HHS proposes withdrawing Trump ‘good guidance’ rules

The Biden administration on Tuesday announced plans to withdraw Trump-era rules that make it harder for regulators to punish individuals and organizations for not following Health and Human Services Department guidances.

The rules, issued in the final months of the Trump administration, ban HHS from penalizing individuals and organizations for noncompliance with agency guidance and requires the agency only carry out civil enforcement actions using standards that are publicly stated.

HHS proposed withdrawing the rules Tuesday, arguing it creates “unnecessary hurdles” to issuing guidance and bringing enforcement actions and is inconsistent with the goals of the Biden administration.

The rule would impede the administration’s response to “urgent challenges facing the nation,” including the pandemic and inequities in healthcare, the agency wrote the proposed rule published Tuesday in the Federal Register.

The Trump rules would “have a disproportionate effect on marginalized and vulnerable historically underserved communities because they make it harder for agencies to take action to protect public health or remove bad actors from the market, which in turn harms those who need HHS services the most,” the agency wrote.

HHS argued Medicaid and the Children’s Health Insurance Program in particular rely on guidance to run effectively.

“Thus, a rule that hinders the publication of guidance may in turn harm the programs and the populations served, who rely on guidance documents to clarify program coverage requirements and have fewer resources to determine, for example, how and why guidance may be rescinded,” the agency wrote Tuesday.

The rules were issued by the Trump administration as part of its attempt to reduce the number of regulations in the healthcare system.

The previous administration argued guidance documents, which don’t require a public notice and comment process, shouldn’t be binding.