The ACA Contraceptive Mandate (Part 2)

Just over two years ago, I wrote about the challenges with implementation of the contraceptive mandate in the Patient Protection and Affordable Care Act (ACA).  You will recall that, despite the ACA, a 2019 HRSA Guideline, and guidance from the federal agencies responsible for enforcing the contraceptive coverage requirement of the ACA (the Departments), women seeking contraceptives that were not specifically identified on an FDA Birth Control Guide were encountering roadblocks to accessing the contraceptive of their choice.

Since that blog post, an important step forward was the decoupling of the coverage requirement from the FDA Birth Control Guide in the guidance provided by the Department to plans and issuers.  This occurred in January 2022 when the Departments issued additional guidance, which discussed reports of denial of coverage in violation of the ACA requirement and provided a reminder to plans and issuers of their responsibilities under the statute and 2019 HRSA Guideline (FAQ Part 51, Q9).  Regarding the latter, the guidance made clear for the first time that “if an individual and their attending provider determine that a particular service or FDA-approved, cleared, or granted contraceptive product is medically appropriate for the individual (whether or not the item or service is identified in the current FDA Birth Control Guide), the plan or issuer must cover that service or product without cost sharing” (FAQ Part 51, Q9, emphasis added).  This guidance was based on stakeholder feedback that the current FDA Birth Control Guide may not identify all and/or newer contraceptive products approved, cleared, or granted by FDA.

Regarding the reports of noncompliance, the guidance provided examples, including denial of coverage for brand name contraceptives, even after the individual’s healthcare provider determines and communicates to the plan or issuer that a particular contraceptive product is medically necessary for that individual; requiring individuals to fail other numerous products within the same contraceptive method before approving coverage for the product that is medically necessary for the individual as determined by their healthcare provider; requiring individuals to fail products in other contraceptive methods before approving coverage for the product that was medically necessary for the individual as determined by their healthcare provider; and failing to provide an easily accessible, transparent, and sufficiently expedient except ion process that is not unduly burdensome.

In July 2022, the Departments issued further guidance in response to reports that individuals continued to experience difficulty in accessing contraceptive coverage without cost sharing.  With this guidance, the Departments decided to reference the 2019 HRSA Guideline rather than the FDA Birth Control Guide for the range of identified categories of contraception (FAQ Part 54, Q2), stating that plans and issuers must cover without cost sharing at least one form of contraception in each category.  The guidance also reiterated prior guidance that plans and issuers are required to “cover without cost sharing any contraceptive services and FDA-approved, cleared, or granted contraceptive products that an individual and their attending provider have determined to be medically appropriate for the individual, whether or not those services or products are specifically identified in the categories listed in the HRSA-Supported Guidelines, including contraceptive products more recently approved, cleared, or granted by FDA” (FAQ Part 54, Q2).

The Departments also reiterated that, while reasonable medical management techniques can be utilized to determine which specific products to cover without cost sharing, “[t]he plan or issuer must defer to the determination of the attending provider, and make available an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome so the individual or their provider (or other individual acting as the individual’s authorized representative) can obtain coverage for the medically necessary service or product without cost sharing” (FAQ Part 54, Q3).

While the Departments were updating their guidance, the House Committee on Oversight and Reform was investigating contraceptive coverage for individuals enrolled in private health plans by seeking information from five of the nation’s largest health insurers and four of the largest pharmacy benefit managers (PBMs) to assess how companies provided patients with access to FDA-approved birth control.  In October 2022, the Committee issued a report titled “Barriers to Birth Control: An Analysis of Contraceptive coverage and Costs for Patients with Private insurance,” which determined that:

• health plans and PBMs have coverage exclusions or cost-sharing requirements for at least 34 different contraceptive products;
• insurers and PBMs disproportionately impose cost-sharing or coverage exclusions for newer contraceptive products;
• many contraceptive products used by patients with distinct healthcare needs or disproportionately used by people with lower incomes are subject to cost-sharing or exclusions;
• health insurers and PBMs deny an average of at least 40% of exception requests with one denying up to almost 80% per year; and
• exceptions processes are inadequate.

The report recommend that Departments consider issuing further guidance to (1) clarify requirements regarding “appropriate medical management” for coverage of contraceptives, which could include providing guidance that “all FDA-approved contraceptive products that do not have a therapeutic equivalent should be covered without cost-sharing as part of every plan or formulary,” which would allow health plans and PBMs to use medical management techniques to prioritize the use of generic pharmaceuticals where possible, while ensuring that patients have access without cost-sharing to products that do not yet have a generic version; and (2) encourage exceptions processes that are automatic at the point of prescribing.

Shortly thereafter in December 2022, HRSA updated its Women’s Preventive Services Guidelines to make it more explicit that the full range of contraceptives  approved, granted, or cleared by FDA be available as part of contraceptive care.

Most recently, in June of this year, the Biden administration issued an Executive Order focused on protecting and expanding access to contraception.  Specifically, Section 2 of this executive order directs the Secretaries of the Treasury, Labor, and Health and Human Services (Secretaries) to

consider issuing guidance, consistent with applicable law, to further improve Americans’ ability to access contraception, without out-of-pocket expenses, under the Affordable Care Act.  In doing so, the Secretaries shall consider actions that would, to the greatest extent permitted by law:

• ensure coverage of comprehensive contraceptive care, including all contraceptives approved, granted, or cleared by the Food and Drug Administration, without cost sharing for enrollees, participants, and beneficiaries; and
• streamline the process for patients and healthcare providers to request coverage, without cost sharing, of medically necessary contraception.

While progress has been made in terms of the Departments’ guidance no longer depending on whether a product is identified in FDA’s Birth Control Guide, the new Executive Order makes it clear that the Biden administration believes that additional guidance is needed to ensure that full effect is given to the ACA contraceptive mandate.  It will be interesting to see what new tactics may be employed by the Departments to implement the Executive Order.