Ranking Member Sanders Warns of Massive Coverage Losses, Premium Spikes, and Health System Instability Under H.R. 1
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 Member Sanders invited people across the country to share how cuts to Medicaid and the Affordable Care Act (ACA) would affect them,… (Eisen, October 7, 2025) #Affordable Care Act, #Budget, #Costs, #Insurance Coverage
Agency Seeks Public Input on Measuring and Evaluating Real-World Performance of AI-Enabled Medical Devices; Comments Due December 1
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 only and is not intended to set policy or guidance, but rather seeks early feedback from the public to inform future FDA discussions… (Colocho, October 7, 2025) #Artificial Intelligence, #Health Information Technology, #Medical Devices, #Transparency
Agency Approves New Generic Version of Mifepristone Amid Federal Scrutiny
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; GenBioPro, which secured approval of the first generic in 2019; and now Evita Solutions. The… (Eisen, October 3, 2025) #Generic Drugs, #Women’s Health
Sen. Peters Urges DOGE Shutdown After Investigation Into Violation of Federal Privacy and Security Laws
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, backed by whistleblower accounts across the Social Security Administration (SSA), the General Services Administration (GSA), and the Office of Personnel… (Colocho, October 3, 2025) #Health Information Technology, #Privacy, #Transparency
Federal Proposal Could Reopen New DACA Applications with Restrictions for Texas Residents; Case on Hold During Shutdown
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 late Monday by the Department of Justice (DOJ) in federal court in Brownsville, Texas, as part of a long-running lawsuit led by… (Colocho, October 2, 2025) #Health Equity
Agency Memo Clarifies Survey & Certification Operations Amid Shutdown
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 remains the top priority. Enforcement and immediate jeopardy investigations will continue, but routine surveys… (Testa, October 1, 2025) #Clinical Labs, #Grants, #Hospice, #Quality
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
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
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
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