WASHINGTON — The Department of Health and Human Services (HHS) will now have 5 years to review regulations that are more than 10 years old before the regulations disappear, according to a final rule issued Friday by HHS.
Under the rule first proposed by HHS in early November 2020, any regulation issued by HHS, with certain exceptions, will cease to be effective 10 years after it is issued, unless HHS assesses the regulation to make sure it’s still useful and is not unduly burdensome; if the rule impacts many small businesses, it undergoes a more detailed review. Under the original proposed “regulatory review” rule, the department would have had only 2 years to assess and review all of the rules that are already 10 years old or older — otherwise, they would simply vanish from the Code of Federal Regulations. It was that provision that was extended to a 5-year window.
That was one of several changes made to the rule, known as the Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule, HHS Chief of Staff Brian Harrison said in a Friday morning phone call with reporters. Another change allows the HHS secretary to extend the review time once on any particular rule for up to 1 year. In addition, certain rules regarding food, over-the-counter drugs, and medical devices also would be exempted from the review requirement, Harrison added, as would the annual Notice of Benefit and Payment Parameters rules that the agency issues. The rule also requires the department to announce in the Federal Register — not just on the HHS website — when new assessments and reviews begin, and allows the public to comment on them.
Other exceptions to the review requirement include regulations that are jointly issued with other agencies, those that legally cannot be rescinded, and those issued with respect to a military or foreign affairs function or addressed solely to internal management or personnel matters.
“If Americans are going to live with regulations and enjoy the benefits they were designed to achieve, we owe it to them to review these regulations on a regular basis … to ensure they are in fact serving the public interest and to modify, extend, or allow them to expire when they are not,” Harrison said. He praised the rule, calling it “the most historic regulatory reform effort in the history of, certainly, HHS, but likely also the federal government.”
“It’s estimated that from 1976 to 2018, agencies across the executive branch issued over 200,000 regulations, while Congress enacted only approximately 10,000 laws over the same period,” he noted. “That’s an astounding ratio of 20 regulations for every one federal statute.”
In 1980, President Carter signed the Regulatory Flexibility Act, which required agencies to review regulations periodically “to determine if they’re delivering the benefits they promised, to determine if they’re overly burdensome, or to determine if they’re still needed at all,” said Harrison. “This has been the law for 40 years and every single presidential administration since Jimmy Carter’s has committed to delivering the benefits of retrospective regulatory review … While some agencies and federal departments — including us at HHS — have done limited retrospective review, no administration has successfully institutionalized retrospective review — until today.”
During a question-and-answer session, Harrison told MedPage Today that he expected the incoming Biden administration would continue on with the rule. “I would, given this is consistent with 40 years of clear congressional intent,” he said. “Given that every president going back to Jimmy Carter, both Republican and Democrat, have tried to tackle this exact problem, I fully expect that this regulation will be enduring.”
He also expressed confidence that HHS would have the personnel and resources needed to accomplish the reviews on top of its other work. “We are quite confident that the Department of Health and Human Services — the largest government agency in the world — easily has the resources to accomplish this review … We lay out in great detail the resources we anticipate taking in our impact analysis.”
The rule will become effective 60 days after its publication in the Federal Register.
Last Updated January 08, 2021