The Department of Health and Human Services (HHS) recently issued a proposed rule to undertake a retrospective review of older regulations to ensure they are making an appropriate impact or are no longer needed. The notice of proposed rulemaking would require HHS to assess its regulations every decade and determine if they are subject to review through the Regulatory Flexibility Act, which requires the federal government to review certain significant regulations. “This proposal—the boldest and most significant regulatory reform effort ever undertaken by HHS—would sunset burdensome regulations unless their necessity is publicly demonstrated to the American people,” said HHS Chief of Staff Brian Harrison in a statement.
More on Rule
If finalized, the rule would require HHS to review all of its regulations that have a significant economic impact upon a substantial number of small entities every ten years. It would also require HHS to assess every regulation, with some exceptions, every ten years, or else they would expire.
The proposed rule defines “assess” as HHS determining whether regulations currently have significant economic impact upon a substantial number of small entities. It also defines “review” as HHS determining which regulations should be continued without change and which should be amended or rescinded.
For regulations not yet promulgated, HHS would need to assess the regulations every ten years. For those that are already in effect, HHS would have the later of two years from the effective date of the proposed rule or ten years from the regulation’s promulgation. Regulations would expire if assessments and reviews are not conducted within the given timeframe.
HHS reviews would consider several things: (1) the continued need for the regulation, consideration of which shall include but not be limited to the extent to which the Regulation defines terms or sets standards used in or otherwise applicable to other federal rules; (2) the nature of complaints or comments received concerning the regulation from the public; (3) the complexity of the regulation; (4) the extent to which the regulation overlaps, duplicates or conflicts with other federal rules, and, to the extent feasible, with state and local governmental rules; (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulation since the regulation was promulgated or the last time the regulation was reviewed by the Department; (6) whether the regulation complies with applicable law; and (7) other considerations as required by relevant executive orders and laws.
Regulations over which HHS has no discretion, such as those that are prescribed by statute, are not subject to the proposed rule. It also excepts regulations whose expiration would violate federal law; regulations that involve a military or foreign affairs function of the U.S.; regulations solely involving agency management or personnel matters; procurement regulations; and regulations issued jointly with other federal agencies.
HHS Comments on Proposed Rule
As reported by Medpage Today, during a media call about the proposed rule, one reporter noted that HHS was founded in 1953. “If this is all the regulations put out by HHS — that’s 67 years’ worth of regulations — if this moves forward the clock starts ticking and you have 2 years to review 67 years’ worth of regulations, and if you don’t get through them they automatically go away?” she asked.
“That’s generally correct, although there are certain exceptions — but yeah, basically 10 years from promulgation of the [affected] rule or 2 years from promulgation of this [new] rule, whichever is longer,” Brian Harrison, HHS chief of staff replied.
Another reporter asked about whether HHS has the authority to sunset regulations wholesale. “We have the existing rulemaking authority as a legal basis for this proposal,” he said. Speaking on background, another HHS official added that “this is using existing statutory authorities for our regulations, and the 05proposal is simply to amend our regulations to add expiration dates if a condition were not to be met. That’s a fairly common practice in the government, so we’re pretty confident of the legal basis for this.”
What is not clear is if the incoming Biden administration will finalize such a rule. Only time will tell.