ACP Comments on Physician-Focused Payment Model (PFPM) Technical Advisory Committee (PTAC)

ACP Support Letter for the Affordable Connectivity Program

Retiree Health Plan Drug Benefits in Light of the New Medicare Drug Law

Tobacco Control and Prevention

Joint Letter to FDA in Support of Banning Use of Menthol in Tobacco Products

Medicaid Expansion: Premium Assistance and Other Options

Reinventing Medicare Managed Care: Improving Choice, Access, and Quality, Reinventing Managed Care Series

ACP Response to CMS RFI on Medicare $2 Drug List Model

Joint letter to the U.S. House Committee on Appropriations Supporting Federal Tobacco Control Efforts

Joint Letter to HHS Secretary Azar opposing Medicaid Work Requirements

Integrated Interventions for Improving Total Worker Health: A Panel Report From the National Institutes of Health Pathways to Prevention Workshop: Total Worker Health—What's Work Got to Do With It?

This National Institutes of Health (NIH) Pathways to Prevention workshop was cosponsored by the NIH Office of Disease Prevention; National Heart, Lung, and Blood Institute; and National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention. A multidisciplinary working group developed the agenda, and an evidence-based practice center prepared an evidence report through a contract with the Agency for Healthcare Research and Quality. During the 1.5-day workshop, experts discussed the body of evidence and participants commented during open discussions. After weighing the data from the evidence report, expert presentations, and public comments, an unbiased, independent panel prepared a draft report that identified research gaps and future research priorities. The report was posted on the NIH Office of Disease Prevention Web site for 5 weeks for public comment. This article highlights 8 recommendations critical for advancing the science of integrated interventions to improve the total health of workers.

Prediction Models of Mortality in Acute Pancreatitis in Adults: A Systematic Review: Annals of Internal Medicine: Vol 165, No 7

Background: Acute pancreatitis (AP) varies in severity, prompting development of systems aimed at predicting prognosis to help guide therapy. Although several prediction approaches are available, their test characteristics and clinical utility are not completely understood. Purpose: To evaluate the test characteristics (prognostic accuracy, incremental predictive value) and clinical utility (effect on patient outcomes) of severity scores for predicting mortality in AP. Data Sources: Ovid MEDLINE and EMBASE (inception to 3 May 2016). Study Selection: Longitudinal studies, in any language, that evaluated the prognostic value of at least 1 clinical severity score in AP. Data Extraction: Dual data extraction and quality assessment. Data Synthesis: Of 4039 citations screened, 94 unique studies evaluating 18 scores in 53 547 patients met the inclusion criteria. All studies provided data on prognostic accuracy, whereas 6 provided data on incremental predictive values. Most scores demonstrated low prognostic accuracy. The Acute Physiology and Chronic Health Evaluation (APACHE) II score and the Ranson criteria were studied most extensively. The median sensitivity and specificity of APACHE II at a threshold of 7 were 100% (range, 68% to 100%) and 63% (range, 21% to 96%), respectively, and those of the Ranson criteria at a threshold of 2 were 90% (range, 0% to 100%) and 67% (range, 14% to 97%), respectively. Estimates of sensitivity were based on relatively few patients. Evidence was limited regarding the incremental predictive value of the scoring systems or their effect on patient outcomes. Limitation: Substantial clinical heterogeneity and inadequate methodological and reporting quality precluded a meta-analysis. Conclusion: The test characteristics and clinical utility of AP severity scores remain uncertain. Additional studies with improved methodological rigor are needed, and the development of new scoring systems may be justified. Primary Funding Source: Global Scholarship Programme for Research Excellence for 2014 to 2015, The Chinese University of Hong Kong.

Diagnosis of Acute Gout: A Clinical Practice Guideline From the American College of Physicians

Description: The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on the diagnosis of gout. Methods: This guideline is based on a systematic review of published studies on gout diagnosis, identified using several databases, from database inception to February 2016. Evaluated outcomes included the accuracy of the test results; intermediate outcomes (results of laboratory and radiographic tests, such as serum urate and synovial fluid crystal analysis and radiographic or ultrasonography changes); clinical decision making (additional testing and pharmacologic or dietary management); short-term clinical (patient-centered) outcomes, such as pain and joint swelling and tenderness; and adverse effects of the tests. This guideline grades the evidence and recommendations by using the ACP grading system, which is based on the GRADE (Grading of Recommendations Assessment, Development and Evaluation) method. Target Audience and Patient Population: The target audience for this guideline includes all clinicians, and the target patient population includes adults with joint inflammation suspected to be gout. Recommendation: ACP recommends that clinicians use synovial fluid analysis when clinical judgment indicates that diagnostic testing is necessary in patients with possible acute gout. (Grade: weak recommendation, low-quality evidence)

Dual Health Care System Use and High-Risk Prescribing in Patients With Dementia: A National Cohort Study: Annals of Internal Medicine: Vol 166, No 3

Background: Recent federal policy changes attempt to expand veterans' access to providers outside the Department of Veterans Affairs (VA). Receipt of prescription medications across unconnected systems of care may increase the risk for unsafe prescribing, particularly in persons with dementia. Objective: To investigate the association between dual health care system use and potentially unsafe medication (PUM) prescribing. Design: Retrospective cohort study. Setting: National VA outpatient care facilities in 2010. Participants: 75 829 veterans with dementia who were continuously enrolled in Medicare from 2007 to 2010; 80% were VA-only users, and 20% were VA–Medicare Part D (dual) users. Measurements: Augmented inverse propensity weighting was used to estimate the effect of dual-system versus VA-only prescribing on 4 indicators of PUM prescribing in 2010: any exposure to Healthcare Effectiveness Data and Information Set (HEDIS) high-risk medication in older adults (PUM-HEDIS), any daily exposure to prescriptions with a cumulative Anticholinergic Cognitive Burden (ACB) score of 3 or higher (PUM-ACB), any antipsychotic prescription (PUM-antipsychotic), and any PUM exposure (any-PUM). The annual number of days of each PUM exposure was also examined. Results: Compared with VA-only users, dual users had more than double the odds of exposure to any-PUM (odds ratio [OR], 2.2 [95% CI, 2.2 to 2.3]), PUM-HEDIS (OR, 2.4 [CI, 2.2 to 2.8]), and PUM-ACB (OR, 2.1 [CI, 2.0 to 2.2]). The odds of PUM-antipsychotic exposure were also greater in dual users (OR, 1.5 [CI, 1.4 to 1.6]). Dual users had an adjusted average of 44.1 additional days of any-PUM exposure (CI, 37.2 to 45.0 days). Limitation: Observational study design of veteran outpatients only. Conclusion: Among veterans with dementia, rates of PUM prescribing are significantly higher among dual-system users than with VA-only users. Primary Funding Source: U.S. Department of Veterans Affairs.

Diagnosis of Gout: A Systematic Review in Support of an American College of Physicians Clinical Practice Guideline

Background: Alternative strategies exist for diagnosing gout that do not rely solely on the documentation of monosodium urate (MSU) crystals. Purpose: To summarize evidence regarding the accuracy of clinical tests and classification algorithms compared with that of a reference standard of MSU crystals in joint aspirate for diagnosing gout. Data Sources: Several electronic databases from inception to 29 February 2016. Study Selection: 21 prospective cohort, cross-sectional, and case–control studies including participants with joint inflammation and no previous definitive gout diagnosis who had MSU analysis of joint aspirate. Data Extraction: Data extraction and risk-of-bias assessment by 2 reviewers independently; overall strength of evidence (SOE) judgment by group. Data Synthesis: Recently developed algorithms including clinical, laboratory, and imaging criteria demonstrated good sensitivity (up to 88%) and fair to good specificity (up to 96%) for diagnosing gout (moderate SOE). Three studies of dual-energy computed tomography (DECT) showed sensitivities of 85% to 100% and specificities of 83% to 92% for diagnosing gout (low SOE). Six studies of ultrasonography showed sensitivities of 37% to 100% and specificities of 68% to 97%, depending on the ultrasonography signs assessed (pooled sensitivity and specificity for the double contour sign: 74% [95% CI, 52% to 88%] and 88% [CI, 68% to 96%], respectively [low SOE]). Limitation: Important study heterogeneity and selection bias; scant evidence in primary and urgent care settings and in patients with conditions that may be confused with or occur with gout. Conclusion: Multidimensional algorithms, which must be validated in primary and urgent care settings, may help clinicians make a provisional diagnosis of gout. Although DECT and ultrasonography also show promise for gout diagnosis, accessibility to these methods may be limited. Primary Funding Source: Agency for Healthcare Research and Quality. (Protocol registration: https://effectivehealthcare.ahrq.gov/ehc/products/564/1937/gout-protocol-140716.pdf)

Bioequivalence of Biosimilar Tumor Necrosis Factor-α Inhibitors Compared With Their Reference Biologics: A Systematic Review: Annals of Internal Medicine: Vol 165, No 8

Background: Biosimilars are of growing clinical, regulatory, and commercial importance. Purpose: To summarize evidence about the bioequivalence between biosimilar and reference tumor necrosis factor-α (TNF-α) inhibitors. Data Sources: PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and LILACS from inception through 13 April 2016 and ClinicalTrials.gov, World Health Organization International Clinical Trials Registry Platform, EU Clinical Trials Register, U.S. Food and Drug Administration, and European Medicines Agency from inception through 30 April 2016. Study Selection: Published English-language studies of any size or design that compared the pharmacokinetics, clinical efficacy, adverse events, or immunogenicity of a biosimilar TNF-α inhibitor with a reference biologic in humans. Data Extraction: Two reviewers independently screened titles and abstracts, extracted data from selected studies, and assessed study quality. Data Synthesis: Of 19 eligible studies, 8 were phase 1 randomized trials, 5 were phase 3 randomized trials, and 6 were observational studies. Most phase 1 trials (n = 7) involved healthy volunteers, phase 3 trials involved patients with rheumatoid arthritis, and observational studies involved those with rheumatoid arthritis or inflammatory bowel disease. All phase 1 trials showed that pharmacokinetic parameters of the biosimilar and respective biologic were within the prespecified equivalence margin of 80% to 125%. Phase 3 trials suggested similar clinical responses and adverse events. Adverse events were usually of mild to moderate severity. Two cross-sectional observational studies showed cross-reactivity between products, whereas 4 cohort studies of patients switched from reference to biosimilar products suggested similar efficacy and safety outcomes. Limitation: Possible publication bias, small sample sizes of many studies, and lack of published studies for several biosimilars. Conclusion: Preliminary evidence supports the biosimilarity and interchangeability of biosimilar and reference TNF-α inhibitors. Primary Funding Source: Johns Hopkins Center of Excellence in Regulatory Science and Innovation. (PROSPERO: CRD42015025262)

Update in Nephrology and Hypertension: Evidence Published in 2015

Update in Pulmonary Medicine: Evidence Published in 2015

Who Is for CO2? Slow Adoption of Carbon Dioxide Insufflation in Colonoscopy

Cost-Effectiveness of Sacubitril–Valsartan in Patients With Heart Failure With Reduced Ejection Fraction

Background: Sacubitril–valsartan therapy reduces cardiovascular mortality compared with enalapril therapy in patients with heart failure with reduced ejection fraction. Objective: To evaluate the cost-effectiveness of sacubitril–valsartan versus angiotensin-converting enzyme inhibitor therapy in patients with chronic heart failure. Design: Markov decision model. Data Sources: Clinical trials, observational analyses, reimbursement data from the Centers for Medicare & Medicaid Services, drug pricing databases, and Centers for Disease Control and Prevention life tables. Target Population: Patients at an average age of 64 years, New York Heart Association (NYHA) class II to IV heart failure, and left ventricular ejection fraction of 0.40 or less. Time Horizon: Lifetime. Perspective: Societal. Intervention: Treatment with sacubitril–valsartan or lisinopril. Outcome Measures: Life-years, quality-adjusted life-years (QALYs), costs, heart failure hospitalizations, and incremental cost-effectiveness ratios. Results of Base-Case Analysis: The sacubitril–valsartan group experienced 0.08 fewer heart failure hospitalization, 0.69 additional life-year, 0.62 additional QALY, and $29 203 in incremental costs, equating to a cost per QALY gained of $47 053. The cost per QALY gained was $44 531 in patients with NYHA class II heart failure and $58 194 in those with class III or IV heart failure. Results of Sensitivity Analysis: Sacubitril–valsartan treatment was most sensitive to the duration of improved outcomes, with a cost per QALY gained of $120 623 if the duration was limited to the length of the trial (median, 27 months). No variations in other parameters caused the cost to exceed $100 000 per QALY gained. Limitation: The benefit of sacubitril–valsartan is based on a single clinical trial. Conclusion: Treatment with sacubitril–valsartan provides reasonable value in reducing cardiovascular mortality and morbidity in patients with NYHA class II to IV heart failure. Primary Funding Source: U.S. Department of Veterans Affairs and Institute for Clinical and Economic Review.