Today, the Biden-Harris Administration, through the Departments of Health and Human Services, Labor, and of the Treasury (together, the Departments), proposed new rules that would continue building upon the Affordable Care Act (ACA) by expanding coverage of recommended preventive health services. As part of this proposal by the Centers for Medicare & Medicaid Services (CMS), for the first time, most group health plans and health insurance issuers would be required to cover over-the-counter (OTC) contraceptives without cost sharing or requiring a prescription, a key action taken by the Administration to expand access to and awareness of coverage for birth control and other critical health services. In addition, plans and issuers would have to provide consumers with more choices of covered contraceptives, such as a broader array of contraceptive drugs (for example, a wider selection of covered oral contraceptive pills) and drug-led combination products (for example, a wider selection of covered intrauterine devices (IUDs)). The proposed rules also further reinforce plans’ and issuers’ responsibility to cover Food and Drug Administration (FDA)-approved, -cleared, and -granted birth control methods without cost sharing. This proposed rule comes in response to reports that many plans and issuers continue to impose barriers to contraceptive coverage, such as requiring patients to satisfy step therapy protocols, imposing unduly burdensome administrative requirements, or requiring cost-sharing for services that are integral to the application of the preventive service provided.
“From day one, the Biden-Harris Administration has made clear that every woman should have access to the health care she needs. That includes contraception and other family planning services,” said HHS Secretary Xavier Becerra. “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.”
“People with private coverage should know they have coverage of preventive services, including FDA-approved contraception, at no additional cost — full stop,” said CMS Administrator Chiquita Brooks-LaSure. “This historic action by the Biden-Harris Administration is vital to ensuring people have control over personal decisions about their health, lives, and families — without facing financial barriers to accessing their birth control method of choice.”
“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,” explained Acting Secretary of Labor Julie Su. “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 proposed rules would build on previous guidance and require health plans and issuers to provide an easily accessible, transparent, and sufficiently expedient exceptions process for all recommended preventive services. An exceptions process can be crucial for people who face limits on medically necessary care or coverage and would ensure they can access all medically necessary, recommended preventive services, including contraception, as well as certain immunizations, screenings, and other critical services for infants, children, and adolescents.
Since its inception, the ACA has required most group health plans and health insurance issuers to provide coverage for preventive services recommended by the United States Preventive Services Task Force, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, and the Health Resources and Services Administration, without any cost-sharing requirements, such as a copayment, coinsurance, or deductible. The proposed rules would strengthen these existing consumer protections by requiring plans and issuers to cover OTC contraception without a prescription and without cost sharing.
Millions of people continue to face barriers to obtaining preventive services, like contraception, even as access has become more critical. In the wake of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization to overturn Roe v. Wade, these proposed rules represent a direct response to President Biden’s Executive Orders on Protecting Access to Reproductive Healthcare Services and Strengthening Access to Affordable, High-Quality Contraception and Family Planning Services.
The rules would require plans and issuers to add a disclosure to the results of any online Transparency in Coverage self-service tool search for covered contraceptives that explains OTC contraceptives are covered and include phone and web contacts for additional information regarding contraceptive coverage. These proposed rules would not modify federal conscience protections related to contraceptive coverage for employers, plans, and issuers.
The Departments also released additional guidance addressing plans’ and issuers’ coverage of other recommended preventive services, as required under the ACA. This guidance focuses on coverage of pre-exposure prophylaxis (PrEP), medication that reduces the risk of HIV infection, reiterating the requirement to cover preventive PrEP and related services without cost sharing. The guidance also responds to continued reports that, in some cases — including where plans and issuers have not provided clear guidance to network providers on how to code preventive services — plans and issuers are denying claims or imposing cost sharing for recommended preventive items and services because of how a provider codes for those services. The guidance released today seeks to clarify how plans and issuers can mitigate challenges with coding and processing of claims for recommended preventive services to ensure that individuals are not improperly charged for important preventive care. In addition to the ACA requirements, the guidance addresses coverage requirements of chest wall reconstruction with aesthetic flat closure, if elected by the patient in connection with a mastectomy, under the Women’s Health and Cancer Rights Act.
For more information on the proposed rules, consult the fact sheet available on CMS.gov.
To review or comment on the proposed rules during the 60-day public comment period, visit the Federal Register. To review the draft rule, visit CMS.gov.
To review the new guidance related to PrEP, coding of preventive services, and women’s health services on CMS.gov, visit CMS.gov.
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