February 21, 2024
On January 22, 2024, the Departments of Labor/Employee Benefits Security Administration (DOL/EBSA), Health and Human Services/Centers for Medicare and Medicaid Services (HHS/CMS) and Treasury/Internal Revenue Service (Treasury/IRS) – collectively, the Tri-Departments – issued Affordable Care Act (ACA) FAQ Part 64 which offers plans an alternative tool for determining the baseline contraceptives to offer without cost-sharing.
The ACA requires plans to cover preventive services meeting certain standards at 100% and without cost-sharing. Among other requirements, the Women’s Preventive Services Guidelines supported by the Health Resources and Services Administration (HRSA) require that plans cover the full range of contraceptives and contraceptive care to prevent unintended pregnancies and improve birth outcomes.
Key Action
Review the FAQ to assess existing practices and guidance (which are not disrupted by this option) and determine if plan changes are desirable or warranted for contraceptive coverage requirements.
In recent years, the Biden Administration has focused on ensuring that plans that use any formulary or other restrictions to provide some contraceptive items and services at zero cost-sharing also provide a streamlined and easy to use exceptions process to ensure that individuals can access all forms of contraception covered 100% ($0 cost-sharing). These FAQs identify a new reference source for plans to consider utilizing in designing which items and services may be considered or offered first (like a formulary may) but do not otherwise limit or change the existing requirements to provide a streamlined and easy exceptions process to access any other available contraceptive items and services.
Summary
ACA FAQ Part 64 generally provides:
- Plans can choose to cover all contraceptive drug or drug-led devices that do not have a therapeutic equivalent (or that are not themselves listed) in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) at 100%.
- For contraceptive drugs and drug-led devices that are: (1) in the Orange Book AND (2) have one or more equivalents, a plan can limit the initial 100% coverage to one of the contraceptives that are equivalents and impose cost-sharing or exclusions on the others.
- However, the plan still must have an easy exceptions process to get those equivalents covered at 100% if/when determined as medically necessary by the individual’s attending provider.
What’s Next?
Plans may wish to review their arrangements and existing formulary for contraceptive items and services, and consider whether using the alternative categorization/coverage design under ACA FAQ Part 64 would be preferred for administration, coverage, user-experience, or other reasons appropriate for plan design and implementation.
If you have questions, comments, or concerns about these or other regulatory and compliance issues, please contact us.
We provide this material for informational purposes only; it is not a substitute for legal advice.
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