The Transitional Coverage for Emerging Technologies Pathway-Enhancing Innovation While Establishing Patient Safeguards.

This Viewpoint discusses the Centers for Medicare & Medicaid Services' Transitional Coverage for Emerging Technologies pathway, which aims to enhance coverage of emerging technologies with supporting evidence.

Value-Based Payment for Clinicians Treating Cardiovascular Disease: A Policy Statement From the American Heart Association.

Clinician payment is transitioning from fee-for-service to value-based payment, with reimbursement tied to health care quality and cost. However, the overarching goals of value-based payment-to improve health care quality, lower costs, or both-have been largely unmet. This policy statement reviews the current state of value-based payment and provides recommended best practices for future design and implementation. The policy statement is divided into sections that detail different aspects of value-based payment: (1) key program design features (patient population, quality measurement, cost measurement, and risk adjustment), (2) the role of equity during design and evaluation, (3) adjustment of payment, and (4) program implementation and evaluation. Each section introduces the topic, describes important considerations, and lists examples from existing programs. Each section includes recommended best practices for future program design. The policy statement highlights 4 key themes for successful value-based payment. First, programs should carefully weigh the incentives between lowering cost and improving quality of care and ensure that there is adequate focus on quality of care. Second, the expansion of value-based payment should be a tool for improving equity, which is central to quality of care and should be a focal point of program design and evaluation. Third, value-based payment should continue to move away from fee for service toward more flexible funding that allows clinicians to focus resources on the interventions that best help patients. Last, successful programs should find ways to channel clinicians' intrinsic motivation to improve their performance and the care for their patients. These principles should guide the future development of clinician value-based payment models.

Association of Medical Liability Reform With Clinician Approach to Coronary Artery Disease Management.

Importance: Physicians often report practicing defensive medicine to reduce malpractice risk, including performing expensive but marginally beneficial tests and procedures. Although there is little evidence that malpractice reform affects overall health care spending, it may influence physician behavior for specific conditions involving clinical uncertainty. Objective: To examine whether reducing malpractice risk is associated with clinical decisions involving coronary artery disease testing and treatment. Design, Setting, and Participants: Difference-in-differences design, comparing physician-specific changes in coronary artery disease testing and treatment in 9 new-cap states that adopted damage caps between 2003 and 2005 with 20 states without caps. We used the 5% national Medicare fee-for-service random sample between 1999 and 2013. Physicians (n = 75 801; 36 647 in new-cap states) who ordered or performed 2 or more coronary angiographies. Data were analyzed from June 2015 to January 2018. Main Outcomes and Measures: Changes in ischemic evaluation rates for possible coronary artery disease, type of initial evaluation (stress testing or coronary angiography), progression from stress test to angiography, and progression from ischemic evaluation to revascularization (percutaneous coronary intervention or coronary artery bypass grafting). Results: We studied 36 647 physicians in new-cap states and 39 154 physicians in no-cap states. New-cap states had younger populations, more minorities, lower per-capita incomes, fewer physicians per capita, and lower managed care penetration. Following cap adoption, new-cap physicians reduced invasive testing (angiography) as a first diagnostic test compared with control physicians (relative change, -24%; 95% CI, -40% to -7%; P = .005) with an offsetting increase in noninvasive stress testing (7.8%; 95% CI, -3.6% to 19.3%; P = .17), and referred fewer patients for angiography following stress testing (-21%; 95% CI, -40% to -2%; P = .03). New-cap physicians also reduced revascularization rates after ischemic evaluation (-23%; 95% CI, -40% to -4%; P = .02; driven by fewer percutaneous coronary interventions). Changes in overall ischemic evaluation rates were similar for new-cap and control physicians (-0.05%; 95% CI, -8.0% to 7.9%; P = .98). Conclusions and Relevance: Physicians substantially altered their approach to coronary artery disease testing and follow-up after initial ischemic evaluations following adoption of damage caps. They performed a similar number of ischemic evaluations but conducted fewer initial left heart catheterizations, referred fewer stress-tested patients for left heart catheterizations, and referred fewer patients for revascularization. These findings suggest that physicians tolerate greater clinical uncertainty in coronary artery disease testing and treatment if they face lower malpractice risk.

Payment Reform to Enhance Collaboration of Primary Care and Cardiology: A Review.

Importance: The US health care system faces an unsustainable trajectory of high costs and inconsistent outcomes. The fee-for-service payment model has contributed to inefficiency, and new payment methods are a promising approach to improving value. Health reforms are needed to increase patient access, reduce costs, and improve health care quality, and the landmark Medicare Access and CHIP Reauthorization Act presents a roadmap for reform. The product of a collaboration between primary care and cardiology clinicians, this review describes a conceptual approach to delivery and payment reforms that aim to better support primary care-cardiology comanagement of chronic cardiovascular disease (CVD). Observations: Few existing alternative payment models specifically address long-term management of CVD. Primary care medical homes and accountable care organizations come closest, but both emphasize primary care, and cardiologists have often not been well engaged. A collaborative care framework should articulate distinct roles and responsibilities for primary care and cardiology in CVD comanagement. Finally, a series of payment models aim to better support clinicians in providing accountable, seamless, and patient-centered cardiac care. Conclusions & Relevance: Clinical leadership is essential during this time of change in the health care system. Patients often struggle to navigate a fragmented and expensive system, whereas clinicians often practice with incomplete information about tests, treatments, and recommendations by their colleagues. The payment models described in this review offer an opportunity to create more satisfying approaches to patient care while improving value. These models have potential to support more effective coordination and to facilitate broader health care system transformation.

Implications of the PEGASUS-TIMI 54 trial for US clinical practice.

OBJECTIVES: This study aims to determine the proportion of real-world patients with myocardial infarction (MI) who would have been eligible for the PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54) trial, to characterise their current use of P2Y12 inhibitors and to explore the estimated costs and ischaemic event consequences of increasing P2Y12 inhibitor use among these patients. METHODS: In the US national ACTION Registry-GWTG (Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines), we identified 273 328 patients with MI and determined the proportion that would have met the eligibility criteria for the PEGASUS trial. We described longitudinal P2Y12 inhibitor use among patients eligible for PEGASUS and estimated the cost and ischaemic consequences of increasing P2Y12 use among eligible patients. RESULTS: A total of 112 222 (41.1%) patients with MI in ACTION Registry-GWTG met eligibility for the PEGASUS trial. Among 83 871 eligible patients with pharmacy claims data, 23 042 (27.5%) were on a P2Y12 inhibitor at 1 year, 9661 (11.5%) at 2 years and 5246 (6.3%) at 3 years, with the majority (79.2%) of these patients on clopidogrel. The use of ticagrelor in eligible patients not yet on a P2Y12 inhibitor at 1 year post-MI would cost an estimated US$885 000 per MI, stroke or cardiovascular death averted over a 3-year time horizon, while the use of clopidogrel would cost an estimated US$19 800 per ischaemic event averted. CONCLUSION: In contemporary clinical practice, a minority of patients are on a P2Y12 inhibitor beyond 1-year post-MI. Applying PEGASUS trial findings to clinical practice would result in a large increase in P2Y12 inhibitor use, with a cost per ischaemic event averted that is strongly influenced by the choice of therapy.

Existing and Emerging Payment and Delivery Reforms in Cardiology.

Importance: Recent health care reforms aim to increase patient access, reduce costs, and improve health care quality as payers turn to payment reform for greater value. Cardiologists need to understand emerging payment models to succeed in the evolving payment landscape. We review existing payment and delivery reforms that affect cardiologists, present 4 emerging examples, and consider their implications for clinical practice. Observations: Public and commercial payers have recently implemented payment reforms and new models are evolving. Most cardiology models are modified fee-for-service or address procedural or episodic care, but population models are also emerging. Although there is widespread agreement that payment reform is needed, existing programs have significant limitations and the adoption of new programs has been slow. New payment reforms address some of these problems, but many details remain undefined. Conclusions and Relevance: Early payment reforms were voluntary and cardiologists' participation is variable. However, conventional fee-for-service will become less viable, and enrollment in new payment models will be unavoidable. Early participation in new payment models will allow clinicians to develop expertise in new care pathways during a period of relatively lower risk.

Medicaid Expansion In 2014 Did Not Increase Emergency Department Use But Did Change Insurance Payer Mix.

In 2014 twenty-eight states and the District of Columbia had expanded Medicaid eligibility while federal and state-based Marketplaces in every state made subsidized private health insurance available to qualified individuals. As a result, about seventeen million previously uninsured Americans gained health insurance in 2014. Many policy makers had predicted that Medicaid expansion would lead to greatly increased use of hospital emergency departments (EDs). We examined the effect of insurance expansion on ED use in 478 hospitals in 36 states during the first year of expansion (2014). In difference-in-differences analyses, Medicaid expansion increased Medicaid-paid ED visits in those states by 27.1 percent, decreased uninsured visits by 31.4 percent, and decreased privately insured visits by 6.7 percent during the first year of expansion compared to nonexpansion states. Overall, however, total ED visits grew by less than 3 percent in 2014 compared to 2012-13, with no significant difference between expansion and nonexpansion states. Thus, the expansion of Medicaid coverage strongly affected payer mix but did not significantly affect overall ED use, even though more people gained insurance coverage in expansion states than in nonexpansion states. This suggests that expanding Medicaid did not significantly increase or decrease overall ED visit volume.

Patient, Caregiver, and Physician Work in Heart Failure Disease Management: A Qualitative Study of Issues That Undermine Wellness.

OBJECTIVE: To identify factors underlying heart failure hospitalization. METHODS: Between January 1, 2012, and May 31, 2012, we combined medical record reviews and cross-sectional qualitative interviews of multiple patients with heart failure, their clinicians, and their caregivers from a large academic medical center in the Midwestern United States. The interview data were analyzed using a 3-step grounded theory-informed process and constant comparative methods. Qualitative data were compared and contrasted with results from the medical record review. RESULTS: Patient nonadherence to the care plan was the most important contributor to hospital admission; however, reasons for nonadherence were complex and multifactorial. The data highlight the importance of patient education for the purposes of condition management, timeliness of care, and effective communication between providers and patients. CONCLUSION: To improve the consistency and quality of care for patients with heart failure, more effective relationships among patients, providers, and caregivers are needed. Providers must be pragmatic when educating patients and their caregivers about heart failure, its treatment, and its prognosis.

Fully Capitated Payment Breakeven Rate for a Mid-Size Pediatric Practice.

BACKGROUND AND OBJECTIVES: Payers are implementing alternative payment models that attempt to align payment with high-value care. This study calculates the breakeven capitated payment rate for a midsize pediatric practice and explores how several different staffing scenarios affect the rate. METHODS: We supplemented a literature review and data from >200 practices with interviews of practice administrators, physicians, and payers to construct an income statement for a hypothetical, independent, midsize pediatric practice in fee-for-service. The practice was transitioned to full capitation to calculate the breakeven capitated rate, holding all practice parameters constant. Panel size, overhead, physician salary, and staffing ratios were varied to assess their impact on the breakeven per-member per-month (PMPM) rate. Finally, payment rates from an existing health plan were applied to the practice. RESULTS: The calculated breakeven PMPM was $24.10. When an economic simulation allowed core practice parameters to vary across a broad range, 80% of practices broke even with a PMPM of $35.00. The breakeven PMPM increased by 12% ($3.00) when the staffing ratio increased by 25% and increased by 23% ($5.50) when the staffing ratio increased by 38%. The practice was viable, even with primary care medical home staffing ratios, when rates from a real-world payer were applied. CONCLUSIONS: Practices are more likely to succeed in capitated models if pediatricians understand how these models alter practice finances. Staffing changes that are common in patient-centered medical home models increased the breakeven capitated rate. The degree to which team-based care will increase panel size and offset increased cost is unknown.

Relationship of Provider and Practice Volume to Performance Measure Adherence for Coronary Artery Disease, Heart Failure, and Atrial Fibrillation: Results From the National Cardiovascular Data Registry.

BACKGROUND: There is a reported association between high clinical volume and improved outcomes. Whether this relationship is true for outpatients with coronary artery disease (CAD), heart failure (HF), and atrial fibrillation (AF) remains unknown. METHODS AND RESULTS: Using the PINNACLE Registry (2009-2012), average monthly provider and practice volumes were calculated for CAD, HF, and AF. Adherence with 4 American Heart Association CAD, 2 HF, and 1 AF performance measure were assessed at the most recent encounter for each patient. Hierarchical logistic regression models were used to assess the relationship between provider and practice volume and performance on eligible quality measures. Data incorporated patients from 1094 providers at 71 practices (practice level analyses n=654 535; provider level analyses n=529 938). Median monthly provider volumes were 79 (interquartile range [IQR], 51-117) for CAD, 27 (16-45) for HF, and 37 (24-54) for AF. Median monthly practice volumes were 923 (IQR, 476-1455) for CAD, 311 (145-657) for HF, and 459 (185-720) for AF. Overall, 55% of patients met all CAD measures, 72% met all HF measures, and 58% met the AF measure. There was no definite relationship between practice volume and concordance for CAD, AF, or HF (P=0.56, 0.52, and 0.79, respectively). In contrast, higher provider volume was associated with increased concordance for CAD and AF performance measures (P<0.001 for both), but not for HF (P=0.36). CONCLUSIONS: In the PINNACLE registry, performance was modest and variable. Higher provider volume was positively associated with quality, whereas practice volume was not.

Implications of the 2013 ACC/AHA cholesterol guidelines for adults in contemporary cardiovascular practice: insights from the NCDR PINNACLE registry.

BACKGROUND: In a significant update, the 2013 American College of Cardiology/American Heart Association (ACC/AHA) cholesterol guidelines recommend fixed-dose statin therapy for those at risk and do not recommend nonstatin therapies or treatment to target low-density lipoprotein cholesterol (LDL-C) levels, limiting the need for repeated LDL-C testing. OBJECTIVES: The goal of this study was to examine the impact of the 2013 ACC/AHA cholesterol guidelines on current U.S. cardiovascular practice. METHODS: Using the NCDR PINNACLE (National Cardiovascular Data Registry Practice Innovation and Clinical Excellence) registry data from 2008 to 2012, we assessed current practice patterns as a function of the 2013 cholesterol guidelines. Lipid-lowering therapies and LDL-C testing patterns by patient risk group (atherosclerotic cardiovascular disease [ASCVD], diabetes, LDL-C ≥190 mg/dl, or an estimated 10-year ASCVD risk ≥7.5%) were described. RESULTS: Among a cohort of 1,174,545 patients, 1,129,205 (96.1%) were statin-eligible (91.2% ASCVD, 6.6% diabetes, 0.3% off-treatment LDL-C ≥190 mg/dl, 1.9% estimated 10-year ASCVD risk ≥7.5%). There were 377,311 patients (32.4%) not receiving statin therapy and 259,143 (22.6%) receiving nonstatin therapies. During the study period, 20.8% of patients had 2 or more LDL-C assessments, and 7.0% had more than 4. CONCLUSIONS: In U.S. cardiovascular practices, 32.4% of statin-eligible patients, as defined by the 2013 ACC/AHA cholesterol guidelines, were not currently receiving statins. In addition, 22.6% were receiving nonstatin lipid-lowering therapies and 20.8% had repeated LDL-C testing. Achieving concordance with the new cholesterol guidelines in patients treated in U.S. cardiovascular practices would result in significant increases in statin use, as well as significant reductions in nonstatin therapies and laboratory testing.

"Innovation" institutes in academic health centers: enhancing value through leadership, education, engagement, and scholarship.

In the next decade, the biggest change in medicine in the United States will be the organizational transformation of the delivery system. Organizations-including academic health centers-able to achieve better outcomes for less will be the financial winners as new payment models become more prevalent. For medical educators, the question is how to prepare the next generation of physicians for these changes. One solution is the development of new "innovation" or "value" institutes. Around the nation, many of these new institutes are focused on surmounting barriers to value-based care in academic health centers, educating faculty, house staff, and medical students in discussions of cost-conscious care. Innovation institutes can also lead discussions about how value-based care may impact education in environments where there may be less autonomy and more standardization. Quality metrics will play a larger role at academic health centers as metrics focus more on outcomes than processes. Optimizing outcomes will require that medical educators both learn and teach the principles of patient safety and quality improvement. Innovation institutes can also facilitate cross-institutional discussions to compare data on utilization and outcomes, and share best practices that maximize value. Another barrier to cost-conscious care is defensive medicine, which is highly engrained in U.S. medicine and culture. Innovation institutes may not be able to overcome all the barriers to making medical care more cost-conscious, but they can be critical in enabling academic health centers to optimize their teaching and research missions while remaining financially competitive.

Hospital-level variation in use of cardiovascular testing for adults with incident heart failure: findings from the cardiovascular research network heart failure study.

OBJECTIVES: This study aimed to characterize the use of cardiovascular testing for patients with incident heart failure (HF) hospitalization who participated in the National Heart, Lung, and Blood Institute sponsored Cardiovascular Research Network (CVRN) Heart Failure study. BACKGROUND: HF is a common cause of hospitalization, and testing and treatment patterns may differ substantially between providers. Testing choices have important implications for the cost and quality of care. METHODS: Crude and adjusted cardiovascular testing rates were calculated for each participating hospital. Cox proportional hazards regression models were used to examine hospital testing rates after adjustment for hospital-level patient case mix. RESULTS: Of the 37,099 patients in the CVRN Heart Failure study, 5,878 patients were hospitalized with incident HF between 2005 and 2008. Of these, evidence of cardiovascular testing was available for 4,650 (79.1%) patients between 14 days before the incident HF admission and ending 6 months after the incident discharge. We compared crude and adjusted cardiovascular testing rates at the hospital level because the majority of testing occurred during the incident HF hospitalization. Of patients who underwent testing, 4,085 (87.9%) had an echocardiogram, 4,345 (93.4%) had a systolic function assessment, and 1,714 (36.9%) had a coronary artery disease assessment. Crude and adjusted testing rates varied markedly across the profiled hospitals, for individual testing modalities (e.g., echocardiography, stress echocardiography, nuclear stress testing, and left heart catheterization) and for specific clinical indications (e.g., systolic function assessment and coronary artery disease assessment). CONCLUSIONS: For patients with newly diagnosed HF, we did not observe widespread overuse of cardiovascular testing in the 6 months following incident HF hospitalization relative to existing HF guidelines. Variations in testing were greatest for assessment of ischemia, in which testing guidelines are less certain.