Having a hand in the FDA approval of important new prescription drugs is one of the things that makes our work at HPM so gratifying. FDA approval is a significant hurdle to overcome, occurring only after scrupulous review of data collected over many years confirm to the satisfaction of seasoned FDA personnel that a drug is safe and effective. In some instances, however, this is only the first hurdle to make innovative products available to patients. The imposition of insurance-related hurdles beyond FDA approval, such as time-consuming prior authorizations or costly co-payments, can impede access to critical health care, such as contraceptives.
In 2010, the Patient Protection and Affordable Care Act (ACA) established a mandate requiring coverage for women’s preventive services including contraceptives. Specifically, the ACA added a section to the Public Health Service Act to require all group health plans and all issuers of group or individual health insurance coverage (other than grandfathered plans, a rapidly shrinking category) to cover without cost-sharing women’s preventive services “provided for in comprehensive guidelines supported by the Health Resources and Services Administration” (HRSA). 42 U.S.C. § 300gg-13(a)(4). HRSA’s current comprehensive guidelines “recommend that adolescent and adult women have access to the full range of female-controlled contraceptives to prevent unintended pregnancy and improve birth outcomes.” HRSA, Women’s Preventive Services Guidelines, Contraception (emphasis added). According to the guidelines, “[t]he full range of contraceptive methods for women currently identified by the [FDA] include[s]” 18 methods of contraception “and additional methods identified by the FDA.” Id. The 18 methods of contraception listed in the guidelines are derived from a Birth Control Guide (Guide) that the FDA developed in the late 1990s to provide education around relative rates of efficacy across types of contraceptives. The Guide, which provides consumers with “high-level information about different birth control options,” is “not meant to be a complete list of all available birth control options.” More importantly, it was never intended to be used as a basis for determining health insurance coverage or reimbursement as it is not fit for that purpose.
While the Guide has 18 categories, some of those categories are so broad that they can encompass contraceptives that are very different from one another. Moreover, as noted, the Guide was designed to highlight the differences in efficacy of various contraceptive methods but does not address the many other considerations that are taken into account by a woman and her provider when determining the best contraceptive to meet family planning needs. Other considerations might include the specific hormones in the product, the levels of hormones, the side effect profile, ease of use, and the ability to comply with the labeled regimen. As to the last point, compliance with a contraceptive method is critical to achieving the desired efficacy.
The federal agencies responsible for enforcing the contraceptive coverage requirement of the ACA (the Departments of Labor, Health and Human Services, and Treasury, collectively, the Departments) have issued regulations and guidance that have served to permit plans to limit the coverage they provide for contraception, despite HRSA’s recommendation that the full range of approved contraceptive methods be covered. As a result of inconsistent implementation of the ACA coverage requirements, the Departments issued guidance that plans and issuers must cover “without cost sharing at least one form of contraception in each of the methods (currently 18) that the FDA has identified for women in its current Birth Control Guide.” In addition, the Department guidance states that plans and issuers must cover at no cost any FDA-approved form of contraception if recommended by an individual’s prescriber based on a determination of medical necessity (i.e., the plan or issuer must defer to the determination of the prescriber) and that for any reasonable medical management techniques utilized within a specified method of contraception, “plans and issuers must have an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome on the individual or provider.” However, as recently described in a report issued by the National Women’s Law Center, this guidance is often not followed. When plans and issuers fail to cover the full range of contraceptives within each of the Guide’s categories or fail to defer to a prescriber’s determination of medical necessity, the form of contraception that a woman has found to be best for her (and therefore most likely to be effective) may not be covered without cost-sharing, forcing her to make the choice between effective contraception and the contraceptive that her insurance will pay for, in contravention of the ACA.
In that vein, a recent letter from congressional leaders to the Biden Administration responded to reports of coverage denials and extensive medical management requirements by health plans limiting access to contraceptives and asked the Administration to “ensure that the progress made by the [ACA] to provide individuals with coverage for the full range of [FDA] approved contraceptives continues to be protected and enforced.” The letter requested the Departments’ assistance in ensuring access “to the full range of FDA-approved contraceptives as required by law.”
The Guide, which was never intended to serve as a basis for reimbursement policy, serves an important purpose – educating women on the potential efficacy of various methods – and it should continue to be utilized for that purpose. However, based on the many factors that come into the decision-making process for each individual regarding their contraceptive, the Guide should not be utilized to limit choice. For a woman to receive access to the contraceptive option that is best for her, the ACA must be implemented as intended. Plans and issuers should be required to cover all FDA-approved contraceptive methods without a therapeutic equivalent without cost sharing – not just one or two per category in a list that was never intended by the FDA to be used for this purpose. This would implement the ACA as intended, and FDA approval of contraceptives would coincide with access for women.