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 FDA on BsUFA II Reauthorization, Citing a Need for Robust Biosimilars Education, Expeditious and Harmonious Guidance Documents, and Post-Market Surveillance

The Academy of Managed Care Pharmacy (AMCP) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2018 through 2022 as published in the Federal Register on September 13, 2016. These written comments are provided in addition to the oral comments AMCP will present at the public meeting on October 20, 2016.
Biosimilars

AMCP Submits Comments on ICER Abuse-Deterrent Opioids: Draft Scoping Document on Critically Evaluating Effectiveness and Value of ADFs

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 scoping document that will examine the clinical effectiveness and value of abuse-deterrent formulation (ADF) of opioids in pain management released on September 8, 2016. AMCP appreciates the broad input from payers as well as patients, pain management specialists, and pharmaceutical manufacturers.

AMCP Requests California Governor Jerry Brown Sign Assembly Bill 1114, Which Would Make Certain Pharmacist Provided Services a Covered Benefit Under the Medi-Cal Program

The Academy of Managed Care Pharmacy (AMCP) urges you to sign Assembly Bill 1114, legislation that would make certain pharmacist provided services a covered benefit under the Medi-Cal program. As health care delivery in the United States continues to evolve and the focus on an interdisciplinary team approach to patient care increases, it is critical to recognize the value of pharmacists as health care providers.

AMCP Submits Comments to the California Senate, Urging Support for Assembly Bill 1114, Which Would Make Certain Pharmacist Provided Services a Covered Benefit Under the Medi-Cal Program

The Academy of Managed Care Pharmacy (AMCP) respectfully requests that you support Assembly Bill 1114 that would make certain pharmacist provided services a covered benefit under the MediCal program. As health care delivery in the United States continues to evolve and the focus increases on an interdisciplinary team approach to patient care, it is critical to recognize the value of pharmacists as health care providers.

AMCP Joins Eight Other Pharmacy Organizations in Comments to the FDA on PDUFA VI Reauthorization, Commending the FDA for its Continued Focus on Patient Safety and Quality Patient Care

The undersigned pharmacist organizations thank the Food and Drug Administration (FDA) for the opportunity to provide comments on the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FY) 2018 through 2022 as published in the Federal Register on July 19, 2016. Collectively, our organizations represent over 100,000 pharmacists across the full spectrum of health care practice settings.
Quality of Care

AMCP Submits Comments to the Massachusetts Joint Committee on Health Care Financing, Supporting House Bill 2041, a Bill That Would Recognize Pharmacists as Health Care Providers and Authorize Them to Perform Certain Patient Services

The Academy of Managed Care Pharmacy (AMCP) supports the passage of House Bill 2041. This legislation would recognize pharmacists as health care providers and authorize them to perform certain patient services including drug therapy management and administering drugs and biological products to a patient pursuant to a physician’s orders. As health care delivery in the United States continues to evolve and the focus increases on an interdisciplinary team approach to patient care, it critical to achieve better quality patient care that pharmacists are recognized as health care providers.

AMCP Submits Comments to the Massachusetts House of Representatives, Opposing House Bill 976, Which Amends the State's Biosimilar Law by Replacing the Words “Biosimilar and Interchangeable” in the Definition of “Interchangeable Biologic Product”

The Academy of Managed Care Pharmacy (AMCP) opposes House Bill 976. This bill would amend Chapter 112 Section 12EE (a) by replacing the words “biosimilar and interchangeable” in the definition of “interchangeable biologic product” with the words “therapeutically equivalent to”. This new proposed definition is inconsistent with existing Massachusetts law, which follows the language in the Biologics and Price Competition and Innovation Act (BPCIA).

AMCP Submits Comments to the California Senate Committee on Health, Opposing Assembly Bill 2050, Which Would Mandate Medication Synchronization

The Academy of Managed Care Pharmacy (AMCP) recognizes the value of medication synchronization as one tool that may improve adherence. However, we urge you to oppose Assembly Bill 2050 because it would mandate synchronization of medications without the benefit of industry input and a study of existing programs.

AMCP Submits Comments to FDA on Biosimilars Labeling Draft Guidance Advocating for Changes to the Biosimilarity Statement and Biosimilar Product Identification & Naming Sections

The Academy of Managed Care Pharmacy (AMCP) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments in response to the draft guidance document titled “Labeling for Biosimilar Products: Guidance for Industry” published in the Federal Register on April 4, 2016.
Biosimilars

AMCP Joins Other Organizations Urging Senate not to Approve Legislative Provision to Remove Requirement for USP Monographs for Biologics and Biosimilars

AMCP is writing to express concern about proposals by the Food and Drug Administration (FDA) and a provision included in Section 11 of the “FDA and NIH Workforce Authorities Modernization Act” (S. 2700) that would exempt certain biological products, including biosimilars, from the requirement to adhere to U.S. Pharmacopeial (USP) public standards for quality, including the naming of biologic and biosimilar medicines.
Biosimilars

AMCP Publishes a Summary of the Provisions in the Comprehensive Addiction and Recovery Act of 2016 (CARA) that are Relevant to AMCP Members. CARA is a Major Piece of Legislation that Creates a Framework for Opioid Abuse Prevention and Treatment

On July 22, President Obama signed into law the Comprehensive Addiction and Recovery Act of 2016 (CARA). CARA creates a framework for opioid abuse prevention and treatment and authorizes $181 million in new spending to address the opioid epidemic. Bipartisan support and overwhelming vote margins (407–5 in the House and 92–2 in the Senate) are evidence that this issue was an important one. CARA aims to strengthen prevention, treatment, and recovery efforts, largely by empowering medical professionals and law enforcement officials with funding and tools.