On October 4, 2023, the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury issued a request for information titled “Coverage of Over-the-Counter Preventive Services”. This request is regarding the application of the preventive services requirements under the Public Health Service Act to over-the-counter (OTC) preventive items and services available without a prescription by a health care provider. Some examples could include certain types of tobacco cessation pharmacotherapy, folic acid supplements, breastfeeding supplies, and contraceptives such as a recently approved OTC progestin-only daily oral contraceptive. Additional recommended preventive products may become available OTC in the future. AMCP submitted comments in response to the proposed rule on December 4, 2023.
Patients need to be aware of the dangers of fake medicines, potentially causing disease progression, adverse events, and even death. AMCP supports the joint statement released by National Association of Boards of Pharmacy and other health care organizations on fighting fake medicines bought online.
On September 18, 2023, the Office of Management and Budget (OMB) issued the draft guidance titled “Advancing Governance, Innovation, and Risk Management for Agency Use of Artificial Intelligence”. While AI is improving operations and efficiency across the Federal Government, agencies must effectively manage its use. As such, this memorandum establishes new agency requirements and guidance for AI governance, innovation, and risk management, including through specific minimum risk management practices for uses of AI that impact the rights and safety of the public. The document focuses on three main pillars:
.Strengthening AI governance;
.Advancing responsible AI innovation; and
.Managing risks from the use of AI by directing agencies to adopt mandatory safeguards for the development and use of AI that impacts the rights and safety of the public.
AMCP submitted comments in response to the proposed rule on December 1, 2023.
On May 30, 2023, Food and Drug Administration (FDA) issued the proposed rule titled “Medication Guides: Patient Medication Information”. The purpose of this rule is to amend its human prescription drug product labeling regulations for Medication Guides (FDA approved written prescription drug product information distributed to patients). This action, if finalized, will require applicants to create a new type of Medication Guide, referred to as Patient Medication Information (PMI), for prescription drug products, including biological products, used, dispensed, or administered on an outpatient basis and for blood and blood components transfused in an outpatient setting. AMCP submitted comments in response to the proposed rule on November 27, 2023.
On September 18, 2023, the U.S. Food and Drug Administration (FDA) issued the draft guidance titled “Labeling for Biosimilar and Interchangeable Biosimilar Products”. AMCP submitted comments in response to the proposed rule on November 17, 2023.
On September 14, 2023, the Department of Health and Human Services (HHS) and the Office for Civil Rights issued the proposed rule titled “Discrimination on the Basis of the Disability in Health and Human Service Programs or Activities". AMCP submitted comments in response to the proposed rule on November 13, 2023.
On Aug. 30, 2023, the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury issued the proposed rule titled “Requirements Related to the Mental Health Parity and Addiction Equity Act. AMCP submitted comments in response to the proposed rule on Oct. 17.
On August 21, 2023, CMS Issued the Maximum Monthly Cap on Cost-Sharing Payments Under Prescription Drug Plans: Draft Part One Guidance on Select Topics, Implementation of Section 1860D-2 of the Social Security Act for 2025. The purpose of this document is to provide interested parties with draft part one guidance on a select set of topics for the Maximum Monthly Cap on Cost-Sharing Payments Program.
On June 22, CMS unveiled proposed guidance titled "Coverage with Evidence Development." Given AMCP's commitment to addressing health disparities in medication use and access, AMCP submitted comments in response to the proposed guidance on Aug. 21.
On April 18, HHS' Office of the National Coordinator for Health Information Technology released a proposed rule titled "Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing." AMCP submitted comments in response to the proposed rule on June 20.
In April, the Department of Health and Human Services published a proposed rule titled "HIPAA Privacy Rule to Support Reproductive Health Care Privacy." AMCP took the opportunity to submit comments and suggestions in support of the rule on June 16.
On May 12, CMS released new draft guidance on the Manufacturer Discount Program, enacted into law as part of the Inflation Reduction Act of 2022 (IRA). In response to the draft guidance, AMCP submitted comments on June 12. In the comment letter, AMCP urges CMS to continue to take precautions against potential unintended consequences throughout its implementation of the IRA.
On May 15, AMCP joined dozens of other health care organizations in a sign-on letter thanking the Biden Administration for relaunching the Cancer Moonshot program. First launched in 2016 with the mission to accelerate the rate of progress against cancer, the program's national goal is to reduce the death rate of cancer by at least 50% over the next 25 years. The letter applauds the program's prioritization of cancer prevention, especially though human papillomavirus (HPV) vaccination.
On April 27, AMCP submitted comments in response to the Office of Management and Budget's Initial Proposals for Updating Race and Ethnicity Standards. In the comment letter, AMCP provides several recommendations which align with the organization's strategic priority of Addressing Disparities in Medication Use and Access.
On March 17, CMS announced an opportunity for the public to comment on the agency’s initial guidance for the Medicare Drug Price Negotiation Program, as required by the Inflation Reduction Act. Given the anticipated impact of the Drug Price Negotiation program on the practice of managed care pharmacy in the United States, AMCP took the opportunity to submit comments on several provisions outlined in CMS’ guidance. AMCP’s comments cover subject areas such as access to the Maximum Fair Price, manufacturer-specific data required for negotiation, evidence about therapeutic alternatives for the selected drug, CMS’ methodology for developing an initial offer, the removal of a drug from the selected drug list, and Part D formulary inclusion of the selected drug.
On March 31, AMCP submitted comments following a Feb. 2 proposed rule by the Internal Revenue Service, Employee Benefits Security Administration, and CMS regarding coverage of certain preventive services under the Affordable Care Act (ACA). In the comment letter, AMCP expresses support for the Departments' goals to increase access to preventive services.
On March 31, AMCP joined 10 other pharmacy organizations in a joint letter to Anne Milgram, Director of the U.S. Drug Enforcement Agency (DEA). The joint letter requests that the DEA extend flexibilities for telehealth prescribing of buprenorphine using the opioids-related public health emergency.
On March 10, AMCP submitted comments to CMS regarding a Notice of Proposed Rulemaking (NPRM) on Advancing Interoperability and Improving Prior Authorization Processes for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children’s Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges, Merit-Based Incentive Payment System (MIPS) Eligible Clinicians, and Eligible Hospitals and Critical Access Hospitals. AMCP's comments address whether CMS should consider policies to require payers to include information about prior authorizations for drugs on the Patient Access API, the Provider Access API, and the Payer-to-Payer API and how information on the APIs might interact with existing prior authorization requirements.
On March 6, AMCP submitted a comment letter in response to the Centers for Medicare and Medicaid Services' Advance Notice of Methodological Changes for Calendar Year (CY) 2024 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies. AMCP's comments support CMS' proposed Universal Foundation and commitment to advancing health equity, as well as the use of inclusive and gender-affirming approaches to HEDIS measures.