On December 6, the Biden administration released its Fall 2023 Unified Agenda of Regulatory and Deregulatory Actions. A unified agenda is issued in the spring and fall each year; it outlines federal agencies' areas of focus going forward and provides timelines for upcoming regulatory actions. The Fall 2023 Unified Agenda is particularly important, as it provides a blueprint for what the Biden administration plans to accomplish before the 2024 election and a potential change in administration.

Unified Agenda: What It Is, and Is Not

The Unified Agenda is required by law as a transparency measure under the Regulatory Flexibility Act of 1980 (as amended). The original law was intended to provide small businesses, small organizations such as nonprofits, and local governments with advance notice of potentially significant economic effects of regulations. Subsequently, President Clinton's Executive Order 12866 further required each agency to prepare a more general list of regulations under development or review; this list is customarily appended to the unified agendas.

Crucially, a unified agenda is not binding. But the timelines provided for regulatory actions shine a light on when a presidential administration aims to complete key components of its agenda, as each rule on the unified agenda has an anticipated completion date listed.

The Congressional Review Act's Nexus with the Unified Agenda

Because of the implications of the Congressional Review Act (CRA), timelines for upcoming regulations become critical for a unified agenda released the fall before an election year. The CRA allows for an expedited procedure by which Congress can block regulations passed within a certain look-back period, subject to presidential veto. When combined with an election and change in administration, the CRA becomes a powerful tool for a new president and Congress of the same party to undo the regulatory work of the previous administration. During the first half of President Trump's first term, for example, Congress overturned 16 rules.

The look-back window for the CRA is 60 congressional session days from when a final rule is published in the Federal Register and submitted to both houses of Congress and the Government Accountability Office (GAO). In the case of a sine die adjournment, however, at the end of every two-year Congress, the 60-day timeline resets and then restarts on the 15th day the Senate is in session and on the House's 15th legislative day. This CRA provision effectively extends the amount of time a new Congress and administration have after an election to act on overturning rules. The CRA can be invoked for the entirety of a two-year session as long as a "joint resolution of disapproval" is introduced by the 60-day deadline, though fast-track procedures in the Senate expire at the end of a similar 60-day window.

Take, for example, a final rule published 59 days before Congress adjourns sine die after the 2024 elections. That rule has not run out the clock on CRA review; instead, it is eligible for an entire new 60-day window in 2025 after Congress has been in session for 15 days. Such a scenario could see the CRA's disapproval resolution window extended to almost half a year (59 days of eligibility in the previous Congress + recess days before the new Congress + 15 days at the beginning of the new Congress + 60 days of eligibility in the new Congress).

Given the extended CRA timeline at the beginning of a new presidential term, the Fall 2023 Unified Agenda effectively provides a look at which rules the Biden administration aims to complete before the CRA's review window. Agencies likely have until late June to finalize rules or else risk CRA review, given that formal publication and notification take time after final rules are issued and the CRA window begins only after these steps are completed. Submission to Congress and the GAO would need to be completed by July or August at the latest.

Key Healthcare Unified Agenda Items

With respect to healthcare regulations, and with the CRA timeline in mind, there are some key rules identified by the Fall 2023 Unified Agenda as ones the Biden administration aims to complete by the July/August cutoff. For example:

• Federal Independent Dispute Resolution Process Fees: This rule concerns how the No Surprises Act (NSA) medical billing law operates in practice. The original completion date and date listed in the unified agenda are in December 2023. However, the administration recently announced a reopening of the comment period in early 2024. Given the importance of the NSA to the administration, look for a quick turnaround to finalize this rule.
• Streamlining the Medicaid, CHIP, and BHP Application, Eligibility Determination, Enrollment, and Renewal Processes: This rule is in response to Medicaid enrollment unwinding (i.e., individuals losing Medicaid coverage) after the expiration of COVID-era policies and waivers. While Medicaid is mostly a state issue, the Biden administration is looking to take any action within its jurisdiction to keep more people enrolled.
• Confidentiality of Substance Use Disorder Patient Records: The rule is intended to harmonize confidentiality and permission requirements in 42 CFR Part 2, HIPAA, and the HITECH Act. The proposed rule received strong support from stakeholders, so the Biden administration will look to publish this as quickly as possible to tout the win.
• Medical Devices; Laboratory-Developed Tests: This rule would clarify that laboratory-developed tests count as medical devices for the purposes of FDA enforcement. The unified agenda has it listed to be completed by April 2024.

There are several important rules that look likely to slip into the CRA window, however, for instance:

• Coverage of Preventative Services under the Affordable Care Act (ACA) (Department of Health and Human Services, with the Department of the Treasury and Department of Labor): This rule would clarify insurance coverage of contraception without cost sharing, as well as moral and religious objections to such coverage. The unified agenda has listed the anticipated completion for August 2024.
• Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation (Drug Enforcement Administration and Department of Justice): The DEA intended to finalize this rule in 2023 but decided to try again after public pushback. The timeline for a new rule is uncertain.

The unified agenda also includes a list of even longer-term proposed regulations, compiled as the "Long-Term Actions" list, which can be found here.

Please note that these lists do not include annual payment regulations required by law, such as the Physician Fee Schedule, that typically come out at the end of the calendar year. While subject to the CRA, Congress has focused on "one-off rules" in the past. Overturning rules of this type is especially difficult because the CRA blocks a rule in its entirety and prevents an agency from issuing a "substantially similar" rule. In other words, the CRA is a blunt instrument.

Conclusion

The Fall 2023 Unified Agenda provides a direct look at what the Biden administration plans to focus on during an election year, when there is a possibility of new majorities in both the House and Senate, as well as an administration change. Companies and organizations can use the unified agenda and the impact of the CRA to gauge regulatory impacts.