March-in authority allows the federal government to grant licenses on privately owned patents for inventions developed with federal funding provided certain statutory requirements are met. It was designed to ensure that the benefits of the American taxpayers’ investment in research and development are reasonably accessible to the public.
Prescription Drugs
Reports
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An Examination of March-in Rights and Drug Products with Government-Interest Patents
Report
Estimating the Effects of the Medicare $2 Drug List on Part D Enrollees
The Centers for Medicare & Medicaid Services (CMS) Innovation Center is in the process of developing the Medicare $2 Drug List (M2DL) Model. This would allow Part D plan sponsors to offer a standardized list of generic drugs for a copayment of $2 or less for a month’s supply that would not be subject to prior authorization, quantity limits, or other utilization management restrictions.
ASPE Issue Brief
Characteristics of Part D Drugs in Shortage
In this Report, we matched a sample of Part D drugs and biological products that had price changes between January 2011 and October 2023 to FDA’s January 2023 list of drug shortages database. Then we analyzed price changes that occurred before and after the shortage, overall and by select drug characteristics of interest.
ASPE Issue Brief
Characteristics of Part B Drugs in Shortage
In this Report, we matched a sample of Part B drugs and biological products that had price changes between January 2011 and October 2023 with the FDA’s January 2023 list of drug shortages database. Then we analyzed price changes that occurred before and after the shortage, overall and by select drug characteristics of interest.
ASPE Issue Brief
Medicare Coverage of Anti-Obesity Medications
In November 2024, the Centers for Medicare & Medicaid Services (CMS) released the Medicare Program; Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly proposed rule.
Buprenorphine Dispensing Among Women of Reproductive Age in the U.S. by Provider Type, 2013-2022 Data Brief
This study of national retail pharmacy data from 2013 to 2022, found an overall increase in buprenorphine dispensed to women of reproductive age and a marked increase in fills that were prescribed by nurse practitioners/physician assistants.
ASPE Issue Brief
Medicare Part D Enrollees Reaching the Out-of-Pocket Limit by June 2024
The Inflation Reduction Act established a limit on out-of-pocket spending (“the 2024 cap”) for enrollees with very high prescription drug spending in Medicare Part D, for the first time in the history of the program.
Report
Impact of Climate Change on Health and Drug Demand
It is anticipated that extreme weather events due to climate change will increase the prevalence of a number of acute and chronic diseases. As a result, the demand for drugs to prevent or treat those conditions is likely to increase.
Research Summary
FDA Breakthrough Therapy Designation Reduced Late-Stage Drug Development Time
This landing page presents the abstract of a paper published in Health Affairs. The full text of the article is available at: https://www.healthaffairs.org/doi/abs/10.1377/hlthaff.2023.00837.
ASPE Issue Brief
Medicare Drug Price Negotiation Program: Medicare Prices Negotiated for 2026 Compared to List and U.S. Market Prices
The Inflation Reduction Act (IRA) makes improvements to Medicare to increase accessibility and affordability of prescription drugs for Medicare enrollees, reduce the rate of growth in Medicare drug spending, and improve the financial sustainability of the Medicare program.