The departments of Labor, Health and Human Services (HHS), and the Treasury have issued Affordable Care Act (ACA) FAQs Part 64 on preventive care coverage of contraceptives and family planning counseling without cost sharing. The guidance restates the law under the ACA dealing with coverage of preventive services and gives non-grandfathered employer-sponsored group health plans and health insurance issuers a new alternative path — the “therapeutic equivalence approach” — to compliance, specifically related to contraceptives.
FAQs Part 64 do not change the timing of the ACA preventive care mandate for contraceptives (which includes the contraceptive coverage requirement). Note: The mandate continues to be challenged in a federal district court in Texas, with no word on when the court may issue its opinion.
The ACA requires non-grandfathered employer-sponsored group health plans and health insurance issuers to provide certain preventive care services with no deductibles or copays. In part, the ACA guarantees coverage of women’s preventive services, including free birth control and contraceptive counseling. At least one form of contraception in each Food and Drug Administration (FDA)-identified contraceptive category must be covered without cost sharing. Any FDA-approved, ‑cleared or -granted contraceptive product that is deemed medically appropriate by the patient and the patient’s physician must also be covered without cost sharing.[1]
The departments have released FAQs Part 64 in response to reports that many plans and issuers have not been using “reasonable” medical management techniques as required under the ACA. For example, many reportedly “continue to impose barriers to contraceptive coverage, such as requiring patients to satisfy step therapy protocols, imposing unduly burdensome administrative requirements, or requiring cost-sharing for services that are integral to the application of the preventive service provided.”
To address these concerns, the new guidance:
With regard to the ACA contraceptive mandate, whether it is “reasonable” depends on all the relevant facts and circumstances. The FAQs reiterate that a reasonable medical management technique is one that is “an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome on the individual or their provider (or other individual acting as the individual’s authorized representative)” and that “covers without cost sharing a contraceptive service or FDA-approved, ‑cleared, or ‑granted contraceptive product determined to be medically necessary with respect to an individual as determined by the individual’s attending provider.”
Under the alternative therapeutic equivalence approach, a plan’s or issuer’s medical management technique with respect to FDA-approved contraceptive drugs and drug-led devices within a specified category — as described in the Health Resources and Services Administration-supported guidelines (or group of substantially similar products that are not included in a specified category) — generally will be considered reasonable if the plan or issuer:
A therapeutically equivalent drug or device is one that is identified as a therapeutic equivalent in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). The FAQs provide an example of a reasonable medical management technique under the therapeutically equivalent drug/device approach.
The departments note that the new approach would not apply to forms of contraception that are not FDA-approved drugs or drug-led devices (which are not listed in the Orange Book).
Employer plan sponsors should:
