Compliance News | February 5, 2024
The Departments of Labor, Health and Human Services and the Treasury (collectively, the “Departments”) have issued guidance regarding reasonable medical management of contraceptive benefits. To advance the Departments’ aim to mitigate unreasonable barriers to contraceptive coverage, they are providing a new alternative approach, the therapeutic equivalence approach, that non-grandfathered group health plans can use to comply with the ACA preventive service rules regarding contraceptive coverage.
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As with the current approach, plans must have an exceptions process to allow women to access contraceptives recommended for them based on medical necessity.
Plan sponsors should consult with their professional advisors and their pharmacy benefit manager (PBM) on which approach is right for them.
The ACA generally requires non-grandfathered group health plans to cover recommended preventive services without cost sharing. With respect to contraceptive coverage, the Departments have interpreted the ACA requirements to cover preventive services in conjunction with the Health Resources and Services Administration (HRSA)-supported Women’s Preventive Services Guidelines.
Under the ACA, a plan must provide the full range of contraceptives which includes the 17 categories listed in the FDA’s Birth Control Guide, current as of July 13, 2023: sterilization surgery for women, implantable rods, copper intrauterine devices, intrauterine devices with progestin (all durations and doses), injectable contraceptives, oral contraceptives (combined pill), oral contraceptives (progestin only), oral contraceptives (extended or continuous use), the contraceptive patch, vaginal contraceptive rings, diaphragms, contraceptive sponges, cervical caps, condoms, spermicides, emergency contraception (levonorgestrel) and emergency contraception (ulipristal acetate), as well as any additional contraceptives approved, cleared or granted by the Food and Drug Administration (FDA). In addition, for those services that are not included in the categories, plans must cover FDA-approved, -cleared or -granted contraceptive services that an individual and their attending provider have determined to be medically appropriate for the individual.
Generally, if a recommendation or guideline does not specify the frequency, method, treatment or setting for the provision of a recommended preventive service, then a plan may use reasonable medical management techniques to determine coverage limitations. Newer contraceptive products and services not included in the categories listed in the HRSA-supported guidelines may also be subject to medical management.
Under the ACA, plans and insurers are required to cover at least one contraceptive in each category without cost sharing and to provide an exceptions process that would ensure an individual could access a contraceptive that the individual’s attending provider determined to be medically appropriate for the individual when a medically appropriate option was not already covered under the plan. In FAQs Part 54, the Departments restated the coverage requirements under the rule and provided examples of unreasonable medical management, such as requiring step therapy within the same category of FDA-approved care before the plan or issuer will approve the contraceptive product that is medically necessary for the individual, as determined by the individual's attending health care provider.
In FAQs Part 54 the Departments remind that reasonable medical management must include an exceptions process available to ensure that individuals can access coverage without cost-sharing for an FDA-approved, -cleared or -granted contraceptive product that is medically necessary for the individual, as determined by their attending provider. The exceptions process must be easily available, transparent and sufficiently expedient and must not be unduly burdensome on the individual or their provider. If there is only one service or product that is medically appropriate for the individual, as determined by their attending provider, it must be covered through the exceptions process.
The exceptions process is separate from a traditional appeal and must be communicated to the participant in plan descriptions.
The exceptions process continues to be required under the alternative method discussed below.
In FAQ Part 64 the Departments provide an approach for reasonable medical management of contraceptive coverage. Specifically, to comply with ACA requirements, plans and insurers can either continue to provide contraceptive coverage consistent with the Departments’ prior guidance as discussed above or alternatively use the following new “therapeutic equivalence approach” related to FDA-approved contraceptives only:
A “therapeutically equivalent” drug is one that is identified as a therapeutic equivalent by the FDA in its publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the “Orange Book”).
FAQ 64 provides an example related to the category of “oral contraceptives (combined pill).” Plans may cover several FDA-approved oral contraceptives (combined pill) without cost sharing. At the same time, the plan may exclude coverage for certain oral contraceptives (combined pill) where there is a therapeutic equivalent that is covered without cost sharing. This essentially allows the plan to exclude certain brand-name drugs as long as a therapeutically equivalent drug, such as a generic, is covered without cost sharing.
The Departments expect that plans choosing to provide coverage under the therapeutic equivalence approach will experience a significant reduction in the frequency with which the exceptions process would be used to access contraceptive drugs. However, the upfront review of benefits necessary to determine whether the approach is part of the plan may be time consuming.
Sponsors of plans that directly administer contraceptive coverage or that rely on an outside administrator may want to explore whether their current process is already consistent with the therapeutic alternative approach or if they might adapt processes to align with the therapeutic alternative approach, including what cost implications they might expect.
Regardless of which approach they choose to follow, plan sponsors must ensure that either they or their administrators offer the exceptions process and communicate that process to plan participants.
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This page is for informational purposes only and does not constitute legal, tax or investment advice. You are encouraged to discuss the issues raised here with your legal, tax and other advisors before determining how the issues apply to your specific situations.