The Trump administration wants to require the Department of Health and Human Services to review most of its regulations by 2023 — and automatically void those not assessed in time.
A proposed rule would require HHS to analyze within 24 months about 2,400 regulations — rules that affect tens of millions of Americans on everything from Medicare benefits to prescription drug approvals.
The move has met a fierce backlash from health providers and consumer advocates who fear it would hamstring federal health officials while they seek to control the COVID-19 pandemic, which has killed more than 250,000 Americans.
The HHS proposal appears designed to tie up the incoming Biden administration, say critics. They note the timing of the proposal, which was issued Nov. 4 — the day after Election Day, when it appeared President Donald Trump would likely lose his bid for a second term.
"The cynical part of me thinks this is a perfectly designed way to bring the department to a standstill in the next administration," said Mary Nelle Trefz, health policy associate at Common Good Iowa, a consumer advocacy group.
She said HHS does not have the bandwidth to review all these regulations during the next two years while running its many programs, including Medicaid and Medicare.
If the proposal is finalized before Jan. 20, it is likely to be undone by the incoming Biden administration. But the chore would add to duties of HHS officials trying to attack the pandemic, she said.
HHS officials deny their proposal was aimed at the Biden administration. Brian Harrison, chief of staff at the department, said he first sought legal review of the proposal in April. "Our lawyers moved as fast as they could," he said, and the rule was written with the expectation it would be implemented during Trump's second term.
"The outcome of the election had nothing to do with it," he said.
Democrats and Republicans for the past 40 years have failed to review existing regulations, leaving unnecessary and irrelevant rules on the books, Harrison said.
But Andy Schneider, a research professor at the Center for Children and Families at Georgetown University who has written about the proposal, said he fears the sunset provision will be one of many actions the Trump team will take to distract the incoming administration.
"It speaks volumes that they waited until the end of the fourth year of the administration to decide that the regulatory process needs to be improved," he said.
Incoming administrations have typically frozen new rules that were pending but have not taken effect before Inauguration Day. That gives new administrations time to unwind them.
Efforts to enact reviews of funding bills and other legislation, known as sunset clauses, have been popular among conservatives for years. The federal government has occasionally used sunset provisions in legislation, such as the tax cuts enacted during the George W. Bush administration, but it is rare to make department regulations subject to these types of mandatory deadlines.
The option is more popular among states, which have adopted varying procedures for measures passed by the legislatures or regulatory boards. Those efforts run the gamut from requiring most initiatives to be reviewed to identifying specific agencies or legislation that must be reconsidered on a regular timetable.
HHS accepted public comments on the proposal though Dec. 4, except on part of the rule affecting Medicare regulations, which has a Jan. 4 deadline. A final rule is expected before Biden becomes president on Jan. 20.
HHS officials don't point to any specific regulations they say are outdated. However, in their supporting material for the proposal, they note in part:
"An artificial-intelligence-driven data analysis of HHS regulations found that 85 percent of department regulations created before 1990 have not been edited; the Department has nearly 300 broken citation references in the Code of Federal Regulations, meaning CFR sections that reference other CFR sections that no longer exist."
Harrison said the scarcity of reviews is due to "inertia" and "lack of an incentive mechanism."
"Many presidents have formally ordered their agencies to review existing regulations, and it has been existing law for 40 years, so simply asking the divisions to review these regulations has been tried for decades and proven to be ineffective," Harrison said.
"We need to incentivize their behaviors," he said.
With more than 80,000 employees, the department should be able to complete the review of 2,400 rules in 24 months, he added.
Harrison said the proposal is authorized by a law signed by President Jimmy Carter in the late 1970s requiring federal agencies to review existing rules. But that law has no provision that calls for cutting regulations that are not reviewed within a certain time frame, Schneider said.
The proposal says the HHS secretary would have flexibility to stop some regulations from being eliminated "on a case by case basis."
HHS estimates the reviews would cost up to $19 million over two years. Regulations would have to be reviewed every 10 years under the proposal.
When he took office in 2017, Trump vowed that for every regulation his administration issued, it would remove two. In July, he said his administration had more than exceeded that goal.
"For every one new regulation added, nearly eight federal regulations have been terminated," he said in a Rose Garden speech. The Washington Post Fact Checker said that claim was based on "dubious math and values each regulation as having equal weight."
One of the few groups to endorse the HHS proposal is the National Federation of Independent Business. The group said the proposal would alleviate regulatory burdens on small businesses.
But other groups, such as the American Academy of Neurology, suggest the proposed rule would limit input from interest groups on changes to existing regulations, because it would not follow the usual process of seeking public comments when altering rules. "The AAN is highly supportive of the current process to modify and rescind regulations through the notice and comment period, as it affords stakeholders the necessary opportunity to provide feedback on proposed regulations prior to changes being implemented," the group told HHS.
The Medicaid and CHIP Payment and Access Commission, which advises Congress, opposes the proposal. "MACPAC questions the need for a proposed rule that creates a duplicative and administratively burdensome new process that is likely to create confusion for beneficiaries, states, providers, and managed care plans," the group said in a letter to HHS. "The new requirements will create additional unnecessary work that will distract the department and CMS from the critical roles they play in our health care system, Medicaid and CHIP amid the pandemic and its resulting economic challenges."
It's unclear how the proposed rule would affect long-standing regulations for product safety and standards, said Betsy Booren, senior vice president of the food lobbying group Consumer Brands Association. "The idea that these regulations would be sunset because a regulations timer went too long is not acceptable," she wrote in comments on the proposed rule.
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