AMCP expresses strong support for S. 340, the “Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act,” bipartisan legislation to increase competition and patient access to safe and affordable generic and biosimilar medicines. AMCP is pleased it was reintroduced into legislation in the 116th Congress on February 5, 2019.
On Dec 12, 2018 The Food and Drug Administration (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 Academy of Managed Care Pharmacy (AMCP) appreciates the opportunity to provide comments to the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) in response to its Request for Information on Modifying HIPAA Rules to Improve Coordinated Care [HHS-OCR-0945-AA00].
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.