The Latest in Regulatory and Reimbursement

The Department of Health and Human Services is undergoing a large-scale reorganization. The FDA has announced a phase-out of animal testing requirements and a new policy for its advisory committee members. President Trump has signed a drug pricing Executive Order. CMS has released its FY 2026 IPPS proposed rule and issued a final rule modernizing the Medicare Advantage and the Medicare Part D.

New HHS Reorganization 

The HHS reorganization would consolidate 28 divisions into 15 and merge OASH, HRSA, SAMHSA, ATSDR and NIOSH to create the Administration for a Healthy America focused on chronic disease. 

FDA Animal Testing Phase Out

FDA’s animal testing requirement is being phased out for monoclonal antibodies and replaced with New Approach Methodologies, such as AI-based computational models and human-based lab models.

New FDA Advisory Committee Policy Announced

FDA Commissioner Makary announced a new policy directive that limits individuals employed at FDA-regulated companies from serving as official members on FDA advisory committees.

President Trump Signed Drug Pricing Executive Order

The Executive Order directs federal agency leaders to fix the IRA’s “pill penalty,” propose regulation to improve PBM fee transparency, accelerate the approval of generics and more.

FY 2026 IPPS Proposed Rule Released

CMS’s proposed Inpatient Prospective Payment System (IPPS) rule includes changes to IPPS payment rates and the proposed cost thresholds by MS-DRG for the cost criteria for new technology add-on payments.

CMS Final Rule Modernizes Medicare Advantage & Part D

The rule finalizes Medicare Part D provisions such as an automatic election renewal process that extends a Part D enrollee’s participation in the program for the next calendar year, unless the enrollee opts out.

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