On October 20, 2021, HHS published in the Federal Register a proposal to repeal two final rules issued during the Trump administration. The final rules up for repeal are the “Department of Health and Human Services Good Guidance Practices,” (the GGP Rule) published in the Federal Register on December 7, 2020 and the “Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions,” (the Civil Enforcement Rule), published in the Federal Register on January 14, 2021. The GGP Rule relates to guidance documents published by federal agencies, and the Civil Enforcement Rule relates to civil administrative enforcement and adjudication processes. As stated in the Federal Register, HHS “has taken a renewed and critical look at the HHS GGP and Civil Enforcement rules and has concluded that both rules frustrate the Department’s ability to efficiently direct and operate in the interest of public health and are inconsistent with the policies and goals of the current Administration.” HHS is seeking comments on the proposed repeal of the GGP and Civil Enforcement Rules. To ensure consideration, comments must be submitted to https://www.regulations.gov by no later than 11:59 on December 20, 2021.

The GGP and Civil Enforcement Rules were promulgated in accordance with two Executive Orders (EO) issued by the Trump administration on October 9, 2019 (EOs 13891 and 13892). These EOs have now been repealed, but the GGP and Civil Enforcement Rules remain in place. The GGP Rule requires: (1) guidance documents issued by federal agencies to state that the guidance does not have the force and effect of law and is not binding unless specifically incorporated into a contract; (2) heightened procedures for “significant guidance documents;” (3) a repository for all guidance documents; and (4) procedures for the public to petition to withdraw or modify guidance documents. Key aspects of the Civil Enforcement Rule require: (1) that agencies only apply standards and practices in a civil enforcement action that have been publicly stated; (2) that if an agency relies on a decision to assert new or expanded claims of jurisdiction, it must publish the initial decision in the Federal Register or the Department’s guidance repository before the conduct over which the jurisdiction is sought occurs; and (3) that before a civil enforcement action is taken, the agency taking the action must give written notice of its initial legal and factual determinations, give the entity an opportunity to respond, and provide a written response to the affected entity if timely requested.

According to HHS, the proposed “repeal is consistent with the policies of the Biden-Harris Administration as reflected in the last three EOs issued by President Biden.”

First, EO 13992, “Revocation of Certain Executive Orders Concerning Federal Regulation,” 86 FR 7049 (Jan. 25, 2021) (EO 13992), revoked both EOs 13891 and 13892 and directed agencies to promptly take steps to rescind any orders, rules, regulations, guidelines, policies, or portions thereof, implementing or enforcing the revoked EOs, as appropriate and consistent with applicable law.

Second, EO 13985, “Advancing Racial Equity and Support for Underserved Communities Through the Federal Government,” 86 FR 7009 (Jan. 25, 2021) (EO 13985), states that it is the policy of the Biden-Harris Administration for the federal government to pursue a comprehensive approach to advancing equity for all, including people of color and others who have been historically underserved, marginalized, and adversely affected by persistent poverty and inequality. The EO directed agencies to recognize and work to redress inequities in their policies and programs that serve as barriers to equal opportunity.

Third, EO 14009, “Strengthening Medicaid and the Affordable Care Act,” 86 FR 7793 (Feb. 2, 2021) (EO 14009), states that it is the policy of the Biden-Harris Administration for the federal government to protect and strengthen Medicaid and the ACA and to make high-quality healthcare accessible and affordable for every American. The EO directs HHS, among others, to examine its regulations, policies, and the like to ensure that they are consistent with the policy of providing high quality and accessible healthcare for all, and do not undermine protections for people with pre-existing conditions under the ACA, reduce coverage under or otherwise undermine Medicaid or the ACA, or undermine the Health Insurance Marketplace or the individual, small group, or large group markets for health insurance in the United States. According to HHS, because it “frequently issues guidance to clarify policies and beneficiary protections under Medicaid, the additional regulatory hurdles and confusion created by the HHS GGP final rule would likely undermine those goals by impeding and delaying the issuance of Medicaid guidance.”

Click here to access HHS’ publication of the proposed repeal of the GGP Rule the Civil Enforcement Rule in the Federal Register.