A coalition of 34 scientific and medical organizations led by the American Association of Immunologists and the American College of Physicians released the following statement.
AMCP Summary of Medicare Part D Rebate Rule
On November 20, HHS released a Final Rule that amends the discount safe harbor regulation to eliminate protections for price concessions offered by pharmaceutical manufacturers to plan sponsors and pharmacy benefit managers (PBMs) under contract with plan sponsors starting January 1, 2022.
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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.
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.
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