On January 31, 2019 the Department of Health and Human Services (HHS) proposed sweeping changes to the current system for medication pricing and contracting by pharmacy benefit management (PBM) companies in federal programs--namely Medicare Part D and Medicaid programs.
The CREATES Act is a bipartisan, market-based solution to increase competition and thus lower prescription drug prices for patients and consumers. This reform helps speed the introduction of generic and biosimilar medicines by facilitating the purchase of brand name drug samples on market-based terms from pharmaceutical companies who otherwise would use anticompetitive tactics to block access.
February 2019 News & Views: General Session Keynote Speaker: Margaret Heffernan; AMCP's Response to the HHS Rebate Proposal; Proceedings on New Payment Models for High-Cost Medications
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.
Leg-Reg Briefing February 2019: Congress Focuses on Pharmaceutical Pricing; States Introduce Bills Affecting Managed Care Pharmacy; Modifying HIPAA Rules to Improve Coordinated Care
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.