Billy Wynne

Agency Releases Final Guidance for IPAY 2028 of the Medicare Drug Price Negotiation Program and Effectuation of Maximum Fair Price in 2026-2028; Implements H.R. 1 Orphan Drug Exclusion Expansion The Centers for Medicare and Medicaid Services released final guidance for initial price applicability year (IPAY) 2028 of the Medicare Drug Price Negotiation Program and effectuation…

President Trump Secures First Most-Favored-Nation Agreement with Pfizer, Announces TrumRx DTC Platform Today, President Trump announced the administration’s first Most-Favored-Nation (MFN) agreement with Pfizer to bring drug prices in line with the lowest paid by other developed nations (MFN pricing) (press conference). The agreement features the following: Providing every state Medicaid program access to MFN…

Agency Announces Updates to Civil Money Penalty Reinvestment Program (CMPRP) On Friday, the Centers for Medicare & Medicaid (CMS) announced it is restructuring the Civil Money Penalty Reinvestment Program (CMPRP) to expand funding opportunities for projects that strengthen quality of care in nursing homes, with a particular emphasis on workforce development, behavioral health, and resident-centered…

White House Sets 2027 R&D Priorities with Strong Focus on AI, Health, and Biotechnology; NIST’s CHIPS R&D Office Launches Funding Opportunity to Drive U.S. Leadership in Microelectronics, AI, and Biotech The White House’s Office of Management and Budget (OMB) and Office of Science and Technology Policy (OSTP) released a fiscal year (FY) 2027 memorandum outlining…

Medicare Advantage and Part D Premiums to Remain Stable in 2026; Agency Details New Features to Help Simplify Plan Selection for Medicare Open Enrollment The Centers for Medicare and Medicaid Services (CMS) released the average premiums and plans choices for Medicare Advantage (MA) and the Medicare Part D prescription drug program. This follows CMS’s previous…

Nutrition Policy Updates: Food Insecurity Survey, MAHA Advisor, and SNAP Retail Rule The Department of Agriculture (USDA) Food and Nutrition Service (FNS) announced several updates to its nutrition programming. While the addition of Dr. Ben Carson as an advisor and the proposed rule on retailer stocking standards in the Supplemental Nutrition Assistance Program (SNAP) promote the…

OSTP Issues RFI Seeking Public Input to Identify Federal AI Regulations the May Hinder Innovation; Comments Due Oct. 26 The White House Office of Science and Technology Policy (OSTP) issued a Request for Information (RFI) to gather public input on identifying outdated or overly restrictive federal statutes, regulations, and administrative processes that hinder the development,…

Trump Administration Takes Actions to Bolster Cell and Gene Therapy Development and Manufacturing The Advanced Research Projects Agency for Health (ARPA-H) announced the launch of two new programs (here and here) to advance the development and manufacturing of cell and gene medicines. Additionally, the Food and Drug Administration (FDA) issued draft guidance on innovative clinical…

Agency Examines the Effects of Physician Consolidation on Spending, Quality, and Access The Government Accountability Office (GAO) released a report examining physician consolidation in the United States, a trend that has raised concerns about reduced competition and higher costs for patients, employers, insurers, and federal health programs. This study, requested in House Report 117-403, reviews…

Trump Administration Imposes $100K Fee, Reshapes H-1B Program; Comments on NPRM Due Oct. 24 On September 19, 2025, President Trump signed a proclamation restricting the entry of certain H-1B nonimmigrant workers by imposing a $100,000 fee on all new H-1B visa petitions, citing systemic abuse of the visa program (fact sheet). The administration’s reasoning centered on evidence that…