The Departments of Health and Human Services, Labor, and the Treasury (the Departments) are seeking public input on how best to ensure coverage and access to over-the-counter (OTC) preventive services, including the benefits of requiring most health insurance plans to cover these services at no cost and without a prescription by a health care provider. This new Request for Information (RFI) solicits comment on access to a range of OTC items recommended by experts for preventive care that can be purchased without a prescription, including contraceptives, tobacco smoking cessation products, folic acid during pregnancy, and breastfeeding supplies.

Under the Affordable Care Act, most plans and issuers must cover certain recommended preventive items and services at no cost. Several of these recommended preventive items and services are currently available to consumers OTC without a prescription but are not required to be covered without cost sharing unless prescribed by a health care provider. The goal of the RFI is to understand the potential challenges and benefits for various interested parties, including consumers, plans, issuers, pharmacies, and health care providers, to provide coverage at no cost for recommended OTC preventive products without requiring a prescription. The Departments are committed to ensuring that everyone is able to access affordable and critical preventive items and services, including OTC preventive products.

“All Americans deserve access to quality health care. We know that making preventive care available over the counter can improve access – but there may still be cost barriers. That’s why we are working with the Department of Labor and Department of the Treasury to better understand how a policy change that could further increase access to affordable, preventive care might affect consumers, pharmacies, and health insurance providers,” said HHS Secretary Xavier Becerra. “I hope everyone who might be impacted will submit their comments and help us advance equity in access to high-quality preventive care like contraception and tobacco cessation.”

“The Centers for Medicare & Medicaid Services (CMS) remains steadfast in its commitment to advancing health equity. Easing financial barriers to preventive health care items, without a prescription, is one way to help achieve this goal,” said CMS Administrator Chiquita Brooks-LaSure. “Public input on this change to current policy is vital, and we look forward to hearing from consumers, plans, issuers, and providers about its potential impact.”

The Biden-Harris Administration is committed to ensuring access to health care and addressing health equity across its programs. Having access to affordable, evidence-based preventive items and services is key to promoting the health and well-being of all people. Issuing this RFI is consistent with President Biden’s executive orders on Strengthening Access to Affordable, High-Quality Contraception and Family Planning Services (June 23, 2023), Strengthening Medicaid and the Affordable Care Act (January 28, 2021), and Continuing To Strengthen Americans’ Access to Affordable, Quality Health Coverage (April 25, 2022). 

The Departments hope that the comments received in response to the RFI will expand their understanding of the potential health equity effects of requiring coverage for OTC preventive products, without cost sharing and without a prescription by a health care provider, in addressing systemic racism and historic inequity for women and LGBTQIA communities. There will be a 60-day comment period. To be assured consideration, comments must be received at one of the addresses provided in the Request for Information 60 days after date of publication in the Federal Register.

For more information on how to submit comments or to review the entire rule, visit the Federal Register https://www.federalregister.gov/public-inspection/current.

The RFI submitted to the OFR is available now at:  https://www.cms.gov/cciio/resources/regulations-and-guidance/downloads/cms-9891-nc.pdf