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Obama health law in greater peril after Ginsburg death; Azar takes rules control

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The nine justices of the U.S. Supreme Court
Source: U.S. Supreme Court

The Sept. 18 death of U.S. Supreme Court Justice Ruth Bader Ginsburg has created more uncertainty about the decade-old Affordable Care Act, which the Trump administration and a group of Republican state attorneys general are seeking to invalidate in a lawsuit.

The Supreme Court is set to hear oral arguments in the case Nov. 10.

It is unclear if President Donald Trump can get a nominee through the U.S. Senate before the Supreme Court hears the arguments or if only eight justices will end up ruling on the matter.

Trump has vowed for four years to dismantle the Affordable Care Act, or ACA — former President Barack Obama's signature legislative achievement. Trump has yet to reveal an alternative healthcare plan.

Trump and the Republican-controlled Senate are seeking to quickly put another conservative justice on the high court — a move opposed by Democratic presidential nominee Joe Biden and others in his party. So far, two Republican senators — Sens. Susan Collins of Maine and Lisa Murkowski of Alaska — have opposed acting before the Nov. 3 election.

At stake are a number of protections and programs created by the ACA, including the law's expansion of Medicaid.

Most notably, Americans with preexisting medical conditions could lose their insurance coverage if the ACA's safeguards are struck down.

Americans diagnosed with COVID-19 would likely be uninsurable or unable to gain coverage for any ill effects to blood vessels, limbs, major organs or their immune systems, which can all be damaged by the disease, tweeted former Centers for Medicare and Medicaid Services Acting Administrator Andy Slavitt, chairman of the nonprofit United States of Care.

Regardless of the Supreme Court's makeup, the plaintiffs' arguments in the case and the lower courts' rulings are "remarkably weak" and have been "roundly criticized" by even conservative scholars and some Republicans on Capitol Hill, said Washington lawyer Katie Keith, principal at Keith Policy Solutions LLC and an adjunct law professor at Georgetown University.

If the case is heard by only eight justices and there is a 4-to-4 tie, the court could delay issuing a ruling and rehear oral arguments after a ninth justice is seated, Keith wrote in a Sept. 20 blog in Health Affairs.

If a 4-to-4 ruling is issued, the appellate court's decision would remain intact, maintaining the status quo. The case would then be remanded back to the district court, which would undertake a provision-by-provision severability analysis, Keith wrote.

Under that scenario, litigation could continue for years and the case would most likely return to the Supreme Court, she said.

Sole control

A move last week by U.S. Health and Human Services Secretary Alex Azar to take sole control of signing off on all regulations and bar any other agency chiefs or senior officials from having that authority creates the perception that the independence of the U.S. Food and Drug Administration is being "eroded or influenced" and the agency is being "bullied," said venture capitalist and Pfizer Inc. board member Scott Gottlieb.

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HHS Secretary Alex Azar
Source: U.S. Department of Health and Human Services

"I think it sends exactly the wrong message" at a time when the FDA is seeking Americans' trust in the midst of the COVID-19 pandemic, said Gottlieb, who ran the agency during the first two years of the Trump administration.

"This is a major distraction," Gottlieb said Sept. 20 on CBS' "Face the Nation."

In a Sept. 20 evening statement, the HHS said Azar had put the policy in place to minimize litigation risk for the department's public health actions and to prevent potential future abuse of authority.

The statement came a day after The New York Times reported Azar had informed HHS agencies about the move in a Sept. 15 memo, which the administration has so far kept secret.

Gottlieb said he had fought the change when he was at the FDA. He noted that conservative groups have long been challenging the authority of lower-level career officials from signing off on regulations.

"If the basis for why the secretary did this is because he thinks the past delegations were inappropriate, that potentially could create another avenue to have legal challenges," he told CBS.

Azar is likely to be asked about his move for sole regulatory control when he goes before the House Select Subcommittee on the Coronavirus Crisis at an Oct. 2 hearing.

The congressional panel is convening the hearing to examine political pressure and intimidation of scientists at the FDA and the U.S. Centers for Disease Control and Prevention by Trump and his political appointees.

Trump's heads of the FDA and CDC are likely to also be questioned about political interference at a Sept. 23 hearing held by the Senate Health, Education, Labor and Pension Committee.

CDC revises testing guidelines — again

Meanwhile, the CDC has again revised its COVID-19 testing guidelines, stating Sept. 18 that anyone who has been in close contact for at least 15 minutes with someone diagnosed with the infection should get tested for the disease.

The Trump administration created confusion and angered the public health community when it posted changes to the CDC's recommendations on Aug. 24 advising against testing people who have no COVID-19 symptoms, even if individuals suspect they had been exposed to the virus.

A spokesman for CDC Director Robert Redfield in an Aug. 26 late-night email to some news reporters clarified that "testing may be considered for all close contacts of confirmed or probable COVID-19 patients."

But Redfield never publicly published his clarification and kept the Aug. 24 changes in place until the CDC posted the new revisions on Sept. 18.