Regulatory Resources

FAQ about Affordable Care Act Implementation Part 64 – Coverage of Preventive Services

On January 22, 2024, Federal regulators (Regulators) issued FAQ Part – 64 clarifying the contraceptive-related services that certain plans and insurers must cover under the Public Health Service Act (PHSA) section 2713 and its implementing regulations.

Background

The Affordable Care Act (“ACA”) enacted PHSA section 2713, requiring non-grandfathered group health plans and health insurance insurers offering non-grandfathered group or individual health insurance coverage to cover certain items and services without cost-sharing, including preventive care and screenings for women provided for by guidelines supported by the Health Resources and Services Administration (“HRSA”).

The HRSA-supported guidelines recommend that adolescent and adult women have access to the full range of contraceptive care included in the Food and Drug Administration (“FDA”)-approved, -cleared, or -granted contraceptives, effective family planning practices, and sterilization procedures. The full range of contraceptives includes:
(1) sterilization surgery for women;
(2) implantable rods;
(3) copper intrauterine devices;
(4) intrauterine devices with progestin;
(5) injectable contraceptives;
(6) oral contraceptives (combined pill);
(7) oral contraceptives (progestin only);
(8) oral contraceptives (extended or continuous use;
(9) the contraceptive patch;
(10) vaginal contraceptive rings;
(11) diaphragms;
(12) contraceptive sponges;
(13) cervical caps;
(14) condoms;
(15) spermicides;
(16) emergency contraception (levonorgestrel);
(17) emergency contraception (ulipristal acetate); and any additional contraceptives approved, cleared, or granted by the FDA.

The Regulators previously issued ACA FAQs Part 54 in July 2022 to reiterate prior guidance interpreting the preventive services rule, clarifying that plans and insurers must cover without cost-sharing: (1) at least one form of contraception in each category of the HRSA-supported guidelines; and (2) any contraceptive services and FDA-approved, -cleared, or -granted products determined to be medically appropriate for the individual, regardless of whether those services or products are specifically identified in the categories listed in the HRSA-supported guidelines.

If a recommendation or guideline does not specify the frequency, method, treatment, or setting for the provision of a recommended preventive service, then the plan or insurer may use reasonable medical management techniques to determine any such coverage limitations. To the extent not specified in a recommendation or guideline, a plan or insure may rely on the relevant clinical evidence base and established reasonable medical management techniques to determine the frequency, method, treatment, or setting for coverage of a recommended preventive item or service. However, prior FAQs clarified that the use of such medical management techniques will generally not be considered reasonable unless the plan or issuer (1) has 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 (2) 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 (including if there is only one service or product that is medically appropriate for the individual, as determined by their attending provider).

The previous FAQs describe several examples of potentially unreasonable medical management techniques, including step therapy protocols, age-related restrictions for medically necessary contraceptives, unduly burdensome administrative requirements such as onerous documentation requirements, and cost-sharing for services integral to the preventive service such as anesthesia, pregnancy testing or other pre- and post-operative items and services integral to sterilization surgeries.

To view the complete FAQ Part 64, click here.

FAQ Part 64

In light of reports of continued barriers and difficulty accessing contraceptive coverage without cost sharing, Regulators have issued FAQs to provide further guidance. A high-level summary follows.

Other than what has been described in previous guidance, how can plans and insurers ensure compliance with the requirement to cover the full-range of FDA-approved contraceptive drugs and drug-led devices¹ without cost sharing under PHS Act section 2713 and its implementing regulations?

If a plan or issuer utilizes medical management techniques within a specified category described in the HRSA-supported Guidelines (or group of substantially similar products that are not included in a specified category), the Departments will generally consider such medical management techniques to be reasonable if the plan or issuer covers all FDA-approved contraceptive drugs and drug-led devices in that category (or group of substantially similar products) without cost sharing, other than those for which there is at least one therapeutic equivalent drug or drug-led device that the plan or issuer covers without cost sharing. Even then, a plan's or issuer's medical management techniques would generally be considered reasonable only if the plan or issuer provides an exceptions process that allows an individual to access without cost sharing the specific contraceptive drug or drug-led device (that is a therapeutic equivalent to the product that is covered without cost sharing) that is determined to be medically necessary with respect to the individual, as determined by the individual's attending provider.²

How will the Departments determine whether a contraceptive drug or drug-led device is therapeutically equivalent to another drug or drug-led device?

The Departments will consider a contraceptive drug or drug-led device to be therapeutically equivalent to another drug or drug-led device if the drug products or drug-led devices are identified as therapeutic equivalents (that is, designated with a code with the first letter "A") in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). The Departments will consider a drug or drug-led device for which the Orange Book has not identified any therapeutic equivalents to have no therapeutic equivalent. For example, as of the date of publication of these FAQs, under the category of "intrauterine devices with progestin (all durations and doses)," there are four FDA-approved products available; however, none of the four products are listed in the Orange Book as therapeutic equivalents to each other, so the Departments would treat each of these products as having no therapeutic equivalent.

The following example illustrates the coverage approach described in the first question on this page.

Example: Within the category of "oral contraceptives (combined pill)," a plan covers all FDA-approved oral contraceptives (combined pill) products without cost sharing, other than those for which there is a therapeutic equivalent that is covered without cost sharing. Specifically, the plan covers Pill A, Pill B, and generic Pill D without cost sharing. Neither Pill A nor Pill B has a therapeutic equivalent product according to the Orange Book. Pill W, Pill X, and Pill Y, as well as Pill Z (which is a more expensive brand name product) are all classified in the Orange Book as therapeutic equivalents to Pill D and are not covered by the plan without cost sharing. However, the plan provides an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome on an individual or their provider (or other individual acting as the individual's authorized representative). The plan's exceptions process allows an individual to receive coverage without cost sharing for a therapeutic equivalent to Pill D (i.e., Pill W, Pill X, Pill Y, or Pill Z) if the therapeutic equivalent product is determined to be medically necessary with respect to the individual, as determined by the individual's attending provider.

Conclusion: The plan's medical management techniques with respect to the category of "oral contraceptives (combined pill)" are generally reasonable. However, the plan's medical management techniques could be considered unreasonable if the plan imposes additional medical management techniques that are problematic, such those highlighted earlier in these FAQs.

Does the approach to reasonable medical management with regard to therapeutically equivalent products described in Q1 and Q2 apply to all forms of contraception required to be covered under PHS Act section 2713?

No. Forms of contraception that are not FDA-approved drugs or drug-led devices are not listed in the Orange Book. Therefore, the therapeutic equivalence approach described in Q1 and Q2 does not apply to such other forms of contraception.

If a plan or issuer covers without cost sharing all FDA-approved contraceptive drugs or contraceptive drug-led devices other than those for which there is a covered therapeutic equivalent, is the plan or issuer still expected to maintain an exceptions process as previously described in guidance?

Yes. The Departments generally do not consider medical management techniques to be reasonable absent the availability of an exceptions process. Therefore, all plans and insurers are expected to have an exceptions process available to ensure that individuals can access coverage without cost sharing for a contraceptive service or FDA-approved, -cleared, or -granted contraceptive product (including another contraceptive drug or drug-led device for which there is a covered therapeutic equivalent) that is medically necessary for the individual, as determined by the individual's attending provider, and that is otherwise not covered without cost sharing.³

Can plans and insurers continue to satisfy the requirements under PHS Act section 2713 with respect to coverage of the full range of FDA-approved, -cleared, or -granted products—including with respect to contraceptive drugs and drug-led devices—by following the Departments' prior guidance?

Yes. Plans and insurers may continue to satisfy the requirements under PHS Act section 2713 and its implementing regulations by implementing the standards described in prior guidance, including by making available 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).

¹Under PHS Act section 2713 and its implementing regulations, in conjunction with the HRSA-supported Guidelines, plans and insurers are required to cover without cost sharing the full range of FDA-approved, -cleared, or -granted contraceptives. The Departments refer to only "FDA-approved" contraceptive drugs and drug-led devices in these FAQs to reflect that the FDA approves, but does not "clear" or "grant," contraceptive drugs and drug-led devices.

²See FAQs Part 54, Q8.

³See FAQs Part 54, Q3, Q8, and Q9.