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 February 28, 2019, AMCP provided comments to the CMS and ONC in response to the draft Strategy on Reducing Burden Relating to the Use of Health IT and EHRs.
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.