As we bid farewell to 2024 and look ahead to the new year, we reflect on the many evolving compliance obligations that health and welfare plan sponsors tackle each year. Although this list is by no means exhaustive, it highlights four items and associated deadlines that have recently emerged on the health and welfare scene. Plan sponsors should review their routine compliance checklists and update as necessary to ensure a smooth transition into 2025.
- Gag Clause Attestations
The Consolidated Appropriations Act of 2021 generally prohibits the use of gag clauses in certain agreements and requires group health plans and health insurance issuers to annually submit a Gag Clause Prohibition Compliance Attestation. A fully insured group health plan’s responsibility is satisfied if the issuer submits an Attestation on behalf of the plan. Similarly, a self-insured plan may delegate the task of submitting the Attestation to a third-party administrator (TPA) via a written agreement if the TPA will accept this responsibility. The Attestation must be submitted to the Departments of Labor, Health & Human Services, and the Treasury by December 31st. See this link for further details and instructions on submission.
- Mental Health Parity – Fiduciary Certification
In September, the Departments of Labor, HHS, and the Treasury issued new final rules amending regulations implementing the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) and adding new regulations implementing the nonquantitative treatment limitation (NQTL) comparative analyses requirements. Consistent with the proposed rules, the final rules strengthen consumer protections by aiming to achieve parity between mental health/substance use disorder (MH/SUD) benefits and medical/surgical (M/S) benefits. The final rules generally apply to group health plans and group health insurance coverage for plan years beginning on or after January 1, 2025, although many provisions will not apply until 2026.
The final rules require that, in addition to the NQTL comparative analysis, each plan or issuer must prepare and make available to the Secretary, upon request, a written list of all NQTLs imposed under the plan or coverage. In addition, for ERISA-covered plans, this written list must be given to the named plan fiduciaries, who are required to include a certification as part of the comparative analysis. At least one of these named fiduciaries will certify they have engaged in a prudent process to select one or more qualified service providers to perform and document a comparative analysis in connection with the imposition of any NQTLs that apply to MH/SUD benefits under the plan in accordance with applicable law and regulations and have satisfied their duty to monitor those service providers as required by part 4 of ERISA. At a minimum, the certifying fiduciary should review the comparative analysis, ask questions, and discuss the findings and conclusions with the service provider responsible for performing and documenting the comparative analysis, and obtain assurance from the service provider that, to the best of its ability, the NQTL and associated comparative analysis complies with MHPAEA and its implementing regulations.
Plans subject to MHPAEA should update their existing comparative analyses to reflect the new certification requirement by the first day of the 2025 plan year.
- Reproductive Health Care ‒ Updates to HIPAA Policies, Procedures, and Notice of Privacy Practices
In response to the decision in Dobbs v. Jackson Women’s Health Organization that effectively overturned Roe v. Wade, the Biden-Harris Administration, through OCR, issued a final rule to modify the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to support privacy in reproductive health care. The rule places limitations on the use and disclosure of reproductive healthcare information by healthcare providers and group health plans. The rule also requires several updates to HIPAA policies and procedures concerning health plans and operations of health care providers. Although most of those changes went into effect on December 23, 2024, HIPAA-covered entities have until February 16, 2026, to update their Notices of Privacy Practices. For more information about this change, see our blog posts: New HIPAA Final Rule Imposes Added Protections for Reproductive Health Care Privacy and HIPAA Final Rule For Reproductive Health Care Privacy with December 23, 2024, Compliance Deadline.
- ACA Section 1557 Notices of Nondiscrimination and Availability
The U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) enforces Section 1557 of the Affordable Care Act (Section 1557), which prohibits discrimination on the basis of race, color, national origin, age, disability, or sex (including pregnancy, sexual orientation, gender identity, and sex characteristics), in covered health programs or activities. Last spring, OCR issued a final rule under Section 1557 advancing protections against discrimination in health care. Under the final rule, covered entities (i.e., health programs and activities that receive HHS funding or are administered by HHS) must provide an annual notice of nondiscrimination to participants, beneficiaries, enrollees, applicants of their health programs and activities, and members of the public. This notice must be provided within 120 days of July 5, 2024, under the requirements of 45 CFR § 92.10. Similarly, covered entities must provide, within one year of July 5, 2024, a notice of the availability of language assistance services and auxiliary aids and services, stating at a minimum that these are free of charge when necessary for compliance with Section 1557. See 45 CFR § 92.11.
Although the rule was scheduled to go into effect on July 5, 2024, certain provisions have been stayed or enjoined pending multiple lawsuits. For example, under the final rule, a notice of nondiscrimination states in part that the covered entity does not discriminate on the basis of sex, which includes discrimination based on gender identity. However, in Tennessee v. Becerra, No. 1:24cv161-LG-BWR (S.D. Miss.), the court stayed nationwide several regulations to the extent they “extend discrimination on the basis of sex to include discrimination on the basis of gender identity”. The case is currently pending appeal.
Covered entities must continue to provide notices of nondiscrimination and availability unless specific provisions are stayed or enjoined. OCR’s sample notice of nondiscrimination currently characterizes as optional the inclusion of a statement of nondiscrimination based on gender identity. Still, covered entities should be prepared to adjust their notices if the stay is lifted. Sample notices are available on OCR’s website. For more information, see Section 1557 of the Patient Protection and Affordable Care Act | HHS.gov.
The new year often presents an opportunity to renegotiate or terminate existing service provider agreements, so now is a perfect time to reanalyze contracts before renewal.