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HHS seeks to secure PrEP, birth control coverage

A proposed rule supports birth control coverage for FDA-approved therapies and devices with no prescriptions or cost-sharing and clarifies the exceptions process for enrollees.

Group health plans might have to provide birth control coverage for over-the-counter contraceptives with no cost-sharing if the Biden-Harris administration finalizes a newly proposed rule, according to an announcement from CMS.

"The proposed rule we announce today would expand access to birth control at no additional cost for millions of consumers. Bottom line: women should have control over their personal health care decisions. And issuers and providers have an obligation to comply with the law," HHS Secretary Xavier Becerra said.

Under the proposed rule, group plans, including employer-sponsored health plans and many health insurers, would have to cover birth control, even without prescriptions. Specifically, plans would be responsible for covering contraceptives that the FDA has approved.

Moreover, enrollees would have to have a selection of drugs. Plans would not be able to cover just one type of contraceptive without cost-sharing or prescriptions.

If the rule goes into effect, enrollees using Transparency in Coverage tools would see disclosures that offer health plan contacts related to birth control and contraceptives. They would also see a clear statement detailing how contraceptives are free from cost-sharing. Payers would be responsible for ensuring this information is up to date.

This proposed rule's publication coincided with new guidance around reducing barriers to pre-exposure prophylaxis (PrEP) medications, commonly used for HIV prevention, and improving coverage for chest wall reconstruction tied to mastectomies.

CMS also addressed exceptions processes. These processes allow patients and their providers to try to override coverage rules when they prevent patients from accessing medically necessary therapies. The new policy would require these processes to be clear and attainable.

Together, these proposed rules and new guidance aim to reduce barriers to preventive care, particularly for certain embattled types of care. Both contraceptive and PrEP access have been the subject of litigation around religious rights and employers' rights to determine coverage.

"The Biden-Harris administration trusts women to make decisions about their bodies. This is why we have prioritized ensuring access to safe, affordable contraception through job-based health coverage," Acting Secretary of Labor Julie Su said in the press release. "Today's proposal to require plans and issuers to cover contraceptive services -- without a prescription and at no cost to the individual -- is a long overdue step in increasing access to basic, reproductive health care to millions of women."

The potential regulations build on previous efforts by the Biden-Harris administration to improve access to preventive, reproductive care in the wake of the Supreme Court overturning Roe v. Wade. Also, they come more than a year after the FDA approved the first nonprescription, over-the-counter contraceptive pill in July 2023.

Health insurers do not have a history of consistently providing birth control coverage, a 2022 report found. Many payers imposed exclusions and cost-sharing on contraceptives and denied cost-sharing requests. However, 17 states and Washington, D.C., do not allow cost-sharing on contraceptives, and in 31 states and D.C., payers have to cover FDA-approved contraceptives, a report from Guttmacher Institute uncovered.

Kelsey Waddill is a managing editor of Healthcare Payers and multimedia manager at Xtelligent Healthcare. She has covered health insurance news since 2019.

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