AMCP Legislative & Regulatory Briefing — September 2025

Urge Congress to Extend Enhanced Premium Tax Credits 

Enhanced Affordable Care Act (ACA) premium tax credits (PTCs) will expire on Dec. 31, 2025, threatening a loss of health insurance coverage and increased premium rates for millions of Americans. Enhanced PTCs, used by patients enrolled in ACA Marketplace plans to finance their health coverage, were extended by Congress in 2021. Since their enhancement, PTCs have helped double the number of Americans enrolled in the Health Insurance Marketplace from 12 million to 24.2 million enrollees. The expiration of enhanced PTCs means patients will pay an average of 75% more in out-of-pocket costs in 2026, and millions of Americans will lose their insurance due to unaffordability. If the enhanced PTCs lapse, the burden of these rising costs will fall on consumers, with the nonpartisan Congressional Budget Office estimating that the expiration of the enhanced subsidies will lead to 4.2 million people losing coverage. Urge your Members of Congress to extend these vital subsidies that keep American patients insured, healthy, and alive.

AMCP Releases Statement on Changes to the Childhood Vaccine Schedule 

This month, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) met to vote on changes to the adult and childhood vaccine schedules and the Vaccines for Children (VFC) Program. During the meeting, ACIP voted to remove the recommendation for the combined measles, mumps, rubella, and varicella vaccine for children under 4 years of age; limit access to the COVID-19 vaccine for individuals under age 65; and recommend shared clinical decision-making for COVID-19 vaccines. AMCP believes these changes do not align with robust, reliable evidence in support of childhood immunization. “AMCP urges ACIP to preserve access and protect children’s health by reinstating the removed vaccines to the childhood vaccine schedule,” stated AMCP CEO Susan Cantrell. Earlier this month, Cantrell spoke with Pharmacy Times, where she raised similar concerns over the while also stressing pharmacists’ role in countering misinformation and maintaining trust in the public health system.

AMCP Comments on the CY 2026 Medicare Physician Fee Schedule Proposed Rule 

In July, the Centers for Medicare and Medicaid Services (CMS) unveiled the CY 2026 Medicare Physician Fee Schedule Proposed Rule, which proposed to expand the agency’s payment policies to include Digital Mental Health Treatment Devices indicated to treat Attention Deficit Hyperactivity Disorder (ADHD). Last year, CMS created the DMHT pathway to cover devices, including several Prescription Digital Therapeutics (PDTs), furnished incident to professional behavioral health services used in conjunction with ongoing behavioral health care treatment. On Sept. 12, AMCP responded to the proposed rule with comments that applaud CMS’ expansion of coverage for innovative digital therapeutics that improve access to chronic disease management. AMCP’s comments also encourage CMS to expand coverage for all PDTs cleared, authorized, or approved by the Food & Drug Administration (FDA) to treat, manage, or diagnose a disease, injury, or condition. The proposed rule, while a promising step forward in expanding access to PDTs, excludes dozens of additional PDTs well suited to combat other chronic conditions such as diabetes, chronic lower back pain, urinary and fecal incontinence and stroke.

HHS Sec. Kennedy, Former CDC Director Monarez Testify Before Senate Committees 

On Sept. 4, Secretary of the Department of Health and Human Services (HHS) Robert F. Kennedy Jr. testified before the Senate Committee on Finance on matters regarding President Trump’s 2026 healthcare agenda. Despite the intended focus of the hearing, much of lawmaker’s questioning centered on recent turnover among the CDC and ACIP, and the consequences of the healthcare provisions included in H.R. 1. Secretary Kennedy testified that firings among the public health sector were necessary to restore trust in the government’s public health infrastructure, while legislators from both parties expressing concern for Secretary Kennedy’s position on vaccines. On Sept. 19, former CDC Director Dr. Susan Monarez and former CDC Chief Medical Officer Dr. Debra Houry testified before the Senate Committee on Health, Education, Labor, and Pensions (HELP) regarding Dr. Monarez’s sudden dismissal from the position in August. Dr. Monarez and Dr. Houry both testified that they had been asked to accept ACIP recommendations on vaccines without a review of the data in question. Both officials also testified that their refusal to comply led to Dr. Monarez’s dismissal, despite receiving Senate confirmation to assume the position just months earlier. Following the hearing, Senate HELP Chair Bill Cassidy (R-LA) called on Secretary Kennedy and HHS leadership to respond to Dr. Monarez and Dr. Houry’s claims at a later hearing.

HHS, White House Unveil MOCHA Strategy Report, Announce Actions to Tackle Autism  

This month, HHS and the White House unveiled the long-awaited Make Our Children Healthy Again Strategy report, which aims to address key drivers of childhood disease outlined in the earlier Make America Healthy Again Assessment report. The MOCHA Strategy outlines 128 actions intended to promote children’s health by reshaping the federal government’s research programs, realigning incentives through policy changes and deregulation, improving public outreach, and fostering public-private partnerships. On Sept. 22, President Trump, Secretary Kennedy, and other public health officials announced a physician notice and intent to begin the process to initiate a safety label change for acetaminophen, claiming that the drug is partially responsible for rising autism diagnoses seen in the United States over the past several decades. However, public health researchers, providers, autism advocates, and Members of Congress have expressed concerns with the administration’s findings, stating that a causal relationship between acetaminophen usage and autism has yet to be established.

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