Value-based purchasing (VBP) refers to a broad set of performance-based payment strategies that link financial incentives to health care providers' performance on a set of defined measures in an effort to achieve better value. The U.S. Department of Health and Human Services is advancing the implementation of VBP across an array of health care settings in the Medicare program in response to requirements in the 2010 Patient Protection and Affordable Care Act, and policymakers are grappling with many decisions about how best to design and implement VBP programs so that they are successful in achieving stated goals. This article summarizes the current state of knowledge about VBP based on a review of the published literature, a review of publicly available documentation from VBP programs, and discussions with an expert panel composed of VBP program sponsors, health care providers and health systems, and academic researchers with VBP evaluation expertise. Three types of VBP models were the focus of the review: (1) pay-for-performance programs, (2) accountable care organizations, and (3) bundled payment programs. The authors report on VBP program goals and what constitutes success; the evidence on the impact of these programs; factors that characterize high- and low-performing providers in VBP programs; the measures, incentive structures, and benchmarks used by VBP programs; evidence on spillover effects and unintended consequences; and gaps in the knowledge base.

/pdf/measuring-success-in-health-care-value-based-purchasing-2iwy91rzli.pdf

Measuring Success in Health Care Value-Based Purchasing Programs: Findings from an Environmental Scan, Literature Review, and Expert Panel Discussions.

OBJECTIVES: 1) To describe how internal medicine residency programs fulfill the Accreditation Council for Graduate Medical Education (ACGME) scholarly activity training requirement including the current context of resident scholarly work, and 2) to compare findings between university and nonuniversity programs.

/pdf/resident-research-and-scholarly-activity-in-internal-9wo5t4d13t.pdf

Resident research and scholarly activity in internal medicine residency training programs.

FDA’s critical path initiative documents have focused on the challenges involved in the development of new drugs. Some of the focus areas identified apply equally to the production of generic drugs. However, there are scientific challenges unique to the development of generic drugs as well. In May 2007, FDA released a document “Critical Path Opportunities for Generic Drugs” that identified some of the specific challenges in the development of generic drugs. The key steps in generic product development are usually characterization of the reference product, design of a pharmaceutically equivalent and bioequivalent product, design of a consistent manufacturing process and conduct of the pivotal bioequivalence study. There are several areas of opportunity where scientific progress could accelerate the development and approval of generic products and expand the range of products for which generic versions are available, while maintaining high standards for quality, safety, and efficacy. These areas include the use of quality by design to develop bioequivalent products, more efficient bioequivalence methods for systemically acting drugs (expansion of BCS waivers, highly variable drugs), and development of new bioequivalence methods for locally acting drugs.

/pdf/fda-critical-path-initiatives-opportunities-for-generic-drug-hpfjb8c8j9.pdf

FDA Critical Path Initiatives: Opportunities for Generic Drug Development

ContextSupport of research to facilitate translation of scientific discoveries
to the prevention and treatment of human disease is a high priority for the
US National Institutes of Health (NIH). Nevertheless, a perception exists
among clinical investigators that the NIH peer review process may discriminate
against clinical research.ObjectiveTo describe recent trends and outcomes of peer review of grant applications
to NIH requesting support for clinical research.Design and SettingPeer review outcomes of grant applications submitted to NIH by MDs were
compared with those of non-MDs, and outcomes of applications involving inclusion
of human subjects were compared with those not involving human subjects. Analyses
were carried out using an inclusive definition of clinical research and after
stratifying clinical research into specific categories.Main Outcome MeasuresMedian priority scores and funding rates.ResultsBetween 1997 and 2002, on average, 25.2% of total grant applications
(ranging from 27 607 to 34 422 per year) were submitted by MDs,
and 27.5% of awards (ranging from 8495 to 10 769 awards per year) were
made to MDs. Median priority scores (239.0 vs 250.0) and funding rates (31.4%
vs 29.1%) reviewed in 2 grant cycles in 2002 were more favorable for MDs than
for non-MDs (P<.001). However, median priority
scores (254.0 vs 244.0) and funding rates (23.9% vs 28.1%) were less favorable
(P<.001) for R01 applications for clinical research
(n = 7227 applications) than for nonclinical research (n = 10 209). This
trend was most convincingly observed for clinical research categorized as
mechanisms of disease (P = .006) or clinical trials
and interventions (P = .001). Similar trends were
observed for grant mechanisms other than R01. Concerns about safety and privacy
of human subjects may have contributed to the less favorable outcomes of clinical
research applications.ConclusionAlthough physicians compete favorably in the peer review process, review
outcomes are modestly less favorable for grant applications for clinical research
than for laboratory research.

https://jamanetwork.com/journals/jama/articlepdf/198219/JOC32232.pdf

NIH Peer Review of Grant Applications for Clinical Research

Leadership Development in Medicine Health care suffers from a persistent disconnect between the capacity of the physician-leadership workforce and the needs of our increasingly complex health syste...

Leadership Development in Medicine.

MISSION STATEMENTS CAPTURE AND EXPRESS THE heart and soul of an organization. Mission may be defined around function—a statement or declaration of fundamental purpose or strategic direction. A mission statement may offer the organization’s definition of vision and values, or it may articulate an inner calling or vocation to pursue an activity or perform a service. In all cases, mission statements ultimately attempt to answer one question: What does an institution or organization seek to achieve? In 1497, the first known academic chair of medicine in the English-speaking world was established at King’s College in Aberdeen, Scotland. Its mission was the “pursuit of health in the service of society. Five centuries later, academic medicine has lost sight of this mission. It is critical that academic medicine now return to the original meaning and mission. Some argue that the mission of academic medicine is to improve human health via the advancement of knowledge. More frequently, leaders of academic medicine describe a tripartite mission consisting of education, research, and clinical service. Although the time allocated to each of these mission components by individual faculty members may be uneven, it is now generally assumed that the contemporary mission (or missions) of an academic health center consist of teaching, research, and clinical practice. For example, in his 2008 address as president of the Association of American Medical Colleges, Kirch reiterated the importance of balance among these 3 missions. Similarly, the mission statements of many medical schools and academic health centers list the 3 interrelated missions. In the first “modern” mission statement at King’s College, the chair of medicine was assigned a single mandate: the pursuit of health for all. Although this remains the ultimate raison d’être of all health care professions, adherence to this mission on the part of academic medicine continues to be carried out using the tripartite-mission model: teaching the next generation of physicians, performing research to advance the understanding of human biology and the practice of medicine, and providing direct health care for individual patients and populations. These activities have waxed and waned in relationship to one another in academic settings, with clinical care predominating prior to the Flexnerian era, giving way to a research focus after World War II, and again shifting to clinical care in recent years as public support for academic health centers has declined. Education has maintained a constant, if sometimes tenuous, role in the academic health center. These 3 activities are connected and interdependent in fundamental ways that are, at their core, independent of finances. Medical students learn the foundations of basic science from researchers; medical students and residents learn their clinical skills under the tutelage of clinicians; research depends on the clinical setting for testing hypotheses and conducting safe experimentation to advance knowledge; clinical care, in turn, evolves and progresses through the knowledge that results from research. Over time, these 3 activities have developed interdependent financial relationships as well. When these activities are treated as a single 3-part mission or 3 connected missions, they are in danger of becoming ends in themselves rather than activities that support a common purpose. Furthermore, although the demands on faculty imposed by this tripartite model are significant, the expectation has developed that faculty members will excel in all 3 missions. From this expectation, the concept of the triple-threat faculty member has evolved into an accepted standard for academic medicine. Whether it was ever possible for more than a small number of productive and highly efficient individuals to achieve excellence in all 3 activities, the triple threat has in recent years been seen increasingly as endangered and counterproductive. Petersdorf and Turner observed nearly 15 years ago, “It cannot be done.” For too long, faculty have been expected to achieve substantial productivity in all 3 realms to advance in their careers. This understanding has led some to conclude that the triple-threat model is inefficient and that an alternative, more efficient model of specialization is required in which each faculty member specializes in 1 or 2 areas.

A single mission for academic medicine: improving health.

Academic medical centers must address financial and cultural barriers to the implementation of new care and payment models such as ACOs. The steps that Johns Hopkins has taken may offer useful lessons for other academic medical centers.

Accountable care at academic medical centers--lessons from Johns Hopkins.

Clinical investigators--the endangered species revisited.

Health A Single Mission for Academic Medicine: Improving

ONE YEAR AFTER THE HISTORIC PASSAGE OF THE AFfordable Care Act (ACA), the individual mandate is subject to ongoing scrutiny both by the federal courts and Congress. This provision of the ACA would require most individuals to purchase health insurance, and recent attention has focused on the important legal issues associated with such a mandate. However, far less attention has been devoted to the potential effects of the mandate on the quality and cost of care and what that would mean—in real terms—for US families and their physicians. The individual mandate is integral to the health reform legislation for at least 3 reasons. First, and critically for physicians, it strengthens the patient-physician relationship. Second, it generally stabilizes insurance premiums, increases access to health insurance coverage, and provides security against significant medical expenses. Third, it addresses the pernicious “free rider” problem that is unique to US health care because of the long dysfunctional health insurance market.

The Individual Mandate and Patient-Centered Care

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