With just 15 days until the presidential election, the federal government is proposing new rules that aim to bolster protections around birth control and other preventive services.
The Department of Labor, the Treasury Department and Health and Human Services are collectively calling on health plans to cover over-the-counter contraceptives for free, without cost sharing or requiring a prescription.
Plans would also have to give consumers additional options among contraceptive drugs, such as more types of pills or IUDs that are covered by insurance.
“The proposed rule we announce today would expand access to birth control at no additional cost for millions of consumers,” HHS Secretary Xavier Becerra said in a statement. “Bottom line: women should have control over their personal healthcare decisions. And issuers and providers have an obligation to comply with the law.”
The Affordable Care Act already requires group health plans and issuers to provide coverage for services detailed by the U.S. Preventive Services Task Force and the Health Resources and Services Administration.
A 60-day comment period begins Oct. 21. Though proposed rules typically take a significant time to finalize, the Biden administration said it is working to finalize the rule before Biden leaves office in January.
Separately, CMS also released guidance requiring insurers to cover all forms of pre-exposure prophylaxis, or PrEP, a drug regiment taken to prevent HIV, without cost-sharing.
The nonprofit patient advocacy group HIV + Hepatitis Policy Institute said they are pleased with the rule, as they continue to receive complaints surrounding coverage of PrEP. The group says some health plans are denying claims or still requiring cost sharing for certain codes.
“We are grateful to the Biden-Harris administration for responding to our request to issue this guidance,” Executive Director Carl Schmid said in a statement shared with Fierce Healthcare. “Without it, we feel some insurers would continue to only cover daily oral PrEP, and not provide PrEP users with the choice they need. With up to a third of privately insured PrEP users still being charged cost-sharing, we must ensure that both federal and state regulators vigorously enforce PrEP coverage requirements.”
Over half of Americans eligible for PrEP have private insurance. Earlier this month, CMS proposed including PrEP as a new cost factor in risk-adjustment models by 2026.
Many health plans will need to adopt the new coverage requirements, and insurers cannot drive patients to certain PrEP drugs through strict prior authorization requirements, an FAQ (PDF) from the federal agencies outlines.
Patients could take advantage of the new rules by purchasing the drugs directly from the pharmacy counter, government officials told the Washington Post. It’s also possible they will be able to reimburse drugs from their health plan after the fact.
Editor's Note: This story has been updated to better reflect the rulemaking and regulatory guidance issued on Oct. 21.