The Trump administration's new proposal to set in motion a process to potentially kill off thousands of U.S. healthcare regulations implemented over decades under congressional mandates may not only be illegal, but an effort to hamper the work of the next administration.
Unwinding questionable proposals the U.S. Department of Health and Human Services is seeking to quickly put in place, like the one it revealed Nov. 4, will take a lot of extra work for people coming into the next administration to tackle if President Donald Trump loses the White House, said Laura MacCleery, policy director at the Center for Science in the Public Interest.
"It's like laying land mines," she told S&P Global Market Intelligence. "That's unpleasant."
In its notice of proposed rulemaking, HHS said it wants certain rules and regulations issued by its agencies, such as the U.S. Food and Drug Administration or the Centers for Medicare and Medicaid Services, to undergo a review process every 10 years to determine if they should be rescinded or amended. If no review is completed, the regulation would expire.
The proposal would give HHS two years from the time the measure is finalized to conduct reviews of all currently implemented regulations that are over 10 years old or those rules will automatically be nixed.
Officials estimated the proposal would affect about 2,480 current regulations that are subject to the Regulatory Flexibility Act of 1980. HHS said the reviews would cost as much as $26 million to complete.
The public has until Dec. 4 to submit comments on the proposal.
Patricia Zettler, associate professor of law at The Ohio State University, questioned the Trump administration's timing of issuing its proposal — in the midst of the COVID-19 pandemic, which she said should be HHS' top priority right now.
"I find it very hard to believe the proposal, if finalized, would not increase burdens on HHS agencies, including FDA," Zettler told S&P Global Market Intelligence.
The proposal also came the day after the Nov. 3 U.S. election, whose results for the White House are being contested by Trump in his run for a second term against Democratic presidential nominee Joe Biden.
Brian Harrison, chief of staff to HHS Secretary Alex Azar, said the administration is seeking to finalize the proposal before Jan. 20, 2021 — potentially Trump's last day in the White House, unless he wins or prevails in his legal challenges.
Harrison declined in a Nov. 4 media telebriefing to describe the types of regulations being targeted by the proposal and which agencies would be affected, only stating any finalized rule would be uniformly applied.
In all likelihood, what HHS has proposed is illegal, MacCleery said.
"It seems to have the legal depth of a teaspoon," she said, adding that she expects the proposal to immediately be tied up in court and eventually invalidated — or rescinded by the next president.
"And what a waste of everyone's time," MacCleery said.
"Each of these measures on the books today was justified as needed at the time by a careful analysis by the agency and many of them in response to assignments from Congress," she said. "You can't just take all of that down with a blunderbuss. You have to create a record that says why a rule is no longer needed and justify amendments that may be made to it."
While there is nothing wrong with reviewing and updating regulations, the Trump administration is taking a "wholesale approach with the default being that the rule ceases to exist," she said. "That's not something that is useful to do or is legal to do."
HHS is also rushing the rulemaking process, MacCleery said.
"There's no practical way you could get comments on the proposal in early December and have enough time to digest the import of those comments in a thoughtful way by January," she said. "It means that the exercise of taking public comment is a sham."
Potentially letting decades of regulations expire if HHS is unable to complete reviews in a timely manner may be a bad outcome for the companies and sectors that have invested in complying with the rules and developed their business practices around them, MacCleery said.
"It would be extreme chaos," she said.
The Trump administration's proposal "appears to be ideologically driven without any basis and understanding of how the system operates" and the "symbiotic relationship between regulations, consumers and companies," MacCleery said.
Some companies benefit from rules and regulations because they allow the businesses to have a sophisticated marketplace position, she said.
"You have a mature marketplace that has evolved in line with the way that the regulations have evolved over time to get better and better," MacCleery said.
Taking that structure down "doesn't benefit consumers, it doesn't benefit stakeholders, it doesn't benefit companies and it thumbs your nose at Congress, which has asked the agencies to take care of this sort of work," she said. "It's incredibly careless."
Regulations are like fabric, where new ones have relationships with existing rules, MacCleery said.
"And so if you just randomly put a hole in the middle of that, you have this series of gaps that open up or inconsistencies," she said.
The Trump administration's proposal would also put the onus on the public to point out to HHS when a rule is in jeopardy of expiring and ask the agency to finish its review, MacCleery said.
"It's really bonkers," she said.