The Pink Sheet Quotes Kelly Cleary on HHS Proposed Rule to Enforce Retrospective Regulation Review

The Pink Sheet has quoted Akin Gump health care and life sciences partner Kelly Cleary in the article “HHS Regulatory Reform Proposal Seen As Blunt Instrument That Could Burden Industry and Agencies.” The article looks at a new proposed rule by the Department of Health and Human Services (HHS) that would lead to the automatic expiration of most Food and Drug Administration and Centers for Medicare and Medicaid regulations a decade after their first issuance unless the agency undertakes a required assessment and review process.

According to the article, agencies would have to assess regulations every 10 years to determine whether they are subject to review.  If they are, the agency would then have to determine whether the regulation is needed and if it is having an appropriate impact.

“It does shift some of the burden of responsibility on to regulated industry to be paying attention to this stuff,” said Cleary, though she pointed out that the annual Medicare Part A and B payment methodology update rules are exempted, as are the regulations pertaining to the federal anti-kickback statute.

As for how various industries might react to the new regulations, Cleary said, “I have to imagine that some of the associations are going to be looking to have conversations with the agency about rules that impose significant burdens that they feel outweigh the benefits.”

Cleary added that reforms to the Stark Law and the beneficiary inducement prohibitions are two areas where industry is always interested in reform and might want to use this rule to push for changes.

“Whether the agency is going to have an appetite to change any of it, I don’t know, but they’re at least going to have the burden of explaining why the regulations when they were written 10 years ago are still necessary and still serve their purpose.”