On February 12, 2019, AMCP provide comments to the HHS OCR in response to its Request for Information on Modifying HIPAA Rules to Improve Coordinated Care. AMCP shared its support of HIPAA modernization, specifically as it relates to aligning 42 CFR Part 2 requirements with HIPAA.
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 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.