Letters, Statements & Analysis
AMCP communicates the importance of managed care pharmacy by collaborating with members to provide comments, analysis, and testimony to Congress and federal and state agencies on the impact of proposed regulations and laws on managed care pharmacy and patients.
AMCP supports a coalition of over 20 health care stakeholders committed to aligning 42 CFR Part 2 (Part 2) with HIPAA to allow appropriate access to patient information that is essential for providing whole-person care.
On behalf of the Academy of Managed Care Pharmacy (AMCP), I wanted to take this opportunity to express our strong support for the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (H.R. 2212), bipartisan legislation to increase competition and patient access to safe and affordable generic and biosimilar medicines.
The Friends of the National Quality Forum (NQF) strongly urge you to support continuing the currently authorized $30 million in annual Medicare funding for NQF and quality and performance measurement. NQF’s work is vital to advancing our national commitment to safer, more effective care.
The undersigned organizations commend you for your leadership in introducing H.R. 2026 – The Pharmaceutical Information Exchange (PIE) Act of 2017 which will improve patient access to emerging medication therapies and devices by codifying a safe harbor for certain health care economic and scientific information communications between biopharmaceutical and medical device manufacturers and population health decision makers.
The Academy of Managed Care Pharmacy (AMCP) thanks the Institute of Clinical and Economic Review (ICER) for the opportunity to provide comments on the draft evidence report titled “Abuse Deterrent Formulations (ADFs) of Opioids: Effectiveness and Value” released on May 5, 2017.
The Academy of Managed Care Pharmacy (AMCP) is writing to express concerns with specific provisions of Senate Bill 4788 regarding the regulation of biological products and the substitution of interchangeable biological products when dispensed by pharmacists.
The Academy of Managed Care Pharmacy (AMCP) is writing to express concerns with specific provisions of House Bill 4472 regarding the regulation of biological products and the substitution of interchangeable biological products when dispensed by pharmacists. We strongly support the language in the Bill that allows a pharmacist to substitute an FDA approved “interchangeable biological product.”
The Academy of Managed Care Pharmacy (AMCP) thanks the International Society for Pharmacoeonomics and Outcomes Research (ISPOR) for the opportunity to comment on the Draft Special Task Force Report “A Health Economics Approach to US Value Assessment Frameworks” issued on May 4, 2017 as part of its Initiative on US Value Assessment Frameworks.
AMCP supports the implementation of a robust biosimilars pathway to ensure that Americans continue to receive access to safe, effective, and affordable biologics and biosimilars. AMCP has been working extensively with the Food and Drug Administration and other stakeholders on federal and state legislation and regulations that impact the biosimilars pathway.
The Academy of Managed Care Pharmacy (AMCP) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments in response to “Considerations in Demonstrating Interchangeability With a Reference Product: Guidance for Industry [Docket No. FDA-2017-D-0154]” as published in the Federal Register on January 18, 2017.
All of the undersigned groups share the FDA's deep commitment to the development of a robust biosimilars market for patients, and greatly appreciate all the work the agency has done in creating certainty around the approval pathway created by the Biologics Price Competition and Innovation Act (BPCIA), including the long anticipated proposed guidance detailing the requirements of obtaining an interchangeability designation for a biosimilar.
The Academy of Managed Care Pharmacy (AMCP) thanks the Washington Department of Labor & Industries for the opportunity to provide comments in response to CR-102 Proposed Language on Interchangeable Biologics, the Prescription Drug Program and Therapeutic Interchange.
