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"McClellan, Mark"
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Reforming Payments to Healthcare Providers: The Key to Slowing Healthcare Cost Growth While Improving Quality?
2011
This paper focuses on a broad movement toward a fundamentally different way of paying healthcare providers. The approach reaches beyond the old dichotomies about whether healthcare providers are reimbursed on a fee-for-service or a “capitated” or per-person payment. Instead, these reforms seek to create direct linkages between payments to healthcare providers and measures of the quality and efficiency of care. After an overview of payment reforms for healthcare providers and their welfare implications, this paper discusses a range of empirical studies. These often small-scale studies suggest that provider payment reforms in conjunction with greater attention to improving measurements of care quality and outcomes can have a significant impact on quality of care and, in some cases, resource use and costs of care.
Journal Article
The FDA Sentinel Initiative — An Evolving National Resource
by
Ball, Robert
,
McClellan, Mark
,
Robb, Melissa
in
Adverse Drug Reaction Reporting Systems
,
Biological products
,
Computer Communication Networks
2018
A decade after the launch of the FDA Sentinel Initiative, it has matured from a pilot program designed to assess potential drug-safety signals in insurance claims into a core component of the agency’s evolving safety surveillance system.
Journal Article
Repairing The Broken Market For Antibiotic Innovation
by
Daniel, Gregory W
,
McClellan, Mark B
,
Powers, John H
in
Antibiotics
,
Bacteria
,
Bacterial diseases
2015
Multidrug-resistant bacterial diseases pose serious and growing threats to human health. While innovation is important to all areas of health research, it is uniquely important in antibiotics. Resistance destroys the fruit of prior research, making it necessary to constantly innovate to avoid falling back into a pre-antibiotic era. But investment is declining in antibiotics, driven by competition from older antibiotics, the cost and uncertainty of the development process, and limited reimbursement incentives. Good public health practices curb inappropriate antibiotic use, making return on investment challenging in payment systems based on sales volume. We assess the impact of recent initiatives to improve antibiotic innovation, reflecting experience with all sixty-seven new molecular entity antibiotics approved by the Food and Drug Administration since 1980. Our analysis incorporates data and insights derived from several multistakeholder initiatives under way involving governments and the private sector on both sides of the Atlantic. We propose three specific reforms that could revitalize innovations that protect public health, while promoting long-term sustainability: increased incentives for antibiotic research and development, surveillance, and stewardship; greater targeting of incentives to high-priority public health needs, including reimbursement that is delinked from volume of drug use; and enhanced global collaboration, including a global treaty.
Journal Article
The potential for artificial intelligence to transform healthcare: perspectives from international health leaders
by
Salzberg, Claudia A.
,
Saunders, Robert
,
Silcox, Christina
in
692/700/1538
,
692/700/228
,
Artificial intelligence
2024
Artificial intelligence (AI) has the potential to transform care delivery by improving health outcomes, patient safety, and the affordability and accessibility of high-quality care. AI will be critical to building an infrastructure capable of caring for an increasingly aging population, utilizing an ever-increasing knowledge of disease and options for precision treatments, and combatting workforce shortages and burnout of medical professionals. However, we are not currently on track to create this future. This is in part because the health data needed to train, test, use, and surveil these tools are generally neither standardized nor accessible. There is also universal concern about the ability to monitor health AI tools for changes in performance as they are implemented in new places, used with diverse populations, and over time as health data may change. The Future of Health (FOH), an international community of senior health care leaders, collaborated with the Duke-Margolis Institute for Health Policy to conduct a literature review, expert convening, and consensus-building exercise around this topic. This commentary summarizes the four priority action areas and recommendations for health care organizations and policymakers across the globe that FOH members identified as important for fully realizing AI’s potential in health care: improving data quality to power AI, building infrastructure to encourage efficient and trustworthy development and evaluations, sharing data for better AI, and providing incentives to accelerate the progress and impact of AI.
Journal Article
Comparing Associations of State Reopening Strategies with COVID-19 Burden
by
Whitaker, Rebecca
,
Mahendraratnam Nirosha
,
Smith, Valerie A
in
Confidence intervals
,
Coronaviruses
,
COVID-19
2020
BackgroundThe novel coronavirus disease 2019 (COVID-19) infected over 5 million United States (US) residents resulting in more than 180,000 deaths by August 2020. To mitigate transmission, most states ordered shelter-in-place orders in March and reopening strategies varied.ObjectiveTo estimate excess COVID-19 cases and deaths after reopening compared with trends prior to reopening for two groups of states: (1) states with an evidence-based reopening strategy, defined as reopening indoor dining after implementing a statewide mask mandate, and (2) states reopening indoor dining rooms before implementing a statewide mask mandate.DesignInterrupted time series quasi-experimental study design applied to publicly available secondary data.ParticipantsFifty United States and the District of Columbia.InterventionsReopening indoor dining rooms before or after implementing a statewide mask mandate.Main MeasuresOutcomes included daily cumulative COVID-19 cases and deaths for each state.Key ResultsOn average, the number of excess cases per 100,000 residents in states reopening without masks is ten times the number in states reopening with masks after 8 weeks (643.1 cases; 95% confidence interval (CI) = 406.9, 879.2 and 62.9 cases; CI = 12.6, 113.1, respectively). Excess cases after 6 weeks could have been reduced by 90% from 576,371 to 63,062 and excess deaths reduced by 80% from 22,851 to 4858 had states implemented mask mandates prior to reopening. Over 50,000 excess deaths were prevented within 6 weeks in 13 states that implemented mask mandates prior to reopening.ConclusionsAdditional mitigation measures such as mask use counteract the potential growth in COVID-19 cases and deaths due to reopening businesses. This study contributes to the growing evidence that mask usage is essential for mitigating community transmission of COVID-19. States should delay further reopening until mask mandates are fully implemented, and enforcement by local businesses will be critical for preventing potential future closures.
Journal Article
Building the Path to Accountable Care
by
Safran, Dana G
,
Fisher, Elliott S
,
McClellan, Mark B
in
Accountability
,
Accountable care organizations
,
Accountable Care Organizations - economics
2011
Implementation of accountable care organizations (ACOs) is still at an early stage, but the growing experience with these organizations and the public comments regarding the Medicare ACO program point to five key challenges — and possible approaches to overcoming them.
The recent release of the regulations that will govern the early years of Medicare's implementation of accountable care organizations (ACOs) provides an important moment to reflect on the transition to this new payment model, which offers health care providers flexible financial support for improving care in return for accepting accountability for its overall quality and cost. It's also an appropriate moment to explore the challenges that must be overcome in order to make more rapid progress.
The final regulations for the Medicare Shared Savings Program, released on October 20, 2011, represent diligent work to try to address many concerns raised . . .
Journal Article
A Threat to Evidence-Based Vaccine Policy and Public Health Security at the FDA
by
Califf, Robert M.
,
Hamburg, Margaret A.
,
von Eschenbach, Andrew C.
in
Aging
,
Aging General
,
and Education
2026
A Threat to Vaccine Policy and Public Health at the FDA Twelve former commissioners of the FDA express concern that the agency’s recent moves will undermine a regulatory model designed to ensure vaccine safety, effectiveness, and availability.
Journal Article
Is More Information Better? The Effects of “Report Cards” on Health Care Providers
by
Satterthwaite, Mark
,
McClellan, Mark
,
Kessler, Daniel
in
Adjustment
,
Angioplasty
,
Cardiac surgery
2003
Health care report cards—public disclosure of patient health outcomes at the level of the individual physician or hospital or both—may address important informational asymmetries in markets for health care, but they may also give doctors and hospitals incentives to decline to treat more difficult, severely ill patients. Whether report cards are good for patients and for society depends on whether their financial and health benefits outweigh their costs in terms of the quantity, quality, and appropriateness of medical treatment that they induce. Using national data on Medicare patients at risk for cardiac surgery, we find that cardiac surgery report cards in New York and Pennsylvania led both to selection behavior by providers and to improved matching of patients with hospitals. On net, this led to higher levels of resource use and to worse health outcomes, particularly for sicker patients. We conclude that, at least in the short run, these report cards decreased patient and social welfare.
Journal Article
Caveolin-1 modulates intraocular pressure: implications for caveolae mechanoprotection in glaucoma
2016
Polymorphisms in the
CAV1/2
genes that encode signature proteins of caveolae are associated with glaucoma, the second leading cause of blindness worldwide, and with its major risk factor, intraocular pressure (IOP). We hypothesized that caveolin-1 (Cav-1) participates in IOP maintenance via modulation of aqueous humor drainage from the eye. We localize caveolae proteins to human and murine conventional drainage tissues and show that caveolae respond to mechanical stimulation. We show that Cav-1-deficient (Cav-1
−/−
) mice display ocular hypertension explained by reduced pressure-dependent drainage of aqueous humor. Cav-1 deficiency results in loss of caveolae in the Schlemm’s canal (SC) and trabecular meshwork. However, their absence did not appear to impact development nor adult form of the conventional outflow tissues according to rigorous quantitative ultrastructural analyses, but did affect cell and tissue behavior. Thus, when IOP is experimentally elevated, cells of the Cav-1
−/−
outflow tissues are more susceptible to plasma membrane rupture indicating that caveolae play a role in mechanoprotection. Additionally, aqueous drainage from Cav-1
−/−
eyes was more sensitive to nitric oxide (NO) synthase inhibition than controls, suggesting that excess NO partially compensates for outflow pathway dysfunction. These results provide a functional link between a glaucoma risk gene and glaucoma-relevant pathophysiology.
Journal Article
Reforms Needed to Modernize the US Food and Drug Administration’s Oversight of Dietary Supplements, Cosmetics, and Diagnostic Tests
by
McClellan, Mark B.
,
Gottlieb, Scott
in
Cosmetics
,
Diagnostic Tests, Routine
,
Dietary supplements
2022
This JAMA Forum discusses long-awaited reforms that could modernize the US Food and Drug Administration’s regulatory processes, promote innovation, and provide US consumers greater assurance that the products they use are safe and reliable.
Journal Article