Regulations issued by federal agencies can have as great of an impact on the health care industry as the broader laws passed by Congress and signed by the president. The Biden administration has released its final so-called Unified Agenda, which provide a list of regulations that federal departments are working on and their expected release dates.
Although the overall list covers a broad range of agencies and regulations, the health care software company Benefitfocus identified the ones with the most potential impact on the health care industry.
Mental health parity. In July 2023, the administration released proposed regulations intended to increase access to mental health and substance-use disorder benefits through increased compliance with mental health parity requirements. Employers and insurance carriers have been vocal about the difficulty of complying with the proposed definitions and mathematical tests used to determine whether an appropriate level of comparability is present. They have been bracing for the release of the final regulations, which the Unified Agenda indicates will be sometime this month.
Surprise billing requirements. In response to feedback from medical providers and payers about how the federal surprise billing payment process is working, federal departments released proposed regulations in October 2023 that would formalize the open negotiation period; require health claim numbers, contact information and other details to be specifically included on both the open negotiation notice and the notice of independent dispute resolution; and revise the use of service codes in “batched” claims. Providers and payers view these regulations as significant improvements. The most recent Unified Agenda shows that the release date has been delayed until November, and final regulations regarding air ambulance services have been pushed back to March 2025.
Advanced explanation of benefits. Federal agencies in 2021 issued guidance instructing stakeholders that until they issue regulations implementing the advanced explanation of benefits requirement, self-insured plans and insurance carriers will not be penalized for the form and content of their explanations if they send one to participants. Two years ago, these agencies requested input from stakeholders on how to implement the regulations. Proposed regulations now are expected in March 2025.
HIPAA privacy and cybersecurity For the first time, federal departments are working on HIPAA regulations 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.