Bradley attorney Travis Lloyd was quoted in MedPage Today on the recent rule finalized by the Department of Health and Human Services (HHS) regarding good guidance practices. HHS announced a Good Guidance Practices rule to help limit its own ability to impose obligations on regulated parties that are not already reflected in duly enacted statutes or regulations lawfully promulgated under them.
Lloyd said 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 2018 DOJ [Department of Justice] memo on the subject and a 2019 HHS internal memo 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."
The original article, "HHS Clarifies Difference Between Guidance and Rules," appeared in MedPage Today on December 14, 2020.