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Politico Pro — Joe Biden is in a race against the clock to cement his health care legacy

Politico Pro — Joe Biden is in a race against the clock to cement his health care legacy

The Biden administration is facing a looming deadline in the next few months to finalize key health care rules.

If agencies take too long to finish regulations on minimum staffing levels at nursing homes, discrimination and abortion data protections, a ban on menthol cigarettes and others still in the pipeline, they could all disappear next year.

That’s because the rules would be easy pickings for Republicans should former President Donald Trump beat President Joe Biden in November and bring a Republican Congress with him.

The Congressional Review Act provides an expedited process that bars use of the Senate filibuster to allow lawmakers to undo rules adopted 60 legislative days before the end of a congressional session. That’s a breeze compared with going through the lengthy notice-and-comment process that would otherwise be required to rescind a prior administration’s rules. The CRA also bars agencies from pursuing substantially similar rules going forward, unless Congress orders it.

The president must sign any CRA bills overturning rules, so a Biden win in November would likely secure his regulations no matter what happens in congressional elections. But because Congress takes so many days off — and days off aren’t legislative days — the deadline to be sure they’re not covered by the CRA is likely to come this summer.

That has advocates of the pending rules fretting.

“We’re very concerned about the CRA being used to peel back a number of potential protections that would improve access to care and save patients money,” said Ben Anderson, deputy senior director of health policy at left-leaning consumer advocacy group Families USA. “The administration has all the tools in place to fix this problem now.”

An HHS spokesperson said it was aware of the deadlines.

“Each proposed rule reflects our mission at HHS to enhance the health and well-being of everyone across America and we will continue to fight for solutions to do just that,” the spokesperson said via email.

The GOP Congress of 1996 passed the CRA and President Bill Clinton signed it into law. Then-Speaker Newt Gingrich had made it a pillar of his 1994 “Contract with America.” That campaign document helped the GOP retake the House for the first time in 40 years and Republicans have made more use of the CRA than Democrats.

When Trump took office in 2017, he and a Republican House and Senate overturned 16 of President Barack Obama’s rules, including HHS regulations around family planning grants. The Biden administration and a Democratic Congress overturned three of the Trump administration’s rules in 2021, including a rollback of methane emissions standards. HHS regulations have been frequent targets of CRA bids.

Supporters of Biden’s regulatory plans fear that failing to meet the CRA deadline will put at risk protections the rules would provide, particularly for people of color, those with low incomes and other vulnerable groups.

The pending rules would “prevent discrimination and improve access to care for low-income and underserved populations,” said Dania Douglas, a senior attorney at the National Health Law Program. If they’re overturned, it could be “devastating,” she said.

“There’s a lot to do in the next short period of time,” Douglas said. “We’re concerned about the politics that come into play if Congress decides to apply the Congressional Review Act.”

Here are some of the rules that advocates could be at risk:

Nursing home staffing mandate

One of Biden’s most controversial proposed regulations would for the first time mandate minimum staffing standards at nursing homes.

The industry has resisted the idea, saying the rule’s requirements would be too expensive and come amid workforce shortages that would lead to facility closures. Some patient advocate groups, however, have argued the rule doesn’t go far enough because it doesn’t mandate enough workers per resident.

The House Ways and Means Committee this month advanced legislation that would block the administration from issuing the rules, though only one Democrat joined Republicans. But several Senate Democrats — including Jon Tester of Montana and Maggie Hassan and Jeanne Shaheen of New Hampshire — have joined Republicans in warning that the proposal would force closures because of the burden it would put on facilities reeling from workforce shortages.

Alexa McKinley, director of government affairs and public policy for the National Rural Health Association, said the group is open to using the CRA to overturn the rule if it doesn’t include carve-outs for rural facilities.

“If rural nursing homes and long-term care facilities can’t comply, they’ll likely be forced to close,” McKinley said. “They’re already struggling to recruit and retain in these areas and compete with the McDonald’s down the road.”

Those who support setting minimum staffing standards at nursing homes, however, are pushing the administration to act before the deadline.

“The nursing home industry continues to make excuses. They, along with GOP members of Congress, continue to look for ways to try to stop this life-saving reform,” said Leslie Frane, executive vice president of health care at Service Employees International Union. “We will continue to speak out in support of … finalization of the rule in a timeframe that protects it from additional legislative challenges and more importantly enables speedy implementation.”

Sam Brooks, director of public policy for the National Consumer Voice for Quality Long-Term Care, said he expects the industry to use “any legal argument” to prevent the standard from being implemented.

“I suspect the administration is aware of this fact, as well, and I hope is planning the rule’s final publication accordingly,” Brooks said. “We hope CMS will issue a strong final standard soon and that the CRA will not be a factor.”

Non-discrimination, abortion rules in flux

Advocates are closely watching two rules waiting to be finalized by the Office of Management and Budget, saying the regulations would have big implications for patients seeking abortions.

One of those rules would expand anti-discrimination provisions in the Affordable Care Act — that had been narrowed under the Trump administration — to protect people who seek abortions and LGBTQ+ patients from discrimination. The other proposes changes to HIPAA, the federal health privacy rule, to prevent health care providers and insurers from turning over information to state officials for the purpose of investigating, suing or prosecuting someone who sought or provided a legal abortion.

Both rules are likely targets of a Trump administration, reproductive health care and LGBTQ+ advocates say. Greer Donley, associate professor of law at University of Pittsburgh School of Law, said that a Trump administration is likely to try and restore the initial HIPAA provisions, which she said are broad enough to be interpreted as allowing law enforcement to be able to ask for certain health records.

And dozens of advocacy groups signed on to a December letter led by The Leadership Conference on Civil and Human Rights, urging HHS to finalize the non-discrimination rule.

“We feel strongly that the [rule] must be finalized as soon as possible so that this administration can lead the response to any legal challenge to the rule, and to avoid any timeline that would leave the regulation subject to the Congressional Review Act,” wrote the groups, including the Center for Medicare Advocacy, Disability Law Center, Families USA and Protect Our Care.

Melanie Fontes Rainer, director for HHS’ Office for Civil Rights, responded to the groups late last month, saying that HHS is “working diligently to finalize it this year,” per a letter shared with POLITICO.

Liz McCaman Taylor, senior federal policy counsel at the Center for Reproductive Rights, whose group also signed the letter, said she is cautiously optimistic about the rules being finalized before May.

“The longer that they don’t come out, the more my anxiety begins to bubble,” she said.

The White House is also fielding contrasting concerns from public health and civil rights groups over its proposed 2022 menthol cigarette ban.

That proposal has led some influential Black alliesof the administration to warn that outlawing the product would fuel an underground market and worsen overpolicing in marginalized communities. Meanwhile, public health organizations have called on the White House to finalize the ban in the interest of reducing smoking-related disease rates.

The American Cancer Society Cancer Action Network has urged the administration to finalize the ban, but CEO Karen Knudsen said it’s hard to say whether federal regulators are being swayed.

“They understand where we come from,” she said. “But our perspective is we have a sense of urgency. The time is now.”

Overhaul of lab-developed tests

An overhaul of regulation for laboratory-developed tests is moving along, with the FDA aiming to finalize the rule in April.

The proposed rule would subject many medical tests to new oversight by regulating them as medical devices. The industry has opposed the rule, arguing it would be a burdensome stretch of the FDA’s authority.

The proposal has reached the White House Office of Management and Budget.

Friends of Cancer Research CEO Jeff Allen said the FDA has “always made it clear” it wants to move quickly.

“Significant skepticism of the administrative state and its perceived overreach by some in Congress may make overturning of the LDT rule through the CRA [when finalized] an attractive proposition,” Sarah Thompson Schick, counsel at Reed Smith, wrote in an email, adding to expect court challenges to the finalized regulations.