Legislation & Regulation

Discover essential legislative and regulatory resources tailored for managed care pharmacy professionals. Stay informed with the latest updates, policies, and advocacy tools to effectively navigate and influence the health care landscape.

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AMCP Regulatory NewsBreaks

HSS Issues Updates to the Final Rule on HIPAA, NCPDP Standards, and the Medicaid Pharmacy Subrogation Standard

On August 20, 2025, the U.S. Department of Health and Human Services (HHS) issued updates (the Interim Final Rule) which amends the final rule titled “Administrative Simplification: Modifications of Health Insurance Portability and Accountability Act of 1996 (HIPAA) National Council for Prescription Drug Programs (NCPDP) Retail Pharmacy Standards; and Modification of the Medicaid Pharmacy Subrogation Standard,” (the December 2024 Final Rule).
Legislation & Regulation
White House

H.R.1 Implementation Timeline

President Trump signed H.R.1, Republicans’ “big, beautiful” reconciliation bill, into law on July 4, 2025. Starting from that date, the law lays out effective dates and implementation dates for its numerous health provisions over the next few years, and beyond.
One Big Beautiful Bill, Legislation & Regulation
Pharmacists in Lab

AMCP Comment Letter on Medicare Drug Price Negotiation Program Draft Guidance

As CMS explores strategies to increase the adoption of digital health tools, AMCP urges CMS to support broader coverage of prescription digital therapeutics (PDTs) under Medicare and Medicaid. PDTs represent an emerging class of software-based treatments that deliver clinically validated therapeutic benefits, either independently or in combination with other interventions. These products can play a transformative role in improving access, especially for patients with behavioral health conditions or chronic diseases.
Quality of Care, Legislation & Regulation, Coverage Parity, Drug Utilization Review (DUR)