NQF

Agenda Synopsis

Full Agenda

Measure Index

• Continuity of Pharmacotherapy for Opioid Use Disorder (Public comments received:4; MUC ID: MUC17-139)
  
  
• Average change in functional status following lumbar spine fusion surgery (Public comments received:3; MUC ID: MUC17-168)
  
  
• Average change in functional status following total knee replacement surgery (Public comments received:4; MUC ID: MUC17-169)
  
  
• Average change in functional status following lumbar discectomy laminotomy surgery (Public comments received:3; MUC ID: MUC17-170)
  
  
• Appropriate Use of DXA Scans in Women Under 65 Years Who Do Not Meet the Risk Factor Profile for Osteoporotic Fracture (Public comments received:3; MUC ID: MUC17-173)
  
  
• Average change in leg pain following lumbar spine fusion surgery (Public comments received:3; MUC ID: MUC17-177)
  
  
• Optimal Diabetes Care (Public comments received:4; MUC ID: MUC17-181)
  
  
• Optimal Vascular Care (Public comments received:5; MUC ID: MUC17-194)
  
  
• Diabetes A1c Control (< 8.0) (Public comments received:5; MUC ID: MUC17-215)
  
  
• Ischemic Vascular Disease Use of Aspirin or Anti-platelet Medication (Public comments received:1; MUC ID: MUC17-234)
  
  
• Routine Cataract Removal with Intraocular Lens (IOL) Implantation (Public comments received:7; MUC ID: MUC17-235)
  
  
• International Prostate Symptom Score (IPSS) or American Urological Association-Symptom Index (AUA-SI) change 6-12 months after diagnosis of Benign Prostatic Hyperplasia (Public comments received:1; MUC ID: MUC17-239)
  
  
• Screening/Surveillance Colonoscopy (Public comments received:7; MUC ID: MUC17-256)
  
  
• Knee Arthroplasty (Public comments received:6; MUC ID: MUC17-261)
  
  
• ST-Elevation Myocardial Infarction (STEMI) with Percutaneous Coronary Intervention (PCI) (Public comments received:4; MUC ID: MUC17-262)
  
  
• Revascularization for Lower Extremity Chronic Limb Ischemia (Public comments received:6; MUC ID: MUC17-263)
  
  
• Zoster (Shingles) Vaccination (Public comments received:6; MUC ID: MUC17-310)
  
  
• Patient reported and clinical outcomes following ilio-femoral venous stenting (Public comments received:1; MUC ID: MUC17-345)
  
  
• Elective Outpatient Percutaneous Coronary Intervention (PCI) (Public comments received:3; MUC ID: MUC17-359)
  
  
• Intracranial Hemorrhage or Cerebral Infarction (Public comments received:5; MUC ID: MUC17-363)
  
  
• Simple Pneumonia with Hospitalization (Public comments received:6; MUC ID: MUC17-365)
  
  
• HIV Screening (Public comments received:2; MUC ID: MUC17-367)
  
  

• Optimal Diabetes Care (Public comments received:5; MUC ID: MUC17-181)
  
  
• Diabetes A1c Control (< 8.0) (Public comments received:3; MUC ID: MUC17-215)
  
  
• Ischemic Vascular Disease Use of Aspirin or Anti-platelet Medication (Public comments received:4; MUC ID: MUC17-234)
  
  

Full Measure Information

Measure Specifications

• NQF Number (if applicable): 3175
  
  
• Description: Percentage of adults with pharmacotherapy for opioid use disorder (OUD) who have at least 180 days of continuous treatment
  
  
• Numerator: Individuals in the denominator who have at least 180 days of continuous pharmacotherapy with a medication prescribed for OUD without a gap of more than seven days
  
  
• Denominator: Adults who had a diagnosis of OUD and at least one claim for an OUD medication
  
  
• Exclusions: There are no numerator or denominator exclusions
  
  
• HHS NQS Priority: Effective Prevention and Treatment
  
  
• HHS Data Source: Administrative claims (non-Medicare), Registry
  
  
• Measure Type: Process
  
  
• Steward: RAND Corporation
  
  
• Endorsement Status: Endorsed
  
  
• 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: Refine and Resubmit Prior to Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:The measure was tested at the health plan level. Testing should be completed at the clinician level of analysis.
  • Impact on quality of care for patients:This measure would encourage care coordination and pro-active outreach for patients receiving OUD treatment. Patients who receive continuous OUD pharmacotherapy, as defined in the measure specifications, are more likely to reduce the risk of relapse, achieve better health outcomes, and improve their odds of opioid abstinence.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure addresses the MIPS domains of Effective Clinical Care and Communication/Care Coordination.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is a process measure based on current evidence cited by the VA/DoD clinical practice guidelines for the management of substance use disorders. Evidence supports the measure specifications of a 6 month minimum duration of pharmacotherapy and no gaps of greater than seven days.
  
  
• Does the measure address a quality challenge? Yes. Measure score testing by the developer found that only a quarter to a third of individuals with commercial insurance or Medicaid coverage taking medication for OUD remained on the medication for at least 180 days without a gap of more than seven days. Low performance on the measure score indicates less-than-optimal performance on this measure and opportunity for improvement.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. This measure is not duplicative of existing measures in the MIPS measure set. Several measures in the current MIPS measure set address OUD, however, none focus on continuous treatment.
  
  
• Can the measure can be feasibly reported? Yes. This is a claims-based measure.
  
  
• 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 was tested at the health plan level of analysis. Testing should be completed at the clinician level of analysis to be reliable and valid for the MIPS program. This measure was endorsed in 2017 under the NQF Behavioral Health project.
  
  
• Measure development status: Fully Developed
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? N/A. The measure is not currently in use.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Endorsed
  
  
• Does the measure address a high-priority quality issue in the dual eligible beneficiary population? Yes; Dual eligible beneficiaries may be particularly vulnerable to opioid addiction or misuse .
  
  
• Preliminary analysis of the MAP Medicaid-relevant measure: Support measurement of ongoing care of behavioral health issues. There is one opiod measure in the 2017 Adult Core Set. Addresses gap in substance abuse measures .
  
  

Rationale for measure provided by HHS
In this section, first we summarize the evidence from the systematic reviews and meta-analyses cited by the 2015 “VA/DoD clinical practice guideline for the management of substance use disorders” that support the recommendations related to pharmacotherapy for treatment of opioid use disorder. Following that, we present evidence in support of the measure definition: using a minimum of 6 months’ duration of pharmacotherapy, and no gaps of more than seven days. EVIDENCE CITED BY 2015 VA/DOD GUIDELINE SUPPORTING PHARMACOTHERAPY FOR TREATMENT OF OUD Mattick RP, Breen C, Kimber J, Davoli M. Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence. Cochrane Database Syst Rev. 2014;2:Cd002207. The results are based on 5430 patients in 31 RCTs. Fixed-dose studies of buprenorphine vs. placebo: “There is high quality of evidence that buprenorphine was superior to placebo medication in retention of participants in treatment at all doses examined. Specifically, buprenorphine retained participants better than placebo: at low doses (2 - 6 mg), 5 studies, 1131 participants, risk ratio (RR) 1.50; 95% confidence interval (CI) 1.19 to 1.88; at medium doses (7 - 15 mg), 4 studies, 887 participants, RR 1.74; 95% CI 1.06 to 2.87; and at high doses (≥ 16 mg), 5 studies, 1001 participants, RR 1.82; 95% CI 1.15 to 2.90. However, there is moderate quality of evidence that only high-dose buprenorphine (≥ 16 mg) was more effective than placebo in suppressing illicit opioid use measured by urinalysis in the trials, 3 studies, 729 participants, standardised mean difference (SMD) -1.17; 95% CI -1.85 to -0.49, notably, low-dose, (2 studies, 487 participants, SMD 0.10; 95% CI -0.80 to 1.01), and medium-dose, (2 studies, 463 participants, SMD -0.08; 95% CI -0.78 to 0.62) buprenorphine did not suppress illicit opioid use measured by urinalysis better than placebo.” Bao YP, Liu ZM, Epstein DH, Du C, Shi J, Lu L. A meta-analysis of retention in methadone maintenance by dose and dosing strategy. Am J Drug Alcohol Abuse. 2009;35(1):28-33. In univariate analyses, doses of MMT greater than or equal to 60 mg/day were associated with greater retention than doses less than 60 mg/day at 3-6 months (62.5% vs. 50.6%; p=0.0005) and 6-12 months (57.0% vs. 42.5%; p<0.0001). Flexible dosing was associated with greater retention than fixed dosing strategies at 3-6 months (61.0% vs. 49.9%; p=0.0007) and 6-12 months (61.7% vs. 45.9%; p<0.0001). In multilevel analyses (follow-up duration, dose, and dosing strategy), retention was greater with methadone doses ≥ 60 mg/day than with doses <60 mg/day (OR: 1.74, 95% CI: 1.43-2.11). Similarly, retention was greater with flexible-dose strategies than with fixed-dose strategies (OR: 1.72, 95% CI: 1.41-2.11). Mattick RP, Breen C, Kimber J, Davoli M. Methadone maintenance therapy versus no opioid replacement therapy for opioid dependence. Cochrane Database Syst Rev. 2009(3):Cd002209. The results are based on 1969 patients in 11 randomized clinical trials. “Methadone appeared statistically significantly more effective than non-pharmacological approaches in retaining patients in treatment and in the suppression of heroin use as measured by self report and urine/hair analysis (6 RCTs, RR = 0.66; 95% CI 0.56-0.78), but not statistically different in criminal activity (3 RCTs, RR=0.39; 95% CI 0.12-1.25) or mortality (4 RCTs, RR=0.48; 95% CI: 0.10-2.39).” Krupitsky E, Nunes EV, Ling W, Illeperuma A, Gastfriend DR, Silverman BL. Injectable extended-release naltrexone for opioid dependence: A double-blind, placebo-controlled, multicentre randomised trial. Lancet. Apr 30 2011;377(9776):1506-1513. The median proportion of weeks of confirmed abstinence was significantly higher in the naltrexone group than in the placebo group (90.0% for naltrexone vs. 35.0% for placebo; p=0.0002). The proportion of patients with total confirmed abstinence was higher in the naltrexone group than the placebo group (RR=1.58; 95% CI, 1.06 to 2.36; p=0.0224). Comparing clinical outcomes between the naltrexone and placebo groups yielded the following results: proportion of self-reported opioid-free days over the 24 weeks (99.2% for naltrexone vs. 60.4% for placebo; p=0.0004), mean change in opioid craving score from baseline (-10.1 for naltrexone vs. 0.7 for placebo; p<0.0001), number of days of retention (>168 days for naltrexone vs. 96 days for placebo; p=0·0042), and number of participants with positive naloxone challenge test (1 for naltrexone vs. 17 for placebo; p<0.0001). EVIDENCE SUPPORTING MEASURE DEFINITION We define treatment continuity as (1) receiving at least 180 days of treatment and (2) no gaps in medication use of more than 7 days. Our definition of minimum duration is based on the fact that the FDA registration trials for OUD drugs studied the effect of treatment over three to six months (US FDAa, undated; US FDAb, undated), and we have no evidence for effectiveness of shorter durations. In addition, several recommendations support a minimum six-month treatment period as the risk of relapse is the highest in the first 6-12 months after start of opioid abstinence (US FDAa, undated; US FDAb, undated; US DHHS, 2015). Longer treatment duration is associated with better outcomes compared to shorter treatments and the best outcomes have been observed among patients in long-term methadone maintenance programs (“Effective medical treatment of opiate addiction”, 1998; Gruber et al., 2008; Moos et al., 1999; NIDA, 1999; Ouimette et al., 1998; Peles et al., 2013). Studies with long-term follow-up suggest that ongoing pharmacotherapy is associated with improved odds of opioid abstinence (Hser et al., 2015; Weiss et al., 2015). We did not specify a maximum duration of treatment, as no upper limit for duration of treatment has been empirically established (US DHHS, 2015). We opted for using a treatment gap of more than seven days in our definition, given that the measure includes three active ingredients with different pharmacological profiles. There is substantial evidence for an elevated mortality risk immediately after treatment cessation (Cornish et al., 2010; Cousins et al., 2016; Davoli et al, 2007; Degenhardt et al., 2009; Gibson & Degenhardt, 2007;Pierce et al., 2016). Research suggests that methadone tolerance is lost after three days and this three-day threshold has been used in other observational methadone studies and in developing a United Kingdom treatment guideline which recommends revaluating patients for intoxication and withdrawal after a three-day methadone treatment gap (Cousins et al., 2016; Cousins et al., 2011; “Drug Misuse and Dependence--Guidelines on Clinical Management”, 1999). Across all of the medications, the mortality risk is highest in the first four weeks out of treatment, with many studies showing an increase in mortality in days 1-14 after treatment cessation. Citations Cornish R, Macleod J, Strang J, Vickerman P, Hickman M. Risk of death during and after opiate substitution treatment in primary care: prospective observational study in UK General Practice Research Database. Bmj. 2010;341:c5475. Cousins G, Teljeur C, Motterlini N, McCowan C, Dimitrov BD, Fahey T. Risk of drug-related mortality during periods of transition in methadone maintenance treatment: a cohort study. J Subst Abuse Treat 2011; 41: 252-60. Cousins G, Boland F, Courtney B, Barry J, Lyons S, Fahey T. Risk of mortality on and off methadone substitution treatment in primary care: a national cohort study. Addiction. 2016;111(1):73-82. Davoli M, Bargagli AM, Perucci CA, et al. Risk of fatal overdose during and after specialist drug treatment: the VEdeTTE study, a national multisite prospective cohort study. Addiction. 2007;102:1954-9. Degenhardt L, Randall D, Hall W, Law M, Butler T, Burns L. Mortality among clients of a state-wide opioid pharmacotherapy program over 20 years: risk factors and lives saved. Drug and alcohol dependence. 2009;105:9-15. “Drug Misuse and Dependence--Guidelines on Clinical Management.” Scottish Office Department of Health, Welsh Office, Social Services Northern Ireland. London: Stationery Office, 1999. Effective medical treatment of opiate addiction. National Consensus Development Panel on Effective Medical Treatment of Opiate Addiction. JAMA.1998;280:1936-1943. Gibson AE, Degenhardt LJ. Mortality related to pharmacotherapies for opioid dependence: a comparative analysis of coronial records. Drug Alcohol Rev. 2007; 26(4), 405-410. Gruber VA, Delucchi KL, Kielstein A, Batki SL. A randomized trial of 6-month methadone maintenance with standard or minimal counseling versus 21-day methadone detoxification. Drug and Alcohol Dependence. 2008;94(1-3):199-206. Hser YI, Evans E, Grella C, Ling W, Anglin D. Long-term course of opioid addiction. Harvard Review of Psychiatry. 2015;23(2):76-89. Moos RH, Finney JW, Ouimette PC, Suchinsky RT. A comparative evaluation of substance abuse treatment: I. Treatment orientation, amount of care, and 1-year outcomes. Alcohol Clin Exp Res. 1999;23(3):529-36. National Institute on Drug Abuse (NIDA). Principles of Drug Addiction Treatment: A Research-Based Guide. NIH Publication No. 99-4180. Rockville, MD: NIDA, 1999, reprinted 2000 Ouimette PC, Moos RH, Finney JW. Influence of outpatient treatment and 12-step group involvement on one-year substance abuse treatment outcomes. J Stud Alcohol. 1998;59:513-522 Peles E, Schreiber S, Adelson M. Opiate-dependent patients on a waiting list for methadone maintenance treatment are at high risk for mortality until treatment entry. J Addict Med. 2013;7(3):177-82. Pierce M, Bird SM, Hickman M, Marsden J, Dunn G, Jones A, et al. Impact of treatment for opioid dependence on fatal drug-related poisoning: a national cohort study in England. Addiction. 2016;111:298-308. U.S. Department of Health and Human Services Assistant Secretary for Planning and Evaluation Office of Disability, Aging and Long-Term Care Policy. Review of Medication-Assisted Treatment Guidelines and Measures for Opioid and Alcohol Use. Washington, DC, 2015. Accessed November 9, 2016 at: https://aspe.hhs.gov/sites/default/files/pdf/205171/MATguidelines.pdf U.S. Food and Drug Administration (FDA) (a). REVIA Label. Accessed November 24, 2016 at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018932s017lbl.pdf U.S. Food and Drug Administration (FDA) (b). VIVITROL Label. Accessed November 24, 2016 at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021897lbl.pdf Weiss RD; Potter JS; Griffin ML, et al. Long-term outcomes from the National Drug Abuse Treatment Clinical Trials Network Prescription Opioid Addiction Treatment Study. Drug and Alcohol Dependence. 2015;150:112-119. EVIDENCE SUPPORTING USE OF 7-DAY GAP IN MEASURE DEFINITION We performed a review of studies that looked at the mortality risk during treatment cessation for OUD pharmacotherapy. All of the studies found evidence for increased mortality during treatment cessation and the results were consistent for the different MAT drugs. For Buprenorphine, we found two studies that both indicated an increased risk of mortality upon treatment cessation (Cornish et al., 2010; Degenhardt et al., 2009). For Methadone, we found four studies that all indicated an increased risk of mortality upon treatment cessation (Cornish et al., 2010; Cousins et al., 2016; Davoli et al., 2007; Degenhardt et al., 2009). For Methadone/Buprenorphine, we found two studies that both indicated an increased risk of mortality upon treatment cessation (Cornish et al., 2010; Pierce et al., 2016). For Naltrexone, we found one study that indicated an increased risk of mortality upon treatment cessation (Gibson & Degenhardt , 2007). Across all the medications, the mortality risk is highest in the first four weeks out of treatment, with many studies showing an increase in mortality in days 1-14 after treatment cessation. This evidence supports the recommendation for no gaps in care of more than 7 days. Citations Cornish R, Macleod J, Strang J, Vickerman P, Hickman M. Risk of death during and after opiate substitution treatment in primary care: prospective observational study in UK General Practice Research Database. Bmj. 2010;341:c5475. Cousins G, Boland F, Courtney B, Barry J, Lyons S, Fahey T. Risk of mortality on and off methadone substitution treatment in primary care: a national cohort study. Addiction. 2016;111(1):73-82. Davoli M, Bargagli AM, Perucci CA, et al. Risk of fatal overdose during and after specialist drug treatment: the VEdeTTE study, a national multisite prospective cohort study. Addiction. 2007;102:1954-9. Degenhardt L, Randall D, Hall W, Law M, Butler T, Burns L. Mortality among clients of a state-wide opioid pharmacotherapy program over 20 years: risk factors and lives saved. Drug and alcohol dependence. 2009;105:9-15. Gibson AE, Degenhardt LJ. Mortality related to pharmacotherapies for opioid dependence: a comparative analysis of coronial records. Drug Alcohol Rev. 2007; 26(4), 405-410. Pierce M, Bird SM, Hickman M, Marsden J, Dunn G, Jones A, et al. Impact of treatment for opioid dependence on fatal drug-related poisoning: a national cohort study in England. Addiction. 2016;111:298-308.

Summary of NQF Endorsement Review

• Year of Most Recent Endorsement Review: 2017
  
  
• Project for Most Recent Endorsement Review: Behavioral Health 2016-2017
  
  
• Review for Importance: 1a. Evidence: 1b. Performance Gap, 1c. High Priority) 38 1a. Evidence: H: 3; M-10; L-0; I-5; 1b. Performance Gap: H-5; M-11; L-1; I-1 Rationale: • The developer provided guidelines on the management of substance use disorders (VA/DoD 2015). In addition, they cited evidence showing the increased mortality associated with interruption of medication, with highest risks being in the first few weeks after stopping the medication. • One Committee member noted an article not included in this submission from the New England Journal of Medicine in March 2016 on Vivitrol that looked at the efficacy of Vivitrol. • The developer also provided evidence on reasoning for choice of 6-month continuation (based on FDA trial lengths) and 7-day gap (drug effectiveness and mortality risk following interruption of medication). The developer noted there is no empirical evidence on the best length of time overall for patients to stay on these medications, and suggests this as a needed area of research. • The Committee noted the gaps in performance, with mean performance in 2014-2015 of 27.7 percent, (10th percentile at 16.2 percent and 90th percentile at 40.9 percent).
  
  
• Review for Scientific Acceptability: 2a. Reliability - precise specifications, testing; 2b. Validity -testing, threats to validity) 2a. Reliability: H-0; M-15; L-2; I-2; 2b. Validity: M-14; L-2; I-3 Rationale: • The Committee had extensive discussions about how the measure was specified –in particular, they expressed concern about the measure capturing individuals who are appropriately discontinuing their medication, as the measure cannot tell which patients have been on medication for years. The Committee asked why the measure was not specified to only look at those who had just initiated treatment. The developer acknowledged this could lead to some measurement error, but they expected this to only be a small number. The developer said they made the choice to err on the side ofsensitivity over specificity in order to be more generalizable and look at a cross-section of patients, given that the performance gap is so large. The developer also noted that the measure has a rolling 2-year timeframe. Furthermore, the developer noted that it can be difficult to identify those who have been on medications long term in commercial insurance because individuals can change plans over time. • One Committee member expressed concern that the measure could encourage providers to keep patients on their medications unnecessarily. • The Committee also questioned why the measure does not include counseling in conjunction with medication. The developer cited issues with defining counseling, and the ability to capture all types of counseling (e.g., community-based support groups). The Committee suggested in the future the measure might be expanded to set a minimum standard for the occurrence of any type of counseling. • The Committee asked why the measure had only been tested in the commercial insurance pool. The developer noted timeline constraints to submit the measure for consideration, but stated they intend to conduct testing in both the Medicare and Medicaid populations. • The developer provided a signal-to-noise analysis showing reliability rates of 0.977 at the state level and 0.891 at the health plan level. 39 • The Committee noted the face validity testing of the measure score resulted in eight of 10 experts in agreement that the measure can be used to distinguish good quality from poor quality. • The Committee had several suggestions for improvements to the measure’s specifications in the future including: o Expansion of the patient pool (e.g., Medicare, Medicaid). o Stratification of the data for patients who have just initiated medication and those who have been on medication for a longer time. o Addition of a counseling component.
  
  
• Review for Feasibility: 3. Feasibility: H-8; M-10; L-1; I-0 (3a. Data generated during care; 3b. Electronic sources; and 3c. Data collection can be implemented (eMeasure feasibility assessment of data elements and logic) Rationale: • The Committee noted that the data are readily available in electronic form and no issues have been reported in testing.
  
  
• Review for Usability: 4. Use and Usability: H-1; M-11; L-5; I-2 (4a. Accountability/transparency; and 4b. Improvement –progress demonstrated; and 4c. Benefits outweigh evidence of unintended negative consequences) Rationale: • The Committee strongly recommended that the measure not be used in pay-for-performance programs initially.
  
  
• Review for Related and Competing Measures: 5. Related and Competing Measures • This measure relates to NQF #0004: Initiation and Engagement of Alcohol and Other Drug Dependence Treatment (IET). NQF #0004 was discussed with the Committee in October 2016, and discussions around harmonization have been deferred until after an update is available. • This measure relates to NQF #1664: SUB-3 Alcohol & Other Drug Use Disorder Treatment Provided or Offered at Discharge and SUB-3a Alcohol & Other Drug Use Disorder Treatment at Discharge, a facility-level measure for the hospital setting. There are minor differences that may be considered for harmonization, but the Committee decided to table discussion.
  
  
• Endorsement Public Comments: 6. Public and Member Comment: • This measure received three comments. One comment supported the endorsement of the measure and two comments raised concerns around the endorsement of the measure at the health plan level and failure to distinguish between dangerous non-therapeutic MAT- 40 discontinuation and appropriate, planned Opioid Substitution Treatment (OST) tapers (e.g., discontinuation of Vivitrol, naltrexone for extended-release injectable suspension). • The developer of this measure also provided additional information and testing data based on Medicaid claims from national databases in response to the Committee’s request for this information during the in-person meeting.
  
  
• Endorsement Committee Recommendation: Standing Committee Recommendation for Endorsement: Y-12; N-7 • The Committee clarified that they were voting on the measure as it stands, and not considering potential updates as previously suggested (e.g., stratification of new users, addition of counseling).
  
  

Measure Specifications

• NQF Number (if applicable): 2643
  
  
• Description: For patients age 18 and older undergoing lumbar spine fusion surgery, the average change from pre-operative functional status to one year (nine to fifteen months) post-operative functional status using the Oswestry Disability Index (ODI version 2.1a) patient reported outcome tool.
  
  
• Numerator: The average change (preoperative to one year post-operative) in functional status for all patients in the denominator. There is not a traditional numerator for this measure; the measure is calculating the average change in functional status score from pre-operative to post-operative functional status score. The measure is NOT aiming for a numerator target value for a post-operative ODI score. The average change is calculated as follows: Change is first calculated for each patient and then changed scores are summed and then an average is determined. Measure calculation takes into account those patients that have an improvement and those patients whose function decreases post-operatively. Example below: Patient Pre-op ODI :I Post-op ODI :I Change in ODI Patient A: I 47 :I 18 :I 29 Patient B: I 45 :I 52 :I -7 Patient C: I 56 :I 12 :I 44 Patient D: I 62 :I 25 :I 37 Patient E: I 42 :I 57 :I -15 Patient F: I 51 :I 10 :I 41 Patient G: I 62 :I 25 :I 37 Patient H: I 43 :I 20 :I 23 Patient I: I 74 :I 35 :I 39 Patient J: I 59 :I 23 :I 36 Average change in ODI one year post-op 26.4 points on a 100 point scale
  
  
• Denominator: Eligible Population: Patients with lumbar spine fusion procedures (Arthrodesis Value Set) occurring during a 12 month period for patients age 18 and older at the start of that period. Denominator: Patients within the eligible population whose functional status was measured by the Oswestry Disability Index, version 2.1a (ODI, v2.1a) within three months preoperatively AND at one year (+/- 3 months) postoperatively. * The measure of average change in function can only be calculated if both a pre-operative and post-operative PRO assessment are completed
  
  
• Exclusions: The following exclusions must be applied to the eligible population: Patient had cancer (Spine Cancer Value Set), fracture (Spine Fracture Value Set) or infection (Spine Infection Value Set) related to the spine. Patient had idiopathic or congenital scoliosis (Congenital Scoliosis Value Set)
  
  
• HHS NQS Priority: Patient and Family Engagement
  
  
• HHS Data Source: Administrative clinical data, EHR, Paper medical record, Registry
  
  
• Measure Type: Patient Reported Outcome
  
  
• Steward: MN Community Measurement
  
  
• Endorsement Status: Endorsed
  
  
• 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 for Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure is fully developed, tested, and NQF endorsed. The measure addresses an important health outcome for patients who have undergone surgical fusion surgery.
  • Impact on quality of care for patients:This measure encourages physicians to deliver high quality care by tracking patient-generated information regarding the patient’s functional status improvement following a surgical fusion surgery.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure addresses the MIPS domain of person and caregiver-centered experience and outcomes.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is a patient-reported outcome measure that addresses average change in functional status for patients before and after lumbar spine fusion surgery. This measure is in alignment with the North American Spine Surgery Guidelines for Lumbar Disc Herniation with Radiculopathy. The guideline recommends collecting data regarding the preoperative characteristics and postoperative outcomes of patients undergoing surgical intervention for lumbar disc herniation.
  
  
• Does the measure address a quality challenge? Yes. This measure addresses a performance gap. Average change in functional status from pre-operative to one year post-operative as measured by the Oswestry Disability Index (100 point scale).On average, patients improved by 16.9 points, with variation demonstrated among practices ranging from 9.3 to 22.6 points.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. A functional status outcome measure, “Functional Status Change for Patients with Lumbar Impairments,” currently exists in MIPS, but there is no measure that examines and compares functional status prior to and following a surgical fusion surgery. There is a related measure for MIPS PY 2018, QPP# 460: Average Change in Back Pain following Lumbar Fusion. QPP# 460 is same target population but not same measure focus. QPP# 460 looks at change in back pain, whereas this MUC 168 looks at change in functional status.
  
  
• Can the measure can be feasibly reported? Yes. This is a fully specified measure, which uses EHR data from structured fields. In addition, a combination of extraction and abstraction or paper records may be used. This measure has now been implemented and publicly reported for three years via MN HealthScores.
  
  
• 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 testing has demonstrated reliability and validity for the group level of analysis. This measure is NQF-endorsed.
  
  
• Measure development status: Fully Developed
  
  
• 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 is implemented in Minnesota and included in the MN Department of Health Statewide Quality Reporting and Measurement System (SQRMS). No unintended consequences have been identified. The Person- and Family-Centered Care Committee endorsed the measure, but raised concerns about the use of Oswestry Disability Index noting that the tool primarily assesses pain and may not capture other neurological dysfunction and surgical side effects.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Endorsed
  
  

Rationale for measure provided by HHS
Patient Reported Outcome Measures and Integration Into Electronic Health Records Pitzen, C. et al, Journal of Oncology Practice DOI: 10.1200/JOP.2016.014118; published online ahead of print at jop.ascopubs.org on July 26, 2016.

Summary of NQF Endorsement Review

• Year of Most Recent Endorsement Review: 2016
  
  
• Project for Most Recent Endorsement Review: Person and Family-Centered Care Phase 2
  
  
• Review for Importance: 1a. Evidence: 1b. Performance Gap, 1c. High Priority) 1a. Evidence: Y-18; N-1; 1b. Performance Gap: H-6; M-8; L-0; I-5 1c. High Priority: H-13; M-6; L-0; I-0 Rationale: • The developer introduced this new measure as a patient-reported outcome measure, which evaluates the change between a patient’s preoperative functional status and their postoperational functional status at one year. • The Committee applauded the developers for tackling this controversial and important area in utilization of surgical procedures, pointing to the developer’s statement that there is a 15-fold increase in the number of complex fusion procedures performed for Medicare beneficiaries, which is a highly variable procedure. However, the Committee stated that this measure could imply that there is a gap in quality of care, but not a gap in variability in performance, based on the pilot data. • The developer explained that this measure has gone through one phase of pilot testing involving four practices and is in the statewide quality reporting and measurement system for Minnesota, which is required of practitioners. The developer noted that they are expecting full implementation data to be available in May, 2015. • The Committee members raised additional concerns that the Oswestry tool (pain questionnaire) may not be the best tool to use, because it is primarily aimed at pain and therefore would not capture other neurological dysfunctions or potential side effects of the surgery itself. They recommended that the measure be improved by adding other questions or tools that might speak to neurological symptoms that could present without pain.
  
  
• Review for Scientific Acceptability: 2a. Reliability - precise specifications, testing; 2b. Validity - testing, threats to validity) 2a. Reliability: H-0; M-6; L-4; I-9 2b. Validity: H-X; M-X; L-X; I-X UPDATED VOTES FOR 2a. Reliability: H-3; M-15; L-0; I-0 2b. Validity: H-1; M-17; L-0; I-0 Rationale: • The Committee members commented that the specifications look very clear but the risk adjustment specifications have not been modeled yet. Further, the Committee noted that there is no score-level reliability testing data presented as well as data to demonstrate the intraclass correlations at the practice-level. The developer confirmed that similar to Measure 2653 Average Change in Functional Status Following Total Knee Replacement Surgery, they will submit final analysis of a risk adjustment methodology based on the Committee’s recommendations. 90 • This measure did not pass reliability so the Committee stopped voting at this juncture and requested the aforementioned testing information from the developers to re-consider the measure after the public comment. One Committee member offered an additional suggestion for the developers to add questions such as whether or not non-invasive treatments were tried (e.g., physical therapy or pain consults, steroid injections) to get a sense for onset of symptoms, other treatments that were tried, and clinical indications for the procedure.
  
  
• Review for Feasibility: 3. Feasibility: H-3; M-14; L-1; I-0 (3a. Data generated during care; 3b. Electronic sources; and 3c. Data collection can be implemented (eMeasure feasibility assessment of data elements and logic) Rationale: • This measure data source is Electronic Clinical Data, Electronic Health Record, Paper Medical Records, and Patient Reported Data/Survey. • Also, all data elements are in defined fields in electronic health records (EHRs)
  
  
• Review for Usability: 4. Use and Usability: H-3; M-14; L-0; I-1 (4a. Accountability/transparency; and 4b. Improvement – progress demonstrated; and 4c. Benefits outweigh evidence of unintended negative consequences) Rationale: • This measure is not currently in use but planned for use in public reporting, payment program, and regulatory and accreditation programs. • The developer also noted that this measure is planned for inclusion in the MN Department of Health (MDH) Statewide Quality Reporting and Measurement System. Mandatory data collection and reporting under 2008 MN Health Reform Legislation. MNCM was a subcontractor to MDH for measure development exploring the concept of low back pain. Statewide implementation is planned for submission in April/May 2015 for dates of procedure 1/1/2013 to 12/31/2013 with follow-up assessment period through March 31, 2015.
  
  
• Review for Related and Competing Measures: 5. Related and Competing Measures • No related or competing measures noted.
  
  
• Endorsement Public Comments: 6. Public and Member Comment Comments received: • Commenters believed this measure should be considered for endorsement once the reliability testing data is submitted by Minnesota Community Measurement because the measure focuses on an important patient-centered outcome and addressees an important gap area for quality improvement. We believe an explicit patient-centered focus on surgical outcomes is necessary and this measure begins to address this important quality issue. Committee response: • The Committee requested additional information to allow for more comprehensive evaluation of the consensus not reached and not recommended measures. This additional information 91 was discussed on the post-comment committee call and the Committee had an opportunity to re-vote on the applicable measures. This measure was recommended by the Committee after reviewing the additional information and the comments. Developer response: • Thank you for your support! We agree that these types of measures focused on patient reported outcomes and change over time, which represent newer cutting-edge measures, are more difficult to evaluate as compared to traditional measures that are expressed as a binary Yes/No. We have provided additional testing in response to the Standing committee’s concerns and look forward to continued conversation and working with NQF staff to determine the best statistical methods and tests for determining the reliability and validity performance scores. A new published study supports the use of the Oswestry Disability Index as a PROM tool appropriate for outcome measurement. “A proposed set of metrics for standardized outcome reporting in the management of low back pain.” Clement, RC et al Acta Orthopaedica 2015; 86 (4)
  
  
• Endorsement Committee Recommendation: Standing Committee Recommendation for Endorsement: Y-18; N-0
  
  

Measure Specifications

• NQF Number (if applicable): 2653
  
  
• Description: For patients age 18 and older undergoing total knee replacement surgery, the average change from pre-operative functional status to one year (nine to fifteen months) post-operative functional status using the Oxford Knee Score (OKS) patient reported outcome tool.
  
  
• Numerator: There is not a traditional numerator for this measure; the measure is calculating the average change in functional status score from pre-operative to post-operative functional status score. The measure is NOT aiming for a numerator target value for a post-operative OKS score. For example: The average change in knee function was an increase of 15.9 points one year post-operatively on a 48 point scale. The average change is calculated as follows: Change is first calculated for each patient and then changed scores are summed and then an average is determined. Measure calculation takes into account those patients that have an improvement and those patients whose function decreases post-operatively. Example below: Patient Pre-op OKS :I Postop OKS :I Change in OKS Patient A: I 33 :I 45 :I 12 Patient B: I 17 :I 39 :I 22 Patient C: I 16 :I 31 :I 15 Patient D: I 23 :I 40 :I 17 Patient E: I 34 :I 42 :I 8 Patient F: I 10 :I 42 :I 32 Patient G: I 14 :I 44 :I 30 Patient H: I 32 :I 44 :I 12 Patient I: I 19 :I 45 :I 26 Patient J: I 26 :I 19 :I -7 Patient K: I 24 :I 43 :I 19 Patient L: I 29 :I 34 :I 5 Patient M : I 23 :I 39 :I 16 Patient N: I 29 :I 45 :I 16 Patient O: I 29 :I 45 :I 16 Patient P: I 34 :I 41 :I 7 Patient Q: I 11 :I 14 :I 3 Patient R: I 13 :I 39 :I 26 Patient S: I18 :I 45 :I 27 Average change in OKS one year post-op 15.9 points on a 48 point scale
  
  
• Denominator: Eligible Population: Patients with total knee replacement procedures (Primary TKR Value Set, Revision TKR Value Set) occurring during a 12 month period for patients age 18 and older at the start of that period. Denominator: Patients within the eligible population whose functional status was measured by the Oxford Knee Score within three months preoperatively AND at one year (+/- 3 months) postoperatively * The measure of average change in function can only be calculated if both a pre-operative and post-operative PRO assessment are completed
  
  
• Exclusions: None
  
  
• HHS NQS Priority: Patient and Family Engagement
  
  
• HHS Data Source: Administrative clinical data, EHR, Paper medical record, Registry
  
  
• Measure Type: Patient Reported Outcome
  
  
• Steward: MN Community Measurement
  
  
• Endorsement Status: Endorsed
  
  
• 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 for Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure is fully developed, tested, and NQF endorsed. It also addresses a high priority area of patient-reported outcome addressing changes in a patient’s functional status following total knee replacement surgery.
  • Impact on quality of care for patients:This measure encourages physicians to deliver high quality care by tracking patient-generated information regarding the patient’s functional status improvement following total knee replacement surgery.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure addresses the MIPS domain of person and caregiver-centered experience and outcomes.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is a patient-reported outcome measure that addresses average change in functional status before and after total knee replacement surgery. The measure is reflective of clinical guidelines from the American Association of Hip and Knee Surgeons, which indicates a focus on collecting patient risk factors and implementing process measures with a future focus on outcome measures.
  
  
• Does the measure address a quality challenge? Yes. This measure addresses a performance gap. On average, patients improved by 16.5 points, with variation among practices ranging from 13.8-18.5.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. There are currently no measures in MIPS that address patient-reported outcomes for patients undergoing total knee replacement procedures. Of note, there is a related measure QPP #375 Functional Status Assessment for Total Knee Replacement, which is a process measure. This measure provides important information to patients and clinicians regarding the quality and outcomes of total knee replacement surgeries.
  
  
• Can the measure can be feasibly reported? Yes. This measure is fully specified, and data are captured during the course of care. Data sources for the measure include administrative clinical data, EHR, and paper medical records.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. This measure was NQF-endorsed in 2015 as NQF#2653. The measure was tested at the group level. The measure has not been reviewed by MAP.
  
  
• Measure development status: Fully Developed
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? No . Measure has been implemented in the Minnesota Department of Health’s Statewide Quality Reporting and Measurement System (SQRMS), using data submitted by all eligible providers. No implementation issues have been identified.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Endorsed
  
  

Rationale for measure provided by HHS
Patient-reported outcomes after total and unicompartmental knee arthroplasty: a study of 14,076 matched patients from the National Joint Registry for England and Wales. Liddle, AD et al Bone Joint J. 2015 Jun;97-B(6):793-801. doi: 10.1302/0301-620X.97B6.35155.

Summary of NQF Endorsement Review

• Year of Most Recent Endorsement Review: 2016
  
  
• Project for Most Recent Endorsement Review: Person and Family-Centered Care Phase 2
  
  
• Review for Importance: 1a. Evidence: Y-16; N-3; 1b. Performance Gap: H-3; M-12; L-3; I-1; 1c. Impact: H-8; M-9; L-2; I-0 Rationale: • The number of total knee replacements (TKR) is rising and will continue to rise over the next 10 years as the Baby Boom generation ages, especially because the standard of care for end-stage degenerative arthritis of the knee is knee arthroplasy. The Committee agreed that patients could use information on what level of functional status they can expect after a TKR. The Committee agreed that a one-year postoperative assessment was the right timeframe as much sooner would not accurately measure real outcomes. • The Committee requested more information on the effect of the measured improvement and whether is an amount that actually impacts outcomes. While the developers had not included that information in the submission form, a Committee member provided data from a different study that the standard deviation is 8, and so the difference noted in the measure would be very significant (two standard deviations). • The Committee was concerned that the measure did not collect data on postoperative interventions, such as rehabilitation, that could affect outcomes separately from the surgery and that could not be held attributable to the surgeon. However, one Committee member suggested that a surgeon should be seen as the leader of a team taking care of a knee and that this sort of measure would encourage more focus on long-term outcomes. • The developer confirmed that patients were involved in the measure development work group
  
  
• Review for Scientific Acceptability: 2a. Reliability: H-0; M-9; L-3; I-7 (consensus not reached) 2b. Validity: H-1; M-7; L-5; I-6 (consensus not reached) UPDATED VOTES FOR 2a. Reliability: H-2; M-13; L-3; I-0 2b. Validity: H-2; M-14; L-1; I-1 Rationale: • Committee members questioned why the measure is not risk adjusted; the developer explained that although a final risk adjustment strategy had not been submitted, upon the receipt of a full set of data they plan to test a number of variablesas potential adjustors. The developer utilizes a workgroup to advise on risk adjustment and a preliminary strategy has been developed and tested, but not yet finalized. • The Committee wanted to know how different the average patient population in Minnesota would be from the average patient across the US, and also raised concerns that the measure 70 was originally tested on a very different patient population, potentially affecting the reliability and validity of the instrument used. • The developer stated that this is a new type of measure that does not have a traditional numerator and denominator; it is a continuous measure. They stated that measurement science has not yet evolved to the point of determining appropriate methodology for testing reliability for this type of measure. The Committee suggested intraclass correlate testing as a possibility. • The developer mentioned they had some difficulty with the PRO tool administration rates and that they were working with a phased approach to improve those rates. • Committee members requested an estimation of reliability at the physician level and the developers agreed to follow up with that information.
  
  
• Review for Feasibility: 4. Feasibility: H-1; M-15; L-2; I-1 (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: • In response to a request for more information, the developers explained that the measure requires a pre-operative OKS summary score, using a simple tool. Practices submit patient-level information to a portal that calculates the measures. They noted that orthopedic practices are new to measurement, and that their pilot groups said getting information into and out of their EMRs was easier than getting the patient-reported tools into their workflows. However, they are seeing gradual improvements. • Post-operatively, the tool is filled out during an office visit or sent to the patient via mail or the patient portal. • Committee members asked if this measure is susceptible to gaming; the developers said that there are no appropriateness criteria guidelines for knee replacement but that they collect the data on all patients, whether they completed one or both assessments.
  
  
• Review for Usability: 3. Use and Usability: H-0; M-12; L-5; I-2 (Meaningful, understandable, and useful to the intended audiences for 3a. Public Reporting/Accountability and 3b. Quality Improvement) Rationale: • The measure is not currently in use, so no usability data is available, but the developer plans to report it statewide in Minnesota in 2016.
  
  
• Review for Related and Competing Measures: 5. Related and Competing Measures • The Committee considered whether this measure potentially competes with 0422: Functional Status Change for Patients with Knee Impairments (FOTO). The Committee determined that the measures have different focus in terms of the target population, provider types, and clinical settings, as well as the clinical area. The developers indicated that the FOTO measure is broader and applicable to any kind of knee impairments, as opposed to measure 2653, which only focuses on patients with knee replacements. Therefore, the Committee agreed that the measures were related but not competing. The Committee did not make recommendations for harmonization.
  
  
• Endorsement Public Comments: 6. Public and Member Comment: March 2, 2015- March 31, 2015 Comments received: • Commenters strongly urge the Committee to reconsider and recommend this measure. The measure is deemed by consumers and purchasers to be important for assessing providers of knee replacement surgery. This is a high frequency and high cost procedure, and currently there is no information that enables patients to choose providers that can achieve better outcomes as assessed by patients themselves. Therefore, this measure is a high priority for these users. Commenters also asked NQF to consider ways to improve upon the validity and reliability of this measure and other similar measures should be considered in the future. Committee response: • The Committee requested additional information to allow for more comprehensive evaluation of the consensus not reached and not recommended measures. This additional information was discussed on the post-comment committee call and the Committee had an opportunity to re-vote on the applicable measures. This measure was recommended by the Committee after reviewing the additional information and the comments. NQF response: • NQF has reviewed your comment and appreciates your input. Your comment has been forwarded to the Standing Committee and Developer for consideration. NQF is not able to improve measures as our role is to endorse measures, not maintain them, but we do encourage improvements to measures over time and at the three-year maintenance cycle review. Developer response: • Thank you for your support! We agree that these types of measures focused on patient reported outcomes and change over time, which represent newer cutting-edge measures, are more difficult to evaluate as compared to traditional measures that are expressed as a binary Yes/No. We have provided additional testing in response to the Standing committee’s concerns and look forward to continued conversation and working with NQF staff to determine the best statistical methods and tests for determining the reliability and validity performance scores. Thanks for your suggestion to determine modes that address survey burden. In addition to obtaining survey information from the patient during an in-person visit, we do allow mailed survey and when permitted by the tool developer/ copyright holder, electronic administration of the tool to the patient by patient portal. Additionally, although not yet submitted for endorsement, MN Community Measurement is also measuring the change in quality of life for this patient population, initially using the EQ5D and now transitioning to PROMIS Global Health-10. • We agree that these types of measures focused on patient reported outcomes and change over time, which represent newer cutting-edge measures, are more difficult to evaluate as compared to traditional measures that are expressed as a binary Yes/No. We have provided additional testing in response to the Standing committee’s concerns and look forward to continued conversation and working with NQF staff to determine the best statistical methods and tests for determining the reliability and validity performance scores.
  
  
• Endorsement Committee Recommendation: Standing Committee Recommendation for Endorsement: Y-11; N-8 (consensus not reached); UPDATED Y-15; N-3
  
  

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: For patients age 18 and older undergoing lumbar discectomy laminotomy surgery, the average change from pre-operative functional status to three months (6 to 20 weeks) post-operative functional status using the Oswestry Disability Index (ODI version 2.1a) patient reported outcome tool.
  
  
• Numerator: The average change (preoperative to three months post-operative) in functional status for all patients in the denominator. There is not a traditional numerator for this measure; the measure is calculating the average change in functional status score from pre-operative to post-operative functional status score. The measure is NOT aiming for a numerator target value for a post-operative ODI score. The average change is calculated as follows: Change is first calculated for each patient and then changed scores are summed and then an average is determined. Measure calculation takes into account those patients that have an improvement and those patients whose function decreases post-operatively. Example below: Patient Pre-op ODI :I Post-op ODI :I Change in ODI Patient A: I 47 :I 18 :I 29 Patient B: I 45 :I 52 :I -7 Patient C: I 56 :I 12 :I 44 Patient D: I 62 :I 25 :I 37 Patient E: I 42 :I 57 :I -15 Patient F: I 51 :I 10 :I 41 Patient G: I 62 :I 25 :I 37 Patient H: I 43 :I 20 :I 23 Patient I: I 74 :I 35 :I 39 Patient J: I 59 :I 23 :I 36 Average change in ODI three months post-op 26.4 points on a 100 point scale
  
  
• Denominator: Eligible Population: Patients with lumbar discectomy laminotomy procedure (Single Disc-Lami Value Set) for a diagnosis of disc herniation (Disc Herniation Value Set)) occurring during a 12 month period for patients age 18 and older at the start of that period. Denominator: Patients within the eligible population whose functional status was measured by the Oswestry Disability Index, version 2.1a (ODI, v2.1a) within three months preoperatively AND at three months (6 to 20 weeks) postoperatively. * The measure of average change in function can only be calculated if both a pre-operative and post-operative PRO assessment are completed
  
  
• Exclusions: The following exclusions must be applied to the eligible population: 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: Administrative clinical data, EHR, Paper medical record, Registry
  
  
• Measure Type: Patient Reported Outcome
  
  
• Steward: MN Community Measurement
  
  
• Endorsement Status: Never Submitted
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional Support for Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure is fully developed and tested. This measure should be submitted to NQF for review and endorsement.
  • Impact on quality of care for patients:This is a patient reported outcome measure that encourages clinicians to improve care management for patients undergoing lumbar discectomy laminotomy surgery.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure addresses the MIPS domain of person and caregiver-centered experience and outcomes.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is a patient reported outcome measure that addresses average change in functional status following lumbar discectomy laminotomy surgery. The measure adheres to clinical guidelines issues by the North American Spine Surgery.
  
  
• Does the measure address a quality challenge? Yes. This is a patient reported outcome measure that focuses on the Average change in functional status from pre-operative to three months post-operative as measured by the Oswestry Disability Index (100 point scale). Evidence provided indicates on average, patients improved by 22.7 points, with variation demonstrated among practices.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. There are similar measures for MIPS PY 2018, QPP #459: Average Change in Back Pain following Lumbar Discectomy/Laminotomy; and QPP#461: Average Change in Leg Pain following Lumbar Discectomy/Laminotomy. QPP#459 and 461 addresses back pain and leg pain whereas this MUC 170 addresses functional status. The steward is the same for MUC 170 and QPP#459 and 461.
  
  
• Can the measure can be feasibly reported? Yes. This measure is fully specified, and data are captured during the course of care. Data sources for the measure include administrative clinical data, EHR, and paper medical records.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? No. This is a new measure that has not been submitted for NQF endorsement, nor been previously submitted on the MUC list. The measure was tested at the group level.
  
  
• Measure development status: Fully Developed
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? Yes. Measure has been implemented in the Minnesota Department of Health’s Statewide Quality Reporting and Measurement System (SQRMS), using data submitted by all eligible providers. No implementation issues have been identified.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted
  
  

Rationale for measure provided by HHS
Patient Reported Outcome Measures and Integration Into Electronic Health Records Pitzen, C. et al, Journal of Oncology Practice DOI: 10.1200/JOP.2016.014118; published online ahead of print at jop.ascopubs.org on July 26, 2016.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of female patients aged 50 to 64 without select risk factors for osteoporotic fracture who received an order for a dual-energy x-ray absorptiometry (DXA) scan during the measurement period.
  
  
• Numerator: Female patients who received an order for at least one DXA scan in the measurement period
  
  
• Denominator: Female patients ages 50 to 64 years with an encounter during the measurement period
  
  
• Exclusions: Exclude from the denominator patients with a combination of risk factors (as determined by age) or one of the independent risk factors: - Ages: 50-54 (>=4 combo risk factors) or 1 independent risk factor - Ages: 55-59 (>=3 combo risk factors) or 1 independent risk factor - Ages: 60-64 (>=2 combo risk factors) or 1 independent risk factor Combination risk factors (The following risk factors are all combination risk factors; they are grouped by when they occur in relation to the measurement period): The following risk factors may occur any time in the patient's history but must be active during the measurement period: - White (race) - BMI <= 20 kg/m2 (must be the first BMI of the measurement period) - Smoker (current during the measurement period) - Alcohol consumption (> two units per day (one unit is 12 oz. of beer, 4 oz. of wine, or 1 oz. of liquor)) The following risk factor may occur any time in the patient's history and must not start during the measurement period: - Osteopenia The following risk factors may occur at any time in the patient's history or during the measurement period: - Rheumatoid arthritis - Hyperthyroidism - Malabsorption syndromes: celiac disease, inflammatory bowel disease, ulcerative colitis, Crohn's disease, cystic fibrosis, malabsorption - Chronic liver disease - Chronic malnutrition The following risk factors may occur any time in the patient's history and do not need to be active at the start of the measurement period: - Documentation of history of hip fracture in parent - Osteoporotic fracture - Glucocorticoids (>= 5 mg/per day) [cumulative medication duration >= 90 days] Independent risk factors (The following risk factors are all independent risk factors; they are grouped by when they occur in relation to the measurement period): The following risk factors may occur at any time in the patient's history and must not start during the measurement period: - Osteoporosis The following risk factors may occur at any time in the patient's history prior to the start of the measurement period, but do not need to be active during the measurement period: - Gastric bypass - FRAX[R] 10-year probability of all major osteoporosis related fracture >= 9.3 percent - Aromatase inhibitors The following risk factors may occur at any time in the patient's history or during the measurement period: - Type I diabetes - End stage renal disease - Osteogenesis imperfecta - Ankylosing spondylitis - Psoriatic arthritis - Ehlers-Danlos syndrome - Cushings syndrome - Hyperparathyroidism - Marfan's syndrome - Lupus
  
  
• HHS NQS Priority: Making Care Affordable
  
  
• HHS Data Source: EHR (enter relevant parts in the field below)
  
  
• Measure Type: Process/Overuse
  
  
• Steward: Centers for Medicare & Medicaid Services
  
  
• Endorsement Status: Never Submitted
  
  
• Is the measure specified as an electronic clinical quality measure? Yes
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional Support for Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:Currently MIPS does not have a measure that addresses appropriate use of DXA scans. This measure should be submitted to NQF for review and endorsement. This newly developed eCQM measure faces feasibility issues. Some EHRs do not capture the necessary data element in discrete fields. NQF also recommends condition of ensuring that implementation is feasible across EHRs and NQF endorsement.
  • Impact on quality of care for patients:This measure encourages clinicians to reduce the inappropriate use DXA scans on women that do not meet the risk factor profile for osteoporotic fracture.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure addresses the MIPS domain of efficiency and cost reduction.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This process measure identifies instances in which a DXA scan is provided against evidence-based practice for Osteoporotic Fracture patients. This measure is based on the USPTF Recommendations for osteoporosis screening.
  
  
• Does the measure address a quality challenge? Yes. This is an appropriate use measure that addresses over-use of DXA scans. Current osteoporosis guidelines recommend screening postmenopausal women younger than 65 for osteoporosis only if they meet a risk-factor profile. Measure testing found that eligible professionals in the highest quartile of the distribution had performance scores between 6 and 24 percent, indicating potential for improvement.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. This measure is complementary to an existing measure NQF 0046: Screening or Therapy for Osteoporosis for Women Aged 65 Years and Older, which assesses use of DXA scans to identify osteoporosis in women ages 65 and older based on current clinical guidelines. Currently MIPS has several measures that address screening for osteoporosis. There are no measures that address the appropriate use and overuse of DXA screenings. The proposed overuse measure will serve as a counterbalance to the existing measure of appropriate use. This is an inverse measure.
  
  
• Can the measure can be feasibly reported? Yes. This process eCQM uses data from EHRs. The measure has been tested for feasibility by four EHR vendors. Since the measure uses EHR data, it is technically feasible, but two of the data elements relevant to exclusions were not available at two EHR sites. Additionally, when testing with physicians, the results of risk-assessment criteria may not be stored in discrete fields.
  
  
• 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 testing has demonstrated reliability and validity for the clinician level of analysis. The measure has not been submitted to NQF for endorsement.
  
  
• Measure development status: Fully Developed
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? N/A. This measure has not yet been implemented. The developer identified no unintended consequences.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted
  
  

Rationale for measure provided by HHS
Current osteoporosis guidelines recommend screening postmenopausal women younger than 65 for osteoporosis only if they meet a risk-factor profile. The risks for those under 65 that merit osteoporosis screening include, but are not limited to, previous osteoporotic fracture, osteoporosis, rheumatoid arthritis and other conditions associated with secondary osteoporosis, parental history of fractures, BMI less than 21 kg/m2, long-term use of glucocorticoids, current smoking, or excessive alcohol intake (USPSTF 2011). Although there is evidence to support the cost-effectiveness of DXA screening in women older than 65, there is not enough evidence to support screening women younger than 65 who do not meet a risk-factor profile (Lim et al. 2009). This measure is expected to increase recording of patient risks for fractures and decrease the number of inappropriate DXA scans. References Lim, L.S., L.J. Hoeksema, and K. Sherin. “Screening for Osteoporosis in the Adult U.S. Population: ACPM Position Statement on Preventive Practice.” American Journal of Preventive Medicine, vol. 36, no. 4, 2009, pp. 366-375. USPSTF. “Screening for Osteoporosis: U.S. Preventive Services Task Force Recommendation Statement.” Annals of Internal Medicine, vol. 154, no. 5, 2011, pp. 356-364.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: For patients age 18 and older undergoing lumbar spine fusion surgery, the average change from pre-operative leg pain to one year (nine to fifteen months) post-operative leg pain using the Visual Analog Scale (VAS) patient reported outcome tool.
  
  
• Numerator: The average change (preoperative to one year post-operative) in leg pain for all patients in the denominator. There is not a traditional numerator for this measure; the measure is calculating the average change in leg pain score from pre-operative to post-operative leg pain score. The measure is NOT aiming for a numerator target value for a post-operative pain score. The average change is calculated as follows: Change is first calculated for each patient and then changed scores are summed and then an average is determined. Measure calculation takes into account those patients that have an improvement and those patients whose pain increases post-operatively. Example below: Patient I: Pre-op VAS I: Post-op VAS I:(Pre-op minus Post-op) Patient A: I: 8.5 I: 3.5 I: 5.0 Patient B: I: 9.0 I: 2.5 I: 6.5 Patient C: I: 7.0 I: 0.5 I: 6.5 Patient D: I: 6.5 I: 8.0 I: -1.5 Patient E I: 8.5 I: 2.0 I: 6.5 Patient F I: 7.5 I: 1.5 I: 6.0 Patient G I: 9.0 I: 4.5 I: 4.5 Patient H I: 5.5 I: 7.5 I: -2.0 Patient I I: 9.0 I: 5.0 I: 4.0 Patient J I: 7.0 I: 2.5 I: 4.5 Average change in VAS points 4.0 Average change in leg pain one year post-op 4.0 points on a 10 point scale
  
  
• Denominator: Eligible Population: Patients with lumbar spine fusion procedures (Arthrodesis Value Set) occurring during a 12 month period for patients age 18 and older at the start of that period. Denominator: Patients within the eligible population whose leg pain was measured by the Visual Analog Scale (VAS) within three months preoperatively AND at one year (+/- 3 months) postoperatively. * The measure of average change in function can only be calculated if both a pre-operative and post-operative PRO assessment are completed
  
  
• Exclusions: The following exclusions must be applied to the eligible population: Patient had cancer (Spine Cancer Value Set), fracture (Spine Fracture Value Set) or infection (Spine Infection Value Set) related to the spine. Patient had idiopathic or congenital scoliosis (Congenital Scoliosis Value Set)
  
  
• HHS NQS Priority: Patient and Family Engagement
  
  
• HHS Data Source: Administrative clinical data, EHR, Paper medical record, Registry
  
  
• Measure Type: Patient Reported Outcome
  
  
• Steward: MN Community Measurement
  
  
• Endorsement Status: Never Submitted
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional Support for Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure is fully developed and tested. This measure should be submitted to NQF for review and endorsement. There is a similar measure for MIPS PY 2018: QPP #461: Average Change in Leg Pain following Lumbar Discectomy/Laminotomy. NQF recommends condition that there are not duplicate or competing measures in the program.
  • Impact on quality of care for patients:This measure encourages clinicians to improve care management for patients with lumbar spine fusion surgery.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure addresses the MIPS domain of person and caregiver-centered experience and outcomes.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is a patient reported outcome measure that addresses average change in leg pain following lumbar spine fusion surgery. The measure adheres to clinical guidelines issued by the North American Spine Surgery.
  
  
• Does the measure address a quality challenge? Yes. This is a patient reported outcome measure that focuses the average change from pre-operative leg pain to one year (nine to fifteen months) post-operative leg pain using the Visual Analog Scale (VAS) patient reported outcome tool. Evidence provided indicates on average, patients improved by 4.3 points, with variation demonstrated among practices.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. There are similar measures for MIPS PY 2018, QPP #460: Average Change in Back Pain following Lumbar Fusion; and QPP #461: Average Change in Leg Pain following Lumbar Discectomy/Laminotomy. QPP#460 is similar/related but not competing as it has different measure focus (average change in back pain) but same target population (population with lumbar fusion). QPP#461 has same measure focus (average change in leg pain) as MUC-177, but different target population (population with lumbar discectomy/laminotomy).
  
  
• Can the measure can be feasibly reported? Yes. This measure is fully specified, and data are captured during the course of care. Data sources for the measure include administrative clinical data, EHR, and paper medical records.
  
  
• Measure development status: Fully Developed
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? Yes. Measure has been implemented in the Minnesota Department of Health’s Statewide Quality Reporting and Measurement System (SQRMS), using data submitted by all eligible providers. No implementation issues have been identified.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted
  
  

Rationale for measure provided by HHS
Patient Reported Outcome Measures and Integration Into Electronic Health Records Pitzen, C. et al, Journal of Oncology Practice DOI: 10.1200/JOP.2016.014118; published online ahead of print at jop.ascopubs.org on July 26, 2016.

Measure Specifications

• NQF Number (if applicable): 729
  
  
• Description: The percentage of patients 18-75 years of age who had a diagnosis of type 1 or type 2 diabetes and whose diabetes was optimally managed during the measurement period as defined by achieving ALL of the following: - HbA1c less than 8.0 mg/dL - Blood Pressure less than 140/90 mmHg - On a statin medication, unless allowed contraindications or exceptions are present - Non-tobacco user - Patient with ischemic vascular disease is on daily aspirin or anti-platelets, unless allowed contraindications or exceptions are present
  
  
• Numerator: The number of patients in the denominator whose diabetes was optimally managed during the measurement period as defined by achieving ALL of the following: - The most recent HbA1c in the measurement period has a value less than 8.0 mg/dL - The most recent Blood Pressure in the measurement period has a systolic value of less than 140 mmHg AND a diastolic value of less than 90 mmHg - On a statin medication, unless allowed contraindications or exceptions are present - Patient is not a tobacco user - Patient with ischemic vascular disease (Ischemic Vascular Disease Value Set) is on daily aspirin or anti-platelets, unless allowed contraindications or exceptions are present
  
  
• Denominator: 18 years or older at the start of the measurement period AND less than 76 years at the end of the measurement period AND Patient had a diagnosis of diabetes (Diabetes Value Set) with any contact during the current or prior measurement period OR had diabetes (Diabetes Value Set) present on an active problem list at any time during the measurement period. AND At least one established patient office visit (Established Pt Diabetes & Vasc Value Set) for any reason during the measurement period
  
  
• Exclusions: The following exclusions are allowed to be applied to the eligible population: - Patient was a permanent nursing home resident at any time during the measurement period - Patient was in hospice or receiving palliative care at any time during the measurement period - Patient died prior to the end of the measurement period - Patient was pregnant (Diabetes with Pregnancy Value Set) at any time during measurement period - Documentation that diagnosis was coded in error - Patient had only urgent care visits during the measurement period
  
  
• HHS NQS Priority: Effective Prevention and Treatment
  
  
• HHS Data Source: Administrative clinical data, EHR, Paper medical record, Claims, Registry
  
  
• Measure Type: Composite
  
  
• Steward: MN Community Measurement
  
  
• Endorsement Status: Endorsed - This measure was endorsed in 2015 as a component of composite measure NQF #0729
  
  
• 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: Conditional Support for Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This is a composite measure. There is also the individual component (i.e. HbA1C value) which is reviewed separately for consideration on this year’s MUC list for MIPS as MUC17-215. The composite measure is fully developed, tested, and NQF endorsed. There is not duplicative measure in MIPS; however, there are related measures to both A1c control (QPP#001) and statin use (QPP#438). NQF recommends condition that there are not duplicate or competing measures in the program.
  • Impact on quality of care for patients:This measure encourages clinicians to improve care management for patients with diabetes, and ultimately improve health outcomes for patients with diabetes
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. This measure addresses the MIPS effective clinical care.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is a composite measure that addresses optimal management of diabetes, including processes and outcomes. Specifically, the measure addresses the following components. The most recent HbA1c in the measurement period has a value less than 8.0 mg/dL. The most recent Blood Pressure in the measurement period has a systolic value of less than 140 mmHg AND a diastolic value of less than 90 mmHgOn a statin medication, unless allowed contraindications or exceptions are present: Patient is not a tobacco user, Patient with ischemic vascular disease (Ischemic Vascular Disease Value Set) is on daily aspirin or anti-platelets, unless allowed contraindications or exceptions are present. The measure adheres to clinical guidelines issued by the American Heart Association, American College of Cardiology, and American society of Hypertension, and Institute for Clinical Systems Improvement.
  
  
• Does the measure address a quality challenge? Yes. This measure addresses unwarrented variation in care. An analysis of 94 medical groups found that of the percentage of diabetic patients age 18 to 75 who achieved all five targets identified in the measure averaged 45%, and ranged from 9% to 77%.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. There are related measures to both A1c control (QPP#001) and statin use (QPP#438)
  
  
• Can the measure can be feasibly reported? Yes. This measure is fully specified, and data is captured during the course of care. Data sources for the measure include administrative clinical data, EHR, and paper medical records. During the 2015 NQF endorsement review, the developers did acknowledge the data collection burden for the new statin component if a patient has not been prescribed a statin (i.e., identifying exceptions due to contraindications).
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. This measure was endorsed in 2015 as NQF #0729. A previous version of the measure was reviewed by the MAP in 2012, 2013, and 2014 and was recommended by MAP all 3 years. It has undergone substantive change related to the cholesterol management component in 2015, therefore is submitted as a new measure. The measure was tested at the group level.
  
  
• Measure development status: Fully Developed
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? No . Measure has been implemented in the Minnesota Department of Health’s Statewide Quality Reporting and Measurement System (SQRMS), using data submitted by all eligible providers. No implementation issues have been identified.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Endorsed - This measure was endorsed in 2015 as a component of composite measure NQF #0729
  
  
• Does the measure address a high-priority quality issue in the dual eligible beneficiary population? Yes; Compared to other Medicare beneficiaries, dual eligibles are much more likely to be diagnosed with diabetes..
  
  
• Preliminary analysis of the MAP Medicaid-relevant measure: Support measurement of managing chronic illness. There are 5 DM measures in the 2017 Adult Core Set..
  
  

Rationale for measure provided by HHS
Addressing Health Care Disparities Using Public Reporting Snowden, A. et al American Journal of Medical Quality August 2012 27 (4): 275-81

Summary of NQF Endorsement Review

• Year of Most Recent Endorsement Review: 2015
  
  
• Project for Most Recent Endorsement Review: Endocrine
  
  
• Review for Importance: 1a. Evidence, 1b. Performance Gap) 1a. Evidence: H-5; M-11; L-0; I-1; 1b. Performance Gap: H-15; 1d. Composite – Quality Construct and Rationale: H-4; M-7; L-4; I-1 Rationale: • For all but one of the components included in this composite (tobacco-free), the developer presented recommendations from the 2014 clinical practice guidelines developed by the Institute for Clinical Systems Improvement (ICSI), which were based on a systematic review of evidence that was graded either high or moderate. Additional evidence-based recommendations from the American College of Cardiology and U.S. Preventive Services Task Force also were presented. Committee members agreed that the evidence supports the relationship between each component and desired health outcomes. • Data provided by the developer indicate that for 2014, only 38.9% of diabetic patients in Minnesota met all five component targets from the composite measure. Committee members agreed that although performance on some of the components is quite high, overall performance indicates opportunity for improvement. • Although some Committee members voiced concern over the “all-or-none” structure of the measure, others agreed that a more comprehensive measure that focuses on management of multiple risk factors is needed. The Committee agreed that the developer description of the quality construct, rationale, and aggregation and weighting approach is explicitly articulated and logical.
  
  
• Review for Scientific Acceptability: 2. Scientific Acceptability of Measure Properties: The measure meets the Scientific Acceptability criteria (2a. Reliability - precise specifications, testing; 2b. Validity - testing, threats to validity) 2a. Reliability: H-9; M-7; L-0; I-0; 2b. Validity: H-1; M-10; L-4; I-1; 2d. Composite: H-1; M-10; L-4; I-1 Rationale: • Committee members noted that the specifications of the statin component of this measure have changed since the most recent endorsement of the measure due to changes in the ACC/AHA clinical practice guidelines on cholesterol management released in November, 2013. In the earlier version of the measure, the statin component assessed reaching a target LDL threshold of < 100 mg/dL; the revised version of this component assesses statin use. • Committee members questioned whether the measure assesses if a patient is on the appropriate statin dose. Developers clarified that the measure does not consider the statin dose but assesses only whether a patient is on a statin. • Members also questioned the age range of 18-75 for the statin component of the measure. The developer clarified that for patients 21-39 years of age, this component is applicable only if the patient has ischemic vascular disease or a very high LDL level, in accordance with the ACC/AHA guidelines. • The developer clarified that the level of analysis for the measure is clinician groups (not individual clinicians), and also noted that multiple clinics may form a clinician group. They also clarified that the measure does not require having a minimum of 30 patients. • Developers presented results of signal-to-noise reliability testing of the performance measure score. They clarified that the beta-binomial method was used for the reliability testing because the composite score itself is a binary (yes/no) measure. Members noted that although the 12 reliability was quite high for most clinician groups, it was lower than 0.7 for some clinician groups. • To demonstrate validity of the performance measure score, developers examined the association between the scores for this measure with the scores from the Optimal Vascular Care measure (NQF #0076), hypothesizing that clinician groups likely provide similar quality of care to different patients who also require management of multiple risk factors. The R2 value from this analysis was 0.64. The developers also described several steps occurring during the data submission process as demonstration of empirical validity testing at the data level element. • Developers also clarified that the measure is risk-adjusted for three factors (insurance type, age group, and diabetes type) and noted that the risk-adjustment strategy was developed using data from all clinicians in Minnesota. However, one member expressed some concern that the only adjustment for sociodemograhic status is insurance type. Developers clarified that other potential risk factors that were considered were not statistically significant and thus were not included in the risk-adjustment model. • Several Committee members voiced concern about holding physicians accountable for the patient’s tobacco use, as some see actual tobacco use (as opposed to efforts for tobacco cessation) as out of the control of the clinician. However, another member referred to data showing that physicians can influence their patients to stop tobacco use. Developers also noted that statewide, they have seen an approximate 2.5% increase in tobacco-free patients in Minnesota. • One Committee member noted the need for clarity about potential adverse effects related to statin use. Another member referenced the flow diagram provided by the developer that details several contraindications for statin use, while another member echoed the importance of the potential for adverse reactions when making treatment decisions. • After developers clarified the performance rates for each of the components, Committee members questioned whether the aspirin component (performance rate =99.5% in MN) is needed in the composite. Developers noted that while this component may be "topped out" in MN, this happened over a four-year period of focus on this component. They also referenced a New England Journal of Medicine article that found a 34.8% performance rate nationally in the primary care setting. Finally, they noted that performance on this component across ACOs is, on average, 75.3%.
  
  
• Review for Feasibility: 3. Feasibility: H-7; M-4; 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 measure data can be collected through electronic clinical data and paper records. • One Committee member noted that, due to the number of components included in the composite, the data collection effort for this composite measure may be intensive. Developers stated that submission of this measure by all clinician groups in MN is mandated by the state. While they acknowledged that MN has many large practices that use EHRs, small practices— even those who still use paper medical records—are able to submit data on this measure. The developers did, however, acknowledge the data collection burden for the new statin component if a patient has not been prescribed a statin (i.e., identifying exceptions due to contraindications).
  
  
• Review for Usability: 4. Usability and Use: H-5; M-7; L-4; 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: • Committee members noted that the measure is publicly reported and is used in pay-forperformance and accreditation programs. Performance is slowly increasing across the state of Minnesota, suggesting quality of care may be improving. • Data submitted by the developer demonstrate relatively consistent improvement of performance in MN from the years 2006-2014. • Committee members agreed that this composite measure is patient-centric and acknowledged the importance of using a comprehensive measure that assesses performance of reducing multiple risk factors. • Some Committee members expressed concern that the measure could incent some providers to "cherry-pick" patients or make their practices less hospitable to certain patients or certain subgroups of patients (the tobacco-free component of the measure was a particular concern).
  
  
• Review for Related and Competing Measures: 5. Related and Competing Measures • This measure is a competing measure to the following measures o 0061: Comprehensive Diabetes Care: Blood Pressure Control (< 7% to < 8% depending on individual patient factors. o 0575: Comprehensive Diabetes Care: Hemoglobin A1c (HbA1c) control (<8%) • NQF staff asked the Committee to discuss whether there is justification for continued endorsement of the individual measures if the composite retains endorsement. The Committee discussed the pros and cons of endorsing both individual measures and the composite measure. The Committee ultimately agreed that while the composite measure is useful to assess patientcentric performance across a variety of clinical areas, endorsement of individual measures also can be beneficial, particularly for users who want to focus on certain components of the composite or those who have data collection constraints and cannot use the composite. The Committee therefore recommended continued endorsement of both the individual measures and the composite measure.
  
  
• Endorsement Public Comments: 6. Public and Member Comment Comments received: • Two commenters raised concern over the glucose control component of the composite, referencing the National Action Plan for Adverse Event Prevention, which was released in August, 2014. The National Action Plan states that the blood glucose threshold of < 7% to < 8% depending on individual patient factors. Benefits: Achieving near-normal glycemic control lowers risk of diabetes microvascular complications such as retinopathy, nephropathy and amputations. Achieving A1c of 6.9 to 7.9% may also significantly reduce macrovascular complications based on Steno-2 and UKPDS data. Quality of Evidence: High Strength of Recommendation: Strong. Measurement does not and should not preclude good clinical judgement; however the measure development work group believes that a target of < 8.0 is reasonable and supported by guidelines. Our measure does have an upper age limit cut-off of 75 years and we allow exclusions for death, permanent nursing home resident or patients who are receiving hospice or palliative care services. • Two commenters were critical of the composite measure itself, citing concern that use of the composite measure could mask the individual care processes that most need improvement. Developer response: While it is true that the measure is reported at the composite level, the individual components and the associated rates are available to the medical groups for better understanding their rates and for use in quality improvement to know which areas have opportunity for improvement. MNCM and the measure development work group firmly believe that achieving the intermediate physiological outcome targets related to blood pressure and glycemic control in addition being tobacco free and use of daily aspirin and statins where appropriate are the diabetic patient’s best mechanisms of avoiding or postponing long term complications associated with this chronic condition which affects millions of Americans. Measuring providers separately on individual targets is not as patient centric as a measure that seeks to reduce multiple risk factors for each patient. Diabetic patients are more likely to reduce their overall risk and maximize health outcomes by achieving several intermediate physiological targets. • Two commenters noted that documenting HbA1c levels >8% but less than 9% cannot be done using CPT-II coding, necessitating need for medical chart review. Developer response: A point of clarification, these measure do not rely on CPTII codes for numerator compliance, nor are they indicated anywhere in our measure specification. Measure specifications focus on the electronic health record as a source of clinical information for calculating numerator compliance; actual A1c values are utilized in the case of the A1c target. Additionally, 80 to 90% of all the clinics in MN are reporting this information from their electronic health records without the need for additional chart abstraction. • One commenter suggested a need for including sociodemographic factors in the risk-adjustment approach. Developer response: Our risk adjustment model does include insurance product, which is a proxy for socioeconomic status. During the process of measure development, the expert panel discusses potential variables for risk adjustment that are important to consider for the measured population. For this measure, variables that are available for evaluation include gender, age, zip, race/ethnicity, country of origin, primary language, insurance product, diabetes type, depression and ischemic vascular disease. The potential risk adjustment variables are then evaluated for appropriate inclusion in the model based on a t value outside the range of -2.0 and +2.0. Currently, the variables that have demonstrated acceptable properties are insurance product, age bands (18-25, 26-50, 51-65 and 65 to 75) and diabetes type (1 or 2). Race/ethnicity has been collected for this measure in MN for the past few years, but has now reached a level of 15 reliability in which it can be evaluated for its impact. MNCM continues to review variables and their impact on the measure and part of its measure risk adjustment strategy. • One commenter suggested the need for additional detail regarding moderate or high intensity in the description of statin use for the measure. Developer response: The measure development work group thoroughly discussed the pros and cons of specifying a certain dose of the statin medication and based on the following factors ultimately decided to not specify a dose of moderate or high intensity for numerator compliance: 1) data burden for practices, 2) controversy and burden surrounding the CV risk calculator, 3) ICSI 2014 Diabetes Guideline recommendations for measurement and 4) cardiology work group member’s believe that there is some benefit for some patients who can only tolerate a lower intensity dose. Committee response: • During its review of the individual measure assessing HbA1c
  
  
• Endorsement Committee Recommendation: Standing Committee Recommendation for Endorsement: Y-13; N-4
  
  

Measure Specifications

• NQF Number (if applicable): 76
  
  
• Description: The percentage of patients 18-75 years of age who had a diagnosis of ischemic vascular disease (IVD) and whose IVD was optimally managed during the measurement period as defined by achieving ALL of the following: - Blood Pressure less than 140/90 mmHg - On a statin medication, unless allowed contraindications or exceptions are present - Non-tobacco user - On daily aspirin or anti-platelets, unless allowed contraindications or exceptions are present The number of patients in the denominator whose IVD was optimally managed during the measurement period as defined by achieving ALL of the following: - The most recent Blood Pressure in the measurement period has a systolic value of less than 140 mmHg AND a diastolic value of less than 90 mmHg - On a statin medication, unless allowed contraindications or exceptions are present - Patient is not a tobacco user - On daily aspirin or anti-platelets, unless allowed contraindications or exceptions are present
  
  
• Numerator: The number of patients in the denominator whose IVD was optimally managed during the measurement period as defined by achieving ALL of the following: - The most recent Blood Pressure in the measurement period has a systolic value of less than 140 mmHg AND a diastolic value of less than 90 mmHg - On a statin medication, unless allowed contraindications or exceptions are present - Patient is not a tobacco user - On daily aspirin or anti-platelets, unless allowed contraindications or exceptions are present
  
  
• Denominator: 18 years or older at the start of the measurement period AND less than 76 years at the end of the measurement period AND Patient had a diagnosis of ischemic vascular disease (Ischemic Vascular Disease Value Set) with any contact during the current or prior measurement period OR had ischemic vascular disease (Ischemic Vascular Disease Value Set) present on an active problem list at any time during the measurement period. AND At least one established patient office visit (Established Pt Diabetes & Vasc Value Set) for any reason during the measurement period
  
  
• Exclusions: The following exclusions are allowed to be applied to the eligible population: - Patient was a permanent nursing home resident at any time during the measurement period - Patient was in hospice or receiving palliative care at any time during the measurement period - Patient died prior to the end of the measurement period - Documentation that diagnosis was coded in error - Patient had only urgent care visits during the measurement period
  
  
• HHS NQS Priority: Effective Prevention and Treatment
  
  
• HHS Data Source: Administrative clinical data, EHR, Paper medical record, Claims, Registry
  
  
• Measure Type: Composite
  
  
• Steward: MN Community Measurement
  
  
• Endorsement Status: Endorsed
  
  
• 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: Conditional Support for Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This is a composite measure. There is also the individual component (i.e. use of aspirin or anti-platelet medication) which is reviewed separately for consideration on this year’s MUC list for MIPS as MUC17-234. The composite measure is fully developed, tested, and NQF endorsed. There is one competing measure in QPP #441 (by WCHQ) for ischemic vascular disease patients that combine multiple intermediate outcomes and medication adherence into a patient centric all-or-none measure. NQF recommends condition that there are not duplicate or competing measures in the program.
  • Impact on quality of care for patients:This measure encourages clinicans to improve care management for patients with ischemic vascular disease, and ultimately improve health outcomes for patients with ischemic vascular disease.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. This measure addresses the MIPS domain of effective clinical care.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is a composite measure that addresses optimal management of vascular care, including processes and outcomes. Specifically, the measure addresses the following components. Blood Pressure less than 140/90 mmHgOn a statin medication, unless allowed contraindications or exceptions are presentNon-tobacco userOn daily aspirin or anti-platelets, unless allowed contraindications or exceptions are presentThe measure went through substantial change related to the cholesterol management component in 2015. The measure went through substantial change related to the cholesterol management component in 2015. The measure adheres to clinical guidelines issued by the American Heart Association, American College of Cardiology, and and American Society of Hypertension Treatment of Hypertension in Patients with Coronary Artery Disease.
  
  
• Does the measure address a quality challenge? Yes. This measure addresses unwarrented variation in care. An analysis of 84 medical groups found that of the percentage of ischemic vascular disease patients age 18 to 75 who achieved all four targets identified in the measure averaged 62%, and ranged from 24% to 76%.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. There is one competing measure in QPP #441 (by WCHQ) for ischemic vascular disease patients that combine multiple intermediate outcomes and medication adherence into a patient centric all-or-none measure. When WCHQ sought NQF endorsement of their version, it was identified as a competing measure with MNCM’s NQF# 0076 and WCHQ withdrew their submission for endorsement. MNCM is proposing replacing QPP #441, an almost identical version of our measure, with MNCM’s NQF endorsed measure.
  
  
• Can the measure can be feasibly reported? Yes. This measure is fully specified, and data is captured during the course of care. Data sources for the measure include administrative clinical data, EHR, and paper medical records.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. Recent re-endorsement in 2016 included the cholesterol component redesign.The measure has been reviewed by the MAP in 2014 and 2015 and was supported or conditionally supported both years. It is being re-submitted as a new measure to MAP due to the substantial changes to the measure. The measure was tested at the group level.
  
  
• Measure development status: Fully Developed
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? No . Competing measure is currently in use in the MIPS program. Measure has also been implemented in the Minnesota Department of Health’s Statewide Quality Reporting and Measurement System (SQRMS), using data submitted by all eligible providers. No implementation issues have been identified.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Endorsed
  
  
• Does the measure address a high-priority quality issue in the dual eligible beneficiary population? Yes; Compared to other Medicare beneficiaries, dual eligibles are much more likely to be diagnosed with heart disease..
  
  
• Preliminary analysis of the MAP Medicaid-relevant measure: Support measurement of managing chronic illness. .
  
  

Rationale for measure provided by HHS
Risk Factor Optimization and Guideline-Directed Medical Therapy in US Veterans With Peripheral Arterial and Ischemic Cerebrovascular Disease Compared to Veterans With Coronary Heart Disease. Hira RS et al Am J Cardiol. 2016 Oct 15;118(8):1144-1149. doi: 10.1016/j.amjcard.2016.07.027. Epub 2016 Jul 29.

Summary of NQF Endorsement Review

• Year of Most Recent Endorsement Review: 2017
  
  
• Project for Most Recent Endorsement Review: Cardiovascular 2016-2017
  
  
• Review for Importance: 1. Importance to Measure and Report: The measure meets the Importance criteria (1a. Evidence, 1b. Performance Gap, 1c. Composite) 1a. Evidence: H-14; M-6; L-1; I-1; 1b. Performance Gap: H-14; M-7; L-1; I-0; Composite: H-12; M-8; L-1; I- 1 Rationale: • For the 2012 maintenance of endorsement evaluation, the developer provided the following clinical practice guidelines to support the blood pressure, statin medication, tobacco free (outcome measure), and daily aspirin or anti-platelet medication components: o Blood pressure, statin medication, tobacco free, and daily aspirin or anti-platelet medication components: The ICSI Stable Coronary Artery Disease (April 2011), Address Modifiable Risk Factors guideline recommended modifiable risk factors for coronary artery disease such as smoking, inadequate physical activity, stress, hyperlipidemia, obesity, hypertension and diabetes mellitus be evaluated. 21 o Blood pressure: The Comorbid Conditions Guideline and the ICSI Hypertension Diagnosis and Treatment Guideline (November 2010) recommended a target blood pressure of 140/90 mmHg or less. o Statin medication: The ICSI Lipid Management in Adults (October 2009) guideline recommended target goals for hyperlipidemic patients with coronary artery disease: LDL – less than 100 mg/dL; HDL – 40 mg/dL or greater; Triglycerides – less than 150 mg/dL. o Daily aspirin or anti-platelet medication: The ICSI Stable Coronary Artery Disease (April 2011), Address Modifiable Risk Factors guideline recommended the use of one aspirin tablet daily (81-162 mg) unless there are medical contraindications. • For the current maintenance of endorsement evaluation, the developer provided the following updated evidence for all four components: o Blood pressure: The 2015 AHA/ACC/ASH Scientific Statement on the Treatment of Hypertension in Patients with Coronary Artery Disease included 3 recommendations for blood pressure targets, including a blood pressure goal of 65 and Medicare. •o Statin medication: The ICSI Lipid Management in Adults (updated Nov 2013/completed prior to ACC/AHA release) recommends that clinicians initiate statin therapy regardless of LDL in patients with established atherosclerotic cardiovascular disease (ASVCD). The 2013 ACC/AHA Guideline for the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults recommends high-intensity statin therapy be initiated or continued as first-line therapy in women and meno Tobacco free outcome measure: The developer provided evidence from the United States Preventive Services Task Force (USPSTF) stating that despite considerable progress in tobacco control over the past 50 years, in 2013, an estimated 17.8% of U.S. adults and 15.9% of pregnant women aged 15 to 44 years were current cigarette smokers. o Daily aspirin or anti-platelet medication: The developer provided three recommendations for antiplatelet agents/anticoagulants for patients with ischemic vascular disease from the AHA/ACCF Secondary Prevention and Risk Reduction Therapy for Patients with Coronary and Other Atherosclerotic Vascular Disease: 2011 Update. • The Standing Committee discussed the potential changes to blood pressure parameters based on the results of the Systolic Blood Pressure Intervention Trial (SPRINT), which compared the benefit of treatment of systolic blood pressure to a target of less than 120 mm Hg with treatment to a target of less than 140 mm Hg. The Committee also discussed the anticipated blood pressure guidelines to be released by AHA/ACC sometime in the future. NQF staff asked the Committee to consider the quantity, quality, and consistency of the body of evidence that was presented in the measure submission form. NQF staff reassured the Committee that the NQF process allows for a measure to be reviewed when new evidence becomes available. One of the Committee members noted that the USPSTF recommendations for daily aspirin include patients aged 50 to 70 years old, while the measure includes patients up to 75 years old. Other Committee members noted that the USPSTF recommendations are for primary prevention rather than patients with a diagnosis of ischemic vascular disease (IVD). Overall, the Standing Committee agreed that the updated evidence supports blood pressure control, statin use, daily aspirin or anti-platelet medication, and tobacco use assessment and 22 intervention(s) in patients to avoid or postpone long-term complications associated with a diagnosis with IVD. The developer provided composite performance rates from clinics in Minnesota for Report Year 2007-2016 (Dates of Service 2006-2015). o In 2007, the rate was 38.9% for 4,662 patients and 33.8% in 2010 for 63,241 patients. In 2011, the blood pressure component target changed from, and the performance rate increase to 39.7% for 66,910 patients. o In 2015, the cholesterol management component was suppressed during redesign of the measure and the performance rate increased to 69.3% for 102,654 patients. o In 2016, the cholesterol management component was changed from LDL <100 to appropriate statin use and the performance rate was 66.1% for 104,395 patients. • The developer also provided performance rates for the individual components. o The blood pressure component increased from 84.0% in 2012 to 85.0% in 2016. o Daily aspirin use or anti-platelet medication use increased from 92.5% in 2009 to 96.7% in 2016. o The number of tobacco free patients increased from 82.4% in 2009 to 83.0 in 2016. o Statin use was 95.2% in 2016 (this was the first year the new component was reported) The developer provided 2014 disparities data from the measure as specified demonstrating a performance rate of 67.2% for White patients, 47.6% for Black/African-American patients, 51.8% for American Indian/Alaska Native patients, and 53.4% for multi-racial patients. The data also showed a higher performance gap for female patients and younger patients. The Committee asked the developer if there were trend data on disparities that demonstrated a change in performance over time and by individual clinic. The developer did not have additional, specific disparities data. However, according to the developer, some clinics that care for a greater proportion of minority patients have lower performance rates but there are a couple of clinics that are excelling in minimizing disparities. • The Standing Committee agreed that the data provided demonstrated a performance gap and opportunity for improvement in optimal vascular care for patients with IVD. • This is an all-or-none composite measure that requires patients to meet all four component targets in the composite measure to be considered ‘optimally managed’; all four components are weighted equally. The developer noted that measuring providers on individual targets is not as patient-centric as this composite measure that seeks to reduce multiple risk factors in patients with IVD and maximize health outcomes. One of the members of the Standing Committee noted that the tobacco free component would be more appropriate as a process measure. The Committee member noted that smoking rates are often influenced by geographic location. Providers in areas with high rates of tobacco use will not appear as effective in increasing the number of tobacco free patients as those in areas where tobacco use is less prevalent. In the pre-evaluation comments, another Committee member noted that the absolute benefit of each component is not equal; achieving blood pressure control or smoking cessation is much more difficult than prescribing a statin or aspirin/anti-platelet medication. • The Standing Committee agreed, that overall, the quality construct and rational for the composite was clearly stated and logical.
  
  
• Review for Scientific Acceptability: 2. For the 2012 maintenance of endorsement evaluation, patient-level data element validity testing was conducted on 63,241 patients with IVD from 128 medical groups representing 573 clinics that submitted data to Minnesota Community Measurement for 2009 dates of service reported in 2010. After data submission, in-person validation audits requiring a 90% accuracy rate were conducted to compare the submission to the patient’s medical record. Of the 128 medical groups that submitted data in 2010, 17 groups initially failed the audit and remedy plans were developed. All 17 groups resubmitted and passed subsequent audit. • For the current maintenance of endorsement evaluation, the measure was tested at the measure score level using a dataset that included 104,395 patients with IVD in Minnesota and neighboring communities from 111 medical groups representing 671 clinics for dates of service from January 1, 2015 to December 31, 2015. • To test the reliability of the measure score, the developer used a beta-binomial model to assess the signal-to-noise ratio. A reliability score of 0.00 implies that all the variability in a measure is attributable to measurement error. A reliability score of 1.00 implies that all the variability is attributable to real differences in performance. The higher the reliability score, the greater is the confidence with which one can distinguish the performance of one facility from another. This is an appropriate test for measure score reliability. A reliability score of 0.70 is generally considered a minimum threshold for reliability. The overall reliability for the composite measure was 0.90 and 0.61 at the minimum number of patients per reportable clinic (=30). The distribution of reliability scores by number of eligible patients per reportable clinic (=30) ranged from 0.61 for 30 patients per clinic to 0.99 for 4,441 patients per clinic. • In the pre-evaluation comments, a member of the Standing Committee mentioned that assessing prescribing behavior of statin therapy (as noted in the specifications) is not consistent with the evidence provided to support the statin component. The Committee member noted that prescribing the lowest dose of the weakest statin would meet the intent of the measure but not generate clinically significant outcomes in the IVD population. Other Committee members questioned why ‘permanent nursing home residents’ are excluded from the denominator. The Committee discussed the fall risks associated with administering blood pressure medication to nursing home patients, excessive treatment in patients with advanced illness, and the lack of clinical trials for these types of medications in the nursing home population. • The Standing Committee did not express additional concerns with the reliability of the measure, but ultimately decided the testing results were sufficient. • For the 2012 maintenance of endorsement evaluation, content and face validity were assessed through the Measurement and Reporting Committee and a panel of experts. There was consensus among the expert workgroup that the target components reflected a quality of care that will reduce patients heart attack and stroke risk. • For the current maintenance of endorsement evaluation, empirical validity testing of the composite measure score was conducted by testing the correlation of a medical group’s performance with their performance on the Optimal Diabetes Care measure (#0729). It is expected that the quality of care provided by a medical group to a patient with ischemic vascular disease would be of similar quality as the care provided to a patient with diabetes, therefore the respective performance measure scores should be similar. This is an appropriate method for assessing conceptually and theoretically sound hypothesized relationships. The Optimal Diabetes Care measure (#0729) includes the same four components as #0074 plus a component for hemoglobin A1C; it also measures a different population. The linear regression analysis demonstrated an R2 value of 0.635, which means that 64.0% of the total variation in performance on the Optimal Vascular Care measure can be explained by variation in performance on the Optimal Diabetes Care measure. The remaining 36.0% of total variation on the Optimal Vascular Care measure remains unexplained. • This measure is risk-adjusted. The final risk factors selected for the risk model were age and insurance product (Medicare, Medicaid, MSHO, Special Needs, Self-pay, Uninsured). The developer analyzed gender and depression as well, but gender did not show sufficient variation between clinics and ‘depression’ was not selected due to the high cost of collection. The developer stated that race, ethnicity, language, and country of origin (RELO) were not considered for risk adjustment because these variables did not have a high completion rate across all clinics. The developer is continuing to work with the medical community to achieve the goal of evaluating RELO at the clinic level. The developer conducted an Analysis of Maximum Likelihood Estimates on the 2014 Dates of Service to compare the optimal rate of patients by insurance product (Commercial, MHCP, and Uninsured) to patients with Medicare and patient age (18-25; 26-50; 51-65) to patients aged 66-75. The Analysis of Maximum Likelihood Estimates demonstrated that all of the results for both variables, age and insurance product, were significant, except for ages less than 26 due to the small sample size (n = 44). The developer also found that the only two variables that were correlated were age >65 and Medicare. The Standing Committee did not express any concerns on the threats to validity and agreed that the testing results satisfied the validity criterion. • The developer conducted a Pearson Correlation Analysis of the individual components rates and the composite rates. The Pearson correlation coefficient value, r, ranges from +1.00 to -1.00. A value of 0.00 indicates that there is no association between the two variables. A value greater than 0.00 indicates a positive association; that is, as the value of one variable increases, so does the value of the other variable. A value less than 0.00 indicates a negative association; that is, as the value of one variable increases, the value of the other variable decreases. The developer conducted the following Pearson Correlation Analysis for each component: Variable Mean Pearson r coefficient Blood pressure 0.85048 0.69813 Tobacco Free 0.80901 0.71336 Daily ASA Use 0.96271 0.59223 Statin Use 0.93973 0.62327 Optimal Vascular Care Rate = 0.63919 • The developer concluded that practices in Minnesota demonstrate relatively high compliance for all of the components; however, there is still an opportunity for improvement at the clinic level. The blood pressure control and tobacco free components demonstrated the most variability, opportunity for improvement, and impact the ability to achieve all four components. Another Committee member suggested that if the two variables with the most variability were more heavily weighted than the other components, the measure would be more impactful. Another Committee member pointed out that three of the components were under the direct control of the provider, yet it was not clear how the tobacco free component captured the quality of care provided by the clinician. A member of the Standing Committee questioned whether there was evidence showing that meeting all four component targets would not 25 generate the same patient outcomes as meeting two or three of the components. The developer pointed out that various combinations of the components and the proportion of patients meeting the different combinations were provided. • The Standing Committee did not express additional concerns with the construct of the composite measure and agreed the information provided was sufficient to satisfy the criterion for composite construct.
  
  
• Review for Feasibility: 3. Feasibility: H-12; M-10; L-0; 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: • All of the data elements are in defined fields in electronic sources and there are no fees, licensure, or other requirements necessary to use this measure. The Standing Committee agreed this measure met the feasibility criterion.
  
  
• Review for Usability: 4. Usability and Use: H-13; M-8; 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 measure is widely used in Minnesota for public reporting, payment, regulatory and accreditation programs, and quality improvement with external benchmarking to multiple organizations. 5. Related and Competing Measures • This measure is related to: o #0067: Chronic Stable Coronary Artery Disease: Antiplatelet Therapy (ACC) o #0068: Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antiplatelet (NCQA) o #0073: Ischemic Vascular Disease (IVD): Blood Pressure Control (NCQA) • The developer stated that #0068 and #0073 focus on the inpatient setting and patients discharged with AMI, CABG, or PCI. #0067 focuses on patients with CAD.
  
  
• Review for Related and Competing Measures: 5. Related and Competing Measures • This measure is related to: o #0067: Chronic Stable Coronary Artery Disease: Antiplatelet Therapy (ACC) o #0068: Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antiplatelet (NCQA) o #0073: Ischemic Vascular Disease (IVD): Blood Pressure Control (NCQA) • The developer stated that #0068 and #0073 focus on the inpatient setting and patients discharged with AMI, CABG, or PCI. #0067 focuses on patients with CAD.
  
  
• Endorsement Public Comments: 6. Public and Member Comment • One commenter did not agree with statin use as a component to address dyslipidemia and believed it would be misleading to include this as a component of “optimal care.” The commenter believed including this component would lead to the lowest level of acceptable care being considered optimal care and would do little to move the quality of care forward. • Developer Response: Thank you for your comment and suggestion for the inclusion of the dose of statin (moderate or high) in the calculation of the cholesterol component of this patient level all-or-none composite measure. While ACC/ AHA guidelines do indicate that most patients with ischemic vascular disease would benefit from high dose intensity statins, there 26 are provisions for moderate intensity statins for patients who cannot tolerate high intensity doses. The measure development work group thoroughly discussed the pros and cons of specifying a certain dose of the statin medication for numerator component compliance and determined that requiring the submission of the dose of statin would cause undue data collection burden for the practices. Additionally, the cardiologists on the workgroup strongly believe that there is some benefit for patients who can only tolerate a low dose of statin. We do not discount the role of ongoing LDL monitoring to determine effectiveness of statin therapy, but having a physiological target (e.g. LDL < 100) is no longer supported by evidence. The American College of Cardiology/ American Heart Associate guidelines for the treatment of blood cholesterol indicate the following: “Treat to target — this strategy has been the most widely used the past 15 years but there are 3 problems with this approach. First, current clinical trial data do not indicate what the target should be. Second, we do not know the magnitude of additional ASCVD risk reduction that would be achieved with one target lower than another. Third, it does not take into account potential adverse effects from multidrug therapy that might be needed to achieve a specific goal. Thus, in the absence of these data, this approach is less useful than it appears (Section 3). It is possible that future clinical trials may provide information warranting reconsideration of this strategy” (pg. 17) Yes, our component rates for prescribing statins are high in MN, which is a little bit unexpected for the newly re-designed component, however we would like to clarify the cholesterol component of statin use is not reported as a stand-alone measure. The Optimal Vascular Care measure is reported as an all-or-none composite, patients achieving multiple components of modifiable risk factors to reduce or delay long term complications. Statin use is one component, the other three are blood pressure control, tobacco-free and daily aspirin or antiplatelet medication. • Committee Response: Thank you for your comment. The Committee agrees that monitoring LDL levels remains an important part of providing care for patients with IVD. However, the statin component in this measure aligns with the 2013 ACC/AHA Guideline for the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults.
  
  
• Endorsement Committee Recommendation: Standing Committee Recommendation for Endorsement: Y-19; N-3
  
  

Measure Specifications

• NQF Number (if applicable): *Note - 729 (This measure is a component of the endorsed composite measure NQF #729)
  
  
• Description: The percentage of patients 18-75 years of age who had a diagnosis of type 1 or type 2 diabetes and whose most recent HbA1c during the measurement period was less than 8.0 mg/dL.
  
  
• Numerator: Denominator patients whose most recent HbA1c during the measurement period was less than 8.0 mg/dL.
  
  
• Denominator: 18 years or older at the start of the measurement period AND less than 76 years at the end of the measurement period AND Patient had a diagnosis of diabetes (Diabetes Value Set) with any contact during the current or prior measurement period OR had diabetes (Diabetes Value Set) present on an active problem list at any time during the measurement period. AND At least one established patient office visit (Established Pt Diabetes & Vasc Value Set) for any reason during the measurement period
  
  
• Exclusions: The following exclusions are allowed to be applied to the eligible population: - Patient was a permanent nursing home resident at any time during the measurement period - Patient was in hospice or receiving palliative care at any time during the measurement period - Patient died prior to the end of the measurement period - Patient was pregnant (Diabetes with Pregnancy Value Set) at any time during measurement period - Documentation that diagnosis was coded in error - Patient had only urgent care visits during the measurement period
  
  
• HHS NQS Priority: Effective Prevention and Treatment
  
  
• HHS Data Source: Administrative clinical data, EHR, Paper medical record, Claims, Registry
  
  
• Measure Type: Intermediate Outcome
  
  
• Steward: MN Community Measurement
  
  
• Endorsement Status: Endorsed - This measure was endorsed in 2015 as a component of composite measure NQF #0729
  
  
• Changes to Endorsed Measure Specifications?: The MUC list indicates the measure has not been modified from its endorsed version.
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional Support for Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure is fully developed, tested, and NQF endorsed. This measure is one component of the endorsed Optimal Diabetes Care composite measure that is on this year’s MUC list for the MIPS progam as MUC17-181. There is a similar measure in the MIPS program, QPP #001 Diabetes: Hemoglobin A1c Poor Control (>9.0%). NQF recommends condition that there are not duplicate or competing measures in the program.
  • Impact on quality of care for patients:This measure is proposed to program as a replacement stand-alone measure of A1c control is evidence based, is stated positively, is patient centric and represents a target supported by guidelines.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. This measure addresses the MIPS domain of effective clinical care.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is an intermediate outcome measure. The measures adheres to clinical guideline issued by ICSI. Specifically, the measure addresses the following: The most recent HbA1c in the measurement period has a value less than 8.0 mg/dL
  
  
• Does the measure address a quality challenge? Yes. This measure addresses unwarrented variation in care. An analysis of 94 medical groups found that of the percentage of diabetic patients age 18 to 75 who achieved an A1C less than 8.0 mg/dL identified in the measure averaged 69%, and ranged from 42% to 88%.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. There is a similar measure, QPP #001 Diabetes: Hemoglobin A1c Poor Control (>9.0%).
  
  
• Can the measure can be feasibly reported? Yes. This measure is fully specificedand data is captured during the course of care. Data sources for the measure include administrative clinical data, EHR, and paper medical records
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. This measure was endorsed in 2015 as a component of composite measure NQF #0729. For this component, the measure proposed follows the component construct exactly.This particular measure is not NQF endorsed as part of the composite.  However, a related measure that is NQF endorsed exists (not in MIPS program) as NQF#0575 Comprehensive Diabestes Care: Hemoglobin A1c (HbA1c) control (<8.0%).The measure was tested at the group level. This measure has not been submitted in a previous year’s MUC list.
  
  
• Measure development status: Fully Developed
  
  
• 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 is not currently in use in the MIPS program. This measure is one component of the Optimal Diabetes Care measure which has been implemented in the Minnesota Department of Health’s Statewide Quality Reporting and Measurement System (SQRMS), using data submitted by all eligible providers. No implementation issues have been identified.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Endorsed - This measure was endorsed in 2015 as a component of composite measure NQF #0729
  
  
• Does the measure address a high-priority quality issue in the dual eligible beneficiary population? Yes.
  
  
• Preliminary analysis of the MAP Medicaid-relevant measure: Support measurement of managing chronic illness. This is a subset of the Optimal Diabetes Care Measure. .
  
  

Rationale for measure provided by HHS
Addressing Health Care Disparities Using Public Reporting Snowden, A. et al American Journal of Medical Quality August 2012 27 (4): 275-81

Summary of NQF Endorsement Review

• Year of Most Recent Endorsement Review: 2015
  
  
• Project for Most Recent Endorsement Review: Endocrine
  
  
• Review for Importance: 1a. Evidence, 1b. Performance Gap) 1a. Evidence: H-5; M-11; L-0; I-1; 1b. Performance Gap: H-15; 1d. Composite – Quality Construct and Rationale: H-4; M-7; L-4; I-1 Rationale: • For all but one of the components included in this composite (tobacco-free), the developer presented recommendations from the 2014 clinical practice guidelines developed by the Institute for Clinical Systems Improvement (ICSI), which were based on a systematic review of evidence that was graded either high or moderate. Additional evidence-based recommendations from the American College of Cardiology and U.S. Preventive Services Task Force also were presented. Committee members agreed that the evidence supports the relationship between each component and desired health outcomes. • Data provided by the developer indicate that for 2014, only 38.9% of diabetic patients in Minnesota met all five component targets from the composite measure. Committee members agreed that although performance on some of the components is quite high, overall performance indicates opportunity for improvement. • Although some Committee members voiced concern over the “all-or-none” structure of the measure, others agreed that a more comprehensive measure that focuses on management of multiple risk factors is needed. The Committee agreed that the developer description of the quality construct, rationale, and aggregation and weighting approach is explicitly articulated and logical.
  
  
• Review for Scientific Acceptability: 2. Scientific Acceptability of Measure Properties: The measure meets the Scientific Acceptability criteria (2a. Reliability - precise specifications, testing; 2b. Validity - testing, threats to validity) 2a. Reliability: H-9; M-7; L-0; I-0; 2b. Validity: H-1; M-10; L-4; I-1; 2d. Composite: H-1; M-10; L-4; I-1 Rationale: • Committee members noted that the specifications of the statin component of this measure have changed since the most recent endorsement of the measure due to changes in the ACC/AHA clinical practice guidelines on cholesterol management released in November, 2013. In the earlier version of the measure, the statin component assessed reaching a target LDL threshold of < 100 mg/dL; the revised version of this component assesses statin use. • Committee members questioned whether the measure assesses if a patient is on the appropriate statin dose. Developers clarified that the measure does not consider the statin dose but assesses only whether a patient is on a statin. • Members also questioned the age range of 18-75 for the statin component of the measure. The developer clarified that for patients 21-39 years of age, this component is applicable only if the patient has ischemic vascular disease or a very high LDL level, in accordance with the ACC/AHA guidelines. • The developer clarified that the level of analysis for the measure is clinician groups (not individual clinicians), and also noted that multiple clinics may form a clinician group. They also clarified that the measure does not require having a minimum of 30 patients. • Developers presented results of signal-to-noise reliability testing of the performance measure score. They clarified that the beta-binomial method was used for the reliability testing because the composite score itself is a binary (yes/no) measure. Members noted that although the 12 reliability was quite high for most clinician groups, it was lower than 0.7 for some clinician groups. • To demonstrate validity of the performance measure score, developers examined the association between the scores for this measure with the scores from the Optimal Vascular Care measure (NQF #0076), hypothesizing that clinician groups likely provide similar quality of care to different patients who also require management of multiple risk factors. The R2 value from this analysis was 0.64. The developers also described several steps occurring during the data submission process as demonstration of empirical validity testing at the data level element. • Developers also clarified that the measure is risk-adjusted for three factors (insurance type, age group, and diabetes type) and noted that the risk-adjustment strategy was developed using data from all clinicians in Minnesota. However, one member expressed some concern that the only adjustment for sociodemograhic status is insurance type. Developers clarified that other potential risk factors that were considered were not statistically significant and thus were not included in the risk-adjustment model. • Several Committee members voiced concern about holding physicians accountable for the patient’s tobacco use, as some see actual tobacco use (as opposed to efforts for tobacco cessation) as out of the control of the clinician. However, another member referred to data showing that physicians can influence their patients to stop tobacco use. Developers also noted that statewide, they have seen an approximate 2.5% increase in tobacco-free patients in Minnesota. • One Committee member noted the need for clarity about potential adverse effects related to statin use. Another member referenced the flow diagram provided by the developer that details several contraindications for statin use, while another member echoed the importance of the potential for adverse reactions when making treatment decisions. • After developers clarified the performance rates for each of the components, Committee members questioned whether the aspirin component (performance rate =99.5% in MN) is needed in the composite. Developers noted that while this component may be "topped out" in MN, this happened over a four-year period of focus on this component. They also referenced a New England Journal of Medicine article that found a 34.8% performance rate nationally in the primary care setting. Finally, they noted that performance on this component across ACOs is, on average, 75.3%.
  
  
• Review for Feasibility: 3. Feasibility: H-7; M-4; 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 measure data can be collected through electronic clinical data and paper records. • One Committee member noted that, due to the number of components included in the composite, the data collection effort for this composite measure may be intensive. Developers stated that submission of this measure by all clinician groups in MN is mandated by the state. While they acknowledged that MN has many large practices that use EHRs, small practices— even those who still use paper medical records—are able to submit data on this measure. The developers did, however, acknowledge the data collection burden for the new statin component if a patient has not been prescribed a statin (i.e., identifying exceptions due to contraindications).
  
  
• Review for Usability: 4. Usability and Use: H-5; M-7; L-4; 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: • Committee members noted that the measure is publicly reported and is used in pay-forperformance and accreditation programs. Performance is slowly increasing across the state of Minnesota, suggesting quality of care may be improving. • Data submitted by the developer demonstrate relatively consistent improvement of performance in MN from the years 2006-2014. • Committee members agreed that this composite measure is patient-centric and acknowledged the importance of using a comprehensive measure that assesses performance of reducing multiple risk factors. • Some Committee members expressed concern that the measure could incent some providers to "cherry-pick" patients or make their practices less hospitable to certain patients or certain subgroups of patients (the tobacco-free component of the measure was a particular concern).
  
  
• Review for Related and Competing Measures: 5. Related and Competing Measures • This measure is a competing measure to the following measures o 0061: Comprehensive Diabetes Care: Blood Pressure Control (< 7% to < 8% depending on individual patient factors. o 0575: Comprehensive Diabetes Care: Hemoglobin A1c (HbA1c) control (<8%) • NQF staff asked the Committee to discuss whether there is justification for continued endorsement of the individual measures if the composite retains endorsement. The Committee discussed the pros and cons of endorsing both individual measures and the composite measure. The Committee ultimately agreed that while the composite measure is useful to assess patientcentric performance across a variety of clinical areas, endorsement of individual measures also can be beneficial, particularly for users who want to focus on certain components of the composite or those who have data collection constraints and cannot use the composite. The Committee therefore recommended continued endorsement of both the individual measures and the composite measure.
  
  
• Endorsement Public Comments: 6. Public and Member Comment Comments received: • Two commenters raised concern over the glucose control component of the composite, referencing the National Action Plan for Adverse Event Prevention, which was released in August, 2014. The National Action Plan states that the blood glucose threshold of < 7% to < 8% depending on individual patient factors. Benefits: Achieving near-normal glycemic control lowers risk of diabetes microvascular complications such as retinopathy, nephropathy and amputations. Achieving A1c of 6.9 to 7.9% may also significantly reduce macrovascular complications based on Steno-2 and UKPDS data. Quality of Evidence: High Strength of Recommendation: Strong. Measurement does not and should not preclude good clinical judgement; however the measure development work group believes that a target of < 8.0 is reasonable and supported by guidelines. Our measure does have an upper age limit cut-off of 75 years and we allow exclusions for death, permanent nursing home resident or patients who are receiving hospice or palliative care services. • Two commenters were critical of the composite measure itself, citing concern that use of the composite measure could mask the individual care processes that most need improvement. Developer response: While it is true that the measure is reported at the composite level, the individual components and the associated rates are available to the medical groups for better understanding their rates and for use in quality improvement to know which areas have opportunity for improvement. MNCM and the measure development work group firmly believe that achieving the intermediate physiological outcome targets related to blood pressure and glycemic control in addition being tobacco free and use of daily aspirin and statins where appropriate are the diabetic patient’s best mechanisms of avoiding or postponing long term complications associated with this chronic condition which affects millions of Americans. Measuring providers separately on individual targets is not as patient centric as a measure that seeks to reduce multiple risk factors for each patient. Diabetic patients are more likely to reduce their overall risk and maximize health outcomes by achieving several intermediate physiological targets. • Two commenters noted that documenting HbA1c levels >8% but less than 9% cannot be done using CPT-II coding, necessitating need for medical chart review. Developer response: A point of clarification, these measure do not rely on CPTII codes for numerator compliance, nor are they indicated anywhere in our measure specification. Measure specifications focus on the electronic health record as a source of clinical information for calculating numerator compliance; actual A1c values are utilized in the case of the A1c target. Additionally, 80 to 90% of all the clinics in MN are reporting this information from their electronic health records without the need for additional chart abstraction. • One commenter suggested a need for including sociodemographic factors in the risk-adjustment approach. Developer response: Our risk adjustment model does include insurance product, which is a proxy for socioeconomic status. During the process of measure development, the expert panel discusses potential variables for risk adjustment that are important to consider for the measured population. For this measure, variables that are available for evaluation include gender, age, zip, race/ethnicity, country of origin, primary language, insurance product, diabetes type, depression and ischemic vascular disease. The potential risk adjustment variables are then evaluated for appropriate inclusion in the model based on a t value outside the range of -2.0 and +2.0. Currently, the variables that have demonstrated acceptable properties are insurance product, age bands (18-25, 26-50, 51-65 and 65 to 75) and diabetes type (1 or 2). Race/ethnicity has been collected for this measure in MN for the past few years, but has now reached a level of 15 reliability in which it can be evaluated for its impact. MNCM continues to review variables and their impact on the measure and part of its measure risk adjustment strategy. • One commenter suggested the need for additional detail regarding moderate or high intensity in the description of statin use for the measure. Developer response: The measure development work group thoroughly discussed the pros and cons of specifying a certain dose of the statin medication and based on the following factors ultimately decided to not specify a dose of moderate or high intensity for numerator compliance: 1) data burden for practices, 2) controversy and burden surrounding the CV risk calculator, 3) ICSI 2014 Diabetes Guideline recommendations for measurement and 4) cardiology work group member’s believe that there is some benefit for some patients who can only tolerate a lower intensity dose. Committee response: • During its review of the individual measure assessing HbA1c
  
  
• Endorsement Committee Recommendation: Standing Committee Recommendation for Endorsement: Y-13; N-4
  
  

Measure Specifications

• NQF Number (if applicable): *Note- 76 (This measure is a component of the endorsed composite measure NQF #76)
  
  
• Description: The percentage of patients 18-75 years of age who had a diagnosis of ischemic vascular disease (IVD) and were on daily aspirin or anti-platelet medication, unless allowed contraindications or exceptions are present.
  
  
• Numerator: Denominator patients with documentation that the patient was on daily aspirin or anti-platelet medication during the measurement period, unless allowed contraindications or exceptions are present.
  
  
• Denominator: 18 years or older at the start of the measurement period AND less than 76 years at the end of the measurement period AND Patient had a diagnosis of ischemic vascular disease (Ischemic Vascular Disease Value Set) with any contact during the current or prior measurement period OR had ischemic vascular disease (Ischemic Vascular Disease Value Set) present on an active problem list at any time during the measurement period. AND At least one established patient office visit (Established Pt Diabetes & Vasc Value Set) for any reason during the measurement period
  
  
• Exclusions: The following exclusions are allowed to be applied to the eligible population: - Patient was a permanent nursing home resident at any time during the measurement period - Patient was in hospice or receiving palliative care at any time during the measurement period - Patient died prior to the end of the measurement period - Documentation that diagnosis was coded in error - Patient had only urgent care visits during the measurement period
  
  
• HHS NQS Priority: Effective Prevention and Treatment
  
  
• HHS Data Source: Administrative clinical data, EHR, Paper medical record
  
  
• Measure Type: Process
  
  
• Steward: MN Community Measurement
  
  
• Endorsement Status: Endorsed
  
  
• Changes to Endorsed Measure Specifications?: The MUC list indicates the measure has not been modified from its endorsed version.
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional Support for Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure is fully developed and tested. This measure is one component of the endorsed Optimal Vascular Care composite measure (NQF#0076). There is a similar measure in the QPP program, QPP #204 IVD Use of Aspirin or Another Antiplatelet. NQF recommends condition that there are not duplicate or competing measures in the program.
  • Impact on quality of care for patients:This measure encourages clinicians to improve care management for patients with ischemic vascular disease, and ultimately improve health outcomes for patients with ischemic vascular disease.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. This measure addresses the MIPS domain of effective clinical care.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is a process measure. This measure adheres to clinical guideline issued by AHA/ACCF.
  
  
• Does the measure address a quality challenge? Yes. This measure addresses unwarranted variation in care. An analysis of 84 medical groups found that of the percentage of ischemic vascular disease patients age 18 to 75 who were achieved target identified in the measure averaged 94%, and ranged from 65% to 100%.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. There is one competing measure in QPP (#204 IVD Use of Aspirin or Another Antiplatelet by NCQA).
  
  
• Can the measure can be feasibly reported? Yes. This measure is fully specified, and data is captured during the course of care. Data sources for the measure include administrative clinical data, EHR, and paper medical records.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. This is one component of the 2016 endorsed Optimal Vascular Care composite measure NQF#0076. For this component, the measure proposed follows the component construct exactly. This particular measure is not NQF endorsed as part of the composite. The measure was tested at the group level. This measure has not been submitted in a previous year’s MUC list.
  
  
• Measure development status: Fully Developed
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? Yes. This measure is one component of the Optimal Vascular Care measure which has been implemented in the Minnesota Department of Health’s Statewide Quality Reporting and Measurement System (SQRMS), using data submitted by all eligible providers. No implementation issues have been identified.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Endorsed
  
  
• Preliminary analysis of the MAP Medicaid-relevant measure: Support measurement of managing chronic illness. This is a subset of the Optimal Vascular Care Measure. .
  
  

Rationale for measure provided by HHS
Risk Factor Optimization and Guideline-Directed Medical Therapy in US Veterans With Peripheral Arterial and Ischemic Cerebrovascular Disease Compared to Veterans With Coronary Heart Disease. Hira RS et al Am J Cardiol. 2016 Oct 15;118(8):1144-1149. doi: 10.1016/j.amjcard.2016.07.027. Epub 2016 Jul 29. Age-specific risks, severity, time course and outcome of bleeding on long-term anti-platelet treatment after vascular events: a population based cohort study. Linix, L et al Published online June 13, 2017 http://dx.doi.org/10.1016/S0140-6736(17)30770-5

Summary of NQF Endorsement Review

• Year of Most Recent Endorsement Review: 2017
  
  
• Project for Most Recent Endorsement Review: Cardiovascular 2016-2017
  
  
• Review for Importance: 1. Importance to Measure and Report: The measure meets the Importance criteria (1a. Evidence, 1b. Performance Gap, 1c. Composite) 1a. Evidence: H-14; M-6; L-1; I-1; 1b. Performance Gap: H-14; M-7; L-1; I-0; Composite: H-12; M-8; L-1; I- 1 Rationale: • For the 2012 maintenance of endorsement evaluation, the developer provided the following clinical practice guidelines to support the blood pressure, statin medication, tobacco free (outcome measure), and daily aspirin or anti-platelet medication components: o Blood pressure, statin medication, tobacco free, and daily aspirin or anti-platelet medication components: The ICSI Stable Coronary Artery Disease (April 2011), Address Modifiable Risk Factors guideline recommended modifiable risk factors for coronary artery disease such as smoking, inadequate physical activity, stress, hyperlipidemia, obesity, hypertension and diabetes mellitus be evaluated. 21 o Blood pressure: The Comorbid Conditions Guideline and the ICSI Hypertension Diagnosis and Treatment Guideline (November 2010) recommended a target blood pressure of 140/90 mmHg or less. o Statin medication: The ICSI Lipid Management in Adults (October 2009) guideline recommended target goals for hyperlipidemic patients with coronary artery disease: LDL – less than 100 mg/dL; HDL – 40 mg/dL or greater; Triglycerides – less than 150 mg/dL. o Daily aspirin or anti-platelet medication: The ICSI Stable Coronary Artery Disease (April 2011), Address Modifiable Risk Factors guideline recommended the use of one aspirin tablet daily (81-162 mg) unless there are medical contraindications. • For the current maintenance of endorsement evaluation, the developer provided the following updated evidence for all four components: o Blood pressure: The 2015 AHA/ACC/ASH Scientific Statement on the Treatment of Hypertension in Patients with Coronary Artery Disease included 3 recommendations for blood pressure targets, including a blood pressure goal of 65 and Medicare. •o Statin medication: The ICSI Lipid Management in Adults (updated Nov 2013/completed prior to ACC/AHA release) recommends that clinicians initiate statin therapy regardless of LDL in patients with established atherosclerotic cardiovascular disease (ASVCD). The 2013 ACC/AHA Guideline for the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults recommends high-intensity statin therapy be initiated or continued as first-line therapy in women and meno Tobacco free outcome measure: The developer provided evidence from the United States Preventive Services Task Force (USPSTF) stating that despite considerable progress in tobacco control over the past 50 years, in 2013, an estimated 17.8% of U.S. adults and 15.9% of pregnant women aged 15 to 44 years were current cigarette smokers. o Daily aspirin or anti-platelet medication: The developer provided three recommendations for antiplatelet agents/anticoagulants for patients with ischemic vascular disease from the AHA/ACCF Secondary Prevention and Risk Reduction Therapy for Patients with Coronary and Other Atherosclerotic Vascular Disease: 2011 Update. • The Standing Committee discussed the potential changes to blood pressure parameters based on the results of the Systolic Blood Pressure Intervention Trial (SPRINT), which compared the benefit of treatment of systolic blood pressure to a target of less than 120 mm Hg with treatment to a target of less than 140 mm Hg. The Committee also discussed the anticipated blood pressure guidelines to be released by AHA/ACC sometime in the future. NQF staff asked the Committee to consider the quantity, quality, and consistency of the body of evidence that was presented in the measure submission form. NQF staff reassured the Committee that the NQF process allows for a measure to be reviewed when new evidence becomes available. One of the Committee members noted that the USPSTF recommendations for daily aspirin include patients aged 50 to 70 years old, while the measure includes patients up to 75 years old. Other Committee members noted that the USPSTF recommendations are for primary prevention rather than patients with a diagnosis of ischemic vascular disease (IVD). Overall, the Standing Committee agreed that the updated evidence supports blood pressure control, statin use, daily aspirin or anti-platelet medication, and tobacco use assessment and 22 intervention(s) in patients to avoid or postpone long-term complications associated with a diagnosis with IVD. The developer provided composite performance rates from clinics in Minnesota for Report Year 2007-2016 (Dates of Service 2006-2015). o In 2007, the rate was 38.9% for 4,662 patients and 33.8% in 2010 for 63,241 patients. In 2011, the blood pressure component target changed from, and the performance rate increase to 39.7% for 66,910 patients. o In 2015, the cholesterol management component was suppressed during redesign of the measure and the performance rate increased to 69.3% for 102,654 patients. o In 2016, the cholesterol management component was changed from LDL <100 to appropriate statin use and the performance rate was 66.1% for 104,395 patients. • The developer also provided performance rates for the individual components. o The blood pressure component increased from 84.0% in 2012 to 85.0% in 2016. o Daily aspirin use or anti-platelet medication use increased from 92.5% in 2009 to 96.7% in 2016. o The number of tobacco free patients increased from 82.4% in 2009 to 83.0 in 2016. o Statin use was 95.2% in 2016 (this was the first year the new component was reported) The developer provided 2014 disparities data from the measure as specified demonstrating a performance rate of 67.2% for White patients, 47.6% for Black/African-American patients, 51.8% for American Indian/Alaska Native patients, and 53.4% for multi-racial patients. The data also showed a higher performance gap for female patients and younger patients. The Committee asked the developer if there were trend data on disparities that demonstrated a change in performance over time and by individual clinic. The developer did not have additional, specific disparities data. However, according to the developer, some clinics that care for a greater proportion of minority patients have lower performance rates but there are a couple of clinics that are excelling in minimizing disparities. • The Standing Committee agreed that the data provided demonstrated a performance gap and opportunity for improvement in optimal vascular care for patients with IVD. • This is an all-or-none composite measure that requires patients to meet all four component targets in the composite measure to be considered ‘optimally managed’; all four components are weighted equally. The developer noted that measuring providers on individual targets is not as patient-centric as this composite measure that seeks to reduce multiple risk factors in patients with IVD and maximize health outcomes. One of the members of the Standing Committee noted that the tobacco free component would be more appropriate as a process measure. The Committee member noted that smoking rates are often influenced by geographic location. Providers in areas with high rates of tobacco use will not appear as effective in increasing the number of tobacco free patients as those in areas where tobacco use is less prevalent. In the pre-evaluation comments, another Committee member noted that the absolute benefit of each component is not equal; achieving blood pressure control or smoking cessation is much more difficult than prescribing a statin or aspirin/anti-platelet medication. • The Standing Committee agreed, that overall, the quality construct and rational for the composite was clearly stated and logical.
  
  
• Review for Scientific Acceptability: 2. For the 2012 maintenance of endorsement evaluation, patient-level data element validity testing was conducted on 63,241 patients with IVD from 128 medical groups representing 573 clinics that submitted data to Minnesota Community Measurement for 2009 dates of service reported in 2010. After data submission, in-person validation audits requiring a 90% accuracy rate were conducted to compare the submission to the patient’s medical record. Of the 128 medical groups that submitted data in 2010, 17 groups initially failed the audit and remedy plans were developed. All 17 groups resubmitted and passed subsequent audit. • For the current maintenance of endorsement evaluation, the measure was tested at the measure score level using a dataset that included 104,395 patients with IVD in Minnesota and neighboring communities from 111 medical groups representing 671 clinics for dates of service from January 1, 2015 to December 31, 2015. • To test the reliability of the measure score, the developer used a beta-binomial model to assess the signal-to-noise ratio. A reliability score of 0.00 implies that all the variability in a measure is attributable to measurement error. A reliability score of 1.00 implies that all the variability is attributable to real differences in performance. The higher the reliability score, the greater is the confidence with which one can distinguish the performance of one facility from another. This is an appropriate test for measure score reliability. A reliability score of 0.70 is generally considered a minimum threshold for reliability. The overall reliability for the composite measure was 0.90 and 0.61 at the minimum number of patients per reportable clinic (=30). The distribution of reliability scores by number of eligible patients per reportable clinic (=30) ranged from 0.61 for 30 patients per clinic to 0.99 for 4,441 patients per clinic. • In the pre-evaluation comments, a member of the Standing Committee mentioned that assessing prescribing behavior of statin therapy (as noted in the specifications) is not consistent with the evidence provided to support the statin component. The Committee member noted that prescribing the lowest dose of the weakest statin would meet the intent of the measure but not generate clinically significant outcomes in the IVD population. Other Committee members questioned why ‘permanent nursing home residents’ are excluded from the denominator. The Committee discussed the fall risks associated with administering blood pressure medication to nursing home patients, excessive treatment in patients with advanced illness, and the lack of clinical trials for these types of medications in the nursing home population. • The Standing Committee did not express additional concerns with the reliability of the measure, but ultimately decided the testing results were sufficient. • For the 2012 maintenance of endorsement evaluation, content and face validity were assessed through the Measurement and Reporting Committee and a panel of experts. There was consensus among the expert workgroup that the target components reflected a quality of care that will reduce patients heart attack and stroke risk. • For the current maintenance of endorsement evaluation, empirical validity testing of the composite measure score was conducted by testing the correlation of a medical group’s performance with their performance on the Optimal Diabetes Care measure (#0729). It is expected that the quality of care provided by a medical group to a patient with ischemic vascular disease would be of similar quality as the care provided to a patient with diabetes, therefore the respective performance measure scores should be similar. This is an appropriate method for assessing conceptually and theoretically sound hypothesized relationships. The Optimal Diabetes Care measure (#0729) includes the same four components as #0074 plus a component for hemoglobin A1C; it also measures a different population. The linear regression analysis demonstrated an R2 value of 0.635, which means that 64.0% of the total variation in performance on the Optimal Vascular Care measure can be explained by variation in performance on the Optimal Diabetes Care measure. The remaining 36.0% of total variation on the Optimal Vascular Care measure remains unexplained. • This measure is risk-adjusted. The final risk factors selected for the risk model were age and insurance product (Medicare, Medicaid, MSHO, Special Needs, Self-pay, Uninsured). The developer analyzed gender and depression as well, but gender did not show sufficient variation between clinics and ‘depression’ was not selected due to the high cost of collection. The developer stated that race, ethnicity, language, and country of origin (RELO) were not considered for risk adjustment because these variables did not have a high completion rate across all clinics. The developer is continuing to work with the medical community to achieve the goal of evaluating RELO at the clinic level. The developer conducted an Analysis of Maximum Likelihood Estimates on the 2014 Dates of Service to compare the optimal rate of patients by insurance product (Commercial, MHCP, and Uninsured) to patients with Medicare and patient age (18-25; 26-50; 51-65) to patients aged 66-75. The Analysis of Maximum Likelihood Estimates demonstrated that all of the results for both variables, age and insurance product, were significant, except for ages less than 26 due to the small sample size (n = 44). The developer also found that the only two variables that were correlated were age >65 and Medicare. The Standing Committee did not express any concerns on the threats to validity and agreed that the testing results satisfied the validity criterion. • The developer conducted a Pearson Correlation Analysis of the individual components rates and the composite rates. The Pearson correlation coefficient value, r, ranges from +1.00 to -1.00. A value of 0.00 indicates that there is no association between the two variables. A value greater than 0.00 indicates a positive association; that is, as the value of one variable increases, so does the value of the other variable. A value less than 0.00 indicates a negative association; that is, as the value of one variable increases, the value of the other variable decreases. The developer conducted the following Pearson Correlation Analysis for each component: Variable Mean Pearson r coefficient Blood pressure 0.85048 0.69813 Tobacco Free 0.80901 0.71336 Daily ASA Use 0.96271 0.59223 Statin Use 0.93973 0.62327 Optimal Vascular Care Rate = 0.63919 • The developer concluded that practices in Minnesota demonstrate relatively high compliance for all of the components; however, there is still an opportunity for improvement at the clinic level. The blood pressure control and tobacco free components demonstrated the most variability, opportunity for improvement, and impact the ability to achieve all four components. Another Committee member suggested that if the two variables with the most variability were more heavily weighted than the other components, the measure would be more impactful. Another Committee member pointed out that three of the components were under the direct control of the provider, yet it was not clear how the tobacco free component captured the quality of care provided by the clinician. A member of the Standing Committee questioned whether there was evidence showing that meeting all four component targets would not 25 generate the same patient outcomes as meeting two or three of the components. The developer pointed out that various combinations of the components and the proportion of patients meeting the different combinations were provided. • The Standing Committee did not express additional concerns with the construct of the composite measure and agreed the information provided was sufficient to satisfy the criterion for composite construct.
  
  
• Review for Feasibility: 3. Feasibility: H-12; M-10; L-0; 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: • All of the data elements are in defined fields in electronic sources and there are no fees, licensure, or other requirements necessary to use this measure. The Standing Committee agreed this measure met the feasibility criterion.
  
  
• Review for Usability: 4. Usability and Use: H-13; M-8; 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 measure is widely used in Minnesota for public reporting, payment, regulatory and accreditation programs, and quality improvement with external benchmarking to multiple organizations. 5. Related and Competing Measures • This measure is related to: o #0067: Chronic Stable Coronary Artery Disease: Antiplatelet Therapy (ACC) o #0068: Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antiplatelet (NCQA) o #0073: Ischemic Vascular Disease (IVD): Blood Pressure Control (NCQA) • The developer stated that #0068 and #0073 focus on the inpatient setting and patients discharged with AMI, CABG, or PCI. #0067 focuses on patients with CAD.
  
  
• Review for Related and Competing Measures: 5. Related and Competing Measures • This measure is related to: o #0067: Chronic Stable Coronary Artery Disease: Antiplatelet Therapy (ACC) o #0068: Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antiplatelet (NCQA) o #0073: Ischemic Vascular Disease (IVD): Blood Pressure Control (NCQA) • The developer stated that #0068 and #0073 focus on the inpatient setting and patients discharged with AMI, CABG, or PCI. #0067 focuses on patients with CAD.
  
  
• Endorsement Public Comments: 6. Public and Member Comment • One commenter did not agree with statin use as a component to address dyslipidemia and believed it would be misleading to include this as a component of “optimal care.” The commenter believed including this component would lead to the lowest level of acceptable care being considered optimal care and would do little to move the quality of care forward. • Developer Response: Thank you for your comment and suggestion for the inclusion of the dose of statin (moderate or high) in the calculation of the cholesterol component of this patient level all-or-none composite measure. While ACC/ AHA guidelines do indicate that most patients with ischemic vascular disease would benefit from high dose intensity statins, there 26 are provisions for moderate intensity statins for patients who cannot tolerate high intensity doses. The measure development work group thoroughly discussed the pros and cons of specifying a certain dose of the statin medication for numerator component compliance and determined that requiring the submission of the dose of statin would cause undue data collection burden for the practices. Additionally, the cardiologists on the workgroup strongly believe that there is some benefit for patients who can only tolerate a low dose of statin. We do not discount the role of ongoing LDL monitoring to determine effectiveness of statin therapy, but having a physiological target (e.g. LDL < 100) is no longer supported by evidence. The American College of Cardiology/ American Heart Associate guidelines for the treatment of blood cholesterol indicate the following: “Treat to target — this strategy has been the most widely used the past 15 years but there are 3 problems with this approach. First, current clinical trial data do not indicate what the target should be. Second, we do not know the magnitude of additional ASCVD risk reduction that would be achieved with one target lower than another. Third, it does not take into account potential adverse effects from multidrug therapy that might be needed to achieve a specific goal. Thus, in the absence of these data, this approach is less useful than it appears (Section 3). It is possible that future clinical trials may provide information warranting reconsideration of this strategy” (pg. 17) Yes, our component rates for prescribing statins are high in MN, which is a little bit unexpected for the newly re-designed component, however we would like to clarify the cholesterol component of statin use is not reported as a stand-alone measure. The Optimal Vascular Care measure is reported as an all-or-none composite, patients achieving multiple components of modifiable risk factors to reduce or delay long term complications. Statin use is one component, the other three are blood pressure control, tobacco-free and daily aspirin or antiplatelet medication. • Committee Response: Thank you for your comment. The Committee agrees that monitoring LDL levels remains an important part of providing care for patients with IVD. However, the statin component in this measure aligns with the 2013 ACC/AHA Guideline for the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults.
  
  
• Endorsement Committee Recommendation: Standing Committee Recommendation for Endorsement: Y-19; N-3
  
  

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: The Routine Cataract Removal with IOL Implantation Cost Measure applies to clinicians who perform routine cataract removal with IOL implantation procedures for Medicare beneficiaries. The cost measure is calculated by determining the risk-adjusted episode cost, averaged across all of a clinician’s episodes during the measurement period. The cost of each episode is the sum of the cost to Medicare for services performed by the attributed clinician and other healthcare providers during the episode window (from 60 days prior to the trigger date to 90 days after the trigger date).
  
  
• Numerator: The numerator of the Routine Cataract Removal with IOL Implantation cost measure is the sum of the ratio of observed to expected payment-standardized cost to Medicare for all episodes attributed to a clinician. This is then multiplied by the national average observed episode cost to generate a dollar figure.
  
  
• Denominator: The cost measure denominator is the total number of episodes from the Routine Cataract Removal with IOL Implantation episode group attributed to a clinician.
  
  
• Exclusions: The following episode-level exclusions apply: (a) The beneficiary has a primary payer other than Medicare for any amount of time overlapping the episode window or in the 120 days prior to the episode trigger day. (b) No attributed clinician is found for the episode. (c) The episode is not attributed to at least one main clinician. (d) The beneficiary’s date of birth is missing. (e) The beneficiary’s death date occurred before the trigger date. (f) The beneficiary’s death date occurred before the episode ended. (g) The beneficiary was not enrolled in Medicare Part A and B for the entirety of the 120-day lookback period plus episode window, or is enrolled in Part C for any part of the lookback period plus episode window. (h) The episode trigger claim was not performed in an office, IP, OP, or ASC setting based on its place of service. Routine Cataract Removal with IOL Implantation episodes are also removed using exclusions specific to the Routine Cataract Removal with IOL Implantation measure that were developed with input from the Ophthalmologic Disease Management Clinical Subcommittee. The “Exclusions” and “Exclusions_Details” tabs in the Routine Cataract Removal with IOL Implantation Measure Codes List file include the list of these exclusions as well as the codes used to define them.
  
  
• HHS NQS Priority: Making Care Affordable
  
  
• HHS Data Source: Claims
  
  
• Measure Type: Cost/Resource Use
  
  
• Steward: Centers for Medicare & Medicaid Services
  
  
• Endorsement Status: Never Submitted
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional Support for Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure is fully developed and tested. This measure should be submitted to NQF for review and endorsement. The measure testing should match the updated specifications.
  • Impact on quality of care for patients:This measure assesses the cost to Medicare for services performed by the attributed clinician, and other clinicians and providers, during the episode window.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure addresses the MIPS domain of Efficiency and Cost Reduction.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is a cost/resource use measure. Cataracts are the leading cause of visual impairment in the U.S. and cataract surgery is the only treatment option for removal. As such, cataract surgery is the most common surgical procedure in the U.S. Each year, Medicare spends more than $3.4 billion on cataract treatment.
  
  
• Does the measure address a quality challenge? Yes. This measures addresses a topic with a performance gap. There is variation in spending per episode for both clinician and clinician groups using episodes ending between June 1, 2016 and May 31, 2017. The performance gap for cost per episode has been risk-adjusted. The developer provided information that the performance gap is significant for both clinicians and clinicians group and suggested that costs could be reduced by improvements in clinical practice.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. There are no competing measures in the program and the measure captures a broad population. This measure is new and is not in use in any program.
  
  
• Can the measure can be feasibly reported? Yes. This measure is a claims-based measure.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. This measure is fully developed and has been tested for reliability and face validity. The reliability testing results indicate the measure is reliable. The measure specifications were refined following testing. The measure was tested at the clinician and group level.This measure has never been submitted to NQF for endorsement.
  
  
• Measure development status: Early Development (Note: Since publication of MUC list, NQF has received updates that this is fully developed and tested)
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? N/A. The measure is not currently in use.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted
  
  

Rationale for measure provided by HHS
Among adults in the United States, cataracts constitute the leading cause of visual impairment, and cataract surgery is the only treatment option for removing cataracts, thereby reversing the visual impairment caused by cataracts (Tseng et al., 2016). Routine cataract surgery is the most frequent surgical procedure in the United States, including among Medicare beneficiaries (Pershing et al., 2016). A study found that there were about 2.3 million procedures for Medicare beneficiaries in 2014, and Medicare covers more than 80 percent of cataract surgeries in the United States (French et al., 2017). In addition, it was estimated that Medicare spends more than $3.4 billion annually on the treatment of cataracts, and cataract extraction with IOL implantation was the most common procedure (Brown et al., 2013). References: Martin, Anne B., Micah Hartman, Benjamin Washington, Aaron Catlin, and the National Health Expenditure Accounts Team. "National Health Spending: Faster Growth in 2015 as Coverage Expands and Utilization Increases." Health Affairs (December 2, 2016 2016). Kaiser Family Foundation. “A Primer on Medicare: Key Facts About the Medicare Program and the People it Covers.” (March 2015) Brown, G. C., M. M. Brown, A. Menezes, B. G. Busbee, H. B. Lieske, and P. A. Lieke. “Cataract Surgery Cost Utility Revisited in 2012: A New Economic Paradigm.” [In eng]. Ophthalmology 120, no. 12 (Dec 2013): 2367-76. French, D. D., C. E. Margo, J.J. Behrens, and P. B. Greenberg. “Rates of Routine Cataract Surgery among Medicare Beneficiaries.” [In eng]. JAMA Ophthalmol (Jan 05 2017). Pershing, S., D. E. Morrison, and T. Hernandez-Boussard. “Cataract Surgery Complications and Revisit Rates among Three States.” [In eng]. Am J Ophthalmol 171 (Nov 2016): 130-38. Tseng, V. L., F. Yu, F. Lum, and A. L. Coleman. “Cataract Surgery and Mortality in the United States Medicare Population.” [In eng]. Ophthalmology 123, no. 5 (May 2016): 1019-26.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Percentage of patients with an office visit within the measurement period and with a new diagnosis of clinically significant Benign Prostatic Hyperplasia who have International Prostate Symptoms Score (IPSS) or American Urological Association (AUA) Symptom Index (SI) documented at time of diagnosis and again 6 to 12 months later with an improvement of 3 points.
  
  
• Numerator: IPSS or AUASI documented at or within 1 month of BPH diagnosis and again documented 6 to 12 months after treatment initiated, showing a 3 point improvement
  
  
• Denominator: Equals initial population, which is Male patients with a new diagnosis of benign prostatic hyperplasia and an office visit during the measurement period
  
  
• Exclusions: Denominator Exclusion Patient refusal to complete IPSS or AUASI document. Denominator exceptions: Urinary retention , BPH diagnosis during hospitalization or within 30 days of hospitalization
  
  
• HHS NQS Priority: Patient and Family Engagement
  
  
• HHS Data Source: Administrative clinical data, EHR , Registry, Survey, Other
  
  
• Measure Type: Outcome
  
  
• Steward: Large Urology Group Practice Association In collaboration with Oregon Urology Institute
  
  
• Endorsement Status: Never Submitted
  
  
• Is the measure specified as an electronic clinical quality measure? Yes
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional Support for Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure is fully developed and tested. This measure should be submitted to NQF for endorsement. Upon receipt of NQF endorsement, this measure would serve as the only measure to capture longitudinal symptomatic improvement in men suffering from a BPH.
  • Impact on quality of care for patients:This measure addresses patient-centered outcomes by engaging patients in their care.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure addresses the MIPS domain of Person and Caregiver-Centered Experience and Outcomes.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This measure is an outcome measure.
  
  
• Does the measure address a quality challenge? Yes. There can be a performance gap in patients’ completion of the International Prostate Symptom Score (IPSS) or American Urological Association-Symptom Index (AUA-SI). Enhanced user options (e.g. electronic tablet for enhanced readibility) have demonstrated improvements in compliance.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. The measure is not duplicative of an existing measure in the program.
  
  
• Can the measure can be feasibly reported? Yes. The measure is fully specified, measure specifications use data found in structured data fields, and data are captured during the course of care.
  
  
• Measure development status: Fully Developed
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? N/A. This measure is not currently in use in any program.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted
  
  

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

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: The Screening/Surveillance Colonoscopy cost measure applies to clinicians who perform screening/surveillance colonoscopy procedures for Medicare beneficiaries. The cost measure is calculated by determining the risk-adjusted episode cost, averaged across all of a clinician’s episodes during the measurement period. The cost of each episode is the sum of the cost to Medicare for services performed by the attributed clinician and other healthcare providers during the episode window (from the trigger date to 14 days after the trigger date).
  
  
• Numerator: The numerator of the Screening/Surveillance Colonoscopy cost measure is the sum of the ratio of observed to expected payment-standardized cost to Medicare for all episodes attributed to a clinician. This is then multiplied by the national average observed episode cost to generate a dollar figure.
  
  
• Denominator: The cost measure denominator is the total number of episodes from the Screening/Surveillance Colonoscopy episode group attributed to a clinician.
  
  
• Exclusions: The following episode-level exclusions apply: (a) The beneficiary has a primary payer other than Medicare for any amount of time overlapping the episode window or in the 120 days prior to the episode trigger day. (b) No attributed clinician is found for the episode. (c) The episode is not attributed to at least one main clinician. (d) The beneficiary’s date of birth is missing. (e) The beneficiary’s death date occurred before the trigger date. (f) The beneficiary’s death date occurred before the episode ended. (g) The beneficiary was not enrolled in Medicare Part A and B for the entirety of the 120-day lookback period plus episode window, or is enrolled in Part C for any part of the lookback period plus episode window. (h) The episode trigger claim was not performed in an office, IP, OP, or ASC setting based on its place of service.
  
  
• HHS NQS Priority: Making Care Affordable
  
  
• HHS Data Source: Claims
  
  
• Measure Type: Cost/Resource Use
  
  
• Steward: Centers for Medicare & Medicaid Services
  
  
• Endorsement Status: Never Submitted
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional Support for Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure is fully developed and tested. This measure should be submitted to NQF for review and endorsement. The measure testing should match the updated specifications.
  • Impact on quality of care for patients:This measure assesses the cost to Medicare of services performed by the attributed clinician, and other clinicians and providers, during the episode window.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure addresses the MIPS domain of efficiency/cost reduction.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is a newly developed cost and resource use measure.
  
  
• Does the measure address a quality challenge? Yes. This measures addresses a topic with a performance gap. There is variation in spending per episode for both clinician and clinician groups using episodes ending between June 1, 2016 and May 31, 2017. The performance gap for cost per episode has been risk-adjusted. The developer provided information that the performance gap is significant for both clinicians and clinicians group and suggested that costs could be reduced by improvements in clinical practice.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. There are no competing measures in the program and the measure captures a broad population. This measure is new and is not in use in any program.
  
  
• Can the measure can be feasibly reported? Yes. This is a claims-based measure.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? N/A. This measure is fully developed and tested. This measure should be submitted to NQF for review and endorsement. The measure testing should match the updated specifications.
  
  
• Measure development status: Early Development (Note: Since publication of MUC list, NQF has received updates that this is fully developed and tested)
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? Yes. This measure is fully developed and has been tested for reliability and face validity. The reliability testing results indicate the measure is reliable. The measure specifications were refined following testing. The measure was tested at the clinician and group level.This measure has never been submitted to NQF for endorsement.
  
  
• 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 American Cancer Society, colorectal cancer (CRC) is the third most diagnosed cancer among adults in the United States, with an estimated 135,430 new cases of CRC to be diagnosed in 2017, and with about 58 percent of the cases occurring in adults ages 65 and older (Siegel et al., 2017). The CRC screening guidelines released by the United States Preventive Services Task Force (USPSTF) recommend either a screening colonoscopy every 10 years or other screening methods, for adults ages 50 through 75 who are at average risk for developing CRC (Bibbins-Domingo et al., 2016). Although there are a number of CRC screening methods available, screening colonoscopy has become the most common CRC screening test in the United States (Sharaf and Ladabaum, 2013). In the past 10 years, the proportion of Medicare beneficiaries ages 65 and older who have received a colonoscopy since qualifying for Medicare at age 65 have increased from 25 percent in 2000 to 63 percent in 2013 (National Center for Health Statistics, 2016). A study found that in 2012, an estimated $239 million worth of professional fees were paid by Medicare to physicians for performing about 1.1 million screening and diagnostic colonoscopies (Mehta and Manaker, 2014). References: Siegel, R. L., K. D. Miller, S. A. Fedewa, D. J. Ahnen, R. G. Meester, A. Barzi, and A. Jemal. “Colorectal Cancer Statistics, 2017.” [In eng]. CA Cancer J Clin (Mar 1 2017). Bibbins-Domingo, K., D. C. Grossman, S.J. Curry, K. W. Davidson, J. W. Epling, Jr., F. A. Garcia, M. W. Gillman, et al. “Screening for Colorectal Cancer: Us Preventive Services Task Force Recommendation Statement.” [In eng]. JAMA 315, no. 23 (Jun 21, 2016): 2564-75. Sharaf, Ravi N., and Uri Ladabaum. “Comparative Effectiveness and Cost-Effectiveness of Screening Colonoscopy Vs. Sigmoidoscopy and Alternative Strategies.” The American Journal of Gastroenterology 108, no. 1 (2013): 120-32. In Health, United States, 2015: With Special Feature on Racial and Ethnic Health Disparities. Health, United States. Hyattsville, MD, 2016. Mehta, Shivan J., and Scott Manaker. “Should We Pay Doctors Less for Colonoscopy?”. American Journal of Managed Care 20, no. 9 (2014): e365-e68.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: The Knee Arthroplasty cost measure applies to clinicians who perform elective total and partial knee arthroplasties for Medicare beneficiaries. The cost measure is calculated by determining the risk-adjusted episode cost, averaged across all of a clinician’s episodes during the measurement period. The cost of each episode is the sum of the cost to Medicare for services performed by the attributed clinician and other healthcare providers during the episode window (from 30 days prior to the trigger date to 90 days after the trigger date).
  
  
• Numerator: The numerator of the Knee Arthroplasty cost measure is the sum of the ratio of observed to expected payment-standardized cost to Medicare for all episodes attributed to a clinician. This is then multiplied by the national average observed episode cost to generate a dollar figure.
  
  
• Denominator: The cost measure denominator is the total number of episodes from the Knee Arthroplasty episode group attributed to a clinician.
  
  
• Exclusions: The following episode-level exclusions apply: (a) The beneficiary has a primary payer other than Medicare for any amount of time overlapping the episode window or in the 120 days prior to the episode trigger day. (b) No attributed clinician is found for the episode. (c) The episode is not attributed to at least one main clinician. (d) The beneficiary’s date of birth is missing. (e) The beneficiary’s death date occurred before the trigger date. (f) The beneficiary’s death date occurred before the episode ended. (g) The beneficiary was not enrolled in Medicare Part A and B for the entirety of the 120-day lookback period plus episode window, or is enrolled in Part C for any part of the lookback period plus episode window. (h) The episode trigger claim was not performed in an office, IP, OP, or ASC setting based on its place of service. Knee Arthroplasty episodes are also removed using exclusions specific to the Knee Arthroplasty measure that were developed with input from the Musculoskeletal Disease Management - Non-Spine Clinical Subcommittee. The “Exclusions” and “Exclusions_Details” tabs in the Knee Arthroplasty Measure Codes List file include the list of these exclusions as well as the codes used to define them.
  
  
• HHS NQS Priority: Making Care Affordable
  
  
• HHS Data Source: Claims
  
  
• Measure Type: Cost/Resource Use
  
  
• Steward: Centers for Medicare & Medicaid Services
  
  
• Endorsement Status: Never Submitted
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional Support for Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure is fully developed and tested. This measure should be submitted to NQF for review and endorsement. The measure testing should match the updated specifications.
  • Impact on quality of care for patients:This measure assesses the cost to Medicare of services performed by the attributed clinician, and other clinicians and providers, during the episode window.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure addresses the MIPS domain of efficiency/cost reduction.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is a newly developed cost and resource use measure.
  
  
• Does the measure address a quality challenge? Yes. This measures addresses a topic with a performance gap. There is variation in spending per episode for both clinician and clinician groups using episodes ending between June 1, 2016 and May 31, 2017. The performance gap for cost per episode has been risk-adjusted. The developer provided information that the performance gap is significant for both clinicians and clinicians group and suggested that costs could be reduced by improvements in clinical practice.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. There are no competing measures in the program and the measure captures a broad population. This measure is new and is not in use in any program.
  
  
• Can the measure can be feasibly reported? Yes. This is a claims-based measure.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. This measure is fully developed and has been tested for reliability and face validity. The reliability testing results indicate the measure is reliable. The measure specifications were refined following testing. The measure was tested at the clinician and group level.This measure has never been submitted to NQF for endorsement.
  
  
• Measure development status: Early Development (Note: Since publication of MUC list, NQF has received updates that this is fully developed and tested)
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? N/A. The measure is not currently in use.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted
  
  

Rationale for measure provided by HHS
An estimated 45 percent of adults in the United States are at risk for developing knee osteoarthritis during their lifetimes, and as a result, the rate of Medicare enrollees receiving knee arthroplasties, or knee replacements, has been increasing. Between 1991 and 2010, the number of knee arthroplasties increased from 93,230 to 243,802, an increase of more than 160 percent (Cram et al., 2012). A 2012 study observed that 615,050 knee arthroplasties were performed in 2008, a 134 percent increase from 1999, and predicted continued increases at a rate greater than predicted by population growth and prevalence of obesity (Losina et al., 2012). References: Cram, Peter, Xin Lu, Stephen L. Kates, Jasvinder A. Singh, Yue Li, and Brian R. Wolf. "Total knee arthroplasty volume, utilization, and outcomes among Medicare beneficiaries, 1991-2010." Jama 308, no. 12 (2012): 1227-1236. Losina, E., T. S. Thornhill, B. N. Rome, J. Wright, and J. N. Katz. "The Dramatic Increase in Total Knee Replacement Utilization Rates in the United States Cannot Be Fully Explained by Growth in Population Size and the Obesity Epidemic." [In eng]. J Bone Joint Surg Am 94, no. 3 (Feb 01 2012): 201-7.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: The STEMI with PCI cost measure applies to clinicians who manage the inpatient care of Medicare beneficiaries hospitalized for a STEMI requiring PCI. The cost measure is calculated by determining the risk-adjusted episode cost, averaged across all of a clinician’s episodes during the measurement period. The cost of each episode is the sum of the cost to Medicare for services performed by the attributed clinician and other healthcare providers during the episode window (from the trigger date to 30 days after the trigger date).
  
  
• Numerator: The numerator of the STEMI with PCI cost measure is the sum of the ratio of observed to expected payment-standardized cost to Medicare for all episodes attributed to a clinician. This is then multiplied by the national average observed episode cost to generate a dollar figure.
  
  
• Denominator: The cost measure denominator is the total number of episodes from the STEMI with PCI episode group attributed to a clinician.
  
  
• Exclusions: The following episode-level exclusions apply: (a) The beneficiary has a primary payer other than Medicare for any amount of time overlapping the episode window or in the 120 days prior to the episode trigger day. (b) No attributed clinician is found for the episode. (c) The episode is not attributed to at least one main clinician. (d) The beneficiary’s date of birth is missing. (e) The beneficiary’s death date occurred before the trigger date. (f) The beneficiary’s death date occurred before the episode ended. (g) The beneficiary was not enrolled in Medicare Part A and B for the entirety of the 120-day lookback period plus episode window, or is enrolled in Part C for any part of the lookback period plus episode window. (h) The episode trigger claim was not performed in an office, IP, OP, or ASC setting based on its place of service. STEMI with PCI episodes are also removed using exclusions specific to the STEMI with PCI measure that were developed with input from the Cardiovascular Disease Management Clinical Subcommittee. The “Exclusions” and “Exclusions_Details” tabs in the STEMI with PCI Measure Codes List file include the list of these exclusions as well as the codes used to define them.
  
  
• HHS NQS Priority: Making Care Affordable
  
  
• HHS Data Source: Claims
  
  
• Measure Type: Cost/Resource Use
  
  
• Steward: Centers for Medicare & Medicaid Services
  
  
• Endorsement Status: Never Submitted
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional Support for Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure is fully developed and tested. This measure should be submitted to NQF for review and endorsement. The measure testing should match the updated specifications.
  • Impact on quality of care for patients:This measure assesses the cost to Medicare for services performed by the attributed clinician, and other clinicians and providers, during the episode window.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure addresses the MIPS domain of efficiency/cost reduction.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is a newly developed cost and resource use measure.
  
  
• Does the measure address a quality challenge? Yes. This measures addresses a topic with a performance gap. There is variation in spending per episode for both clinician and clinician groups using episodes ending between June 1, 2016 and May 31, 2017. The performance gap for cost per episode has been risk-adjusted. The developer provided information that the performance gap is significant for both clinicians and clinicians group and suggested that costs could be reduced by improvements in clinical practice.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. There are no competing measures in the program and the measure captures a broad population. This measure is new and is not in use in any program.
  
  
• Can the measure can be feasibly reported? Yes. This is a claims-based measure.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. This measure is fully developed and has been tested for reliability and face validity. The reliability testing results indicate the measure is reliable. The measure specifications were refined following testing. The measure was tested at the clinician and group level.This measure has never been submitted to NQF for endorsement.
  
  
• Measure development status: Early Development (Note: Since publication of MUC list, NQF has received updates that this is fully developed and tested)
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? N/A. The measure is not currently in use.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted
  
  

Rationale for measure provided by HHS
The ST-Elevation Myocardial Infarction (STEMI) with Percutaneous Coronary Intervention (PCI) Cost Measure represents one of the most common types of hospitalization among Medicare beneficiaries and is associated with high mortality. It was estimated that acute myocardial infarction (AMI) accounted for $11.5 billion in total hospital costs in 2011. There are approximately 580,000 new incidences of AMI each year in the US and 210,000 recurrent incidences (AHA, 2017). The average age at the first AMI is 65.3 years for males and 71.8 years for females, so it is a condition that affects the Medicare-aged population. The high prevalence and considerable morbidity and mortality affect beneficiaries and their family members and caregivers. It also exacts a significant economic burden on the healthcare system that has been increasing over time. A 2013 study found that Medicare spending per patient with an AMI has increased: Medicare spending increased by 16.5 percent when comparing a sample of beneficiaries with AMI from 1998 to 1999 to a sample of beneficiaries with AMI in 2008. Most of the observed expenditure growth resulted from the increased use of home health agencies, hospices, durable medical equipment, skilled nursing facilities, and inpatient services that occurred after the 30 day mark following an AMI and out of the control of Medicare’s bundle payment system (Likosky et al., 2013). References: Benjamin, Emelia J., Michael J. Blaha, Stephanie E. Chiuve, Mary Cushman, Sandeep R. Das, Rajat Deo, Sarah D. de Ferranti et al. "Heart disease and stroke statistics--2017 update: a report from the American Heart Association." Circulation 135, no. 10 (2017): e146-e603. Likosky, Donald S., Weiping Zhou, David J. Malenka, William B. Borden, Brahmajee K. Nallamothu, and Jonathan S. Skinner. "Growth in Medicare expenditures for patients with acute myocardial infarction: a comparison of 1998 through 1999 and 2008." JAMA internal medicine 173, no. 22 (2013): 2055-2061.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: The Revascularization for Lower Extremity Chronic Critical Limb Ischemia cost measure applies to clinicians who perform elective revascularization for lower extremity chronic critical limb ischemia for Medicare beneficiaries. The cost measure is calculated by determining the risk-adjusted episode cost, averaged across all of a clinician’s episodes during the measurement period. The cost of each episode is the sum of the cost to Medicare for services performed by the attributed clinician and other healthcare providers during the episode window (from 30 days prior to the trigger date to 90 days after the trigger date).
  
  
• Numerator: The numerator of the Revascularization for Lower Extremity Chronic Critical Limb Ischemia cost measure is the sum of the ratio of observed to expected payment-standardized cost to Medicare for all episodes attributed to a clinician. This is then multiplied by the national average observed episode cost to generate a dollar figure.
  
  
• Denominator: The cost measure denominator is the total number of episodes from the Revascularization for Lower Extremity Chronic Critical Limb Ischemia episode group attributed to a clinician.
  
  
• Exclusions: The following episode-level exclusions apply: (a) The beneficiary has a primary payer other than Medicare for any amount of time overlapping the episode window or in the 120 days prior to the episode trigger day. (b) No attributed clinician is found for the episode. (c) The episode is not attributed to at least one main clinician. (d) The beneficiary’s date of birth is missing. (e) The beneficiary’s death date occurred before the trigger date. (f) The beneficiary’s death date occurred before the episode ended. (g) The beneficiary was not enrolled in Medicare Part A and B for the entirety of the 120-day lookback period plus episode window, or is enrolled in Part C for any part of the lookback period plus episode window. (h) The episode trigger claim was not performed in an office, IP, OP, or ASC setting based on its place of service
  
  
• HHS NQS Priority: Making Care Affordable
  
  
• HHS Data Source: Claims
  
  
• Measure Type: Cost/Resource Use
  
  
• Steward: Centers for Medicare & Medicaid Services
  
  
• Endorsement Status: Never Submitted
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional Support for Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:TThis measure is fully developed and tested. This measure should be submitted to NQF for review and endorsement. The measure testing should match the updated specifications.
  • Impact on quality of care for patients:This measure assesses the cost to Medicare of services performed by the attributed clinician, and other clinicians and providers, during the episode window.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure addresses the MIPS domain of efficiency/cost reduction.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is a cost/resource use measure that addresses the resource use of revascularization for lower extremity chronic limb ischemia relative to the national median. Roughly 8.5 million people in the United States are affected by Peripheral Vascular Disease (PVD). The total costs of PVD in the United States are over $21 billion annually, (Ogilvie et al., 2017).A subset of PVD patients have critical limb ischemia (CLI).The costs of CLI in the United States are over $4 billion, (Ibid).
  
  
• Does the measure address a quality challenge? Yes. This measures addresses a topic with a performance gap. There is variation in spending per episode for both clinician and clinician groups using episodes ending between June 1, 2016 and May 31, 2017. The performance gap for cost per episode has been risk-adjusted. The developer provided information that the performance gap is significant for both clinicians and clinicians group and suggested that costs could be reduced by improvements in clinical practice. .
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. There are no competing measures in the program and the measure captures a broad population. This measure is new and is not in use in any program.
  
  
• Can the measure can be feasibly reported? Yes. This cost/resource use measure use claims as the data source.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. This measure is fully developed and has been tested for reliability and face validity. The reliability testing results indicate the measure is reliable. The measure specifications were refined following testing. The measure was tested at the clinician and group level.This measure has never been submitted to NQF for endorsement.
  
  
• Measure development status: Early Development (Note: Since publication of MUC list, NQF has received updates that this is fully developed and tested)
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? N/A. The measure is not currently in use.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted
  
  

Rationale for measure provided by HHS
Roughly 8.5 million people in the United States are affected by Peripheral Vascular Disease (PVD), and according to the CDC this includes between 12 and 20 percent of individuals over age 60 (CDC, 2017). Additionally, five percent of Americans over the age of 50 have PVD (NIH, 2017). A host of factors increase the risk of PVD. For example, the condition affects one in three diabetics and one in three people with heart disease, and the risk of PVD increases with high blood pressure and high cholesterol (NIH, 2017). PVD is treated by a variety of methods including lifestyle change, such as exercise, cessation of smoking, and weight reduction, or for cases unresponsive to these changes alone, medication to lower blood pressure and cholesterol or dissolve clots, or surgical procedures such as revascularization (NIH, 2017).The total costs of PVD in the United States are over $21 billion annually, and PVD is associated with reduced quality of life and increased risk of amputation and death (Ogilvie et al., 2017). A subset of PVD patients has critical limb ischemia (CLI) (in which blood flow to the extremities is greatly reduced, causing pain, ulcers, or sores), and this is considered the end stage of PVD, in which revascularization is necessary to prevent the dysfunction and loss of a limb (Farber and Eberhardt, 2016). The costs of CLI in the United States are over $4 billion, and CLI patients have an annual cardiovascular event rate of 5 percent to 7 percent, as well as a 2-year mortality rate of 40 percent (Ibid). References: CDC. “Peripheral Arterial Disease (PAD) Fact Sheet.” https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_pad.htm [Accessed July 29, 2017]. NIH. “Facts About Peripheral Arterial Disease (P.A.D.).” NIH Publication No. 06-5837. (Aug 2006). https://www.nhlbi.nih.gov/health/educational/pad/docs/pad_extfctsht_general_508.pdf [Accessed July 29, 2017]. Ogilvie, R.P., P.L. Lutsey, G. Heiss, A.R. Folsom, and L.M. Steffen. “Dietary intake and peripheral arterial disease incidence in middle-aged adults: the Atherosclerosis Risk in Communities (ARIC) Study.” [In eng]. The American Journal of Clinical Nutrition. 105, no. 3 (Mar 2017): 651-659. Farber, A., R.T. Eberhardt. “The Current State of Critical Limb Ischemia: A Systematic Review.” [In eng]. JAMA Surgery. 151, no. 11 (Nov 2016): 1070-1077.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: The percentage of patients 60 years of age and older who have a Varicella Zoster (shingles) vaccination
  
  
• Numerator: Patients with a shingles vaccine ever recorded
  
  
• Denominator: Patients 60 years of age and older
  
  
• Exclusions: n/a
  
  
• HHS NQS Priority: Effective Prevention and Treatment (*NQF received an update following the publication of the MUC List that this should be categorized as "Working with communities to promote wide use of best practices to enable healthy living")
  
  
• HHS Data Source: Registry
  
  
• Measure Type: Process
  
  
• Steward: PPRNet 
  
  
• Endorsement Status: Submitted
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional Support for Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure is fully developed and tested. The program measure set does not currently have any measures related to Varicella Zoster (shingles). This measure should be submitted to NQF for review and endorsement.
  • Impact on quality of care for patients:This measures encourages the measurement of the patients (60 years and older) who have received the shingles vaccine. A complication of varicella Zoster (shingles) is post herpetic neuralgia (PHN), a chronic and debilitating pain condition. One study found the vaccine has an efficacy of 39.6% for prevention of herpes zoster and 60.1% for prevention of PHN.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure addresses the MIPS domain of effective clinical care.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is a process measure. The Advisory Committee on Immunization Practices (ACIP) of CDC recommends Zosters (shingles) vaccine for adults over 60.
  
  
• Does the measure address a quality challenge? Yes. The measure addresses an performance gap. The median performance across eligible providers in PPRNet is 47.9%.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. MIPS does not currently include measures related to Zoster (shingles).
  
  
• Can the measure can be feasibly reported? Yes. All data elements can be abstracted from EHR 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. The measure testing has demonstrated reliability and validity for the clinician and group level of analyses.
  
  
• Measure development status: Fully Developed
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? No. There have been no implementation issues identified. This measure has been used in QCDR (non-PQRS) Measure Reporting (2015-2016) and is currently used in QCDR (non-MIPS) 2017.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Submitted
  
  
• Preliminary analysis of the MAP Medicaid-relevant measure: Support measurement for preventive care. Note: Not NQF endorsed.
  
  

Rationale for measure provided by HHS
The CDC ACIP first recommended the zoster vaccine in 2008. Harpaz R, Ortega-Sanchez IR, Seward JF. Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2008;57(No. RR-5) states that "Zoster is a localized, generally painful cutaneous eruption that occurs most frequently among older adults and immunocompromised persons. . Approximately one in three persons will develop zoster during their lifetime, resulting in an estimated 1 million episodes in the United States annually. A common complication of zoster is postherpetic neuralgia (PHN), a chronic, often debilitating pain condition that can last months or even years. The risk for PHN in patients with zoster is 10%-18%. Another complication of zoster is eye involvement, which occurs in 10%-25% of zoster episodes and can result in prolonged or permanent pain, facial scarring, and loss of vision. Approximately 3% of patients with zoster are hospitalized; many of these episodes involved persons with one or more immunocompromising condition." The 2014 update on the recommendation published in MMWR, August 22, 2014, Vol 63, 33:729-731 cited two studies that have evaluated the short-term efficacy of the zoster vaccine in adults aged ≥60 years. The shingles prevention study, a randomized controlled trial, followed 38,546 subjects for up to 4.9 years after vaccination and found a vaccine efficacy of 51.3% (CI = 44.2%-57.6%) for prevention of herpes zoster and 66.5% (CI = 47.5%-79.2%) for prevention of PHN. The short-term persistence substudy followed a subset of 14,270 subjects primarily 4 to 7 years after vaccination and found a vaccine efficacy of 39.6% (CI = 18.2%-55.5%) for prevention of herpes zoster and 60.1% (CI = -9.8%-86.7%) for prevention of PHN. The NQF deems zoster vaccine as a priority in its report, Priority Setting for Healthcare Performance Measurement: Addressing Performance Measure Gaps for Adult Immunizations FINAL REPORT AUGUST 15, 2014. http://www.qualityforum.org/Publications/2014/08/Adult_Immunizations_Final_Report.aspx

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: Composite outcome assessment documenting an improvement in the clinical evaluation of patients using the venous clinical severity score (VCSS) and on a disease-specific PRO survey instrument following ilio-femoral venous stenting
  
  
• Numerator: Number of patients who demonstrate improvement in a disease specific patient reported quality of life score AND who document improvement in the Venous Clinical Severity Score 3-6 months after ilio-femoral venous stenting.
  
  
• Denominator: The total number of patients undergoing ilio-femoral venous stenting
  
  
• Exclusions: Patients who did not complete a disease specific patient reported quality of life score at baseline or 3-6 months post-procedure OR Did not return to clinic 3-6 months post-procedure for assessment of the Venous Clinical Severity Score
  
  
• HHS NQS Priority: Patient and Family Engagement
  
  
• HHS Data Source: Hybrid, Registry (enter which Registry in the field below)
  
  
• Measure Type: Composite Outcome
  
  
• Steward: Society of Interventional Radiology;
  
  
• Endorsement Status: Never Submitted
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Refine and Resubmit Prior to Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This newly developed measure has not yet been tested. The individual measures have been tested separately. Benchmarking will be available on those individual measures by the end of the yearThis measure is not an eCQM and uses a hybrid of registry and EHR data. This measure testing should demonstrate reliability and validity at the clinician level.
  • Impact on quality of care for patients:This measure encourages the use of a standardized clinical PRO survey to assess the clinical evaluation of patients who have undergone an ilio-femoral venous stenting.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure addresses the MIPS domains of person and caregiver-centered experience and outcomes and patient safety.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is a composite measure supported by the following quality improvement guideline and position statement:1.Vendantham et al. Society of Interventional Radiology Position Statement: Treatment of Acute Iliofemoral Deep Vein Thrombosis with Use of Adjunctive Catheter-Directed Intrathrombus Thyombolysis. JVIR 2006; 17: 417-434.2.Vendantham et al. Quality improvement guidelines for the treatment of lower-extremity deep venous thrombosis with use of endovascular thrombus removal. JVIR 2014; 25: 1317-1325.
  
  
• Does the measure address a quality challenge? Yes. Currently, there is no standardized clinical assessment and patient documentation of disease severity before and after ilio-femoral venous stenting will lead to better communication of disease severity between health care providers, and better patient selection and objective treatment planning and follow-up management for this complex patient population. This measure would fill this gap.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. Currently MIPS does not have any measures that assesses an improvement in the clinical evaluation of patients using the venous clinical severity score (VCSS) and on a disease-specific PRO survey instrument following ilio-femoral venous stenting. The design of this measure as a composite measure combining a PRO with a clinical disease severity score was suggested by the MAP review of individual measures (MUC15-411 & MUC15-413).
  
  
• Can the measure can be feasibly reported? Yes. This measure is not an eCQM and utilizes a hybrid source of EHR and/or claims data from the 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? N/A. This measure is in early development and has not yet been tested for reliability and validity.This measure has never been submitted to NQF for endorsement.
  
  
• Measure development status: Early Development
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? N/A. This measure is in early development and is not in use.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted
  
  

Rationale for measure provided by HHS
The financial burden of chronic venous disease on the health-care system is enormous, with recent estimates placing the cost of CVD treatment at $3 billion per year in the United States, or up to 2% of the total health-care budget of all Western countries. The post-thrombotic syndrome (PTS) is a frequent and important complication of deep venous thrombosis (DVT) with as many as two-thirds of patients developing symptoms of pain, edema, hyperpigmentation, or ulceration. Ilio-femoral vein stenting has become a safe and effective alternative to traditional open surgery to correct iliac vein obstruction as a cause of post thrombotic syndrome. A RAND evidence review in 2013 reported relief of pain (86-94%), relief from swelling (66%-89%) and healing of venous ulcers (55-89%) in published studies, thereby improving quality of life. The RAND summary concluded the benefits outweigh the risks (1B). The Venous Clinical Severity Score (VCSS) replaced the older CEAP (clinical grade, etiology, anatomy, pathophysiology) grading system to assess the severity of chronic venous disease. Unlike the CEAP system, the venous clinical severity score is more useful in the assessment of changes in venous disease and thus is most appropriate to apply to patients undergoing treatment to assess outcomes from therapy, such as ilio-femoral venous stenting. By encouraging the routine use of the venous clinical severity score, centers will be able to objectively assess the intermediate outcome of venous stenting on the symptoms and signs of chronic venous disease. The VCSS score focuses more on the clinical signs, rather than patient symptoms, which was demonstrated to be a more useful marker for subtle changes in the severity of venous disease. o Analysis of patients from the American Venous Forum (AVF), National Venous Screening Program (NVSP) data registry from 2007 to 2009 concluded that VCSS has more global application in determining overall severity of venous disease than other venous assessment tools. (J Vasc Surg 2011;54:2S-9S.) o The Chronic Venous Insufficiency Questionnaire, the Venous Insufficiency Epidemiological and Economic Study, the Aberdeen Varicose Vein Questionnaire, and the Charing Cross Venous ulceration questionnaire, among others, are validated disease-specific instruments to assess patient symptoms before and after iliofemoral venous stenting in patient with deep venous system abnormalities. These surveys are complimentary to commonly used clinical scoring systems including the venous clinical severity score or the villalta score. Indeed one study suggests that combination of the Villalta score with a venous disease-specific quality-of-life questionnaire, to be considered the “reference standard” for the diagnosis and classification of post-thrombotic syndrome (Soosainathan A, Moore HM, Gohel MS, Davies AH. Scoring systems for the post-thrombotic syndrome. J Vasc Surg. 2013 Jan;57(1):254-61.) o In addition, this measure is supported by the following quality improvement guideline and position statement: 1. Vendantham et al. Society of Interventional Radiology Position Statement: Treatment of Acute Iliofemoral Deep Vein Thrombosis with Use of Adjunctive Catheter-Directed Intrathrombus Thyombolysis. JVIR 2006; 17: 417-434. 2. Vendantham et al. Quality improvement guidelines for the treatment of lower-extremity deep venous thrombosis with use of endovascular thrombus removal. JVIR 2014; 25: 1317-1325.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: The Elective Outpatient PCI cost measure applies to clinicians who perform elective outpatient PCIs for Medicare beneficiaries. The cost measure is calculated by determining the risk-adjusted episode cost, averaged across all of a clinician’s episodes during the measurement period. The cost of each episode is the sum of the cost to Medicare for services performed by the attributed clinician and other healthcare providers during the episode window (from the trigger date to 30 days after the trigger date).
  
  
• Numerator: The numerator of the Elective Outpatient PCI cost measure is the sum of the ratio of observed to expected payment-standardized cost to Medicare for all episodes attributed to a clinician. This is then multiplied by the national average observed episode cost to generate a dollar figure.
  
  
• Denominator: The cost measure denominator is the total number of episodes from the Elective Outpatient PCI episode group attributed to a clinician.
  
  
• Exclusions: The following episode-level exclusions apply: (a) The beneficiary has a primary payer other than Medicare for any amount of time overlapping the episode window or in the 120 days prior to the episode trigger day. (b) No attributed clinician is found for the episode. (c) The episode is not attributed to at least one main clinician. (d) The beneficiary’s date of birth is missing. (e) The beneficiary’s death date occurred before the trigger date. (f) The beneficiary’s death date occurred before the episode ended. (g) The beneficiary was not enrolled in Medicare Part A and B for the entirety of the 120-day lookback period plus episode window, or is enrolled in Part C for any part of the lookback period plus episode window. (h) The episode trigger claim was not performed in an office, IP, OP, or ASC setting based on its place of service. Elective Outpatient PCI episodes are also removed using exclusions specific to the Elective Outpatient PCI measure that were developed with input from the Cardiovascular Disease Management Clinical Subcommittee. The “Exclusions” and “Exclusions_Details” tabs in the Elective Outpatient PCI Measure Codes List file include the list of these exclusions as well as the codes used to define them.
  
  
• HHS NQS Priority: Making Care Affordable
  
  
• HHS Data Source: Claims
  
  
• Measure Type: Cost/Resource Use
  
  
• Steward: Centers for Medicare & Medicaid Services
  
  
• Endorsement Status: Never Submitted
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional Support for Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure is fully developed and tested. This measure should be submitted to NQF for review and endorsement. The measure testing should match the updated specifications.
  • Impact on quality of care for patients:This measure assesses the cost to Medicare for services performed by the attributed clinician, and other clinicians and providers, during the episode window.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure addresses the MIPS domain of efficiency/cost reduction.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is a cost/resource use measure. PCI procedures are performed in 600,000 patients each year and have the highest aggregate costs of all cardiovascular procedures, totaling about $10 billion annually (Amin et al., 2017). Between 2005 and 2010, PCI prices increased by 19.1 percent nationally, significantly more than the rate of inflation during the same period (Dor et al., 2015).
  
  
• Does the measure address a quality challenge? Yes. This measures addresses a topic with a performance gap. There is variation in spending per episode for both clinician and clinician groups using episodes ending between June 1, 2016 and May 31, 2017. The performance gap for cost per episode has been risk-adjusted. The developer provided information that the performance gap is significant for both clinicians and clinicians group and suggested that costs could be reduced by improvements in clinical practice.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. There are no competing measures in the program and the measure captures a broad population. This measure is new and is not in use in any program.
  
  
• Can the measure can be feasibly reported? Yes. This cost/resource use measure use claims as the data source.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. This measure is fully developed and has been tested for reliability and face validity. The reliability testing results indicate the measure is reliable. The measure specifications were refined following testing. The measure was tested at the clinician and group level.This measure has never been submitted to NQF for endorsement.
  
  
• Measure development status: Early Development (Note: Since publication of MUC list, NQF has received updates that this is fully developed and tested)
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? N/A. The measure is not currently in use.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted
  
  

Rationale for measure provided by HHS
Percutaneous coronary intervention (PCI) is one of the most common major medical procedures performed in the United States. PCI procedures are performed in 600,000 patients each year and have the highest aggregate costs of all cardiovascular procedures, totaling about $10 billion annually (Amin et al., 2017). Between 2005 and 2010, PCI prices increased by 19.1 percent nationally, significantly more than the rate of inflation during the same period (Dor et al., 2015). Approximately 25 percent of patients treated with PCI are 75 years or older and 12 percent are 80 years or older. This growing trend of the use of PCI in the elderly does not appear to be slowing (Vandermolen et al., 2015). With increased age, there are also greater risks for procedural complications, including bleeding (Wang et al., 2011). Other notable complications include vascular compromise (Anderson et al., 2002), stroke, recurrent infarction (Lee 2015), and death (Aggawal et al., 2013). To focus on one type of complication affecting the Medicare population, the risk of bleeding remains highest in older adults (Dodson & Maurer, 2011). This is associated with increased morbidity, mortality, lengthened hospitalization, transfusions, and other significant costs following PCI. (Dauerman et al., 2011). References: Amin, Amit P., Mark Patterson, John A. House, Helmut Giersiefen, John A. Spertus, Dmitri V. Baklanov, Adnan K. Chhatriwalla et al. "Costs associated with access site and same-day discharge among Medicare beneficiaries undergoing percutaneous coronary intervention: an evaluation of the current percutaneous coronary intervention care pathways in the United States." JACC: Cardiovascular Interventions 10, no. 4 (2017): 342-351. Dor, Avi, William E. Encinosa, and Kathleen Carey. "Medicare’s hospital compare quality reports appear to have slowed price increases for two major procedures." Health affairs 34, no. 1 (2015): 71-77. Vandermolen, Sebastian, Jane Abbott, and Kalpa De Silva. "What’s age got to do with it? A review of contemporary revascularization in the elderly." Current cardiology reviews 11, no. 3 (2015): 199-208. Wang, Tracy Y., Antonio Gutierrez, and Eric D. Peterson. "Percutaneous coronary intervention in the elderly." Nature Reviews Cardiology 8, no. 2 (2011): 79-90. Anderson, H. Vernon, Richard E. Shaw, Ralph G. Brindis, Kathleen Hewitt, Ronald J. Krone, Peter C. Block, Charles R. McKay, and William S. Weintraub. "A contemporary overview of percutaneous coronary interventions: the American College of Cardiology--National Cardiovascular Data Registry (ACC--NCDR)." Journal of the American College of Cardiology39, no. 7 (2002): 1096-1103. Lee, Joo Myung, Doyeon Hwang, Jonghanne Park, Kyung-Jin Kim, Chul Ahn, and Bon-Kwon Koo. "Percutaneous coronary intervention at centers with and without on-site surgical backup: an updated meta-analysis of 23 studies." Circulation (2015): CIRCULATIONAHA-115. Aggarwal, Bhuvnesh, Stephen G. Ellis, A. Michael Lincoff, Samir R. Kapadia, Joseph Cacchione, Russell E. Raymond, Leslie Cho et al. "Cause of death within 30 days of percutaneous coronary intervention in an era of mandatory outcome reporting." Journal of the American College of Cardiology 62, no. 5 (2013): 409-415. Dodson, John A., and Mathew S. Maurer. "Changing nature of cardiac interventions in older adults." Aging health 7, no. 2 (2011): 283-295. Dauerman, Harold L., Sunil V. Rao, Frederic S. Resnic, and Robert J. Applegate. "Bleeding avoidance strategies." Journal of the American College of Cardiology 58, no. 1 (2011): 1-10.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: This cost measure applies to clinicians who manage the inpatient care of Medicare beneficiaries hospitalized for an intracranial hemorrhage or cerebral infarction. The cost measure is calculated by determining the risk-adjusted episode cost, averaged across all of a clinician’s episodes during the measurement period. The cost of each episode is the sum of the cost to Medicare for services performed by the attributed clinician and other healthcare providers during the episode window (from the trigger date to 90 days after the trigger date).
  
  
• Numerator: The numerator of the Intracranial Hemorrhage or Cerebral Infarction cost measure is the sum of the ratio of observed to expected payment-standardized cost to Medicare for all episodes attributed to a clinician. This is then multiplied by the national average observed episode cost to generate a dollar figure.
  
  
• Denominator: The cost measure denominator is the total number of episodes from the Intracranial Hemorrhage or Cerebral Infarction episode group attributed to a clinician.
  
  
• Exclusions: The following episode-level exclusions apply: (a) The beneficiary has a primary payer other than Medicare for any amount of time overlapping the episode window or in the 120 days prior to the episode trigger day. (b) No attributed clinician is found for the episode. (c) The episode is not attributed to at least one main clinician. (d) The beneficiary’s date of birth is missing. (e) The beneficiary’s death date occurred before the trigger date. (f) The beneficiary’s death date occurred before the episode ended. (g) The beneficiary was not enrolled in Medicare Part A and B for the entirety of the 120-day lookback period plus episode window, or is enrolled in Part C for any part of the lookback period plus episode window. (h) The episode trigger claim was not performed in an office, IP, OP, or ASC setting based on its place of service.
  
  
• HHS NQS Priority: Making Care Affordable
  
  
• HHS Data Source: Claims
  
  
• Measure Type: Cost/Resource Use
  
  
• Steward: Centers for Medicare & Medicaid Services
  
  
• Endorsement Status: Never Submitted
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional Support for Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure is fully developed and tested. This measure should be submitted to NQF for review and endorsement. The measure testing should match the updated specifications.
  • Impact on quality of care for patients:This measure assesses the cost to Medicare for services performed by the attributed clinician, and other clinicians and providers, during the episode window.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure addresses the MIPS domain of cost efficiency/cost reduction.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is a cost/resource use measure. A 2010 study estimated that ischemic strokes alone, which represent a majority of overall strokes, were responsible for close to $65.5 billion of healthcare spending in the US given the need for long-term care after the events (Guilhaume et al., 2010).
  
  
• Does the measure address a quality challenge? Yes. This measures addresses a topic with a performance gap. There is variation in spending per episode for both clinician and clinician groups using episodes ending between June 1, 2016 and May 31, 2017. The performance gap for cost per episode has been risk-adjusted. The developer provided information that the performance gap is significant for both clinicians and clinicians group and suggested that costs could be reduced by improvements in clinical practice.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. There are no competing measures in the program and the measure captures a broad population. This measure is new and is not in use in any program.
  
  
• Can the measure can be feasibly reported? Yes. This cost/resource use measure use claims as the data source.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. This measure is fully developed and has been tested for reliability and face validity. The reliability testing results indicate the measure is reliable. The measure specifications were refined following testing. The measure was tested at the clinician and group level.This measure has never been submitted to NQF for endorsement.
  
  
• Measure development status: Early Development (Note: Since publication of MUC list, NQF has received updates that this is fully developed and tested)
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? N/A. The measure is not currently in use. use.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted
  
  

Rationale for measure provided by HHS
Intracranial hemorrhage and ischemic stroke are common conditions that can have serious consequences for patients and their families, such as death or permanent disability. Approximately 780,000 Americans suffer a new or recurring stroke every year (Guilhaume et al., 2010). Strokes are the leading cause of permanent disability in adults and the third leading cause of death in the US, with a 30 day mortality rate of around 8 percent for patients who have suffered an ischemic stroke and 20 percent in the case of a hemorrhagic stroke (Birenbaum 2010, Collins et al., 2003). Elderly patients are particularly at risk after suffering from either an ischemic or hemorrhagic stroke with studies showing increased mortality risk in patients age 65 years or older with an ischemic stroke and in patients age 75 years or older with a hemorrhagic stroke. The 30-day mortality rate for hemorrhagic stroke is twice that of the rate for ischemic stroke (Collins et al., 2003). Finally, a 2010 study estimated that ischemic strokes alone, which represent a majority of overall strokes, were responsible for close to $65.5 billion of healthcare spending in the US given the need for long-term care after the events (Guilhaume et al., 2010). References: Guilhaume, Chantal, Delphine Saragoussi, John Cochran, Clément François, and Mondher Toumi. "Modeling Stroke Management: A Qualitative Review of Cost-Effectiveness Analyses." The European Journal of Health Economics : HEPAC 11, no. 4 (August 2010): 419-26. Birenbaum, Dale. "Emergency Neurological Care of Strokes and Bleeds." Journal of Emergencies, Trauma and Shock 3, no. 1 (January 2010): 52-61. Collins, Tracie C., Nancy J. Petersen, Terri J. Menke, Julianne Souchek, Wednesday Foster, and Carol M. Ashton. "Short-Term, Intermediate-Term, and Long-Term Mortality in Patients Hospitalized for Stroke." Journal of Clinical Epidemiology 56, no. 1 (January 2003): 81-7.

Measure Specifications

• NQF Number (if applicable):
  
  
• Description: The Simple Pneumonia with Hospitalization cost measure applies to clinicians who manage the inpatient care of Medicare beneficiaries hospitalized with simple pneumonia. The cost measure is calculated by determining the risk-adjusted episode cost, averaged across all of a clinician’s episodes during the measurement period. The cost of each episode is the sum of the cost to Medicare for services performed by the attributed clinician and other healthcare providers during the episode window (from the trigger date to 30 days after the trigger date).
  
  
• Numerator: The numerator of the Simple Pneumonia with Hospitalization cost measure is the sum of the ratio of observed to expected payment-standardized cost to Medicare for all episodes attributed to a clinician. This is then multiplied by the national average observed episode cost to generate a dollar figure.
  
  
• Denominator: The cost measure denominator is the total number of episodes from the Simple Pneumonia with Hospitalization episode group attributed to a clinician.
  
  
• Exclusions: The following episode-level exclusions apply: (a) The beneficiary has a primary payer other than Medicare for any amount of time overlapping the episode window or in the 120 days prior to the episode trigger day. (b) No attributed clinician is found for the episode. (c) The episode is not attributed to at least one main clinician. (d) The beneficiary’s date of birth is missing. (e) The beneficiary’s death date occurred before the trigger date. (f) The beneficiary’s death date occurred before the episode ended. (g) The beneficiary was not enrolled in Medicare Part A and B for the entirety of the 120-day lookback period plus episode window, or is enrolled in Part C for any part of the lookback period plus episode window. (h) The episode trigger claim was not performed in an office, IP, OP, or ASC setting based on its place of service. Simple Pneumonia with Hospitalization episodes are also removed using exclusions specific to the Simple Pneumonia with Hospitalization measure that were developed with input from the Pulmonary Disease Management Clinical Subcommittee. The “Exclusions” and “Exclusions_Details” tabs in the Simple Pneumonia with Hospitalization Measure Codes List file include the list of these exclusions as well as the codes used to define them.
  
  
• HHS NQS Priority: Making Care Affordable
  
  
• HHS Data Source: Claims
  
  
• Measure Type: Cost/Resource Use
  
  
• Steward: Centers for Medicare & Medicaid Services
  
  
• Endorsement Status: Never Submitted
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional Support for Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure is fully developed and tested. This measure should be submitted to NQF for review and endorsement. The measure testing should match the updated specifications.
  • Impact on quality of care for patients:This measure assesses the cost to Medicare for services performed by the attributed clinician, and other clinicians and providers, during the episode window.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure addresses the MIPS domain of efficiency/cost reduction.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is a cost/resource use measure. A 2012 study found that among the Medicare fee-for-service population, there was an estimated 1.3 million community-acquired pneumonia (CAP) cases and 74,000 CAP-related deaths, accounting for an annual cost of $13 billion (Yu et al., 2012).
  
  
• Does the measure address a quality challenge? Yes. This measures addresses a topic with a performance gap. There is variation in spending per episode for both clinician and clinician groups using episodes ending between June 1, 2016 and May 31, 2017. The performance gap for cost per episode has been risk-adjusted. The developer provided information that the performance gap is significant for both clinicians and clinicians group and suggested that costs could be reduced by improvements in clinical practice.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. There are no competing measures in the program and the measure captures a broad population. This measure is new and is not in use in any program.
  
  
• Can the measure can be feasibly reported? Yes. This cost/resource use measure use claims as the data source.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. This measure is fully developed and has been tested for reliability and face validity. The reliability testing results indicate the measure is reliable. The measure specifications were refined following testing. The measure was tested at the clinician and group level.This measure has never been submitted to NQF for endorsement.
  
  
• Measure development status: Early Development (Note: Since publication of MUC list, NQF has received updates that this is fully developed and tested)
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? N/A. The measure is not currently in use.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Never Submitted
  
  

Rationale for measure provided by HHS
Among adults in the United States, pneumonia is a leading infectious cause of hospitalization and death (Healthcare Cost and Utilization Project, 2013). Although pneumonia encompasses a broad range of diagnoses depending on -- among other things -- where the infection was acquired and certain comorbidities of the patient, simple pneumonia is mostly focused on community-acquired pneumonia (CAP), which is a major driver of Medicare morbidity and mortality. A patient’s pneumonia is considered CAP when the patient has not been hospitalized or been a resident of a long-term care facility for more than 72 hours in the past 90 days before the onset of symptoms (Fung and Monteagudo-Chu, 2010). The annual incidence of CAP requiring hospitalization was 24.8 cases per 10,000 adults, with estimated incidence increasing with age. The estimated incidences of hospitalization among adults in the United States 50 to 64 years of age, 65 to 79 years of age, and 80 years of age or older were approximately 4, 9, and 25 times as high, respectively, compared to the incidence among adults 18 to 49 years of age (Jain et al., 2015). In addition, a 2012 study found that among the Medicare fee-for-service population, there was an estimated 1.3 million CAP cases and 74,000 CAP-related deaths, accounting for an annual cost of $13 billion (Yu et al., 2012). References: Healthcare Cost and Utilization Project. “Statistical Brief #168: Costs for Hospital Stays in the United States, 2011.” (December 2013). Fung, H. B., and M. O. Monteagudo-Chu. "Community-Acquired Pneumonia in the Elderly." [In eng]. Am J Geriatr Pharmacother 8, no. 1 (Feb 2010): 47-62. Jain, S., W. H. Self, R. G. Wunderink, S. Fakhran, R. Balk, A. M. Bramley, C. Reed, et al. "Community-Acquired Pneumonia Requiring Hospitalization among U.S. Adults." [In eng]. N Engl J Med 373, no. 5 (Jul 30 2015): 415-27. Yu, H., J. Rubin, S. Dunning, S. Li, and R. Sato. "Clinical and Economic Burden of Community-Acquired Pneumonia in the Medicare Fee-for-Service Population." [In eng]. J Am Geriatr Soc 60, no. 11 (Nov 2012): 2137-43.

Measure Specifications

• NQF Number (if applicable): 3067
  
  
• Description: Percentage of patients 15-65 years of age who have ever been tested for human immunodeficiency virus (HIV)
  
  
• Numerator: Patients with documentation of the occurrence of an HIV test between their 15th and 66th birthdays and before the end of the measurement period
  
  
• Denominator: Patients 15 to 65 years of age who had an outpatient visit during the measurement period
  
  
• Exclusions: Exclude from the denominator: patients diagnosed with HIV prior to the start of the measurement period
  
  
• HHS NQS Priority: Effective Prevention and Treatment
  
  
• HHS Data Source: EHR
  
  
• Measure Type: Process/Population Health
  
  
• Steward: Centers for Disease Control and Prevention
  
  
• Endorsement Status: Failed Endorsement
  
  
• 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? Yes
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional Support for Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This eCQM has been tested and is fully specified, with specifications data found in structured data fields in an EHR. The measure had previously been submitted to NQF for endorsement, but failed on scientific acceptability. The developer has since implemented changes based on the NQF Standing Committee’s recommendations; however, it has not been resubmitted to NQF for further evaluation. This measure should be submitted to NQF for review and endorsement with completed testing demonstrating reliability and validity at the clinician level.
  • Impact on quality of care for patients:This measure encourages the clinicians to screen and document the testing of HIV for patients 15-65 years of age.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure addresses the MIPS domains of community/population health and effective clinical care.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is a process measure. Based on the National Health Interview Survey, fewer than half of people 18 and older reported ever having been tested for HIV as of 2016 (Clarke 2017).
  
  
• Does the measure address a quality challenge? Yes. In the United States, an estimated 1.2 million people are living with human immunodeficiency virus (HIV), a serious, communicable infection that, if untreated, leads to illness and premature death (CDC 2016).
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. MIPS does not currently have measures that address the screening of patients for HIV/AIDS.
  
  
• Can the measure can be feasibly reported? Yes. Early feasibility testing has found mixed results. Testing results indicate that the structured fields necessary to support this measure are present in EHRs, however prior tests from other providers were not consistently captured in the EHR. A manual review of patient files showed that of the patients with no HIV test in the automated data extraction, approximately 6% of patients had, in fact, been tested for HIV. Consequently, the measure may not capture a patient’s full HIV screening history as intended.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. This measure was submitted the Health and Well-Being project and was not endorsed. The measure did not pass the reliability criteria because it did not exclude patients diagnosed with HIV prior to the start of the measurement period. The developer has since updated the measure to account for this exclusion.The measure has been tested and full specifications are provided. The measure testing has been tested for reliability and validity at the clinician and group level of analysis.Per the developer, electronically extracted and manually abstracted data had agreement rates of over 90% for both the denominator and numerator. The kappa statistics showed moderate to excellent agreement, 0.66 for the denominator, and 0.76 for the numerator, indicating high data element validity. The agreement rate for HIV diagnosis rate was also high (95.3 percent), but the weighted kappa was only 0.57, showing moderate agreement. In most cases where the dates did not agree, the abstractors identified older HIV diagnoses on the patient records than were included in the electronic health record extract. This finding suggests that the measures might not accurately exclude all patients with HIV diagnoses prior to the measurement period, which might reduce a provider’s score. Also, the measure also shows high provider-performance reliability, with a median of 0.94 for clinicians with more than 10 patients in the denominator, and 0.96 for clinicians with more than 50 patients in the denominator.In addition, face validity testing showed about half of clinicians interviewed supported the exclusion of patients who refuse the HIV test. Conversely, about half of the clinicians interviewed supported the including patients who refuse testing in the denominator. The measure does not currently exclude this population.
  
  
• Measure development status: Field Testing
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? N/A. This measure is tested and has not been implemented
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Failed Endorsement
  
  
• Does the measure address a high-priority quality issue in the dual eligible beneficiary population? Yes; Dual eligible beneficaries have a higher incidence of HIV than Medicare beneficaries .
  
  
• Preliminary analysis of the MAP Medicaid-relevant measure: Support measurement of screening for chronic illnesses. There is one HIV measure in the 2017 Adult Core Set. Addresses gap Note: Measure was not recommended by the Health and Well Being Standing Committee for endorsement .
  
  

Rationale for measure provided by HHS
HIV is a communicable infection that leads to a progressive disease with a long asymptomatic period. In 2014, approximately 37,600 persons in the United States were newly infected with HIV (CDC 2017). Without treatment, most people develop acquired immunodeficiency syndrome (AIDS) within 10 years of HIV infection. Antiretroviral therapy (ART) delays this progression and increases the length of survival, but it is most effective when initiated during the asymptomatic phase. It is estimated that, on average, an HIV-infected person who is age 25 and receives high quality health care will live an additional 38 years (Farnham 2013). According to guidelines from the U.S. Department of Health and Human Services (HHS), antiretroviral therapy should be used for all HIV-infected people to reduce the risk of disease progression (regardless of CD4 cell count at diagnosis) (Panel on Antiretroviral Guidelines for Adults and Adolescents 2016). In the United States, an estimated 1.2 million people are living with human immunodeficiency virus (HIV), a serious, communicable infection that, if untreated, leads to illness and premature death (CDC 2016). At the end of 2013, 13 percent, or about 161,200, of those infected with HIV were undiagnosed, and almost 23 percent of the people who were diagnosed had a Stage 3 (AIDS) classification at the time of diagnosis (CDC 2016). One study showed that the median CD4 count at diagnosis is less than 350 cells/mm3, which is the threshold commonly used to determine when patients should initiate ART (Althoff et al. 2010). HIV screening identifies infected people who were previously unaware of their infection, which enables them to seek medical and social services that can improve their health and the quality and length of their lives. The use of ART with high levels of medication adherence has been shown to substantially reduce risk for HIV transmission (Panel on Antiretroviral Guidelines for Adults and Adolescents 2016). Based on the National Health Interview Survey, fewer than half of people 18 and older reported ever having been tested for HIV as of 2016 (Clarke 2017). References Althoff, K.N., S.J. Gange, M.B. Klein, J.T. Brooks, R.S. Hogg, R.J. Bosch, M.A. Horber, M.S. Saag, M.M. Kitahata, A.C. Justice, K.A. Gebo, J.J. Eron, S.B. Rourke, M.J. Gill, B. Rodriguez, T.R. Sterling, L.M. Calzavara, S.G. Deeks, J.N. Martin, A.R. Rachlis, S. Napravnik, L.P. Jacobson, G.D. Kirk, A.C. Collier, C.A. Benson, M.J. Silverberg, M. Kushel, J.J. Goedert, R.G. McKaig, S.E. Van Rompaey, J. Zhang, and R.D. Moore. “Late Presentation for Human Immunodeficiency Virus Care in the United States and Canada.” Clinical Infectious Diseases, vol. 50, 2010, pp. 1512-1520. CDC. “Monitoring Selected National HIV Prevention and Care Objectives by Using HIV Surveillance Data--United States and 6 U.S. Dependent Areas--2014.” HIV Surveillance Supplemental Report, vol. 21, no. 4, 2016. CDC. “HIV Incidence: Estimated Annual Infections in the U.S., 2008-2014 Overall and by Transmission Route.” Washington, DC: U.S. Department of Health and Human Services, 2017. Available at https://www.cdc.gov/nchhstp/newsroom/docs/factsheets/HIV-Incidence-Fact-Sheet_508.pdf. Accessed 6/7/2017. Clarke, T.C., Norris, T., Schiller, J.S. “Early Release of Selected Estimates Based on Data from 2016 National Health Interview Survey.” Washington, DC: National Center for Health Statistics, 2017. Available at https://www.cdc.gov/nchs/data/nhis/earlyrelease/earlyrelease201705.pdf. Farnham, P.G., Gopalappa, C., Sansom, S.L., Hutchinson, A.B., Brooks, J.T., Weidle, P.J., Marconi, V.C., Rimland, D. “Updates of Lifetime Costs of Care and Quality-of-Life Estimates for HIV-Infected Persons in the United States: Late Versus Early Diagnosis and Entry Into Care.” Journal of Acquired Immune Deficiency Syndromes, vol. 64, no. 2, 2013, pp. 183-189. Panel on Antiretroviral Guidelines for Adults and Adolescents. “Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents.” 2016. Available at http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed June 13, 2017.

Summary of NQF Endorsement Review

• Year of Most Recent Endorsement Review: 2016
  
  
• Project for Most Recent Endorsement Review: Health and Well-Being 2015-2017
  
  
• Review for Importance: 1a. Evidence: H-10; M-5; L-0; I-0; 1b. Performance Gap: H-12; M-3; L-0; I-0 Rationale: • This new, HIV infection screening measure is based on a 2013 US Preventive Services Task Force (USPSTF) guideline that recommends clinicians screen for HIV infection in adolescents and adults aged 15 to 65 years. The guideline also recommends that younger adolescents and older adults who are at increased risk should also be screened. Grade A: High Certainty of Net Benefit. (Moyer, 2013). • USPSTF found no direct evidence on the effects of screening versus no screening on clinical outcomes. Since the 2013 USPSTF recommendation, however, the developer reported that two randomized controlled trials have demonstrated that immediate initiation of anti-retroviral therapy meaningfully affects morbidity, mortality, and forward transmission. • The Committee asked whether the measure captures patients who are screened, diagnosed, and referred to timely, appropriate care. The developer cited surveillance data that show approximately 70% of HIV infected patients receive care within three months of diagnosis. However, the developer also noted the difficulty of assessing these linkages, especially referral documentation in electronic health records (EHRs). The developer also mentioned unsuccessful uptake of measures that assess retention in care. • Committee members questioned the upper age limit of 65 years. The developer acknowledged interest within the CDC in reexamining the upper age bound, but doubted widespread uptake in the absence of aligned USPSTF guidelines. • The Committee asked why the lower age limit is 15 years, while the CDC recommends screening to begin at age 13. The developer noted significant resistance from influential stakeholder groups when attempts were made to align the measure with CDC’s lower age limit. • The Committee also discussed the challenges of adequately assessing screening for adolescents, specially related to confidentially and unintended consequences of disclosing screening to their parents through insurance claims. • One Committee member noted that “testing” and “screening” were used interchangeably. The CDC uses screening to refer to a generalized assessment of HIV infection, not dependent on risk. Whereas testing is used to refer to risk-based or diagnostic testing. • Several Committee members questioned how “evidence of HIV infection” in the numerator can be substantiated without testing. The developer noted that this was included to capture patients with HIV who were tested or screened at some point. The developer is willing to remove this data element from the numerator and denominator to minimize confusion. • The developer does not have national gap information for this new measure, however testing at four community health centers (CHC) found a range of 20.6-31.1%. Results for a fifth CHC with a significant high-risk pool were 65.3%. • 2011 data from the Behavioral Risk Factor Surveillance System (BRFSS) found that for adults 18- 64 years, • 66.2% of Blacks/African Americans, 44.8% of Hispanics, 38.1% of Whites and 38.8% of other races/ethnicities reported ever being tested for HIV.
  
  
• Review for Scientific Acceptability: 2. Scientific Acceptability of Measure Properties: The measure failed to meet the Scientific Acceptability criteria (2a. Reliability - precise specifications, testing; 2b. Validity - testing, threats to validity) 105 2a. Reliability: H-0; M-5; L-5; I-5; 2b. Validity: H-X; M-X; L-X; I-X Rationale: • This is a Health Quality Measures Format-compliant (HQMF) eMeasure. • All components in the measure logic of the submitted eMeasure are represented using the HQMF and Quality Data Model (QDM). • The submitted eMeasure specifications use existing value sets when possible and use new value sets that have been vetted through the Value Set Authority Center (VSAC). • The measure submission includes test results from five Chicago-area community health centers (CHC) that belong to a Health Center Controlled Network and using GE Centricity Practice Solutions (3 versions among the five sites) and that demonstrate the measure logic can be interpreted precisely and unambiguously. • The submission contained a feasibility assessment of the data elements. For one organization (five sites), data availability, data accuracy, and workflow scored three for each criterion (best possible score). For the second organization, the developer stated the feasibility assessment was conducted early in the development process, so two elements were not included; no information on individual criterion was provided for this early phase assessment. Follow-up with the developer indicated the measure logic is feasible based on an assessment by EHR vendors. • The developer assessed empirical reliability at the data element level and validity of the measure score. • Data element testing used a random sample of 300 charts; 100 patients who met the measure and 200 who did not were pulled for chart review. Data element testing results were 96% sensitivity, 100% specificity, and kappa=0.97. The developer concluded results represent a highly valid and reliable representation of the numerator elements between the manual vs. automated extractions. • Score-level testing involved examining performance at the five different CHCs, each of which involved multiple care sites and three versions of the GE Centricity platform, and also comparing these score results to other practices with established EHRs (Kaiser Permanente Mid-Atlantic States and the Department of Veterans Affairs). • For score-level testing, the developer concluded the share of visits ever screened in its sample “compares favorably” (20.6-65.3%) to the data from Kaiser (35% screened) and VA (22.9% screened for VA facilities in Chicago area. • The Committee raised concern about reliability testing of the data elements in the EHR; specifically, it questioned how patients who opt out were handled; limited geographic focus on Chicago; and verification of previous screening or test without self-reporting. • The developer confirmed that opt outs are not factored into the measure because screening should be part of standard practice. With regard to geographic variation, the developer confirmed future testing in other cities and in different health systems. Finally, the developer acknowledged potential over-testing with this measure, but concluded that the value of testing outweighed the potential risk of over-testing. • Some concerns were raised about the inclusion of HIV status in the numerator and the cumulative effect on the measure’s ability to discern meaningful differences in HIV infection screening for accountability purposes. • While the Committee was generally supportive of the measure, several concerns were raised about the numerator and denominator. Ultimately, the measure failed the Reliability criterion.
  
  

Measure Specifications

• NQF Number (if applicable): 729
  
  
• Description: The percentage of patients 18-75 years of age who had a diagnosis of type 1 or type 2 diabetes and whose diabetes was optimally managed during the measurement period as defined by achieving ALL of the following: - HbA1c less than 8.0 mg/dL - Blood Pressure less than 140/90 mmHg - On a statin medication, unless allowed contraindications or exceptions are present - Non-tobacco user - Patient with ischemic vascular disease is on daily aspirin or anti-platelets, unless allowed contraindications or exceptions are present
  
  
• Numerator: The number of patients in the denominator whose diabetes was optimally managed during the measurement period as defined by achieving ALL of the following: - The most recent HbA1c in the measurement period has a value less than 8.0 mg/dL - The most recent Blood Pressure in the measurement period has a systolic value of less than 140 mmHg AND a diastolic value of less than 90 mmHg - On a statin medication, unless allowed contraindications or exceptions are present - Patient is not a tobacco user - Patient with ischemic vascular disease (Ischemic Vascular Disease Value Set) is on daily aspirin or anti-platelets, unless allowed contraindications or exceptions are present
  
  
• Denominator: 18 years or older at the start of the measurement period AND less than 76 years at the end of the measurement period AND Patient had a diagnosis of diabetes (Diabetes Value Set) with any contact during the current or prior measurement period OR had diabetes (Diabetes Value Set) present on an active problem list at any time during the measurement period. AND At least one established patient office visit (Established Pt Diabetes & Vasc Value Set) for any reason during the measurement period
  
  
• Exclusions: The following exclusions are allowed to be applied to the eligible population: - Patient was a permanent nursing home resident at any time during the measurement period - Patient was in hospice or receiving palliative care at any time during the measurement period - Patient died prior to the end of the measurement period - Patient was pregnant (Diabetes with Pregnancy Value Set) at any time during measurement period - Documentation that diagnosis was coded in error - Patient had only urgent care visits during the measurement period
  
  
• HHS NQS Priority: Effective Prevention and Treatment
  
  
• HHS Data Source: Administrative clinical data, EHR, Paper medical record
  
  
• Measure Type: Composite
  
  
• Steward: MN Community Measurement
  
  
• Endorsement Status: Endorsed - This measure was endorsed in 2015 as a component of composite measure NQF #0729
  
  
• 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: Conditional Support for Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This is a composite measure. There is also the individual component (i.e. HbA1C value) which is reviewed separately for consideration on this year’s MUC list for MSSP as MUC17-215. The composite measure is fully developed tested, and NQF endorsed. There is no duplicative measure in the MSSP program; however, there are related measures to both A1c control (ACO-27) and statin use (ACO-42). NQF recommends condition that there are not duplicate or competing measures in the program.
  • Impact on quality of care for patients:This measure encourages clinicians to improve care management for patients with diabetes, and ultimately improve health outcomes for patients with diabetes.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. The measure addresses the MSSP domain of clinical care for at risk.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is a composite measure that addresses optimal management of diabetes, including processes and outcomes. Specifically, the measure addresses the following components. The most recent HbA1c in the measurement period has a value less than 8.0 mg/dL. The most recent Blood Pressure in the measurement period has a systolic value of less than 140 mmHg AND a diastolic value of less than 90 mmHgOn a statin medication, unless allowed contraindications or exceptions are present: Patient is not a tobacco user, Patient with ischemic vascular disease (Ischemic Vascular Disease Value Set) is on daily aspirin or anti-platelets, unless allowed contraindications or exceptions are present. The measure adheres to clinical guidelines issued by the American Heart Association, American College of Cardiology, and American society of Hypertension, and Institute for Clinical Systems Improvement.
  
  
• Does the measure address a quality challenge? Yes. This measure addresses unwarranted variation in care. An analysis of 94 medical groups found that of the percentage of diabetic patients age 18 to 75 who achieved all five targets identified in the measure averaged 45%, and ranged from 9% to 77%.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. There are related measures to both A1c control (ACO-27) and statin use (ACO-42).
  
  
• Can the measure can be feasibly reported? Yes. This measure is fully specified and data are captured during the course of care. Data sources for the measure include administrative clinical data, EHR, and paper medical records. During the 2015 NQF endorsement review of the current measure, the developer did acknowledge the data collection burden for the new statin component if a patient has not been prescribed a statin (i.e., identifying exceptions due to contraindications).
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. This measure was endorsed in 2015 as NQF #0729. A previous version of the measure was reviewed by the MAP in 2012, 2013, and 2014 and was recommended by MAP all 3 years. It has undergone substantive change related to the cholesterol management component in 2015, therefore is submitted as a new measure. The measure was tested at the group level.
  
  
• Measure development status: Fully Developed
  
  
• If the measure is in current use, do the benefits of the measure outweigh any unreasonable implementation issues that have been identified? No . Measure has been implemented in the Minnesota Department of Health’s Statewide Quality Reporting and Measurement System (SQRMS), using data submitted by all eligible providers. No implementation issues have been identified.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Endorsed - This measure was endorsed in 2015 as a component of composite measure NQF #0729
  
  
• Does the measure address a high-priority quality issue in the dual eligible beneficiary population? Yes; Compared to other Medicare beneficiaries, dual eligibles are much more likely to be diagnosed with diabetes..
  
  
• Preliminary analysis of the MAP Medicaid-relevant measure: Support measurement of managing chronic illness. There are 5 DM measures in the 2017 Adult Core Set..
  
  

Rationale for measure provided by HHS
Addressing Health Care Disparities Using Public Reporting Snowden, A. et al American Journal of Medical Quality August 2012 27 (4): 275-81

Summary of NQF Endorsement Review

• Year of Most Recent Endorsement Review: 2015
  
  
• Project for Most Recent Endorsement Review: Endocrine
  
  
• Review for Importance: 1a. Evidence, 1b. Performance Gap) 1a. Evidence: H-5; M-11; L-0; I-1; 1b. Performance Gap: H-15; 1d. Composite – Quality Construct and Rationale: H-4; M-7; L-4; I-1 Rationale: • For all but one of the components included in this composite (tobacco-free), the developer presented recommendations from the 2014 clinical practice guidelines developed by the Institute for Clinical Systems Improvement (ICSI), which were based on a systematic review of evidence that was graded either high or moderate. Additional evidence-based recommendations from the American College of Cardiology and U.S. Preventive Services Task Force also were presented. Committee members agreed that the evidence supports the relationship between each component and desired health outcomes. • Data provided by the developer indicate that for 2014, only 38.9% of diabetic patients in Minnesota met all five component targets from the composite measure. Committee members agreed that although performance on some of the components is quite high, overall performance indicates opportunity for improvement. • Although some Committee members voiced concern over the “all-or-none” structure of the measure, others agreed that a more comprehensive measure that focuses on management of multiple risk factors is needed. The Committee agreed that the developer description of the quality construct, rationale, and aggregation and weighting approach is explicitly articulated and logical.
  
  
• Review for Scientific Acceptability: 2. Scientific Acceptability of Measure Properties: The measure meets the Scientific Acceptability criteria (2a. Reliability - precise specifications, testing; 2b. Validity - testing, threats to validity) 2a. Reliability: H-9; M-7; L-0; I-0; 2b. Validity: H-1; M-10; L-4; I-1; 2d. Composite: H-1; M-10; L-4; I-1 Rationale: • Committee members noted that the specifications of the statin component of this measure have changed since the most recent endorsement of the measure due to changes in the ACC/AHA clinical practice guidelines on cholesterol management released in November, 2013. In the earlier version of the measure, the statin component assessed reaching a target LDL threshold of < 100 mg/dL; the revised version of this component assesses statin use. • Committee members questioned whether the measure assesses if a patient is on the appropriate statin dose. Developers clarified that the measure does not consider the statin dose but assesses only whether a patient is on a statin. • Members also questioned the age range of 18-75 for the statin component of the measure. The developer clarified that for patients 21-39 years of age, this component is applicable only if the patient has ischemic vascular disease or a very high LDL level, in accordance with the ACC/AHA guidelines. • The developer clarified that the level of analysis for the measure is clinician groups (not individual clinicians), and also noted that multiple clinics may form a clinician group. They also clarified that the measure does not require having a minimum of 30 patients. • Developers presented results of signal-to-noise reliability testing of the performance measure score. They clarified that the beta-binomial method was used for the reliability testing because the composite score itself is a binary (yes/no) measure. Members noted that although the 12 reliability was quite high for most clinician groups, it was lower than 0.7 for some clinician groups. • To demonstrate validity of the performance measure score, developers examined the association between the scores for this measure with the scores from the Optimal Vascular Care measure (NQF #0076), hypothesizing that clinician groups likely provide similar quality of care to different patients who also require management of multiple risk factors. The R2 value from this analysis was 0.64. The developers also described several steps occurring during the data submission process as demonstration of empirical validity testing at the data level element. • Developers also clarified that the measure is risk-adjusted for three factors (insurance type, age group, and diabetes type) and noted that the risk-adjustment strategy was developed using data from all clinicians in Minnesota. However, one member expressed some concern that the only adjustment for sociodemograhic status is insurance type. Developers clarified that other potential risk factors that were considered were not statistically significant and thus were not included in the risk-adjustment model. • Several Committee members voiced concern about holding physicians accountable for the patient’s tobacco use, as some see actual tobacco use (as opposed to efforts for tobacco cessation) as out of the control of the clinician. However, another member referred to data showing that physicians can influence their patients to stop tobacco use. Developers also noted that statewide, they have seen an approximate 2.5% increase in tobacco-free patients in Minnesota. • One Committee member noted the need for clarity about potential adverse effects related to statin use. Another member referenced the flow diagram provided by the developer that details several contraindications for statin use, while another member echoed the importance of the potential for adverse reactions when making treatment decisions. • After developers clarified the performance rates for each of the components, Committee members questioned whether the aspirin component (performance rate =99.5% in MN) is needed in the composite. Developers noted that while this component may be "topped out" in MN, this happened over a four-year period of focus on this component. They also referenced a New England Journal of Medicine article that found a 34.8% performance rate nationally in the primary care setting. Finally, they noted that performance on this component across ACOs is, on average, 75.3%.
  
  
• Review for Feasibility: 3. Feasibility: H-7; M-4; 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 measure data can be collected through electronic clinical data and paper records. • One Committee member noted that, due to the number of components included in the composite, the data collection effort for this composite measure may be intensive. Developers stated that submission of this measure by all clinician groups in MN is mandated by the state. While they acknowledged that MN has many large practices that use EHRs, small practices— even those who still use paper medical records—are able to submit data on this measure. The developers did, however, acknowledge the data collection burden for the new statin component if a patient has not been prescribed a statin (i.e., identifying exceptions due to contraindications).
  
  
• Review for Usability: 4. Usability and Use: H-5; M-7; L-4; 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: • Committee members noted that the measure is publicly reported and is used in pay-forperformance and accreditation programs. Performance is slowly increasing across the state of Minnesota, suggesting quality of care may be improving. • Data submitted by the developer demonstrate relatively consistent improvement of performance in MN from the years 2006-2014. • Committee members agreed that this composite measure is patient-centric and acknowledged the importance of using a comprehensive measure that assesses performance of reducing multiple risk factors. • Some Committee members expressed concern that the measure could incent some providers to "cherry-pick" patients or make their practices less hospitable to certain patients or certain subgroups of patients (the tobacco-free component of the measure was a particular concern).
  
  
• Review for Related and Competing Measures: 5. Related and Competing Measures • This measure is a competing measure to the following measures o 0061: Comprehensive Diabetes Care: Blood Pressure Control (< 7% to < 8% depending on individual patient factors. o 0575: Comprehensive Diabetes Care: Hemoglobin A1c (HbA1c) control (<8%) • NQF staff asked the Committee to discuss whether there is justification for continued endorsement of the individual measures if the composite retains endorsement. The Committee discussed the pros and cons of endorsing both individual measures and the composite measure. The Committee ultimately agreed that while the composite measure is useful to assess patientcentric performance across a variety of clinical areas, endorsement of individual measures also can be beneficial, particularly for users who want to focus on certain components of the composite or those who have data collection constraints and cannot use the composite. The Committee therefore recommended continued endorsement of both the individual measures and the composite measure.
  
  
• Endorsement Public Comments: 6. Public and Member Comment Comments received: • Two commenters raised concern over the glucose control component of the composite, referencing the National Action Plan for Adverse Event Prevention, which was released in August, 2014. The National Action Plan states that the blood glucose threshold of < 7% to < 8% depending on individual patient factors. Benefits: Achieving near-normal glycemic control lowers risk of diabetes microvascular complications such as retinopathy, nephropathy and amputations. Achieving A1c of 6.9 to 7.9% may also significantly reduce macrovascular complications based on Steno-2 and UKPDS data. Quality of Evidence: High Strength of Recommendation: Strong. Measurement does not and should not preclude good clinical judgement; however the measure development work group believes that a target of < 8.0 is reasonable and supported by guidelines. Our measure does have an upper age limit cut-off of 75 years and we allow exclusions for death, permanent nursing home resident or patients who are receiving hospice or palliative care services. • Two commenters were critical of the composite measure itself, citing concern that use of the composite measure could mask the individual care processes that most need improvement. Developer response: While it is true that the measure is reported at the composite level, the individual components and the associated rates are available to the medical groups for better understanding their rates and for use in quality improvement to know which areas have opportunity for improvement. MNCM and the measure development work group firmly believe that achieving the intermediate physiological outcome targets related to blood pressure and glycemic control in addition being tobacco free and use of daily aspirin and statins where appropriate are the diabetic patient’s best mechanisms of avoiding or postponing long term complications associated with this chronic condition which affects millions of Americans. Measuring providers separately on individual targets is not as patient centric as a measure that seeks to reduce multiple risk factors for each patient. Diabetic patients are more likely to reduce their overall risk and maximize health outcomes by achieving several intermediate physiological targets. • Two commenters noted that documenting HbA1c levels >8% but less than 9% cannot be done using CPT-II coding, necessitating need for medical chart review. Developer response: A point of clarification, these measure do not rely on CPTII codes for numerator compliance, nor are they indicated anywhere in our measure specification. Measure specifications focus on the electronic health record as a source of clinical information for calculating numerator compliance; actual A1c values are utilized in the case of the A1c target. Additionally, 80 to 90% of all the clinics in MN are reporting this information from their electronic health records without the need for additional chart abstraction. • One commenter suggested a need for including sociodemographic factors in the risk-adjustment approach. Developer response: Our risk adjustment model does include insurance product, which is a proxy for socioeconomic status. During the process of measure development, the expert panel discusses potential variables for risk adjustment that are important to consider for the measured population. For this measure, variables that are available for evaluation include gender, age, zip, race/ethnicity, country of origin, primary language, insurance product, diabetes type, depression and ischemic vascular disease. The potential risk adjustment variables are then evaluated for appropriate inclusion in the model based on a t value outside the range of -2.0 and +2.0. Currently, the variables that have demonstrated acceptable properties are insurance product, age bands (18-25, 26-50, 51-65 and 65 to 75) and diabetes type (1 or 2). Race/ethnicity has been collected for this measure in MN for the past few years, but has now reached a level of 15 reliability in which it can be evaluated for its impact. MNCM continues to review variables and their impact on the measure and part of its measure risk adjustment strategy. • One commenter suggested the need for additional detail regarding moderate or high intensity in the description of statin use for the measure. Developer response: The measure development work group thoroughly discussed the pros and cons of specifying a certain dose of the statin medication and based on the following factors ultimately decided to not specify a dose of moderate or high intensity for numerator compliance: 1) data burden for practices, 2) controversy and burden surrounding the CV risk calculator, 3) ICSI 2014 Diabetes Guideline recommendations for measurement and 4) cardiology work group member’s believe that there is some benefit for some patients who can only tolerate a lower intensity dose. Committee response: • During its review of the individual measure assessing HbA1c
  
  
• Endorsement Committee Recommendation: Standing Committee Recommendation for Endorsement: Y-13; N-4
  
  

Measure Specifications

• NQF Number (if applicable): *Note - 729 (This measure is a component of the endorsed composite measure NQF #729)
  
  
• Description: The percentage of patients 18-75 years of age who had a diagnosis of type 1 or type 2 diabetes and whose most recent HbA1c during the measurement period was less than 8.0 mg/dL.
  
  
• Numerator: Denominator patients whose most recent HbA1c during the measurement period was less than 8.0 mg/dL.
  
  
• Denominator: 18 years or older at the start of the measurement period AND less than 76 years at the end of the measurement period AND Patient had a diagnosis of diabetes (Diabetes Value Set) with any contact during the current or prior measurement period OR had diabetes (Diabetes Value Set) present on an active problem list at any time during the measurement period. AND At least one established patient office visit (Established Pt Diabetes & Vasc Value Set) for any reason during the measurement period
  
  
• Exclusions: The following exclusions are allowed to be applied to the eligible population: - Patient was a permanent nursing home resident at any time during the measurement period - Patient was in hospice or receiving palliative care at any time during the measurement period - Patient died prior to the end of the measurement period - Patient was pregnant (Diabetes with Pregnancy Value Set) at any time during measurement period - Documentation that diagnosis was coded in error - Patient had only urgent care visits during the measurement period
  
  
• HHS NQS Priority: Effective Prevention and Treatment
  
  
• HHS Data Source: Administrative clinical data, EHR, Paper medical record
  
  
• Measure Type: Intermediate Outcome
  
  
• Steward: MN Community Measurement
  
  
• Endorsement Status: Endorsed - This measure was endorsed in 2015 as a component of composite measure NQF #0729
  
  
• Changes to Endorsed Measure Specifications?: The MUC list indicates the measure has not been modified from its endorsed version.
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional Support for Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure is fully developed and tested. This measure is one component of the endorsed Optimal Diabetes Care composite measure that is on this year’s MUC list for MSSP as MUC17-181. There is also a similar measure in the MSSP program, ACO-27, Diabetes: Hemoglobin A1c Poor Control (>9.0%). Additionally, a similar measure that is NQF endorsed exists (not in MSSP program) as NQF#0575 Comprehensive Diabetes Care: Hemoglobin A1c (HbA1c) control (<8.0%). NQF recommends condition that there are not duplicate or competing measures in the program.
  • Impact on quality of care for patients:This measure is proposed to program as a replacement stand-alone measure of A1c control is evidence based, is stated positively, is patient centric and represents a target supported by guidelines.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. This measure addresses the MSSP domain of clinical care for at risk.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is an intermediate outcome measure. The measure adheres to clinical guidelines issued by ICSI. Specifically, the measure addresses the following: The most recent HbA1c in the measurement period has a value less than 8.0 mg/dL
  
  
• Does the measure address a quality challenge? Yes. This measure addresses unwarrented variation in care. An analysis of 94 medical groups found that of the percentage of diabetic patients age 18 to 75 who achieved an A1C less than 8.0 mg/dL identified in the measure averaged 69%, and ranged from 42% to 88%.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. There is a similar measure, ACO-27 Diabetes: Hemoglobin A1c Poor Control (>9.0%).
  
  
• Can the measure can be feasibly reported? Yes. This measure is fully specificed, and data are captured during the course of care. Data sources for the measure include administrative clinical data, EHR, and paper medical records
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. This measure was endorsed in 2015 as a component of composite measure NQF #0729. For this component, the measure proposed follows the component construct exactly.This particular measure is not NQF endorsed as part of the composite.  However, a related measure that is NQF endorsed exists (not in MSSP program) as NQF#0575 Comprehensive Diabestes Care: Hemoglobin A1c (HbA1c) control (<8.0%).The measure was tested at the group level. This measure has not been submitted in a previous year’s MUC list.
  
  
• Measure development status: Fully Developed
  
  
• 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 is not currently in use in the MSSP program. This measure is one component of the Optimal Diabetes Care measure which has been implemented in the Minnesota Department of Health’s Statewide Quality Reporting and Measurement System (SQRMS), using data submitted by all eligible providers. No implementation issues have been identified.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Endorsed - This measure was endorsed in 2015 as a component of composite measure NQF #0729
  
  
• Does the measure address a high-priority quality issue in the dual eligible beneficiary population? Yes.
  
  
• Preliminary analysis of the MAP Medicaid-relevant measure: Support measurement of managing chronic illness. This is a subset of the Optimal Diabetes Care Measure. .
  
  

Rationale for measure provided by HHS
Addressing Health Care Disparities Using Public Reporting Snowden, A. et al American Journal of Medical Quality August 2012 27 (4): 275-81

Summary of NQF Endorsement Review

• Year of Most Recent Endorsement Review: 2015
  
  
• Project for Most Recent Endorsement Review: Endocrine
  
  
• Review for Importance: 1a. Evidence, 1b. Performance Gap) 1a. Evidence: H-5; M-11; L-0; I-1; 1b. Performance Gap: H-15; 1d. Composite – Quality Construct and Rationale: H-4; M-7; L-4; I-1 Rationale: • For all but one of the components included in this composite (tobacco-free), the developer presented recommendations from the 2014 clinical practice guidelines developed by the Institute for Clinical Systems Improvement (ICSI), which were based on a systematic review of evidence that was graded either high or moderate. Additional evidence-based recommendations from the American College of Cardiology and U.S. Preventive Services Task Force also were presented. Committee members agreed that the evidence supports the relationship between each component and desired health outcomes. • Data provided by the developer indicate that for 2014, only 38.9% of diabetic patients in Minnesota met all five component targets from the composite measure. Committee members agreed that although performance on some of the components is quite high, overall performance indicates opportunity for improvement. • Although some Committee members voiced concern over the “all-or-none” structure of the measure, others agreed that a more comprehensive measure that focuses on management of multiple risk factors is needed. The Committee agreed that the developer description of the quality construct, rationale, and aggregation and weighting approach is explicitly articulated and logical.
  
  
• Review for Scientific Acceptability: 2. Scientific Acceptability of Measure Properties: The measure meets the Scientific Acceptability criteria (2a. Reliability - precise specifications, testing; 2b. Validity - testing, threats to validity) 2a. Reliability: H-9; M-7; L-0; I-0; 2b. Validity: H-1; M-10; L-4; I-1; 2d. Composite: H-1; M-10; L-4; I-1 Rationale: • Committee members noted that the specifications of the statin component of this measure have changed since the most recent endorsement of the measure due to changes in the ACC/AHA clinical practice guidelines on cholesterol management released in November, 2013. In the earlier version of the measure, the statin component assessed reaching a target LDL threshold of < 100 mg/dL; the revised version of this component assesses statin use. • Committee members questioned whether the measure assesses if a patient is on the appropriate statin dose. Developers clarified that the measure does not consider the statin dose but assesses only whether a patient is on a statin. • Members also questioned the age range of 18-75 for the statin component of the measure. The developer clarified that for patients 21-39 years of age, this component is applicable only if the patient has ischemic vascular disease or a very high LDL level, in accordance with the ACC/AHA guidelines. • The developer clarified that the level of analysis for the measure is clinician groups (not individual clinicians), and also noted that multiple clinics may form a clinician group. They also clarified that the measure does not require having a minimum of 30 patients. • Developers presented results of signal-to-noise reliability testing of the performance measure score. They clarified that the beta-binomial method was used for the reliability testing because the composite score itself is a binary (yes/no) measure. Members noted that although the 12 reliability was quite high for most clinician groups, it was lower than 0.7 for some clinician groups. • To demonstrate validity of the performance measure score, developers examined the association between the scores for this measure with the scores from the Optimal Vascular Care measure (NQF #0076), hypothesizing that clinician groups likely provide similar quality of care to different patients who also require management of multiple risk factors. The R2 value from this analysis was 0.64. The developers also described several steps occurring during the data submission process as demonstration of empirical validity testing at the data level element. • Developers also clarified that the measure is risk-adjusted for three factors (insurance type, age group, and diabetes type) and noted that the risk-adjustment strategy was developed using data from all clinicians in Minnesota. However, one member expressed some concern that the only adjustment for sociodemograhic status is insurance type. Developers clarified that other potential risk factors that were considered were not statistically significant and thus were not included in the risk-adjustment model. • Several Committee members voiced concern about holding physicians accountable for the patient’s tobacco use, as some see actual tobacco use (as opposed to efforts for tobacco cessation) as out of the control of the clinician. However, another member referred to data showing that physicians can influence their patients to stop tobacco use. Developers also noted that statewide, they have seen an approximate 2.5% increase in tobacco-free patients in Minnesota. • One Committee member noted the need for clarity about potential adverse effects related to statin use. Another member referenced the flow diagram provided by the developer that details several contraindications for statin use, while another member echoed the importance of the potential for adverse reactions when making treatment decisions. • After developers clarified the performance rates for each of the components, Committee members questioned whether the aspirin component (performance rate =99.5% in MN) is needed in the composite. Developers noted that while this component may be "topped out" in MN, this happened over a four-year period of focus on this component. They also referenced a New England Journal of Medicine article that found a 34.8% performance rate nationally in the primary care setting. Finally, they noted that performance on this component across ACOs is, on average, 75.3%.
  
  
• Review for Feasibility: 3. Feasibility: H-7; M-4; 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 measure data can be collected through electronic clinical data and paper records. • One Committee member noted that, due to the number of components included in the composite, the data collection effort for this composite measure may be intensive. Developers stated that submission of this measure by all clinician groups in MN is mandated by the state. While they acknowledged that MN has many large practices that use EHRs, small practices— even those who still use paper medical records—are able to submit data on this measure. The developers did, however, acknowledge the data collection burden for the new statin component if a patient has not been prescribed a statin (i.e., identifying exceptions due to contraindications).
  
  
• Review for Usability: 4. Usability and Use: H-5; M-7; L-4; 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: • Committee members noted that the measure is publicly reported and is used in pay-forperformance and accreditation programs. Performance is slowly increasing across the state of Minnesota, suggesting quality of care may be improving. • Data submitted by the developer demonstrate relatively consistent improvement of performance in MN from the years 2006-2014. • Committee members agreed that this composite measure is patient-centric and acknowledged the importance of using a comprehensive measure that assesses performance of reducing multiple risk factors. • Some Committee members expressed concern that the measure could incent some providers to "cherry-pick" patients or make their practices less hospitable to certain patients or certain subgroups of patients (the tobacco-free component of the measure was a particular concern).
  
  
• Review for Related and Competing Measures: 5. Related and Competing Measures • This measure is a competing measure to the following measures o 0061: Comprehensive Diabetes Care: Blood Pressure Control (< 7% to < 8% depending on individual patient factors. o 0575: Comprehensive Diabetes Care: Hemoglobin A1c (HbA1c) control (<8%) • NQF staff asked the Committee to discuss whether there is justification for continued endorsement of the individual measures if the composite retains endorsement. The Committee discussed the pros and cons of endorsing both individual measures and the composite measure. The Committee ultimately agreed that while the composite measure is useful to assess patientcentric performance across a variety of clinical areas, endorsement of individual measures also can be beneficial, particularly for users who want to focus on certain components of the composite or those who have data collection constraints and cannot use the composite. The Committee therefore recommended continued endorsement of both the individual measures and the composite measure.
  
  
• Endorsement Public Comments: 6. Public and Member Comment Comments received: • Two commenters raised concern over the glucose control component of the composite, referencing the National Action Plan for Adverse Event Prevention, which was released in August, 2014. The National Action Plan states that the blood glucose threshold of < 7% to < 8% depending on individual patient factors. Benefits: Achieving near-normal glycemic control lowers risk of diabetes microvascular complications such as retinopathy, nephropathy and amputations. Achieving A1c of 6.9 to 7.9% may also significantly reduce macrovascular complications based on Steno-2 and UKPDS data. Quality of Evidence: High Strength of Recommendation: Strong. Measurement does not and should not preclude good clinical judgement; however the measure development work group believes that a target of < 8.0 is reasonable and supported by guidelines. Our measure does have an upper age limit cut-off of 75 years and we allow exclusions for death, permanent nursing home resident or patients who are receiving hospice or palliative care services. • Two commenters were critical of the composite measure itself, citing concern that use of the composite measure could mask the individual care processes that most need improvement. Developer response: While it is true that the measure is reported at the composite level, the individual components and the associated rates are available to the medical groups for better understanding their rates and for use in quality improvement to know which areas have opportunity for improvement. MNCM and the measure development work group firmly believe that achieving the intermediate physiological outcome targets related to blood pressure and glycemic control in addition being tobacco free and use of daily aspirin and statins where appropriate are the diabetic patient’s best mechanisms of avoiding or postponing long term complications associated with this chronic condition which affects millions of Americans. Measuring providers separately on individual targets is not as patient centric as a measure that seeks to reduce multiple risk factors for each patient. Diabetic patients are more likely to reduce their overall risk and maximize health outcomes by achieving several intermediate physiological targets. • Two commenters noted that documenting HbA1c levels >8% but less than 9% cannot be done using CPT-II coding, necessitating need for medical chart review. Developer response: A point of clarification, these measure do not rely on CPTII codes for numerator compliance, nor are they indicated anywhere in our measure specification. Measure specifications focus on the electronic health record as a source of clinical information for calculating numerator compliance; actual A1c values are utilized in the case of the A1c target. Additionally, 80 to 90% of all the clinics in MN are reporting this information from their electronic health records without the need for additional chart abstraction. • One commenter suggested a need for including sociodemographic factors in the risk-adjustment approach. Developer response: Our risk adjustment model does include insurance product, which is a proxy for socioeconomic status. During the process of measure development, the expert panel discusses potential variables for risk adjustment that are important to consider for the measured population. For this measure, variables that are available for evaluation include gender, age, zip, race/ethnicity, country of origin, primary language, insurance product, diabetes type, depression and ischemic vascular disease. The potential risk adjustment variables are then evaluated for appropriate inclusion in the model based on a t value outside the range of -2.0 and +2.0. Currently, the variables that have demonstrated acceptable properties are insurance product, age bands (18-25, 26-50, 51-65 and 65 to 75) and diabetes type (1 or 2). Race/ethnicity has been collected for this measure in MN for the past few years, but has now reached a level of 15 reliability in which it can be evaluated for its impact. MNCM continues to review variables and their impact on the measure and part of its measure risk adjustment strategy. • One commenter suggested the need for additional detail regarding moderate or high intensity in the description of statin use for the measure. Developer response: The measure development work group thoroughly discussed the pros and cons of specifying a certain dose of the statin medication and based on the following factors ultimately decided to not specify a dose of moderate or high intensity for numerator compliance: 1) data burden for practices, 2) controversy and burden surrounding the CV risk calculator, 3) ICSI 2014 Diabetes Guideline recommendations for measurement and 4) cardiology work group member’s believe that there is some benefit for some patients who can only tolerate a lower intensity dose. Committee response: • During its review of the individual measure assessing HbA1c
  
  
• Endorsement Committee Recommendation: Standing Committee Recommendation for Endorsement: Y-13; N-4
  
  

Measure Specifications

• NQF Number (if applicable): *Note- 76 (This measure is a component of the endorsed composite measure NQF #76)
  
  
• Description: The percentage of patients 18-75 years of age who had a diagnosis of ischemic vascular disease (IVD) and were on daily aspirin or anti-platelet medication, unless allowed contraindications or exceptions are present.
  
  
• Numerator: Denominator patients with documentation that the patient was on daily aspirin or anti-platelet medication during the measurement period, unless allowed contraindications or exceptions are present.
  
  
• Denominator: 18 years or older at the start of the measurement period AND less than 76 years at the end of the measurement period AND Patient had a diagnosis of ischemic vascular disease (Ischemic Vascular Disease Value Set) with any contact during the current or prior measurement period OR had ischemic vascular disease (Ischemic Vascular Disease Value Set) present on an active problem list at any time during the measurement period. AND At least one established patient office visit (Established Pt Diabetes & Vasc Value Set) for any reason during the measurement period
  
  
• Exclusions: The following exclusions are allowed to be applied to the eligible population: - Patient was a permanent nursing home resident at any time during the measurement period - Patient was in hospice or receiving palliative care at any time during the measurement period - Patient died prior to the end of the measurement period - Documentation that diagnosis was coded in error - Patient had only urgent care visits during the measurement period
  
  
• HHS NQS Priority: Effective Prevention and Treatment
  
  
• HHS Data Source: Administrative clinical data, EHR, Paper medical record, Claims, Registry
  
  
• Measure Type: Process
  
  
• Steward: MN Community Measurement
  
  
• Endorsement Status: Endorsed
  
  
• Changes to Endorsed Measure Specifications?: The MUC list indicates the measure has not been modified from its endorsed version.
  
  
• Is the measure specified as an electronic clinical quality measure? No
  
  

Preliminary Analysis of Measure

• Preliminary analysis result: Conditional Support for Rulemaking
  
  
• Preliminary analysis summary
  • Contribution to program measure set:This measure is fully developed and tested. This measure is one component of the endorsed Optimal Vascular Care composite measure (NQF#0076). There is also a similar measure in the MSSP program, ACO-30: Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic. NQF recommends condition that there are not duplicate or competing measures in the program.
  • Impact on quality of care for patients:This measure encourages clinicans to improve care management for patients with ischemic vascular disease, and ultimately improve health outcomes for patients with ischemic vascular disease.
  
  
  
• Does the measure address a critical quality objective not adequately addressed by the measures in the program set? Yes. This measure addresses the MSSP domain of clinical care for at risk.
  
  
• Is the measure evidence-based and is either strongly linked to outcomes or an outcome measure? Yes. This is a process measure. This measure adheres to clinical guideline issed by AHA/ACCF.
  
  
• Does the measure address a quality challenge? Yes. This measure addresses unwarrented variation in care. An analysis of 84 medical groups found that of the percentage of ischemic vascular disease patients age 18 to 75 who achieved target identified in the measure averaged 94%, and ranged from 65% to 100%.
  
  
• Does the measure contribute to efficient use of resources and/or support alignment of measurement across programs? Yes. Measure currently used in a CMS program.There is one competing measure in MSSP, ACO-30, Ischemic Vascular Disease: Use of Aspirin or Another Antithrombotic
  
  
• Can the measure can be feasibly reported? Yes. This measure is fully specified, and data are captured during the course of care. Data sources for the measure include administrative clinical data, EHR, and paper medical records.
  
  
• Is the measure reliable and valid for the level of analysis, program, and/or setting(s) for which it is being considered? Yes. This measure is one component of the 2016 endorsed Optimal Vascular Care composite measure NQF#0076. For this component, the measure proposed follows the component construct exactly. This particular measure is not NQF endorsed as part of the composite. The measure was tested at the group level. This measure has not been submitted in a previous year’s MUC list.
  
  
• Measure development status: Fully Developed
  
  
• 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 currently used in a CMS program but is undergoing substantial change. This measure is one component of the Optimal Vascular Care measure which has been implemented in the Minnesota Department of Health’s Statewide Quality Reporting and Measurement System (SQRMS), using data submitted by all eligible providers. No implementation issues have been identified.
  
  
• Is the measure NQF endorsed for the program's setting and level of analysis? Endorsed
  
  
• Preliminary analysis of the MAP Medicaid-relevant measure: Support measurement of managing chronic illness. This is a subset of the Optimal Vascular Care Measure. .
  
  

Rationale for measure provided by HHS
Risk Factor Optimization and Guideline-Directed Medical Therapy in US Veterans With Peripheral Arterial and Ischemic Cerebrovascular Disease Compared to Veterans With Coronary Heart Disease. Hira RS et al Am J Cardiol. 2016 Oct 15;118(8):1144-1149. doi: 10.1016/j.amjcard.2016.07.027. Epub 2016 Jul 29. Age-specific risks, severity, time course and outcome of bleeding on long-term anti-platelet treatment after vascular events: a population based cohort study. Linix, L et al Published online June 13, 2017 http://dx.doi.org/10.1016/S0140-6736(17)30770-5

Summary of NQF Endorsement Review

• Year of Most Recent Endorsement Review: 2017
  
  
• Project for Most Recent Endorsement Review: Cardiovascular 2016-2017
  
  
• Review for Importance: 1. Importance to Measure and Report: The measure meets the Importance criteria (1a. Evidence, 1b. Performance Gap, 1c. Composite) 1a. Evidence: H-14; M-6; L-1; I-1; 1b. Performance Gap: H-14; M-7; L-1; I-0; Composite: H-12; M-8; L-1; I- 1 Rationale: • For the 2012 maintenance of endorsement evaluation, the developer provided the following clinical practice guidelines to support the blood pressure, statin medication, tobacco free (outcome measure), and daily aspirin or anti-platelet medication components: o Blood pressure, statin medication, tobacco free, and daily aspirin or anti-platelet medication components: The ICSI Stable Coronary Artery Disease (April 2011), Address Modifiable Risk Factors guideline recommended modifiable risk factors for coronary artery disease such as smoking, inadequate physical activity, stress, hyperlipidemia, obesity, hypertension and diabetes mellitus be evaluated. 21 o Blood pressure: The Comorbid Conditions Guideline and the ICSI Hypertension Diagnosis and Treatment Guideline (November 2010) recommended a target blood pressure of 140/90 mmHg or less. o Statin medication: The ICSI Lipid Management in Adults (October 2009) guideline recommended target goals for hyperlipidemic patients with coronary artery disease: LDL – less than 100 mg/dL; HDL – 40 mg/dL or greater; Triglycerides – less than 150 mg/dL. o Daily aspirin or anti-platelet medication: The ICSI Stable Coronary Artery Disease (April 2011), Address Modifiable Risk Factors guideline recommended the use of one aspirin tablet daily (81-162 mg) unless there are medical contraindications. • For the current maintenance of endorsement evaluation, the developer provided the following updated evidence for all four components: o Blood pressure: The 2015 AHA/ACC/ASH Scientific Statement on the Treatment of Hypertension in Patients with Coronary Artery Disease included 3 recommendations for blood pressure targets, including a blood pressure goal of 65 and Medicare. •o Statin medication: The ICSI Lipid Management in Adults (updated Nov 2013/completed prior to ACC/AHA release) recommends that clinicians initiate statin therapy regardless of LDL in patients with established atherosclerotic cardiovascular disease (ASVCD). The 2013 ACC/AHA Guideline for the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults recommends high-intensity statin therapy be initiated or continued as first-line therapy in women and meno Tobacco free outcome measure: The developer provided evidence from the United States Preventive Services Task Force (USPSTF) stating that despite considerable progress in tobacco control over the past 50 years, in 2013, an estimated 17.8% of U.S. adults and 15.9% of pregnant women aged 15 to 44 years were current cigarette smokers. o Daily aspirin or anti-platelet medication: The developer provided three recommendations for antiplatelet agents/anticoagulants for patients with ischemic vascular disease from the AHA/ACCF Secondary Prevention and Risk Reduction Therapy for Patients with Coronary and Other Atherosclerotic Vascular Disease: 2011 Update. • The Standing Committee discussed the potential changes to blood pressure parameters based on the results of the Systolic Blood Pressure Intervention Trial (SPRINT), which compared the benefit of treatment of systolic blood pressure to a target of less than 120 mm Hg with treatment to a target of less than 140 mm Hg. The Committee also discussed the anticipated blood pressure guidelines to be released by AHA/ACC sometime in the future. NQF staff asked the Committee to consider the quantity, quality, and consistency of the body of evidence that was presented in the measure submission form. NQF staff reassured the Committee that the NQF process allows for a measure to be reviewed when new evidence becomes available. One of the Committee members noted that the USPSTF recommendations for daily aspirin include patients aged 50 to 70 years old, while the measure includes patients up to 75 years old. Other Committee members noted that the USPSTF recommendations are for primary prevention rather than patients with a diagnosis of ischemic vascular disease (IVD). Overall, the Standing Committee agreed that the updated evidence supports blood pressure control, statin use, daily aspirin or anti-platelet medication, and tobacco use assessment and 22 intervention(s) in patients to avoid or postpone long-term complications associated with a diagnosis with IVD. The developer provided composite performance rates from clinics in Minnesota for Report Year 2007-2016 (Dates of Service 2006-2015). o In 2007, the rate was 38.9% for 4,662 patients and 33.8% in 2010 for 63,241 patients. In 2011, the blood pressure component target changed from, and the performance rate increase to 39.7% for 66,910 patients. o In 2015, the cholesterol management component was suppressed during redesign of the measure and the performance rate increased to 69.3% for 102,654 patients. o In 2016, the cholesterol management component was changed from LDL <100 to appropriate statin use and the performance rate was 66.1% for 104,395 patients. • The developer also provided performance rates for the individual components. o The blood pressure component increased from 84.0% in 2012 to 85.0% in 2016. o Daily aspirin use or anti-platelet medication use increased from 92.5% in 2009 to 96.7% in 2016. o The number of tobacco free patients increased from 82.4% in 2009 to 83.0 in 2016. o Statin use was 95.2% in 2016 (this was the first year the new component was reported) The developer provided 2014 disparities data from the measure as specified demonstrating a performance rate of 67.2% for White patients, 47.6% for Black/African-American patients, 51.8% for American Indian/Alaska Native patients, and 53.4% for multi-racial patients. The data also showed a higher performance gap for female patients and younger patients. The Committee asked the developer if there were trend data on disparities that demonstrated a change in performance over time and by individual clinic. The developer did not have additional, specific disparities data. However, according to the developer, some clinics that care for a greater proportion of minority patients have lower performance rates but there are a couple of clinics that are excelling in minimizing disparities. • The Standing Committee agreed that the data provided demonstrated a performance gap and opportunity for improvement in optimal vascular care for patients with IVD. • This is an all-or-none composite measure that requires patients to meet all four component targets in the composite measure to be considered ‘optimally managed’; all four components are weighted equally. The developer noted that measuring providers on individual targets is not as patient-centric as this composite measure that seeks to reduce multiple risk factors in patients with IVD and maximize health outcomes. One of the members of the Standing Committee noted that the tobacco free component would be more appropriate as a process measure. The Committee member noted that smoking rates are often influenced by geographic location. Providers in areas with high rates of tobacco use will not appear as effective in increasing the number of tobacco free patients as those in areas where tobacco use is less prevalent. In the pre-evaluation comments, another Committee member noted that the absolute benefit of each component is not equal; achieving blood pressure control or smoking cessation is much more difficult than prescribing a statin or aspirin/anti-platelet medication. • The Standing Committee agreed, that overall, the quality construct and rational for the composite was clearly stated and logical.
  
  
• Review for Scientific Acceptability: 2. For the 2012 maintenance of endorsement evaluation, patient-level data element validity testing was conducted on 63,241 patients with IVD from 128 medical groups representing 573 clinics that submitted data to Minnesota Community Measurement for 2009 dates of service reported in 2010. After data submission, in-person validation audits requiring a 90% accuracy rate were conducted to compare the submission to the patient’s medical record. Of the 128 medical groups that submitted data in 2010, 17 groups initially failed the audit and remedy plans were developed. All 17 groups resubmitted and passed subsequent audit. • For the current maintenance of endorsement evaluation, the measure was tested at the measure score level using a dataset that included 104,395 patients with IVD in Minnesota and neighboring communities from 111 medical groups representing 671 clinics for dates of service from January 1, 2015 to December 31, 2015. • To test the reliability of the measure score, the developer used a beta-binomial model to assess the signal-to-noise ratio. A reliability score of 0.00 implies that all the variability in a measure is attributable to measurement error. A reliability score of 1.00 implies that all the variability is attributable to real differences in performance. The higher the reliability score, the greater is the confidence with which one can distinguish the performance of one facility from another. This is an appropriate test for measure score reliability. A reliability score of 0.70 is generally considered a minimum threshold for reliability. The overall reliability for the composite measure was 0.90 and 0.61 at the minimum number of patients per reportable clinic (=30). The distribution of reliability scores by number of eligible patients per reportable clinic (=30) ranged from 0.61 for 30 patients per clinic to 0.99 for 4,441 patients per clinic. • In the pre-evaluation comments, a member of the Standing Committee mentioned that assessing prescribing behavior of statin therapy (as noted in the specifications) is not consistent with the evidence provided to support the statin component. The Committee member noted that prescribing the lowest dose of the weakest statin would meet the intent of the measure but not generate clinically significant outcomes in the IVD population. Other Committee members questioned why ‘permanent nursing home residents’ are excluded from the denominator. The Committee discussed the fall risks associated with administering blood pressure medication to nursing home patients, excessive treatment in patients with advanced illness, and the lack of clinical trials for these types of medications in the nursing home population. • The Standing Committee did not express additional concerns with the reliability of the measure, but ultimately decided the testing results were sufficient. • For the 2012 maintenance of endorsement evaluation, content and face validity were assessed through the Measurement and Reporting Committee and a panel of experts. There was consensus among the expert workgroup that the target components reflected a quality of care that will reduce patients heart attack and stroke risk. • For the current maintenance of endorsement evaluation, empirical validity testing of the composite measure score was conducted by testing the correlation of a medical group’s performance with their performance on the Optimal Diabetes Care measure (#0729). It is expected that the quality of care provided by a medical group to a patient with ischemic vascular disease would be of similar quality as the care provided to a patient with diabetes, therefore the respective performance measure scores should be similar. This is an appropriate method for assessing conceptually and theoretically sound hypothesized relationships. The Optimal Diabetes Care measure (#0729) includes the same four components as #0074 plus a component for hemoglobin A1C; it also measures a different population. The linear regression analysis demonstrated an R2 value of 0.635, which means that 64.0% of the total variation in performance on the Optimal Vascular Care measure can be explained by variation in performance on the Optimal Diabetes Care measure. The remaining 36.0% of total variation on the Optimal Vascular Care measure remains unexplained. • This measure is risk-adjusted. The final risk factors selected for the risk model were age and insurance product (Medicare, Medicaid, MSHO, Special Needs, Self-pay, Uninsured). The developer analyzed gender and depression as well, but gender did not show sufficient variation between clinics and ‘depression’ was not selected due to the high cost of collection. The developer stated that race, ethnicity, language, and country of origin (RELO) were not considered for risk adjustment because these variables did not have a high completion rate across all clinics. The developer is continuing to work with the medical community to achieve the goal of evaluating RELO at the clinic level. The developer conducted an Analysis of Maximum Likelihood Estimates on the 2014 Dates of Service to compare the optimal rate of patients by insurance product (Commercial, MHCP, and Uninsured) to patients with Medicare and patient age (18-25; 26-50; 51-65) to patients aged 66-75. The Analysis of Maximum Likelihood Estimates demonstrated that all of the results for both variables, age and insurance product, were significant, except for ages less than 26 due to the small sample size (n = 44). The developer also found that the only two variables that were correlated were age >65 and Medicare. The Standing Committee did not express any concerns on the threats to validity and agreed that the testing results satisfied the validity criterion. • The developer conducted a Pearson Correlation Analysis of the individual components rates and the composite rates. The Pearson correlation coefficient value, r, ranges from +1.00 to -1.00. A value of 0.00 indicates that there is no association between the two variables. A value greater than 0.00 indicates a positive association; that is, as the value of one variable increases, so does the value of the other variable. A value less than 0.00 indicates a negative association; that is, as the value of one variable increases, the value of the other variable decreases. The developer conducted the following Pearson Correlation Analysis for each component: Variable Mean Pearson r coefficient Blood pressure 0.85048 0.69813 Tobacco Free 0.80901 0.71336 Daily ASA Use 0.96271 0.59223 Statin Use 0.93973 0.62327 Optimal Vascular Care Rate = 0.63919 • The developer concluded that practices in Minnesota demonstrate relatively high compliance for all of the components; however, there is still an opportunity for improvement at the clinic level. The blood pressure control and tobacco free components demonstrated the most variability, opportunity for improvement, and impact the ability to achieve all four components. Another Committee member suggested that if the two variables with the most variability were more heavily weighted than the other components, the measure would be more impactful. Another Committee member pointed out that three of the components were under the direct control of the provider, yet it was not clear how the tobacco free component captured the quality of care provided by the clinician. A member of the Standing Committee questioned whether there was evidence showing that meeting all four component targets would not 25 generate the same patient outcomes as meeting two or three of the components. The developer pointed out that various combinations of the components and the proportion of patients meeting the different combinations were provided. • The Standing Committee did not express additional concerns with the construct of the composite measure and agreed the information provided was sufficient to satisfy the criterion for composite construct.
  
  
• Review for Feasibility: 3. Feasibility: H-12; M-10; L-0; 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: • All of the data elements are in defined fields in electronic sources and there are no fees, licensure, or other requirements necessary to use this measure. The Standing Committee agreed this measure met the feasibility criterion.
  
  
• Review for Usability: 4. Usability and Use: H-13; M-8; 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 measure is widely used in Minnesota for public reporting, payment, regulatory and accreditation programs, and quality improvement with external benchmarking to multiple organizations. 5. Related and Competing Measures • This measure is related to: o #0067: Chronic Stable Coronary Artery Disease: Antiplatelet Therapy (ACC) o #0068: Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antiplatelet (NCQA) o #0073: Ischemic Vascular Disease (IVD): Blood Pressure Control (NCQA) • The developer stated that #0068 and #0073 focus on the inpatient setting and patients discharged with AMI, CABG, or PCI. #0067 focuses on patients with CAD.
  
  
• Review for Related and Competing Measures: 5. Related and Competing Measures • This measure is related to: o #0067: Chronic Stable Coronary Artery Disease: Antiplatelet Therapy (ACC) o #0068: Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antiplatelet (NCQA) o #0073: Ischemic Vascular Disease (IVD): Blood Pressure Control (NCQA) • The developer stated that #0068 and #0073 focus on the inpatient setting and patients discharged with AMI, CABG, or PCI. #0067 focuses on patients with CAD.
  
  
• Endorsement Public Comments: 6. Public and Member Comment • One commenter did not agree with statin use as a component to address dyslipidemia and believed it would be misleading to include this as a component of “optimal care.” The commenter believed including this component would lead to the lowest level of acceptable care being considered optimal care and would do little to move the quality of care forward. • Developer Response: Thank you for your comment and suggestion for the inclusion of the dose of statin (moderate or high) in the calculation of the cholesterol component of this patient level all-or-none composite measure. While ACC/ AHA guidelines do indicate that most patients with ischemic vascular disease would benefit from high dose intensity statins, there 26 are provisions for moderate intensity statins for patients who cannot tolerate high intensity doses. The measure development work group thoroughly discussed the pros and cons of specifying a certain dose of the statin medication for numerator component compliance and determined that requiring the submission of the dose of statin would cause undue data collection burden for the practices. Additionally, the cardiologists on the workgroup strongly believe that there is some benefit for patients who can only tolerate a low dose of statin. We do not discount the role of ongoing LDL monitoring to determine effectiveness of statin therapy, but having a physiological target (e.g. LDL < 100) is no longer supported by evidence. The American College of Cardiology/ American Heart Associate guidelines for the treatment of blood cholesterol indicate the following: “Treat to target — this strategy has been the most widely used the past 15 years but there are 3 problems with this approach. First, current clinical trial data do not indicate what the target should be. Second, we do not know the magnitude of additional ASCVD risk reduction that would be achieved with one target lower than another. Third, it does not take into account potential adverse effects from multidrug therapy that might be needed to achieve a specific goal. Thus, in the absence of these data, this approach is less useful than it appears (Section 3). It is possible that future clinical trials may provide information warranting reconsideration of this strategy” (pg. 17) Yes, our component rates for prescribing statins are high in MN, which is a little bit unexpected for the newly re-designed component, however we would like to clarify the cholesterol component of statin use is not reported as a stand-alone measure. The Optimal Vascular Care measure is reported as an all-or-none composite, patients achieving multiple components of modifiable risk factors to reduce or delay long term complications. Statin use is one component, the other three are blood pressure control, tobacco-free and daily aspirin or antiplatelet medication. • Committee Response: Thank you for your comment. The Committee agrees that monitoring LDL levels remains an important part of providing care for patients with IVD. However, the statin component in this measure aligns with the 2013 ACC/AHA Guideline for the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults.
  
  
• Endorsement Committee Recommendation: Standing Committee Recommendation for Endorsement: Y-19; N-3
  
  

Program Index

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

Full Program Summaries

Program History and Structure: The Merit-Based Incentive Payment System (MIPS) is established by H.R. 2 Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which repeals the Medicare sustainable growth rate (SGR) and improves Medicare payment for physician services. The MACRA consolidates the current programs of the Physician Quality Reporting System (PQRS), The Value-Based Modifier (VM), and the Electronic Health Records (EHR) Incentive Program into one program (MIPS) that streamlines and improves on the three distinct incentive programs. MIPS will apply to doctors of medicine or osteopathy, doctors of dental surgery or dental medicine, doctors of podiatric medicine, doctors of optometry, chiropractors, physician assistants, nurse practitioners, clinical nurse specialists, and certified registered nurse anesthetists beginning in the 2019 payment year. Other professionals paid under the physician fee schedule may be included in the MIPS beginning in the 2021 payment year, provided there are viable performance metrics available. Positive and negative adjustments will be applied to items and services furnished beginning January 1, 2019 based on providers meeting a performance threshold for four performance categories: quality, resource use, clinical practice improvement activities, and meaningful use of certified EHR technology. Adjustments will be capped at 4 percent in 2019; 5 percent in 2020; 7 percent in 2021; and 9 percent in 2022 and future years.

High Priority Domains for Future Measure Consideration:

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

1. Person and caregiver-centered Experience and Outcomes: This means that the measure should address the experience of each person and their family; and the extent to which they are engaged as partners in their care. a. CMS wants to specifically focus on patient reported outcome measures (PROMs). Person or family-reported experiences of being engaged as active members of the health care team and in collaborative partnerships with providers and provider organizations.

2. Communication and Care Coordination: This means that the measure must address the promotion of effective communication and coordination of care; and coordination of care and treatment with other providers.

3. Efficiency/Cost Reduction: This means that the measure must address the affordability of health care including unnecessary health services, inefficiencies in health care delivery, high prices, or fraud. Measures should cause change in efficiency and reward value over volume.

4. Patient Safety: This means that the measure must address either an explicit structure or process intended to make care safer, or the outcome of the presence or absence of such a structure or process; and harm caused in the delivery of care. This means that the structure, process or outcome described in “a” must occur as a part of or as a result of the delivery of CMS Program Priorities and Needs: April 2017 17 care.

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

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

Program History and Structure: Section 3022 of the Affordable Care Act (ACA) requires the Centers for Medicare & Medicaid Services (CMS) to establish a Shared Savings Program that promotes accountability for a patient population, coordinates items and services under Medicare Parts A and B, and encourages investment in infrastructure and redesigned care processes for high-quality and efficient service delivery. The Medicare Shared Savings Program (Shared Savings Program) was designed to facilitate coordination and cooperation among providers to improve the quality of care for Medicare Fee-For-Service (FFS) beneficiaries and reduce the rate of growth in health care costs. Eligible providers, hospitals, and suppliers may voluntarily participate in the Shared Savings Program by creating or participating in an Accountable Care Organization (ACO). If ACOs meet program requirements and the ACO quality performance standard, they are eligible to share in savings, if earned. There are 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

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

Index of Measures (by Program)

• Continuity of Pharmacotherapy for Opioid Use Disorder (Public comments received:4; MUC ID: MUC17-139)
  
  
• Average change in functional status following lumbar spine fusion surgery (Public comments received:3; MUC ID: MUC17-168)
  
  
• Average change in functional status following total knee replacement surgery (Public comments received:4; MUC ID: MUC17-169)
  
  
• Average change in functional status following lumbar discectomy laminotomy surgery (Public comments received:3; MUC ID: MUC17-170)
  
  
• Appropriate Use of DXA Scans in Women Under 65 Years Who Do Not Meet the Risk Factor Profile for Osteoporotic Fracture (Public comments received:3; MUC ID: MUC17-173)
  
  
• Average change in leg pain following lumbar spine fusion surgery (Public comments received:3; MUC ID: MUC17-177)
  
  
• Optimal Diabetes Care (Public comments received:4; MUC ID: MUC17-181)
  
  
• Optimal Vascular Care (Public comments received:5; MUC ID: MUC17-194)
  
  
• Diabetes A1c Control (< 8.0) (Public comments received:5; MUC ID: MUC17-215)
  
  
• Ischemic Vascular Disease Use of Aspirin or Anti-platelet Medication (Public comments received:1; MUC ID: MUC17-234)
  
  
• Routine Cataract Removal with Intraocular Lens (IOL) Implantation (Public comments received:7; MUC ID: MUC17-235)
  
  
• International Prostate Symptom Score (IPSS) or American Urological Association-Symptom Index (AUA-SI) change 6-12 months after diagnosis of Benign Prostatic Hyperplasia (Public comments received:1; MUC ID: MUC17-239)
  
  
• Screening/Surveillance Colonoscopy (Public comments received:7; MUC ID: MUC17-256)
  
  
• Knee Arthroplasty (Public comments received:6; MUC ID: MUC17-261)
  
  
• ST-Elevation Myocardial Infarction (STEMI) with Percutaneous Coronary Intervention (PCI) (Public comments received:4; MUC ID: MUC17-262)
  
  
• Revascularization for Lower Extremity Chronic Limb Ischemia (Public comments received:6; MUC ID: MUC17-263)
  
  
• Zoster (Shingles) Vaccination (Public comments received:6; MUC ID: MUC17-310)
  
  
• Patient reported and clinical outcomes following ilio-femoral venous stenting (Public comments received:1; MUC ID: MUC17-345)
  
  
• Elective Outpatient Percutaneous Coronary Intervention (PCI) (Public comments received:3; MUC ID: MUC17-359)
  
  
• Intracranial Hemorrhage or Cerebral Infarction (Public comments received:5; MUC ID: MUC17-363)
  
  
• Simple Pneumonia with Hospitalization (Public comments received:6; MUC ID: MUC17-365)
  
  
• HIV Screening (Public comments received:2; MUC ID: MUC17-367)
  
  

• Optimal Diabetes Care (Public comments received:5; MUC ID: MUC17-181)
  
  
• Diabetes A1c Control (< 8.0) (Public comments received:3; MUC ID: MUC17-215)
  
  
• Ischemic Vascular Disease Use of Aspirin or Anti-platelet Medication (Public comments received:4; MUC ID: MUC17-234)
  
  

Full Comments (Listed by Measure)

• MUC17-139 is a meaningful measure of a highly-effective evidence-based best practice in the treatment of Opioid Use Disorder (OUD). While some current measures for SUD measure engagement and follow up, this measure will specifically allow for payers and others to track continued use of medication which is one, if not the most, effective practice for treating OUD. Use of medications for SUD, including OUD, have shown improvements in healthcare for individuals that receive medication. Depending on the technical specifications—we do not believe that collecting this information would be onerous for providers or payers. Most of this information could be available through both pharmacy and other encounter (claims-based information). In addition, some states are looking at successful efforts to increase the use of Medicaid Assistant Treatment as a pay for performance strategy. While slightly different, we could envision the use of this measure in a balue based payment strategy. This measure could also be used as a critical indicator of if and how well particular specialty providers, healthcare providers (or systems), including FQHCs are successful at having clients continue their medication regimen. However; we strongly urge the consideration of additional measures around the quality of care for OUD, as well as substance use disorder treatment more broadly. While there is an extensive body of research around best practices in addiction treatment, there are not enough meaningful measures, particularly at the provider level, to establish and report on whether care is delivered using these methods. In the addiction treatment system, even more so then the general healthcare setting, there is a lack of standardization of care to align with practices which deliver the best outcomes. Tragically, there are even sham providers who prey on individuals and families seeking treatment, and do not provide evidence-based care. The following Principles of Care improve outcomes in addiction treatment: 1) universal screening, 2) personalized biopsychosocial assessment and treatment planning, 3) rapid access to the appropriate level of care, 4) engagement in continuing long-term outpatient care with monitoring and adjustments to treatment, 5) concurrent, coordinated care for physical and mental illness, 6) use of evidence-based therapies delivered by fully trained and accredited behavioral health professionals, 7) use of FDA-approved medications (MUC17-139 is one potential measure for this concept), 8) non-medical recovery support services. While measures can be adapted from other specialties, it is necessary to establish a comprehensive suite of measures for addiction treatment for all purposes listed: QI, certification/recognition, regulatory/accreditation, payment, public reporting, and disease surveillance. These measures can help incentivize care delivery that is high quality, allow transparency in provider selection by consumers, and reduce the prevalence of fraudulent providers. These steps are necessary to improve the quality of addiction treatment and reduce the fragmentation of this system, which is in critical demand. (Submitted by: Shatterproof )
  
  
• The source of data was not specified and results would vary, depending on whether data was extracted from an EHR or a pharmacy database (such as Express Scripts) that captures prescriptions from multiple providers. Patients that pay cash may not show up in the numerator, and we anticipate cash may represent a large portion of these payments. Performance is likely to be highly affected by socioeconomic issues such as affordability, lack of insurance, access to providers, state regulations, etc. Reporting for accountability purposes could discourage physicians from accepting patients or undergoing the training needed to treat the patients to battle the opioid epidemic. The level of measurement (individual, system, ACO) isn’t clear. Prior to adopting into MIPS, we would encourage analysis and endorsement by the NQF. While research evidence is strong, more field testing is needed prior to validate the measure (Submitted by: American Academy of Family Physicians)
  
  
• The American Medical Association (AMA) is actively working to reverse the opioid epidemic through our “End the Epidemic” initiative and other activities of our Opioid Task Force. We believe that performance measurement is one avenue by which we can track progress and make improvements with tackling the opioid epidemic and the AMA supports every effort underway to meet this need. Promoting access to evidence-based medication-assisted treatment for opioid use disorder through a quality measure is a very worthy goal because it has the potential to reduce mortality due to opioid overdoses. We encourage the developer to consider measuring patient compliance related to taking medication along with evaluations on drug screenings to ensure that patients are adhering to treatment and do not continue to take opioids. Otherwise, the measure is only measuring whether a prescription has been filled and not assessing other aspects of patient adherence to medication-assisted therapy for opioid use disorder, including taking the prescribed medication and not taking other substances. Information around the attribution method, reliability and validity of the data at the physician and practice level are also needed before the measure should be implemented in MIPS because the measure was specified and tested at the health plan and state level, as well as endorsed by NQF at the health plan and state level. The AMA encourages the developer to refine and retest the measure to demonstrate its scientific acceptability at the physician and practice level and asks that the MAP not support inclusion of the measure until these questions are answered. (Submitted by: American Medical Association)
  
  
• We support this measure as it would likely improve the focus on treatment of the underlying condition. (Submitted by: Ascension)
  
  

• AOTA supports the measure using the ODI to measure patient report of disability. This tool is particularly appropriate because it asks questions about pain and how the pain limits a person's ability to interact with their environment and complete meaningful activities. As with many outcome measures, specialty societies should be encouraged to implement process measures to be able to impact the outcomes of interest and understand how to improve care. (Submitted by: American Occupational Therapy Association)
  
  
• We would recommend choosing a single measure related to lumbar spine metrics. (Submitted by: Ascension)
  
  
• CMS has implemented a number of standardized data elements for post-acute care providers to measure function, yet these items are not used to measure function for physicians? How well will this measure correlate with other functional measures that are clinician based and currently used in post-acute care settings? Will this measure be available for post-acute care physicians to utilize if they provide care to one of these patients? (Submitted by: Uniform Data System for Medical Rehabilitation)
  
  

• AOTA supports the measure using the OKS to measure patient report of pain and the pain's impact on function. This tool is particularly appropriate because it asks questions about pain and how the pain limits a person's ability to interact with their environment and complete meaningful activities. As with many outcome measures, specialty societies should be encouraged to implement process measures to be able to impact the outcomes of interest and understand how to improve care. (Submitted by: American Occupational Therapy Association)
  
  
• We support this measure as it would likely improve the focus on treatment of the underlying condition. (Submitted by: Ascension)
  
  
• CMS has implemented a number of standardized data elements for post-acute care providers to measure function, yet these items are not used to measure function for physicians? How well will this measure correlate with other functional measures that are clinician based and currently used in post-acute care settings? Will this measure be available for post-acute care physicians to utilize if they provide care to one of these patients? (Submitted by: Uniform Data System for Medical Rehabilitation)
  
  
• While written comments were not provided, the commenter indicated their support for this measure in this program (Submitted by: Empire Spanish Meadows )
  
  

• AOTA supports the measure using the ODI to measure patient report of disability. This tool is particularly appropriate because it asks questions about pain and how the pain limits a person's ability to interact with their environment and complete meaningful activities. As with many outcome measures, specialty societies should be encouraged to implement process measures to be able to impact the outcomes of interest and understand how to improve care. (Submitted by: American Occupational Therapy Association)
  
  
• We would recommend choosing a single measure related to lumbar spine metrics. (Submitted by: Ascension)
  
  
• CMS has implemented a number of standardized data elements for post-acute care providers to measure function, yet these items are not used to measure function for physicians? How well will this measure correlate with other functional measures that are clinician based and currently used in post-acute care settings? Will this measure be available for post-acute care physicians to utilize if they provide care to one of these patients? (Submitted by: Uniform Data System for Medical Rehabilitation)
  
  

• The exclusions to the denominator are extremely complicated and while it’s possible that many of the criteria will be in the problem list, the details may never be coded for billing or captured as structured data in the clinical EHR. Coding in a hospital environment, where clinical data abstraction is the norm, could potentially support a measure as complex as this, but we believe it is beyond the scope for most physician practices. (Submitted by: American Academy of Family Physicians)
  
  
• We support this measure as it would likely improve the focus on treatment of the underlying condition. (Submitted by: Ascension)
  
  
• AACE suggests rewording so it measures the percentage of female patients aged 50 to 64 with select risk factors for osteoporotic fracture who received an order for a dual energy x-ray absorptiometry (DXA) scan during the measurement period. With the increase in hip fractures, this measure should really be asking the question of how many who should be getting the study are. We would ask that these edits be incorporated prior to the measure being included in the MIPS program. (Submitted by: American Association of Clinical Endocrinologists (AACE))
  
  

• Would avoid use of simple change in pain intensity ratings which can have idiosyncratic meanings. There should be some focus on functional improvements. Suggest follow BREE collaborative recommendations: Results of measures from 2b, specifically the score from the Oswestry Disability Index and questions regarding everyday physical activities (Question 7) and pain (Question 10) on the PROMIS-10 Global Health survey). See full reports at http://www.breecollaborative.org/wp-content/uploads/4.Lumbar-Fusion-Bundle.pdf (Submitted by: Harborview Medical Center)
  
  
• AOTA supports the use of a pain measure following surgical interventions. Pain can significantly limit indepedence and the ability participate in everyday activities safely. AOTA would encourage CMS to consider the use of pain scales that are patient reported and identify when pain interferes with function rather than solely relying on the VAS. (Submitted by: American Occupational Therapy Association)
  
  
• We would recommend choosing a single measure related to lumbar spine metrics. (Submitted by: Ascension)
  
  

• December 6, 2017 RE: List of Measures under Consideration (MUC) for December 1, 2017 Novo Nordisk is pleased to provide the following comments on CMS’ list of measures under consideration. Headquartered in Denmark, and with nearly 5,000 U.S. employees, Novo Nordisk is a global health care company with 90 years of innovation and leadership in diabetes, obesity, hemophilia and growth hormone disorders. Novo Nordisk is committed to the goal of ensuring that patients have access to high-quality, affordable health care. As a life sciences company with a focus on chronic disease management, we support the Agency’s continued efforts to develop policies that are reflective of system capabilities and grounded in core strategies to drive progress and reform efforts. Diabetes remains an important condition affecting 30.3 million individuals—9.4 percent of the US population. Novo Nordisk is encouraged to see CMS consider diabetes a national priority by considering measures to improve the quality of care for millions of individuals. We strongly support the two diabetes measures on the MUC list—Optimal Diabetes Care (MUC17-181) and Diabetes A1c Control (<8.0) (MUC17-215). However, we suggest a review of the blood pressure criteria in MUC17-181, due to new clinical practice guidelines that redefine high blood pressures as 130/80 mm Hg. Novo Nordisk is pleased to see the inclusion of two diabetes measures on the MUC list; however, there remain opportunities for measures, including (1) screening for type 2 diabetes aligned with the USPSTF recommendation for screening for abnormal blood glucose and type 2 diabetes mellitus, (2) referral to diabetes prevention programs for individuals with prediabetes, also aligned with the USPSTF recommendation for screening for abnormal blood glucose and type 2 diabetes mellitus, (3) patient-reported outcomes, including concepts such as shared-decision making and patient engagement, (4) insulin adherence, and (5) hypoglycemia. Novo Nordisk would encourage CMS to consider diabetes outcomes beyond A1c measurement and control, as these outcomes are particularly important for patients living with the disease. In review of the MUC list, we also note the continued gaps in quality measures related to effective treatment and improving outcomes for people living with obesity. Since obesity is a significant risk factor for type 2 diabetes, and impacts both costs and utilization of health care, we encourage CMS to move beyond process measures of BMI assessment and referrals to treatment and toward more specific outcomes measures, including exploration of trends in obesity and patient-reported outcomes that could impact quality of care and reduce morbidity and mortality. Thank you for this opportunity to comment on CMS’ List of Measures Under Consideration. If you have any questions about the comments included here, please do not hesitate to reach out to me at TDDH@novonordisk.com. Sincerely, Todd Hobbs, MD Chief Medical Officer North America Novo Nordisk Inc. (Submitted by: Novo Nordisk Inc)
  
  
• The American Medical Association (AMA) recommends that this measure receive a recommendation of “refine and resubmit.” The American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines released updated recommendations on high blood pressure in November. Stage 1 hypertension is now defined as a systolic blood pressure of equal to or greater than 130 mm Hg or a diastolic blood pressure of equal to or greater than 80 mm Hg. The developer should modify the measure to reflect these changes prior to the MAP supporting this measure for the MIPS program. In addition, the shift to payment based on the achievement of a performance score against set benchmarks increases the importance of measures that are precisely specified and risk adjusted or stratified, particularly if the measure is an outcome or composite. Specifically, physicians are able to earn up to 10 points on this measure if implemented in the MIPS program and the benchmarking and points system assumes that a 100% performance rate is attainable for each individual measure. Given the broad denominator population, it is not reasonable to assume that every physician or practice could achieve an A1c less than 8% and a blood pressure based on the updated guideline recommendations in every patient. When these types of measures were first developed, the assumption was that many physicians and other healthcare providers would not be able to achieve 100% since the measures were broadly defined and some imprecision in defining the patient population was deemed acceptable. This approach does not work well when performance is assigned to deciles with an assumption that top performance should eventually reach 100%; yet, at the same time, there is no evidence to demonstrate what scores should be defined as top performance in measures that have some degree of imprecision. In addition, the American Diabetes Association and medical societies are moving towards more person-centered individualized A1C goals. Engaging in shared decision-making allows for patients to keep A1Cs closer to 8, but not to exactly 8. For physicians and practices that treat greater numbers of the elderly or those with multiple chronic conditions, each will be at risk to be penalized if the A1c target is 8 and the blood pressure target is less than 130 mm HG systolic or less than 80 mm Hg diastolic and the top decile set at 100%. As a result, the AMA believes that the MAP should not support measures that lack the necessary precision through risk adjustment or stratification given the potential unintended consequences. (Submitted by: American Medical Association)
  
  
• Given that this is a composite metric with hga1c, we do not believe there is sufficient need for additional measures (i.e., MUC17-215, Diabetes A1c Control (< 8.0)). (Submitted by: Ascension)
  
  
• MUC17-181: We do not have any issues with this specific measure, per se, but we have concerns about how it might be applied. Patients with diabetic foot ulcers are often referred by the primary care physician to a physician specializing in a wound care. We know of wound physicians that they are being held accountable for measures such as not prescribing statins to a diabetic patient under their wound care only. The physician treating the patient’s diabetes should be solely responsible for this. Chronic conditions that result in a chronic wound are often treated outside of the hospital by multiple physicians across multiple sites of care. These measures need to take that into consideration. (Submitted by: Integra LifeSciences)
  
  

• Type 1 and type 2 diabetes are two completely different diseases and should not be lumped together in a combined measure. Also, the HbA1C threshold seems to change from year to year and recent evidence points to no difference in outcomes for type 2 with a HbA1C as high as 9. The AAFP has opposed composite measures in the past, because they assume that unless all measures are met, there is no value to the care provided or the achievements that were made. It is challenging to accomplish each individual measure separately, and even more challenging to accomplish all measures as a whole. While we understand there is value to gaining a complete picture of disease-based care via composite measures, we fear performance rates will be extremely low and not meaningful. We would like to see a performance calculation that takes into account the relative performance of each measure, rather than an “all or none” performance rate. (Submitted by: American Academy of Family Physicians)
  
  
• The American Medical Association recommends that this measure receive a recommendation of "refine and resubmit". The American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines released updated recommendations on high blood pressure in November. Stage 1 hypertension is now defined as a systolic blood pressure of equal to or greater than 130 mm Hg or a diastolic blood pressure of equal to or greater than 80 mm Hg. The developer should modify the measure to reflect these changes prior to the MAP supporting this measure for the MIPS program. IIn addition, the shift to payment based on the achievement of a performance score against set benchmarks increases the importance of measures that are precisely specified and risk adjusted or stratified, particularly if the measure is an outcome or composite. Specifically, physicians are able to earn up to 10 points on this measure if implemented in the MIPS program and the benchmarking and points system assumes that a 100% performance rate is attainable for each individual measure. Given the broad denominator population, it is not reasonable to assume that every physician or practice could achieve an A1c less than 8% and a blood pressure based on the updated guideline recommendations in every patient. When these types of measures were first developed, the assumption was that many physicians and other healthcare providers would not be able to achieve 100% since the measures were broadly defined and some imprecision in defining the patient population was deemed acceptable. This approach does not work well when performance is assigned to deciles with an assumption that top performance should eventually reach 100%; yet, at the same time, there is no evidence to demonstrate what scores should be defined as top performance in measures that have some degree of imprecision. In addition, the American Diabetes Association and medical societies are moving towards more person-centered individualized A1C goals. Engaging in shared decision-making allows for patients to keep A1Cs closer to 8, but not to exactly 8. For physicians and practices that treat greater numbers of the elderly or those with multiple chronic conditions, each will be at risk to be penalized if the A1c target is 8 and the blood pressure target is less than 130 mm HG systolic or less than 80 mm Hg diastolic and the top decile set at 100%. As a result, the AMA believes that the MAP should not support measures that lack the necessary precision through risk adjustment or stratification given the potential unintended consequences. (Submitted by: American Medical Association)
  
  
• MSSP already includes diabetes measures developed by NCQA (ACO-11 A1C poor control and ACO-41 eye exam). ACOs have been reporting the NCQA measures for years and have processes in place to collect and report the existing diabetes measures. Switching the measures for the MN Community measures would place undue burden on ACOs. If CMS wants to add additional diabetes rates they shold look to the NCQA Diabetes measures. (Submitted by: Premier, Inc.)
  
  
• Given that this is a composite metric with hga1c, we do not believe there is sufficient need for additional measures (i.e., MUC17-215, Diabetes A1c Control (< 8.0)). (Submitted by: Ascension)
  
  
• AACE believes the targets set for A1C and blood pressure are too high. We refer you to the AACE diabetes comprehensive algorithm (A1c < 6.5% and BP < 130/80) https://www.aace.com/publications/algorithm (Submitted by: American Association of Clinical Endocrinologists (AACE))
  
  

• The Society for Vascular Surgery appreciates the opportunity to comment on this measure. We believe that there is overlap between this measure and the MUC17-234 measure regarding ischemic vascular disease. Use of anti-platelet medications should be part of optimal vascular care. Also, to succeed with reporting this measure it appears that the patient has to be a non-smoker. While this is optimal, it seems inappropriate to penalize the physician for something over which her or she has limited control. SVS recommends that the measure be modified to also include smoking-cessation counseling documentation as having met that aspect of the quality measure. Finally, This measure would be appropriate for management of claudicants but is not appropriate for all patients specifically those with critical limb ischemia (CLI). This measure should be reworded to include only those patients presenting for elective management of claudication and exclude procedures done for tissue loss, rest pain or acute limb ischemia. (Submitted by: Society for Vascular Surgery )
  
  
• A high percentage of patients with PVD were at one time a smoker. The definition of a non-tobacco-user must be clarified and aligned with codes that accurately represent the status. For example, does non-smoker mean “never” or “currently not a tobacco user” or “recently stopped smoking (there is no code that we are aware of for absence of smoking indicating length of time). Many people who had been smoking have now abstained, but this is handled differently by various measure specifications and not captured well by codes. We also strongly object to using the last BP taken because it does not take into account home BP monitoring which is more accurate The AAFP has opposed composite measures in the past because they assume that unless all measures are met, there is no value to the care provided or the achievements that were made. It is challenging to accomplish each individual measure separately, and even more challenging to accomplish all measures as a whole. While we understand there is value to gaining a complete picture of disease-based care via composite measures, we fear performance rates will be extremely low and not meaningful. We would like to see a performance calculation that takes into account the relative performance of each measure, rather than an “all or none” performance rate. (Submitted by: American Academy of Family Physicians)
  
  
• The American Medical Association (AMA) recommends that this measure receive a recommendation of “refine and resubmit.” The American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines released updated recommendations on high blood pressure in November. Stage 1 hypertension is now defined as a systolic blood pressure of equal to or greater than 130 mm Hg or a diastolic blood pressure of equal to or greater than 80 mm Hg. The developer should modify the measure to reflect these changes prior to the MAP supporting this measure for the MIPS program. In addition, the shift to payment based on the achievement of a performance score against set benchmarks increases the importance of measures that are precisely specified and risk adjusted or stratified, particularly if the measure is an outcome or composite. Specifically, physicians are able to earn up to 10 points on this measure if implemented in the MIPS program and the benchmarking and points system assumes that a 100% performance rate is attainable for each individual measure. Given the broad denominator population, it is not reasonable to assume that every physician or practice could achieve a blood pressure based on the updated guideline recommendations in every patient. When these types of measures were first developed, the assumption was that many physicians and other healthcare providers would not be able to achieve 100% since the measures were broadly defined and some imprecision in defining the patient population was deemed acceptable. This approach does not work well when performance is assigned to deciles with an assumption that top performance should eventually reach 100%; yet, at the same time, there is no evidence to demonstrate what scores should be defined as top performance in measures that have some degree of imprecision. For physicians and practices that treat greater numbers of the elderly or those with multiple chronic conditions, each will be at risk to be penalized if the blood pressure target is less than 130 mm HG systolic or less than 80 mm Hg diastolic and the top decile set at 100%. As a result, the AMA believes that the MAP should not support measures that lack the necessary precision through risk adjustment or stratification given the potential unintended consequences. (Submitted by: American Medical Association)
  
  
• Given that this is a composite metric, we do not believe there is sufficient need for additional measures (i.e., MUC17-234, Ischemic Vascular Disease Use of Aspirin or Anti-platelet Medication). (Submitted by: Ascension)
  
  
• MUC17-194: This measure focuses broadly on ischemic vascular disease, but could be modified to include an ankle-brachial index measurement above/below 0.9 for peripheral arterial disease specifically. PAD can often lead to skin ulcers of the lower leg. (Submitted by: Integra LifeSciences)
  
  

• December 6, 2017 RE: List of Measures under Consideration (MUC) for December 1, 2017 Novo Nordisk is pleased to provide the following comments on CMS’ list of measures under consideration. Headquartered in Denmark, and with nearly 5,000 U.S. employees, Novo Nordisk is a global health care company with 90 years of innovation and leadership in diabetes, obesity, hemophilia and growth hormone disorders. Novo Nordisk is committed to the goal of ensuring that patients have access to high-quality, affordable health care. As a life sciences company with a focus on chronic disease management, we support the Agency’s continued efforts to develop policies that are reflective of system capabilities and grounded in core strategies to drive progress and reform efforts. Diabetes remains an important condition affecting 30.3 million individuals—9.4 percent of the US population. Novo Nordisk is encouraged to see CMS consider diabetes a national priority by considering measures to improve the quality of care for millions of individuals. We strongly support the two diabetes measures on the MUC list—Optimal Diabetes Care (MUC17-181) and Diabetes A1c Control (<8.0) (MUC17-215). However, we suggest a review of the blood pressure criteria in MUC17-181, due to new clinical practice guidelines that redefine high blood pressures as 130/80 mm Hg. Novo Nordisk is pleased to see the inclusion of two diabetes measures on the MUC list; however, there remain opportunities for measures, including (1) screening for type 2 diabetes aligned with the USPSTF recommendation for screening for abnormal blood glucose and type 2 diabetes mellitus, (2) referral to diabetes prevention programs for individuals with prediabetes, also aligned with the USPSTF recommendation for screening for abnormal blood glucose and type 2 diabetes mellitus, (3) patient-reported outcomes, including concepts such as shared-decision making and patient engagement, (4) insulin adherence, and (5) hypoglycemia. Novo Nordisk would encourage CMS to consider diabetes outcomes beyond A1c measurement and control, as these outcomes are particularly important for patients living with the disease. In review of the MUC list, we also note the continued gaps in quality measures related to effective treatment and improving outcomes for people living with obesity. Since obesity is a significant risk factor for type 2 diabetes, and impacts both costs and utilization of health care, we encourage CMS to move beyond process measures of BMI assessment and referrals to treatment and toward more specific outcomes measures, including exploration of trends in obesity and patient-reported outcomes that could impact quality of care and reduce morbidity and mortality. Thank you for this opportunity to comment on CMS’ List of Measures Under Consideration. If you have any questions about the comments included here, please do not hesitate to reach out to me at TDDH@novonordisk.com. Sincerely, Todd Hobbs, MD Chief Medical Officer North America Novo Nordisk Inc. (Submitted by: Novo Nordisk Inc)
  
  
• The American Medical Association (AMA) recommends that this measure receive a recommendation of “refine and resubmit.” The shift to payment based on the achievement of a performance score against set benchmarks increases the importance of measures that are precisely specified and risk adjusted or stratified, particularly if the measure is an outcome or composite. Specifically, physicians are able to earn up to 10 points on this measure if implemented in the MIPS program and the benchmarking and points system assumes that a 100% performance rate is attainable for each individual measure. Given the broad denominator population, it is not reasonable to assume that every physician or practice could achieve an A1c less than 8% in every patient. When these types of measures were first developed, the assumption was that many physicians and other healthcare providers would not be able to achieve 100% since the measures were broadly defined and some imprecision in defining the patient population was deemed acceptable. This approach does not work well when performance is assigned to deciles with an assumption that top performance should eventually reach 100%; yet, at the same time, there is no evidence to demonstrate what scores should be defined as top performance in measures that have some degree of imprecision. In addition, the ADA and medical societies are moving towards more person-centered individualized A1C goals. Engaging in shared decision-making allows for patients to keep A1Cs closer to 8, but not to exactly 8. For physicians and practices that treat greater numbers of the elderly or those with multiple chronic conditions, each will be at risk to be penalized if the A1c target is 8 and the top decile set at 100%. As a result, the AMA believes that the MAP should not support measures that lack the necessary precision through risk adjustment or stratification given the potential unintended consequences. (Submitted by: American Medical Association)
  
  
• MSSP already includes diabetes measures developed by NCQA (ACO-11 A1C poor control and ACO-41 eye exam). ACOs have been reporting the NCQA measures for years and have processes in place to collect and report the existing diabetes measures. Switching the measures for the MN Community measures would place undue burden on ACOs. If CMS wants to add additional diabetes rates they shold look to the NCQA Diabetes measures. (Submitted by: Premier, Inc.)
  
  
• We believe this measure would be somewhat redundant as part of another global metric. (Submitted by: Ascension)
  
  
• MUC17-215: This measure is more narrow and a bit redundant to MUC17-181. Even though it is an intermediate outcome measure and not a composite measure, we question whether MUC17-181 could be used in both situations. (Submitted by: Integra LifeSciences)
  
  

• Type 1 and Type 2 should not be lumped together—they are two completely different diseases. The debate is still out as to the value of going from a HbA1c of 9 to 8. Recent evidence points to no difference in outcomes for type 2 with a HbA1C as high as 9. (Submitted by: American Academy of Family Physicians)
  
  
• The American Medical Association (AMA) recommends that this measure receive a recommendation of “refine and resubmit.” The shift to payment based on the achievement of a performance score against set benchmarks increases the importance of measures that are precisely specified and risk adjusted or stratified, particularly if the measure is an outcome or composite. Specifically, physicians are able to earn up to 10 points on this measure if implemented in the MIPS program and the benchmarking and points system assumes that a 100% performance rate is attainable for each individual measure. Given the broad denominator population, it is not reasonable to assume that every physician or practice could achieve an A1c less than 8% in every patient. When these types of measures were first developed, the assumption was that many physicians and other healthcare providers would not be able to achieve 100% since the measures were broadly defined and some imprecision in defining the patient population was deemed acceptable. This approach does not work well when performance is assigned to deciles with an assumption that top performance should eventually reach 100%; yet, at the same time, there is no evidence to demonstrate what scores should be defined as top performance in measures that have some degree of imprecision. In addition, the ADA and medical societies are moving towards more person-centered individualized A1C goals. Engaging in shared decision-making allows for patients to keep A1Cs closer to 8, but not to exactly 8. For physicians and practices that treat greater numbers of the elderly or those with multiple chronic conditions, each will be at risk to be penalized if the A1c target is 8 and the top decile set at 100%. As a result, the AMA believes that the MAP should not support measures that lack the necessary precision through risk adjustment or stratification given the potential unintended consequences. (Submitted by: American Medical Association)
  
  
• We believe this measure would be somewhat redundant as part of another global metric. (Submitted by: Ascension)
  
  

• We believe this measure would be somewhat redundant as part of another global metric. (Submitted by: Ascension)
  
  

• The Society for Vascular Surgery appreciates the opportunity to comment on this measure. We believe with some minor modifications that this could be a valuable measure. The term, IVD, needs to be clarified in the measure. Also, use of statins needs to be added to the measure. Finally, in general this measure needs some better definitions. Definition of chronic must be defined to separate these patients from acutely ischemic patients. Definition of critical limb ischemia also needs to be defined, i.e. rest pain or tissue loss. Does this measure capture a patient with chronic, stable disease (i.e. claudicant) who presents acutely ischemic? Given the years (decades) long disease process of atherosclerosis, where do you start to define chronic? (Submitted by: Society for Vascular Surgery )
  
  
• This measure was recently updated and endorsed by NQF. We agree with the measure, although we would like to see an exclusion for history of GI bleed. (Submitted by: American Academy of Family Physicians)
  
  
• MSSP already includes a similar measure developed by NCQA (ACO30). ACOs have been reporting the NCQA measure for years and have processes in place to collect and report the existing measures. Switching the measure for the MN Community versopm would place undue burden on ACOs. (Submitted by: Premier, Inc.)
  
  
• We believe this measure would be somewhat redundant as part of another global metric. (Submitted by: Ascension)
  
  

• On behalf of the more than 10,000 physiatrists of the American Academy of Physical Medicine and Rehabilitation (AAPM&R), we appreciate the opportunity to submit comments on the 2017 MAP MUC list. AAPM&R has been fortunate to have two of our members serve on the MACRA Episode-Based Cost Measures Clinical Subcommittee for Musculoskeletal Non-Spine, engaged in the development of the measure for knee arthroplasty. AAPM&R also submitted comments to the recent measures field testing and later this week we will participate in a follow up call with the subcommittee to discuss possible changes to the draft measure. As NQF has noted, the cost measures are in an early stage of development. In their current state, the risk adjustment methodologies used to predict costs for the episode-based measures are not strong enough. We also do not believe that CMS has done enough to educate providers about the implications of cost measurement. We therefore do not support inclusion of the episode-based cost measures on the MUC list at this time. Thank you in advance for your consideration. If you have any questions regarding these comments, please contact Carolyn Winter-Rosenberg, Manager of Reimbursement and Regulatory Affairs in the AAPM&R Division of Health Policy and Practice Services. She may be reached at cwinterrosenberg@aapmr.org or at (847) 737-6024. (Submitted by: American Academy of Physical Medicine and Rehabilitation)
  
  
• The American Association of Nurse Anesthetists (AANA) appreciate the opportunity to address concerns about the potential use of these measures in the Quality Payment Program, and how the measures and reporting format should be improved to provide clinicians actionable information to ensure high quality and high value care. We have noted that for procedural episode groups, like the Routine Cataract Removal with IOL Implantation measure, episodes are attributed to the clinician(s) rendering the trigger services (HCPCS/CPT procedure codes). The comments are based on the documentation provided in the field testing appendices that were made available on the CMS website (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html ) posted on October 16, 2017 as well as the 2015 QRUR Supplemental material (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/Downloads/2015-SQRUR-Detailed-Methods.pdf ) referenced in Appendix C of the field testing documentation. After having reviewed the test codes for attribution and exclusions and appendices for clinician service assignment in the mock report we have noted that anesthesia is a post-trigger service ( ie, 00142, 00144, and 00145) as identified by the anesthesia CPT codes in the clinician service assignments for the Routine Cataract Removal with IOL Implantation measure. We note that the mock report in Appendix A under “Other Services” includes Anesthesia Services which accounts for 93 % national average of the share of cost by episode. In addition, we also noted that the 2015 QRUR Supplemental Materials and the attribution exclusions in the test code documentation that anesthesia modifiers AA, QX, and QZ were used for the exclusion rule on the claim when determining attribution. We are concerned by the mechanism for which anesthesia cost has been incorporated into the measure given that three other predominant anesthesia modifiers (QK, QY, AD) are not included in the exclusion attribution rule. We are seeking clarification for why the other anesthesia modifiers (QK, QY, and AD) are not included in the exclusion attribution rule given that AA, QX, and QZ have been included. Based on the discrepancies, we believe further testing and refinement of the measure is warranted. Finally, it is possible that the report generated by this measure will be read and interpreted by a wide audience such as small rural health care facilities or large multihospital healthcare systems whose clinicians are employed by the hospitals and whose NPIs are included under the hospitals’ TIN. Given that the cost data contained in these reports may potentially affect resource allocation and staffing decisions in the years to come, it is critical that these reports be available to all NPIs under the TIN and the information be understandable by all. Lorraine M. Jordan, PhD, CRNA, CAE, FAAN Senior Director of Research and Quality/AANA (Submitted by: American Association of Nurse Anesthetists)
  
  
• Measure: MUC17-235: Routine Cataract Removal with Intraocular Lens (IOL) Implantation We recommend that this measure be adopted only under certain conditions. Before this measure can be judged ready for adoption, we need to understand how it will be implemented. To accomplish this, the cost calculation formulas and raw data need to be made available. In addition, this measure should be modified to take into account the differences in coding for pre-op visits, and the differences in cases completed with trainees (residents and fellows) and in rural cases. Our first concern is that the way the measure is specified requires cataract diagnosis to be the primary diagnosis for pre-op costs in the 60-day pre-trigger window. This may be causing some pre-op costs to not be accounted for if cataract is the secondary or tertiary diagnosis for the pre-op visit. During the field test of this measure, there were occasional cases in which no pre-op visits were recorded for clinicians performing cataract surgery. We are also concerned about the method for calculating each clinician’s/group’s Cost category score. We have been told that it will be done as a weighted average of the subgroups, however we have not seen the calculation and are concerned that this measure may not truly compare like practices. We would like to ensure that the physician or TIN’s risk bracket and mix of sub-groups is accurately controlled for in the cost comparisons. In order to adequately control for risk, the risk adjustments must be made based on factors that are germane to the procedure. HCC risk scores are not germane to ophthalmology. For example, a patient’s chronic obstructive pulmonary disease has no impact on the course of their cataract surgery. In order to better understand and evaluation this measure, we request the scoring formula and patient-level data for total costs per case before and after risk adjustment. We also know that trainee cases take longer, costing an average of $100 - $200 more per case. (1,2) Moreover, trainee cases do not exclusively occur at teaching hospitals. Often, trainees perform cases in private settings as part of their education. We are concerned that practices that help to train residents and fellows into competent ophthalmologists will be labelled as higher cost under the current measure. Therefore, we ask that a subgroup be created in this measure to distinguish cases with trainee involvement so that this variable can be adequately controlled. Finally, in rural areas, there is often one ophthalmologist, at most. Because of this, that ophthalmologist often treats a wide variety of conditions with limited resources. The alternative to this rural care, is to require patients with limited vision to drive or travel hours to a non-rural setting for care. This alternative would not only decrease access to care, but also increase cost to the system. We would like to ensure that considerations are made to ensure that access problems are not exacerbated. References: 1. Time and cost of teaching cataract surgery. Taravella, Michael J. et al. Journal of Cataract & Refractive Surgery, Volume 40, Issue 2, 212 – 216. 2. Impact of Resident Participation in Cataract Surgery on Operative Time and Cost. Hosler, Matthew R. et al. Ophthalmology, Volume 119, Issue 1, 95 – 98. (Submitted by: American Academy of Ophthalmology)
  
  
• We support the use of this measure. (Submitted by: Ascension)
  
  
• December 7, 2017 Measure Application Partnership Clinician Workgroup National Quality Forum 1030 15th Street NW Suite 800 Washington DC 20005 Re: 2017 Measure Application Partnership Measure Under Consideration; MUC17-235, Routine Cataract Removal with Intraocular Lens (IOL) Implantation To Whom It May Concern: The American Society of Cataract and Refractive Surgery (ASCRS) is a medical specialty society representing nearly 9,000 ophthalmologists in the United States and abroad who share a particular interest in cataract and refractive surgical care. We appreciate the opportunity to provide feedback on the Routine Cataract Removal with Intraocular Lens (IOL) Implantation episode cost measure (MUC17-235). ASCRS’ representative, Parag Parekh, MD, served on both the MACRA Episode-Based Cost Measures Technical Expert Panel (TEP) and the ophthalmic clinical TEP convened by CMS to advise its contractor, Acumen, on the development of these measures. While we are pleased that many of his recommendations have been incorporated into the cataract cost measure, the measures still need refinement in how the physician’s average cost is presented and to the readability and actionability of the feedback reports. We support this measure with some conditions. Specifically, we support: • The selection of CPT code 66984 as the trigger code; • Excluding patients with significant ocular co-morbidities; and • The selection of sub-groups based on site of service, laterality, and co-management included in the measure. However, we believe CMS should consider an alternative metric to a total national average cost as the basis of comparison for a physician’s cost score, such as the difference between the physician’s expected cost versus the physician’s observed cost. Given the wide range in average costs for each of the episode sub-groups noted during the recent field test of this measure, the national average cost of cataract surgery identified, $2,676, is fa misleading number to ophthalmologists. We suggest the measure be based on comparing physicians to how far they diverge from the expected cost, based on their mix of episode sub-groups and risk percentile. Furthermore, we have also expressed concerns to CMS about the readability and actionability of the draft feedback report recently provided to physicians during a field test of the measures. Not only do the reports include the problematic national average figure discussed above, they also lack information about the measure specifications themselves, making it difficult for physicians and groups to understand how they are being evaluated. While we understand the feedback reports are not under review by the MAP, we believe this is a significant issue CMS must address before using the measure to evaluate the cost of cataract surgery. Full details on these recommendations are included below. Trigger Code • ASCRS supports the use of CPT code 66984 as a trigger for the cataract episode measure. Routine cataract removal with 66984 requires homogeneous and comparable resources for nearly all patients. As a high-volume code, it will provide enough data to identify outlier physicians who are practicing outside of established patterns. 66984 is the only code submitted to the MAP as a trigger code. No other codes should be considered. • ASCRS does not support including other codes, such as complex cataract surgery, 66982, in this measure as it will not yield comparable enough data to measure a physician’s resource use accurately. Patients undergoing cataract surgery that requires the use of the complex cataract code may suffer from a wide variety of ocular co-morbidities, or other non-ocular co-morbidities, which could require varying levels of resource use depending on the condition. For example, patients taking Tamsulosin or similar medications very frequently require the use of iris retractors, leading to the use of code 66982 instead of the usual 66984. Furthermore, these patients often have complications requiring further surgery, such as a vitrectomy. Complex cataract surgery may require additional supplies and increases the likelihood of potential complications, resulting in a range in value too significant to provide a homogenous patient group for cost measures and should not be used as a trigger code. Exclusions • ASCRS supports the use of criteria to exclude patients with significant ocular co-morbidities from the cost measure. We support the use of the exclusionary criteria from quality measure 191, Cataracts: 20/40 or Better Visual Acuity within 90 Days Following Cataract Surgery. The criteria excludes patients with documentation of significant ocular conditions. The exclusions include such chronic conditions as diabetic retinopathy, macular degeneration, and glaucoma. • The rational for excluding these patients is that since patients with significant ocular co-morbidities are excluded from quality measurement, they should also be excluded from cost measurement. The developers of quality measure 191 excluded these patients because ocular co-morbidities play a significant role in whether the patient will have a predictably good outcome and if complications may arise. Surgeons do not have control over a patient’s co-morbidities and should not be held accountable for additional costs in an episode if a patient suffers from one of these conditions. If physicians are not measured on the quality outcomes of these surgeries, therefore, they should not be held responsible for the cost of these surgeries. • These exclusions ensure a greater level of risk adjustment than has previously been incorporated in cost measures, such as current measure total cost per capita and Medicare spending per beneficiary. While we are aware CMS includes a basic level of risk adjustment calculation for existing cost measures, and for the proposed episode-based measures, CMS has not been able to demonstrate that its risk adjustment impacts the cost of cataract surgery. This risk adjustment includes factors such as beneficiary age, dual-eligibility, and some co-morbidities, but does not include ocular co-morbidities. Cataract surgery is performed on a relatively older patient base, and while some co-morbidities may require additional resource use as discussed above, ocular co-morbidities play a much larger role in determining the resource use and likelihood of a good outcome than do the factors used in CMS’ current risk adjustment. Using the exclusionary criteria from the cataract quality measure is a much more accurate means of risk adjustment to ensure that physicians are not held accountable for the cost of care related to factors outside their control. Episode Sub-Groups • ASCRS supports the inclusion of all of the submitted sub-groups, which relate to site of service, laterality, and co-management. We believe the eight sub-groups in the cataract episode measure represent significant differences in the cost of cataract surgery—largely related to Medicare’s own billing and reimbursement policies—and should be separated for basis of comparison in this measure. • Cataract surgery can be performed in either hospital outpatient departments (HOPDs) or ambulatory surgery centers (ASCs), with reimbursements for ASCs well below HOPDs. Cataract surgery is reimbursed 45% less in the ASC than in the HOPD. While some ophthalmologists have the option of building and owning their own ASC, some states with certificate of public need laws limit the number of existing ASCs or prevent physicians from opening new ASCs, so they may be forced to operate in HOPDs. In addition, some physicians, especially solo practitioners, may not have the resources to construct and manage their own ASC, and must operate in whatever facility, either ASC or HOPD, is available. Despite these limitations and given the choice, ophthalmic surgeons would likely prefer to operate in the lower cost ASC. ASCs are not subject to the same requirements as HOPDs, such as extensive pre-operative testing, that are not relevant to treating ophthalmic disease. In addition, patients may prefer to undergo surgery in ASCs, which are generally easier to navigate since they are smaller, less intimidating, and have shorter wait times. Ophthalmic surgeons want to make the cost-effective choice, but cannot always do so. Given that, the episodes must include sub-groups for ASCs and HOPDs, since the site of service is not always in the control of the physician. • ASCRS supports the submitted sub-groups for laterality because they reflect whether the surgeon removed cataracts in either one or both eyes during the episode window. Patients frequently develop cataracts in both eyes, and while both eyes are rarely operated on at the same time, many patients find it convenient to have the second surgery shortly after the first, usually still within the 90-day global post-operative period. Medicare has specific billing rules for physicians performing multiple procedures on the same patient related to pre- and post-operative care, therefore, the expected cost of cataract surgery performed during the global period of previous cataract surgery would be substantially different from two surgeries performed more than 90 days apart. • ASCRS supports the submitted sub-groups for co-management because they reflect whether or not the post-operative care for the cataract surgery was furnished by another provider. Ophthalmology is unique among other specialties as post-operative care for cataract surgery patients may be performed by another ophthalmologist or an optometrist. This arrangement is generally at the request of, and for the convenience of, the patient. This usually occurs when a patient may have to travel some distance to receive cataract surgery and does not want to make that trip for subsequent post-operative visits, his or her own ophthalmologist does not perform cataract surgery, or he or she prefers to continue care with the optometrist. While the surgeon may not provide all the care to the patient, he or she will be attributed the episode by billing 66984. The surgeon may not be aware if some of the practitioners who are co-managing the case are providing care with unreasonable costs outside established practice patterns. Sub-grouping co-managed cases allows the surgeon to be aware of how other practitioners may be impacting his or her cost scores, and take action if necessary. Consider an Alternative to a National Average Price for a Final Measure Determination As noted above, we support the measure sub-groups, which were determined by the clinical TEP. The physicians on the TEP selected those sub-groups to separate and avoid comparing surgeries where fundamentally different factors are contributing to the amount Medicare is reimbursing in total for the episode that are not always in the control of the physician. Given that fact, it is confusing to the physician receiving feedback on cost performance to see one dollar figure representing his or her “average” cost compared to a national average. We believe physicians would better understand their performance on the measure and be able to take action in response if they were shown how their average observed cost compared to their average expected cost. • The cataract episode should compare each physician or TIN’s average observed cost to that same physician or TIN’s average expected cost and not compare overall to a national average. The clinical TEP determined that the eight sub-groups broadly represent the main drivers of cost in relation to cataract surgery. CMS and Acumen have determined risk-adjusted expected costs for each of the sub-groups. Each of a physician’s attributed episodes’ observed costs are then compared to the expected cost for the respective sub-group and assigned a ratio to represent the divergence between the expected and observed costs. The ratios for each of the episodes are then averaged to determine the frequency of the physician’s divergence from the expected cost. We support this approach as it ensures that the varying costs of the sub-groups outside of the physician’s control, such as the facility fee, are not impacting the physician’s score. • However, the steps following the calculation of the average ratio should be re-thought to make the final average cost more meaningful to the physician or group practice. Based on field test reports released earlier this fall, the ratios of observed and expected costs are converted back to a dollar figure and compared to a national average. Hearing from several of our members who have reviewed their feedback reports, they question how their final average cost and the national average costs were determined, and how it relates to the actual reimbursement they received for the surgery. While we understand that the supplemental methodology documents released in conjunction with the field test discuss this process, they were neither easy to understand or access. In addition, physicians are aware that geographic differences contribute to the reimbursement level, and may question why they should be compared to a national dollar average. • To overcome this issue, we recommend the physician’s score be based on his or her own expected and observed costs, and not based on a misleading national average. For example, if a surgeon’s case mix means that 70% of his or her surgeries are performed in the ASC, unilateral, and not co-managed, and 30% are performed in the HOPD, unilateral, and not co-managed, then his or her expected cost should be a weighted average of those two sub-groups. Then, the surgeon’s actual observed costs are compared to that expected average of a 70/30 mix of those two sub-groups. The average cost for this surgeon would be substantially different from a physician who performed 90% of surgeries in an HOPD and 10% in an ASC. The surgeon would then be evaluated on the extent, above or below, that he or she deviates from the expected cost for his or her specific case mix. We believe this is a much more useful value to a physician than a national average. Improve Report Readability and Actionability We believe the feedback reports for these measures provided to physicians need substantial improvements to make them more understandable and actionable. In conversations with ASCRS members who received draft feedback reports on the measures during the recent field test, most reported difficulty understanding what the measure was evaluating, and how they could use the report to make changes that may impact their overall cost of providing cataract surgery. While we understand that the MAP is not considering the feedback reports at this time, we believe it is important to provide additional rationale for what issues have led us to determine support with conditions. • Feedback reports on cost measures are inherently different than feedback reports for quality measures. For quality reporting, the physician and clinical staff must be familiar with the measure specifications and submit data only on patients that meet the specific criteria related to diagnoses and services performed. When they receive their feedback reports on quality measures, they are able to digest the information with the pre-existing knowledge of which patients are included in the measure. • Cost measures, however, are calculated by CMS on administrative claims, and physicians may not know in advance what patients will be attributed to them or what costs are included in the measure. While the specifications of this measure would make it largely predictable for ophthalmologists to know which episodes are included, the field test report does not include this information, and accessing it is difficult. Physicians and practices would have had to know to visit another CMS website, and then download two more files to determine the measure methodology, trigger code, exclusions, and services included in the episode to understand why those specific patients were included in the measure—all before even beginning to consider their cost outcomes. In addition, some of the terminology used in the reports could be misinterpreted and should be defined in the report. The feedback report format should be improved in the following ways: • Provide a summary of the measure specifications at the beginning of the feedback report. While we appreciate that CMS and Acumen have made extensive information about the development and methodology of the measure available, it is not easily accessible and requires substantial time to read and digest. As noted above, a physician is likely unaware of the specifications of the cost measure when he or she receives the report. However, the physician will likely know how his or her cost of care may differ from other physicians based on factors that influence the cost, but may not be within their control, such as if the physician performs surgery in an HOPD with a higher facility cost, or often performs glaucoma surgery in conjunction with cataract surgery. The measure has accounted for those differences, but they are not immediately apparent when viewing the feedback report. The feedback reports should include a brief executive summary of the measure specifications that include the trigger code, episode window, explanation of sub-groups, and a brief word on exclusions and where to find the full list of excluded diagnoses. • Provide a short description of the rationale for the breakdown of the sub-groups. As mentioned above, most ophthalmologists have a sense of what factors are driving the costs of cataract surgery, and how they may differ from other surgeons. An ophthalmologist performing cataract surgery in an HOPD is aware that the facility charge is significantly higher than that of surgery performed in an ASC. While they will notice there is a breakdown of the costs for each sub-group, without accessing the separate methodology, they may not be able to determine that only surgeries of the same sub-groups are being compared. One or several sentences could be added to the paragraph above the cost breakdown to explain why the sub-groups are present, and how it factors into the overall score. There is some discussion of the concept of sub-groups in general on the Appendix C, “How to Interpret this Report” tab, but the description is not specific to the cataract episode and the factors the developers were considering for the episode being displayed. While we realize more specific information is included in the methodology document, busy surgeons who receive these documents do not have the time to search for separate information to understand the reports. Without a clear explanation of the measure specifications embedded with the report, physicians will likely not view them as credible or useful. • Include a glossary of terms in the report to reduce confusion and misunderstanding. There are several examples of terms used in these reports that could be interpreted in different ways, and should be explained to improve readability and actionability. For example, the physician is compared to other physicians in the same “risk percentile,” which is represented with a numerical value. There is no explanation in the report of what is encompassed in the percentile or what the percentile represents. Does the higher the percentile value mean the included beneficiaries are an intrinsically riskier group, or the opposite? In addition, several of our members have questioned the use of the term “bilateral” for the sub-groups and interpreted it as having cataract surgery on both eyes on the same day. This is not typically done, which leads physicians to question the validity of the data. A short glossary that explained that the second eye’s surgery occurred within the 90-day post-operative period after the first eye’s surgery would add immediate clarity, without the physician having to seek additional resources. We urge CMS and Acumen to work with the clinical TEP to identify and define other terms that may not be immediately familiar to a physician reviewing the report. Conclusion We appreciate the opportunity to provide comment on the cataract episode currently under consideration. While we support the measure’s trigger code, exclusions and sub-groups, we believe more refinement for the final score calculation is necessary to ensure physicians will understand the feedback and be able to take an appropriate action in response. We believe physicians would find a comparison of their observed costs to their expected costs much more meaningful than a final comparison to a national average cost. We urge the MAP to incorporate our feedback as it considers this measure. ***** Should you have any questions regarding our comments, please do not hesitate to contact Allison Madson, manager of regulatory affairs, at amadson@ascrs.org or 703-591-2220. Sincerely, Bonnie An Henderson, MD President, ASCRS (Submitted by: American Society of Cataract and Refractive Surgery)
  
  
• The American Academy of Neurology (AAN) welcomes the opportunity to submit comments on the 2017 Measures Under Consideration (MUC) list. The AAN represents 32,000 neurologists and neuroscience professionals worldwide treating neurologic conditions. The AAN is also a leading expert in the measure development field with 133 measures currently spanning a wide variety of neurologic conditions. The AAN is concerned that the cost/resource use measures are listed as early development which indicates that they may not be ready for widespread use. Please clarify the process for selecting early development measures, specifically why some that are in early development are considered and others that are deemed not fully developed are not considered. What are the criteria for early development measures? The AAN has requested this clarification in past years, and the process continues to be not transparent. The AAN submitted numerous measures to be considered which were subsequently rejected based on the fact that they were not fully developed. Also, the measures developed by Acumen recently concluded field testing but are listed on the MUC list. We believe that the testing feedback was not considered or incorporated into the development of the MUC list. In the testing feedback AAN members found the intracranial hemorrhage or cerebral infarction measure, in particular, difficult to interpret and did not feel the measure accurately represented their resource use. Moreover, in regard to the same measure, AAN members whose own records suggested they should have had sufficient cases did not receive field test reports and those that suggested they did not have sufficient cases did receive field test reports. These comments suggest that measures that are not fully developed should not be considered for the MUC list. The AAN is also concerned with the lack of specialty measures included in the list. As stated above the AAN submitted numerous measures, which were all rejected. We have heard from several other specialties who had a very similar experience when submitting measures. Please clarify the appropriate time in measure development to submit measures for consideration into CMS programs. (Submitted by: American Academy of Neurology)
  
  
• As an umbrella organization for more than 100 medical specialties and 50 state medical societies, the AMA has played a facilitator role in the formation and work of the clinical panels that are assisting Acumen with the development and refinement of the episode cost measures that will be part of the Merit-based Incentive Program. We believe that Acumen has constructed a process that should be used as a model in the development of additional episode measures and that the clinical panels have provided invaluable advice on both the overall structure and details of this and the other seven episodes CMS is bringing before the MAP. Unfortunately, due to a truncated time line for testing and refining the episodes, the AMA is not ready to give unqualified support to any of the eight measures though we expect to support most of them once there has been more time for analysis and refinement. We believe that structural changes should not be ruled out in the course of this refinement and that the recommendations of the specialties who provide care associated with this episode including the American Academy of Ophthalmology and American Society of Cataract and Refractive Surgery should be given great weight in the MAP ’s decision-making. Areas where the AMA believes more analysis is needed include: • extent to which risk adjustment, exclusions and subgroups distinguish between and adjust for appropriate cost differences • shortcomings of administrative claims data to identify patient conditions with significant impact on costs • identification/development of appropriate quality measures to match each episode • how practice size, site of service and specialty affect reliability and episode results • the impact of multiple attribution for different practice sizes, sites of service and specialties • degree of cost variation within the episode. • potential interplay/overlap between the episode cost measures and the MIPS Total Cost of Care and Medicare Spending Per Beneficiary measures (Submitted by: American Medical Association)
  
  

• We are concerned that this measure seems to be very specific and represents only a small area of focus. As such, it is unclear what value the use of this measure would add. (Submitted by: Ascension)
  
  

• AGA recommends against inclusion of the Screening/Surveillance Colonoscopy cost measure in MIPS at this time. Field testing of the measure was rife with challenges exacerbated by an incredibly short timeline. The time allotted for review and comment was insufficient given the volume and complexity of the material and the difficulty our members had accessing field test reports. Moreover, as our members accessed and reviewed their test reports, a number of concerns were identified. Concerns focused on all aspects of the measure, including but not limited to – care setting, trigger codes, assigned services, and risk adjustment. Our comments to the Centers for Medicare & Medicaid Services and Acumen were 71 pages long, which demonstrates the breadth and depth of our concern. While AGA is eager to have a specialty-specific cost measure, the Screening/Surveillance Colonoscopy cost measure is not yet ready for inclusion in MIPS. AGA urges NQF to recommend against inclusion of this measure in MIPS. (Submitted by: American Gastroenterological Association )
  
  
• The American Society for Gastrointestinal Endoscopy’s (ASGE) commitment to working on a specialty specific measure, and creation of this measure is validated by the volume of this procedure (it was 400% higher than the next highest volume, lens replacement), but we believe further field testing and feedback is needed. It was our understanding that CMS would submit this episode to NQF after the Clinical Subcommittee had sufficient time to review and assess the feedback received from field testing. At this time, ASGE recommends against inclusion of the Screening/Surveillance Colonoscopy cost measure in MIPS. Field testing of the measure was rife with challenges exacerbated by an incredibly short timeline. The time allotted for review and comment was insufficient given the volume and complexity of the material and the difficulty our members had accessing field test reports. Moreover, as our members accessed and reviewed their test reports, a number of concerns were identified. Concerns focused on all aspects of the measure, including but not limited to – care setting, trigger codes, and assigned services. Our comments to the Centers for Medicare & Medicaid Services and Acumen demonstrate the breadth and depth of our concern. While ASGE is eager to have a specialty-specific cost measure, the Screening/Surveillance Colonoscopy cost measure is not yet ready for inclusion in MIPS. ASGE urges NQF to recommend against inclusion of this measure in MIPS. (Submitted by: American Society for Gastrointestinal Endoscopy)
  
  
• The American Association of Nurse Anesthetists (AANA) appreciate the opportunity to address concerns about the potential use of these measures in the Quality Payment Program, and how the measures and reporting format should be improved to provide clinicians actionable information to ensure high quality and high value care. We have noted that for procedural episode groups, like the We appreciate the opportunity to address concerns about the potential use of these measures in the Quality Payment Program, and how the measures and reporting format should be improved to provide clinicians actionable information to ensure high quality and high value care. We have noted that for procedural episode groups, like the Screening/Surveillance Colonoscopy measure, episodes are attributed to the clinician(s) rendering the trigger services (HCPCS/CPT procedure codes). The comments are based on the documentation provided in the field testing appendices that were made available on the CMS website (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html ) posted on October 16, 2017 as well as the 2015 QRUR Supplemental material (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/Downloads/2015-SQRUR-Detailed-Methods.pdf ) referenced in Appendix C of the field testing documentation. After having reviewed the test codes for attribution and exclusions and appendices for clinician service assignment in the mock report we have noted that anesthesia is a post-trigger service ( ie, 00790, 00810, 00840, 00902) as identified by the anesthesia CPT codes in the clinician service assignments for the Screening/Surveillance Colonoscopy measure. We note that the mock report in Appendix A under “Other Services” includes Anesthesia Services which accounts for 2 % national average of the share of cost by episode. In addition, we also noted that the 2015 QRUR Supplemental Materials and the attribution exclusions in the test code documentation that anesthesia modifiers AA, QX, and QZ were used for the exclusion rule on the claim when determining attribution. We are concerned by the mechanism for which anesthesia cost has been incorporated into the measure given that three other predominant anesthesia modifiers (QK, QY, AD) are not included in the exclusion attribution rule. We are seeking clarification for why the other anesthesia modifiers (QK, QY, and AD) are not included in the exclusion attribution rule given that AA, QX, and QZ have been included. Based on the discrepancies, we believe further testing and refinement of the measure is warranted. Finally, it is possible that the report generated by this measure will be read and interpreted by a wide audience such as small rural health care facilities or large multihospital healthcare systems whose clinicians are employed by the hospitals and whose NPIs are included under the hospitals’ TIN. Given that the cost data contained in these reports may potentially affect resource allocation and staffing decisions in the years to come, it is critical that these reports be available to all NPIs under the TIN and the information be understandable by all. Lorraine M. Jordan, PhD, CRNA, CAE, FAAN Senior Director of Research and Quality/AANA (Submitted by: American Association of Nurse Anesthetists)
  
  
• The American College of Gastroenterology (ACG) recommends against inclusion of the Screening/Surveillance Colonoscopy cost measure in MIPS at this time. ACG is a member of the CMS administered “Gastrointestinal (GI) Disease Management Clinical” medical and surgical subcommittee, and is eager to have a specialty-specific cost measure incorporated into the Merit Incentive-based Payment System (MIPS). Yet, it is clear the “Screening/Surveillance Colonoscopy” cost measure is not yet ready for inclusion in MIPS. ACG was under the impression that CMS would submit this episode of care only after (not during) the measure was reviewed, vetted, and improved by the GI Disease Management Clinical subcommittee. Field testing of this episode was rife with challenges exacerbated by significant problems accessing the feedback reports. The time allotted for review and comment was insufficient given the volume and complexity of the material. Moreover, as our members accessed and reviewed their test reports, a number of concerns were identified, including site of service variance, trigger codes, and assigned services. As a result of these concerns, significant changes have been recommended by subcommittee (and after CMS submitted this measure to NQF) regarding subdividing the screening/surveillance episode group into subgroups. ACG also joined the other GI societies in submitting comments to CMS and Acumen outlining these issues and concerns. It is unclear at this time whether these comments were addressed prior to CMS submitting the measure to NQF. ACG fears that the same problems regarding validity and reliability associated with the current measures in the MIPS’ Cost performance category will again occur with this specialty-specific episode absent a careful and thorough review. The goal of getting this measure incorporated into MIPS prior to the 2019 reporting year should not eclipse the review process for getting it right. (Submitted by: American College of Gastroenterology)
  
  
• We are unable to make an informed recommendation on this episode-based cost measure until data is available for analysis. The AAFP would find it very useful to be provided de-identified feedback reports for a representative sample of family physicians to better inform us of measure results. (Submitted by: American Academy of Family Physicians)
  
  
• We support the use of this measure. (Submitted by: Ascension)
  
  
• As an umbrella organization for more than 100 medical specialties and 50 state medical societies, the AMA has played a facilitator role in the formation and work of the clinical panels that are assisting Acumen with the development and refinement of the episode cost measures that will be part of the Merit-based Incentive Program. We believe that Acumen has constructed a process that should be used as a model in the development of additional episode measures and that the clinical panels have provided invaluable advice on both the overall structure and details of this and the other seven episodes CMS is bringing before the MAP. Unfortunately, due to a truncated time line for testing and refining the episodes, the AMA is not ready to give unqualified support to any of the eight measures though we expect to support most of them once there has been more time for analysis and refinement. We believe that structural changes should not be ruled out in the course of this refinement and that the recommendations of the specialties who provide care associated with this episode including the American Gastroentrology Association, American Society for Gastrointestinal Endoscopy and American College of Gastroentrologyshould be given great weight in the MAP’s decision-making. Areas where the AMA believes more analysis is needed include: • extent to which risk adjustment, exclusions and subgroups distinguish between and adjust for appropriate cost differences • shortcomings of administrative claims data to identify patient conditions with significant impact on costs • identification/development of appropriate quality measures to match each episode • how practice size, site of service and specialty affect reliability and episode results • the impact of multiple attribution for different practice sizes, sites of service and specialties • degree of cost variation within the episode. • potential interplay/overlap between the episode cost measures and the MIPS Total Cost of Care and Medicare Spending Per Beneficiary measures (Submitted by: American Medical Association)
  
  

• On behalf of the more than 10,000 physiatrists of the American Academy of Physical Medicine and Rehabilitation (AAPM&R), we appreciate the opportunity to submit comments on the 2017 MAP MUC list. AAPM&R has been fortunate to have two of our members serve on the MACRA Epsiode-Based Cost Measures Clinical Subcommittee for Musculoskeletal Non-Spine, engaged in the development of the measure for knee arthroplasty. AAPM&R also submitted comments to the recent measures field testing and later this week we will participate in a follow up call with the subcommittee to discuss possible changes to the draft measure. As NQP has noted, the cost measures are in an early stage of development. In their current state, the risk adjustment methodologies used to predict costs for the episode-based measures are not strong enough. We also do not believe that CMS has done enough to educate providers about the implications of cost measurement. We therefore do not support inclusion of the episode-based cost measures on the MUC list at this time. Thank you in advance for your consideration. If you have any questions regarding these comments, please contact Carolyn Winter-Rosenberg, Manager of Reimbursement and Regulatory Affairs, in the AAPM&R Division of Health Policy and Practice Services. She may be reached at cwinterrosenberg@aapmr.org or at (847) 737-6024. (Submitted by: American Academy of Physical Medicine & Rehabilitation)
  
  
• The American Association of Nurse Anesthetists (AANA) appreciate the opportunity to address concerns about the potential use of these measures in the Quality Payment Program, and how the measures and reporting format should be improved to provide clinicians actionable information to ensure high quality and high value care. We have noted that for procedural episode groups, like the Knee Arthroplasty measure, episodes are attributed to the clinician(s) rendering the trigger services (HCPCS/CPT procedure codes). The comments are based on the documentation provided in the field testing appendices that were made available on the CMS website (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html ) posted on October 16, 2017 as well as the 2015 QRUR Supplemental material (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/Downloads/2015-SQRUR-Detailed-Methods.pdf ) referenced in Appendix C of the field testing documentation. After having reviewed the test codes for attribution and exclusions and appendices for clinician service assignment in the mock report we have noted that anesthesia is a post-trigger service( ie, 00400, 01320, 01360, 01380, 01400,01402,01480,01922,01996) as identified by the anesthesia CPT codes in the clinician service assignments for the Knee Arthroplasty measure. We note that the mock report in Appendix A under “Other Services” includes Anesthesia Services which accounts for 99 % national average of the share of cost by episode. In addition, we also noted that the 2015 QRUR Supplemental Materials and the attribution exclusions in the test code documentation that anesthesia modifiers AA, QX, and QZ were used for the exclusion rule on the claim when determining attribution. We are concerned by the mechanism for which anesthesia cost has been incorporated into the measure given that three other predominant anesthesia modifiers (QK, QY, AD) are not included in the exclusion attribution rule. We are seeking clarification for why the other anesthesia modifiers (QK, QY, and AD) are not included in the exclusion attribution rule given that AA, QX, and QZ have been included. Based on the discrepancies, we believe further testing and refinement of the measure is warranted. Finally, it is possible that the report generated by this measure will be read and interpreted by a wide audience such as small rural health care facilities or large multihospital healthcare systems whose clinicians are employed by the hospitals and whose NPIs are included under the hospitals’ TIN. Given that the cost data contained in these reports may potentially affect resource allocation and staffing decisions in the years to come, it is critical that these reports be available to all NPIs under the TIN and the information be understandable by all. Lorraine M. Jordan, PhD, CRNA, CAE, FAAN Senior Director of Research and Quality/AANA (Submitted by: American Association of Nurse Anesthetists)
  
  
• AOTA supports the inclusion of this measure. However, it is unclear if the measure is developed sufficiently enough for MAP approval at this point. Continued discussion and review of the CMS survey responses is needed to ensure that the appropriate attribution is completed and that the charges included in the measure are appropriate. During the weeks of December 4, 2017 Acumen is holding conference calls with their technical expert panels and making revisions to cost measures. AOTA requests that stakeholder feedback on the final cost measure in this area be collected prior to finalization. (Submitted by: American Occupational Therapy Association)
  
  
• We support the use of this measure, but note that there appears to be a significant number of orthopedic measures under consideration, which may create redundancy. (Submitted by: Ascension)
  
  
• The measure risk adjusts based on variables, such as age, and comorbidities by using HCC data and other clinical characteristics. However, The AAMC is concerned that the measure is not adjusted to account for socio-demographic status. In addition to differences in patient clinical complexity, socio-demographic status can drive differences in average episode costs. Recent reports from the National Academies of Science, Engineering and Medicine and Assistant Secretary for Planning and Evaluation (ASPE) have clearly acknowledged that SDS variables (such as low income and education) may explain adverse outcomes and higher costs. Without accounting for these factors, the scores of physicians that treat vulnerable patients will be negatively and unfairly impacted and their performance will not be adequately represented to patients. As these episode groups are designed, it is critical that there be an accurate determination of the relationship between a patient and a clinician to ensure that the correct clinician is held responsible for the patient’s outcomes and costs. This is complicated given that most patients receive care from numerous clinicians across several facilities. For procedural episode groups, episodes are attributed to the clinician(s) rendering the trigger services (HCPCS/CPT procedure codes). We believe that better data sources and analytic techniques should be explored in the future to support more accurate attribution for all clinicians involved. (Submitted by: Association of American Medical Colleges)
  
  
• As an umbrella organization for more than 100 medical specialties and 50 state medical societies, the AMA has played a facilitator role in the formation and work of the clinical panels that are assisting Acumen with the development and refinement of the episode cost measures that will be part of the Merit-based Incentive Program. We believe that Acumen has constructed a process that should be used as a model in the development of additional episode measures and that the clinical panels have provided invaluable advice on both the overall structure and details of this and the other seven episodes CMS is bringing before the MAP at this meeting. Unfortunately, due to a truncated time line for testing and refining the episodes, the AMA is not ready to give unqualified support to any of the eight measures though we expect to support most of them once there has been more time for analysis and refinement. We believe that structural changes should not be ruled out in the course of this refinement and that the recommendations of the specialties who provide care associated with this episode including the American Association of Orthopedic Surgeons its sub-specialties, as well as the American Academy of Physician Medicine and Rehabilitationshould be given great weight in the MAP clinical work group’s decision-making. Areas where the AMA believes more analysis is needed include: • extent to which risk adjustment, exclusions and subgroups distinguish between and adjust for appropriate cost differences • shortcomings of administrative claims data to identify patient conditions with significant impact on costs • identification/development of appropriate quality measures to match each episode • how practice size, site of service and specialty affect reliability and episode results • the impact of multiple attribution for different practice sizes, sites of service and specialties • degree of cost variation within the episode. • potential interplay/overlap between the episode cost measures and the MIPS Total Cost of Care and Medicare Spending Per Beneficiary measures (Submitted by: American Medical Association)
  
  

• The American Association of Nurse Anesthetists (AANA) appreciate the opportunity to address concerns about the potential use of these measures in the Quality Payment Program, and how the measures and reporting format should be improved to provide clinicians actionable information to ensure high quality and high value care. We have noted that for acute inpatient medical condition episode groups, episodes are attributed to the clinician(s) rendering least 30 percent of inpatient evaluation and management (E&M) services during an inpatient hospitalization with a Medicare Severity Diagnosis-Related Group (MS-DRG) for the episode group. We have noted that for the acute IP medical condition episode groups, like the STEMI with PCI measure, the episode is triggered by an MS-DRG 246, 247, 248, 249, 250, or 251. The comments are based on the documentation provided in the field testing appendices that were made available on the CMS website (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html ) posted on October 16, 2017 as well as the 2015 QRUR Supplemental material (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/Downloads/2015-SQRUR-Detailed-Methods.pdf ) referenced in Appendix C of the field testing documentation. After having reviewed the test codes for attribution and exclusions and appendices for clinician service assignment in the mock report we have noted that anesthesia is a post trigger service but was not identified by any of the anesthesia CPT codes in the clinician service assignments for the STEMI with PCI measure. We note that the mock report in Appendix A under “Other Services” includes Anesthesia Services which accounts for 12 % national average of the share of cost by episode. Because the acute inpatient medical episodes are geared toward hospital based clinicians that provide 30% or more of E&M services, this should not apply to anesthesia professionals with specialty codes 43 (CRNA) and 05 (anesthesiologist). Clarification is warranted as to why procedure based non-patient facing clinicians are on the attribution list found in the test codes. Finally, it is possible that the report generated by this measure will be read and interpreted by a wide audience such as small rural health care facilities or large multihospital healthcare systems whose clinicians are employed by the hospitals and whose NPIs are included under the hospitals’ TIN. Given that the cost data contained in these reports may potentially affect resource allocation and staffing decisions in the years to come, it is critical that these reports be available to all NPIs under the TIN and the information be understandable by all. Lorraine M. Jordan, PhD, CRNA, CAE, FAAN Senior Director of Research and Quality/AANA (Submitted by: American Association of Nurse Anesthetists)
  
  
• We support the use of this measure. (Submitted by: Ascension)
  
  
• The measure risk adjusts based on variables, such as age, and comorbidities by using HCC data and other clinical characteristics. However, we are concerned that the measures is not adjusted to account for socio-demographic status. In addition to differences in patient clinical complexity, socio-demographic status can drive differences in average episode costs. Recent reports from the National Academies of Science, Engineering and Medicine and Assistant Secretary for Planning and Evaluation (ASPE) have clearly acknowledged that SDS variables (such as low income and education) may explain adverse outcomes and higher costs. Without accounting for these factors, the scores of physicians that treat vulnerable patients will be negatively and unfairly impacted and their performance will not be adequately represented to patients. As these episode groups are designed, it is critical that there be an accurate determination of the relationship between a patient and a clinician to ensure that the correct clinician is held responsible for the patient’s outcomes and costs. This is complicated given that most patients receive care from numerous clinicians across several facilities. For procedural episode groups, episodes are attributed to the clinician(s) rendering the trigger services (HCPCS/CPT procedure codes) and for acute inpatient medical condition episode groups, episodes are attributed to the clinician(s) rendering at least 30 percent of inpatient evaluation and management (E&M) services during an inpatient hospitalization with the Medicare Severity Diagnosis Related Groups (MS-DRGs) for the episode group. We believe that better data sources and analytic techniques should be explored in the future to support more accurate attribution. (Submitted by: Association of American Medical Colleges)
  
  
• As an umbrella organization for more than 100 medical specialties and 50 state medical societies, the AMA has played a facilitator role in the formation and work of the clinical panels that are assisting Acumen with the development and refinement of the episode cost measures that will be part of the Merit-based Incentive Program. We believe that Acumen has constructed a process that should be used as a model in the development of additional episode measures and that the clinical panels have provided invaluable advice on both the overall structure and details of this and the other seven episodes CMS is bringing before the MAP. Unfortunately, due to a truncated time line for testing and refining the episodes, the AMA is not ready to give unqualified support to any of the eight measures though we expect to support most of them once there has been more time for analysis and refinement. We believe that structural changes should not be ruled out in the course of this refinement and that the recommendations of the specialties who provide care associated with this episode including the American College of Cardiology and its sub-specialtiesshould be given great weight in the MAP’s decision-making. Areas where the AMA believes more analysis is needed include: • extent to which risk adjustment, exclusions and subgroups distinguish between and adjust for appropriate cost differences • shortcomings of administrative claims data to identify patient conditions with significant impact on costs • identification/development of appropriate quality measures to match each episode • how practice size, site of service and specialty affect reliability and episode results • the impact of multiple attribution for different practice sizes, sites of service and specialties • degree of cost variation within the episode. • potential interplay/overlap between the episode cost measures and the MIPS Total Cost of Care and Medicare Spending Per Beneficiary measures (Submitted by: American Medical Association)
  
  

• The American Association of Nurse Anesthetists (AANA) appreciate the opportunity to address concerns about the potential use of these measures in the Quality Payment Program, and how the measures and reporting format should be improved to provide clinicians actionable information to ensure high quality and high value care. We have noted that for procedural episode groups, like the Revascularization for Lower Extremity Chronic Critical Limb Ischemia measure, episodes are attributed to the clinician(s) rendering the trigger services (HCPCS/CPT procedure codes). The comments are based on the documentation provided in the field testing appendices that were made available on the CMS website (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html ) posted on October 16, 2017 as well as the 2015 QRUR Supplemental material (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/Downloads/2015-SQRUR-Detailed-Methods.pdf ) referenced in Appendix C of the field testing. After having reviewed the test codes for attribution and exclusions and appendices for clinician service assignment in the mock report we have noted that no anesthesia CPT codes were identified in the clinician service assignments for the Revascularization for Lower Extremity Chronic Critical Limb Ischemia measure; however, the mock report in Appendix A under “Other Services” includes Anesthesia Services which accounts for 40% national average of the share of cost by episode. In addition, we also noted that the 2015 QRUR Supplemental Materials and the attribution exclusions in the test code documentation that anesthesia modifiers AA, QX, and QZ were used for the exclusion rule on the claim when determining attribution. We are concerned by the mechanism for which anesthesia cost has been incorporated into the measure given that three other predominant anesthesia modifiers (QK, QY, AD) are not included in the exclusion attribution rule. Given that no anesthesia CPT codes were present in the test documentation we are unclear where the average national anesthesia service cost for the episode was derived. We also seek clarification for why the other anesthesia modifiers (QK, QY, and AD) are not included in the exclusion attribution rule given that AA, QX, and QZ have been included. Based on the discrepancies, we believe further testing and refinement of the measure is warranted. Finally, it is possible that the report generated by this measure will be read and interpreted by a wide audience such as small rural health care facilities or large multihospital healthcare systems whose clinicians are employed by the hospitals and whose NPIs are included under the hospitals’ TIN. Given that the cost data contained in these reports may potentially affect resource allocation and staffing decisions in the years to come, it is critical that these reports be available to all NPIs under the TIN and the information be understandable by all. Lorraine M. Jordan, PhD, CRNA, CAE, FAAN Senior Director of Research and Quality/AANA (Submitted by: American Association of Nurse Anesthetists)
  
  
• SVS is concerned that the group attribution methodology is not yet specific enough to ensure that the patients attributed to a group, then have their individual services attributed to the correct specialist that has input or control of the services delivered to that patient by the group. For example, while anesthesia is certainly a part of the cost of the surgical care episode, the cost report does not appear to be set up so that the anesthetic costs should not be included for the surgeon, but instead attributed to the anesthesiologist in the group. In fact, there does appear to be a rule for anesthesiologists that includes the use of modifier “AA” to remove their costs from the claim during attribution process for the surgeon. However, this does not appear to be happening on anything but a random basis. SVS believes this is an area that the Acumen, LLC working groups needs to continue to refine to ensure that all methodologies are reliable and repeatable prior to using these cost reports in any CMS quality reporting programs. SVS members had an extremely difficult time determine how CMS calculates the risk scores from the information contained in the cost measure field testing reports. This is problematic because this number has a huge impact on cost. We believe the methodology is that you would divide the actual cost by the risk score to calculate the “risk-adjusted cost”. And, thus a score of 1 means that the actual cost is the same as the risk-adjusted cost. A score <1 means the actual cost is lower than the risk adjusted cost (the denominator is <1 thus increasing the calculation) and a score of >1 lowers the risk adjusted cost below the actual cost. SVS is not sure that this type of risk adjustment methodology works for lower limb ischemia patients. Most vascular surgeons intervene in the lower limb for mostly, limb threatening ischemia, and so it is hard to imagine any risk adjustment that would not lower the costs given the multitude of comorbidities. We are wondering if the problem is simply that CMS is not using all the information it may have from all claims sources, including hospital claims and Medicare Advantage claims. If this methodology is only using data for E&M claims or a pre-service diagnostic testing claims, we suspect that these claims do not accurately contain all the comorbidities ICD-10 diagnosis codes for the patient’s conditions. For example, a patient is seen in hospital requiring a femoral-tibial bypass. Does the surgeon who turns in a bill for the initial consult, pre-op days and the surgery, include the diagnosis for coronary artery disease, diabetes, renal failure with her diagnosis of gangrene? If not, was this not attributed to the patient in this risk-adjustment methodology? We believe that would be the case and it would cause the risk-adjustment methodology to be incorrect. SVS would encourage Acumen, LLC to analyze the impact of other risk adjustment methodologies, such as the 1 year elixhauser index versus using 1 year of diagnosis codes under the hcc hierarchy. SVS understand that it is very difficult to get the details of all the chronic illnesses—yet, these are certainly captured in the hospital coding as it constitutes the case-mix index for the hospital—a vital metric for the hospital’s payment. Therefore, SVS recommends that all claims data – hospital and physician – be used to gather all the patient’s risk factors to allow for a complete understanding of said patient’s risk-adjusted costs. SVS members had trouble finding any reference information in the cost report appendix regarding the time window or episode lengths. CMS states “the time window, or episode length, was selected for each episode type based on the typical course of medical care provided for the episodic type.” But, there does not appear to be a table identifying the lengths for the 67 types and subtypes of episodes. Also, we believe it is very confusing how the reports show the episode start dates and that the timelines for episodes are inconsistent. Having the same patient attributed multiple times to the same provider for different episodes does not seem to fit with CMS and its comment regarding defining a hierarchy for episodes. SVS believes this is an area of the cost reports that needs better explanation and more work. (Submitted by: Society for Vascular Surgery )
  
  
• We support the use of this measure. (Submitted by: Ascension)
  
  
• The measure risk adjusts based on variables, such as age, and comorbidities by using HCC data and other clinical characteristics. However, The AAMC is concerned that the measure is not adjusted to account for socio-demographic status. In addition to differences in patient clinical complexity, socio-demographic status can drive differences in average episode costs. Recent reports from the National Academies of Science, Engineering and Medicine and Assistant Secretary for Planning and Evaluation (ASPE) have clearly acknowledged that SDS variables (such as low income and education) may explain adverse outcomes and higher costs. Without accounting for these factors, the scores of physicians that treat vulnerable patients will be negatively and unfairly impacted and their performance will not be adequately represented to patients. As these episode groups are designed, it is critical that there be an accurate determination of the relationship between a patient and a clinician to ensure that the correct clinician is held responsible for the patient’s outcomes and costs. This is complicated given that most patients receive care from numerous clinicians across several facilities. For procedural episode groups, episodes are attributed to the clinician(s) rendering the trigger services (HCPCS/CPT procedure codes). We believe that better data sources and analytic techniques should be explored in the future to support more accurate attribution for all clinicians involved. (Submitted by: Association of American Medical Colleges)
  
  
• As an umbrella organization for more than 100 medical specialties and 50 state medical societies, the AMA has played a facilitator role in the formation and work of the clinical panels that are assisting Acumen with the development and refinement of the episode cost measures that will be part of the Merit-based Incentive Program. We believe that Acumen has constructed a process that should be used as a model in the development of additional episode measures and that the clinical panels have provided invaluable advice on both the overall structure and details of this and the other seven episodes CMS is bringing before the MAP. Unfortunately, due to a truncated time line for testing and refining the episodes, the AMA is not ready to give unqualified support to any of the eight measures though we expect to support most of them once there has been more time for analysis and refinement. We believe that structural changes should not be ruled out in the course of this refinement and that the recommendations of the specialties who provide care associated with this episode including the Society for Vascular Surgery and its subspecialties should be given great weight in the MAP’s decision-making. Areas where the AMA believes more analysis is needed include: • extent to which risk adjustment, exclusions and subgroups distinguish between and adjust for appropriate cost differences • shortcomings of administrative claims data to identify patient conditions with significant impact on costs • identification/development of appropriate quality measures to match each episode • how practice size, site of service and specialty affect reliability and episode results • the impact of multiple attribution for different practice sizes, sites of service and specialties • degree of cost variation within the episode. • potential interplay/overlap between the episode cost measures and the MIPS Total Cost of Care and Medicare Spending Per Beneficiary measures (Submitted by: American Medical Association)
  
  
• Cook Medical has the following comment to quality measure MIPS MUC17-263 Revascularization for Lower Extremity Chronic Critical Limb Ischemia: The episode window -- from 30 days prior to the trigger date to 90 days after the trigger date -- suggested for MUC17-263 for Revascularization for Lower Extremity Chronic Critical Limb Ischemia seems short and may very well offer some unintended consequences which should be closely considered. As discussed below, an episode window for 12 or 24 months, though difficult to administer, may be a better alternative. The treatment of Lower Extremity Chronic Critical Limb Ischemia has evolved significantly over the last two decades. Open surgical bypass had been the traditional gold standard, but is being steadily replaced by minimally invasive treatments. However, the minimally invasive options themselves are very heterogeneous with physicians able to treat these patients with angioplasty, atherectomy, stenting, or some combination of the three. The treatment option chosen for any given patient will be based on a number of factors, including that patient’s overall health status, the character of the lesion(s) being treated (location, length, degree of narrowing, degree of calcification, etc.), and whether or not this is an initial intervention or a reintervention of some sort. Balloon angioplasty is the simplest and least expensive (when looking at episodic costs) of the treatment options, and it may very well be successful in opening up a lesion at the initial treatment. However, it is well-recognized that angioplasty's long-term success is sub-optimal for many lesions in the lower extremity. Short, discrete lesions may be well-treated with angioplasty, but longer lesions are likely to re-narrow ("restenose") with many patients requiring a reintervention within 12 months. On the other hand, initial treatment of these lower extremity lesions with a stent, for example, will result in a more expensive initial procedure, but may significantly lower the likelihood of patients required re-intervention in the future. We feel it is important to draw attention to this issue, since establishing an episode window of only 30 days prior to the trigger date to 90 days after the trigger date for this measure may encourage physicians to: (a) provide a less expensive initial treatment (angioplasty) for patients, that could ultimately result in higher overall spending for CMS since a significant portion of these patients would require reintervention in the future, outside of the episode window; and (b) result in a lower quality of care for patients, since with angioplasty alone they may be more likely to have a recurrence of their symptoms (rest pain, recurrence of ulcers, gangrene, etc.) and to have to undergo additional procedures (Submitted by: Cook Medical)
  
  

• The current measure should be updated to reflect the October 25, 2017 decision of the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) to recommend the Herpes Zoster Subunit vaccine for the prevention of herpes zoster and related complications for immunocompetent adults aged 50 years and older, and for the prevention of herpes zoster and related complications for immunocompetent adults who previously received Zoster Vaccine Live. The American Academy of Ophthalmology has developed a measure which would be preferable to this measure, as it covers patients aged 50 – 59. Herpes zoster is a serious health problem in the United States. Current estimates of new cases in the US are up to 1.2 million each year, about 20% of which are herpes zoster ophthalmicus (HZO) It is estimated that one in three people over their lifetime will have zoster. Although it is more common and severe in immunocompromised persons, the vast majority, or over 90%, of patients afflicted with zoster are not immunocompromised. While the incidence goes up significantly with age, starting in the 40s, the number of cases is highest in people in their 50s. In one Centers for Disease Control and Prevention (CDC) study, the mean age of onset was 52 years. Given the highest vaccine efficacy in the age group 50-59 years, the decreasing age of disease onset, the greatest number of cases in the 50-59 year old age group and the risk of significant ocular and systemic morbidity, the current evidence supports the use of the zoster vaccine in immunocompetent people age 50 years and older. Vaccination at an earlier age would reduce the burden of morbidity, loss of work productivity and sequelae due to the occurrence of zoster seen in this working age population. References: Recommendations for Herpes Zoster Vaccine for patients 50 years and older -2016. American Academy of Ophthalmology, Cornea Society, Ocular Microbiology and Immunology Group. Accessed on May 30, 2017 https://www.aao.org/clinical-statement/recommendations-herpes-zoster-vaccine-patients-50- 404f Yawn BP, Saddier P, Wollan PC, et al. A population-based study of the incidence and complication rates of herpes zoster before zoster vaccine introduction. Mayo Clin Proc 2007;82:1341-9. Li X, Zhang JH, Betts RF, et al. Modeling the durability of ZOSTAVAX(R) vaccine efficacy in people >/=60 years of age. Vaccine 2015;33:1499-505. Moore L, Remy V, Martin M, et al. A health economic model for evaluating a vaccine for the prevention of herpes zoster and post-herpetic neuralgia in the UK. Cost Eff Resour Alloc 2010;8:7. Preaud E, Uhart M, Bohm K, et al. Cost-effectiveness analysis of a vaccination program for the prevention of herpes zoster and post-herpetic neuralgia in adults aged 50 and over in Germany. Hum Vaccin Immunother 2015;11:884-96. CDC’s Advisory Committee on Immunization Practices recommends Shingrix as the preferred vaccine for the prevention of shingles for adults aged 50 and up. Press Release October 25 2017; Glaxo Smith Kline, London UK. (Submitted by: American Academy of Ophthalmology)
  
  
• Since the advent of Shingrix this measure does not meet current evidence. All people who have received Zostavax are now being told to get Shingrix and Shingrix is a 2-dose vaccine, not one. Also, data collection of vaccines is extremely challenging for when so many people get the vaccine at the pharmacy and many pay cash. (Submitted by: American Academy of Family Physicians)
  
  
• We support the use of this measure. (Submitted by: Ascension)
  
  
• We support this measure, which we believe has the potential to address over-utilization. (Submitted by: Ascension)
  
  
• The Infectious Diseases Society of America (IDSA) appreciates the opportunity to provide comments on the 2017 List of Measures under Consideration (MUC List). Specifically, we would like to express our concerns with MUC17-310 Zoster (Shingles) Vaccination. IDSA fully supports the need for this measure but from our review Medicare does not reimburse physicians for the shingles vaccination. The measure specifications are also unclear whether a physician will be required to vaccinate a patient who has no documentation for being vaccinated for shingles, which would the next logical step. Furthermore, if the measure is focused on the live strain vaccine, denominator exclusions for immunocompromised patients (myeloproliferative disorders, HIV, etc.) would be needed. We recommend that this measure be further specified to provide clear next steps accounting for the type of shingles vaccine, active or inactive, as well as the immunocompromised patient population. (Submitted by: The Infectious Diseases of America)
  
  
• AVAC is pleased to see that the 2017 MUC list of 32 measures includes a zoster (shingles) vaccination measure for patients 60 years of age and older. We commend the MAP for recognizing the importance of adult vaccination measures in the provision of effective care and improved patient outcomes. Inclusion of a zoster measure is an important interim step as adult immunization quality measure development drives toward advancements in tools that balance provider burden with a more comprehensive assessment of immunization status for adult populations. AVAC urges the MAP to retain this measure on the final 2017 MUC list for broader use in the Medicare program. While immunizations are essential to protecting health across the lifespan, it is especially important to immunize older adults, who are at increased risk for vaccine-preventable conditions as a result of waning immunity and increased likelihood of co-morbid, chronic conditions, and who are more likely to develop complications. AVAC has closely followed NQF’s work to identify gaps and prioritize measurement needs in the adult vaccine space. In particular, the NQF August 2014 report “Priority Setting for Healthcare Performance Measurement: Addressing Performance Measures Gaps for Adult Immunizations”, provided a comprehensive assessment of performance measurement for adult vaccines. The report highlighted ten age specific and composite measure gap priorities that should be addressed and identified several areas where performance measurement could “optimize vaccination rates and outcomes across adult populations.”5 The recommendations complement AVACs own work to achieve increased adult immunization rates through federal benchmarks and measures that encourage tracking and reporting of recommended vaccines. In 2016, AVAC brought together public health and quality measure experts on a white paper, The Value and Imperative of Quality Measures for Adult Vaccines. This document describes how vaccine quality measures can prevent illness and death, reduce caregiving demands, save unnecessary healthcare spending, and set the foundation for healthy aging. The paper also provides recommendations for advancing adult immunization quality measures by building off of existing measure tools, integrating the role of the provider as well as working toward the development and implementation of adult immunization composite measures. AVAC is excited about work in this area and looks forward to further advancements in the development of a composite measure in the coming months. Including a zoster (shingles) vaccination measure examining, “The percentage of patients 60 years of age and older who have a Varicella Zoster (shingles)vaccination” as part of the 2017 MUC list represents an important opportunity to address a gap priority area from the 2014 NQF adult immunization measure report. We urge you maintain this measure for broader use in the Medicare program. Presently, only the Medicare home health value-based purchasing program includes a shingles vaccination measure.Shingles is painful rash illness caused by the varicella zoster virus (VZV), the same virus that causes chickenpox. It affects a million Americans each year, half of whom are adults age 60 and older. People who are immunocompromised are at even greater risk of getting shingles. As Appendix B (Measure Rationales) in the MUC list notes, herpes zoster is an extremely debilitating condition that takes a significant toll on Medicare beneficiaries’ health and quality of life and also costs millions in health care dollars annually. Almost one in three Americans will be affected by shingles in their lifetime, inclusion of this measure on the 2018 MUC list presents an opportunity to change this statistic. We would also encourage NQF to prioritize the development of an updated pneumococcal immunization measures that reflects the current Advisory Committee for Immunization Practice (ACIP) recommendations for PCV13 and PPSV23 vaccination in adults age 65 and older as well as at risk adults ages 19-64 for use across various health care settings. Pneumonia is also a serious, yet preventable condition that causes serious illness and morbidity each year. The Health and Well-Being Committee for (NQF) proposed standards specifications for pneumococcal measures in order to better align measures across healthcare settings and to bring measures in accordance with ACIP recommendations. AVAC encourages NQF to work with CMS on proposed standards toward that end since it reflects CMS' broader goals around quality measure alignment. Reducing the number of missed immunization opportunities for Medicare beneficiaries is an important step to improving health and reducing the burden of vaccine-preventable illness among this rapidly growing segment of our population. Thank you for your continued work to advance health and wellbeing through your stewardship of the quality measure development and improvement continuum. We greatly appreciate the opportunity to share our views. Should you have any questions or would like to discuss our comments or adult immunization issues in general, please contact the AVAC Coalition Manager at (202) 540-1070 or info@adultvaccinesnow.org. (Submitted by: Adult Vaccine Access Coalition (AVAC))
  
  

• We support this measure, which we believe has the potential to address over-utilization. (Submitted by: Ascension)
  
  

• The American Association of Nurse Anesthetists (AANA) appreciate the opportunity to address concerns about the potential use of these measures in the Quality Payment Program, and how the measures and reporting format should be improved to provide clinicians actionable information to ensure high quality and high value care. We have noted that for procedural episode groups, like the Elective Outpatient PCI measure, episodes are attributed to the clinician(s) rendering the trigger services (HCPCS/CPT procedure codes). The comments are based on the documentation provided in the field testing appendices that were made available on the CMS website (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html ) posted on October 16, 2017 as well as the 2015 QRUR Supplemental material (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/Downloads/2015-SQRUR-Detailed-Methods.pdf ) referenced in Appendix C of the field testing. After having reviewed the test codes for attribution and exclusions and appendices for clinician service assignment in the mock report we have noted that no anesthesia CPT codes were identified in the clinician service assignments for the Elective Outpatient PCI measure; however, the mock report in Appendix A under “Other Services” includes Anesthesia Services which accounts for 2% national average of the share of cost by episode. In addition, we also noted that the 2015 QRUR Supplemental Materials and the attribution exclusions in the test code documentation that anesthesia modifiers AA, QX, and QZ were used for the exclusion rule on the claim when determining attribution. We are concerned by the mechanism for which anesthesia cost has been incorporated into the measure given that three other predominant anesthesia modifiers (QK, QY, AD) are not included in the exclusion attribution rule. Given that no anesthesia CPT codes were present in the test documentation we are unclear where the average national anesthesia service cost for the episode was derived. We also seek clarification for why the other anesthesia modifiers (QK, QY, and AD) are not included in the exclusion attribution rule given that AA, QX, and QZ have been included. Based on the discrepancies, we believe further testing and refinement of the measure is warranted. Finally, it is possible that the report generated by this measure will be read and interpreted by a wide audience such as small rural health care facilities or large multihospital healthcare systems whose clinicians are employed by the hospitals and whose NPIs are included under the hospitals’ TIN. Given that the cost data contained in these reports may potentially affect resource allocation and staffing decisions in the years to come, it is critical that these reports be available to all NPIs under the TIN and the information be understandable by all. Lorraine M. Jordan, PhD, CRNA, CAE, FAAN Senior Director of Research and Quality/AANA (Submitted by: American Association of Nurse Anesthetists)
  
  
• We support this measure, as we believe it will promote better coordinated care and/or the avoidance of inappropriate catheterization. (Submitted by: Ascension)
  
  
• The measure risk adjusts based on variables, such as age, and comorbidities by using HCC data and other clinical characteristics. However, The AAMC is concerned that the measure is not adjusted to account for socio-demographic status. In addition to differences in patient clinical complexity, socio-demographic status can drive differences in average episode costs. Recent reports from the National Academies of Science, Engineering and Medicine and Assistant Secretary for Planning and Evaluation (ASPE) have clearly acknowledged that SDS variables (such as low income and education) may explain adverse outcomes and higher costs. Without accounting for these factors, the scores of physicians that treat vulnerable patients will be negatively and unfairly impacted and their performance will not be adequately represented to patients. As these episode groups are designed, it is critical that there be an accurate determination of the relationship between a patient and a clinician to ensure that the correct clinician is held responsible for the patient’s outcomes and costs. This is complicated given that most patients receive care from numerous clinicians across several facilities. For procedural episode groups, episodes are attributed to the clinician(s) rendering the trigger services (HCPCS/CPT procedure codes). We believe that better data sources and analytic techniques should be explored in the future to support more accurate attribution for all clinicians involved. (Submitted by: Association of American Medical Colleges)
  
  

• The American Association of Nurse Anesthetists (AANA) appreciate the opportunity to address concerns about the potential use of these measures in the Quality Payment Program, and how the measures and reporting format should be improved to provide clinicians actionable information to ensure high quality and high value care. We have noted that for acute inpatient medical condition episode groups, episodes are attributed to the clinician(s) rendering least 30 percent of inpatient evaluation and management (E&M) services during an inpatient hospitalization with a Medicare Severity Diagnosis-Related Group (MS-DRG) for the episode group. We have noted that for the acute IP medical condition episode groups, like the Intracranial Hemorrhage or Cerebral Infarction measure, the episode is triggered by an MS-DRG 065, 066, 064, 070, 072, or 071. The comments are based on the documentation provided in the field testing appendices that were made available on the CMS website (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html ) posted on October 16, 2017 as well as the 2015 QRUR Supplemental material (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/Downloads/2015-SQRUR-Detailed-Methods.pdf ) referenced in Appendix C of the field testing documentation. After having reviewed the test codes for attribution and exclusions and appendices for clinician service assignment in the mock report we have noted that anesthesia is a post trigger service ( ie, 00210, 00211, 00216, 00300, 00320, 00350, 00740, 00790, 00910, 01916, 01924, 01925, 01926) as identified by the anesthesia CPT codes in the clinician service assignments for the Intracranial Hemorrhage or Cerebral Infarction measure. We note that the mock report in Appendix A under “Other Services” includes Anesthesia Services which accounts for 6 % national average of the share of cost by episode. Because the acute inpatient medical episodes are geared toward hospital based clinicians that provide 30% or more of E&M services, this should not apply to anesthesia professionals with specialty codes 43 (CRNA) and 05 (anesthesiologist). Clarification is warranted as to why procedure based non-patient facing clinicians are on the attribution list found in the test codes. Finally, it is possible that the report generated by this measure will be read and interpreted by a wide audience such as small rural health care facilities or large multihospital healthcare systems whose clinicians are employed by the hospitals and whose NPIs are included under the hospitals’ TIN. Given that the cost data contained in these reports may potentially affect resource allocation and staffing decisions in the years to come, it is critical that these reports be available to all NPIs under the TIN and the information be understandable by all. Lorraine M. Jordan, PhD, CRNA, CAE, FAAN Senior Director of Research and Quality/AANA (Submitted by: American Association of Nurse Anesthetists)
  
  
• We are concerned that two different diseases with different protocols and guidelines are being lumped together. In addition, both are susceptible to a few outlier patients with very high costs that will skew the data- for example a patient with a severe stroke that is unable to swallow or has brainstem infarction; a cerebral bleed that required neurosurgical intervention. Low volume high cost episodes are notoriously inaccurate. Perhaps this might be a measure of system wide rather than practitioner performance. The AAFP would find it very useful to be provided de-identified feedback reports for a representative sample of family physicians to better inform us of measure results. (Submitted by: American Academy of Family Physicians)
  
  
• AOTA supports the inclusion of this measure. However, it is unclear if the measure is developed sufficiently enough for MAP approval at this point. Continued discussion and review of the CMS survey responses is needed to ensure that the appropriate attribution is completed and that the charges included in the measure are appropriate. During the weeks of December 4, 2017 Acumen is holding conference calls with their technical expert panels and making revisions to cost measures. AOTA requests that stakeholder feedback on the final cost measure in this area be collected prior to finalization. (Submitted by: American Occupational Therapy Association)
  
  
• We support this measure, as we believe it will promote better coordinated care. (Submitted by: Ascension)
  
  
• As an umbrella organization for more than 100 medical specialties and 50 state medical societies, the AMA has played a facilitator role in the formation and work of the clinical panels that are assisting Acumen with the development and refinement of the episode cost measures that will be part of the Merit-based Incentive Program. We believe that Acumen has constructed a process that should be used as a model in the development of additional episode measures and that the clinical panels have provided invaluable advice on both the overall structure and details of this and the other seven episodes CMS is bringing before the MAP. Unfortunately, due to a truncated time line for testing and refining the episodes, the AMA is not ready to give unqualified support to any of the eight measures though we expect to support most of them once there has been more time for analysis and refinement. We believe that structural changes should not be ruled out in the course of this refinement and that the recommendations of the specialties who provide care associated with this episode including American Association of Neurological Surgeons and its sub-specialties and American Academy of Neurology and its sub-specialties should be given great weight in the MAP’s decision-making. Areas where the AMA believes more analysis is needed include: • extent to which risk adjustment, exclusions and subgroups distinguish between and adjust for appropriate cost differences • shortcomings of administrative claims data to identify patient conditions with significant impact on costs • identification/development of appropriate quality measures to match each episode • how practice size, site of service and specialty affect reliability and episode results • the impact of multiple attribution for different practice sizes, sites of service and specialties • degree of cost variation within the episode. • potential interplay/overlap between the episode cost measures and the MIPS Total Cost of Care and Medicare Spending Per Beneficiary measures (Submitted by: American Medical Association)
  
  

• The American Association of Nurse Anesthetists (AANA) appreciate the opportunity to address concerns about the potential use of these measures in the Quality Payment Program, and how the measures and reporting format should be improved to provide clinicians actionable information to ensure high quality and high value care. We have noted that for acute inpatient medical condition episode groups, episodes are attributed to the clinician(s) rendering least 30 percent of inpatient evaluation and management (E&M) services during an inpatient hospitalization with a Medicare Severity Diagnosis-Related Group (MS-DRG) for the episode group. We have noted that for the acute IP medical condition episode groups, like the Simple Pneumonia with Hospitalization measure, the episode is triggered by an MS-DRG 193, 194, or 195. The comments are based on the documentation provided in the field testing appendices that were made available on the CMS website (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html ) posted on October 16, 2017 as well as the 2015 QRUR Supplemental material (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/Downloads/2015-SQRUR-Detailed-Methods.pdf ) referenced in Appendix C of the field testing documentation. After having reviewed the test codes for attribution and exclusions and appendices for clinician service assignment in the mock report we have noted that anesthesia is a post trigger service ( ie, 00320, 00520, 00528, 00532, 00540, 00541, 00542, 01922) as identified by the anesthesia CPT codes in the clinician service assignments for the Simple Pneumonia with Hospitalization measure. We note that the mock report in Appendix A under “Other Services” includes Anesthesia Services which accounts for 2 % national average of the share of cost by episode. Because the acute inpatient medical episodes are geared toward hospital based clinicians that provide 30% or more of E&M services, this should not apply to anesthesia professionals with specialty codes 43 (CRNA) and 05 (anesthesiologist). Clarification is warranted as to why procedure based non-patient facing clinicians are on the attribution list found in the test codes. Finally, it is possible that the report generated by this measure will be read and interpreted by a wide audience such as small rural health care facilities or large multihospital healthcare systems whose clinicians are employed by the hospitals and whose NPIs are included under the hospitals’ TIN. Given that the cost data contained in these reports may potentially affect resource allocation and staffing decisions in the years to come, it is critical that these reports be available to all NPIs under the TIN and the information be understandable by all. Lorraine M. Jordan, PhD, CRNA, CAE, FAAN Senior Director of Research and Quality/AANA (Submitted by: American Association of Nurse Anesthetists)
  
  
• We are unable to make an informed recommendation on this episode-based cost measure until data is available for analysis. The AAFP would find it very useful to be provided de-identified feedback reports for a representative sample of family physicians to better inform us of measure results. (Submitted by: American Academy of Family Physicians)
  
  
• AOTA supports the inclusion of this measure. However, it is unclear if the measure is developed sufficiently enough for MAP approval at this point. Continued discussion and review of the CMS survey responses is needed to ensure that the appropriate attribution is completed and that the charges included in the measure are appropriate. During the weeks of December 4, 2017 Acumen is holding conference calls with their technical expert panels and making revisions to cost measures. AOTA requests that stakeholder feedback on the final cost measure in this area be collected prior to finalization. (Submitted by: American Occupational Therapy Association)
  
  
• We support the use of this measure. (Submitted by: Ascension)
  
  
• The measure risk adjusts based on variables, such as age, and comorbidities by using HCC data and other clinical characteristics. However, we are concerned that the measures is not adjusted to account for socio-demographic status. In addition to differences in patient clinical complexity, socio-demographic status can drive differences in average episode costs. Recent reports from the National Academies of Science, Engineering and Medicine and Assistant Secretary for Planning and Evaluation (ASPE) have clearly acknowledged that SDS variables (such as low income and education) may explain adverse outcomes and higher costs. Without accounting for these factors, the scores of physicians that treat vulnerable patients will be negatively and unfairly impacted and their performance will not be adequately represented to patients. As these episode groups are designed, it is critical that there be an accurate determination of the relationship between a patient and a clinician to ensure that the correct clinician is held responsible for the patient’s outcomes and costs. This is complicated given that most patients receive care from numerous clinicians across several facilities. For acute inpatient medical condition episode groups, episodes are attributed to the clinician(s) rendering at least 30 percent of inpatient evaluation and management (E&M) services during an inpatient hospitalization with the Medicare Severity Diagnosis Related Groups (MS-DRGs) for the episode group. We believe that better data sources and analytic techniques should be explored in the future to support more accurate attribution. (Submitted by: Association of American Medical Colleges)
  
  
• As an umbrella organization for more than 100 medical specialties and 50 state medical societies, the AMA has played a facilitator role in the formation and work of the clinical panels that are assisting Acumen with the development and refinement of the episode cost measures that will be part of the Merit-based Incentive Program. We believe that Acumen has constructed a process that should be used as a model in the development of additional episode measures and that the clinical panels have provided invaluable advice on both the overall structure and details of this and the other seven episodes CMS is bringing before the MAP. Unfortunately, due to a truncated time line for testing and refining the episodes, the AMA is not ready to give unqualified support to any of the eight measures though we expect to support most of them once there has been more time for analysis and refinement. We believe that structural changes should not be ruled out in the course of this refinement and that the recommendations of the specialties who provide care associated with this episode including the American Thoracic Societyshould be given great weight in the MAP’s decision-making. Areas where the AMA believes more analysis is needed include: • extent to which risk adjustment, exclusions and subgroups distinguish between and adjust for appropriate cost differences • shortcomings of administrative claims data to identify patient conditions with significant impact on costs • identification/development of appropriate quality measures to match each episode • how practice size, site of service and specialty affect reliability and episode results • the impact of multiple attribution for different practice sizes, sites of service and specialties • degree of cost variation within the episode. • potential interplay/overlap between the episode cost measures and the MIPS Total Cost of Care and Medicare Spending Per Beneficiary measures (Submitted by: American Medical Association)
  
  

• Screening of the general population for HIV does not seem to be a cost-effective measure. The measure failed NQF endorsement for good reason. We would expect many patients to decline screening or obtain screening outside the medical system, leading to invalid data. (Submitted by: American Academy of Family Physicians)
  
  
• We do not believe that there is sufficient need for this measure, particularly among the Medicare population, given significant positive progress to date on HIV screening. In lieu of this relatively specific measure, we would support the use of a population health measure or measure(s) that promote(s) greater attention to addressing social determinants of health (e.g., asking whether a beneficiary has access to appropriate housing). (Submitted by: Ascension)
  
  

Navigating the Discussion Guide

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

Content

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

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• Under “Enter a Meeting” type in the meeting number for Day 1: 942049
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