HHS Withdraws Harmful Guidance Rule

HHS Withdraws Harmful Guidance Rule

On July 25, 2022 Biden-Harris Administration announced the repeal of the so-called “Good Guidance” Rule a regulation that placed significant restrictions on HHS’s ability to issue and utilize sub-regulatory guidance documents. Finalized in the waning days, of the Trump Administration, the rule was part of the former Administration’s deregulatory agenda that set the foundation for many harmful and restrictive health policies.

The final Guidance Rule was issued in December 2020, as an attempt to rein in agency use of informal guidance. The rule required HHS to include a disclaimer on all guidance documents that they are not legally binding. The rule would have required “significant guidance” to undergo formal notice and comment procedures. Further, the rule mandated that the agency create a searchable database for all agency guidance. Any guidance not included in the database would have been automatically repealed. In our comments on the proposed rule, NHeLP noted that the rule would open the door to an administration repealing guidance without notice or explanation, and create a time-consuming and burdensome process to reinstate or implement new guidance.

On his first day in office, President Biden issued an Executive Order, revoking several of the prior Administration’s Executive Orders on regulation and guidance, including those providing the foundation for the Guidance Rule. Additionally, the President issued two Executive Orders on advancing racial equity and support for underserved communities and strengthening Medicaid and the Affordable Care Act.  Taken together, these actions indicated a new direction in regulatory policy that prioritize health policies that are more flexible and responsive to the needs of low-income Americans and other underserved populations.

To amend or repeal a rule issued under notice and comment rulemaking, an agency must generally go back through the full rulemaking process. HHS issued a Notice of Proposed Rulemaking (NPRM) to repeal the Guidance Rule in October of 2021. After consideration of the public comments, HHS concluded that the rule created administrative hurdles that made it difficult to leverage regulatory tools. Further, HHS  determined that the rule conflicted with the Biden-Harris Administration’s goals of advancing health equity and strengthening Medicaid and the Affordable Care Act.

NHeLP supports the repeal of the Guidance Rule. The rule created unnecessary technical burdens that undercut HHS’s ability to appropriately address health matters. More importantly, repeal of the rule gives HHS the flexibility necessary to improve access to health care for low-income and underserved populations.

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