Richard H. Hughes, IV, and Spreeha Choudhury, attorneys in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, co-authored an article in Health Affairs, titled “Paving the Way for Prevention Over the Counter.”

Following is an excerpt:

On October 4, 2023, the Departments of Health and Human Services, Labor, and the Treasury issued an Request for Information (RFI) aimed at garnering input on enhanced coverage and access to over-the-counter (OTC) preventive services. It seeks to understand the potential benefits and challenges of mandating insurance plans to cover costs for recommended OTC items like contraceptives, tobacco cessation products, and breastfeeding supplies, among others, without cost-sharing and without necessitating a prescription.

The Patient Protection and Affordable Care Act (ACA) significantly advanced the substantive requirements for health insurance in the United States. Among those advancements was the requirement that payors provide “first dollar” coverage of certain recommended preventive services. Specifically, the ACA’s addition of Section 2713 of the Public Health Service ACT (PHSA), requires insurers to cover preventive services without imposing cost-sharing requirements such as co-payments, deductibles, or co-insurance. This includes immunizations recommended by the CDC’s Advisory Committee on Immunization Practices (ACIP), women’s and children’s preventive services as determined by the Health Resources and Services Administration (HRSA) and services recommended with an A or B rating by the United States Preventive Services Task Force (USPSTF).

Of those preventive services, most require interaction with a health care provider or prescription, such as statin drugs for the prevention of cardiovascular disease in adults or pre-exposure prophylaxis (PrEP) for HIVHRSA-recommended preventive services for women include well-woman visits, gestational diabetes screening, breastfeeding services and supplies, and breast cancer mammography screenings. That said, USPSTF does recommend certain OTC products as preventive services, such as folic acid supplements for individuals who may become pregnant, or low-dose aspirin for pregnant persons at risk of preeclampsia. Other recommended OTC prevention products include oral fluoridestobacco cessation products, and some bowel preparation medications for colonoscopies. …

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