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WASHINGTON -- Healthcare providers, if you're concerned that any guidance from the Department of Health and Human Services (HHS) will be taken as gospel and enforced as regulation by Washington bureaucrats, HHS has two words for you: Don't worry.

On December 3, the agency "to help ensure that the public receives appropriate notice of new guidance documents and that HHS guidance documents do not impose obligations on regulated parties that are not already reflected in statutes or regulations," HHS . "This final rule ... is part of a broader regulatory reform initiative within HHS."

"For too long, federal agencies have succumbed to the temptation to create law without notice and comment or public participation," said HHS Chief of Staff Brian Harrison. "Our Good Guidance Practices regulation empowers and protects those we regulate by requiring increased transparency and raising the standards for issuing significant guidance."

The guidance rule also outlines a petition process for people to request that unlawful guidances be corrected. The agency also announced that in response to a comment it received from a request for information about possible unlawful guidances, HHS was rescinding some guidance that the Centers for Medicare & Medicaid Services had issued earlier related to ligature risks in psychiatric hospitals and hospital psychiatric units.

"The commenter pointed out that this draft guidance purported to impose binding obligations on providers that exceed the requirements found in statute and regulation," the agency . "HHS agrees. The department has rescinded that draft guidance document and it is no longer available on the HHS or any other HHS website."

Anders Gilberg, senior vice president for government affairs at the Medical Group Management Association here, said in an email that "there have been situations where guidance goes too far in creating new requirements and, as such, bypasses the rulemaking process ... A minor change in a regulatory interpretation by HHS can often have far-reaching implications in terms of the operational and clinical impact on medical practices."

"This rule comes very late in the day for this administration and its impact on the next isn't entirely clear," he added. "We will continue to review it, but it is important that stakeholders like MGMA are given an opportunity to review and respond to significant regulatory changes impacting medical groups. That sentiment at least is something we can support." He added that because it came out within 60 days of President-Elect Biden's inauguration -- what some critics are calling "" -- "ironically, the rule may not have gone through the proper process itself" and could get thrown out, he said.

Travis Lloyd, JD, MPH, a partner and chair of the Healthcare Practice Group at Bradley Arant Boult Cummings, a law firm in Nashville, Tennessee, said in an email that the rule on good guidance is "significant in several respects."

First, "the rule builds on prior statements cautioning against the use of sub-regulatory guidance as the basis for enforcement actions, such as a on the subject and a regarding the implications of the Supreme Court's decision in Azar v. Allina Health Services," he said. "In so doing, the rule strengthens the shield of providers accused of wrongdoing."

It also gives providers a sword by allowing them to challenge "whether a guidance document inappropriately creates new obligations," he added. In addition, the guidance repository that HHS mentioned "is a huge undertaking that provides industry stakeholders with greater certainty as to what interpretive guidance is 'guidance' within the meaning of the rule."

"Because health care providers are subject to such a voluminous body of sub-regulatory guidance, the good guidance rule will, in all likelihood, be a welcome development," Lloyd said. "It reflects a continued effort by HHS to consolidate and organize its interpretive guidance in a way that will likely benefit the regulated community."

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