On January 25, 2019, AMCP provided comments to CMS in response to the proposed rule on Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses. AMCP offered comments on the following CMS proposals; Providing Plan Flexibility to Manage Protected Classes; Prohibition Against Gag Clauses in Pharmacy Contracts; E-Prescribing and the Part D Prescription Drug Program; Updating Part D E-Prescribing Standards; Part D Explanation of Benefits; and Medicare Advantage and Step Therapy for Part B Drugs.
On December 31, 2018, AMCP provided comments to CMS on its Advanced Notice of Public Rulemaking (ANPRM) for a potential International Pricing Index (IPI) Model for Medicare Part B Drugs. The potential model would be phased in over a five-year period starting in Spring 2020 and will be tested as a pilot program through CMMI. It also seeks to reform the current “buy and bill” system for Part B drugs and alter reimbursement methodology. AMCP shared its concerns that elements outlined in the ANPRM need further consideration to ensure that they are sustainable solutions for decreasing medication costs before making substantial changes to existing programs.
On Dec 12, 2018, FDA issued a new proposal to amend its regulation that defines “biological product” to incorporate changes made by the Biologics Price Competition Act of 2009 (BPCI Act). The BPCI Act amended the definition of biological product to include a “protein (except any chemically synthesized polypeptide.” To clarify these terms, FDA is proposing to provide its interpretation of the terms “protein” and “chemically synthesized polypeptide" to reduce regulatory uncertainty over what products are regulated as drugs or biological products.