ACA FAQs clarify reproductive preventive care coverage requirements

The Departments of Labor, Health and Human Services (HHS), and the Treasury have issued ACA FAQs Part 54 providing guidance on reproductive preventive care coverage by employer-sponsored group health plans and health insurance issuers. Specifically, the guidance addresses the coverage of contraceptives (including emergency contraceptives) and family planning counseling without cost sharing (i.e., copays, deductibles or coinsurance) and restates the law dealing with coverage of preventive services under the Affordable Care Act (ACA).

Background

The ACA requires certain preventive care services to be provided by non-grandfathered employer-sponsored group health plans and health insurance issuers without cost sharing. For women, the 2019 Women’s Preventive Services Guidelines recommend that adolescent and adult women have access to the full range of female-controlled contraceptive methods approved by the Food and Drug Administration (FDA), effective family planning practices and sterilization procedures to prevent unintended pregnancy and improve birth outcomes.

Under the 2019 Guidelines:

• Contraceptive care should include contraceptive counseling, initiation of contraceptive use and follow-up care (e.g., management and evaluation as well as changes to the contraceptive method).
• Instruction in fertility awareness-based methods, including the lactation amenorrhea method, should be provided for women desiring an alternative method.

The 2019 Guidelines were updated in 2021 regarding breastfeeding services and supplies, well-woman preventive care visits, access to contraceptives and contraceptive counseling, screening for human immunodeficiency virus and counseling for sexually transmitted infections. Under these 2021 guidelines, the updated preventive coverage would need to be included with no cost sharing effective January 1, 2023. Together, the 2019 and 2021 Guidelines are referred to as “the Guidelines.”

In response to the recent U.S. Supreme Court decision overturning the constitutional right to abortion services,¹ President Biden issued an Executive Order aimed at ensuring access to reproductive healthcare. As a reminder, the ACA guarantees coverage of women’s preventive services, including free birth control and contraceptive counseling, for all individuals and covered dependents with the capacity to reproduce.

The departments issued FAQs Part 54 in response to reports that individuals continue to experience difficulty accessing contraceptive coverage without cost sharing and to clarify application of the contraceptive coverage requirements to fertility awareness-based methods and to emergency contraceptives as well as address federal preemption of state law.

Reproductive preventive care requirements

The FAQs clarify that plans and issuers are:

• Required to cover, without cost sharing, items and services that are integral to furnishing recommended preventive service, such as anesthesia necessary for a tubal ligation procedure or pregnancy tests needed before certain forms of contraceptives are provided, such as an intrauterine device (also known as an IUD), regardless of whether the items and services are billed separately. (Q&A #1)
• Required to cover, without cost sharing, contraceptive products and services that are not included in a category of contraception described in the Guidelines, as well as related patient education and counseling. This includes contraceptive services and FDA-approved, cleared or granted contraceptive products that individuals and their attending providers have determined to be medically appropriate, including those more recently approved, cleared or granted by the FDA. (Q&A #2)
• Allowed to use reasonable medical management techniques for contraceptive products or services not included in the categories described in the Guidelines to determine which specific products to cover without cost sharing only if they are available and medically appropriate for the individual. (Q&A #3)
• Required to provide coverage for instruction in fertility awareness-based methods without cost sharing. The 2021 Guidelines include “screening, education, counseling, and provision of contraceptives (including in the immediate postpartum period).” Counseling and education under the 2021 Guidelines include instruction in fertility awareness-based methods, including lactation amenorrhea. (Q&A #4)
• Required to cover without cost sharing (including when they are prescribed ahead of time) FDA-approved (1) emergency contraception (levonorgestrel), and (2) emergency contraception (ulipristal acetate), including over-the-counter (OTC) products, when the product is prescribed by an attending provider. Plans and issuers are also encouraged (but not required) to cover OTC emergency contraceptive products with no cost sharing when they are purchased without a prescription. (Q&A #5)
• Encouraged, though not required, to cover the dispensing of a 12-month supply of contraception, such as oral contraceptives, without cost sharing. (Q&A #7)

Account-based group health plans

Health savings accounts (HSAs), health flexible spending arrangements (health FSAs) or health reimbursement arrangements (HRAs) may reimburse expenses incurred for OTC contraception obtained without a prescription, to the extent that cost is not paid or reimbursed by another plan or coverage.

According to the FAQs (Q&A #6), plans and issuers covering costs of OTC contraceptives without a prescription should advise individuals not to seek reimbursement from an account-based plan for the cost (or the portion of the cost) of contraception paid or reimbursed by the plan or issuer and not to use an account-based plan (including any related debit card) to purchase contraception for which the individual intends to seek reimbursement from the plan or issuer.

Medical management techniques

With respect to contraception, plans and issuers may utilize reasonable medical management techniques only within a specified category of contraception and only when they are not specified in the Guidelines.

The FAQs reiterate that plans and issuers must cover, without cost sharing, at least one form of contraception in each category described in the Guidelines (or at least one form in a group of substantially similar services or products).

Whether a medical management technique is “reasonable” depends on all the relevant facts and circumstances. FAQ #8 provides examples of unreasonable medical management techniques, and FAQ #9 provides details on acceptable exception processes (and reminds plan sponsors that these processes must be prominently displayed in plan documents and shared with plan participants). The Departments also encourage plans and issuers to make this information readily accessible, such as electronically (on a website, for example) and on paper.

FAQ #10 makes it clear that a plan or issuer cannot require a participant to appeal an adverse benefit determination using the plan’s or issuer’s internal claims and appeals process as the means for an individual to obtain an exception, as that would be unduly burdensome.

Preemption and enforcement

The FAQs reiterate that federal law preempts any state law or laws preventing the application of the ACA’s preventive care mandate.

The Departments may also act to enforce the requirement that a state permit the free coverage of preventive care subject to the ACA. For example:

• Employee Benefits Security Administration (EBSA), which enforces Title I of ERISA, may identify group health plan violations and work to ensure that the plan makes necessary changes to come into compliance and that the plan re-adjudicates any improperly denied benefit claims. EBSA also may require the plan or third-party administrator (TPA) to notify potentially affected participants and beneficiaries.
• Centers for Medicare and Medicaid Services (CMS) may enforce the preventive services requirements with respect to non-federal governmental group health plans (e.g., plans for employees of state and local governments), as well as health insurance issuers selling products in the individual and fully insured group markets in states that elect not to enforce or fail to substantially enforce the preventive services requirements.
• HHS may investigate claims that a state might be enforcing a state law that goes against the ACA preventive care requirement (e.g., a state law prohibiting issuers from covering an FDA-approved, cleared or granted contraceptive product or service).
• Violations may also be subject to an excise tax under the tax code or a civil money penalty under the Public Health Service Act.

Going forward

• Employer plan sponsors should review their group health plan provisions with their TPAs and insurance carriers to determine if they are providing the appropriate ACA preventive care services and supplies with no cost sharing, including services and supplies for reproductive care.
• Employer plan sponsors and their TPAs/carriers should take steps to ensure their medical management techniques are reasonable in light of the FAQ guidance.
• Employer plan sponsors and their TPAs/carriers should work with their legal counsel to determine a course of action if any future state laws are enacted that conflict with the ACA reproductive preventive care requirements.

Footnote

¹ See “Supreme Court overturns Roe v. Wade: Q&As for employer plan sponsors,” Insider, July 2022.