Departments Issue ACA FAQs on Coverage of Contraceptives as Preventive Care

On January 22, 2024, the DOL, HHS, and IRS (the departments) issued FAQ guidance addressing required coverage of contraceptive drugs under the ACA in response to reports of “unreasonable medical management techniques and other problematic practices” imposing barriers to contraceptive coverage without cost-sharing.

The ACA requires non-grandfathered group health plans and insurers to cover without any cost-sharing at least one form of contraception in each of 17 FDA-identified contraceptive categories, as well as any newer contraceptive service or FDA-approved, -cleared, or -granted contraceptive products that an individual and their medical provider have determined to be medically appropriate for an individual, regardless of whether those products have been specifically categorized.

With respect to those newer contraceptive products and services, the departments have allowed plans and insurers to use reasonable medical management techniques to determine which specific products or services to cover without cost-sharing so long as at least one of multiple, substantially similar products or services have been made available, and provided that it is medically appropriate for the individual.

The FAQs state that despite past attempts by the departments to clarify medical management techniques they have considered reasonable, provided there is an “easily accessible, transparent, and sufficiently expedient” exceptions process available, potentially unreasonable techniques and other problematic practices have nevertheless proliferated, including:

• Requiring individuals to satisfy step therapy protocols using other products within the same category of contraception before approving coverage for the newer product.

• Applying age-related restrictions for a product.

• Imposing onerous documentation requirements or multiple levels of processes that result in denials of coverage or the imposition of cost-sharing requirements.

• Requiring cost-sharing for services (e.g., anesthesia, pregnancy tests needed before the provision of certain forms of contraceptives, etc.) that are integral to the preventive services provided.

In response, the FAQs provide for an alternative “therapeutic equivalence approach” to compliance for contraceptive drugs and drug-led devices. Under this approach, a medical management technique will be deemed reasonable if all FDA-approved contraceptive drugs and drug-led devices in a category are covered without cost-sharing, not including any for which there is at least one therapeutic equivalent drug or drug-led device that the plan or insurer covers without cost-sharing. Additionally, there must be an exceptions process available to individuals that allows them to access a specific therapeutic equivalent determined to be medically necessary by their attending provider.

Coverage of contraceptive products and services has been and will likely remain a subject of primary concern for the departments. Plans and insurers should review these FAQs carefully as well as any contraceptive coverage requirements imposed by various states to whose laws they may be subject.

FAQS about Affordable Care Act Implementation Part 64 (dol.gov) »