The Food and Drug Administration (FDA) announced the Rare Disease Framework Initiative to develop a more consistent, flexible and tailored approach to reviewing drugs and biologics for rare diseases. The initiative seeks to align regulatory expectations with the realities of rare disease development, including small patient populations, limited understanding of disease progression and challenges generating traditional clinical trial evidence. According… (Colocho, October 14, 2026) #Food and Drug Administration, #Prescription Drugs

Today, the Centers for Medicare and Medicaid Services (CMS) final rule restricting federal Medicaid and Children’s Health Insurance Program (CHIP) funding for gender-affirming care took effect. The rule prohibits federal Medicaid matching funds from covering specified gender-affirming services, including puberty blockers, hormone therapy, and surgical interventions, for Medicaid enrollees under age 18 and CHIP enrollees under age 19 when provided… (Eisen, October 13, 2026) #Health Equity

The White House announced more than $6 billion in federal, industry, academic, and philanthropic investments and commitments during its Science: A New Golden Age Summit. The initiatives focus on expanding access to artificial intelligence (AI), referred to by the administration as super intelligence (SI), for scientific research; supporting early-career scientists; advancing national research priorities; and developing new research institutions and… (Colocho, October 9, 2026) #Artificial Intelligence, #Grants, #Health Information Technology, #Workforce

The Medicare Payment Advisory Commission (MedPAC) convened a session to discuss the workplan to assess the accuracy of the skilled nursing facility (SNF) and home health prospective payment systems (PPS). The Commission plans to examine payment accuracy, potential patient selection as a result of financial incentives, and the relationship between providers’ coding practices and Medicare payment.   Staff Presentation  … (McClurg, October 9, 2026) #Home Health, #Skilled Nursing Facilities

The Centers for Medicare and Medicaid Services (CMS) announced the 2027 Medicare Advantage (MA) and Part D Star Ratings, which measure the quality of health and prescription drug services received by Medicare beneficiaries. What is it. The Star Ratings are intended to help individuals with Medicare and their caregivers compare the quality of Medicare health and prescription drug plans, alongside… (Slifer, October 8, 2026) #Medicare Advantage, #Medicare Part D, #Quality

The Medicare Payment Advisory Commission (MedPAC) convened an educational session on payment accuracy under the Medicare Physician Fee Schedule (PFS) and Clinical Laboratory Fee Schedule (CLFS). Staff reviewed opportunities to better align payment with services furnished and resource costs, focusing on global surgical services, “incident to” billing, telehealth, and clinical labs. The presentation was not intended to inform a published… (Testa, October 8, 2026) #Costs, #Mid-Level Practitioners, #Physicians, #Program Integrity, #Telehealth

The Centers for Medicare & Medicaid Services (CMS) issued guidance to State Medicaid Directors on adding a new state option for Certified Community Behavioral Health Clinic (CCBHC) services that was authorized by the Consolidated Appropriations Act of 2024 (CAA, 2024). CCBHCs provide community-based substance use disorder treatment and mental health services to all, independent of ability to pay. Funding for… (Marceno, October 7, 2026) #Demonstration Programs, #Insurance Coverage, #Mental and Behavioral Health

The Government Accountability Office (GAO) released a report examining how vertical integration among Medicare Part D plan sponsors, pharmacy benefit managers (PBMs), and pharmacies affects prescription drug utilization, payments, and beneficiary costs. GAO analyzed 2023 Medicare Part D data for four large, vertically integrated plan sponsors and found that their owned pharmacies, which primarily dispensed prescriptions through mail order, accounted… (Eisen, October 5, 2026) #Medicare Part D

The Food and Drug Administration (FDA) issued a request for information (RFI) seeking input on the design and safety of early-phase clinical trials of ibogaine, a psychedelic compound being studied for potential treatment of substance use and other mental health conditions (press release). FDA is considering approaches to patient selection, dosing and dose escalation, clinical settings, cardiac and neurologic safety… (Colocho, October 5, 2026) #Food and Drug Administration, #Mental and Behavioral Health

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently issued guidance for state Medicaid programs that clarifies when the regulation establishing Confidentiality of Substance Use Disorder (SUD) Patient Records under 42 CFR part 2 (“Part 2”) would allow an agency to use protected SUD patient records to verify an exclusion from Medicaid work requirements…. (Marceno, October 2, 2026) #Insurance Coverage, #Mental and Behavioral Health, #Public Health