Departments Investigate ACA Contraceptives Noncompliance; Updated HRSA Guidelines

Practical Law Legal Update w-034-0589 (Approx. 6 pages)

Departments Investigate ACA Contraceptives Noncompliance; Updated HRSA Guidelines

by Practical Law Employee Benefits & Executive Compensation

Coverage of Follow-Up Colonoscopies

Under the ACA's preventive health services rules, plans and insurers may not impose cost-sharing regarding preventive colorectal cancer screenings, including services integral to the screening, with a rating of "A" or "B" under current recommendations from the USPSTF. For more information, see:

The USPSTF recommends (with an "A" rating) screening for colorectal cancer in all adults aged 50 to 75 years old. In May 2021, the USPSTF also recommended (with a "B" rating) screening for colorectal cancer in adults aged 45 to 49 years old (see Legal Update, USPSTF Recommends That Colorectal Cancer Screenings Start at Age 45). The 2021 recommendation also indicated that a follow-up colonoscopy should be performed following an abnormal stool-based or direct visualization screening test.

The Departments' FAQs specify that for individuals covered by the USPSTF recommendation, plans and insurers must cover—without cost-sharing—a follow-up colonoscopy performed after a positive, non-invasive stool-based or direct visualization screening test (for example, sigmoidoscopy or CT colonography) for colon cancer. In these situations, according to the Departments, the follow-up colonoscopy is considered an integral part of the screening. Plans and insurers must provide this coverage for plan or policy years beginning on or after May 31, 2022 (that is, one year after USPSTF's related recommendation was issued).

Noncompliance with ACA Contraceptives Mandate

In another FAQ, the Departments addressed coverage, without cost-sharing, of FDA-approved contraceptives that are not included in the FDA's Birth Control Guide.

Under the ACA's preventive services rules, plans and insurers that are not exempt from the contraceptives mandate must cover, without cost-sharing, all FDA-approved contraceptive methods, sterilization procedures, and patient education and counseling for women with reproductive capacity, as prescribed by a doctor (see Practice Notes, Contraceptives Coverage Under the ACA and ACA Contraceptives: Trump Administration Religious Beliefs/Moral Convictions Exemption and Accommodation). Plans and insurers may use reasonable medical management techniques to determine the frequency, method, treatment, or setting for an item or service (if not otherwise specified in a recommendation or guideline), provided they offer an exceptions process that meets certain requirements (see Practice Note, Contraceptives Coverage Under the ACA: Exceptions Process Requirement and Related Restrictions). If an individual's attending provider recommends a particular service or item based on a medical necessity determination for the individual, the plan or insurer must:

Cover that service or item without cost-sharing.
Defer to the attending provider's determination.

In prior guidance, the Departments indicated that plans and insurers must cover without cost-sharing at least one form of contraception in each of the contraceptive methods that the FDA has identified for women in its current Birth Control Guide (see Practice Note, Contraceptives Coverage Under the ACA: List of Required Contraceptive Methods and Legal Update, ACA FAQs Address Coverage of Contraceptive Methods). In addition, plans and insurers that use reasonable medical management techniques within a specified method of contraception must have an easily accessible, transparent, and efficient exception process that is not unreasonably burdensome for individuals.

In an FAQ, the Departments stated that they have received numerous complaints and reports that participants and beneficiaries are being denied coverage of contraceptives consistent with the ACA and its implementing guidance. These reports include noncompliance by plans, insurers, and pharmacy benefit managers (PBMs). This noncompliance includes:

Denying coverage for one or more brand name contraceptives, after the individual's provider had concluded—and informed the plan or insurer—that a particular service or FDA-approved contraceptive product was medically necessary for the individual.
Requiring individuals to "fail first" using other services or FDA-approved contraceptive products within the same contraception method before a plan or insurer would approve coverage for the service or FDA-approved contraceptive product that is medically appropriate for the individual, as determined by the individual's provider.
Not providing a compliant exception process (for example, requiring individuals to appeal a benefits denial through the plan's or insurer's internal claims and appeal procedures to obtain an exception) (see Practice Note, Internal Claims and Appeals Under the ACA).

As a result, the Departments cautioned plans and insurers that they must cover, without cost-sharing, any FDA-approved contraceptive deemed medically appropriate for an individual by the attending provider, regardless of whether the particular service or product is included in the FDA's Birth Control Guide. The Departments also noted that they:

Are "actively investigating" individuals' complaints and reports of noncompliance.
May take enforcement or other corrective actions.

As a result of these complaints, the Departments also are considering whether their existing regulations and guidance should be amended to promote individuals' access as required under the ACA (as implemented).

HRSA Updates to Women's and Children's Preventive Services Guidelines

On January 11, 2022, the Health Resources and Services Administration (HRSA) announced updates to its preventive services guidelines for women and children (87 Fed. Reg. 1763 (Jan. 12, 2022); 87 Fed. Reg. 1762 (Jan. 12, 2022) (children)). The updated guidelines, which were approved in December 2021, apply for plan years beginning in 2023.

The 2021 updates consist of:

One additional service (that is, preventing obesity in midlife women).
Updates to the following five existing services:
- contraception;
- breastfeeding services and supplies;
- screening for HIV infections;
- counseling for sexually transmitted infections (STIs); and
- well-woman preventive visits.

Updates to Women's Preventive Services Guidelines

HRSA updated the Women's Preventive Services Guidelines to:

Add obesity prevention counseling for women between the ages of 40 and 60.
Include double electric breast pumps in breastfeeding equipment and supplies that must be covered without cost-sharing.
Regarding contraceptives:
- remove surgical sterilization via implant from the list of contraceptives approved, granted, or cleared by the FDA;
- include screening and education as contraceptive care; and
- remove the recommendation that instruction on fertility awareness-based methods of contraception be provided as an alternative.
Recommend HIV screening for adolescent and adult women, beginning at age 15. HRSA recommends additional education and screening beginning at age 13 for adolescent and adult women who have an increased risk of contracting HIV.
Clarify that in identifying women who may be at an increased risk of STIs, clinicians are not limited to the factors listed in the guidelines.
Clarify that recommended preventive services for women may occur during a single visit or a series of visits.

Updates to Children's Preventive Services Guidelines

HRSA also updated the preventive services guidelines for children to include:

Risk assessments for sudden cardiac arrest and death.
Risk assessments for Hepatitis B virus infections.
Suicide risk as part of depression screenings for children ages 12 to 21.

Departments Investigate ACA Contraceptives Noncompliance; Updated HRSA Guidelines | Practical Law