On April 18, 2023, the U.S. Department of Health and Human Services (“HHS”) announced its plan to maintain access to COVID-19 vaccines and treatment following the end of the Public Health Emergency on May 11, 2023. The “HHS Bridge Access Program for COVID-19 Vaccines and Treatments” is a $1.1 billion public-private partnership between HHS, pharmacy chains, and drug manufacturers. Essentially, HHS and drug manufacturers will provide COVID-19 vaccines and treatments, like Paxlovid and Lagevrio, to pharmacy chains, which will administer them to individuals without insurance at no cost.

Under the program, the Centers for Disease Control and Prevention (“CDC”), will use its existing authority under Section 317 of the Public Health Service Act to purchase and distribute COVID-19 vaccines and allocate them through its network of 64 state and local health departments, as well as through Health Resources and Services Administration (“HRSA”) supported health centers.

The program will also leverage public commitments by drug manufacturers to provide vaccines and treatments for free to the uninsured. At the patient level, community pharmacies will continue to administer the vaccines and treatments without cost to uninsured individuals and will receive a per-dose administration fee paid by the CDC. Pharmacies will receive an additional one-time base payment to target areas with poor access to care and low vaccination rates. In exchange, pharmacies will be responsible for oversight, including monitoring patient attestations of lack of insurance and conducting patient outreach with a focus on underserved populations.

Over the next several months, HHS will begin contracting with large retail pharmacy chains, local pharmacy chains, and independently-owned pharmacies. HHS intends to launch the program in Fall 2023 and has identified sufficient existing COVID-19 supplemental funds to support the program through December 2024.

Seeking a more permanent measure, the Biden administration’s FY 2023 and FY 2024  budgets include a proposed $25 billion over 10 years to establish mandatory funding for the Vaccines for Adults Program (modeled after the Vaccines for Children Program). The Vaccines for Adults Program would cover vaccination, including against COVID-19, at no cost for uninsured adults. However neither of these proposed budget lines have yet been approved by Congress.

Reed Smith will continue to track developments on the HHS Bridge Access Program for COVID-19 Vaccines and Treatment. Should you have any questions related to the Program, or any other health care compliance issues, please do not hesitate to reach out to the health care attorneys at Reed Smith.