The U.S. Food and Drug Administration (FDA) announced the approval of new COVID-19 vaccines for both adults and children for the 2024-2025 season.
Among these FDA approvals:
Emergency room visits for COVID-19 among working-age individuals (ages 18 to 64) hovers around 2%. The overall U.S. death rate remains 5% to 10% higher than pre-pandemic levels, influenced by both the direct impact of COVID-19 and its effects on routine healthcare and the broader healthcare system.
Employers offering fully funded health plans and self-insured employer-sponsored health plans are required by the Affordable Care Act to cover these vaccinations without any cost-sharing for patients.
The Biden administration recently released its final Unified Agenda, a comprehensive list of regulations being developed by various federal departments, along with their anticipated release dates.
Key Regulations to Watch
Aimed at enhancing access to mental health and substance-use disorder benefits by tightening compliance with mental health parity requirements. Employers and insurance carriers have raised concerns about the challenges in meeting these new definitions and tests. The final regulations are expected to be released in September 2024.
These regulations include formalizing the open negotiation period, specifying details required on negotiation notices, and revising the use of service codes for batched claims. The release of these final regulations has been delayed until November 2024, with regulations on air ambulance services pushed to March 2025.
Federal agencies issued guidance in 2021 allowing self-insured plans and insurance carriers to send explanations of benefits (EOBs) without penalty until formal regulations on advanced EOBs are in place. After seeking input from stakeholders two years ago, proposed regulations are now expected in March 2025.
For the first time, federal departments are working on HIPAA regulations specifically aimed at enhancing cybersecurity measures for medical providers, health plans, and third parties that manage personal health information. The proposed regulations are scheduled for release in December 2024.
Q: Our client was advised in error to pay the PCORI fee for last year under the assumption the group’s plan was self-funded. However, the group plan was, in fact, fully insured at the time. How should the client handle the over-payment?
A: If a plan sponsor overpaid the PCORI fee, it can file Form 720-X for an over-payment of a previously-filed PCORI liability. Form 720-X is available on IRS.gov.
Answers to the Question of the Week are provided by Kutak Rock LLP. Kutak Rock provides general compliance guidance through the UBA Compliance Help Desk, which does not constitute legal advice or create an attorney-client relationship. Please consult your legal advisor for specific legal advice.
Resources
Overview of ACA affordability requirements for employer-sponsored health coverage, including annual percentage thresholds, IRS safe harbors (FPL, Rate of Pay, Form W-2), and key factors affecting employee contributions such as flex credits, opt-out incentives, and wellness programs.
The IRS released the 2027 health savings account (HSA) annual contribution limits and high deductible health plan (HDHP) requirements in IRS Rev. Proc. 2026-24.
Each year, employers may be responsible for reporting and paying the Patient-Centered Outcomes Research Institute (PCORI) fee. Here’s a high-level overview of what to expect for the 2026 filing cycle.
What "covered" should feel like.
What "covered" should feel like.
What "covered" should feel like.
What "covered" should feel like.
What "covered" should feel like.
