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AMCP Submits Comments to the FDA on the Biosimilar Interchangeability Draft Guidance Seeking Additional Clarity Prior to Finalization

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.

AMCP Joins 10 Organizations in Joint Comment Letter to the FDA on Draft Interchangeability Guidance

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.

AMCP Sends a Letter to Connecticut House Leadership Expressing Concerns with Specific Provisions of Substitute Bill No. 7118 Regarding the Regulation of Biological Products and the Substitution of Interchangeable Biological Products

The Academy of Managed Care Pharmacy (AMCP) is writing to express concerns with specific provisions of Substitute Bill No.7118 regarding the regulation of biological products and the substitution of interchangeable biological products when dispensed by pharmacists.

AMCP Submits Comments to Tennessee House Leadership Expressing Strong Support for House Bill No. 628 Which Would Establish a Medication Therapy Management (MTM) Pilot Program as a Component of the Tenncare Program

The Academy of Managed Care Pharmacy (AMCP) urges you to support House Bill No. 628, which would establish a Medication Therapy Management (MTM) pilot program as a component of the TennCare program. MTM services have demonstrated success for Medicare Part D beneficiaries by improving patient outcomes while decreasing overall health care costs, and AMCP strongly supports the expansion of MTM services for other patient groups including Medicaid beneficiaries.

AMCP Submits Comments to PQA on Three New Measures Under Consideration for Endorsement, Advocating for Measures with a Focus on Outcomes, Consideration for Clinical Appropriateness of Medications, and Avoidance of Duplication of Measures

The Academy of Managed Care Pharmacy (AMCP) thanks the Pharmacy Quality Alliance (PQA) for the opportunity to provide comments in response to the memo titled Endorsement Consideration by PQA Members of Three New Performance Measures.

AMCP Joins 17 Other Health Care Organizations and Consumer Groups in Support of the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2017 – H.R. 2212 and S. 974

As stakeholders firmly committed to fostering patient access to affordable medicines and pharmaceutical competition, we would like to thank you for introducing the bicameral and bipartisan Creating and Restoring Equal Access to Equivalent Samples (“CREATES”) Act.

AMCP Submits Comments to CMS Advocating for Transformation and Modernization of the Medicare Part D Program to Best Meet the Individual Health Care Needs of Medicare Beneficiaries

The Academy of Managed Care Pharmacy (AMCP) thanks the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) for the opportunity to provide comments in response to the request for information (RFI) for Medicare Advantage (MA) and Medicare Part D programs included in the “Announcement of Calendar Year (CY) 2018 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter and Request for Information” released on April 3, 2017.
Medicare Part D

AMCP Submits Comments to FDA Advocating for Clarification of FDAMA Section 114 and the Creation of a Safe Harbor for Preapproval Information Exchange

The undersigned organizations thank the Food and Drug Administration (FDA) for the opportunity to provide comments in response to “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers [FDA-2016-D-1307]” as published in the Federal Register on January 19, 2017.