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Articles 1 - 9 of 9
Full-Text Articles in Law
Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs
Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs
Articles
Throughout the United States, escalating drug prices are putting immense pressure on state budgets. Several states are looking for ways to push back. Last year, Massachusetts asked the Trump administration for a waiver that would, among other things, allow its Medicaid program to decline to cover costly drugs for which there is limited or inadequate evidence of clinical efficacy. By credibly threatening to exclude such drugs from coverage, Massachusetts hoped to extract price concessions and constrain the fastest-growing part of its Medicaid budget.
Drug Approval In A Learning Health System, W. Nicholson Price
Drug Approval In A Learning Health System, W. Nicholson Price
Articles
The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to learn how well they work and how safe they are. This is hard to do. FDA has its own surveillance systems, but those systems face substantial limitations in practical use. Drug companies can also conduct their own studies, but have little incentive to do so, and often fail to fulfil study commitments made to FDA. Proposals to improve this dynamic often suggest gathering more …
Reform At Risk — Mandating Participation In Alternative Payment Plans, Scott Levy, Nicholas Bagley, Rahul Rajkumar
Reform At Risk — Mandating Participation In Alternative Payment Plans, Scott Levy, Nicholas Bagley, Rahul Rajkumar
Articles
In an ambitious effort to slow the growth of health care costs, the Affordable Care Act created the Center for Medicare and Medicaid Innovation (CMMI) and armed it with broad authority to test new approaches to reimbursement for health care (payment models) and delivery-system reforms. CMMI was meant to be the government’s innovation laboratory for health care: an entity with the independence to break with past practices and the power to experiment with bold new approaches. Over the past year, however, the Department of Health and Human Services (HHS) has quietly hobbled CMMI, imperiling its ability to generate meaningful data …
Are Medicaid Work Requirements Legal?, Nicholas Bagley
Are Medicaid Work Requirements Legal?, Nicholas Bagley
Articles
On January 12, 2018, the Centers for Medicare & Medicaid Services (CMS) approved a waiver allowing Kentucky to impose a work requirement on some nondisabled Medicaid beneficiaries. Similar waivers are sure to follow. Supporters see work requirements as a spur to force the idle poor to work; opponents see the requirements as a covert means of withholding medical care from vulnerable people. Setting the policy debate aside, however, are work requirements legal?
Innovative Contracting For Pharmaceuticals And Medicaid’S Best-Price Rule, Nicholas Bagley
Innovative Contracting For Pharmaceuticals And Medicaid’S Best-Price Rule, Nicholas Bagley
Articles
In recent years, drug manufacturers and private payers have expressed interest in novel pricing models that more closely link a drug’s price to its value. Indication-based pricing, outcome-based pricing, drug licenses, and drug mortgages have all been discussed as alternatives to paying strictly for volume. Manufacturers and payers have complained, however, that Medicaid’s “best-price rule” inhibits their ability to enter into these newpricing arrangements. This article examines the best-price rule and assesses to what extent, if any, it might frustrate the goal of paying for value. We conclude that the best-price rule is not as serious a problem as it …
Big Data: Destroyer Of Informed Consent, A. Michael Froomkin
Big Data: Destroyer Of Informed Consent, A. Michael Froomkin
Articles
The 'Revised Common Rule' took effect on January 21, 2019, marking the first change since 2005 to the federal regulation that governs human subjects research conducted with federal support or in federally supported institutions. The Common Rule had required informed consent before researchers could collect and use identifiable personal health information. While informed consent is far from perfect, it is and was the gold standard for data collection and use policies; the standard in the old Common Rule served an important function as the exemplar for data collection in other contexts. Unfortunately, true informed consent seems incompatible with modern analytics …
Strategic Litigation To Advance Public Health, Tamar Ezer, Priti Patil
Strategic Litigation To Advance Public Health, Tamar Ezer, Priti Patil
Articles
The HIV movement has relied on strategic litigation as an important tool to develop and enforce legal protections critical to health. This experience contains lessons on the potential of strategic litigation to advance public health more generally. Beyond impacting laws and policies, strategic litigation can change practice, breathing life into existing legal rules never implemented. While cases may target a particular law, policy, or practice, indirect impacts beyond a particular court decision on future cases, other branches of government, and the public record may be just as important. Each case is only one step towards change, and a judgment can …
Bundling Justice: Medicaid's Support For Housing, Mary Crossley
Bundling Justice: Medicaid's Support For Housing, Mary Crossley
Articles
Achieving safe and stable housing presents a profound and ongoing challenge for many people living in poverty. The challenges include housing that is substandard or unaffordable and continuing risks of eviction. For a growing number, these challenges prove too much, and they become homeless. In addition, housing-related challenges that are part of daily life for many poor people can influence their physical and mental health. Increased attention to the health impacts of inadequate, insecure, and unaffordable housing has prompted some – including public health experts, physicians, and sociologists studying housing – to urge that housing issues, and homelessness in particular, …
The Broken Medicare Appeals System: Failed Regulatory Solutions And The Promise Of Federal Litigation, Greer Donley
The Broken Medicare Appeals System: Failed Regulatory Solutions And The Promise Of Federal Litigation, Greer Donley
Articles
The Medicare Appeals System is broken. For years, the System has been unable to accommodate a growing number of appeals. The result is a backlog so large that even if no new appeals were filed, it would take the System a decade or more to empty. Healthcare providers wait many years for their appeals to be heard before an Administrative Law Judge (ALJ), and because the government recoups providers' Medicare payments while they wait, the delays cause them serious financial harm. Even worse, providers are more likely than not to prevail before the ALJ, proving that the payment should never …