Federal Departments Propose New Regulations for Contraceptive Services Mandate


Published March 29, 2023

The Federalist Society

On February 2, 2023, the U.S. Department of Health and Human Services (HHS), Department of Labor, and Department of Treasury (together, “Departments”) issued a proposed rule entitled “Coverage of Certain Preventive Services Under the Affordable Care Act.” The 46-page Proposed Rule is open for public comment for 60 days until Monday, April 3, 2023.

In its press release announcing the proposed rule, HHS states that the proposed rule would “bolster access to birth control at no cost.” It claims that the “U.S. Supreme Court’s decision in Dobbs has placed a heightened importance on access to contraceptive services nationwide.”

History of the Departments’ Contraceptive Services Mandate

The Departments’ proposed rule would modify “regulations regarding coverage of certain preventive services under the [Affordable Care Act],” specifically the requirement that “non-grandfathered group or individual health insurance coverage [] cover certain contraceptive services without cost sharing.” The Departments ground their mandate in Section 2713 of the Public Health Service Act (“PHS Act”), which was added to the PHS Act through the Affordable Care Act (ACA). Section 2713 requires non-grandfathered group health plans and health insurance issuers to provide coverage of certain specified preventive services without cost-sharing. A separate law, the Women’s Health Amendment of 2010, amended the preventive services requirement in Section 2713 to include “certain women’s preventive services.” Congress did not specify which women’s preventive services were to be covered, but tasked an office within HHS—the Health Resources and Services Administration (HRSA)—with filling in the details.

HRSA in turn deferred to the Institute of Medicine (IOM), which then developed a Committee on Preventive Services for Women. Eleven of the fifteen members on that committee were either affiliated with major pro-abortion groups or had made substantial contributions to the campaigns of pro-abortion politicians. The Committee chair, Linda Rosenstock, had donated over $40,000 to Barack Obama, Hilary Clinton, Barbara Boxer, and the Democratic National Committee.

In July 2011, the IOM issued a report that recommended that HRSA adopt guidelines that cover a range of preventive services as well as “the full range of Food and Drug Administration (FDA)-approved contraceptive methods, sterilization procedures, and patient education and counseling for women with reproductive capacity.”

A few weeks later, on August 1, 2011, HRSA created the Contraceptive Services Mandate by publishing a website with their Women’s Preventive Services Guidelines, which adopted the IOM’s recommendations in full. Over the past dozen years, HRSA has occasionally changed the scope of the Women’s Preventive Services Mandate by updating this website, though the requirement to cover all FDA-approved contraceptives has remained unchanged. The website presently says that its list of mandated services is reviewed “biennially, or upon the availability of new evidence.”

Neither the initial publication of this HRSA list nor any of the updates to this website have been subject to notice and comment. The Supreme Court observed in Little Sisters v. Pennsylvania, a challenge to the mandate:

HRSA has altered its Guidelines multiple times since 2011, always proceeding without notice and comment. . . . Accordingly, if HRSA chose to exercise that discretion to remove contraception coverage from the next iteration of its Guidelines, it would arguably nullify the contraceptive mandate altogether without proceeding through notice and comment. The combination of the agency practice of proceeding without notice and comment and HRSA’s discretion to alter the Guidelines . . . provides yet another indication of Congress’ failure to provide strong protections for contraceptive coverage.

Some of the controversy associated with the HHS Mandate comes from the fact that the FDA’s list of contraceptives includes items that do more than merely prevent conception. In HHS’s own words, “[b]ecause FDA includes in the category of ‘contraceptives’ certain drugs and devices that may not only prevent conception (fertilization), but may also prevent implantation of an embryo, the IOM’s recommendation included several contraceptive methods that many persons and organizations believe are abortifacient—that is, as causing early abortion.”

Regulatory and Litigation History of the Contraceptive Services Mandate

By HHS’s own count, the new proposed rule marks the nineteenth regulatory change the Departments have issued related to the contraception mandate. According to the Departments, these “several rules of rulemaking” reflect their ongoing “effort to address the claims of [] religious employers . . . that object to providing contraceptive services.”

The proposed rule’s brief overview of the extensive litigation over the Contraceptive Services Mandate seems to indicate otherwise. The Mandate prompted an unprecedented wave of lawsuits brought by or on behalf of hundreds of non-profit and for-profit employers with religious and non-religious moral objections to providing employees with free access to contraceptives, abortifacients, sterilization procedures, and related services.

The Departments’ first regulations related to the Mandate made no provision for religious employers. In 2011, the Departments issued one of the narrowest religious exemptions ever seen, the Departments retreated somewhat, but their new marginally-broader definition of “religious employer” was still hooked to a provision in the Internal Revenue Code that allows churches, their integrated auxiliaries, and religious orders to avoid filing informational tax returns. Religious schools and ministries—clearly religious under any reckoning—were excluded.

Religious employers that didn’t qualify for the “religious employer” exemption were offered instead an “accommodation.” The Departments represented that, under this arrangement, objecting religious employers would not be “not required to contract, arrange, pay, or refer for contraceptive coverage; however, plan participants and beneficiaries” would still have access to free mandated contraceptive services.

However, religious employers that were paying attention to the details saw quickly that the “accommodation” could not possibly work the way the Departments claimed. They objected because they saw that the “accommodation” still left them morally complicit in the delivery of contraceptive and abortifacient drugs and devices. The “accommodation” required them to execute paperwork that amended their health care plans to make their plan administrators liable for giving their employees free contraceptives under the religious employers’ own health plan.

The Departments did not budge. In court they called this arrangement an “opt out” and said that religious employers “need only attest to their religious beliefs and step aside.” They claimed that the Department of Labor had unilateral authority to amend health plans and could also force third party administrators to provide contraceptive coverage outside of the objecting employers’ plans.

As dozens of lawsuits made their way through the federal court system—including one brought by the Little Sisters of the Poor religious order—nearly every court of appeals accepted the defendants’ arguments at face value. Judge Posner, writing for the Seventh Circuit, declared that under the accommodation, “new contracts are created,” through “governmental plan instrument[s],” “to which [objecting employers are] not a party.” None of this was true. ERISA 3(16) plainly states that Congress did not give the Labor Department the power to take over private insurance contracts.

In 2016, the litigation over the accommodation reached the Supreme Court. There, the Departments made an about face and made major concessions that undercut the victories they had secured below. First, the Departments admitted that the objecting employers had been right all along: the contraception coverage under the “accommodation” was “part of the same plan as the coverage provided by the employer.” Second, the Departments conceded that their interests did not require women to get free contraceptives through their employers: their interests would be satisfied so long as women had access to a plan with some contraceptive coverage, which they could obtain from many sources, including “a family member’s employer,” “an Exchange,” or “another government program.” Third, after years of telling the lower courts that they were already using the least restrictive means possible, the Departments told the Court that their system actually “could be modified” to give women access to contraceptives without forcing religious organizations to execute documents that violated their faith.

The Supreme Court unanimously overturned the lower court rulings against the Little Sisters and ordered the lower courts to give the Departments an opportunity to find a way to advance their interest in giving the Little Sisters’ employees free contraceptives without involving the Little Sisters or their health plan. However, the Departments later changed their mind again and insisted that their accommodation was “the least restrictive means” of advancing their interest in expanding contraceptive access. In January 2017, the Departments issued an FAQ that said they would not be adjusting their accommodation, as “no feasible approach has been identified at this time that would resolve the concerns of religious objectors, while still ensuring that the affected women receive . . . contraceptive coverage.”

The saga over the Departments’ Contraceptive Coverage Mandate took a major turn in 2018 when the Departments issued two new regulations that took their concessions before the Supreme Court into account. The November 2018 Religious Exemption final rules stopped using the tax code to determine who counted as a “religious employer.” The revised exemption was available to any non-governmental employer with “sincerely held religious beliefs[] to []establishing, maintaining, providing, offering, or arranging for (as applicable)” coverage of or payments for some or all FDA-approved contraceptives. The Departments recognized that their accommodation substantially burdened the religious exercise of many objecting religious employers, and therefore made the accommodation optional for religious employers.

The same day, the Departments issued the November 2018 Moral Exemption final rules, which offered a separate exemption for employers with sincerely held non-religious moral objections to cooperating with the Mandate.

These new rules sparked another round of lawsuits. But whereas previously the lawsuits were brought by employers seeking to protect their civil rights, this time the lawsuits were brought by state attorneys general—including then-California Attorney General and current HHS Secretary Xavier Becerra. These lawsuits argued that the Departments acted unlawfully by broadening the religious employer exemption. Obama-appointed district court judges in Pennsylvania and California promptly agreed and enjoined the 2018 rules. The Third and Ninth Circuits agreed. But in 2020, the Supreme Court in Little Sisters of the Poor v. Pennsylvania overturned the lower courts, holding that HRSA had broad authority from Congress to craft religious exemptions to the Mandate.

Major Aspects of the Proposed Rule

Five years after the 2018 final rules, three years after the Supreme Court’s latest intervention upholding religious objections to the Mandate, the Departments have proposed new regulations aimed at expanding access to contraception. Three aspects of the proposed rule are of special significance:

Keep Broad Religious Exemption and Optional Accommodation

In the proposed rule, the Departments state their desire “to resolve the long-running litigation with respect to religious objections to providing contraceptive coverage.” Given the relative peace since the Supreme Court’s latest intervention on behalf of religious employers in 2020, it appears the Departments are expressing their reticence to spark new litigation and another adverse ruling from the Supreme Court. Whatever their motive, the Departments “propose to maintain the November 2018 final rules’ religious exemption for entities with sincerely held religious objection to providing coverage for contraceptive services.” The Departments likewise propose to leave untouched the 2018 decision to make their problematic accommodation optional for objecting religious employers.

Establish New Individual Contraceptive Arrangement

Though the Departments intend to leave in place some changes introduced in the 2018 Rule, they claim the 2018 Final Rule “did not give sufficient consideration to women’s significant interests in access to contraceptive services.” As such, they propose to create a new “independent pathway” to cost-free contraception called the “individual contraception arrangement.”

Unlike the Departments’ longstanding “accommodation,” the proposed “individual contraception arrangement” will involve a separate “provider of contraception services”—not the religious’ employers’ plan and third party administrator. This separate provider would provide these services at no cost, and then seek reimbursement “from an issuer with which it has a signed agreement for the cost of providing contraceptive services to women covered under these plans.”

According to the Departments, “This individual contraception arrangement would be available to the participant, beneficiary, or enrollee without the plan sponsor or issuer having to take any action that would facilitate the coverage to which it objects. Simply put, the action is undertaken by the individual, for the individual.”

The Departments claim this arrangement “would not achieve the Women’s Health Amendment’s goal of ensuring that women have seamless cost-free coverage of contraceptives.” This is a deceptive claim. First, as noted above, Supreme Court recognized in Little Sisters v. Pennsylvania that the Women’s Health Amendment did not mention contraceptives at all. Dozens of bill have been introduced in Congress that have explicitly proposed a contraception mandate, but those bills all failed. In this case, Congress ducked the issue and chose to let HRSA (and HRSA chose to let IOM) decide what women’s preventive services would have to be covered.

Second, neither in the ACA nor in the Women’s Health Amendment did Congress assert any interest in “seamless” access. Congress’ focus was on reducing the cost of women’s preventive services. The term “seamless” showed up first in DOJ briefing in Mandate cases as the Departments’ lawyers were trying to defeat religious employers’ claim that the Departments had other ways of getting women free contraceptives.

The first court decision in a Mandate case to use the term “seamless” was the D.C. Circuit’s 2014 decision in Priests for Life v. HHS. This was one of the many appellate decisions that relied on the Departments’ incorrect statements about how their accommodation worked. By that time, the Departments had issued eight sets of regulations concerning the Mandate; the word “seamless” didn’t appear in any of them. The Departments started claiming Congress wanted women to have “seamless” access to contraceptives in their first set of regulations after Priests for Life, and the term has been a regular feature of the Departments’ regulatory and legal arguments ever since.

The financial part of the “individual contraceptive arrangement” is a bit complicated. Women get covered services free of charge through “separate providers of contraception services.” Those separate providers can seek reimbursement from a participating qualified health plan issuer. The Departments will reimburse the health plan issuer in turn by adjusting the issuer’s Federally-facilitated Exchange (FFE) or State-based Exchange on the Federal platform (SBE-FP) user fee. This is essentially the same reimbursement scheme that the Departments have used for years under their accommodation. Given Planned Parenthood’s outsized role in filling prescriptions for contraceptives (its sites account for 6% of publicly funded health clinics, but serve 32% of all contraceptive clients), the reimbursement arrangement functions as another means of funneling taxpayer dollars to the largest abortion provider.

Revoke Moral Exemption

Finally, the NPRM proposes to revoke the November 2018 Moral Exemption final rules, which created an “exemption for entities and individuals that object to contraceptive coverage based on non-religious moral beliefs.”

The Departments’ given reasons for wanting to withdraw this provision for conscientious objectors ring hollow. They acknowledge that they have lost at least one lawsuit on this issue, citing the March for Life case, where a federal court issued a permanent injunction against the Departments because there was “no rational basis for the Departments to distinguish between religious and moral objections.” Yet the Departments “respectfully disagree” with this decision vindicating the plaintiff’s non-religious moral objections on the basis that “there is no analogous need to heed the possibility of successful claims to a non-religious moral exemption.”

The Departments declare that their 2018 decision to respect non-religious moral objections to their Mandate was wrong because of the “strong public interest in making contraceptive coverage as accessible to women as possible.” Yet the Departments acknowledge that honoring these conscientious objectors’ convictions “likely affects very few individuals.”

It would seem that the Departments could craft a win-win situation by simply extending the aforementioned “individual contraceptive arrangement” to women that work for employers with non-religious moral objections to the Mandate. However, the Departments reject that solution because “it is possible that through the individual contraceptive arrangement, an eligible individual would need to seek care from a provider who is not one of their regular providers, which not only adds inconvenience, but also could lead to disruptions in care.” This is essentially the same “seamless” argument described above.

These arguments apply with equal force to creating an individual contraceptive arrangement for women that work for objecting religious employers. So what is the difference? Why do the Departments deem the same arrangement unacceptable to for women that work for objecting non-religious employers?

On the one hand, the Departments “have determined that it is necessary to provide [women who work for objecting religious employers] with an alternative pathway [i.e. the individual contraceptive arrangement] to obtaining contraceptive services at no cost.” On the other hand, the Departments claim “it is necessary to provide [women who work for objecting non-religious employers] with such coverage directly through their plan.” (emphases added). Nothing in the proposed rule resolves this tension. If the alternative pathway adequately advances the Departments’ interests with objecting religious employers, it is hard to understand why it is “necessary” to deny this option to objecting non-religious employers.

Public Comment Opportunity

The Departments are seeking public comment on their proposal. Written comments (identified by Regulatory Information Number (RIN) 0938-AU94) are due Monday, April 3, 2023, and can be submitted online here. To learn more about public comments on agency rulemaking, see the Ethics and Public Policy Center’s one-page explainer.

Eric Kniffin is a fellow at the Ethics and Public Policy Center, where he works on a range of initiatives to protect and strengthen religious liberty as part of EPPC’s HHS Accountability Project.


Eric Kniffin is a fellow at the Ethics and Public Policy Center, where he works on a range of initiatives to protect and strengthen religious liberty as part of EPPC’s HHS Accountability Project.

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