Regulatory Updates

 

 

Letters, Statements, and Analysis

See All Letters, Statements, & Analysis
The United States Capitol Building

Protecting Pharmacies in Medicaid Act Summary

The Protecting Pharmacies in Medicaid Act would prohibit the use of spread pricing arrangements in Medicaid programs. Pharmacy benefit managers (PBMs) would be required to pass through to pharmacies the full amount of the money paid to the PBMs by Medicaid programs, except for a fixed administrative fee. The total reimbursement amount will be determined by a survey of national average drug acquisition costs administered by the Department of Health & Human Services.
Legislation & Regulation
Pharmacist and Access to Medicines - MVP Act

AMCP Comment Letter on Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway

In AMCP's latest comments to the FDA, we emphasize the need for standardized public reporting of confirmatory trial progress, ensuring payers and health care providers have the necessary data to make informed coverage decisions. By supporting proactive communication and rigorous confirmatory trials, AMCP aims to balance early access to innovative treatments with patient safety and long-term therapeutic value.
Quality of Care, Legislation & Regulation, Coverage Parity, Drug Utilization Review (DUR)