The Trump administration wants the Department of Health and Human Services to review most of its regulations by 2023 – and automatically invalidate those that weren’t assessed in a timely manner.
One proposed rule would require HHS to analyze approximately 2,400 prescriptions within 24 months – rules that affect tens of millions of Americans in everything from Medicare benefits to prescription drug approvals.
The move met fierce backlash from health care providers and consumer advocates, who fear it would hamper federal health officials as they attempt to control the COVID-19 pandemic that killed more than 250,000 Americans.
The HHS proposal appears to be designed to bind the incoming Biden administration, critics say. They take note of the timing of the proposal, which was released on November 4th – the day after election day when President Donald Trump would likely lose his offer 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 officer for Common Good Iowa, a consumer protection group.
She said HHS didn’t have the bandwidth to review all of these regulations over the next two years while executing its numerous programs, including Medicaid and Medicare.
If the proposal is finalized before January 20th, it will likely be rolled back by the incoming Biden administration. But the housework would increase the duties of HHS officials trying to attack the pandemic, she said.
HHS officials deny their proposal was addressed to the Biden administration. Brian Harrison, the department’s chief of staff, said he first requested a legal review of the proposal in April. “Our lawyers moved as quickly as possible,” he said, and the rule was written with the expectation that it would be implemented during Trump’s second term.
“The result of the election had nothing to do with it,” he said.
Democrats and Republicans have failed to review existing regulations for the past 40 years, leaving unnecessary and irrelevant rules on the books, Harrison said.
However, Andy Schneider, a research professor at the Center for Children and Families at Georgetown University who wrote on the proposal, fears that deploying the sunset will be one of many measures the Trump team will take to distract the incoming administration .
“It speaks volumes that they waited until the end of the fourth year of administration to decide that the regulatory process needed to be improved,” he said.
Incoming administrations have typically frozen new rules that were pending but did not come into effect before the day of inauguration. This gives new administrations time to wind them up.
Efforts to conduct reviews of financial bills and other laws called sunset clauses have been popular with conservatives for years. The federal government has occasionally used expiration provisions in legislation, such as the tax cuts enacted during the administration of George W. Bush. However, it is rare for departmental regulations to be subject to these mandatory deadlines.
The option is more popular with states that have adopted different procedures for measures passed by lawmakers or regulators. These efforts range from asking for a review of most initiatives to identifying specific agencies or pieces of legislation that need to be reviewed on a regular basis.
HHS accepted public comments on the proposal until December 4th, except for part of the Medicare regulation rule, which has a January 4th deadline. A final rule is expected before Biden becomes president on January 20th.
HHS officials do not point out specific regulations that they believe are out of date. However, in their material accompanying the proposal, they state in part:
“An artificial intelligence based data analysis of the HHS regulations showed that 85 percent of the department regulations created before 1990 were not processed. The division 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 lack of ratings was due to “sluggishness” and “lack of an incentive mechanism”.
“Many presidents have officially ordered their agencies to review existing regulations and the law has been in place for 40 years. So, for decades, simply asking departments to review those regulations has proven ineffective,” Harrison said .
“We have to create incentives for their behavior,” 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 was approved by law signed by President Jimmy Carter in the late 1970s that asked federal agencies to review the existing rules. However, there is no provision in that law that provides for curtailment rules that are not reviewed within a certain time frame, Schneider said.
Under the proposal, the HHS secretary would have the flexibility to prevent some regulations from being removed “on a case-by-case basis”.
HHS estimates the reviews would cost up to $ 19 million in two years. The proposal would have to revise the rules every 10 years.
When he took office in 2017, Trump vowed that for every regulation his administration made, two would be removed. In July he said his government had more than exceeded this target.
“Almost eight federal regulations were terminated for each new regulation,” he said in a speech in the rose garden. The Washington Post Fact Checker said the claim is based on “doubtful math and rates each regulation as equivalent”.
One of the few groups to support the HHS proposal is the National Federation of Independent Business. The group said the proposal would ease regulatory burdens on small businesses.
However, other groups, such as the American Academy of Neurology, suggest that the proposed rule would limit the contribution of stakeholders to changes in existing regulations as it would not follow the usual process of soliciting public comments when changing rules. “AAN strongly supports the current process of changing and repealing regulations during the notice and comment period, as it gives those involved the opportunity to provide feedback on the proposed regulations before changes are implemented,” the group told HHS.
The Medicaid and CHIP Payments and Access Commission, which advises Congress, rejects the proposal. “MACPAC questions the need for a proposed rule that creates a duplicate and administratively burdensome new process that can create confusion among 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 healthcare system, Medicaid and CHIP in the face of the pandemic and the economic challenges it poses.”
It is 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 ran too long is not acceptable,” she wrote in comments on the proposed rule.