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.
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).
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.
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(AMCP) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments in response to the draft guidance document titled “Labeling for Biosimilar Products: Guidance for Industry” published in the Federal Register on April 4, 2016.
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.
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.
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.
The Academy of Managed Care Pharmacy (AMCP) supports the passage of Assembly Bill 3982 mandating that practitioners issue prescriptions for controlled substances electronically using an electronic health records system. E-prescribing for controlled substances would reduce some prescription errors and help prevent more than 2 million adverse drug events per year, 130,000 of which are life threatening. AMCP members seek to reduce the public health crises associated with medication prescribing errors, abuse and diversion of opioids, all of which AB 3982 addresses.
The Academy of Managed Care Pharmacy (AMCP) appreciates the opportunity to submit comments for the record on the hearing titled “Examining the Proposed Medicare Part B Drug Demonstration” held on June 28, 2016. AMCP submitted detailed comments1 to the Centers for Medicare and Medicaid Services (CMS) in response to the proposed rule titled “Medicare Program; Part B Drug Payment Model (CMS-1670-P)” published in the Federal Register on March 11, 2016.
The Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) released a final rule titled “Medication Assisted Treatment for Opioid Use Disorders” scheduled to be published in the Federal Register on July 8, 2016. AMCP had submitted comments on the draft rule urging for provisions related to team-based care, education on diversion mitigation strategies, and the expansion of practitioner eligibility to prescribe buprenorphine for opioid abuse disorders.
The Academy of Managed Care Pharmacy (AMCP) thanks the Centers for Medicare and Medicaid Services (CMS) for the opportunity to provide comments in support of the notice titled “Medicare Part D Reporting Requirements and Supporting Regulations (CMS-10185)” published in the Federal Register on May 6, 2016. Under the notice, Part D sponsors would be responsible for submitting Medication Therapy Management (MTM) program reports as described in Title I, Part 423, Subpart D, § 423.153 for CY2017 by the last Monday of February in 2018.
The Academy of Managed Care Pharmacy (AMCP) supports Senate Bill 2313 –establishing a task force to study and analyze health insurance payer practices regarding the dispensing of specialty drugs directly to a patient or provider. AMCP recommends that the Committee add language including a managed care pharmacist as a member on the task force.
The undersigned pharmacy organizations would like to thank the Centers for Medicare and Medicaid Services (“CMS”) for the opportunity to comment on the Proposed Rule for the Medicare Program; Merit-Based Incentive Payment System and Alternative Payment Model Incentive under the Physician Fee Schedule (“PFS”), and Criteria for Physician-Focused Payment Models (the “Proposed Rule”).
