WHG - Spring 2024 Regulatory Outlook

Summary

The Biden Administration recently released its Spring 2024 Unified Agenda, which outlines regulatory plans for federal agencies over the coming year. The Unified Agenda reflects the Biden Administration’s continued priority on policies addressing health. In our regulatory outlook, we highlight rulemaking on coverage and payment, public health and safety, mental and behavioral health, drug pricing, and health IT, and more.

• What it is. The Spring 2024 edition of the semiannual unified agenda contains regulatory actions that federal agencies plan to undertake in the next 12 months. The Unified Agenda includes annual regulatory updates (e.g., Medicare payment policies); regulations implementing recently enacted laws, such as the Inflation Reduction Act of 2022 and the No Surprises Act; and regulations implementing Executive Orders and other priorities, such as regulatory proposals in the President’s Budget. Most of the entries were included in the Fall 2024 edition and may have been updated with new timetables.

 

Each entry is organized by federal agency and its stage in the rulemaking process – prerule stage (e.g., Advanced Notices of Proposed Rulemaking), proposed rule stage (e.g., Notice of Proposed Rulemaking), final rule stage, long-term actions, and completed actions.

 

We include entries from the following departments:

 

• Department of Health and Human Services (HHS) – Administration for Children and Families (ACF), Centers for Disease Control and Prevention (CDC), Centers for Medicare and Medicaid Services (CMS), Food and Drug Administration, Health Resources and Services Administration (HRSA), Office for Civil Rights (OCR), Office of the Assistant Secretary for Health (OASH), Office of Inspector General (OIG), Office of the National Coordinator for Health Information Technology (ONC), Office of the Secretary (OS), and Substance Abuse and Mental Health Services Administration (SAMHSA)
• Department of Labor (DOL) – Employee Benefits Security Administration (EBSA) and Occupational Safety and Health Administration (OSHA);
• Department of Treasury – Community Development Financial Institutions Fund (CDFI Fund) and Internal Revenue Service (IRS);
• Department of Agriculture – Food and Nutrition Service (FNS);
• Department of Housing and Urban Development (HUD) – various agencies;
• Department of Justice (DOJ) – Drug Enforcement Administration (DEA), Executive Office for Immigration Review (EOIR), and other agencies;
• Federal Trade Commission (FTC); and
• Office of Management and Budget (OMB).

 

• Why it is important for you. As a roadmap of the Biden Administration’s regulatory priorities, the Unified Agenda enables stakeholders to anticipate and prepare for rulemaking. Stakeholders can participate by requesting an EO 12866 meeting with OMB and/or submitting public comments. Projected dates for regulatory actions may shift, but they are helpful guides for advocacy planning.

 

• Recent U.S. Supreme Court decisions (IHPP memo). A series of recent Supreme Court decisions – including a ruling that overturned Chevron deference, i.e., judicial deference to agency interpretations of ambiguous statutes – has reshaped the regulatory landscape, further shifting power away from the executive and legislative branches to the judiciary branch. Because federal agencies have generally tried to minimize its reliance on Chevron deference and instead point to specific statutory authority (e.g., Social Security Act) to mitigate legal challenges to regulations, the extent to which the end of Chevron deference will alter rulemaking is unclear.

 

We anticipate that the regulatory process will slow down as agencies divert resources to prevent and defend against more frequent legal challenges and take time to ensure decisions are positioned as findings of fact rather than interpretations of law. Regulators are also likely to shy away from taking bold action or making dramatic shifts in policy and may instead issue non-binding guidance. Ultimately, more litigation means that some regulations may not take effect in a timely manner or ever, increasing uncertainty for stakeholders.

• Presidential election. The Biden Administration released the Spring 2024 Unified Agenda on July 2, 2024. Some regulations are forecasted for 2025, highlighting policy priorities for a potential second term. Another Democratic Administration, regardless of who the President is, will likely continue to pursue the same or a similar regulatory agenda. It is unlikely that the Biden Administration will accelerate timetables and promulgate these regulations in 2024. Instead, federal agencies will likely wind down their rulemaking (with the exception of statutorily mandated rulemaking) to limit political liability.

 

• Congressional Review Act. The Congressional Review Act (CRA) governs the federal rulemaking process and gives Congress the ability to overturn rules issued by federal agencies within a limited period following their finalization. The Congressional Research Service unofficially estimates that the “lookback” period will begin in August, meaning that rules submitted to the House or Senate on or after August, 1, 2024 may be subject to CRA review in the first few months of the first session of the 119^th Given that a President’s signature is required to enact any such action by Congress, this procedure is generally pursued when the same party controls Congress and the White House. If former President Donald Trump is reelected and Republicans win control of the House and Senate, then some Biden-era regulations might be vulnerable to CRA.

 

• Next steps. Impact Health flags regulatory actions as they move through the process, specifically when they reach OMB for review and when regulatory review is completed. We include these updates in our Weekly sent on Mondays. For each policy area below, we note the lead Impact Health team member that can answer any questions or provide additional assistance.