
  
  

• 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)
  
  
• 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) )
  
  

• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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) )
  
  

• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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)
  
  
• 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) )
  
  

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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