Billy Wynne

President Trump Announces Second Most-Favored-Nation Agreement with AstraZeneca Earlier this evening, President Trump announced the administration’s second Most-Favored-Nation (MFN) agreement with AstraZeneca to bring drug prices in line with the lowest paid by other developed nations (MFN pricing). The agreement mirrors that of Pfizer’s that was announced at the end of September (Impact summary) features the following: Providing every…

Committee Examines Promise and Risks of Artificial Intelligence in Health Care; Sen. Cassidy Proposes Using AI to Regulate AI The Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing to explore how artificial intelligence (AI) can improve patient care, accelerate drug discovery, reduce administrative burdens, and cut costs, while also examining the ethical,…

Agency Report Finds Medicare Advantage and Medicaid Managed Care Plans Have Limited Behavioral Health Provider Networks The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) conducted a review of Medicare and Medicaid provider networks to assess the usefulness and limitations of selected plan networks, and to review compliance with network…

House Democrats Press CMS on Telehealth and Hospital-at-Home Guidance Today, Frank Pallone (D-NJ), Ranking Member of the Committee on Energy and Commerce and Richard Neal (D-MA), Ranking Member of the Committee on Ways and Means, sent a letter to HHS Secretary Kennedy and CMS Administrator Oz criticizing CMS for failing to provide timely and clear…

Ranking Member Sanders Warns of Massive Coverage Losses, Premium Spikes, and Health System Instability Under H.R. 1 Yesterday, Sen. Bernie Sanders (I-VT), Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a report warning of the projected impact of health care cuts in H.R. 1 (press release; report). Last week, Ranking…

Agency Seeks Public Input on Measuring and Evaluating Real-World Performance of AI-Enabled Medical Devices; Comments Due December 1 The Food and Drug Administration (FDA) issued a Request for Public Comment (RFC) to gather input on how AI-enabled medical devices perform in clinical settings after deployment. The agency notes that the RFC is for discussion purposes…

Agency Approves New Generic Version of Mifepristone Amid Federal Scrutiny This week, the Food and Drug Administration (FDA) approved another generic version of mifepristone, one of the two drugs used in medication abortion. With this approval, three U.S. companies are now authorized to manufacture the medication: Danco Laboratories, which first received FDA approval in 2000;…

Sen. Peters Urges DOGE Shutdown After Investigation Into Violation of Federal Privacy and Security Laws Sen. Gary Peters (D-MI), Ranking Member of the Senate Homeland Security and Governmental Affairs Committee, released a report revealing that the Department of Government Efficiency (DOGE) is operating outside federal law with unchecked access to Americans’ personal data. The investigation,…

Federal Proposal Could Reopen New DACA Applications with Restrictions for Texas Residents; Case on Hold During Shutdown The Trump administration has outlined a proposal that, if approved by a federal judge, would allow immigration officials to resume processing new applications for Deferred Action for Childhood Arrivals (DACA) after a four-year pause. The plan was filed…

Agency Memo Clarifies Survey & Certification Operations Amid Shutdown Today, the CMS Center for Clinical Standards and Quality released a memo (QSO-26-01-ALL) outlining which survey and certification functions will continue during the federal government shutdown, which will pause, and how state agencies and contractors should proceed. The agency emphasized that protecting beneficiaries from immediate harm…