RECENT UPDATES
Agency Launches Rare Disease Framework Initiative to Modernize Drug Development and Regulatory Review; Public Meeting on Oct. 28 and RFI to Follow
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
CMS Gender-Affirming Care Federal Funding Restrictions Take Effect as States Work to Preserve Coverage
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
Administration Announces More Than $6 Billion in Science Initiatives at Golden Age Summit
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
Commissioners Consider Workplan on SNF and Home Health Payment Accuracy
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
2027 MA and Part D Star Ratings Announced
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
Commission Reviews Issues Affecting Payment Accuracy of the Physician Fee Schedule and Clinical Laboratory Fee Schedule
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
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