Bloomberg Law
Jan. 12, 2021, 10:04 PM

HHS Restricts Use of Guidance Standards in Civil Enforcement

Shira Stein
Shira Stein

The Department of Health and Human Services won’t be able to use standards solely from guidance documents when taking civil enforcement actions under a rule finalized Tuesday.

“A cornerstone of fair governance is transparency—regulated parties need to know in advance the standards by which the government will judge their conduct,” HHS Chief of Staff Brian Harrison said in a statement. “When HHS takes civil enforcement actions, we will only do so in a manner that promotes accountability and ensures fairness.”

The rule takes effect Tuesday and didn’t undergo a proposed rule or notice and comment, which could lead to a ...