Legislation & Regulation

Read about the widespread support for this important legislation that will increase competition and decrease patients' drug costs.

Press Release: AMCP CEO Susan A. Cantrell, RPh, CAE, issued the following statement on HHS’s proposed rule to eliminate negotiated rebates for pharmaceuticals under Medicare Part D and managed Medicaid programs.

On January 31, 2019, HHS proposed sweeping changes to the current system for medication pricing and contracting by PBM companies in federal programs. This summary reviews OIG's proposal to eliminate the safe harbor protections for rebates that exist in the federal Anti-Kickback Statute (AKS) and replace these protections with proposed new safe harbors allowing for point-of-sale discounts to beneficiaries and for manufacturer-paid service fees to PBMs.

On January 30, 2019, CMS issued its draft Part D Payment Policies and 2020 Draft Call Letter. The draft Call Letter outlines payment amounts for beneficiary cost sharing, risk corridors for Part C and Part D plans, and beneficiary payments for calendar year 2020. Many of the draft provisions for the 2020 plan year revolve around opioids and CMS’s effort to ensure beneficiaries are receiving appropriate pain management therapy. CMS also proposes numerous updates, changes and potential new measure concepts for the Star Ratings Program. CMS is also considering changing policies and is accepting comments relating to its tier composition policy for generics and specialty medications in Part D.

On January 25, 2019, AMCP provided comments to CMS in response to its proposed rule on lowering drug prices and reducing out-of-pocket expenses in the Medicare program. The letter outlines the proposal’s impact on providing plan flexibility to manage protected classes, prohibition against gag clauses in pharmacy contracts, E-Prescribing and the Part D Prescription Drug Program, Part D explanation of benefits, and Medicare Advantage and step therapy in Part B.

Press Release: The prevalence of those diagnosed with opioid-related disorders in the Medicare fee-for-service (FFS) population is higher than among any other studied payer groups, and the majority of disorders were found among those receiving Medicare based on disability.

The Academy of Managed Care Pharmacy (AMCP) thanks the Centers for Medicare & Medicaid Services (CMS) for the opportunity to provide comments in response to the proposed rule “Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-Inclusive Care for the Elderly (PACE), Medicaid Fee-for-Service and Medicaid Managed Care Programs for Years 2020 and 2021 [CMS-4185-P]” published in the Federal Register on November 1, 2018.

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.

Press Release: DA’s Proposed Guidance That Would Reclassify Insulin as a Biologic

AMCP webinar that discussed the midterm elections, the party split for the 116th Congress, and what may or may not come up as health care priorities for federal and state legislators.