The U.S. Department of Health and Human Services on Friday released a final rule requiring the agency to review its regulations once every ten years.
If a regulation is not reviewed, it may expire, said HHS.
The Securing Updated and Necessary Statutory Evaluations Timely, or “SUNSET,” rule, means that rules that are issued by an HHS component that are more than ten years old will need to be reviewed within five years.
“By terminating burdensome regulations unless their necessity is publicly demonstrated to the American people, our SUNSET rule will prove the boldest and most significant regulatory reform effort ever undertaken by the federal government,” said HHS Chief of Staff Brian Harrison.
WHY IT MATTERS
HHS representatives ballyhooed the final rule in a press call Friday, describing it as “unprecedented” and pointing to previous administrations’ efforts to institutionalize retrospective reviews.
The rule, said Harrison, represented the “most significant regulatory reform in the history of the federal government.”
With some exceptions, the new rule mandates all HHS regulations to be subject to a two-step review.
First, they must be assessed as to whether they have a significant economic impact on a substantial number of small entities.
If so, reviewers must consider the continued need for the rule, complaints about it, its complexity, the extent to which it duplicates or conflicts with other rules, and whether technological, economic and legal changes favor amending or rescinding it.
“An artificial-intelligence-driven data analysis of HHS regulations found that 85 percent of Department regulations created before 1990 have not been edited,” said the agency in a press release.
The rule does not apply to guidances; some Food and Drug Administration device-specific, food-standard and over-the-counter-drug specific regulations; regulations that are jointly issued with other agencies; and rules that legally cannot be rescinded; among others.
The American Hospital Association voiced concerns about the initial version of the proposed rule last year.
“While we appreciate that this process has the potential to alleviate some regulatory burden for our hospital and health system members, we have substantial concerns that it does not provide an adequate mechanism for obtaining public input on the substance of regulations being reviewed,” AHA officials wrote in comments submitted this past December.
“HHS states that the risk of a regulation inadvertently expiring is outweighed by the benefit of institutionalizing retrospective review,” they said. “We strongly disagree.”
AHA added: “There very well may be scenarios where a regulation was not assessed, but it is unclear whether it has expired or was exempt from this regulatory review process and is still in place. At best, this would leave those subject to the regulation with no guidance on what is expected of them. At worst, there would be serious consequences of inadvertently removing rules, with negative impacts on beneficiaries, consumers and the public in general.”
HHS representatives said that President-elect Joe Biden’s new administration could roll back the rule, but that the agency did not anticipate such a thing occurring.
THE LARGER TREND
HHS has proposed a number of regulations and guidances following President Donald Trump’s Electoral College defeat, raising potential questions about the longevity of such rules.
In December, the HHS Office for Civil Rights on Thursday floated substantial new changes to the HIPAA Privacy Rule, with the goal of furthering value-based reimbursement and improving care coordination.
That same month, the OCR issued guidance on the disclosure of protected information using health information exchanges, saying that it would not impose penalties on a business-associate HIE for disclosing information to a public health authority during the COVID-19 emergency when its business associate agreements do not authorize the disclosure.
ON THE RECORD
“For decades, presidents have said agencies should retrospectively review their regulations. With the SUNSET rule, HHS is actually doing it,” said HHS Secretary Alex Azar in a statement.
“Finalizing our SUNSET rule will deliver for the American people better, smarter, less burdensome regulations in the years to come,” Azar added.