NQF

Agenda Synopsis

Full Agenda

Measure Index

• Adult Local Current Smoking Prevalence (Public comments received:6; MUC ID: MUC16-069)
  
  
• Appropriate Use Criteria - Cardiac Electrophysiology (Public comments received:2; MUC ID: MUC16-398)
  
  
• Average change in back pain following lumbar discectomy and/or laminotomy (Public comments received:1; MUC ID: MUC16-087)
  
  
• Average change in back pain following lumbar fusion. (Public comments received:1; MUC ID: MUC16-088)
  
  
• Average change in leg pain following lumbar discectomy and/or laminotomy (Public comments received:1; MUC ID: MUC16-089)
  
  
• Bone Density Evaluation for Patients with Prostate Cancer and Receiving Androgen Deprivation Therapy (Public comments received:2; MUC ID: MUC16-287)
  
  
• Febrile Neutropenia Risk Assessment Prior to Chemotherapy (Public comments received:1; MUC ID: MUC16-151)
  
  
• Fixed-dose Combination of Hydralazine and Isosorbide Dinitrate Therapy for Self-identified Black or African American Patients with Heart Failure and Left Ventricular Ejection Fraction (LVEF) <40% on ACEI or ARB and Beta-blocker Therapy (Public comments received:3; MUC ID: MUC16-074)
  
  
• HIV Medical Visit Frequency (Public comments received: 0; MUC ID: MUC16-073)
  
  
• HIV Viral Suppression (Public comments received:1; MUC ID: MUC16-075)
  
  
• Identification of Major Co-Morbid Medical Conditions (Group measure as defined by Am. Coll. of Surgeons) (Public comments received: 0; MUC ID: MUC16-279)
  
  
• Intraoperative Surgical Debriefing (Group measure as defined by Am. Coll. of Surgeons) (Public comments received: 0; MUC ID: MUC16-316)
  
  
• Intraoperative Timeout Safety Checklist (Group measure as defined by Am. Coll. of Surgeons) (Public comments received: 0; MUC ID: MUC16-280)
  
  
• Intravesical Bacillus Calmette-Guerin for NonMuscle Invasive Bladder Cancer (Public comments received:2; MUC ID: MUC16-310)
  
  
• Otitis Media with Effusion: Systemic Antimicrobials - Avoidance of Inappropriate Use (Public comments received:1; MUC ID: MUC16-269)
  
  
• Otitis Media with Effusion: Systemic Corticosteroids - Avoidance of Inappropriate Use (Public comments received:1; MUC ID: MUC16-268)
  
  
• Participation in a National Risk-adjusted Outcomes Surgical Registry (Group measure as defined by Am. Coll. of Surgeons) (Public comments received:1; MUC ID: MUC16-286)
  
  
• Patient Experience with Surgical Care Based on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) ® Surgical Care Survey (S-CAHPS) (Public comments received:3; MUC ID: MUC16-291)
  
  
• Patient Frailty Evaluation (Group measure as defined by Am. Coll. of Surgeons) (Public comments received:1; MUC ID: MUC16-278)
  
  
• Patient-Centered Surgical Risk Assessment and Communication (Group measure as defined by Am. Coll. of Surgeons) (Public comments received:1; MUC ID: MUC16-293)
  
  
• Perioperative Composite (Group measure as defined by Am. Coll. of Surgeons) (Public comments received: 0; MUC ID: MUC16-282)
  
  
• Post-Discharge Review of Patient Goals of Care (Group measure as defined by Am. Coll. of Surgeons) (Public comments received:2; MUC ID: MUC16-345)
  
  
• Postoperative Care Coordination and Follow-up with Primary/Referring Provider (Group measure as defined by Am. Coll. of Surgeons) (Public comments received: 0; MUC ID: MUC16-281)
  
  
• Postoperative Care Plan (Group measure as defined by Am. Coll. of Surgeons) (Public comments received: 0; MUC ID: MUC16-283)
  
  
• Postoperative Plan Communication with Patient and Family (Group measure as defined by Am. Coll. of Surgeons) (Public comments received:1; MUC ID: MUC16-277)
  
  
• Postoperative Review of Patient Goals of Care (Group measure as defined by Am. Coll. of Surgeons) (Public comments received:2; MUC ID: MUC16-284)
  
  
• Preoperative Key Medications Review for Anticoagulation Medication (Group measure as defined by Am. Coll. of Surgeons) (Public comments received: ; MUC ID: MUC16-276)
  
  
• Prescription of HIV Antiretroviral Therapy (Public comments received: 0; MUC ID: MUC16-072)
  
  
• Preventative Care and Screening: Tobacco Screening and Cessation Intervention (Group measure as defined by Am. Coll. of Surgeons) (Public comments received:2; MUC ID: MUC16-289)
  
  
• Prevention of Post-Operative Vomiting (POV) - Combination Therapy (Pediatrics) (Public comments received: 0; MUC ID: MUC16-312)
  
  
• Resumption Protocol (Group measure as defined by Am. Coll. of Surgeons) (Public comments received: 0; MUC ID: MUC16-292)
  
  
• Safety Concern Screening and Follow-Up for Patients with Dementia (Public comments received:4; MUC ID: MUC16-317)
  
  
• Surgical Plan and Goals of Care (Preoperative Phase) (Group measure as defined by Am. Coll. of Surgeons) (Public comments received:1; MUC ID: MUC16-288)
  
  
• Unplanned Hospital Readmission within 30 Days of Principal Procedure (Public comments received: 0; MUC ID: MUC16-285)
  
  
• Uterine artery embolization technique: Documentation of angiographic endpoints and interrogation of ovarian arteries (Public comments received: 0; MUC ID: MUC16-343)
  
  

• Adult Local Current Smoking Prevalence (Public comments received:1; MUC ID: MUC16-069)
  
  

Full Measure Information

Measure Specifications

• NQF Number (if applicable): 2020
  
  
• Description: Percentage of adult (age 18 and older) in select county that currently smoke, defined as adults who reported having smoked at least 100 cigarettes in their lifetime and currently smoke.(The endorsed specifications of the measure are: Percentage of adult (age 18 and older) U.S. population that currently smoke.)
  
  
• Numerator: The numerator is current adult smokers (age 18 and older) in a geographically defined area who live in households.(The endorsed specifications of the measure are: The numerator is current adult smokers (age 18 and older) in the U.S. who live in households.)
  
  
• Denominator: The adult (age 18 and older) population in a geographically defined area who live in households. (The endorsed specifications of the measure are: The adult (age 18 and older) population of the U.S. who live in households. One adult per household is interviewed.)
  
  
• Exclusions: Adults 18 years or older are asked to take part in the survey and only one adult is interviewed per household. Adults living in vacation homes not occupied by household members for more than 30 days per year, group homes, institutions, prisons, hospitals and college dorms are excluded. (The endorsed specifications of the measure are: Adults 18 years or older are asked to take part in the survey and only one adult is interviewed per household. Adults living in vacation homes not occupied by household members for more than 30 days per year, group homes, institutions, prisons, hospitals and college dorms are excluded. Military services members and adults who speak a language other than English and Spanish are also excluded.)
  
  
• HHS NQS Priority: Effective Prevention and Treatment, Best Practice of Healthy Living
  
  
• HHS Data Source: Survey
  
  
• Measure Type: Outcome
  
  
• Steward: Centers for Disease Control and Prevention, Centers for Medicare & Medicaid Services
  
  
• Endorsement Status:
  
  
• 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: Refine and resubmit
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure addresses an important topic; however, it has not been tested to show that it can affect outcomes at the level of the MSSP attribution. Additionally, the data collection is not that of structured data that can be related back to an episode of care.
  • Impact on quality of care for patients:If this measure were to be successfully tested at the level specified, it could have a significant impact on death and cardiovascular disease.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. Working with community to promote best practices to enable healthy living
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. Significant literature exists to demonstrate the negative impacts of smoking on health.
  
  
• Does the measure address a quality challenge? Yes. Smoking is the leading preventable cause of death and disease in the US.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. The measure captures a broad population and is not duplicative of other measures.
  
  
• Can the measure can be feasibly reported? No. The measure is fully specified. It is related to NQF#2020 that looks at prevalence at the national level. The data does not come from structured data that are captured before, during, or after the course of care. The measure relies on surveys of an adult within the home but does not specify that the adult had received care.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? No. The measure is related to NQF#2020 that looks at prevalence at the national level. The data does not come from structured data that are captured before, during, or after the course of care. The measure relies on surveys of an adult within the home but does not specify that the adult had received care.
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? . The measure had previously been submitted to MAP in 2015 for IQR and further development was recommended.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Endorsed.
  
  

Rationale for measure provided by HHS
Cigarette smoking is still the leading preventable cause of death and disease in the U.S. and costs the U.S. health care system nearly $170 billion in direct medical care for adults each year (CDC 2014a; HHS 2014; Xu et al. 2014). Currently more than 16 million US residents are living with a smoking-related illness (HHS 2014). Smoking harms nearly every organ in the body and has been causally linked to numerous cancers, heart disease and stroke, chronic obstructive pulmonary disease, pneumonia, other respiratory diseases, aortic aneurysm, peripheral vascular disease, cataracts and blindness, age-related macular degeneration, periodontitis, diabetes, pregnancy and reproductive complications, bone fractures, arthritis, and reduced immune function (HHS, 2014). Mortality among current smokers is two to three times that of persons who never smoked (Jha et al. 2013). Since the first Surgeon General’s Report on Smoking and Health in 1964, cigarette smoking has killed more than 20 million people in the U.S. (HHS 2014). Between 2005-2009, 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all coronary heart disease deaths were attributable to smoking and secondhand smoke exposure (HHS, 2014), making it an essential risk factor to address to reduce both disease burden and health care costs. The toll smoking takes on health extends beyond the smokers. Since 1964, almost 2.5 million nonsmoking adults have died from heart disease and lung cancer caused by exposure to secondhand smoke, and 100,000 babies have died of sudden infant death syndrome or complications from prematurity, low birth weight, or other conditions caused by parental smoking, particularly smoking by the mother (HHS, 2014). Reducing cigarette smoking in the community can impact the health and health care costs of nonsmokers as well. CDC (Centers for Disease Control and Prevention). (2014a). CDC’s Tips from Former Smokers campaign provided outstanding return on investment. Atlanta, GA. Available at: http://www.cdc.gov/media/releases/2014/p1210-tips-roi.html. (Accessed 27 October, 2015). HHS (US Department of Health and Human Services). (2014). The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General. Atlanta, GA: US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health. Available at: http://www.surgeongeneral.gov/library/reports/50-years-of-progress/full-report.pdf. (Accessed 23 September, 2015). Xu X, Bishop EE, Kennedy SM, Simpson SA, Pechacek TF. (2014) Annual Healthcare Spending Attributable to Cigarette Smoking: An Update. American Journal of Preventive Medicine, 48(3), p.326-333. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4603661/ (Accessed 24 September, 2015). Jha, P. and Peto, R. (2014). Global effects of smoking, of quitting, and of taxing tobacco. New England Journal of Medicine, 2014(370), p.60-68. Available at: http://www.nejm.org/doi/full/10.1056/nejmra1308383. (Accessed 22 October, 2015). doi: 10.1056/NEJMra1308383

Summary of NQF Endorsement Review

• Year of Most Recent Endorsement Review: 2012
  
  
• Project for Most Recent Endorsement Review: Population Health: Prevention
  
  
• Review for Importance: 1a. Impact: H-9; M-2; L-0; I-0; 1b. Performance Gap: H-5; M-6; L-0; I-0 1c. Evidence: Y-10; N-0; I-1 Rationale: • Sufficient evidence about the burden of smoking at state and national levels, and evidence-based interventions to reduce the burden. • Useful community assessment to help determine resource allocation and strategic plans for combatting smoking.
  
  
• Review for Scientific Acceptability: 2a. Reliability: H-8; M-3; L-0; I-0 2b. Validity: H-7; M-4; L-0; I-0 Rationale: • Concern about validity because of the exclusion of people serving in the military and those that are institutionalized. Although these are relatively small populations, smoking prevalence is high among these groups. • Some Committee members stated an additional limitation of using NHIS as a data source: o Lower age limit – perhaps consider those younger than 18 years, which data show high prevalence. • Several concerns about the survey questions and apparent and/or potential lack of harmonization with similar smoking survey measures, including BRFSS etc. o “Have you smoked at least 100 cigarettes in your entire life? (Yes, No, Refused, Don’t Know)” does not appear to be aligned with other survey questions, which ask “do you smoke every day, some days, or at all…” The former is listed twice in the measure submission form. • Why are non-combustibles and other tobacco products omitted from the measure? Following the in-person meeting, the steward and developer provided the following responses: • The measure, as currently specified, is based on the National Health Interview Survey (NHIS) measure of current smoking, which tracks the Healthy People 2020 measure for smoking prevalence among adults. • The measure uses the following questions, which are harmonized with BRFSS: o Have you smoked at least 100 cigarettes in your entire life? (Yes, No, Refused, Don’t Know) and, o Do you now smoke every day, some days, or not at all (asked of those who smoked 100 cigarettes in the above question)? (Every day, Some days, Not at all, Refused, Don’t know) The developer agreed to utilize the BRFSS question for smoking prevalence, which can be assessed at the state level. The developer updated the measure submission form accordingly. In response to the Committee’s concern about non-combustible tobacco products, the CDC recognizes the importance of this assessment and adds that some of their surveys “…are moving towards a question like: In the past 30 days have you smoked a cigarette, cigar or pipe (FDA/NIDA proposed question in PATH study) and a separate question on non-combustibles like, In the past 30 days have you used smokeless tobacco such as chewing tobacco, snuff, snus, or dip (FDA/NIDA proposed question in PATH study).” The CDC and the developer are considering the addition of a question on noncombustibles in a future iteration of the measure.
  
  
• Review for Feasibility: 4. Feasibility: H-8; M-3; L-0; I-0 (4a. Clinical data generated during care process; 4b. Electronic sources; 4c. Exclusions-no additional data source; 4d. Susceptibility to inaccuracies/unintended consequences identified; 4e. Data collection strategy can be implemented) Rationale: • Data are accessible from existing survey.
  
  
• Review for Usability: 3. Usability: H-9; M-2; L-0; I-0 (3a. Meaningful/useful for public reporting and quality improvement; 3b. Harmonized; 3c. Distinctive or additive value to exiting measures) Rationale: • Concern about the incentive to drive quality improvement at the national level only, if the measure cannot be drilled down to lower levels of aggregation. • Consider harmonization with other measures. For example, smoking-related measure from NCQA in ongoing Behavioral Health project. Need more to review measure specifications – what questions are used in NCQA’s CAHPS survey measure? Are these aligned with other national surveys? Following the meeting, the developer agreed to use BRFSS’ state-level smoking prevalence measure. The developer revised the measure submission accordingly. In addition, NQF staff reviewed NCQA’s 0027: Medical assistance with smoking and tobacco use cessation. The survey questions used to assess smoking prevalence are generally standardized, except NCQA also assess tobacco use. The survey reads, “Do you now smoke cigarettes or use tobacco every day, some days, or not at all.” CDC asks, “Do you know smoke cigarettes every day, some days, or not at all”.
  
  
• Review for Related and Competing Measures: 5. Related and Competing Measures This measure is related to measure #0027: Medical assistance with smoking and tobacco use cessation, which is currently under endorsement consideration in an on-going behavioral health project. The Committee largely supported the endorsement of this measure per the suggested revision, but also encourages harmonization with measure #0027 if possible.
  
  
• Endorsement Public Comments: Public & Member Comment [July 19-August 17, 2012] Comments include: • Concerns about the systematic biases related to validity and accuracy of responses across different populations for patient-reported data. Developer response: This measure assesses members of the population, not patients. Generally, selfreported smoking status is a valid indicator of population-level smoking prevalence, and most national surveys in the United States that assess health behavior rely on self-reported data, such as NHIS and NSDUH. A study by Assaf et al., which examined potential gender differences in self-reported smoking data, compared self-reported smoking behavior to serum thiocyanate and serum cotinine levels. The authors concluded that although there were some differences in self-reporting of smoking status by gender, the results were similar between self-reports and biochemical tests. The authors asserted that the results lent “credibility to the use of self-reports as low-cost accurate approach to obtaining information on smoking behaviors among both men and women in large population-based surveys” (Assaf 2002). • Harmonize measure 2020 with measure 0027 Medical assistance with smoking tobacco use cessation (under consideration in the ongoing Behavioral Health project). Developer response: The two metrics assess different aspects of smoking and/or tobacco use. The denominator population for measure 0027 includes health plan members that currently smoke and use tobacco and those that have received tobacco use and smoking cessation advice during a specific time period. Measure 2020 assesses current smoking prevalence (only) among the adult population in the United States. Therefore, harmonization would not be practical or necessary. • Include military personnel in the measure’s denominator. Developer response: This would be ideal. While the BRFSS does not include this population in their sample, there is no reason why future iterations of this measure could not accurately assess smoking status in the military as compared to the general population. Many studies examining smoking status in a military population have relied on self-reported data and have used measures similar to the measure used in the BRFSS. • Include an assessment of smokeless tobacco. Developer response: This would require a separate measure, with specific validity and reliability testing data. This current smoking prevalence measure is thoroughly tested and has been in use for several years. Steering Committee response: The Committee accepted the developer’s responses and did not change their endorsement consideration. The Committee agreed that military personnel and smokeless tobacco are important assessments to add to the measure in the future.
  
  
• Endorsement Committee Recommendation: Steering Committee Recommendation for Endorsement: Y-10; N-0 Rationale: The Committee is in favor of developer’s proposed revision to use the BRFSS survey questions. Recommendation: • The Steering Committee encourages harmonization with NCQA’s measure #0027 Medical assistance with smoking and tobacco use cessation if possible.
  
  

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: The IAC Cardiac Electrophysiology accreditation program requires compliance to and evaluation of appropriate using published guidelines warranting the procedure.
  
  
• Numerator: Number of reports meeting AUC
  
  
• Denominator: Total number of reviews
  
  
• Exclusions: None
  
  
• HHS NQS Priority: Making Care Safer, Communication and Care Coordination, Effective Prevention and Treatment
  
  
• HHS Data Source: Administrative clinical data, Claims, Record Review, Survey
  
  
• Measure Type: Process
  
  
• Steward: IAC
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Refine and resubmit
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure submission does not provide testing data that demonstrates that it influences outcomes at the individual clinician level. Additionally, the measure specifications do not outline the detail of how both "compliance to" and "evaluation of" the appropriate use criteria would be delineated. For example, the reference provided describes clinical scenarios that "should be considered in the context of the clinical situation." The current specifications do not provide enough detail as to how those would be handled by the measure. Once fully specified, complete testing would need to be performed.
  • Impact on quality of care for patients:This measure would assess adherence to appropriate use criteria as well as best practices. This could assist in effective use of resources as well as effective clinical practice.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure supports the NQS priority of promoting effective practices
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. The measure promotes the appropriate use criteria of implantable cardioverter defibrillators.
  
  
• Does the measure address a quality challenge? Yes. The submitter cites an article that outlines the appropriateness of interventions including some that are deemed "Rarely Appropriate". http://content.onlinejacc.org/article.aspx?articleid=1659563
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative and addresses the topic of appropriate use criteria in the field of electrophysiology.
  
  
• Can the measure can be feasibly reported? Yes. The submitter describes the use of a QI tool for physicians that can be used to review, document, and analyze the AUC in their practices
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? No. The submitter does not provide documentation that the measure has been tested at the individual clinician level.
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that 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
ACCF/HRS/AHA/ASE/HFSA/SCAI/SCCT/SCMR 2013 – Appropriate Use Criteria for Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy: A Report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Heart Rhythm Society, American Heart Association, American Society of Echocardiography, Heart Failure Society of America, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography and Society for Cardiovascular Magnetic Resonance. Endorsed by the American Geriatrics Society. Russo, A., et al, J Amer Coll Cardiol, 2013; 61(12):1318-1368. content.onlinejacc.org/article.aspx?articleid=1659563 There are many factors affecting patient care and patient management. One of the most critical to patient management is to order the right testing to diagnose the pathology, disease process or condition. There is a plethora of published data outlining the negative impact that inappropriate diagnostic testing has on the patient and the health care system on many levels. There are several components that must be in place to ensure that the imaging tests are performed safely, and ordered appropriately. However, it starts with a baseline measurement of review, evaluation documentation. Once cannot put process improvement plans in place if they are not aware that they are needed. It is only through evaluating metrics at the physician level that provides a mechanism for behavioral change and fosters a culture of quality. IAC provides a QI tool for physicians to use to review, document and benchmark the AUC in their practices. The data is secure and can be queried and benchmarked for their own purpose or against their peers. Physicians/facilities sign a Business agreement with the IAC to use the QI tool. IAC ISO 9001 – 2008 project management and ISO 2700:2013 – Information Security certified, fully compliant with HITECH and HIPAA requirements and the data is confidential. IAC medical imaging accreditation obtains and verifies many metrics of quality to ensure better patient care leading to better patient outcomes.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: The average change (preoperative to three months postoperative) in back pain for patients 18 years of age or older who had lumbar discectomy laminotomy procedure.
  
  
• Numerator: This measure is not a proportion or rate, and as such, does not have a numerator and denominator, but has an eligible population with a calculated result. The calculated result is: The average change (preoperative to three months postoperative) in back pain for all eligible patients.
  
  
• Denominator: This measure is not a proportion or rate, and as such, does not have a numerator and denominator, but has an eligible population with a calculated result. The eligible population is: Patients 18 years of age or older as of January 1 of the measurement period who had a lumbar discectomy and/or laminotomy procedure for a diagnosis of disc herniation performed by an eligible provider in an eligible specialty during the measurement period and whose back pain was measured by the Visual Analog Scale (VAS) within three months preoperatively AND at three months (6 to 20 weeks) postoperatively.
  
  
• Exclusions: Patient had any additional spine procedures performed on the same date as the lumbar discectomy laminotomy.
  
  
• HHS NQS Priority: Patient and Family Engagement
  
  
• HHS Data Source: Registry
  
  
• Measure Type: Patient Reported Outcome
  
  
• Steward: MN Community Measurement
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support (NQF endorsement & testing supports variation at the individual provider level)
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure would add PRO to the set as well as spine surgery specific measures. The submitter does not provide specific test data. In order for full support, the submitter will need to provide data at the individual provider level.
  • Impact on quality of care for patients:Patient-reported outcomes provide valuable information for patients and consumers when selecting healthcare providers. This measure would assess the outcome of a lumbar discectomy and/or laminectomy.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. This is a patient-reported outcome. The measure supports the NQS priority of ensuring that each person and family is engaged as partners in their care.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is a patient reported outcome performance measure.
  
  
• Does the measure address a quality challenge? Yes. The measures assesses the desired outcome of the spinal surgery procedure. The submitter states variation in the current outcomes.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. The measure is not duplicative and addresses the topic of spinal surgery.
  
  
• Can the measure can be feasibly reported? Yes. The measure uses a common visual analog scale. The submitter states that the data is available via a registry, but no further information is provided.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. The measure is fully developed. The submitter provides a summary of testing that was performed at group practices – whether testing is at the individual clinician, group or facility is not reported. Testing results are not provided.
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that 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
Studies demonstrate that visual analog scales for the assessment of adult pain in general and back and leg pain specifically are valid, reliable and sensitive to change. Hawker, G. A., Mian, S., Kendzerska, T. and French, M. (2011), Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care & Research, 63: S240–S252. doi: 10.1002/acr.20543

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: The average change (preoperative to one year postoperative) in back pain for patients 18 years of age or older who had lumbar spine fusion surgery.
  
  
• Numerator: This measure is not a proportion or rate, and as such, does not have a numerator and denominator, but has an eligible population with a calculated result. The calculated result is: The average change (preoperative to one year postoperative) in back pain for all eligible patients.
  
  
• Denominator: This measure is not a proportion or rate, and as such, does not have a numerator and denominator, but has an eligible population with a calculated result. The eligible population is: Patients 18 years of age or older as of January 1 of the measurement period who had a lumbar spine fusion surgery performed by an eligible provider in an eligible specialty during the measurement period and whose back pain was measured by the Visual Analog Scale (VAS) within three months preoperatively AND at one year (+/- 3 months) postoperatively.
  
  
• Exclusions: None
  
  
• HHS NQS Priority: Patient and Family Engagement
  
  
• HHS Data Source: Registry
  
  
• Measure Type: Patient Reported Outcome
  
  
• Steward: MN Community Measurement
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support (NQF endorsement & testing supports variation at the individual provider level)
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure would add PRO to the set as well as spine surgery specific measures. The submitter does not provide specific test data. In order for full support, the submitter will need to provide data at the individual provider level.
  • Impact on quality of care for patients:Patient-reported outcomes provide valuable information for patients and consumers when selecting healthcare providers. This measure would assess the outcome of a lumbar fusion.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. This is a patient-reported outcome. The measure supports the NQS priority of ensuring that each person and family is engaged as partners in their care.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is a patient reported outcome performance measure.
  
  
• Does the measure address a quality challenge? Yes. The measures assesses the desired outcome of the spinal surgery procedure. The submitter states variation in the current outcomes.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. The measure is not duplicative and addresses the topic of spinal surgery.
  
  
• Can the measure can be feasibly reported? Yes. The measure uses a common visual analog scale. The submitter states that the data is available via a registry, but no further information is provided.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. The measure is fully developed. The submitter provides a summary of testing that was performed at group practices – whether testing is at the individual clinician, group or facility is not reported. Testing results are not provided.
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that 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
According to the Journal of Neurosurgery: Spine’s Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine, the assessment of functional outcomes, including pain, continues to be essential. Studies demonstrate that visual analog scales for the assessment of adult pain in general and back and leg pain specifically are valid, reliable and sensitive to change. Ghogawala MD, Zoher, et al. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 2: Assessment of functional outcome following lumbar fusion. Journal of Neurosurgery: Spine. Jul 2014. DOI: 10.3171/2014.4.SPINE14258 Hawker, G. A., Mian, S., Kendzerska, T. and French, M. (2011), Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care & Research, 63: S240–S252. doi: 10.1002/acr.20543

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: The average change (preoperative to three months postoperative) in leg pain for patients 18 years of age or older who had lumbar discectomy laminotomy procedure
  
  
• Numerator: This measure is not a proportion or rate, and as such, does not have a numerator and denominator, but has an eligible population with a calculated result. The calculated result is: The average change (preoperative to three months postoperative) in leg pain for all eligible patients.
  
  
• Denominator: This measure is not a proportion or rate, and as such, does not have a numerator and denominator, but has an eligible population with a calculated result. The eligible population is: Patients 18 years of age or older as of January 1 of the measurement period who had a lumbar discectomy and/or laminotomy procedure for a diagnosis of disc herniation performed by an eligible provider in an eligible specialty during the measurement period and whose leg pain was measured by the Visual Analog Scale (VAS) within three months preoperatively AND at three months (6 to 20 weeks) postoperatively.
  
  
• Exclusions: Patient had any additional spine procedures performed on the same date as the lumbar discectomy laminotomy.
  
  
• HHS NQS Priority: Patient and Family Engagement
  
  
• HHS Data Source: Registry
  
  
• Measure Type: Patient Reported Outcome
  
  
• Steward: MN Community Measurement
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support (NQF endorsement & testing supports variation at the individual provider level)
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure would add PRO to the set as well as spine surgery specific measures. The submitter does not provide specific test data. In order for full support, the submitter will need to provide data at the individual provider level.
  • Impact on quality of care for patients:Patient-reported outcomes provide valuable information for patients and consumers when selecting healthcare providers. This measure would assess the outcome of leg pain after a discectomy and/or laminectomy.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. This is a patient-reported outcome. The measure supports the NQS priority of ensuring that each person and family is engaged as partners in their care.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is a patient reported outcome performance measure.
  
  
• Does the measure address a quality challenge? Yes. The measures assess the desired outcome of the spinal surgery procedure. The submitter states variation in the current outcomes.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. The measure is not duplicative and addresses the topic of spinal surgery.
  
  
• Can the measure can be feasibly reported? Yes. The measure uses a common visual analog scale. The submitter states that the data is available via a registry, but no further information is provided.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. The measure is fully developed. The submitter provides a summary of testing that was performed at group practices – whether testing is at the individual clinician, group or facility is not reported. Testing results are not provided.
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that 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
Studies demonstrate that visual analog scales for the assessment of adult pain in general and back and leg pain specifically are valid, reliable and sensitive to change. Hawker, G. A., Mian, S., Kendzerska, T. and French, M. (2011), Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care & Research, 63: S240–S252. doi: 10.1002/acr.20543

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Patients determined as having prostate cancer currently undergoing androgen deprivation therapy (ADT) or prior use of ADT who receive an initial bone density evaluation.
  
  
• Numerator: Patient with DEXA scan or bone mineral density scan initially or within 3 months of ADT initiation.
  
  
• Denominator: Diagnosis of prostate cancer Current or past usage of androgen deprivation therapy
  
  
• Exclusions: None
  
  
• HHS NQS Priority: Making Care Safer, Effective Prevention and Treatment
  
  
• HHS Data Source: Administrative clinical data, Electronic Health Record
  
  
• Measure Type: Process
  
  
• Steward: Oregon Urology Institute in collaboration with Large Urology Group Practice Association
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? Yes
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support (pending NQF endorsement)
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure fulfills a gap and has been tested with multiple EHRs and registries. Recommended conditional supporting pending NQF review and endorsement.
  • Impact on quality of care for patients:This measure provides information as to whether phyiscians are appropriately conducting and documenting bone density evaluation.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. This measure supports the NQS priorities of safety and promoting effective prevention and treatment.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. There is evidence to demonstrate that androgen suppression as a treatment for prostate cancer can cause osteoporosis .
  
  
• Does the measure address a quality challenge? Yes. The measures fills a gap in quality measurement. The submitter states there is variation in the current outcomes.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. The measure is not duplicative and addresses the topic of bone density.
  
  
• Can the measure can be feasibly reported? Yes. This measure underwent alpha and beta testing. It was beta tested in two (2) electronic health records which have reported directly to CMS and also via two (2)registries. The operational elements met with the structured data requirements.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. CMS has been provided with testing data and the measure has been assigned an eCQM number.
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? N/A.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Submitted.
  
  

Rationale for measure provided by HHS
Androgen suppression as a treatment for prostate cancer can cause osteoporosis. (Gleason et al. General & Epidemiological Trends & Socioeconomics: Practice Patterns, Cost Effectiveness). Men undergoing prolonged androgen deprivation therapy (ADT) incur bone loss at a rate higher than menopausal women. (AUA. Business Cases in Urology: CRPC). In preserving bone health, the goal is to prevent or treat osteopenia /osteoporosis for the patient on ADT and to prevent or delay skeletal related events (SRE). The National Osteoporosis Foundation recommendations including a baseline assessment of bone density with a DEXA scan and daily calcium and Vitamin D supplementation. (Gaylis et al. Compliance with Evidence Based Bone Health Management in Men on chronic ADT: Opportunities for Improvement). The DEXA scan is the gold standard for bone density screening. Men at risk for adverse bone consequences from chronic ADT do not always receive care according to evidence based guidelines. These findings call for improved processes that standardize evidence based practice including baseline and follow up bone density assessment. (Gaylis et al).

Measure Specifications

• NQF Number (if applicable): 2930
  
  
• Description: Percentage of patients with a solid malignant tumor or lymphoma who had a febrile neutropenia (FN) risk assessment completed and documented in the medical record prior to the first cycle of intravenous chemotherapy
  
  
• Numerator: Number of patients who had an FN risk assessment documented in the medical record prior to the first cycle of intravenous chemotherapy.
  
  
• Denominator: Number of patients 18 years of age or older with a solid malignant tumor or lymphoma receiving the first cycle of intravenous chemotherapy.
  
  
• Exclusions: There are no exclusions
  
  
• HHS NQS Priority: Making Care Safer, Communication and Care Coordination
  
  
• HHS Data Source: Administrative claims (non-Medicare), Electronic Health Record, Hybrid, Paper medical record, Record review
  
  
• Measure Type: Process
  
  
• Steward: RAND Corporation
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Support
  
  
• Preliminary analysis summary
  • Contribution to program measure set:The measure is NQF endorsed and fills an important gap.
  • Impact on quality of care for patients:Information about a patient’s febrile neutropenia (FN) risk allows the identification of patients at higher risk of FN who are more likely to benefit from treatment with prophylactic colony-stimulating factor (CSF).
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. This measure supports the NQS priorities of safety and promoting effective communication and coordination.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. There is evidence to demonstrate that having information about a patient’s febrile neutropenia (FN) risk allows the identification of patients at higher risk of FN who are more likely to benefit from treatment with prophylactic colony-stimulating factor (CSF). CSF stimulates the production of white blood cells and lowers the risk of FN and its complications.
  
  
• Does the measure address a quality challenge? Yes. The measure addresses a significant variation in care with data from April 2011-February 2016 that included 192 patient records from 5 community oncology clinics with the mean performance rate as 12.0%, the median as 16.0%, and the maximum as 27.0%.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. The measure is not duplicative and addresses FN risk assessment.
  
  
• Can the measure can be feasibly reported? Yes. The measure is fully developed and full specifications are provided.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. The measure is currently being reviewed the Cancer Standing Committee. It has been ratified by the Executive Committee of the NQF Board.
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? No. Measure 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
Seven articles published from 2006 to 2016 provide insights into the benefits of FN risk assessment: Donohue (2006): Among patients receiving chemotherapy, the rates CSF prophylaxis were higher in those who were managed with a Risk Assessment Tool, than those in a “control group” that received care without use of the tool in an earlier time period (72% versus 28%, respectively, p<0.001). Conversely, the rates of adverse outcomes were higher in the control group than in the Risk Assessment Tool Group, but not statistically significant: febrile neutropenia (14% versus 11%, respectively), treatment with IV antibiotics (28% versus 14%), hospitalizations secondary to febrile neutropenia (16% versus 11%), and chemotherapy dose reductions (10% versus 3%). Doyle (2006): In a pre-post intervention study of patients initiating chemotherapy or a new regimen, use of tool for assessing patient risk of FN lowered the rate of FN-related hospitalization by 78%, from 9.7% among 155 patients in FY04 to 2.1% among 189 patients in FY05 (P = 0.003). Miller (2006): In a study of an intervention with a computer-based risk assessment tool (CBRAT), the rate of documenting performance of an FN risk assessment was 13% before use of the CBRAT and 100% after its introduction (p<0.001). O’Brien et al. (2014): An intervention study in a hospital-based oncology unit used an FN risk assessment tool to decide which patients receiving chemotherapy to treat with CSF. Comparing the time periods before (N=233 patients) and after (N=226 patients) the tool was used, the incidence of FN was reduced by 52% (p=0.02). Krzemieniecki et al. (2014): A total of 1,347 patients with solid tumors were eligible for the study based on being scheduled for “myelotoxic” chemotherapy and having an “investigator-assessed FN risk” of = 20%. The study found 45-80% of these patients, depending on the tumor site, did not receive G-CSF that was indicated by results of the FN risk assessment by the investigator and guideline recommendations. Freyer et al. (2015): In a study of 165 physicians and 944 patients, each physician rated FN risk for their own patients using factors they selected. Only 82% of patients with an FN risk at or above 20% based on the physician-assessed FN risk were scheduled to receive CSF indicating almost one of five patients would not receive G-CSF PP even though the patient’s risk was rated higher than the threshold of 20%. Mäenpää et al. (2016): In a study of 690 breast cancer patients (stages I-III) receiving chemotherapy, a higher proportion of those with a high-risk regimen were given G-CSF primary prophylaxis than those with a lower-risk regimen (48% versus 22%). However, these results indicate that less than half of patients on a high-risk regimen received appropriate treatment with G-CSF. References: Donohue, R. (2006). Development and implementation of a risk assessment tool for chemotherapy-induced neutropenia. Oncol Nurs Forum, 33(2), 347-352. Doyle, A. M. (2006). Prechemotherapy assessment of neutropenic risk. Oncology (Williston Park), 20(10 Suppl Nurse Ed), 32-39; discussion 39-40. Miller, K. (2010). Using a computer-based risk assessment tool to identify risk for chemotherapy-induced febrile neutropenia. Clin J Oncol Nurs, 14(1), 87-91. O'Brien, C., Dempsey, O., & Kennedy, M. J. (2014). Febrile neutropenia risk assessment tool: improving clinical outcomes for oncology patients. Eur J Oncol Nurs, 18(2), 167-174. Krzemieniecki, K., Sevelda, P., Erdkamp, F., Smakal, M., Schwenkglenks, M., Puertas, J., et al. (2014). Neutropenia management and granulocyte colony-stimulating factor use in patients with solid tumours receiving myelotoxic chemotherapy--findings from clinical practice. Support Care Cancer, 22(3), 667-677. Freyer, G., Kalinka-Warzocha, E., Syrigos, K., Marinca, M., Tonini, G., Ng, S. L., et al. (2015). Attitudes of physicians toward assessing risk and using granulocyte colony-stimulating factor as primary prophylaxis in patients receiving chemotherapy associated with an intermediate risk of febrile neutropenia. Med Oncol, 32(10), 236. Maenpaa, J., Varthalitis, I., Erdkamp, F., Trojan, A., Krzemieniecki, K., Lindman, H., et al. (2016). The use of granulocyte colony stimulating factor (G-CSF) and management of chemotherapy delivery during adjuvant treatment for early-stage breast cancer-Further observations from the IMPACT solid study. Breast, 25, 27-33.

Summary of NQF Endorsement Review

• Year of Most Recent Endorsement Review: 2016
  
  
• Project for Most Recent Endorsement Review: Cancer
  
  
• Review for Importance: 1a. Evidence: H-4; M-15; L-0; I-0; 1b. Performance Gap: H-3; M-12; L-2; I-2 Rationale: • The developer provided a clinical practice guideline from the 2015 American Society of Clinical Oncology (ASCO) Recommendations for the Use of WBC Growth Factors and the 2015 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) to support the assessment of febrile neutropenia (FN) risk and administration of appropriate colony-stimulating factor (CSF) prophylaxis prior to chemotherapy. The developer provided additional studies evaluating the effectiveness of FN risk assessment tools. The Committee noted that the developer presented strong evidence supporting the administration of CSF prophylaxis prior to chemotherapy. However, the focus of the measure is documentation of a FN risk assessment prior to chemotherapy. The developer clarified that there is no evidence supporting 1 FN risk assessment tool over another at this time. The Committee agreed the evidence the developer provided to support the use of a FN assessment tool demonstrated a decrease in the incidence of febrile neutropenia and related complications. • The developer provided performance rates from April 2011-February 2016 that included 192 patient records from 5 community oncology clinics. The mean performance rate was 12.0%, the median was 16.0%, and the maximum was 27.0%. The performance rates were stratified by age, race/ethnicity, and gender. The developer provided data from the literature that showed disparities on the use of prophylactic CSF based on gender, race, geographic location, and lower socioeconomic status. The developer stated that there is limited published data on the frequency of risk assessment for FN but cited a study (Miller, 2010) conducted at 4 offices of a community oncology practice to assess the effect of a computer-based risk assessment tool (CBRAT) for FN. Before implementation of the CBRAT, 13 of 101 (13.0%) patients had documented risk assessments for FN. After implementation of CBRAT, documented risk assessments increased to 100.0%. • The Committee noted that appropriately administering prophylactic CSF and preventing FN in high-risk cancer patients is important, but based on the limited data the developer provided, the Committee questioned whether a gap in care/quality problem exists related to documentation of a FN assessment. The Committee suggested that the low performance rates presented by the developer may be due to the adoption of computerized physician order entry (CPOE) and standard order sets that include supportive care treatments appropriate for the regimen, including pre-medications, hydration, CSF, and hypersensitivity medications. Providers using standardized orders sets are not likely to include additional documentation explicitly stating the FN risk or a note in the chart that reflects the rationale for either administering or not administering CSF based on patient and regimen risk factors as required by the measure. • The Committee agreed that is it important to assess patients for FN risk and administer CSF appropriately, however, they encouraged the developer to expand the measure so that evidence-based standing orders meet the intent of the measure.
  
  
• Review for Scientific Acceptability: 2a. Reliability: M-14; L-4; I-1 2b. Validity: H-17; M-0; L-1 Rationale: • The Committee agreed the data elements are clearly defined, but somewhat complex and may be difficult to calculate consistently. • Inter-rater reliability testing was assessed using 2 abstractors who were instructed to abstract the same randomly selected 50 medical records from 5 community oncology clinics, 10 records per clinic, for a 25 percent inter-rater reliability (IRR) sample. The kappa statistic and percent agreement between the abstractors was calculated based on whether documentation of a febrile neutropenia risk assessment was in the medical record. The developer provided kappa statistics and percent agreement results for 1 data element included in the numerator (documentation of a febrile neutropenia risk assessment in the medical record). Kappa estimates ranged from 0.783 to 1.0 for the 5 clinics; percent agreement ranged from 90-100%. NQF guidance states that testing should be done for all critical data elements. The clinics determined which patients met the denominator inclusion criteria (age at least 18 years, solid tumor or lymphoma, initiating chemotherapy, and not participating in a clinical trial). The developers excluded additional patients due to incomplete records, malignancy other than solid tumor or lymphoma, or concurrent radiation. The Committee commented that the sample used for reliability testing was relatively small, yet the reliability score was acceptable and met the reliability criterion. • The Committee encouraged the developer to conduct a statistical analysis, in the future, of the computed measure score to assess the proportion of variability due to real differences among the measured entities. • The developer assessed face validity of the measure score using a panel of 10 experts in clinical oncology. Eighty percent (8/10) of the respondents either agreed or strongly agreed that performance scores resulting from the measure as defined can be used to distinguish good and poor quality. One of the Committee members commented that they would like to see data showing that groups with high scores on the measure have less FN. Another Committee member suggested that missing data may be a threat to validity, although the developer stated that missing data was not identified during the medical record abstraction. The Committee concluded that the validity criterion was met.
  
  
• Review for Feasibility: 3. Feasibility: H-1; M-14; L-3; I-0 (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: • Some of the data elements are easily found in electronic sources but information about FN risk assessment may not be generated during routine care delivery and require manual chart abstraction. The Committee suggested incorporating the FN risk assessment into CPOE and standard orders to increase the feasibility of the measure in the future.
  
  
• Review for Usability: 4. Usability and Use: H-1; M-16; L-1; I-0 (Used and useful to the intended audiences for 4a. Accountability and Transparency; 4b. Improvement; and 4c. Benefits outweigh evidence of unintended consequences) Rationale: • The developer stated that because the measure is being submitted to NQF for initial endorsement, they do not yet have plans to submit it for use in a specific federal, state or local program. However, the measure would be appropriate for use in a CMS reporting program for outpatient care provided to oncology patients. • The Committee emphasized that a febrile neutropenia outcome measure would further the goal of highquality, efficient healthcare rather than this process measure. The Committee requested that, if endorsed, the developer provide data on the performance of the measure and include patients who were administered CSF prophylaxis and patients with febrile neutropenia to understand the impact of the measure. Another Committee member questioned the impact this measure will have on the appropriate use of CSF but acknowledged that additional data will be useful to improve quality.
  
  
• Review for Related and Competing Measures: No related or competing measures noted
  
  
• Endorsement Public Comments: 6. Public and Member Comment • One commenter noted that an outcome measure will assist in determining more than appropriate use of colony-stimulating factor (CSF), specifically resource utilization related to urgent care due to febrile neutropenia (FN). The commenter also noted the challenges of documenting FN risk assessment in electronic health records (EHR). • Developer response: We agree that measuring febrile neutropenia (FN) outcomes is important, but view an outcome measure as a complement to our proposed measure rather than a substitute.
  
  
• Endorsement Committee Recommendation: Standing Committee Recommendation for Endorsement: Y-16; N-2
  
  

Measure Specifications

• NQF Number (if applicable): 2764
  
  
• Description: Percentage of patients aged 18 years and older with a diagnosis of heart failure (HF) and a current or prior left ventricular ejection fraction (LVEF) <40% who are self-identified Black or African Americans and receiving Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) and Beta-blocker therapy who were prescribed a fixed-dose combination of hydralazine and isosorbide dinitrate seen for an office visit in the measurement period in the outpatient setting or at each hospital discharge
  
  
• Numerator: Patients prescribed a fixed-dose combination of hydralazine and isosorbide dinitrate seen for an office visit in the measurement period in the outpatient setting or at each hospital discharge
  
  
• Denominator: All patients aged 18 years and older with a diagnosis of heart failure with a current or prior LVEF <40% who are self-identified Black or African Americans and receiving ACEI or ARB and Beta-blocker therapy
  
  
• Exclusions: Denominator exclusions include: • Hypotension (severe or symptomatic) • Severe lupus erythematosus • Unstable angina • Peripheral neuritis • Patient actively taking Phosphodiesterase Type 5 (PDE5) Inhibitors
  
  
• HHS NQS Priority: Effective Prevention and Treatment
  
  
• HHS Data Source: Electronic Health Record
  
  
• Measure Type: Process
  
  
• Steward: National Minority Quality Forum
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? Yes
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Refine and resubmit
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure addresses both effective clinical care and potential disparities in heart failure. However, it has not been fully tested for validity.
  • Impact on quality of care for patients:This measure would track a therapy that can reduce morbidity and mortality in patients who self-identify as Black or African American.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure supports the NQS priority of promoting effective practices
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This eMeasure was approved for trial use. It met all criteria for endorsement, including evidence with the exception of eMeasure testing for scientific acceptability. The measure submission stated that the measure would reduce amenable morbidity and mortality in the patient cohort that is not receiving this highly effective therapy. During the endorsement process, concerns were raised regarding the limitation of this measure to a fixed dose of hydralazine and isosorbide dinitrate therapy.
  
  
• Does the measure address a quality challenge? Yes. This measure addresses both the use of evidenced based practices as well as addresses potential disparities in care.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. The measure is not duplicative, and no other measures address the use of the combination therapy to treat heart failure.
  
  
• Can the measure can be feasibly reported? Yes. The measure was approved for eMeasure trial use by NQF in February 2016
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? No. The measure was approved for trial use. The eMeasure testing for validity will be reviewed by the Cardiovascular Standing Committee on 2/3/2017.
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? n/a.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Submitted.
  
  

Rationale for measure provided by HHS
The African-American Heart Failure Trial (A-HeFT) first published in 2004 demonstrated that there is significant benefit for African American patients who receive the fixed-dose combination therapy of hydralazine and isosorbide dinitrate. A-HeFT built on the findings from the two Vasodilator-Heart Failure Trials (V-HeFT). A-HeFT, which was ended early due to the mortality rates in the placebo population, demonstrated a 43% reduction in mortality, a 33% decrease in initial hospitalizations, and a 50% improvement in patient-reported quality of life (Taylor, 2004; Sharma, 2014). These results clearly demonstrate that the fixed-dose combination therapy significantly improves patient morbidity, mortality and quality of life in this clinical cohort. There is no substitute for the fixed-dose combination therapy. Even with this strong evidence of unprecedented efficacy and cost-effectiveness, research shows that more than 85% of African American patients are not receiving the quality of care that this therapy affords, constituting a significant gap in care quality (Dickson, 2015). The underuse of the fixed-dose combination of hydralazine plus isosorbide dinitrate in African Americans with severe heart failure is a health care and health quality disparity that exposes these patients to an elevated risk for mortality and hospitalization, and compromises efforts to contain the escalating system costs by preventing or reducing unnecessary hospitalizations and readmissions. Based upon research on the mortality benefit of the fixed-dose combination (Fonarow, 2011), the National Minority Quality Forum estimates that 51,542 (27%) of the 189,891 African American Medicare beneficiaries who were being treated for heart failure and received their prescription drugs under Part D should have been treated with the fixed-dose combination; but only 2,377 (5%) had at least one prescription (30-day supply) of the therapy. Further, the National Minority Quality Forum estimates that between 2008 and 2010, only 3% of the eligible patient cohort in Medicare received the therapy. Given the documented number to treat to receive the mortality benefit (21), it can be estimated that from 2007 through 2010, 20,000 African American Medicare beneficiaries died as a result of the failure to receive quality care as defined by evidence-based guidelines. The proven benefits to this patient population are significant and there is a clear opportunity for improvement. Failure to do so constitutes a failure to provide quality and cost-effective care. As with other diagnoses and available therapies, we anticipate that the evidence supporting this measure will continue to evolve. For example, research continues to explore if the fixed-dose combination of hydralazine and isosorbide dinitrate is linked to a particular genetic polymorphism (NIH funded Genomic Response Analysis of Heart Failure Therapy in African Americans). References Dickson VV, Knafl GJ, Wald J, Riegel B. Racial differences in clinical treatment and self-care behaviors of adults with chronic heart failure. J Am Heart Assoc. 2015;4:1-13. Fonarow GC, Yancy CW, Hernandez AF, Peterson ED, Spertus JA, Heidenreich PA. Potential impact of optimal implementation of evidence-based heart failure therapies on mortality. Am Heart J. 2011;161:1024-1030. Sharma A, Colvin-Adams M, Yancy CW. Heart failure in African Americans: disparities can be overcome. Cleve Clin J Med. 2014;81:301-11. Taylor AL, Ziesche S, Yancy C, et al. Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. N Engl J Med 2004; 351:2049–57.

Measure Specifications

• NQF Number (if applicable): 2079
  
  
• Description: Percentage of patients, regardless of age, with a diagnosis of HIV who had at least one medical visit in each 6-month period of the 24-month measurement period with a minimum of 60 days between medical visits. (The endorsed specifications of the measure are: Percentage of patients, regardless of age, with a diagnosis of HIV who had at least one medical visit in each 6-month period of the 24-month measurement period with a minimum of 60 days between medical visitsA medical visit is any visit in an outpatient/ambulatory care setting with a nurse practitioner, physician, and/or a physician assistant who provides comprehensive HIV care.)
  
  
• Numerator: Patients who had at least one medical visit in each 6-month period of the 24-month measurement period with a minimum of 60 days between first medical visit in the prior 6-month period and the last medical visit in the subsequent 6-month period. (Measurement period is a consecutive 24-month period of time.)
  
  
• Denominator: Patients, regardless of age, with a diagnosis of HIV with at least one medical visit in the first 6 months of the 24-month measurement period
  
  
• Exclusions: Patients who died at any time during the measurement period.
  
  
• HHS NQS Priority: Effective Prevention and Treatment
  
  
• HHS Data Source: Administrative clinical data, Claims, Paper medical records, Record review
  
  
• Measure Type: Process
  
  
• Steward: Health Resources and Services Administration (HRSA) - HIV/AIDS Bureau
  
  
• Endorsement Status:
  
  
• 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? Yes
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Refine and resubmit
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure addresses an important clinical area. However, it has not been fully tested as an e-CQM. The testing data is in the process of being updated from the 2011 data, which should be evaluated to determine if a quality challenge remains. If the review continues to demonstrate a quality challenge and testing is successful, it would support alignment with the claims based measure that is already part of MIPS.
  • Impact on quality of care for patients:The measure would address an important issue regarding the HIV continuum of care and would provide an additional mechanism for submitting data on this topic.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure supports the NQS priority of promoting effective practices
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. The measure tracks retention, which is part of the HIV care continuum, which is a widely accepted model for measuring the strategies people living with HIV progress through with the goal of achieving HIV viral suppression.
  
  
• Does the measure address a quality challenge? Yes. A 2015 CDC study shows that 91.5 percent of new HIV infections in 2009 were attributable to people with HIV who were not in medical care, including those who didn’t know they were infected.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. This measure is aligned with the current measure NQF#2079, which is included in the final rule for MIPS.
  
  
• Can the measure can be feasibly reported? Yes. The measure passed alpha testing for face validity, measure logic validity, and data element reliability and was scheduled to being beta testing in July 2016.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? No. Though similar to the NQF measure 2079, the measure has not been fully tested as an e-CQM.
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? n/a.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Endorsed.
  
  

Rationale for measure provided by HHS
Early linkage to and long-term retention in HIV care leads to better health outcomes. Linkage to HIV medical care shortly after HIV diagnosis and continuous care thereafter provide opportunities for risk reduction counseling, initiation of treatment, and other strategies that improve individual health and prevent onward transmission of infection (1-6). Delayed linkage and poor retention in care are associated with delayed receipt of antiretroviral treatment, higher rate of virologic failure, and increased morbidity and mortality (5,7). Poor retention in care during the first year of outpatient medical care is associated with delayed or failed receipt of antiretroviral therapy, delayed time to virologic suppression and greater cumulative HIV burden, increased sexual risk transmission behaviors, increased risk of long-term adverse clinical events, and low adherence to antiretroviral therapy (1,5,7,9). Early retention in HIV care has been found to be associated with time to viral load suppression and 2-year cumulative viral load burden among patients newly initiating HIV medical care (8). References: 1. Giordano TP, Gifford AL, White AC Jr, Suarez-Almazor ME, Rabeneck L, Hartman C, et al. Retention in care: a challenge to survival with HIV infection. Clin Infect Dis. 2007; 44:1493-9. 2. Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, et al.; HPTN 052 Study Team. Prevention of HIV -1 infection with early antiretroviral therapy. N Engl J Med. 2011; 365:493-505. 3. Giordano TP, White AC Jr, Sajja P, Graviss EA, Arduino RC, Adu-Oppong A, et al. Factors associated with the use of highly active antiretroviral therapy in patients newly entering care in an urban clinic. J Acquir Immune Defic Syndr. 2003; 32:399-405. 4. Lucas GM, Chaisson RE, Moore RD. Highly active antiretroviral therapy in a large urban clinic: risk factors for virologic failure and adverse drug reactions. Ann Intern Med. 1999; 131:81-7. 5. Metsch LR, Pereyra M, Messinger S, Del Rio C, Strathdee SA, Anderson-Mahoney P, et al.; Antiretroviral Treatment and Access Study (ART AS) Study Group. HIV transmission risk behaviors among HIV -infected persons who are successfully linked to care. Clin Infect Dis. 2008; 47:577-84. 6. Montaner JS, Lima VD, Barrios R, Yip B, Wood E, Kerr T, et al. Association of highly active antiretroviral therapy coverage, population viral load, and yearly new HIV diagnoses in British Columbia, Canada: a population-based study. Lancet. 2010; 376:532- 9. 7. Ulett KB, Willig JH, Lin HY, Routman JS, Abrams S, Allison J, Chatham A, Raper JL, Saag MS, Mugavero MJ. The therapeutic implications of timely linkage and early retention in HIV care. AIDS Patient Care STDS. 2009 Jan; 23(1):41-9. 8. Mugavero MJ, Amico KR, Westfall AO, Crane HM, Zinski A, Willig JH, Dombrowski JC, Norton WE, Raper JL, Kitahata MM, Saag MS. Early retention in HIV care and viral load suppression: implications for a test and treat approach to HIV prevention. J Acquir Immune Defic Syndr. 2012 Jan 1; 59(1):86-93. 9. Mugavero MJ, Lin HY, Willig JH, Westfall AO, Ulett KB, Routman JS, Abroms S, Raper JL, Saag MS, Allison JJ. Missed visits and mortality among patients establishing initial outpatient HIV treatment. Clin Infect Dis. 2009 Jan 15;48(2):248-56.

Summary of NQF Endorsement Review

• Year of Most Recent Endorsement Review: 2012
  
  
• Project for Most Recent Endorsement Review: Infectious Disease Endorsement Maintenance 2012
  
  
• Review for Importance: 1a. Impact: H-13; M-5; L-1; I-0; 1b. Performance Gap: H-6; M-13; L-0; I-0 1c. Evidence: Y-14; N-4; I-1 Rationale: • This measure is looking at medical visits for HIV care in a 24-month period rather than a single year period. The measure is not specific to newly enrolled patients, but rather any patient currently receiving care. • The intent of the measure is to examine not only adherence to the visit but also how frequently an individual made those visits over a 2-year period. • The measure examines retention in care for HIV patients. Regular care provides opportunities for risk reduction counseling, monitoring of labs and initiation of treatment. The submission provides data that showed that each no-show clinic visit conveyed a 17 percent increased risk of delayed viral load suppression and CD4 counts were significantly greater amongst those with optimal retention. • The evidence focused on two consistent, cohort studies and the DHHS guidelines for adults and adolescents with 14 studies examining the impact of treatment on reducing morbidity and mortality, 8 of studies focused on the impact of treatment on preventing transmission, 3 studies that supported the frequency of CD4 count monitoring and 9 studies supporting the frequency of viral load monitoring. • There is significant room for improvement, as the data provided demonstrated that only 42.6 percent of patients met the HRSA criterion for retention to medical visits. • The developer provided data on disparities which indicated that females, racial minorities and patient lacking private health insurance were significantly more likely to fail at establishing care.
  
  
• Review for Scientific Acceptability: 2a. Reliability: H-2; M-13; L-2; I-1 2b. Validity: H-0; M-16; L-1; I-2 Rationale: • This measure encourages providers to examine what they can do to maximize retention, such as providing good customer satisfaction programs. Committee members agreed that if you are not in care, you will not do well. • The Committee discussed the role of patient compliance and agreed that patient compliance is out of the clinic or the provider's control. Some Committee members noted that this measure provided an opportunity for the provider to reengage the patient. • The developer does not expect this measure to have 100 percent performance; there is leeway to account for patients who do not make their medical visit. • The developer indicated that they had considered exclusions for incarcerated patients but found difficulty in capturing this data. • Face validity was used to establish validity of this measure; however threats to validity were not addressed.
  
  
• Review for Feasibility: 4. Feasibility: H-4; M-12; L-3; I-0 (4a. Clinical data generated during care delivery; 4b. Electronic sources; 4c.Susceptibility to inaccuracies/ unintended consequences identified 4d. Data collection strategy can be implemented) Rationale: • All the data elements are contained within an electronic claims, appointment systems or EHRs.
  
  
• Review for Usability: 3. Usability: H-4; M-12; L-3; I-0 (Meaningful, understandable, and useful to the intended audiences for 3a. Public Reporting/Accountability and 3b. Quality Improvement) Rationale: • The intended use is for public health and disease surveillance, public reporting and quality improvement with benchmarking. The Committee agreed that a goal of 100 percent performance is unrealistic but improvement can be monitored. • The developer intents to submit this measure for meaningful use and PQRS programs.
  
  
• Review for Related and Competing Measures: 5. Related and Competing Measures • This measure directly relates to measure 2080: Gaps in medical visit. Measure 2079 looks at a twoyear time period and measure 2080 looks at a one-year time period. • Committee members concluded that the measures are complementary. Measure 2079 is assessing the clinic’s persistency with care and excludes new patients who have not been treated in clinic for at least two years. Measure 2080 includes new patients who did not have a visit in the last six months. Measure 2080 has a shorter measurement period and includes more patients.
  
  
• Endorsement Public Comments: Public and Member Comment (October 3, 2012-November 5, 2012) • Revise the measure title to include the language “HIV/AIDS” to indicate this measure is applicable to patients with a diagnosis of HIV. o Developer Response: We would accept a title change to “HIV medical visit frequency.” • There is a high correlation between medical visit frequency and viral load suppression. This measure incentivizes provider practices to retain patients, which greatly assists with the provision of needed care to the patient. Should this measure be publically reported, it would benefit from stratification by race, gender, and type of insurance coverage in order to capture disparities. The two-year measurement period allows clinics to track their patient populations over time to create a better trajectory of care continuity. Using data from this measure, clinics are able to build a list of patients that, when juxtaposed to the new patients captured in #2080, can reveal which patients have fallen into a gap in care. The measure’s denominator population is inclusive. o Developer Response: We anticipate that this is a disparities-sensitive measure and it could be used to highlight differences in access to care between subpopulations. • Medical Visit Measures: Revisit measures #0403 and #2079, which cannot be viewed separately from a comparative and practical standpoint. Although NQF measure #0403 was not re-endorsed, from a practical standpoint it makes more sense than the variation of this metric (#2079) which was endorsed. The fact that measure #0403 is based on CPT II coding should not have ruled it out, because both the Veteran’s Administration and Kaiser Permanente have demonstrated on a large scale that this measure can be captured electronically.[i],[ii] In addition, the 12-month medical visit frequency utilized in measure #0403 is consistent with the time period captured in all the other HIV metrics, whereas measure #2079 relies on a 24-month frequency. We question the rationale and practicality of using a 24-month timeframe, given that the patient population being measured may shift considerably within a 24-month window, and considering that the same 24-month outcome could be captured by looking at #0403 serially, over time. We also express concern about how measure #2079 could be reported as the denominator would be different every six months. Lastly, we would note that measure #2079 was tested only in HIV-specific clinical settings (Ryan White clinics) and may not be as applicable in other clinical settings. [i]Backus LI, Boothroyd DB, Phillips BR, Belperio PS, Halloran JP, Valdiserri RO, Mole LA, Arch Intern Med. National quality forum performance measures for HIV/AIDS care: the Department of Veterans Affairs' experience. 2010 Jul 26;170(14):1239-46. [ii]Horberg M, Hurley L, Towner W, Gambatese R, Klein D, Antoniskis D, Weinberg W, Kadlecik P, Remmers C, Dobrinich R, Quesenberry C, Silverberg M, Johnson M, “HIV Quality Performance Measures in a Large Integrated Healthcare System,” AIDS, Patient Care, and STDs, 2011; 25(1): 21-28. o Developer Response: 1. Our understanding of what linkage to and retention in HIV medical care mean, and how they relate to morbidity and mortality outcomes, continues to evolve ,and thus so should our measurements. Studies have examined retention from multiple perspectives in order to understand its impact on patient health outcomes. Retention, as measured by #403, has a moderate impact on morbidity and mortality yet declines over time (1, 2). Long term retention in medical care among people living with HIV is associated with a significantly greater mean increase in baseline CD4 count (3). Additionally, mortality is higher among those with suboptimal retention (3). Examining retention over a greater period of time may thus be more meaningful with respect to how well it correlates with patient morbidity and mortality. Retention in care is crucial in maximizing the health outcomes of people living with HIV. As eloquently outlined by Mugavero, et al., there are several ways to measure retention and engagement with each having its own strengths and limitations (4). Facilities/Clinic may choose to utilize one or more measures depending on the facility/clinic characteristics, personnel administering the measure (clinician vs. administrator), and/or purpose of the measure (quality improvement, benchmarking, or monitoring). HIV care and treatment as well as performance measures are dynamic systems. As a result, it may be necessary to have more than one measure available for use. Additionally, we feel that serially measuring #403 over two time periods may result in additional work to compare the two sets of results and may not yield the same results as using #2079. Also, serially measuring #403 doesn’t yield the same results as using #2079 since no one is ever required to be in care for 24 months to count as a success. For example, utilizing #403 for CY2010 and then again for CY2011 would not yield the same results as using #2079 which also spans 24 month retention. Measure #2079 follows the first 6 month patient cohort for the subsequent three 6 month periods. Measure #403 looks at a cohort of patients who had at least one visit in a 12 month period to see if they had two visits in the same period. Comparing the two measures, one could determine that measure 2079 assesses retention over a longer period of time. Also, we would like to clarify that the denominator doesn’t shift every 6 months. Rather, it represents people who had a medical visit during one 6 month period and the measure then determines how many continue to be seen over the 48 2079: HIV medical visit frequency subsequent 3 six-month periods. 2. When using #2079, it can report a “snapshot” of a cohort of patients with a medical visit from a 6 month period of time. (This is similar to using a denominator where the cohort is from a 12 month period.) This measure can be used to understand the retention of the patients retrospectively or monitor retention moving forward. HRSA has plans to promote this measure’s inclusion in CMS’s Meaningful Use program which would require its e-specification. 3. HRSA’s HIV/AIDS Bureau currently has a HIV workforce study in the data collection phase. It is hypothesized that a significant portion clinical providers caring for people living with HIV in the U.S. receive Ryan White funding. Therefore, using a Ryan White clinic setting to test the measure is appropriate. The Ryan White provider community consists of a diverse cross-section of medical providers and locations. We believe the locations used for the scientific acceptability portion of the submission are representative of locations where people living with HIV receive medical care in the U.S. It is also important to note that the scientific acceptability (reliability and validity testing) is assessed to determine the reliability and validity of the measure score. Scientific acceptability is not dependent on the source of the data. The variables used in #2079 are the same variables used in #403. The variables, diagnosis date, medical visit dates, and date of death, are common within HIV medical care and also readily available in EHRs. 1. Please note: On July 24, 2012, Secretary Sebelius approved a package of seven common core measures for monitoring HHS-funded HIV prevention, treatment, and care services. The measures were generated following multiple consultations with a group of federal and non-federal stakeholders and are consistent both with the Institute of Medicine’s recommendations for monitoring HIV services and measures deployed by the National Quality Forum (NQF) and the National Committee for Quality Assurance (NCQA). This measure, #2079 medical visit frequency, is one of the seven measures approved by Secretary Sebelius, supporting alignment of measures across HHS. 1. Marks G, Gardner L, Craw JA, Crepaz N. Entry and retention in medical care among HIV-diagnosed persons in the United States: a meta-analysis. AIDS 2010;24:2665–78. 2. Fleishman JA, Yehia BR, Moore RD, Korthuis PT, Gebo KA; for the HIV Research Network. Establishment, Retention, and Loss to Follow-Up in Outpatient HIV Care. J Acquir Immune Defic Syndr. 2012 Apr 23. [Epub ahead of print] 3. Tripathi A, Youmans E, Gibson JJ, Duffus WA. The impact of retention in early HIV medical care on viro-immunological parameters and survival: a statewide study. AIDS Res Hum Retroviruses. 2011; 27:751-8. 4. Mugavero MJ, Davila JA, Nevin CR, Giordano TP. From Access to Engagement: Measuring Retention in Outpatient HIV Clinical Care. AIDS Patient Care and STDs. October 2010, 24(10): 607-613 Committee Response: Committee members noted that consumers strongly support the 24-month timeframe as it provides a richer image of care provided to patients. The Committee maintained their original recommendation for measure 2079.
  
  
• Endorsement Committee Recommendation: Steering Committee Recommendation for Endorsement: Y-18; N-1
  
  

Measure Specifications

• NQF Number (if applicable): 2082
  
  
• Description: Percentage of patients, regardless of age, with a diagnosis of HIV with a HIV viral load less than 200 copies/mL at last HIV viral load test during the measurement year. (The endorsed specifications of the measure are: Percentage of patients, regardless of age, with a diagnosis of HIV with a HIV viral load less than 200 copies/mL at last HIV viral load test during the measurement yearA medical visit is any visit in an outpatient/ambulatory care setting with a nurse practitioner, physician, and/or a physician assistant who provides comprehensive HIV care.)
  
  
• Numerator: Patients with a HIV viral load less than 200 copies/mL at last HIV viral load test during the measurement year.
  
  
• Denominator: Patients, regardless of age, diagnosed with HIV during the first 3 months of the measurement year or prior to the measurement year who had at least one medical visit in the measurement year.
  
  
• Exclusions: None
  
  
• HHS NQS Priority: Effective Prevention and Treatment
  
  
• HHS Data Source: Administrative clinical data, Claims, Paper medical records, Record review
  
  
• Measure Type: Outcome
  
  
• Steward: Health Resources and Services Administration (HRSA) - HIV/AIDS Bureau
  
  
• Endorsement Status:
  
  
• 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? Yes
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Refine and resubmit
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure addresses an important clinical area. However, it has not been fully tested as an e-CQM. The testing data is in the process of being updated from the 2011 data, which should be evaluated to determine if a quality challenge remains. If the review continues to demonstrate a quality challenge and testing is successful, it would support alignment with the claims based measure that is already part of MIPS.
  • Impact on quality of care for patients:The measure would address an important issue regarding HIV viral suppression would provide an additional mechanism for submitting data on this topic.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure supports the NQS priority of promoting effective practices
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. Sustained viral load suppression is directly related to reduction in disease progression and to reduction in potential for transmission of infection. Among persons in care, sustained viral load suppression represents the cumulative effect of prescribed therapy, ongoing monitoring, and patient adherence. The proposed measure will direct providers’ attention and quality improvement efforts towards this important outcome"
  
  
• Does the measure address a quality challenge? Yes. CDC data from 2011 shows that only an estimated 30% of people living with HIV are HIV virally suppressed
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? . This measure is aligned with the current measure NQF#2082, which is included in the final rule for MIPS.
  
  
• Can the measure can be feasibly reported? . The measure passed alpha testing for face validity, measure logic validity, and data element reliability and was scheduled to being beta testing in July 2016.
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? n/a.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Endorsed.
  
  

Rationale for measure provided by HHS
Sustained viral load suppression is directly related to reduction in disease progression and to reduction in potential for transmission of infection. Among persons in care, sustained viral load suppression represents the cumulative effect of prescribed therapy, ongoing monitoring, and patient adherence. The proposed measure will direct providers’ attention and quality improvement efforts towards this important outcome.

Summary of NQF Endorsement Review

• Year of Most Recent Endorsement Review: 2012
  
  
• Project for Most Recent Endorsement Review: Infectious Disease Endorsement Maintenance 2012
  
  
• Review for Importance: 1a. Impact: H-18; M-1; L-0; I-0; 1b. Performance Gap: H-7; M-12; L-0; I-0 1c. Evidence: Y-18; N-1; I-0 Rationale: • There is a substantial relationship between viral load suppression and the reduction of morbidity, mortality and HIV transmission. Emerging evidence of earlier antiretroviral therapy indicates decreased HIV-associated complications. • There is data to support the measure focus for the adolescent and adult populations; however, there are limited data for the pediatric population. • While there is a movement towards treating all children with HIV, there are providers who do not treat asymptomatic high viral loads and high CD4 counts, in which this measure does not account for. • The DHHS guidelines whose treatment recommendations are based on the analysis of six randomized controlled trials. One of those is a meta-analysis of nine randomized controlled trials. In addition, there were eight observational studies. • The Committee asked why it is the last viral load and not any of the viral loads within that year. The developer responded that it's two fold. First, the last viral load is the most current information about the patient and second, it is very straightforward and easy to calculate. • Data from the Medical Monitoring Project18 showing 77 percent achieved viral load suppression at most recent test. Additional data from King County showed 65 percent achieved undetectable at the last test. Data from Kaiser Permanente showed that 94.5 percent achieved undetectable at the last viral load if they were known to be on ARV therapy with 69 percent achieving undetectable when looking at all HIV-infected populations in their data set. • Disparities in race, sex and age were identified for viral load suppression.
  
  
• Review for Scientific Acceptability: 2a. Reliability: H-2; M-17; L-0; I-0 2b. Validity: H-1; M-17; L-0; I-0; Abstain-1 Rationale: • Reliability and validity were only assessed at the measure score level. • The goal of treatment is an undetectable viral load, maximal suppression, which most assays now it's less than 50, less than 48, less than 20. However, blips in viral load that are thought to probably not be clinically relevant, at least immediately clinically relevant, are not uncommon. A treatment failure is when reproducible viral loads are over 200. The empiric data indicated that 200 is the appropriate cut off point. However, most experts would agree that's a reasonable standard and only a minor component of this measure. • The Committee noted that the testing data for reliability was well-defined. • Face validity was used as the method to test validity. [Note: Dr. Giordano was a member of the panel to assess validity of this measure. He recused himself from voting on validity
  
  
• Review for Feasibility: 4. Feasibility: H-8; M-11; L-0; I-0 (4a. Clinical data generated during care delivery; 4b. Electronic sources; 4c.Susceptibility to inaccuracies/ unintended consequences identified 4d. Data collection strategy can be implemented) Rationale: • Though not yet specified for EHRs, all data elements are available in electronic health records.
  
  
• Review for Usability: 3. Usability: H-10; M-9; L-0; I-0 (Meaningful, understandable, and useful to the intended audiences for 3a. Public Reporting/Accountability and 3b. Quality Improvement) Rationale: • The developer reports that this measure is currently in use as a national quality improvement project focusing on retention in medical care for individuals with HIV. Agencies with DHHS, Department of Veteran Affairs, HIV Medical Association and Kaiser Permanente commented on the importance of this measure.
  
  
• Review for Related and Competing Measures: 5. Related and Competing Measures • No related or competing measures noted.
  
  
• Endorsement Public Comments: Public and Member Comment (October 3, 2012-November 5, 2012) • This which is the sole outcome measure of this infectious disease endorsement measure set. There is a strong correlation between the reduction of viral loads and that of morbidity, mortality, and HIV transmission, which makes this measure beneficial not only to individual patients but to populations as well as transmission of the virus is reduced. Data for this measure should be stratified by race, ethnicity, gender, and age when it is publically reported so as to build a capacity to identify disparities in a nationally standardized, meaningful fashion. eSpecification of this measure should be developed for use with EHRs. o Developer Response: We appreciate the comment. We expect this is a disparities-sensitive measure and it can be used to highlight disparities in outcomes among HIV-infected patients. • Reconsider, from a comparative and practical standpoint, the endorsed measure #2082 and the rejected measure #0407. Measure #2082 captures the percentage of ALL HIV-diagnosed patients that have achieved RNA control in a given 12 month period, whereas the rejected metric #0407 captures viral control within a six-month window from the start of treatment for patients on anti-retroviral therapy. Adoption of measure #2082 may penalize providers that have higher numbers of long-term nonprogressors in their patient populations, and that the measure does not account for clinical judgment and patient choices not to begin ART for various reasons. Use of such a composite downstream outcome measure where all patients with an HIV diagnosis are presumed indicated to be on ART, suggests there is no need for Measure #2083 (Prescription of Anti-Retroviral Therapy). o Developer Response: As for no exclusion: A.) We do not expect performance to be at 100%. B.) This measure captures the entire population of people living with HIV within facilities or clinics that are engaged or accessing medical care. It does not apply any additional criteria such as needing to have a greater number of medical visits or be prescribed HIV antiretroviral therapy. This is important as a greater emphasis is placed on community HIV viral load and the body of evidence of “treatment as prevention” grows. C.) We have been working closely with CMS and ONC on the inclusion of HIV measures into Meaningful Use. From that experience, CMS and ONC are warning of the use of patient and provider exclusions. Adding exclusions to measures makes it more difficult, if not impossible, to e-specify the measure’s use in an EHR. Long-term non-progressors make up a very small percentage of the HIV-infected population overall. In addition, long-term non-progressors generally have undetectable viral loads. As some of these patients could develop detectable viral loads over time, decisions would need to be made between patients and providers about when/if to begin ART. 2. We see value in having both a prescribed HIV antiretroviral therapy and viral load suppression measure. The #2083 “Prescribed HIV antiretroviral therapy” can be used to understand access to HIV medications, which is a key step on the road towards viral suppression. In addition, some patients, despite good adherence to ART, may never achieve viral load suppression due to their resistance profiles. Measuring ART use will help providers understand their viral load suppression data more fully. 3. Please note: On July 24, 2012, Secretary Sebelius approved a package of seven common core measures for monitoring HHS-funded HIV prevention, treatment, and care services. The measures were generated following multiple consultations with a group of federal and non-federal stakeholders and that are consistent both with the Institute of Medicine’s recommendations for monitoring HIV services and measures deployed by the National Quality Forum (NQF) and the National Committee for Quality Assurance (NCQA). This measure, #2082 viral load suppression, is one of the seven measures approved by Secretary Sebelius, supporting alignment of HIV measures across HHS. Committee Response: The Committee discussed that measure #407 does not capture patients that are not on anti-retroviral therapy; it is important to include all patients. There is benefit in knowing the percentage of all patients in the population being treated. The goal is for the measure results to be as high as possible but 100 percent compliance is not expected. The Committee indicated that measure 2082 provides the best view of the desired outcome and continued its recommendation for endorsement.
  
  
• Endorsement Committee Recommendation: Steering Committee Recommendation for Endorsement: Y-18; N-1
  
  

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of patients age 18 or older who are taken to the operating room for an elective surgical intervention under regional, and/or general anesthesia AND who have documentation of a significant co-morbid condition(s) in their medical record within 30 days of operation date.
  
  
• Numerator: All patients evaluated by an eligible professional who are scheduled for an elective surgical procedure AND who have documentation of clinically accurate and relevant co-morbid medical conditions in the medical record within 30 days prior to the procedure.
  
  
• Denominator: All adults (18 years and older) evaluated by an eligible professional who are scheduled for an elective surgical procedure.
  
  
• Exclusions: Documentation in the patient’s medical record that patient does not have any co-morbid medical conditions within 30 days prior to a patient undergoing an elective surgical procedure.
  
  
• HHS NQS Priority: Making Care Safer, Effective Prevention and Treatment
  
  
• HHS Data Source: Electronic Health Record, Paper Medical Record, Record Review, Registry
  
  
• Measure Type: Process
  
  
• Steward: American College of Surgeons
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Removed from Review by CMS
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
ASA class is a reliable independent predictor of medical complications and mortality following surgery. Hackett N; De Oliveira G; Jain U; Kim J. World J Surg. 2015 May 8th A New method of classifying prognostic comorbidity in longitudinal studies: development and validation Charlson, M; Pompei, P; Ales, K; MacKenzie, C. J Chron Dis. 198; 40(5):373-383. Association of comorbidities with postoperative in-hospital mortality: a retrospective cohort study Kork, F; Balzer, F, et al. Medicine 2015; 94(8): 576

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of patients age 18 or older who are taken to the operating room for an elective or emergent surgical intervention under regional, MAC, and/or general anesthesia for whom an intraoperative surgical debriefing takes place at the end of the case by the surgeon confirming wound classification, correct counts, procedure performed, specimen review, equipment review, postoperative destination and postoperative care plan including plan for perioperative antibiotics, VTE prophylaxis and Foley catheter.
  
  
• Numerator: All adults (18 years and older) who undergo an elective or emergent surgical procedure under regional, MAC, and/or general anesthesia for whom an intraoperative surgical debriefing takes place at the end of the case confirming correct counts, procedure and specimen review, wound class, fluids recorded, equipment review, postoperative destination and postoperative care plan including plan for perioperative antibiotics, VTE prophylaxis and Foley catheter. The debriefing must be documented in the medical record.
  
  
• Denominator: All adults, female and male, (18 years and older) who undergo an elective or emergent surgical procedure under regional, MAC, and/or general anesthesia.
  
  
• Exclusions: N/A
  
  
• HHS NQS Priority: Making Care Safer, Communication and Care Coordination
  
  
• HHS Data Source: Electronic Health Record, Paper Medical Record, Record Review, Registry
  
  
• Measure Type: Process
  
  
• Steward: American College of Surgeons
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Removed from Review by CMS
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Cumin D, Skilton C, Weller J. Information transfer in multidisciplinary operating room teams: a simulation-based observational study. BMJ Qual Saf. 2016 doi: 10.1136/bmjqs-2015-005130 WHO Guidelines for Safe Surgery 2009: Safe Surgery Saves Lives. World Health Organization (WHO). 2009. http://www.who.int/patientsafety/safesurgery/tools_resources/9789241598552/en/ Wyrick DL, Smith SD, Dassinger MS. Implementation of the World Health Organization checklist and debriefing improves accuracy of surgical wound class documentation. Am J Surg. 2015; 210(6):1051-4 Porta CR, Foster A, Causey MW, Cordier P, et al. Operating room efficiency improvement after implementation of a postoperative team assessment. J Surg Res. 2013; 180(1):15-20 Papaspyros SC, Javangula KC, Alduri RK, O’Regan DJ. Briefing and debriefing in the cardiac operating room: Analysis of impact on theatre team attitude and patient safety. Interact Cardiovasc Thorac Surg. 2010;10(1)43-7 Berenholtz SM, Schumacher K, Hayanga AJ, Simon M, et al. Implementing standardized operating room briefings and debriefings at a large regional medical center. Jt Comm J Qual Patient Saf 2009; 35(8):391-7 Bethune R, Sasirekha G, Sahu A, Cawthorn S, et al. Use of briefings and debriefings as a tool in improving team work, efficiency, and communication in the operating theatre. Postgrad Med J. 2011; 87(1027):331-4

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of patients age 18 or older who are taken to the operating room for an elective or emergent surgical intervention under regional, MAC, and/or general anesthesia for whom an intraoperative safety checklist is performed prior to incision that includes the patient’s name, the procedure to be performed, laterality, confirmation of site marking, allergies, confirmation of the administration of preoperative antibiotic prophylaxis and VTE prophylaxis if appropriate, anticipated equipment, placement of Bovie pad, correct patient positioning, and display of essential imaging.
  
  
• Numerator: All patients age 18 or older who are taken to the operating room for an elective or emergent surgical intervention under regional, MAC, and/or general anesthesia for whom an intraoperative safety checklist is performed prior to incision that includes the patient’s name, the procedure to be performed, laterality, confirmation of site marking, allergies, confirmation of the administration of preoperative antibiotic prophylaxis and VTE prophylaxis if appropriate, anticipated equipment, placement of Bovie pad, correct patient positioning, and display of essential imaging
  
  
• Denominator: All adults (18 years and older) who undergo an elective or emergent surgical procedure under regional, MAC, and/or general anesthesia
  
  
• Exclusions: Trauma or emergent cases in which the patient is unstable, and completion of a full time-out is felt to compromise the patient’s safety
  
  
• HHS NQS Priority: Making Care Safer, Communication and Care Coordination
  
  
• HHS Data Source: Electronic Health Record, Paper Medical Record, Record Review, Registry
  
  
• Measure Type: Process
  
  
• Steward: American College of Surgeons
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Removed from Review by CMS
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Submitted.
  
  

Rationale for measure provided by HHS
Van Klei WA, Hoff RG, et al. Effects of the introduction of the WHO "Surgical Safety Checklist" on in-hospital mortality: a cohort study. Annals of Surgery. 2012 Jan;255(1):44-9. Mayer EK, Sevdais N, et al. Surgical Checklist Implementation Project: The Impact of Variable WHO Checklist Compliance on Risk-adjusted Clinical Outcomes After National Implementation: A Longitudinal Study. Annals of Surgery. 2016 Jan;263(1):58-63. Paull DE, Mazzia LM, et al. Briefing guide study: preoperative briefing and postoperative debriefing checklists in the Veterans Health Administration medical team training program. American Journal of Surgery. 2010 Nov;200(5):620-3.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of patients initially diagnosed with nonmuscle invasive bladder cancer and who received intravesical Bacillus-Calmette-Guerin (BCG) within 6 months of initial diagnosis.
  
  
• Numerator: Intravesical Bacillus-Calmette Guerin (BCG) instillation for initial dose or series. BCG dose can be full or partial and can be from any lot or manufacturer. BCG is initiated within 6 months of the bladder cancer diagnosis.
  
  
• Denominator: All patients initially diagnosed with nonmuscle invasive bladder cancer.
  
  
• Exclusions: Denominator Exceptions: Immunosuppressed patients - AIDS, Leukemia, Lymphoma Active Tuberculosis Recurrent bladder cancer Unavailability of BCG
  
  
• HHS NQS Priority: Effective Prevention and Treatment
  
  
• HHS Data Source: Administrative clinical data, Electronic Health Record
  
  
• Measure Type: Process
  
  
• Steward: Oregon Urology Institute
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? Yes
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional support (pending NQF endorsement)
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure fulfills a gap and has been tested with multiple EHRs and registries. Recommended conditional supporting pending NQF review and endorsement.
  • Impact on quality of care for patients:This measure provides information on the gap area of bladder cancer measures, the 5th most common cancer diagnosis in 2016. Failure to treat the bladder cancer in a nonmuscle invasive stage can lead to invasion into the muscle layer of the bladder, requiring bladder removal and further chemotherapy and/or radiation.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. This measure supports the NQS priority of promoting effective prevention and treatment.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. There is evidence to demonstrate that identification and treatment of bladder cancer early can result in less recurrence or progression to a high grade or stage of bladder cancer.
  
  
• Does the measure address a quality challenge? Yes. The measures fills a gap in quality measurement. The submitter states there is variation in the current outcomes.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. The measure is not duplicative and addresses the gap area of bladder cancer.
  
  
• Can the measure can be feasibly reported? Yes. This measure has been tested in the clinical environment and at an electronic level in 2 electronic health records.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. CMS has assigned an eCQM number to this measure.
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? N/A.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Submitted.
  
  

Rationale for measure provided by HHS
There are no bladder cancer measures, yet it is the 5th common cancer diagnosis in 2016. Failure to treat the bladder cancer in a nonmuscle invasive stage can lead to invasion into the muscle layer of the bladder, requiring bladder removal and further chemotherapy and/or radiation.

Measure Specifications

• NQF Number (if applicable): 657
  
  
• Description: Percentage of patients aged 2 months through 12 years with a diagnosis of OME who were not prescribed systemic antimicrobials
  
  
• Numerator: Patients who were not prescribed systemic antimicrobials
  
  
• Denominator: All patients aged 2 months through 12 years with a diagnosis of OME
  
  
• Exclusions: Denominator Exceptions: Documentation of medical reason(s) for prescribing systemic antimicrobials
  
  
• HHS NQS Priority: Making Care Safer, Best Practice of Healthy Living, Effective Prevention and Treatment
  
  
• HHS Data Source: Registry
  
  
• Measure Type: Process
  
  
• Steward: American Academy of Otolaryngology – Head and Neck Surgery (AAOHN)
  
  
• Endorsement Status:
  
  
• Changes to Endorsed Measure Specifications?: The MUC list indicates the measure has been modified from its endorsed version.
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Support
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure would address the avoidance of inappropriate use of systemic antimicrobials.
  • Impact on quality of care for patients:This measure provides information as to whether physicians are appropriately administrating systemic antimicrobials.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. This measure supports the NQS priorities of safety, and promoting effective communication and coordination.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. There is evidence to demonstrate that Clinicians should recommend against using systemic antimicrobials with patients aged two months through 12 years with a diagnosis of otitis media with effusion
  
  
• Does the measure address a quality challenge? No. The submitter states that there is variation in the current performance.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. The measure is not duplicative and addresses systemic antimicrobials for otitis media with effusion.
  
  
• Can the measure can be feasibly reported? Yes. The measure is included in one registry, the AAO-HNSF clinical data registry, Regent).
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. The measure is fully developed and full specifications are provided.
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? . Measure is currently not being used in a program.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Endorsed.
  
  

Rationale for measure provided by HHS
OME usually resolves spontaneously with indications for therapy only if the condition is persistent and clinically significant benefits can be achieved. Systemic antimicrobials have no proven long-term effectiveness and have potential adverse effects. The purpose of the corresponding guideline statement is to reduce ineffective and potentially harmful medical interventions in OME when there is no long-term benefit to be gained in the vast majority of cases. Medications have long been used to treat OME, with the dual goals of improving QOL and avoiding more invasive surgical interventions. Both the 1994 guidelines and the 2004 guidelines determined that the weight of evidence did not support the routine use of steroids (either oral or intranasal), antimicrobials, antihistamines, or decongestants as therapy for OME. STATEMENT 8b. ANTIBIOTICS: Clinicians should recommend against using systemic antibiotics for treating OME. Strong recommendation based on systematic review of RCTs and preponderance of harm over benefit. Clinical Practice Guideline: Otitis Media with Effusion (Update). Rosenfeld RM et al. Otolaryngol Head Neck Surg. (2016) Data detailing the prescription of systemic antimicrobials for otitis media with effusion in children is limited. However, in a small 2008 study by Patel et al, 7% of physicians in an otolaryngology practice prescribed systemic antimicrobials for pediatric patients presenting with OME [1]. In a 2014 study involving 5 focus groups of parents, most parents believed that antibiotics were needed to treat otitis media and expressed frustration with a “watchful waiting” approach [2]. In a 2013 study by Forrest et al evaluating clinical decision support for management of OME, 78%-93% of physicians employed a “watchful waiting” strategy to manage OME [3]. 1. Patel MM, Eisenberg L, Witsell D, Schulz KA. Assessment of acute otitis externa and otitis media with effusion performance measures in otolaryngology practices. Otolaryngol Head Neck Surg. 2008;139:490-494. 2. Finkelstein JA, Dutta-Linn M, Meyer R, Goldman R. Childhood infections, antibiotics, and resistance: what are parents saying now? Clin Pediatr (Phila). 2014;53(2):145-150. Doi:10.1177/0009922813505902. 3. Forrest CB, Fiks AG, Bailey LC, et al. Improving adherence to otitis media guidelines with clinical decision support and physician feedback. Pediatrics. 2013;131(4):e1071-e1081.

Summary of NQF Endorsement Review

• Year of Most Recent Endorsement Review: 2015
  
  
• Project for Most Recent Endorsement Review: Eye Care and Ear, Nose,and Throat Conditions,2014-2016
  
  
• Review for Importance: 1a. Evidence: 7-H; 6-M; 2-L; 0-I; 1b. Performance Gap: 7-H; 8-M; 0-L; 0-I Rationale: • Evidence provided by the developer for the use of systemic antimicrobials measure included the 2004 guidelines from the American Academy of Family Physicians, and two systematic reviews: American Academy of Otolaryngology-Head and Neck Surgery and American Academy of Pediatrics and a 2011 Cochrane review. • The Committee agreed that there was strong evidence to support not using systemic antimicrobials with patients aged two months through 12 years with a diagnosis of otitis media with effusion. • The Committee also acknowledged that there is a high level of opportunity for improvement. The Committee cited evidence provided by the developer that in a 2013 study by Forrest, et al., evaluating clinical decision support for management of OME, 78%-93% of physicians employed a “watchful waiting” strategy to manage OME. • The Committee noted the importance of this measure for antibiotic stewardship
  
  
• Review for Scientific Acceptability: 2a. Reliability: 6-H; 4-M; 5-L; 0-I 2b. Validity: 3-H; 7-M; 5-L; 0-I Rationale: • The Committee agreed that the method of testing and the testing results demonstrate that this measure is reliable and that the specifications align with the evidence presented by the developer. • This measure is specified for paper medical records, the numerator is specified with a CPT II code, and the denominator is specified with ICD-9 CM and ICD-10 CM and CPT codes. • While the Committee did agree that the measure was valid, some cautioned that ‘medical reasons’ as an exclusion was too broad. The developer explained that a non-specific exclusion allowed for co-occurring conditions that might justify prescribing an antimicrobial. The developer shared that there was an 11.43 percent exception rate for this measure and found that co-occurring conditions were example of reasons for exclusions. • Reliability was tested at the data element level in two large pediatric practice networks between 2008 and 2009. Inter-rater reliability of two independent chart abstractors found 95 percent agreement for the numerator and 74 percent for the denominator. • Validity was assessed by systematic assessment of face validity by an expert panel of 21 members who generally agreed that the measure could distinguish quality of care.
  
  
• Review for Feasibility: 3. Feasibility: 2-H; 9-M; 4-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: • The Committee agreed the measure is feasible for implementation. • Some Committee members questioned why the measure was being submitted with paper medical records for the data source. The developer explained that the measure has only been tested in paper charts. The developer also explained that there is a chart abstraction tool that guides the manual review of medical records. Since this measure is not currently in a program such as PQRS, the developer relied on earlier data from when the measure was originally developed. The developer clarified that while the measure was currently specified to use paperbased testing data, it has the potential to be implemented in an electronic format. • Initially, the Committee did not reach consensus on the criterion ‘Feasibility’ because members were concerned about the burden of a measure specified for paper medical records. After further discussion the Committee re-voted and passed the measure on the criterion ‘Feasibility,’ noting that the measure could be reported using electronic medical records
  
  
• Review for Usability: 4. Use and Usability: H-1; M-12; L-1; I-1 (Meaningful, understandable, and useful to the intended audiences for 4a. Public Reporting/Accountability and 4b. Quality Improvement) Rationale: • This measure is currently not publically reported, however, it is currently being used by the American Board of Internal Medicine Self-Directed Performance Improvement Module (PIM). • The Committee agreed the measure is usable, as it measures a very prevalent condition with a clear diagnostic criterion seen frequently in primary care specialist offices but there is no data to support that thought. 84 • Although the measure is not in use, the Committee agreed practice seems to have changed such that steroid use is not common.
  
  
• Review for Related and Competing Measures: This measure relates to: o 0655 Otitis Media with Effusion: Antihistamines or decongestants – Avoidance of inappropriate use; and o 0657 Otitis Media with Effusion: Systemic antibiotics – Avoidance of inappropriate use. • All three measures use the same definitions and codes to identify the denominator population. • There are no competing measures noted.
  
  
• Endorsement Public Comments: One commenter generally supported this measure. Two commenters suggested that the Committee reconsider their recommendation of this measure for reserve status, stating that it is a good quality measure and should be recommended for full endorsement with continued active endorsement. One commenter referenced the work of Lester, et al. which highlights that removing incentives from reporting can result in a decrease in performance. One of these commenters also NQF REVIEW DRAFT— Member Votes due by September 23, 2015 by 6:00 PM ET questioned the burden of data collection this measure may have on physicians. o Developer's Response: The American Academy of Otolaryngology – Head and Neck Surgery Foundation (AAO-HNSF) appreciates the comment from the American Academy of Family Physicians (AAFP) regarding concern about the potential data collection burden of reporting measure 0656: Otitis Media with Effusion: Systemic Corticosteroids – Avoidance of Inappropriate Use. The AAO-HNSF recently assumed stewardship of this pediatric, paper-based measure. The AAO-HNSF was required to submit measure 0656 for endorsement consideration as a paper-based measure due to existing NQF policy requiring measures to be submitted for endorsement in the format in which they were tested. The AAO-HNSF believes the OME paper-based measures could be readily converted to e-measures, and hopes to formulate measure 0656 such that it may be electronically extracted from EHRs and utilized in a registry. This will eliminate the inherent burden of use associated with a paper-based measure. o Committee Response: While the Committee recognizes the commenters’ concerns that removing active endorsement of this measure may potentially lead to a decrease in performance, the Committee agreed there is little room for performance improvement with this measure and maintains the recommended for reserve status.
  
  
• Endorsement Committee Recommendation: Standing Committee Recommendation for Inactive Endorsement with Reserve Status: Y-13; N-2
  
  

Measure Specifications

• NQF Number (if applicable): 656
  
  
• Description: Percentage of patients aged 2 months through 12 years with a diagnosis of OME who were not prescribed systemic corticosteroids
  
  
• Numerator: Patients who were not prescribed systemic corticosteroids
  
  
• Denominator: All patients aged 2 months through 12 years with a diagnosis of OME
  
  
• Exclusions: Denominator Exception: Documentation of medical reason(s) for prescribing systemic corticosteroids
  
  
• HHS NQS Priority: Making Care Safer, Best Practice of Healthy Living, Effective Prevention and Treatment
  
  
• HHS Data Source: Administrative clinical data, Paper medical record, Registry
  
  
• Measure Type: Process
  
  
• Steward: American Academy of Otolaryngology – Head and Neck Surgery (AAOHN)
  
  
• Endorsement Status:
  
  
• Changes to Endorsed Measure Specifications?: The MUC list indicates the measure has been modified from its endorsed version.
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Do Not Support
  
  
• Preliminary analysis summary
  • Contribution to program measure set:The measure received inactive endorsement with reserve status during its last endorsement review indicating the measure is topped out.
  • Impact on quality of care for patients:This measure provides information as to whether physicians are appropriately administrating systemic corticosteroids.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? No. This measure supports the NQS priorities of safety, and promoting effective communication and coordination. However, during its recent review by the NQF Standing Committee, the measure received inactive endorsement with reserve status indicating that the Committee felt the measure is topped out.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. There is evidence to demonstrate that oral steroids do not have long-term benefits for ear infections and pose risk of side effects. The NQF EENT Standing Committee members noted during its review that the evidence provided is sufficient on the fact that systemic steroids provide little benefit and significant harm.
  
  
• Does the measure address a quality challenge? No. The submitter states that there is variation in the current performance, however, the NQF Standing Committee members had doubts that use of oral steroids in OME represented a significant quality problem.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. The measure is not duplicative and addresses systemic corticosteroids for otitis media with effusion.
  
  
• Can the measure can be feasibly reported? Yes. The submitter gives multiple data sources including registry data.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. The measure is fully developed and full specifications are provided.
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? . Measure is currently not being used in a program.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Endorsed.
  
  

Rationale for measure provided by HHS
OME usually resolves spontaneously with indications for therapy only if the condition is persistent and clinically significant benefits can be achieved. Systemic steroids have no proven long-term effectiveness and have potential adverse effects. The purpose of the corresponding guideline statement is to reduce ineffective and potentially harmful medical interventions in OME when there is no long-term benefit to be gained in the vast majority of cases. Medications have long been used to treat OME, with the dual goals of improving QOL and avoiding more invasive surgical interventions. Both the 1994 guidelines and the 2004 guidelines determined that the weight of evidence did not support the routine use of steroids (either oral or intranasal), antimicrobials, antihistamines, or decongestants as therapy for OME. STATEMENT 8a. STEROIDS: Clinicians should recommend against using intranasal steroids or systemic steroids for treating OME. Strong recommendation against based on systematic review of RCTs and preponderance of harm over benefit. Clinical Practice Guideline: Otitis Media with Effusion (Update). Rosenfeld RM et al. Otolaryngol Head Neck Surg. (2016) Data detailing the prescription of systemic corticosteroids for otitis media with effusion in children is limited. However, in a small 2008 study by Patel et al, 10% of physicians in an otolaryngology practice prescribed systemic corticosteroids for pediatric patients presenting with OME [1]. In a 2013 study by Forrest et al evaluating clinical decision support for management of OME, 78%-93% of physicians employed a “watchful waiting” strategy to manage OME [2]. 1. Patel MM, Eisenberg L, Witsell D, Schulz KA. Assessment of acute otitis externa and otitis media with effusion performance measures in otolaryngology practices. Otolaryngol Head Neck Surg. 2008;139:490-494. 2. Forrest CB, Fiks AG, Bailey LC, et al. Improving adherence to otitis media guidelines with clinical decision support and physician feedback. Pediatrics. 2013;131(4):e1071-e1081.

Summary of NQF Endorsement Review

• Year of Most Recent Endorsement Review: 2015
  
  
• Project for Most Recent Endorsement Review: Eye Care and Ear, Nose,and Throat Conditions,2014-2016
  
  
• Review for Importance: 1a. Evidence: H-9; M-5; L-1; I-1; 1b. Performance Gap: H-1; M-4; L-6; I-4; Evidence Exception: Y-0; N-0 Rationale: • Multiple randomized trials were provided by the developer as evidence. The randomized trials highlighted how oral steroids do not have long-term benefits for ear infections and pose risk of side effects. • The Committee members noted that the evidence provided is sufficient on the fact that systemic steroids provide little benefit and significant harm. • Some Committee members noted concerns that medications, antimicrobials and corticosteroids, have been lumped together in the 2004 Guideline and the 2011 Cochrane Review. The developer responded that they are updating the media with effusion clinical practice guidelines and hopes that it will be published early 2016. The updated guideline, to be published early 2016, will have three separate strong recommendations, individually, for the different medications. • The developer presented unpublished data from a national survey that found that about 3% of physicians prescribed oral antibiotics for OME – an improvement from 10% in 2008. Based on the new data, Committee members were not convinced that use of oral steroids in OME represents a significant quality problem. Some Committee members noted that the small percentage of patients that were prescribed steroids actually needed them for another chronic condition like asthma. Therefore, the 3% prescribed oral antibiotics inappropriately would be reduced even further if taken into account the small percent of patients who actually needed the medication. 83 • The developer responded that the prevalence of the condition is between 50 and 90 percent of children. Therefore, even a small amount of systemic steroid prescribing is still very serious to children. • Ultimately the Committee agreed that with such limited resources, issues with much more prevalence should be addressed, such as antibiotic overuse. The measure did not pass the performance gap criteria.
  
  
• Review for Scientific Acceptability: 2a. Reliability: H-10; M-5; L-0; I-0 2b. Validity: H-6; M-9; L-0; I-0 Rationale: • The Committee agreed that the reliability and validity testing were sufficient to meet the criteria. • Data element reliability was tested in 2008-2009 in two large pediatric practice networks. Interrater reliability (IRR) of two independent chart abstractors found 99% agreement (Kappa = 0.85, almost perfect agreement) for the numerator and 97% for the denominator (Kappa = 0.65, substantial agreement). • Validity was assessed by systematic assessment of face validity by an expert panel of 21 members who generally agreed that the measure could distinguish quality of care. • The measure included broad exclusions for “medical reasons”, the Committee suggested the exclusions need to be more specified. There may be diagnoses that may warrant use of steroids such as nasal polyps, asthma, and allergic rhinitis
  
  
• Review for Feasibility: 3. Feasibility: H-2; M-9; L-4; I-0 (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: • The Committee agreed the measure is feasible to implement, as the measure is abstracted from paper medical record. • Some Committee members noted the measure would be easier to implement if it were an electronic health record.
  
  
• Review for Usability: 4. Use and Usability: 1-H; 12-M; 1-L; 1-I (Meaningful, understandable, and useful to the intended audiences for 4a. Public Reporting/Accountability and 4b. Quality Improvement) Rationale: • The measure is not currently being publically reported but is being used in the American Board of Internal Medicine Self-Directed Performance Improvement Module (PIM).
  
  
• Review for Related and Competing Measures: This measure relates with two additional measures addressing otitis media with effusion: o 0655 Otitis Media with Effusion: Antihistamines or decongestants – Avoidance of inappropriate use: Percentage of patients aged 2 months through 12 years with a diagnosis of OME were not prescribed or recommended to receive either antihistamines or decongestants o 0656 Otitis Media with Effusion: Systemic corticosteroids – Avoidance of inappropriate use: Percentage of patients aged 2 months through 12 years with a diagnosis of OME who were not prescribed systemic corticosteroids o These measures all use the same definitions and codes to identify the denominator population. • There are no competing measures.
  
  
• Endorsement Public Comments: Two commenters were generally in support of this measure.
  
  
• Endorsement Committee Recommendation: 13-Y; 2-N
  
  

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: This measure requires participation in at least one multi-center, standardized national data collection and feedback program that provides benchmarking relative to national data and uses process and/or outcome measures. This measure requires a “yes” or “no” response to whether a facility, program, or individual surgeon participates in a national risk-adjusted outcomes surgical registry.
  
  
• Numerator: Whether or not there is participation in at least one multi-center national data collection and feedback program for elective surgery cases either via an institution based registry or surgeon specific registry.
  
  
• Denominator: N/A
  
  
• Exclusions: N/A
  
  
• HHS NQS Priority: Making Care Safer
  
  
• HHS Data Source: Registry
  
  
• Measure Type: Structure
  
  
• Steward: American College of Surgeons
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Removed from Review by CMS
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
The American college of surgeons national surgical quality improvement program: achieving better and safer surgery. Ko, CY; Hall BL; Hart AJ; Cohen ME; Hoyt, DB. Jt. Comm J Qual Patient Saf. 2015; 41(5) 199 Adverse outcomes in surgical patients: implementation of a nationwide reporting system. Marang-van P; Stadlander M; Kievit J. Qual Saf Health Care 2006 15(5): 320-4. The future of quality measurement in the United States. Yi F. Clin Colon Rectal Surg 2014 27(1) 32-8.

Measure Specifications

• NQF Number (if applicable): 1741
  
  
• Description: The original S-CAHPS survey, as part of the surgical patient experience battery, were designed by the American College of Surgeons (ACS) and the Surgical Quality Alliance (SQA) to address the specific needs of surgical patients. The 6 composites and 1 single-item measure were endorsed by the CAHPS Consortium in 2010 and by the National Quality Forum (NQF) in 2012. Each composite and/or grouping is used to assess a particular domain of patient experience with surgical care quality, from the patient’s perspective. This entry combined 7 measures into one MUC List entry. They are 7 separate measures (6 composite and 1 single item measure). (The endorsed specifications of the measure are: The original S-CAHPS survey, as part of the surgical patient experience battery, were designed by the American College of Surgeons (ACS) and the Surgical Quality Alliance (SQA) to address the specific needs of surgical patients. The 6 composites and 1 single-item measure were endorsed by the CAHPS Consortium in 2010 and by the National Quality Forum (NQF) in 2012. Each composite and/or grouping is used to assess a particular domain of patient experience with surgical care quality, from the patient’s perspective. This entry combined 7 measures into one MUC List entry. They are 7 separate measures (6 composite and 1 single item measure). (The endorsed specifications of the measure are: The following 6 composites and 1 single-item measure are generated from the Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Surgical Care Survey. Each measure is used to assess a particular domain of surgical care quality from the patient’s perspective.Measure 1: Information to help you prepare for surgery (2 items)Measure 2: How well surgeon communicates with patients before surgery (4 items) Measure 3: Surgeon’s attentiveness on day of surgery (2 items) Measure 4: Information to help you recover from surgery (4 items) Measure 5: How well surgeon communicates with patients after surgery (4 items) Measure 6: Helpful, courteous, and respectful staff at surgeon’s office (2 items) Measure 7: Rating of surgeon (1 item)The Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Surgical Care Survey is administered to adult patients (age 18 and over) having had a major surgery as defined by CPT codes (90 day globals) within 3 to 6 months prior to the start of the survey.)
  
  
• Numerator: We recommend that S-CAHPS composites be calculated using a top-box scoring method. The top box score refers to the percentage of patients whose responses indicated excellent performance for a given measure. This approach is a kind of categorical scoring because the emphasis is on the score for a specific category of responses. The composite measures do not have a typical numerator. This section is used to describe the composite score. The composite score is the average proportion of respondents who answered the most positive response category across the questions in the composite. The top box numerators for items within Composite measures 1, 2, 4, 5, and 6 is the number of respondents who answered “Yes, definitely” across the items in each composite. The top box composite score is the average proportion of respondents who answered “Yes, definitely” across the items in the composite. The top box numerator for items within Composite measure 3 is the number of respondents who answered “Yes” across the items in this composite. The top box composite score is the average proportion of respondents who answered “Yes” across the items in this composite. The top box numerator for the Measure 7, the Global Rating Item, is the number of respondents who answered 9 or 10 to the Global Rating Item. Note that for users who want to case-mix adjust their scores, case-mix adjustment can be done using the CAHPS macro and the adjustment is made prior to the calculation of the total score.
  
  
• Denominator: The composite does not have a typical denominator statement. This section describes the target population. The major criteria for selecting patients were having had a major surgery as defined by CPT codes (90 day globals) within 3 to 6 months prior to the start of the survey. Both male and female adults (18 years of age and older) Measure/Component 1. Information to Help You Prepare for Surgery. Denominator statement: The top box denominator is the number of respondents who answer at least one of the questions in this multi-item measure, that is, Question 3 and Question 4. Measure/Component 2. How Well Surgeon Communicates with Patients Before Surgery. Denominator statement: The top box denominator is the number of respondents who answer at least one of the questions in this multi-item measure, that is, Question 9, Question 10, Question 11, and Question 12. Measure/Component 3. Surgeon’s Attentiveness on Day of Surgery. Denominator statement: The top box denominator is the number of respondents who answer at least one of the questions in this multi-item measure, that is, Question 15 and Question 17. Measure/Component 4. Information To Help You Recover From Surgery. Denominator statement: The top box denominator is the number of respondents who answer at least one of the questions in this multi-item measure, that is, Question 26, Question 27, Question 28, and Question 29. Measure/Component 5. How Well Surgeon Communicates With Patients After Surgery. Denominator statement: The top box denominator is the number of respondents who answer at least one of the questions in this multi-item measure, that is, Question 31, Question 32, Question 33, and Question 34. Measure/Component 6. Helpful, Courteous, and Respectful Staff at Surgeon’s Office. Denominator statement: The top box denominator is the number of respondents who answer at least one of the questions in this multi-item measure, that is, Question 36, and Question 37. Measure/Component 7. Patients’ Rating of the Surgeon. Denominator statement: The top box denominator is the number of respondents who answered this single-item global measure, that is, Question 35. (The endorsed specifications of the measure are: The composite does not have a typical denominator statement. This section describes the target population.The major criteria for selecting patients were having had a major surgery as defined by CPT codes (90 day globals) within 3 to 6 months prior to the start of the survey. . [For the full list of CPT codes, see Attachment J].)
  
  
• Exclusions: The following patients would be excluded from all composites: (1) Surgical patients whose procedure was greater than 6 months or less than 3 months prior to the start of the survey. (2) Surgical patients younger than 18 years old. (3) Surgical patients who are institutionalized (e.g., psychiatric facility, nursing facility, or imprisoned) or deceased." (4) Surgery performed had to be scheduled and not an emergency procedure since emergency procedures are unlikely to have visits with the surgeon before the surgery
  
  
• HHS NQS Priority: Patient and Family Engagement, Communication and Care Coordination
  
  
• HHS Data Source: Electronic Health Record, Hybrid, Registry, Survey
  
  
• Measure Type: Patient Reported Outcome
  
  
• Steward: American College of Surgeons
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Support
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This patient reported outcome measure is NQF endorsed and addresses surgical care.
  • Impact on quality of care for patients:This measure provides information on the quality of the provider-patient relationship.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. This measure supports the NQS priorities of patient and family engagement, and communication and care coordination.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. There is evidence to demonstrate that improving the quality of surgical care is of paramount importance to patients and the healthcare system alike.
  
  
• Does the measure address a quality challenge? Yes. The submitter states that there is variation in the current performance.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. The measure is not duplicative and is a patient reported outcome measure addresses surgical care.
  
  
• Can the measure can be feasibly reported? Yes. The submitter gives multiple data sources including EHRs.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. The measure is fully developed and full specifications are provided. The measure was last endorsed in 2012.
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? No. Measure is currently not being used in a program.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Endorsed.
  
  

Rationale for measure provided by HHS
Surgeries are frequently performed procedures that affect large numbers of patients in the population, have high resource use, and poor quality can have serious consequences for patients, including death. Therefore, improving the quality of surgical care is of paramount importance to patients and the healthcare system alike. In a study based on the HCUP 2007 data, in 28 states that were evaluated, there were nearly 5,600 ambulatory surgery (AS) visits per 100,000 in the population and almost 4,100 inpatient surgical visits per 100,000. The mean charge for ambulatory surgery is about $6,100 and for inpatient surgery is about $39,900. The aggregate charge across the 28 states for ambulatory surgery was about $55.6 billion and the total inpatient charges were about $259 billion. Patient experience measures as indicators of quality for health plans are linked to health plan disenrollment. The mean voluntary disenrollment rate among Medicare managed care enrollees is four times higher for plans in the lowest 10 percent of overall CAHPS Health Plan survey ratings than for those in the highest 10 percent. At the provider level, patients who reported the poorest-quality relationships with their physicians are three times more likely to voluntarily leave the physician’s practice than patients with the highest-quality relationships. The quality of the provider-patient relationship as evident in good patient experience scores correlates with lower medical malpractice risk. Although average patient experience scores can mask variations within a provider’s scores, the minimum score a provider receives correlates with the likelihood of being implicated in a medical malpractice suit. Each drop in minimum overall score along a five-step scale of “very good” to “very poor” corresponds to a 21.7 percent increase in the likelihood of being named in a suit. Forty-six percent of malpractice risk is attributed to physician specific characteristics, including patient experience. Efforts to improve patient experience also result in greater employee satisfaction, reducing turnover. Improving patients’ experiences requires improving work processes and systems that enable clinicians and staff to provide effective care. A focused endeavor to improve patients’ experiences at one hospital also resulted in a 4.7 percent reduction in employee turnover. Similarly, nurse satisfaction is strongly positively correlated with patients’ intent to return to or to recommend the hospital.

Summary of NQF Endorsement Review

• Year of Most Recent Endorsement Review: 2012
  
  
• Project for Most Recent Endorsement Review: Surgery
  
  
• Review for Importance: 1. Importance to Measure and Report: Y-16, N-4 (1a. Impact; 1b. Performance gap; 1c. Outcome or Evidence) Rationale: This measure provides important information regarding quality of care to consumers as well as individual providers and institutions. However, some Committee members were concerned as to whether a survey is a direct link to medical outcomes and unsure if patient perception and experience is a good proxy for quality.
  
  
• Review for Scientific Acceptability: 2. Scientific Acceptability of Measure Properties: C-5; P-9; M-2; N-4 (2a. Precise specifications; 2b. Reliability testing; 2c. Validity testing; 2d. Exclusions justified; 2e. Risk adjustment/stratification; 2f. Meaningful differences; 2g. Comparability; 2h. Disparities) Rationale: The 40 percent recommended response rate is relatively high and may not be attainable, especially if the survey is administered via mail. Case-mix adjustment is optional for this measure. Some Committee members indicated that case-mix adjustment being optional is not appropriate for a national standard for performance evaluation for accountability. Other Committee members noted that case-mix adjustment is not necessary for internal quality improvement usage and felt there would not be a vast distinction between adjusted and unadjusted data for external public reporting. Committee members also expressed concern of applying one patient experience survey to all surgical specialties and sub-specialties as well as anesthesia. In response to this concern, the measure developer noted that multiple surgical specialties and sub-specialties do support this measure with the exception of the one specialty that raised this concern during comment. In addition, the developer clarified that the questions included in the survey are those that are applicable across all surgical specialties and sub-specialties.
  
  
• Review for Feasibility: 4. Feasibility: C-5; P-8; M-4; N-3 (4a. Clinical data generated during care process; 4b. Electronic sources; 4c. Exclusions – no additional data source; 4d. Susceptibility to inaccuracies/ unintended consequences identified 4e. Data collection strategy can be implemented) Rationale: Sampling patients 6 months post-surgery can be complicated and expensive. There may be an inherent bias caused by which patients choose to respond to the survey. There is also a possibility of creating a burden on surgical practices to provide follow-up communication to patients in an effort to retrieve surveys in order to achieve the recommended response rate.
  
  
• Review for Usability: 3. Usability: C-6; P-7; M-5; N-2 (3a. Meaningful/useful for public reporting and quality improvement; 3b. Harmonized; 3c. Distinctive or additive value to existing measures) Rationale: This measure is not currently in use; however, the steward is in the process of integrating the measure into a number of quality programs that are used for public reporting. Adding another survey could potential add burden to the patients causing a decrease in the proportion of patients participating in every survey
  
  
• Review for Related and Competing Measures: N/A
  
  
• Endorsement Public Comments: Public and Member Comment • Applicability of the survey to all surgical specialties and sub-specialties as well as anesthesia • Concerns with the validity of the measure and the ability to achieve adequate sample sizes Applicability of the survey to all surgical specialties and sub-specialties as well as anesthesia Committee Response: The Committee discussed the comments received regarding whether one survey can appropriately represent all surgical specialties, sub-specialties and anesthesia practices. The Committee understood the concerns with the requirement to use the S-CAHPS survey instead of using a survey that is more specific to a particular specialty. It was mentioned that anesthesia practices have been instructed not to send an additional survey more specifically related to anesthesia because the institutions did not want patients receiving numerous surveys. Measure Developer Response: The measure developer noted that multiple surgical specialties and sub-specialties do support this measure with the exception of the one specialty that raised this concern during comment. In addition, the developer clarified that the questions included in the survey are those that are applicable across all surgical specialties and sub-specialties. Concerns with the validity of the measure and the ability to achieve adequate sample sizes Committee Response: The Committee discussed the comments received related to the validity of the measure and the current lack of information provided on whether patient experience has been other outcomes. It was noted that this type of testing has not yet been provided for other patient experience measures and it is not unexpected to not have this information on this measure. The Committee also discussed the comments around the implementation concerns of the measure and the responsibility of the surgeon to meet the minimum response rate requirement of 40 percent. Adding another survey could potential add burden to the patients causing a decrease in the proportion of patients participating in every survey as well as a burden on the providers who are responsible for administering the survey. In addition, committee members asked if there were issues with achieving adequate response rates if the sampling methodology did not account for the same patients receiving the HCAHPS survey and that if by increasing the number of surveys sent to patients led to decreased response rates. Measure Developer Response: Continuous sampling strategies can be implemented to allow for greater sample sizes over time. While with a one-time administration sample sizes may in fact be very low for some sub-specialties, with continuous sampling, enough data should be collected to meet the CAHPS standard requirements.
  
  
• Endorsement Committee Recommendation: Steering Committee Recommendation for Endorsement: Y-12, N-8; Rationale: The Committee noted the importance of patient centered measures. This measure provides information from the patient perspective regarding their surgical experience.
  
  

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of patients age 80 and older who have been evaluated for frailty prior to an elective operation.
  
  
• Numerator: All patients age 80 years and over who are 1) brought from their home or normal living environment on the day of surgery AND 2) undergo a non-emergent/non-urgent, scheduled surgical procedure, AND 3) have documented frailty screening AND outcome of screening in the medical record.
  
  
• Denominator: All adults 80 years and older who 1) are brought from their home or normal living environment on the day of surgery AND 2) undergo a non-emergent/non-urgent, scheduled surgical procedure.
  
  
• Exclusions: Frailty screen could not be completed due to patient condition (cognitive impairment, physical disability preventing participation) OR Frailty screen offered and patient refused participation.
  
  
• HHS NQS Priority: Making Care Safer, Communication and Care Coordination
  
  
• HHS Data Source: Electronic Health Record, Paper Medical Record, Record Review, Registry
  
  
• Measure Type: Process
  
  
• Steward: American College of Surgeons
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Removed from Review by CMS
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. Makary MA, Segev DL, Pronovost PJ, Syin D, Bandeen-Roche K, Patel P, Takenaga R, Devgan L, Holzmueller CG, Tian J, Fried LP. Frailty as a predictor of surgical outcomes in older patients. J Am Coll Surg. 2010 Jun;210(6):901-8.. Theou O, Brothers TD, Peña FG, Mitnitski A, Rockwood K. Identifying common characteristics of frailty across seven scales. J Am Geriatr Soc. 2014 May;62(5):901-6. Malmstrom TK, Miller DK, Morley JE. A comparison of four frailty models. J Am Geriatr Soc. 2014 Apr;62(4):721-6. Hewitt J, Moug SJ, Middleton M, Chakrabarti M, Stechman MJ, McCarthy K; Older Persons Surgical Outcomes Collaboration. Prevalence of frailty and its association with mortality in general surgery. Am J Surg. 2015 Feb;209(2):254-9. Collard RM, Boter H, Schoevers RA, Oude Voshaar RC. Prevalence of frailty in community- dwelling older persons: a systematic review. J Am Geriatr Soc. 2012 Aug;60(8):1487-92. Example of FRAIL scale, from: Morley JE, Malmstrom TK, Miller DK. A simple frailty questionnaire (FRAIL) predicts outcomes in middle aged African Americans. J Nutr Health Aging. 2012 Jul;16(7):601-8.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of patients age 18 or older who underwent a non-emergency surgery who had their personalized risks of postoperative complications assessed by their surgical team prior to surgery using a clinical data-based, patient-specific risk calculator and who received personal discussion of those risks with a surgeon
  
  
• Numerator: Documentation of empirical, personalized risk assessment based on the patient’s risk factors with a validated risk calculator using multi-institutional clinical data, the specific risk calculator used, and communication of risk assessment from risk calculator with the patient and/or family
  
  
• Denominator: All adults (18 years and older) who underwent non-emergency surgery
  
  
• Exclusions: N/A
  
  
• HHS NQS Priority: Patient and Family Engagement, Communication and Care Coordination
  
  
• HHS Data Source: Electronic Health Record, Paper Medical Record, Record Review, Registry
  
  
• Measure Type: Process
  
  
• Steward: American College of Surgeons
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Removed from Review by CMS
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Preoperative risk assessment and communication between surgeons and patients is critical for effective informed consent and shared decision making in surgical care. Shared decision-making is considered an integral component of patient-centered care, especially for preference-sensitive issues. Evidence suggests that there is room for improving communication and the informed consent/shared decision-making processes between physicians and patients. Use of a risk calculator helps improve the quality of the informed consent/shared decision-making process by providing a personalized, customized, empirically-based estimate of a patient’s risk of post-operative complications. Moreover, evidence suggests that sharing numeric estimates of patient-specific risk may enhance patient trust in providers.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of patients who are taken to the operating room for an elective surgical intervention under regional anesthesia, monitored anesthesia care (MAC), and/or general anesthesia who have an updated history and physical (H&P), documentation that recent laboratory values were reviewed, and documentation of the site and side of surgery in the medical record within the 24 hours prior to surgery.
  
  
• Numerator: All patients who are taken to the operating room for an elective surgical intervention under regional, MAC, and/or general anesthesia for whom an updated H&P, documentation of the review of recent laboratory values, and documentation of the site and side of surgery are present in the medical record within the 24 hours prior to surgery.
  
  
• Denominator: All adults (18 years and older) who undergo an elective surgical procedure under regional, MAC, and/or general anesthesia.
  
  
• Exclusions: Documentation within the 24 hours prior to surgery that no BMP, CBC, and/or PT/INR results from the 30 days prior to surgery are available for review.
  
  
• HHS NQS Priority: Making Care Safer, Communication and Care Coordination
  
  
• HHS Data Source: Electronic Health Record, Paper Medical Record, Record Review, Registry
  
  
• Measure Type: Process
  
  
• Steward: American College of Surgeons
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Removed from Review by CMS
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
WHO guidelines for safe surgery: safe surgery saves lives. World Health Organization. 2009 Hospital Conditions of Participation (CoPs). Centers for Medicare and Medicaid Services. February 2008. The Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery. The Joint Commission. November 26, 21012. Haugen et al. Effect of the World Health Organization Checklist on Patient Outcomes: A Stepped Wedge Cluster Randomized Controlled Trial. Ann Surg; epub May 2014. Askarian M, et al. Effect of surgical safety checklists on postoperative morbidity and mortality rates, Shiraz, Faghihy Hospital, a 1-year study. Qual Manag Health Care 2011; 20: 293–7. de Vries EN, et al. Effect of a comprehensive surgical safety system on patient outcomes. New England Journal of Medicine 2010; 363: 1928–37.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of patients who are taken to the operating room for an elective surgical procedure under regional anesthesia, MAC, and/or general anesthesia who had documented postoperative communication reviewing original goals of care expressed preoperatively and updating goals of care as appropriate occurring after discharge up until 90 days following discharge date.
  
  
• Numerator: All patients who had documented post-discharge communication reviewing original goals of care expressed preoperatively and updating goals of care as appropriate occurring after discharge up until 90 days following discharge date. The patient’s dominant goal of care and the goal of care discussion have been documented as one or more of the following: 1. Living as long as possible 2. Living independently 3. Keeping comfortable, symptom relief 4. Establishing a diagnosis or treating / curing a condition 5. Other (single sentence)
  
  
• Denominator: All patients who are brought from their home or normal living environment on the day of surgery AND taken to the operating room for an elective surgical procedure under regional anesthesia, MAC, and/or general anesthesia AND have goals of care discussion performed in the preoperative phase and documented in the medical record. The patient’s dominant goals of care and the goal of care discussion have been documented as one or more of the following: 1. Living as long as possible 2. Living independently 3. Keeping comfortable, symptom relief 4. Establishing a diagnosis or treating / curing a condition 5. Other (single sentence)
  
  
• Exclusions: 1. Patients who are inpatient at an acute care hospital at the time of their current operation 2. Patients who are transferred from the Emergency Department (ED) 3. Patients who are transferred from a clinic 4. Patients who undergo an emergent/urgent surgical operation 5. Patients whose admission to the hospital was on any date prior to the date of the scheduled surgical procedure for any reason
  
  
• HHS NQS Priority: Patient and Family Engagement, Communication and Care Coordination
  
  
• HHS Data Source: Electronic Health Record, Paper Medical Record, Record Review, Registry
  
  
• Measure Type: Process
  
  
• Steward: American College of Surgeons
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Removed from Review by CMS
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Steffens NM, Tucholka JL, Nabozny MK, Schmick AE, et al. Engaging patients, health care professionals, and community members to improve preoperative decision making for older adults facing high-risk surgery. JAMA Surg. 2016. doi: 10.1001/jamasurg.2016.1308 Kelly KN, Noyes K, Dolan J, Fleming F, et al. Patient perspective on care transitions after colorectal surgery. J Surg Res. 2016; 203(1):103-12 Gussous Y, Than K, Mummameni P, Smith J, et al. Appropriate use of limited interventions vs extensive surgery in the elderly patient with spinal disorders. Neurosurgery. 2015; 77 suppl 4:S142-63 Kim Y, Winner M, Page A, Tisnado DM, et al. Patient perceptions regarding the likelihood of cure after surgical resection of lung and colorectal cancer. Cancer 2015; 121(20):3564-73 Paul Olson TJ, Brasel JH, Redmann AJ, Alexander GC, et al. Surgeon-reported conflict with intensivist about postoperative goals of care. JAMA Surg. 2013. 148(1):29-35.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of patients age 18 or older who are taken to the operating room for an elective or emergent surgical intervention under regional, MAC, and/or general anesthesia who had documented post-operative communication regarding the surgery with the patient’s primary care physician or referring physician within the 30 days following surgery.
  
  
• Numerator: All adults (18 years and older) who undergo an elective or emergent surgical procedure under regional, MAC, and/or general anesthesia for whom documentation of post-operative communication with the patient’s PCP or referring physician regarding the surgery is present in the medical record within the 30 days following surgery.
  
  
• Denominator: All adults (18 years and older) who undergo an elective or emergent surgical procedure under regional, MAC, and/or general anesthesia.
  
  
• Exclusions: Documentation that the patient does not have a PCP or referring physician to communicate with post-operatively within 30 days following surgery.
  
  
• HHS NQS Priority: Communication and Care Coordination
  
  
• HHS Data Source: Electronic Health Record, Paper Medical Record, Record Review, Registry
  
  
• Measure Type: Process
  
  
• Steward: American College of Surgeons
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Removed from Review by CMS
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Care Coordination. May 2015. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/professionals/prevention-chronic-care/improve/coordination/index.html. May 2015.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of patients age 18 or older who are taken to the operating room for an elective or emergent surgical intervention under regional, MAC, and/or general anesthesia who have a documented plan of care at the beginning of the postoperative phase of care that addresses: mobilization, pain management, diet, resumption of preoperative medications, management of drains/catheters/invasive lines, and wound care
  
  
• Numerator: All patients age 18 or older who are taken to the operating room for an elective or emergent surgical intervention under regional, MAC, and/or general anesthesia who have a documented plan of care at the beginning of the postoperative phase of care that addresses: mobilization, pain management, diet, resumption of preoperative medications, management of drains/catheters/invasive lines, and wound care
  
  
• Denominator: All adults (18 years and older) who undergo an elective or emergent surgical procedure under regional, MAC, and/or general anesthesia
  
  
• Exclusions: N/A
  
  
• HHS NQS Priority: Making Care Safer, Communication and Care Coordination
  
  
• HHS Data Source: Electronic Health Record, Paper Medical Record, Record Review, Registry
  
  
• Measure Type: Process
  
  
• Steward: American College of Surgeons
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Removed from Review by CMS
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Kaufmnan J, et al. A handoff protocol from the cardiovascular operating room to cardiac ICU is associated with improvements in care beyond the immediate postoperative period. Joint Commission Journal on Quality and Patient Safety. 2013 Jul;39(7):306-11. McElroy LM, Collins KM, et al. Operating room to intensive care unit handoffs and the risks of patient harm. Surgery. 2015 Sep;158(3):588-94. Symons NR, Almoudaris AM, Nagpal K, Vincent CA, Moorthy K. An observational study of the frequency, severity, and etiology of failures in postoperative care after major elective general surgery. Annals of Surgery. 2013 Jan;257(1):1-5.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of patients who are taken to the operating room for an elective or emergent surgical procedure under regional anesthesia, MAC, and/or general anesthesia who had documented postoperative communication regarding the surgery and plan for care after discharge with the patient and the patient’s family
  
  
• Numerator: All patients age 18 or older who are taken to the operating room for an elective or emergent surgical procedure under regional anesthesia, MAC, and/or general anesthesia who had documented postoperative communication regarding the surgery and plan for care after discharge with the patient and the patient’s family
  
  
• Denominator: All patients age 18 or older who are taken to the operating room for an elective or emergent surgical procedure under regional anesthesia, MAC, and/or general anesthesia
  
  
• Exclusions: none]
  
  
• HHS NQS Priority: Patient and Family Engagement, Communication and Care Coordination
  
  
• HHS Data Source: Electronic Health Record, Paper Medical Record, Record Review, Registry
  
  
• Measure Type: Process
  
  
• Steward: American College of Surgeons
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Removed from Review by CMS
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Kelly KN, Noyes K, et al. Patient perspective on care transitions after colorectal surgery. Journal of Surgical Research. 2016 Jun 1;203(1):103-12. Schmocker RK, Holden SE, et al. Association of Patient-Reported Readiness for Discharge and Hospital Consumer Assessment of Health Care Providers and Systems Patient Satisfaction Scores: A Retrospective Analysis. Journal of the American College of Surgeons. 2015 Dec;221(6):1073-82. McMurray A, Johnson P, Wallis M, Patterson E, Griffiths S. General surgical patients' perspectives of the adequacy and appropriateness of discharge planning to facilitate health decision-making at home. Journal of Clinical Nursing. 2007 Sep;16(9):1602-9.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of patients who are taken to the operating room for an elective surgical procedure under regional anesthesia, MAC, and/or general anesthesia who had documented postoperative communication reviewing original goals of care expressed preoperatively and updating goals of care as appropriate.
  
  
• Numerator: All patients who had documented postoperative communication reviewing original goals of care expressed preoperatively and updating goals of care as appropriate. The patient’s dominant goal of care and the goal of care discussion have been documented as one or more of the following: 1. Living as long as possible 2. Living independently 3. Keeping comfortable, symptom relief 4. Establishing a diagnosis or treating / curing a condition 5. Other (single sentence)
  
  
• Denominator: All patients who are brought from their home or normal living environment on the day of surgery AND taken to the operating room for an elective surgical procedure under regional anesthesia, MAC, and/or general anesthesia AND have goals of care discussion documented in the medical record. The patient’s dominant goal of care and the goal of care discussion have been documented as one or more of the following: 1. Living as long as possible 2. Living independently 3. Keeping comfortable, symptom relief 4. Establishing a diagnosis or treating / curing a condition 5. Other (single sentence)
  
  
• Exclusions: 1. Patients who are inpatient at an acute care hospital at the time of their current operation 2. Patients who are transferred from the Emergency Department (ED) 3. Patients who are transferred from a clinic 4. Patients who undergo an emergent/urgent surgical operation 5. Patients whose admission to the hospital was on any date prior to the date of the scheduled surgical procedure for any reason
  
  
• HHS NQS Priority: Patient and Family Engagement, Communication and Care Coordination
  
  
• HHS Data Source: Electronic Health Record, Paper Medical Record, Record Review, Registry
  
  
• Measure Type: Process
  
  
• Steward: American College of Surgeons
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Removed from Review by CMS
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Steffens NM, Tucholka JL, Nabozny MK, Schmick AE, et al. Engaging patients, health care professionals, and community members to improve preoperative decision making for older adults facing high-risk surgery. JAMA Surg. 2016. doi: 10.1001/jamasurg.2016.1308 Kelly KN, Noyes K, Dolan J, Fleming F, et al. Patient perspective on care transitions after colorectal surgery. J Surg Res. 2016; 203(1):103-12 Gussous Y, Than K, Mummameni P, Smith J, et al. Appropriate use of limited interventions vs extensive surgery in the elderly patient with spinal disorders. Neurosurgery. 2015; 77 suppl 4:S142-63 Kim Y, Winner M, Page A, Tisnado DM, et al. Patient perceptions regarding the likelihood of cure after surgical resection of lung and colorectal cancer. Cancer 2015; 121(20):3564-73 Paul Olson TJ, Brasel JH, Redmann AJ, Alexander GC, et al. Surgeon-reported conflict with intensivist about postoperative goals of care. JAMA Surg. 2013. 148(1):29-35.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of patients who take anticoagulation medication who are taken to the operating room for an elective intervention under regional anesthesia, monitored anesthesia care (MAC), and/or general anesthesia who have a peri-operative management plan for anticoagulation medications documented in the medical record.
  
  
• Numerator: All adults (18 years and older) who undergo an elective or emergent surgical procedure under regional, MAC, and/or general anesthesia for whom an intraoperative surgical debriefing takes place at the end of the case confirming correct counts, procedure and specimen review, wound class, fluids recorded, equipment review, postoperative destination and postoperative care plan including plan for perioperative antibiotics, VTE prophylaxis and Foley. The debriefing must be documented in the medical record.
  
  
• Denominator: All patients who take anticoagulation medication who are taken to the operating room for an elective surgical intervention under regional, MAC, or general anesthesia.
  
  
• Exclusions: Documentation that the plan for pre-operative anticoagulation management was discussed with the physician responsible for managing the patient’s anticoagulation between 48 hours and 30 days prior to surgery.
  
  
• HHS NQS Priority: Making Care Safer
  
  
• HHS Data Source: Electronic Health Record, Paper Medical Record, Record Review, Registry
  
  
• Measure Type: Process
  
  
• Steward: American College of Surgeons
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Removed from Review by CMS
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Douketis JD, Spyropoulos AC, Spencer FA, et al. Perioperative management of antithrombotic therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141:e326S. Perioperative management of patients receiving anticoagulants. Gregory YH LIP and James D Douketis. UpToDate May 2015. Douketis JD. Perioperative management of patients who are receiving warfarin therapy: an evidence-based and practical approach. Blood 2011; 117:5044. Gallego P, Apostolakis S, Lip GY. Bridging evidence-based practice and practice-based evidence in periprocedural anticoagulation. Circulation 2012; 126:1573. Kearon C, Hirsh J. Management of anticoagulation before and after elective surgery. N Engl J Med 1997; 336:1506.

Measure Specifications

• NQF Number (if applicable): 2083
  
  
• Description: Percentage of patients, regardless of age, with a diagnosis of HIV prescribed HIV antiretroviral therapy for the treatment of HIV infection during the measurement year. (The endorsed specifications of the measure are: Percentage of patients, regardless of age, with a diagnosis of HIV prescribed antiretroviral therapy for the treatment of HIV infection during the measurement yearA medical visit is any visit in an outpatient/ambulatory care setting with a nurse practitioner, physician, and/or a physician assistant who provides comprehensive HIV care.)
  
  
• Numerator: Patients prescribed HIV antiretroviral therapy during the measurement year.
  
  
• Denominator: Patients, regardless of age, diagnosed with HIV during the first 3 months of the measurement year or prior to the measurement year who had at least one medical visit in the measurement year.
  
  
• Exclusions: None
  
  
• HHS NQS Priority: Effective Prevention and Treatment
  
  
• HHS Data Source: Administrative clinical data, Claims, Paper medical records, Record review
  
  
• Measure Type: Process
  
  
• Steward: Health Resources and Services Administration (HRSA) - HIV/AIDS Bureau
  
  
• Endorsement Status:
  
  
• 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? Yes
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Refine and resubmit
  
  
• Preliminary analysis summary
  • Contribution to program measure set:Though an important clinical area, the measure does not support alignment as CMS has removed the claims based related measure, NQF#2083. Additionally, the measure has not been fully tested as an e-CQM. The testing data is in the process of being updated from the 2011 data, which should be evaluated to determine if a quality challenge remains.
  • Impact on quality of care for patients:This measure would impact the use of HIV antiretroviral therapies that are associated with reduction in morbidity and mortality.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure supports the NQS priority of promoting effective practices
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. The measure is supported by evidence of efficacy of HIV antiretroviral therapy on morbidity and mortality
  
  
• Does the measure address a quality challenge? Yes. The measure addresses a significant variation in care with data from 2011 stating only 37% of people with HIV are prescribed antiretroviral treatment
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? No. Per the final rule, "CMS is finalizing its proposal to remove this measure. This measure is related to one if the conditions covered under the Core Measure Collaborative but is not included in the core measure set. The clinical performance identified with this measure can be addressed by the measures within the core measure set."
  
  
• Can the measure can be feasibly reported? Yes. The measure passed alpha testing for face validity, measure logic validity, and data element reliability and was scheduled to being beta testing in July 2016.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? No. Though similar to the NQF measure 2083, the measure has not been fully tested as an e-CQM.
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? Yes. The measure is supported by evidence of efficacy of HIV antiretroviral therapy on morbidity and mortality
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Endorsed.
  
  

Rationale for measure provided by HHS
HIV Antiretroviral therapy reduces HIV-associated morbidity and mortality by maximally inhibiting HIV replication (as defined by achieving and maintaining plasma HIV RNA (viral load) below levels detectable by commercially available assays). Emerging evidence also suggests that additional benefits of ART-induced viral load suppression include a reduction in HIV-associated inflammation and possibly its associated complications.

Summary of NQF Endorsement Review

• Year of Most Recent Endorsement Review: 2012
  
  
• Project for Most Recent Endorsement Review: Infectious Disease Endorsement Maintenance 2012
  
  
• Review for Importance: 1a. Impact: H-18; M-1; L-0; I-0; 1b. Performance Gap: H-7; M-10; L-1; I-1 1c. Evidence: Y-14; N-3; I-1 Rationale: • Antiretroviral therapy delays the progression to AIDS and increases an individual’s length of survival. It has also been shown to reduce transmission of HIV. • The developer sees this measure not only being used within the HRSA programs, but also used at the Department of Health and Human Services (DHHS) level as well as in public reporting programs. • Committee members noted that while it’s not the current standard, there is growing evidence that children over the age of 5 who have higher CD4 counts should be treated. Most of the children in active treatment are adolescents. Many of these adolescents have trouble with adherence to medications that may have higher CD4 counts and are monitored due to concern of compliance. • There were greater than five studies cited, including randomized clinical trials, Meta analyses and observational studies. Several of the observational studies were a collaboration of cohort studies. • The Committee noted that the evidence for treatment is very clear for CD4 counts less than 500 but somewhat limited for individuals whose CD4 count is greater than 500. It was noted that the overall number of individuals with a CD4 count greater than 500 would be only 3 percent. However, an HIVCAUSAL study suggested a morbidity benefit for individuals with CD4 counts above 500. The developer indicated that according to Jack Skarbinski’s presentation on the Medical Monitoring Project (MMP) data from the 2012 Conference on Retroviruses and Opportunistic Infections (CROI), 66 percent of individuals with a CD4 count above 500 were prescribed antiretroviral therapy. In recent guidelines, both the International Antiviral Society USA guidelines and the HHS guidelines recommend treatment for all patients regardless of their CD4 count. The NA-ACCORD study19 also suggested a survival benefit in people above 500. • Committee members noted that in large jurisdictions including San Francisco and New York City, health officials are implementing a policy that all patients diagnosed with HIV regardless of CD4 counts should be treated. • A Committee member stated that at the International AIDS Conference data was presented that showed a disparities gap in which African Americans had lower levels of suppressed HIV RNA levels and also had a low percentage in being on antiretroviral therapy. o The developer commented that in 2009 MMP data, a multivariate model of factors associated with prescription of ART found that young adults (18 to 29), non-Hispanic blacks, women who have sex with men and persons more recently diagnosed with HIV were less likely to be prescribed ART. The MMP only includes patients aged 18 years and over.
  
  
• Review for Scientific Acceptability: 2a. Reliability: H-2; M-17; L-0; I-0 2b. Validity: H-1; M-18; L-0; I-0 Rationale: • The data source is electronic medical records, electronic clinical data, pharmacy, and paper medical records. • This measure does not provide exclusions for patients that refuse treatment or are not prescribed treatment for various reasons. o The developer responded that patient refusals are expected and the goal of the measure is not 100 percent performance. The developer noted that children less than 5 are approximately 0.1 percent of the population in the United States which is part of the reason the developer did not consider that particular age population as exclusion. A Committee member expressed a concern of the lack of exclusions, especially for patients depending on their clinical status and CD4 count who may be on the Ryan White ADAP waiting list for over a year before receiving antiretroviral therapy. The developer stated that they work closely with States to ensure that patients who are on the waiting list are on antiretroviral medication through the pharmacy assistance programs. However, the developer also noted that they do not expect 100 percent compliance; this measure was created to improve the quality of care and to bring awareness to low refusal rates and disparity issues amongst clinics. • The developer used the HIV Research Network, a group of community and academic HIV provider sites to test the reliability of the measure. The range of the reliability scores was 0.93-0.99, with a median of 0.98.
  
  
• Review for Feasibility: 4. Feasibility: H-2; M-17; L-0; I-0 (4a. Clinical data generated during care delivery; 4b. Electronic sources; 4c.Susceptibility to inaccuracies/ unintended consequences identified 4d. Data collection strategy can be implemented) Rationale: • The list of ARVs has some potential for difficulties in data collection. The Committee preferred outlining the medications that should not be used together, rather than the approach of an abstractor trying to review regiments to see if they are consistent with the current guidelines. The developer stated that the definition of antiretroviral therapy is any regimen combination that is not “not recommended” should alleviate this concern.
  
  
• Review for Usability: 3. Usability: H-7; M-12; L-0; I-0 (Meaningful, understandable, and useful to the intended audiences for 3a. Public Reporting/Accountability and 3b. Quality Improvement) Rationale: • The developer will be submitting this measure for potential inclusion in the Stage 3 meaningful use program as well as PQRS.
  
  
• Review for Related and Competing Measures: 5. Related and Competing Measures • No related or competing measures noted.
  
  
• Endorsement Public Comments: Public and Member Comment (October 3, 2012-November 5, 2012) • This measure should mirror the national guidelines which indicate that all persons with HIV regardless of CD4 count should be offered ART. This measure should include all persons with HIV with an exclusion for individuals who decline the care. o Developer Response: By not having any patient or provider exclusions, we do not expect performance to be at 100%. In addition, we believe it is important to capture all patients who are prescribed or not prescribed ART, in order to explore the myriad reasons why ART was not prescribed. We have been working closely with CMS and ONC on the inclusion of HIV measures into Meaningful Use. From that experience, CMS and ONC are warning of the use of patient and provider exclusions. Adding exclusions to measures makes it more difficult, if not impossible, to e-specify the measure’s use in an EHR. • This measure does not capture whether the ARV therapy was received by or had an effect on the patient. Though it is important to have measures that capture the effects of ARV therapy on HIV+ patients, this documentation measure falls short of meeting the needs of the affected population. o Developer Response: The intent of this measure is to assess the prescription of HIV antiretroviral therapy by medical providers. We see that this process measure that works in tandem with the viral load suppression measure (#2082). Ideally, medical care providers would use both measure in order to understand gaps in performance. We also see utility of this measure among support service and care coordination providers. Such providers can use this measure to focus adherence activities in order to support people living with HIV. Finally, “prescription” of HIV antiretroviral therapy is easily captured in an EHR. It would not be practical to measure “received” HIV antiretroviral therapy, because to truly measure this, one would have to observe patients swallowing pills. Please note: On July 24, 2012, Secretary Sebelius approved a package of seven common core measures for monitoring HHS-funded HIV prevention, treatment, and care services. The measures were generated following multiple consultations with a group of federal and non-federal stakeholders and that are consistent both with the Institute of Medicine’s recommendations for monitoring HIV services and measures deployed by the National Quality Forum (NQF) and the National Committee for Quality Assurance (NCQA). This measure, #2084 prescription of HIV antiretroviral therapy, is one of the seven measures approved by Secretary Sebelius, supporting alignment of HIV measures across HHS. Committee Response: The Committee preferred the specification of 2083 that defines HIV anti-retroviral therapy “as any combination of HIV medications other than the regimens or components identified as not recommended at any time by the Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents from the Department of Health and Human Services” rather than trying to define “potent ART” as specified in measure 406. The Committee agreed that the prescription of ART is an important process related to outcomes that will assist in understanding performance on the outcome measure (#2082)
  
  
• Endorsement Committee Recommendation: Steering Committee Recommendation for Endorsement: Y-18; N-1
  
  

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of patients age 18 or older who are active tobacco users who receive tobacco screening AND are offered cessation counseling at least 2 months prior to elective surgical procedure in order to delay the procedure until smoking cessation is possibly achieved.
  
  
• Numerator: All adults (18 years and older) who undergo an elective surgical procedure AND who are active tobacco users AND received cessation counseling at least 2 months prior to the scheduled elective procedure.
  
  
• Denominator: All patients evaluated by an eligible professional who are scheduled for an elective surgical procedure AND who are active tobacco users.
  
  
• Exclusions: Documentation in the patient’s medical record that the patient did not receive tobacco cessation counseling at least 2 months prior to the procedure due to the risk of delaying the elective surgical procedure is greater than the benefits of cessation of tobacco use.
  
  
• HHS NQS Priority: Making Care Safer, Communication and Care Coordination
  
  
• HHS Data Source: Electronic Health Record, Paper Medical Record, Record Review, Registry
  
  
• Measure Type: Process
  
  
• Steward: American College of Surgeons
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Removed from Review by CMS
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Effects of a perioperative smoking cessation intervention on postoperative complications. Lindstrom D; Azodi OS et al. Annals of Surgery 2008; 248(5); 739-45. The effectiveness of a perioperative smoking cessation program: A randomized clinical trial Lee SM; Landry J; Jones PM et al. Anesthesia & Analgesia 2013; 177(3); 605-13. U.S. Department of Health and Human Services. Public Health Service, 2008 Interventions for preoperative smoking cessation Thomsen T, Villebro N, Moller AM. Cochrane Database Systematic Review. 2014 • Strength of Evidence = A o All patients should be asked if they use tobacco and should have their tobacco use status documented on a regular basis. Evidence has shown that clinic screening systems, such as expanding the vital signs to include tobacco use status, significantly increase rates of clinical intervention. o All physicians should strongly advise every patient who smokes to quit because evidence suggests that physicians’ advice to quit smoking increases abstinence rates. o The combination of counseling and medication is more effective for smoking cessation than either medication or counseling alone. Therefore, both counseling and medication should be provided to patients trying to quit smoking.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of patients aged 3 through 17 years of age, who undergo a procedure under general anesthesia in which an inhalational anesthetic is used for maintenance AND who have two or more risk factors for post-operative vomiting (POV), who receive combination therapy consisting of at least two prophylactic pharmacologic anti-emetic agents of different classes preoperatively or intraoperatively.
  
  
• Numerator: Patients who receive combination therapy consisting of at least two prophylactic pharmacologic anti-emetic agents of different classes preoperatively and intraoperatively
  
  
• Denominator: All patients, aged 3 through 17 years of age, who undergo a procedure under general anesthesia in which an inhalational anesthetic is used for maintenance AND who have two or more risk factors for POV
  
  
• Exclusions: Cases in which an inhalational anesthetic is used only for induction
  
  
• HHS NQS Priority: Making Care Safer
  
  
• HHS Data Source: Registry
  
  
• Measure Type: Process
  
  
• Steward: American Society of Anesthesiologists
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional Support
  
  
• Preliminary analysis summary
  • Contribution to program measure set:Conditional Support pending NQF endorsement.
  • Impact on quality of care for patients:This measure provides information as to whether physicians are appropriately conducting and documenting inhalational anesthetic use.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. This measure supports the NQS priority of safety.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. There is evidence to demonstrate that postoperative nausea and vomiting (PONV) is an important undesired patient-centered outcome of anesthesia care.
  
  
• Does the measure address a quality challenge? Yes. The submitter states that there is variation in the current performance.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. The measure is not duplicative and addresses PONV.
  
  
• Can the measure can be feasibly reported? Yes. The measure is included in one registry, Anesthesia Quality Institute National Anesthesia Clinical Outcomes Registry (NACOR).
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. The measure is fully developed and full specifications are provided.
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? No. Measure is currently not being used 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
Postoperative nausea and vomiting (PONV) is an important patient-centered outcome of anesthesia care. PONV is highly dissatisfying to patients, although rarely life-threatening. A large body of scientific literature has defined risk factors for PONV; demonstrated effective prophylactic regimes based on these risk factors; and demonstrated high variability in this outcome across individual centers and providers (Kranke & Eberhart, 2011; Singla et al., 2010). Further, a number of papers have shown that performance can be assessed at the level of individual providers — the outcome is common enough that sufficient power exists to assess variability and improvement at this level (Dzwonczyk et al., 2012). A separate measure is needed for pediatric patients because the risk factors and recommended prophylaxis are different from adults. Dzwonczyk R, Weaver TE, Puente EG, Bergese SD. Postoperative nausea and vomiting prophylaxis from an economic point of view. Am J Ther. 2012 Jan;19(1):11-5. Kranke P, Eberhart LH. Possibilities and limitations in the pharmacological management of postoperative nausea and vomiting. Eur J Anaesthesiol. 2011 Nov;28(11):758-65. Singla NK, Singla SK, Chung F, Kutsogiannis DJ, Blackburn L, Lane SR, Levin J, Johnson B, Pergolizzi JV Jr. Phase II study to evaluate the safety and efficacy of the oral neurokinin-1 receptor antagonist casopitant (GW679769) administered with ondansetron for the prevention of postoperative and postdischarge nausea and vomiting in high-risk patients. Anesthesiology. 2010;113(1):74-82.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of patients age 18 or older who are taken to the operating room for an elective or emergent surgical intervention under regional, MAC, and/or general anesthesia who have a documented plan during a post-discharge follow-up encounter updating patient improvements in mobility, pain control, diet, resumption of home medications, wound care, and management of cutaneous/invasive devices (drains, IV lines, etc.).
  
  
• Numerator: All patients age 18 or older who are taken to the operating room for an elective or emergent surgical intervention under regional, MAC, and/or general anesthesia who have a documented plan during a post-discharge follow-up encounter updating patient improvements in mobility, pain control, diet, resumption of home medications, wound care, and management of cutaneous/invasive devices (drains, IV lines, etc.). This encounter must take place within 30 days of discharge.
  
  
• Denominator: All adults (18 years and older) who undergo an elective or emergent surgical procedure under regional, MAC, and/or general anesthesia.
  
  
• Exclusions: N/A
  
  
• HHS NQS Priority: Making Care Safer, Communication and Care Coordination
  
  
• HHS Data Source: Electronic Health Record, Paper Medical Record, Record Review, Registry
  
  
• Measure Type: Process
  
  
• Steward: American College of Surgeons
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Removed from Review by CMS
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Henderson PW, Landford W, Gardenier J, Otterburn DM, et al. A simple, visually oriented communication system to improve postoperative care following microvascular free tissue transfer: development, results and implications. J Reconstr Microsurg. 2016; 32(6): 464-9 Salzwedel C, Mai V, Punke MA, Kluge S, et al. The effect of a checklist on the quality of patient handover from the operating room to the intensive care unit: A randomized controlled trial. J Crit Care. 2016;32:170-4 Streeton A, Bisbey C, O’Neill C, Allen D, et al. Improving nurse-physician teamwork: a multidisciplinary collaboration. Medsurg Nurs. 2016; 25(1):31-4 Agarwal HS, Saville BR, Slayton JM, Donahue DS, et al. Standardized postoperative handover process improves outcomes in the intensive care unit: a model for operational sustainability and improved team performance. Crit Care Med. 2012; 40(7):2109-15 Segall N, Bonifacio AS, Schroeder RA, Barbeito A, et al. Can we make postoperative patient handovers safer? A systematic review of the literature. Anesth Analg. Jul; 115(1):102-15 Joy BF, Elliott E, Hardy C, Sullivan C, et al. Standardized multidisciplinary protocol improves handover of cardiac surgery patients to the intensive care unit. Pediatr Crit Care Med. 2011; 12(3):304-8

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of patients with dementia or their caregiver(s) for whom there was a documented safety screening * in two domains of risk: dangerousness to self or others and environmental risks; and if screening was positive in the last 12 months, there was documentation of mitigation recommendations, including but not limited to referral to other resources.
  
  
• Numerator: Patients with dementia or their caregiver(s) for whom there was a documented safety screening * in two domains of risk: dangerousness to self or others and environmental risks; and if screening was positive in the last 12 months, there was documentation of mitigation recommendations, including but not limited to referral to other resources. *The following is a non-exhaustive list of safety concerns in the two domains pertinent to this measure. To meet measure requirements a patient’s medical record must have documentation of being screened on at least one concern from each of the two domains. Dangerousness to self (patient) or others(caregivers and other individuals) · Medication misuse · Physical aggressiveness · Wandering, including addressing precautions that may include physical measures (e.g., locks, fences or hedges), video surveillance, GPS monitoring and Safe Return programs, personal companions, schedule modifications (e.g., adult day care and day programs), rehabilitative measures, and risk mitigation strategies · Inability to respond rapidly to crisis/household emergencies · Financial mismanagement, including being involved in “scams” · Other concerns raised by patient or their caregiver Environmental risks · Home safety risks that could arise from cooking or smoking · Access to firearms or other weapons · Access to potentially dangerous chemicals and other materials · Access to and operation of tools and equipment · Trip hazards in the home increasing the risk of falling · Other concerns raised by patient or their caregiver
  
  
• Denominator: All patients with dementia
  
  
• Exclusions: Patient unable to communicate and informant not available.
  
  
• HHS NQS Priority: Making Care Safer
  
  
• HHS Data Source: Administrative clinical data, Claims, Electronic Health Record
  
  
• Measure Type: Process
  
  
• Steward: American Academy of Neurology, American Psychological Association
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional Support
  
  
• Preliminary analysis summary
  • Contribution to program measure set:Conditional Support pending NQF endorsement.
  • Impact on quality of care for patients:This measure provides information as to whether physicians are appropriately screening and documenting safety concerns for persons with dementia.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. This measure supports the NQS priority of safety.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. There is evidence to demonstrate that screening for safety concerns has been identified as a major unmet need of persons with dementia
  
  
• Does the measure address a quality challenge? Yes. The submitter states that there is variation in the current performance but testing data is not provided.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. The measure is not duplicative and addresses safety concerns for persons with dementia.
  
  
• Can the measure can be feasibly reported? Yes. The submitter gives multiple data sources including EHRs.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. Full specifications are provided and the submitter states the measure is fully developed but testing results are not provided.
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? No. Measure is currently not being used 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
Recommended assessments include evaluation of suicidality, dangerousness to self and others, and the potential for aggression, as well as evaluation of living conditions, safety of the environment, adequacy of supervision, and evidence of neglect or abuse (Category I). Important safety issues in the management of patients with dementia include interventions to decrease the hazards of wandering and recommendations concerning activities such as cooking, driving, hunting, and the operation of hazardous equipment. Caregivers should be referred to available books [and other materials] that provide advice and guidance about maximizing the safety of the environment for patients with dementia…As patients become more impaired, they are likely to require more supervision to remain safe, and safety issues should be addressed as part of every evaluation. Families should be advised about the possibility of accidents due to forgetfulness (e.g., fires while cooking), of difficulties coping with household emergencies, and of the possibility of wandering. Family members should also be advised to determine whether the patient is handling finances appropriately and to consider taking over the paying of bills and other responsibilities. At this stage of the disease [i.e., moderately impaired patients], nearly all patients should not drive. (1) For mild to moderate Alzheimer's disease Assess for safety risks (e.g., driving, financial management, medication management, home safety risks that could arise from cooking or smoking, potentially dangerous behaviors such as wandering) (2) 1. American Psychiatric Association (APA). Practice guideline for the treatment of patients with Alzheimer's disease and other dementias. Arlington (VA): American Psychiatric Association (APA). October 2007 85 p. 2. Chertkow H. Diagnosis and treatment of dementia: introduction. Introducing a series based on the Third Canadian Consensus Conference on the Diagnosis and Treatment of Dementia. CMAJ. 2008;178:316-321.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of patients who have been given the purpose for the recommended procedure AND goals of care discussion has been documented in the medical record.
  
  
• Numerator: All patients who are 1) brought from their home or normal living environment on the day of surgery AND 2) undergo a non-emergent/non-urgent, scheduled surgical procedure, AND 3) have the purpose of the procedure documented in the medical record AND 4) have goals of care discussion documented in the medical record. (A) The purpose of the procedure was described and documented to be one or more of the following: 1. Establish a diagnosis 2. Relieve symptoms 3. Treat or cure a condition 4. Improve function and/or quality of life 5. Other (B) The patient’s dominant goal of care and the goal of care discussion have been documented as one or more of the following: 1. Living as long as possible 2. Living independently 3. Keeping comfortable, symptom relief 4. Establishing a diagnosis or treating / curing a condition 5. Other (single sentence)
  
  
• Denominator: All adults (18 years and older) who 1) are brought from their home or normal living environment on the day of surgery AND 2) Surgery must be non-emergent/non-urgent scheduled procedure, performed in an operating room under MAC, regional, or general anesthesia
  
  
• Exclusions: 1. Patients who are inpatient at an acute care hospital 2. Patients who are transferred from an ED 3. Patients who are transferred from a clinic 4. Patients who undergo an emergent/urgent surgical case 5. Patients whose admission to the hospital was on any date prior to the date of the scheduled surgical procedure for any reason
  
  
• HHS NQS Priority: Patient and Family Engagement, Communication and Care Coordination
  
  
• HHS Data Source: Electronic Health Record, Paper Medical Record, Record Review, Registry
  
  
• Measure Type: Process
  
  
• Steward: American College of Surgeons
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Removed from Review by CMS
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
Fried TR, Bradley EH, Towle VR, Allore H. Understanding the treatment preferences of seriously ill patients. N Engl J Med. 2002 Apr 4;346(14):1061-6. Kaldjian LC, Curtis AE, Shinkunas LA, Cannon KT. Goals of care toward the end of life: a structured literature review. Am J Hosp Palliat Care. 2008 Dec-2009 Jan;25(6):501-11. Reuben DB. Medical care for the final years of life: "When you're 83, it's not going to be 20 years". JAMA. 2009 Dec 23;302(24):2686-94. Oresanya LB, Lyons WL, Finlayson E. Preoperative assessment of the older patient: a narrative review. JAMA. 2014 May;311(20):2110-20.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of patients age 18 or older who had an unplanned hospital readmission within 30 days of principal procedure
  
  
• Numerator: All adults (18 years and older) who underwent elective or emergency surgery who had an Inpatient readmission to the same hospital for any reason or an outside hospital (if known to the surgeon), within 30 days of the principal surgical procedure
  
  
• Denominator: All adults (18 years and older) who underwent elective or emergency surgery
  
  
• Exclusions: N/A
  
  
• HHS NQS Priority: Making Care Safer
  
  
• HHS Data Source: Electronic Health Record, Paper Medical Record, Record Review, Registry
  
  
• Measure Type: Outcome
  
  
• Steward: American College of Surgeons
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Removed from Review by CMS
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure assesses the important issue of unplanned readmissions after surgery. It is a duplicate of a current measure.
  • Impact on quality of care for patients:This measure represents a surgical outcomes, which is viewed as particularly useful quality indicators, since they integrate multiple care processes and disciplines involved in patient care.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure supports the NQS priority of promoting effective practices
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. The measure is an outcome measure and the American Board of Surgery identified this to be a critical outcome for surgical procedures.
  
  
• Does the measure address a quality challenge? Yes. The submitter states that there is evidence that there is variation in performance on this measure among providers and that the measure is not topped out; however, testing data has not been provided.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? No. This measure is duplicative of PQRS #356
  
  
• Can the measure can be feasibly reported? Yes. The measure can be reported from multiple data sources including a registry.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? No. The submitter does not provide testing data for the use of the measure at the clinician level. The submitter states that the measure has been used at the facility level.
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? Yes. There are no known issues with the implementation of PQRS #356.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted.
  
  

Rationale for measure provided by HHS
A modified-Delphi methodology using an expert panel of surgeons who are Directors of the American Board of Surgery identified this to be a critical outcome for this surgical procedure (Surgeon Specific Registry Report on Project for ABS MOC Part IV. Unpublished study by the American College of Surgeons in conjunction with the American Board of Surgery, 2011).

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Documentation of angiographic endpoints of embolization AND the documentation of embolization strategies in the presence of unilateral or bilateral absent uterine arteries.
  
  
• Numerator: Number of patients undergoing uterine artery embolization for symptomatic leiomyomas and/or adenomyosis in whom embolization endpoints are documented separately for each embolized vessel AND ovarian artery angiography or embolization performed in the presence of variant uterine artery anatomy. Embolization endpoints: Complete stasis (static contrast column for at least 5 heartbeats) / Near-stasis (not static, but contrast visible for at least 5 heartbeats) / Slowed flow (contrast visible for fewer than 5 heartbeats) / Normal velocity flow with pruning of distal vasculature / Other [specify] / Not documented Embolization strategy options for variant uterine artery anatomy: Ovarian artery angiography, Ovarian artery embolization, Abdominal Aortic angiography, None
  
  
• Denominator: All patients undergoing uterine artery embolization for symptomatic leiomyomas and/or adenomyosis.
  
  
• Exclusions: SIR Guidance: Any patients that should be excluded from reporting either in the eligible population (denominator) or from both numerator and denominator (if patient experiences outcome then exclude from denominator and numerator; if not then include in denominator). Method to risk adjust measure.
  
  
• HHS NQS Priority: Making Care Safer
  
  
• HHS Data Source: Reigstry
  
  
• Measure Type: Process
  
  
• Steward: Society of Interventional Radiology
  
  
• Endorsement Status:
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Refine and Resubmit
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure does not appear to be tested at the Clinician level.
  • Impact on quality of care for patients:This measure provides information as to whether physicians are appropriately documenting procedural aspects of uterine artery embolization.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. This measure supports the NQS priority of safety.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes . Documentation of angiographic endpoints of embolization AND the documentation of embolization strategies in the presence of unilateral or bilateral absent uterine arteries
  
  
• Does the measure address a quality challenge? Yes. The submitter states that there is variation in the current performance but testing data is not provided.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. The measure is not duplicative and addresses documentation of two important procedural aspects of uterine artery embolization.
  
  
• Can the measure can be feasibly reported? Yes. The measure is included in one registry, American College of Radiology National Radiology Data Registry.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? No. Full specifications are provided and the submitter states the measure is fully developed but testing results are not provided.
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? No. Measure is currently not being used 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
This measure ensures documentation of two important procedural aspects of uterine artery embolization, which are known to be associated with treatment efficacy: (1) appropriate embolization endpoints achieved and (2) delineation of all uterine arterial supply with embolization where possible. Inadequate embolization alone is a known cause of treatment failure1. The ovarian arteries often provide an alternate route of arterial supply to the uterus when the uterine artery is occluded or absent; however routine aortography is not recommended when conventional uterine artery anatomy is present2. 1. Dariushnia SR et al. Quality Improvement Guidelines for Uterine Artery Embolization for Symptomatic leiomyomata. JVIR 2014; 25:1737-1747. 2. White AM et al. Patient radiation exposure during uterine fibroid embolization and the dose attributable to aortography. JVIR 2007; 18:573-576.

Measure Specifications

• NQF Number (if applicable): 2020
  
  
• Description: Percentage of adult (age 18 and older) in select county that currently smoke, defined as adults who reported having smoked at least 100 cigarettes in their lifetime and currently smoke.(The endorsed specifications of the measure are: Percentage of adult (age 18 and older) U.S. population that currently smoke.)
  
  
• Numerator: The numerator is current adult smokers (age 18 and older) in a geographically defined area who live in households.(The endorsed specifications of the measure are: The numerator is current adult smokers (age 18 and older) in the U.S. who live in households.)
  
  
• Denominator: The adult (age 18 and older) population in a geographically defined area who live in households. (The endorsed specifications of the measure are: The adult (age 18 and older) population of the U.S. who live in households. One adult per household is interviewed.)
  
  
• Exclusions: Adults 18 years or older are asked to take part in the survey and only one adult is interviewed per household. Adults living in vacation homes not occupied by household members for more than 30 days per year, group homes, institutions, prisons, hospitals and college dorms are excluded. (The endorsed specifications of the measure are: Adults 18 years or older are asked to take part in the survey and only one adult is interviewed per household. Adults living in vacation homes not occupied by household members for more than 30 days per year, group homes, institutions, prisons, hospitals and college dorms are excluded. Military services members and adults who speak a language other than English and Spanish are also excluded.)
  
  
• HHS NQS Priority: Effective Prevention and Treatment, Best Practice of Healthy Living
  
  
• HHS Data Source: Survey
  
  
• Measure Type: Outcome
  
  
• Steward: Centers for Disease Control and Prevention, Centers for Medicare & Medicaid Services
  
  
• Endorsement Status:
  
  
• 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: Refine and resubmit
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure addresses an important topic; however, it has not been tested to show that it can affect outcomes at the level of the individual clinician. The data collection is not that of structured data that can be related back to an episode of care. Additionally, an endorsed smoking screening and intervention measure already exists within the program.
  • Impact on quality of care for patients:If this measure were to be successfully tested at the individual clinician level, it could have a significant impact on death and cardiovascular disease.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. Working with community to promote best practices to enable healthy living
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. Significant literature exists to demonstrate the negative impacts of smoking on health.
  
  
• Does the measure address a quality challenge? Yes. Smoking is the leading preventable cause of death and disease in the US.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? No. The measure captures a broad population. However, PQRS#226/NQF#28 (Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention) already exists within the program that has been specified at the clinician level. In addition, this measure does not align with the recommendations in the Treating Tobacco Use and Dependence 2008 Update Clinical Practice Guideline which support the use of counseling and medication treatment.
  
  
• Can the measure can be feasibly reported? No. The measure is related to NQF#2020 that looks at prevalence at the national level. It is not fully specified at the clinician level. The data does not come from structured data that are captured before, during, or after the course of care. The measure relies on surveys of an adult within the home but does not specify that the adult had received care.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? No. The measure has not been tested at the level of the individual clinician.
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? No. The measure had previously been submitted to MAP in 2015 for IQR and further development was recommended.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Endorsed.
  
  

Rationale for measure provided by HHS
Cigarette smoking is still the leading preventable cause of death and disease in the U.S. and costs the U.S. health care system nearly $170 billion in direct medical care for adults each year (CDC 2014a; HHS 2014; Xu et al. 2014). Currently more than 16 million US residents are living with a smoking-related illness (HHS 2014). Smoking harms nearly every organ in the body and has been causally linked to numerous cancers, heart disease and stroke, chronic obstructive pulmonary disease, pneumonia, other respiratory diseases, aortic aneurysm, peripheral vascular disease, cataracts and blindness, age-related macular degeneration, periodontitis, diabetes, pregnancy and reproductive complications, bone fractures, arthritis, and reduced immune function (HHS, 2014). Mortality among current smokers is two to three times that of persons who never smoked (Jha et al. 2013). Since the first Surgeon General’s Report on Smoking and Health in 1964, cigarette smoking has killed more than 20 million people in the U.S. (HHS 2014). Between 2005-2009, 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all coronary heart disease deaths were attributable to smoking and secondhand smoke exposure (HHS, 2014), making it an essential risk factor to address to reduce both disease burden and health care costs. The toll smoking takes on health extends beyond the smokers. Since 1964, almost 2.5 million nonsmoking adults have died from heart disease and lung cancer caused by exposure to secondhand smoke, and 100,000 babies have died of sudden infant death syndrome or complications from prematurity, low birth weight, or other conditions caused by parental smoking, particularly smoking by the mother (HHS, 2014). Reducing cigarette smoking in the community can impact the health and health care costs of nonsmokers as well. CDC (Centers for Disease Control and Prevention). (2014a). CDC’s Tips from Former Smokers campaign provided outstanding return on investment. Atlanta, GA. Available at: http://www.cdc.gov/media/releases/2014/p1210-tips-roi.html. (Accessed 27 October, 2015). HHS (US Department of Health and Human Services). (2014). The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General. Atlanta, GA: US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health. Available at: http://www.surgeongeneral.gov/library/reports/50-years-of-progress/full-report.pdf. (Accessed 23 September, 2015). Xu X, Bishop EE, Kennedy SM, Simpson SA, Pechacek TF. (2014) Annual Healthcare Spending Attributable to Cigarette Smoking: An Update. American Journal of Preventive Medicine, 48(3), p.326-333. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4603661/ (Accessed 24 September, 2015). Jha, P. and Peto, R. (2014). Global effects of smoking, of quitting, and of taxing tobacco. New England Journal of Medicine, 2014(370), p.60-68. Available at: http://www.nejm.org/doi/full/10.1056/nejmra1308383. (Accessed 22 October, 2015). doi: 10.1056/NEJMra1308383

Summary of NQF Endorsement Review

• Year of Most Recent Endorsement Review: 2012
  
  
• Project for Most Recent Endorsement Review: Population Health: Prevention
  
  
• Review for Importance: 1a. Impact: H-9; M-2; L-0; I-0; 1b. Performance Gap: H-5; M-6; L-0; I-0 1c. Evidence: Y-10; N-0; I-1 Rationale: • Sufficient evidence about the burden of smoking at state and national levels, and evidence-based interventions to reduce the burden. • Useful community assessment to help determine resource allocation and strategic plans for combatting smoking.
  
  
• Review for Scientific Acceptability: 2a. Reliability: H-8; M-3; L-0; I-0 2b. Validity: H-7; M-4; L-0; I-0 Rationale: • Concern about validity because of the exclusion of people serving in the military and those that are institutionalized. Although these are relatively small populations, smoking prevalence is high among these groups. • Some Committee members stated an additional limitation of using NHIS as a data source: o Lower age limit – perhaps consider those younger than 18 years, which data show high prevalence. • Several concerns about the survey questions and apparent and/or potential lack of harmonization with similar smoking survey measures, including BRFSS etc. o “Have you smoked at least 100 cigarettes in your entire life? (Yes, No, Refused, Don’t Know)” does not appear to be aligned with other survey questions, which ask “do you smoke every day, some days, or at all…” The former is listed twice in the measure submission form. • Why are non-combustibles and other tobacco products omitted from the measure? Following the in-person meeting, the steward and developer provided the following responses: • The measure, as currently specified, is based on the National Health Interview Survey (NHIS) measure of current smoking, which tracks the Healthy People 2020 measure for smoking prevalence among adults. • The measure uses the following questions, which are harmonized with BRFSS: o Have you smoked at least 100 cigarettes in your entire life? (Yes, No, Refused, Don’t Know) and, o Do you now smoke every day, some days, or not at all (asked of those who smoked 100 cigarettes in the above question)? (Every day, Some days, Not at all, Refused, Don’t know) The developer agreed to utilize the BRFSS question for smoking prevalence, which can be assessed at the state level. The developer updated the measure submission form accordingly. In response to the Committee’s concern about non-combustible tobacco products, the CDC recognizes the importance of this assessment and adds that some of their surveys “…are moving towards a question like: In the past 30 days have you smoked a cigarette, cigar or pipe (FDA/NIDA proposed question in PATH study) and a separate question on non-combustibles like, In the past 30 days have you used smokeless tobacco such as chewing tobacco, snuff, snus, or dip (FDA/NIDA proposed question in PATH study).” The CDC and the developer are considering the addition of a question on noncombustibles in a future iteration of the measure.
  
  
• Review for Feasibility: 4. Feasibility: H-8; M-3; L-0; I-0 (4a. Clinical data generated during care process; 4b. Electronic sources; 4c. Exclusions-no additional data source; 4d. Susceptibility to inaccuracies/unintended consequences identified; 4e. Data collection strategy can be implemented) Rationale: • Data are accessible from existing survey.
  
  
• Review for Usability: 3. Usability: H-9; M-2; L-0; I-0 (3a. Meaningful/useful for public reporting and quality improvement; 3b. Harmonized; 3c. Distinctive or additive value to exiting measures) Rationale: • Concern about the incentive to drive quality improvement at the national level only, if the measure cannot be drilled down to lower levels of aggregation. • Consider harmonization with other measures. For example, smoking-related measure from NCQA in ongoing Behavioral Health project. Need more to review measure specifications – what questions are used in NCQA’s CAHPS survey measure? Are these aligned with other national surveys? Following the meeting, the developer agreed to use BRFSS’ state-level smoking prevalence measure. The developer revised the measure submission accordingly. In addition, NQF staff reviewed NCQA’s 0027: Medical assistance with smoking and tobacco use cessation. The survey questions used to assess smoking prevalence are generally standardized, except NCQA also assess tobacco use. The survey reads, “Do you now smoke cigarettes or use tobacco every day, some days, or not at all.” CDC asks, “Do you know smoke cigarettes every day, some days, or not at all”.
  
  
• Review for Related and Competing Measures: 5. Related and Competing Measures This measure is related to measure #0027: Medical assistance with smoking and tobacco use cessation, which is currently under endorsement consideration in an on-going behavioral health project. The Committee largely supported the endorsement of this measure per the suggested revision, but also encourages harmonization with measure #0027 if possible.
  
  
• Endorsement Public Comments: Public & Member Comment [July 19-August 17, 2012] Comments include: • Concerns about the systematic biases related to validity and accuracy of responses across different populations for patient-reported data. Developer response: This measure assesses members of the population, not patients. Generally, selfreported smoking status is a valid indicator of population-level smoking prevalence, and most national surveys in the United States that assess health behavior rely on self-reported data, such as NHIS and NSDUH. A study by Assaf et al., which examined potential gender differences in self-reported smoking data, compared self-reported smoking behavior to serum thiocyanate and serum cotinine levels. The authors concluded that although there were some differences in self-reporting of smoking status by gender, the results were similar between self-reports and biochemical tests. The authors asserted that the results lent “credibility to the use of self-reports as low-cost accurate approach to obtaining information on smoking behaviors among both men and women in large population-based surveys” (Assaf 2002). • Harmonize measure 2020 with measure 0027 Medical assistance with smoking tobacco use cessation (under consideration in the ongoing Behavioral Health project). Developer response: The two metrics assess different aspects of smoking and/or tobacco use. The denominator population for measure 0027 includes health plan members that currently smoke and use tobacco and those that have received tobacco use and smoking cessation advice during a specific time period. Measure 2020 assesses current smoking prevalence (only) among the adult population in the United States. Therefore, harmonization would not be practical or necessary. • Include military personnel in the measure’s denominator. Developer response: This would be ideal. While the BRFSS does not include this population in their sample, there is no reason why future iterations of this measure could not accurately assess smoking status in the military as compared to the general population. Many studies examining smoking status in a military population have relied on self-reported data and have used measures similar to the measure used in the BRFSS. • Include an assessment of smokeless tobacco. Developer response: This would require a separate measure, with specific validity and reliability testing data. This current smoking prevalence measure is thoroughly tested and has been in use for several years. Steering Committee response: The Committee accepted the developer’s responses and did not change their endorsement consideration. The Committee agreed that military personnel and smokeless tobacco are important assessments to add to the measure in the future.
  
  
• Endorsement Committee Recommendation: Steering Committee Recommendation for Endorsement: Y-10; N-0 Rationale: The Committee is in favor of developer’s proposed revision to use the BRFSS survey questions. Recommendation: • The Steering Committee encourages harmonization with NCQA’s measure #0027 Medical assistance with smoking and tobacco use cessation if possible.
  
  

Program Index

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

Full Program Summaries

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 (MSSP) 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 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 three shared savings options: 1) one- sided risk model (sharing of savings only for the first two years, and sharing of savings and losses in the third year), 2) two-sided risk model (sharing of savings and losses for all three years), and 3) two-sided risk model (sharing of savings and losses for all three years) with prospective assignment

High Priority Domains for Future Measure Consideration: N/A

Measure Requirements:

Specific measure requirements include: