ASPE Issue Brief

The U.S. has a number of policies related to drug pricing, affordability, and availability. To encourage manufacturers to innovate with new therapies, patent policy rewards the creation of new branded medicines. As those patents come to an end, generic drug manufacturers may enter a market and seek to sell their products at lower prices than the competing brand drugs.

To understand the size and impact of costs to clinical trial participants, the Office of the Assistant Secretary for Planning and Evaluation (ASPE) conducted an exploratory survey of 112 U.S. adults who participated in an oncology clinical trial between 2018-2024.

We evaluated both the Center for Medicare and Medicaid Services Innovation Center (CMS Innovation Center) models and the Medicare Shared Savings Program (MSSP) and found that they have generated gross savings for all beneficiaries in the Traditional Medicare program while demonstrating positive impacts on selected quality measures.

Biosimilars provide competition for biologics, which account for a significant and growing portion of Medicare Part B drug spending. This report evaluates the current state of biosimilar competition in Medicare Part B and explores opportunities to achieve further savings.

The National Guidelines for Behavioral Health Crisis Care from the Substance Abuse and Mental Health Services Administration (SAMHSA) call for a sustainable infrastructure to respond to behavioral health crises, through crisis services that are accessible to anyone, anywhere, at any time.

Interviews were held with key informants from harm reduction organizations or similar programs from across the United States, to better understand how they are responding to the presence of xylazine in their communities. All participants noted an increase in xylazine prevalence in their communities, ranging from a years-long problem to first being identified in early 2023.

To improve Medicare provider and supplier enrollment data transparency, in 2023, the Centers for Medicare & Medicaid Services publicly released detailed ownership data, including data on change of ownership transactions, for Medicare-enrolled hospices. This brief presents a descriptive analysis of hospice agency changes of ownership nationally between 2018 and 2022.

The Inflation Reduction Act includes many provisions that aim to reduce out-of-pocket spending for prescription drugs covered under Medicare Part D. In 2024, cost-sharing in the final phase of the Part D benefit, the catastrophic coverage phase, was eliminated.

Over one million Americans rely on nursing homes for care, yet nursing homes face challenges in recruiting and retaining staff. Nursing homes rely on registered nurses (RNs), licensed practical nurses (LPNs), and nursing assistants (NAs) to provide care, but staff shortages that increased during the COVID-19 pandemic have persisted.

The ASPE issue brief examines the research and development cost and duration associated with bringing novel vaccines to the U.S. market. The results indicate that bringing a novel vaccine to the U.S. market costs an estimated $886.8 million on average, and its development process lasts 10 years.