Regulatory Updates
Regulatory Updates provide quick access to employee benefit regulations, rulings and other guidance released by governmental agencies in the U.S. and Canada.
New updates to this page may be included in Today’s Headlines which is emailed to International Foundation members each business day. Inquiries regarding these updates should be directed to the Benefits Knowledge Center at the International Foundation at (888) 334-3327, option 5 or [email protected].
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ACA Implementation FAQ Part 64 Addresses Coverage of Preventive Services
Jan 22, 2024, 06:00
by
Amanda Wilke
The Departments of Labor (DOL), Health and Human Services (HHS), and the Treasury (collectively, the Departments) released Affordable Care Act (ACA) Frequently Asked Questions (FAQs) Part 64 discussing implementation of certain provisions of the Affordable Care Act (ACA) to help plans and issuers understand the law and promote compliance.
The Departments issued the FAQs on coverage of contraceptives and contraceptive care pursuant to HRSA-supported guidance after reports of continued barriers and difficulty accessing contraceptive coverage without cost sharing. The FAQs provide further guidance on a therapeutic equivalence approach, which plans and issuers may adopt (in combination with an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome) to comply with the requirements under PHS Act section 2713 regarding the coverage of contraceptive drugs and drug-led devices.
FAQs relate to:
- Ensuring compliance with the requirement to cover the full-range of FDA-approved contraceptive drugs and drug-led devices24 without cost sharing;
- Determining whether a contraceptive drug or drug-led device is therapeutically equivalent to another drug or drug-led device;
- Whether the approach to reasonable medical management with regard to therapeutically equivalent products described in Q1 and Q2 applies to all forms of contraception required to be covered
- Whether the plan is expected to maintain an exceptions process if a plan covers without cost sharing all FDA-approved contraceptive drugs or contraceptive drug-led devices other than those for which there is a covered therapeutic equivalent;
- Whether plans and issuers continue to satisfy the requirements under PHS Act section 2713 with respect to coverage of the full range of FDA-approved, -cleared, or -granted products—including with respect to contraceptive drugs and drug-led devices—by following the Departments’ prior guidance; and
- What an individual should do if they have concerns regarding, or have difficulty with, accessing contraceptive coverage under their group health plan.