New Federal Laws Address Digital Therapeutics, Care Access

Last updated Oct 30, 2023

TL/DR –

The U.S. healthcare legislation has been crucially affected by the removal of Kevin McCarthy as the Speaker of the House; however, progress around digital therapeutics, access to care, and health care disparities is still important. The federal legislative and regulatory updates include the Access to Prescribing Digital Therapeutics Act, designed to provide benefits for prescription digital therapeutics in Medicare and Medicaid, and the creation of a Digital Health Advisory Committee by the FDA. Other significant legislation includes the Medicaid Value-Based Purchasing for Patients Act, the Equitable Community Access for Pharmacist Services Act, the Biosimilar Research Fund and National Biosimilars Project Act, and various Pharmacy Benefit Manager laws.

Updates in Federal Legislation: Digital Therapeutics and Access to Care

Despite the hold on health care legislation at the federal level due to Kevin McCarthy’s removal as Speaker of the House, advancements in digital therapeutics, access to care, and health care disparities remain crucial.

At AMCP Nexus 2023, Jennifer Mathieu and Geni Tunstall discussed coming federal legislative and regulatory updates, noting the continuation of health care legislation efforts into 2024.

They addressed the Access to Prescribing Digital Therapeutics Act. Introduced in 2022 and reintroduced in 2023, this bill aims to benefit Medicare and Medicaid coverage and reimbursement for FDA-approved prescription digital therapeutics (PDTs). However, it would not mandate specific PDTs coverage by CMS.

A Digital Health Advisory Committee will be established by the FDA to advise on digital health technologies, including artificial intelligence, machine learning, and digital therapeutics. Nominations for the committee will be accepted until December 11, 2023.

High-cost therapies are a legislative focus, including the Medicaid Value-Based Purchasing for Patients Act aimed at enhancing Medicaid access to new, high-cost therapies.

The Equitable Community Access for Pharmacist Services Act seeks to authorize pharmacists to receive reimbursements under Part B for COVID-19 care, thus improving care access in underserved communities. Furthermore, the Biosimilar Research Fund and National Biosimilars Project Act will support research on biosimilars, aiding in defining interchangeability.

Pharmacy benefit manager (PBM) reform is a noteworthy topic for 2023 with multiple pieces of legislation under consideration. AMCP predicts that end-of-year health care packages will address drug access, PBMs, insulin caps, and product hopping.

Regulatory updates around the Inflation Reduction Act (IRA) were provided by Tunstall. Provisions include Medicare drug pricing negotiation, Part D reforms, and inflationary rebates. CMS will negotiate drug prices with ten medication manufacturers, including Eliquis, Entresto, Fiasp, Januvia, Stelara, Enbrel, Farxiga, Imbruvica, Jardiance, and Xarelto.

Key dates for the IRA include January 1, 2024; July 1, 2024; September 1, 2024; January 1, 2025; September 30, 2025; and January 1, 2026.

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