With the inauguration of President Biden and Democrats holding a slim majority in Congress, policymakers are likely to consider whether and how to reverse various health policy regulations issued by the Trump Administration. As with other recent outgoing administrations,1 the pace of regulatory activity accelerated in the last several months, with the Trump Administration finalizing a number of new regulations in its last days. Rule-making by federal agencies is governed by the Administrative Procedure Act (APA),2 which generally requires a notice of proposed rule-making (NPRM) followed by a public comment period.3 The agency then responds to comments and issues a final rule, with a future effective date.4 An exception to this process is an interim final rule, which requires the agency to find “good cause” to adopt a rule that takes effect immediately, before notice and comment; the agency subsequently considers public comments and may make changes when finalizing the rule.5 Final regulations generally can be rescinded or altered only by issuing a new NPRM, in which the agency provides a reasonable justification for the policy change.6
Some additional processes, including the Congressional Review Act (CRA) and executive orders imposing a temporary moratorium on regulations in progress,7 may come into play when a new Congress and Presidential Administration take office, particularly when the outgoing Congress and/or Presidency was headed by the opposite political party. This brief explains options for rescinding or changing regulations at various stages8 and identifies some of the key candidates within health care that policymakers may be considering in the coming days, weeks, and months. Table 1 summarizes the processes available to change regulations, under either the CRA or administratively, from the perspective of a new presidential administration taking office.
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