Billy Wynne

Agency Policy Roundup: Leadership Upheaval, AI Modernization, Gene Editing Oversight, and New Regulatory Initiatives

By Billy Wynne / May 12, 2026

The Food and Drug Administration (FDA) entered another period of uncertainty this week following the resignation of Commissioner Marty Makary after just 13 months leading…

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Reproductive Health Roundup: Supreme Court Temporarily Preserves Access to Mifepristone as FDA Leadership Shakeup Creates Opening for Stricter Oversight of FDA Mifepristone Review

By Billy Wynne / May 12, 2026

This week brought major developments related to medication abortion access and federal reproductive health policy. For now, the Supreme Court has temporarily preserved nationwide access…

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Excepted Fertility Benefits Proposed Rule

By Billy Wynne / May 11, 2026

The Departments of Labor, Health and Human Services, and Treasury (Departments) announced a proposed rule to allow employers to provide standalone fertility benefits (press release;…

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Commissioners Finalize Recommendations on Work Requirements, Children and Youth with Special Health Care Needs Transitioning to Adult Coverage, and the Role of Medicaid Agencies in PACE

By Billy Wynne / May 8, 2026

The Medicaid and CHIP Payment and Access Commission (MACPAC) met to vote on previously considered recommendations for the June Report to Congress. The commission advanced…

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Commissioners Finalize Recommendations to Improve Use of Automation in Prior Authorization for State Medicaid Programs

By Billy Wynne / May 8, 2026

The Medicaid and CHIP Payment and Access Commission (MACPAC) convened a session to discuss draft recommendations to oversee the use of automation in the prior authorization (PA) process…

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ARPA-H Launches AI-Enabled “IGoR” Program to Transform Biomedical Research; Solution Summaries Due June 25 and Full Proposals Due August 6

By Billy Wynne / May 7, 2026

The Advanced Research Projects Agency for Health (ARPA-H), through the Department of Health and Human Services (HHS), announced the Intelligent Generator of Research (IGoR), a…

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Department Delays Compliance Deadlines for Disability Accessibility Requirements for Websites and Mobile Applications; Signals Future Revisions to Disability Nondiscrimination Framework

By Billy Wynne / May 7, 2026

The Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) released an interim final rule (IFR) entitled “Extension of Compliance Dates for…

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Sen. Cassidy Holds Field Hearing in Louisiana Examining Health Care Affordability Ahead of Senate Primary

By Billy Wynne / May 6, 2026

Yesterday, Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Bill Cassidy (R-LA) convened a field hearing in Baton Rouge, LA, to examine drivers of…

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Administration Releases Analysis of Savings from Most-Favored-Nation Drug Pricing Policy; Estimates $529 Billion in Savings Over 10 Years

By Billy Wynne / May 5, 2026

The White House released an analysis of the Administration’s Most-Favored-Nation (MFN) drug pricing policy, prepared by administration officials for the Council of Economic Advisers. The…

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LEAD Model Clarifications from Alignment and Financial Methodology Office Hour

By Billy Wynne / May 5, 2026

Today, the Center for Medicare & Medicaid Innovation (CMMI/Innovation Center) held an office hour on the LEAD (Long-term Enhanced ACO Design) Model, providing additional detail on…

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