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Proposed Rules Expand Access to Contraceptive Care as a Preventive Service

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On January 30, 2023, the Departments of Health and Human Services, Treasury, and Labor (collectively “the Departments”) issued proposed rules entitled “Coverage of Certain Preventive Services under the Affordable Care Act” (the “Proposed Rules”).  The Proposed Rules reflect the Departments’ continuing efforts to ensure that women have access to contraceptive care without cost sharing through non-grandfathered group health plans or non-grandfathered group or individual insurance plans.  Xavier Becerra, Secretary of the Department of Health and Human Services, stated in the press release announcing the Proposed Rules that access to and coverage for birth control and contraceptive counseling is critical as the Biden-Harris Administration seeks to ensure that women continue to get the contraceptive care they need, when they need, it at no out of pocket cost. The Proposed Rules follow the Departments’ previous guidance clarifying protections for contraceptives in response to the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization.

The Departments issued the Proposed Rules pursuant to Section 2713 of the Public Health Services Act, which was added by the Affordable Care Act and incorporated into the Employee Income Retirement Security Act of 1974 (“ERISA”) and the Internal Revenue Code of 1986, as amended (the “Code”).  This provision requires that non-grandfathered group health plans and group or individual insurance plans provide certain specified preventive services without cost sharing, including benefits for certain women’s preventative health services as provided for in comprehensive health guidelines supported by the Health Resources and Services Administration (“HRSA”).  In 2011, the HRSA adopted guidelines that, in relevant part, included sterilization procedures, patient education and counseling for women with reproductive capacity, and all Food and Drug Administration approved, cleared or granted contraceptives as prescribed by a healthcare provider.  The HRSA has modified its guidelines over the years, most recently in 2021.

Since 2010, the Departments have issued rules and other guidance in attempts to clarify the requirements for coverage of contraceptive services and to provide certain exemptions from these requirements for those who object to contraceptive coverage on religious and moral grounds.  In November 2018, the Departments issued final rules that include exemptions from the contraceptive coverage mandate for group health plans, institutions of higher education arranging student health insurance coverage, and health insurance issuers.  They also exempt individuals with religious or moral objections from enrolling in plans or policies that follow the mandate.  The regulations also offer an optional accommodation process that allows objecting colleges, universities, and employers to refrain from providing birth control coverage while, at the same time, ensuring that the women and covered dependents who are enrolled in these plans have access to contraceptive services with no cost share. The Departments’ rules have been litigated at nearly every turn.

The Proposed Rules modify the 2018 final rules in an effort to address President Biden’s directives regarding the availability of healthcare coverage and, in particular, women’s access to reproductive healthcare services.  The Proposed Rules retain the existing religious exemption for entities and individuals with religious objections, but they eliminate the moral exemption.  They also preserve the optional accommodation process.  Importantly, the Proposed Rules introduce a new “individual contraceptive arrangement.”  The individual contraceptive arrangement makes available providers and facilities that are willing to provide contraceptive services at no cost to individuals who are covered through objecting entities that do not use the existing accommodation process.  The objecting entity does not have to be involved in the individual contraceptive arrangement.  Providers and facilities that participate in an individual contraceptive arrangement can seek reimbursement for their services by entering into an agreement with an issuer on a Federally Facilitated Exchange or a State-Based Exchange. The Exchange can then seek an adjustment of its Exchange user fees to pay for the cost of the reimbursement.