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HHS Clarifies Difference Between Guidance and Rules


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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 finalized a Good Guidance Practices rule 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 said in a press release. This final rule . is part of a broader regulatory reform initiative within HHS. ....

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HHS Limits the Use of Guidance Documents in the Good Guidance Practices Rule and Advisory Opinion 20-05 | Epstein Becker & Green


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On December 7, 2020, the Department of Health and Human Services (“HHS”) published the Good Guidance Practices final rule (“Rule”), which limits HHS’s ability to issue and rely upon sub-regulatory guidance documents in enforcement actions, investigations, and audits, including actions relating to coverage and reimbursement for items and services under Medicare and other federal health care programs.[1] In addition, the HHS Office of the General Counsel (“HHS-OGC”) released Advisory Opinion 20-05, which sets out HHS-OGC’s interpretation of
Azar v. Allina Health Services, 139 S. Ct. 1804 (2019) (“
Allina”), in which the U.S. Supreme Court held that HHS must use notice-and-comment rulemaking (as opposed to issuing guidance) when establishing or changing “substantive legal standards” that affect Medicare eligibility, benefits, or payments for services.[2] In Advisory Opinion 20-05, HHS-OG ....

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