TL/DR –
Federal health care legislation is currently on hold due to the removal of Kevin McCarthy as the Speaker of the House. However, key issues such as digital therapeutics and access to care are still being highlighted. Current legislative proposals include the Access to Prescribing Digital Therapeutics Act, the Medicaid Value-Based Purchasing for Patients Act, the Equitable Community Access for Pharmacist Services Act, and various bills addressing pharmacy benefit manager reform.
Updates in Health Care Legislation Addressing Digital Therapeutics and Care Access
Despite recent halt in federal level health care legislation following Kevin McCarthy’s removal as House Speaker, key issues surrounding digital therapeutics, care access, and health disparities remain critical.
In a session at AMCP Nexus 2023, Jennifer Mathieu and Geni Tunstall discussed upcoming federal legislative and regulatory updates. They stressed that even though current Congress is in a stalemate, there is still a full calendar year to work on various healthcare legislation.
One such legislation is the Access to Prescribing Digital Therapeutics Act, introduced in 2022, then reintroduced in March 2023. This bill aims to extend Medicare and Medicaid coverage and reimbursement to prescription digital therapeutics (PDTs) that are cleared or authorized by the FDA, and prescribed by a healthcare provider.
The FDA is also setting up a Digital Health Advisory Committee to guide on digital health technologies. The committee, open for nominations until December 11, 2023, will have 9 core members who will advise the FDA commissioner on all digital health technology developments.
Current legislation also focuses on high-cost therapies. The Medicaid Value-Based Purchasing for Patients Act aims to improve Medicaid access to new and high-cost therapies, including cell and gene therapies. If passed, the Equitable Community Access for Pharmacist Services Act will authorize reimbursements to pharmacists under Part B for COVID-19 care, and expand to cover future public health emergencies.
With more biosimilars becoming integral to healthcare, the Biosimilar Research Fund and National Biosimilars Project Act will fund research on biosimilars to define interchangeability. This will allow for biosimilar-to-biosimilar substitutions under pharmacy entities.
Pharmacy Benefit Manager (PBM) reform is a notable topic for 2023, with legislation such as the Pharmacy Benefit Manager Transparency Act and the Modernizing PBMs and Ensuring Accountability Act being discussed. Tunstall also provided regulatory updates on the Inflation Reduction Act (IRA), which includes drug price negotiations and inflationary rebates.
For drug price negotiations, CMS will hold negotiations with manufacturers of 10 medications, who will then have a month to either accept the CMS offer or present a counteroffer. Key dates for the IRA include January 1, 2024 for the start of the Medicare catastrophic phase and premium stabilization, and September 1, 2024 for the fair price publication for the first 10 drugs.
Reference
Mathuieu J, Tunstall G. Federal legislative and regulatory update. AMCP Nexus 2023. October 17, 2023.
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