The DOL, IRS, and HHS have jointly issued FAQs Part 54, addressing required coverage of contraceptives by non-grandfathered health plans and insurers. The FAQs, which are the latest in the Biden administration’s effort to bolster access to contraceptives after the U.S. Supreme Court’s Dobbs decision (see our Checkpoint article), follow an executive order (see our Checkpoint article), a warning letter from the agencies (see our Checkpoint article), and previous FAQ guidance (see our Checkpoint article)—all responding to reports of noncompliance with the Affordable Care Act’s contraceptive coverage mandate. Here are highlights of the latest guidance:
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Required Coverage. Based on recommendations published by the federal Health Resources and Services Administration (HRSA) (see our Checkpoint article), plans generally must cover, without cost-sharing, at least one form of contraception in each category identified in the current FDA Birth Control Guide. Q/A-1 clarifies that this includes items and services integral to the furnishing of a recommended preventive service, such as anesthesia necessary for a tubal ligation procedure or pregnancy tests before provision of an intrauterine device. Q/A-2 explains that plans must also cover, without cost-sharing, contraceptive products and services that are not included in a listed category if determined by an individual’s provider to be medically appropriate for that individual. Q/A-4 makes clear that plans must continue to provide coverage for instruction in fertility awareness-based methods (including the lactation amenorrhea method for women desiring an alternative method) without cost-sharing under updated HRSA guidelines taking effect in 2023. The agencies explain that although the updated guidelines no longer specifically recommend such coverage, it is encompassed under “screening, education, counseling, and provision of contraceptives (including in the immediate postpartum period).” And Q/A-5 confirms that plans must cover without cost-sharing FDA-approved emergency contraception (levonorgestrel or ulipristal acetate)—including products sold over-the-counter (OTC)—when prescribed by a provider.
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Reasonable Medical Management. Plans and insurers may use reasonable medical management techniques within a specified category of contraception only to the extent a HRSA recommendation or guideline does not specify the frequency, method, treatment, or setting for the provision of a recommended product or service. Q/A-8 explains that whether a medical management technique is reasonable depends on the facts and circumstances. It also lists examples of unreasonable techniques, including denying coverage for a particular contraceptive product despite a provider’s declaration of medical necessity, requiring individuals to “fail first” using products within the same or a different contraception category before approving coverage for a medically necessary product, and imposing an age limit on contraceptive coverage. Q/A-3 states that plans may use reasonable medical management techniques for contraceptive products or services that are not included in a category described in the HRSA guidelines only if multiple, substantially similar services or products that are not included in a category are available and medically appropriate for the individual. In that case, one of those products or services must be covered without cost-sharing. Plans must also cover without cost-sharing products or services not included in a category if an individual’s provider deems them medically necessary. An accessible, transparent, and expedient exceptions process that is not unduly burdensome to individuals and providers must be available.
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Exceptions Process. According to Q/A-9, the agencies will determine whether an exceptions process is easily accessible, transparent, sufficiently expedient, and not unduly burdensome based on the facts and circumstances, including whether and how the plan notifies providers and participants of the process, and the steps that must be taken to utilize it. Information about the exceptions process should be prominently displayed in plan documentation, including SPDs and other plan materials (such as drug formularies) that describe the terms of the plan’s coverage of contraceptive items. Plans are “strongly encouraged” to develop and make available a standard exception form and instructions. Q/A-10 makes clear that requiring individuals to appeal an adverse benefit determination using the plan’s internal claims and appeals process as the means for obtaining an exception would be considered unduly burdensome.
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HSAs/HRAs/Health FSAs. Q/A-6 confirms that HSAs, HRAs, and health FSAs may reimburse the cost of OTC contraception to the extent the cost is not paid or reimbursed by another plan or coverage. Plans and insurers that choose to cover OTC contraceptive costs without a prescription (in addition to the required coverage of prescribed OTC items) should advise individuals not to seek reimbursement from an HSA, HRA, or health FSA for the cost (or portion of the cost) of contraceptives paid or reimbursed by the plan or issuer, and not to use HSA, HRA, or health FSA debit cards to purchase contraceptives for which reimbursement will be sought from the plan or issuer. Individuals who mistakenly take an HSA distribution or receive an HRA or health FSA reimbursement for contraception costs paid or reimbursed by another plan or insurer must (1) include the HSA distribution in gross income or, if permitted, repay the distribution to the HSA; or (2) contact the HRA or health FSA administrator regarding correction procedures.
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Interaction With State Laws. Q/A-11 notes that federal law preempts any state law that would make it impossible to comply with the contraceptive coverage mandate. Q/A-12 explains that, while states have primary enforcement authority over insurers with respect to the ACA’s preventive services requirements, HHS will assume enforcement responsibility if it determines that a state has failed to substantially enforce a provision. Thus, for example, if a state enforces a state law prohibiting insurers from covering an FDA-approved contraceptive product or service, HHS may initiate an investigatory process and, if indicated, assume responsibility for enforcing the contraceptive coverage mandate within that state.
EBIA Comment: The agencies note that this guidance does not apply to plans with a religious or moral exemption from the contraceptive coverage mandate. However, the agencies make clear that all other non-grandfathered plans and insurers are expected to remove impermissible barriers and ensure that plan participants, beneficiaries, and enrollees have access to the contraceptive coverage they need. As the agencies warn in Q/A-13, plans that do not comply may face DOL or HHS investigations resulting in re-adjudication of improperly denied claims and possible penalties. For more information, see EBIA’s Health Care Reform manual at Section XII.C (“Coverage of Preventive Health Services”). See also EBIA’s Group Health Plan Mandates manual at Sections XIV.C.4.a (“HRSA Recommendations: Contraceptives”) and XIV.E (“Contraceptive Coverage: Exemptions and Accommodations Based on Religious Beliefs and Moral Convictions”), EBIA’s Self-Insured Health Plans manual at Section XIII.C.1 (“Preventive Health Services”), EBIA’s Cafeteria Plans manual at Sections XX.I (“Expense Cannot Be Reimbursed (and Participant Must Certify That Reimbursement Will Not Be Sought) From Other Health Plan Coverage”) and XX.L.2 (“Medicines and Drugs (Over-the-Counter and Prescription)”), and EBIA’s Consumer-Driven Health Care manual at Sections XV.C (“What Is an HSA-Qualified Medical Expense”) and XXIV (“HRAs: Reimbursements”).
Contributing Editors: EBIA Staff.