Bloomberg Quotes Kelly Cleary on HHS Proposed Rule for Decennial Review of Regulations

November 12, 2020

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Akin Gump health care and life sciences partner Kelly Cleary has been quoted in the Bloomberg Law article “Top-to-Bottom Rule Review Poses Test of HHS’ Staff and Resolve.”

The article reports on a plan by the Department of Health and Human Services (HHS) to review all of its regulations every 10 years—something the article says would demand thousands of hours of staff time and open the agency up to a wave of new legal challenges. It would, according to Bloomberg, be the broadest audit of HHS’ regulations ever undertaken.

With this move, Cleary, a former HHS Deputy General Counsel, said the department is “creating a pretty big stick for itself to get it to do the reviews that Congress has told it to do,” and it’s a “good thing for regulated industry.”

Cleary said she expects the health industry would ask HHS to review some older regulations pertaining to the physician self-referral rule. In addition, she said, some states might ask for Medicaid state plan submission requirements to be amended or rescinded.

Cleary also added that the proposal would open HHS up to additional legal challenges because there will be more decisions made about each rule, which creates more points that could be challenged. A new Biden administration, though, could either rescind this regulation before it takes effect or push back its effective date, she pointed out.

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