United States: New Final Regulations And FAQs Provide Guidance On Preventive Services Coverage

Through new FAQs and final regulations, the U.S. Departments of Labor ("DOL"), Health and Human Services ("HHS") and the Treasury (the "Departments") have further clarified various issues related to the preventive care coverage requirement for non-grandfathered group health plans under the Affordable Care Act ("ACA") as related to preventive care coverage.


The ACA requires that non-grandfathered group health plans provide benefits for certain preventive care without cost sharing, including:

  • Evidenced-based items or services that have a rating of "A" or "B" in the current recommendations of the United States Preventive Services Task Force ("USPSTF") for the individual (except for breast cancer screening, mammography, and prevention, where there are updated USPSTF standards);
  • Immunizations for routine use recommended by the Advisory Committee on Immunization Practices ("ACIP") of the Centers for Disease Control and Prevention ("CDC") for the individual;
  • For infants, children, and adolescents: evidence-informed preventive care and screenings provided for in the comprehensive guidelines supported by the Health Resources and Services Administration ("HRSA"); and
  • For women: other evidence-informed preventive care and screening provided for in comprehensive guidelines supported by the HRSA

FAQs on Preventive Care Coverage

Noting that confusion still remained regarding the scope of the preventive care coverage requirements, on May 11, 2015, the Departments issued new sub-regulatory guidance, DOL FAQs Part XXVI, to further clarify these guidelines.  Noteworthy clarifications include that:

  • Prior guidance had stated that these guidelines and recommendations include coverage for genetic counseling and, if indicated after counseling, BRCA (breast cancer susceptibility genes) testing for women who have positive family history screening results.  The new guidance clarified that plans must cover recommended genetic counseling and BRCA genetic testing for women who have not been diagnosed with BRCA-related cancer but who previously had breast, ovarian or other cancer.  This would appear to apply to asymptomatic and cancer-free women with a personal history of cancer even if no other family members are known to have the cancer.
  • Plans must cover, without cost sharing, at least one form of women's contraception in each of the 18 methods identified by the Food and Drug Administration ("FDA").  The 18 methods include: (1) sterilization surgery for women; (2) surgical sterilization implant for women; (3) implantable rod; (4) IUD copper; (5) IUD with progestin; (6) shot/injection; (7) oral contraceptives (combined pill); (8) oral contraceptives (progestin only); (9) oral contraceptives (extended/continuous use); (10) patch; (11) vaginal contraceptive ring; (12) diaphragm; (13) sponge; (14) cervical cap; (15) female condom; (16) spermicide; (17) emergency contraception (Plan B/Plan B One Step/Next Choice); and (18) emergency contraception (Ella).

Thus, for example, a plan could not cover some forms of oral contraceptives, some types of IUDs, and some types of diaphragms without cost sharing, but then completely exclude other forms of contraception.  Similarly, a plan that covers oral contraceptives cannot impose cost sharing on all items or services within other FDA-identified hormonal contraceptive methods such as the vaginal contraceptive ring or the contraceptive patch.

Within each women's contraceptive method, plans can utilize reasonable medical management techniques, such as imposing cost sharing on some items and services to encourage the individual to use other specific items and services within the particular method.  Thus, for example, the plan can cover generic drugs within a method with no cost sharing but impose cost sharing on brand drugs in the same method.

However, if the plan does use reasonable medical management techniques within a particular contraceptive method, it must have "an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome" on the individual (or provider or representative).  In addition, the plan must cover a particular service or FDA-approved item without cost sharing if the individual's attending provider recommends that service or item based on a determination of medical necessity for that individual.   The plan must defer to the provider's determination.  The plan must also make determinations taking into account the type of claim and the medical exigencies in a case involving urgent care.

The Departments will not be enforcing these interpretations until the first plan year beginning at least 60 days after May 11, 2015—meaning that for calendar year plans, this portion of the new FAQ guidance will not apply until January 1, 2016.

  • Plans cannot limit sex-specific recommended preventive services based on an individual's sex assigned at birth, gender identity or recorded gender where the attending provider determines that a service is appropriate for the individual (and the individual otherwise satisfies the recommendation/guideline criteria).  Thus, for example, if the attending provider determines it appropriate, a plan would be required to provide a mammogram or pap smear for a transgender man who has residual breast tissue or an intact cervix.
  • If a plan covers dependent children, it must cover, without cost sharing, recommended women's preventive care services for dependent children, including recommended preventive services related to pregnancy, such as preconception and prenatal care.
  • A plan cannot impose cost sharing for anesthesia services performed in connection with a colonoscopy performed as a preventive screening procedure for colorectal cancer pursuant to the USPSTF recommendations.

New Final Regulations

On July 14, 2015, the Departments published final regulations further clarifying preventive services coverage.  Important changes in the new final rules are as follows:

  • Prior Department FAQ guidance on preventive services remains applicable.
  • The final regulations explicitly incorporate DOL FAQ Part XII's clarification that plans or issuers may not impose cost sharing on preventive services provided by an out-of-network provider when such services are not offered by an in-network provider.
  • The final regulations explicitly incorporate DOL FAQ Part II and Part XXVI clarifications that plans or issuers can rely on the relevant evidence base and established reasonable medical management techniques when determining frequency, treatment, method or setting for providing a recommended preventive service when such coverage limits are not specified in recommendations or guidelines.
  • Plans or issuers generally cannot eliminate coverage for preventive services that are no longer recommended during the course of a plan or policy year (i.e., the plan or issuer must usually cover a preventive service until the last day of the plan or policy year in which the recommendation or guideline was narrowed or eliminated).  However, plans or issuers are permitted to cease coverage for a preventive service that is no longer recommended during a plan or policy year if:

    • An "A" or "B" rating in the current recommendations of the USPSTF is downgraded to a "D" rating; or
    • An item or service associated with a preventive service is recalled for safety reasons or is determined to pose a significant safety risk by a federal agency regulating that service.
  • Prior guidance provides for an accommodation process that allows certain non-profit entities and, due to the Supreme Court decisions in Burwell v. Hobby Lobby Stores, Inc., closely held for-profit entities who have religious objections, not to provide or pay for certain preventive services. The final regulations define "closely held for-profit entity" for this purpose. This new definition takes into account the more than 75,000 comments the Departments received on how to structure the definition.  To qualify for a religious objection accommodation, a for-profit entity must be an organization (which can be a personal services corporation) that:

    • Is not publicly traded;
    • Is majority-owned (51% or more) directly or indirectly by five or fewer individuals as of the date of the entity's self-certification or notice to HHS, or has a substantially similar ownership structure (e.g., 49% owned by six people or 45% owned by three people); and
    • Objects to providing contraceptive coverage due to its owners' religious beliefs.
  • Prior final regulations explicitly permitted issuers of fully insured plans (that are paying for contraceptive services under the religious objection accommodation) to pay for either (i) all FDA-approved contraceptive services, or (ii) only those services to which the eligible organization has a religious objection.  The new final regulations clarify that third party administrators of self-insured plans (and not only issuers of fully insured plans) are permitted the same option.
  • The final regulations confirm that the regulations' guidance will apply in the same way to health insurance coverage bought and sold through the Small Business Health Options Program ("SHOP") as to health insurance coverage bought through other avenues.

The new final regulations are effective September 14, 2015, and are applicable starting with the first plan year beginning on or after September 14, 2015—for calendar year plans, the final regulations will not apply until January 1, 2016.

What Employers Should Do

  1. Ensure that their plans and summary plan descriptions do not contain provisions that contradict the FAQ or final regulation guidance on preventive services coverage;
  2. Review preventive services coverage annually to ensure that preventive services remain covered throughout the full policy or plan year, unless the service is downgraded to a "D" rating or is recalled for safety reasons (or is deemed a significant safety risk); and
  3. Analyze plan administration procedures and communicate with outside administrators to confirm that all claims administration and communications with plan participants are consistent with the FAQ and final regulation guidance.

New Final Regulations And FAQs Provide Guidance On Preventive Services Coverage

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