New frequently asked questions (FAQs), define the contraceptive coverage that a non-grandfathered group health plan must provide in order to comply with the Affordable Care Act (ACA) mandate to cover certain preventive services without cost-sharing. The FAQs refer to 18 FDA-approved contraception methods and require coverage of at least one form of contraception within each of the 18 methods. If the FDA approves additional contraception methods, it appears that at least one form of contraception within each of those additional methods also would be required. The new FAQs are Part XXVI of an ongoing series issued by the agencies responsible for implementation of the ACA mandates (the Departments of Treasury, Labor and Health and Human Services).
The ACA requires non-grandfathered plans to provide a wide variety of preventive care benefits with no cost-sharing…no deductible, no co-payment, no co-insurance. If a recommendation or guideline does not specify the frequency, method, treatment or setting for the provision of a recommended preventive service, a plan may use reasonable medical management techniques to determine those limits. The required preventive care items include FDA-approved contraceptive methods, sterilization procedures, and patient education and counseling for all women with reproductive capacity, as prescribed by a healthcare provider.
In 2013, the agencies responsible for implementation of the preventive care mandate issued FAQs that:
- Required access to the full range of FDA-approved contraceptive methods including, but not limited to, barrier methods, hormonal methods, and implanted devices.
- Noted that plans may use reasonable medical management techniques to control costs and promote efficient delivery of care, such as covering a generic drug without cost-sharing and imposing cost-sharing for equivalent branded drugs.
- Required plans to waive otherwise-applicable cost-sharing for a brand or non-preferred brand version of a particular drug if it would be medically inappropriate, as determined by the woman’s health care provider (the contraceptive coverage mandate applies only to women, not to men).
New FAQs Are More Specific
Noting that prior guidance may have reasonably been interpreted as allowing exclusion of some FDA-approved contraception methods, the agencies provided clarification in the new FAQs and committed to applying it prospectively only, starting with plan years beginning on or after July 10, 2015 (at least 60 days after publication of the FAQs). With respect to contraceptives, the FAQs specify the following:
- Plans must cover without cost-sharing at least one form of contraception in each of the methods (of which there are currently 18) the FDA has identified for women in its current Birth Control Guide. The coverage must also include the clinical services, including patient education and counseling, needed for provision of the contraceptive method.
- Within each method, a plan may continue to use reasonable medical management techniques and may require cost-sharing for some items and services within the chosen contraceptive method, so long as at least one form of contraception is available within that method without cost-sharing. For example, a plan may discourage use of brand name pharmacy items within a given method over generic pharmacy items within that method through the imposition of cost-sharing.
- If using such medical management techniques within a method of contraception, an “easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome” must be available. A plan must waive cost-sharing that would otherwise apply to an item if a woman’s attending provider recommends that item based on medical necessity, even if multiple other FDA-approved forms of the same method of contraception are available with no cost-sharing.
- Based on previous guidance requiring coverage of hormonal contraception methods, some plans apparently cover oral contraceptives without cost-sharing, but exclude or require cost-sharing for other FDA-approved hormonal contraceptive methods. Examples include injectables, implants, the contraceptive patch, emergency contraception (Plan B/Plan B One Step/Next Choice), and emergency contraception (Ella). The agencies now specify that coverage of at least one form of contraception within each of these separate methods must be covered without cost-sharing.
The FAQs do not address the extent to which religious objections of a plan sponsor would exempt a plan from providing any or all of the contraceptive methods or qualify it for an accommodation under agency guidance.
The Kaiser Family Foundation has compiled a helpful chart regarding required coverage of the 18 contraceptive methods.
Agencies Also Addressed Other Preventive Issues in FAQs
The agencies took the occasion of these FAQs to provide clarification on a few other issues. Related to women’s preventive healthcare, the agencies noted that plans must provide these benefits to enrolled children, if age-appropriate. This apparently includes prenatal preventive care services for a pregnant dependent daughter, even if the plan generally excludes coverage of such pregnancies.
- A plan must cover preventive screening, genetic counseling and BRCA genetic testing without cost-sharing for women who previously had breast cancer, ovarian cancer or other non-BRCA-related cancer.
- Plans may not limit sex-specific recommended preventive services based on an individual’s sex assigned at birth, gender identity or recorded gender.
- A plan may not require cost-sharing with respect to anesthesia services performed in connection with a screening colonoscopy if the provider determines the services are medically appropriate.