If you remember back to Civics 101, the Executive Branch issues Federal regulations implementing legislation passed by Congress. As you may recall, the Federal Departments within the Executive Branch (like the Department of Health and Human Services, the Department of Labor and the Department of Treasury) are the ones responsible for writing these regulations.
At various points in the year, the Federal Departments release what is called the Unified Agenda. The Unified Agenda provides everyone with a list of what regulations the Federal Departments are working on and their expected release date.
Some of the regulations that show up in the Unified Agenda are not a surprise. Why? Because these regulations are issued on an annual basis and we expect to see them. Some of the other listed regulations have been in development for months, and they were already listed on prior versions of the Unified Agenda. But oftentimes, there are regulations that were NOT on previous Unified Agendas, or regulations that we are expecting, but the release date has been delayed.
The most recently released Unified Agenda came out on July 5. And there are a couple of regulations that stakeholders in the health care industry should take note of.
Mental Health Parity
Back in July 2023, the Biden Administration released proposed regulations intended to increase access to mental health and substance use disorder (MH/SUD) benefits through increased compliance with the Mental Health Parity requirements.
These proposed regulations focused exclusively on Non-Quantitative Treatment Limitations (NQTLs) (such as prior authorization, concurrent review and other utilization management tools) that fully-insured and self-insured health plans impose on MH/SUD benefits, requiring plans to ensure that the NQTLs imposed on MH/SUD benefits are comparable to the NQTLs imposed on medical and surgical (M/S) benefits.
The employer and insurance carrier communities have been vocal about the inability and difficulty to comply with the proposed definitions and mathematical tests used to determine whether an appropriate level of comparability is present, and they have been bracing for the release of the final regulations, which the Unified Agenda indicates will be some time in August 2024. So, stay tuned…
Surprise Billing Requirements
In response to feedback, suggestions and complaints from medical providers and payers (i.e., self-insured plans and insurance carriers) about how the Federal Surprise Billing Payment Process is working (and not working), the Federal Departments released proposed regulations back in October 2023 that would (1) Formalize the Open Negotiation Period by requiring providers and payers to submit the Open Negotiation Notice through the Federal Portal system, (2) Require health claim numbers, contact information and other details to be specifically included on both the Open Negotiation Notice as well as the Notice of IDR, and (3) Revise the use of service codes in “batched” claims.
Stakeholders have been anxiously awaiting these regulations, as they are viewed by both providers and payers as significant improvements to the Federal Surprise Billing Payment Process, and most expected that final regulations would be released this Summer; however, the most recent Unified Agenda shows that the release date has been delayed to November 2024.
The Unified Agenda also speaks to proposed regulations that were issued back in 2021, but never finalized. The final regulations – that relate to the form and manner in which air ambulance services should be reported – have been pushed all the way to March 2025.
Advanced Explanation of Benefits (AEOBs)
The No Surprise Act (NSA) is most well-known for the Federal Surprise Billing Protections. However, there were a number of “other provisions” included in the NSA that are intended to increase medical literacy and shine a light on participant out-of-pocket costs for scheduled medical procedures. One such provision is the Advanced Explanation of Benefits (AEOBs). Learn more about the NSA and AEOBs in this blog post.
Back on August 20, 2021, the Federal Departments issued guidance instructing stakeholders that until the Federal Departments issue regulations implementing the AEOB requirement, the Departments will NOT penalize self-insured plans and insurance carriers for the form and content of their AEOBs, should they even send one to participants.
Back on September 16, 2022, the Federal Departments issued a Request for Information (RFI) asking health care industry stakeholders to submit public comments suggesting how the Departments should develop proposed regulations implementing the AEOB requirement. And ever since, stakeholders have been asking: Will we ever see regulations on the AEOBs?
Well, the recently released Unified Agenda tells us that we should expect proposed regulations in March 2025.
HIPAA Privacy and Cybersecurity
On February 21, 2023, Change Healthcare – the largest health care payment processor in the U.S. – was the target of a cyberattack. The attack had wide-ranging impacts, disrupting payments to hospitals, physicians, pharmacists and other health care providers.
The scale of this cyberattack – on top of years of multiple cyberattacks plaguing the health care industry – has sparked serious questions about what the government’s role should be when it comes to cybersecurity.
The Unified Agenda seems to answer this question. For the first time, we see that the Federal Departments are working on HIPAA regulations that are intended to improve cybersecurity measures for medical providers, health plans and third parties that handle and store personal health information. The Unified Agenda stipulates that proposed regulations will be released in December 2024.
The information provided does not, and is not intended to, constitute legal advice; instead, all information and content herein is provided for general informational purposes only and may not constitute the most up-to-date legal or other information. This summary is provided by a consultant to Benefitfocus.com, Inc., and any opinions expressed within do not necessarily reflect those of Benefitfocus.com, Inc. or its affiliates and are not intended to provide specific advice or recommendations for any plan or individual.
