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

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 of maximum fair prices (MFPs) in IPAYs 2026, 2027, and 2028 (press release, fact sheet). What is it. The draft guidance described how CMS will implement the Negotiation Program for IPAY 2028 and included… (Slifer, September 30, 2025) #Drug Pricing, #Medicare Part D, #Prescription Drugs

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President Trump Secures First Most-Favored-Nation Agreement with Pfizer, Announces TrumRx DTC Platform

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 prices on all Pfizer products; Ensuring that foreign nations can no loner use price controls to “freeride… (Slifer, September 30, 2025) #Drug Pricing, #Prescription Drugs

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Agency Announces Updates to Civil Money Penalty Reinvestment Program (CMPRP)

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 technology. The changes raise funding caps, standardize applications, and increase transparency, but also require clearer… (Testa, September 29, 2025) #Mental and Behavioral Health, #Quality, #Skilled Nursing Facilities, #Workforce

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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

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 federal research and development (R&D) priorities for federal agencies. The memo aims to realign government-funded science and technology investments toward mission-driven, “Gold Standard Science” that directly advances U.S. economic growth, national security, and global competitiveness…. (Colocho, September 29, 2025) #Health Information Technology

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Medicare Advantage and Part D Premiums to Remain Stable in 2026; Agency Details New Features to Help Simplify Plan Selection for Medicare Open Enrollment

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 announcement of the 2026 Part D base beneficiary premiums and Part D Premium Stabilization Parameters. Additional details follow for each program. Medicare Advantage – CMS details that the average… (Colocho, September 26, 2025) #Medicare Advantage, #Medicare Part D

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Nutrition Policy Updates: Food Insecurity Survey, MAHA Advisor, and SNAP Retail Rule

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 Administration’s emphasis on expanding access to and consumption of healthy foods, the termination of the food insecurity… (McClurg, September 26, 2025) #Nutrition

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OSTP Issues RFI Seeking Public Input to Identify Federal AI Regulations the May Hinder Innovation; Comments Due Oct. 26

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, deployment, and adoption of artificial intelligence (AI) technologies in the United States. This effort supports directives from the White House’s AI Action Plan, which… (Colocho, September 25, 2025) #Health Information Technology, #Privacy, #Transparency

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Trump Administration Takes Actions to Bolster Cell and Gene Therapy Development and Manufacturing

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 trial designs for cell and gene therapies in small populations. Additional information on each development follows. The Treating… (Slifer, September 25, 2025) #Food and Drug Administration, #Prescription Drugs

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Agency Examines the Effects of Physician Consolidation on Spending, Quality, and Access

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 existing research on the extent of physician consolidation and its potential effects on health care spending, prices,… (Eisen, September 23, 2025) #Costs, #Physicians, #Quality

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Trump Administration Imposes $100K Fee, Reshapes H-1B Program; Comments on NPRM Due Oct. 24

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 H-1B visas, initially designed to fill labor shortages with highly skilled foreign workers, have increasingly been used by IT… (Testa, Colocho, September 23, 2025) #Workforce

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