Why health care experts are so concerned about fishing boats

Several cases that more directly attack health agencies are also working their way through lower courts, and their outcome could hinge on how the Supreme Court rules this term.

The slew of cases has alarmed legal experts, patient advocates and former health officials from both parties who say the consequences for the health care system — from drugmakers to nurses to patients — could be dire. If the court moves in the coming months to restrict federal agencies’ powers, they warn, a raft of health policy decisions would be punted to a gridlocked Congress.

Mark McClellan, a former FDA commissioner and CMS administrator under President George W. Bush, is among those warning that limiting the executive branch’s ability to make policy — especially health agencies making rules based on the latest science — would upend how government functions.

“This is a really key feature of effective government,” McClellan said. “Disrupting that reliability — not having an effective mechanism to replace it with — means more uncertainty about health, probably less investment … needed to keep Americans safe.”

The conservative groups behind the legal efforts, which would constrain most federal agencies if successful, argue that health policy is one of many areas where bureaucrats have overreached, and see the cases as a corrective step.

“This is business as usual when it comes to holding federal agencies accountable for failing to follow the law,” said Erik Baptist, a senior counsel for Alliance Defending Freedom who is leading several challenges to federal agency powers, including FDA regulation of abortion pills. “We’ve seen many recent examples where an agency may purport to have expertise in an area, but when it exceeds its statutory authority to prescribe new laws or regulations on a vast group of society or industry, then it’s the court’s obligation to rein in that unlawful activity.”

While right-leaning groups have long wanted to shrink the federal government’s role in health care and other areas, their efforts have recently found a smoother path through the courts. Many of the current cases have been funneled to a handful of Texas judges and the conservative-leaning 5th U.S. Circuit Court of Appeals, hoping for rulings that will tie the hands of agencies working to expand access to care, combat infectious and chronic diseases, and curb insurance and pharmaceutical industries.

“It’s an effort to use friendly judges to take health care away from people,” said Leslie Dach, a former senior counselor to the secretary of Health and Human Services during the Obama administration. “And as dire as the consequences are for the specifics of each lawsuit, the total effect will be even more dire.”

Just days before the Supreme Court’s term began on Monday, advocacy groups representing patients fighting cancer, ALS, epilepsy, mental illnesses and other conditions warned the justices that rolling back federal agency powers and putting the onus on Congress to write and update regulations would cause chaos. Their amicus brief argued low-income people, the elderly and people with disabilities would bear the brunt of any ensuing harm.

Mary Rouvelas, the managing counsel and legal advocacy director at the American Cancer Society Cancer Action Network and lead author of the brief, pointed to the pending fishing boat regulations case that attacks Chevron — the precedent that courts defer to federal agencies’ interpretations of laws. Should the justices overturn Chevron, she cautioned, crucial updates to federal health programs would grind to a halt, and groups would have a green light to file lawsuits to strike down any longstanding rules.

“Congress can’t be legislating every time the science changes — it’s just not physically possible,” she said. “If Congress is not capable of even funding its annual programs in a timely fashion, I don’t see them legislating about what a ‘geographic area’ is for the purposes of a specific nursing home statute.”

Overturning Chevron is only one tactic. Other cases before the Supreme Court this term and cases likely to reach the high court in the future target federal agencies in different ways. Some contend that Congress never delegated to federal bureaucrats or advisers the authority to make health care rules. Others argue that agencies shouldn’t be able to tackle “major questions” — like vaccine mandates and abortion pill regulations — without explicit permission from Congress.

One case pending before the justices concerns the FDA’s ability to regulate abortion pills. The case will likely turn on whether the Supreme Court believes the agency adequately considered the safety risks or made a series of “arbitrary and capricious” decisions to make the pills more accessible.

But groups on both sides of the lawsuit see its potential to place more sweeping restrictions on the FDA’s authority. The group Students for Life recently told its members that a blow to Chevron would aid its efforts to ban abortion pills because judges wouldn’t be compelled to defer to the FDA’s expertise. Meanwhile, the Biden administration and pharmaceutical industry have warned in statements and legal briefs that striking down agency policies allowing the pills to be mailed and dispensed at local pharmacies would spark a wave of challenges to other drug approvals — and hamper the regulator’s ability to make rules based on science.

Right-leaning groups have successfully targeted many other federal health regulations in recent years using similar arguments — going after mask and vaccine mandates, bans on smoking in public housing, and discounts on some prescription drugs — and are expected to lean heavily on this tactic going forward.

“It’s a longer road to really chipping away at agency discretion and agency expertise to decide what good policy is,” said Rachel Rebouché, a dean of Temple University’s Beasley School of Law who specializes in reproductive health law.

Another case now before the right-leaning 5th Circuit targets more than a decade of HHS rules around preventive care services that insurance companies must cover with no out-of-pocket costs for patients under the Affordable Care Act — policies that have made STD tests, HIV prevention drugs and mental health screenings free for tens of millions of people.

The conservative employers behind the case argue that because the United States Preventive Services Task Force is made up of outside experts who were neither Senate-confirmed nor chosen by a Senate-confirmed agency head, its recommendations of what services should be covered must be “set aside” and can’t be enforced.

If they prevail, insurance coverage would likely never evolve to reflect new scientific research or medical needs, warned Dach, the former HHS official.

“You need people who understand the science to continually upgrade these things — that’s why Congress established these mechanisms,” he said. “They can’t tell a woman when to get a mammogram. They’re not reading the latest medical literature to see what’s changed. We really expect Congress to sit down with a list of preventive services and decide which we do and don’t need anymore? It’s a joke, but one where the punchline could result in people dying.”

Many conservatives are cheering on these challenges with renewed enthusiasm following Covid-19 mandates that they saw as government going too far.

The Heritage Foundation recently touted the pending Supreme Court cases as “an opportunity to wake Congress up with the only thing that might do the trick: a judicial slap in the face,” arguing the House and Senate have ceded too much power to federal bureaucrats and need to take it back. The Christian Employers Alliance argued in a brief to the top court that “agency officials are far too willing to impose their personal political agendas,” citing several different vaccine and health insurance mandates as examples of overreach.

But some on the right warn that the ripple effects from these cases could make it harder to keep Americans safe.

Marc Scheineson, a former FDA associate commissioner under President George H.W. Bush, who’s now a partner at Alston & Bird LLP, said that because Congress tends to write vague legislation, agencies need the right to clarify statutes through their rulemaking powers. If courts continue to question that right, he warned, any industry or advocate with enough resources will have the incentive to sue to take down any regulation they don’t like.

“We’re going to be back in the wild wild west where whoever has the biggest gun and is able to draw it the fastest wins,” he said.

Scheineson added that should courts side with those seeking to disempower federal agencies, the government could have even more trouble retaining and recruiting workers — especially scientists — who could earn more in the private sector.

“If their experience is not being honored and their hard work is not being rewarded, the motive for dedicating their lives to these issues is definitely removed,” he said.

The Supreme Court’s rulings this term threaten to hamper future policymaking for conservatives and progressives alike.

The Trump administration relied on health agency authority to push Medicaid work requirements, restrictions on medical research using fetal tissue and job protections for doctors refusing to offer contraception or other services that clashed with their religious beliefs. Left-leaning organizations tried to knock down those rules with lawsuits just as groups on the right are doing now with Biden administration policies.

The difference, said University of Michigan law professor Nick Bagley, is that conservatives have a 6-3 Supreme Court majority, so they “are going to win more. That’s just gravity.”

The current wave of cases seeking to “defang the administrative state,” he added, is “about limiting the scope of federal power and undermining the decisions of democratically-elected presidents.”

“It’s profoundly anti-democratic no matter who is doing it,” he said.