President-elect Joe Biden’s win over President Donald Trump signals a 180-degree shift in several health policies Trump pushed over the last four years, many of which landed in court.
The Biden administration will likely withdraw from several lawsuits the Trump administration is appealing, including
“The Trump administration has come up with rules that would be inconsistent with the position of the Biden administration,” said Timothy Jost, an emeritus professor at the Washington and Lee University School of Law. “They’re going to have a very full plate and they’re going to have to do some prioritization as to which rules they get rid of first.”
The U.S. Supreme Court will have already heard arguments in the high stakes case challenging the constitutionality of the Affordable Care Act when Biden takes office, but his Justice Department could change its position in the case and support the coalition of mostly Democratic states trying to save the law.
“I don’t know much difference that would make, but I would think that the administration would want to go on record as supporting the Affordable Care Act rather than calling for its invalidation,” Jost said.
With the recent appointment of Justice Amy Coney Barrett to fill the seat vacated by the late Justice Ruth Bader Ginsburg, the court tilts more conservative. If the justices decide to strike down the ACA, it will fall to the Biden administration to figure out how to respond. The Supreme Court will likely rule on the case after Biden is sworn into office.
Biden differed from several of his primary challengers by refusing to support a universal government-run health-care system dubbed Medicare for All. Instead, he wants to strengthen Obamacare by expanding premium subsidies for ACA coverage to include people who earn more than 400% of the federal poverty level, for example. Biden also called for lowering how much a family can spend on individual market coverage to no more than 8.5% of its annual income. The current limit is 9.8%. Both of those proposals would require Congress to act and would likely see pushback from Republicans.
Biden also wants to add a government-offered “public option” health plan that Americans could buy into on the Obamacare exchanges. Unlike Medicare for All, that federal health plan would compete with private insurers for customers rather than replace them.
There are 14 states that haven’t expanded eligibility for the low-income health program Medicaid, even though they’re allowed under the ACA to offer coverage to people at or below 138% of the federal poverty level. Biden supports providing premium-free coverage under the public option for nearly 5 million adults in those states who aren’t now eligible for Medicaid but could be if the state expanded the program. This proposal also requires action from Congress.
To lower drug prices, Biden wants to repeal the law prohibiting Medicare from negotiating lower prices with drugmakers. He’s also called for allowing people to import drugs from other countries and establishing an independent review board to limit launch prices for drugs that don’t have competing versions on the market. Biden favors limiting price hikes for all brand, biotech, and some generic drugs as a condition of participation in the Medicare program and the public option.
Biden’s election was voter referendum on how they want to see the U.S. combat the pandemic. More than half of Americans took a dim view of Trump’s handling of the novel coronavirus outbreak, but the opinions skewed heavily on party lines. An Oct. 15 AP-NORC poll found 66% of Americans disapproved of Trump’s response to Covid-19, but only 28% of Republicans took that view. Virtually all Democrats in that survey—97%—disapproved.
Biden vowed to listen to scientists, embracing public health measures such as a push to encourage wearing masking nationally. Trump eschewed those public health recommendations as he held campaign rallies without requiring masks.
“This is a public health election. I can’t think of another election where the lead issue is a public health challenge,” said Joshua Sharfstein, former principal deputy commissioner at the Food and Drug Administration and vice dean for public health practice and community engagement at Johns Hopkins’s public health school.
Ellie Dehoney, vice president of policy and advocacy for Research!America, said she expects public health recommendations like mask wearing and social distancing to pick up dramatically under Biden as well as efforts to improve contact tracing. “He’s made that very clear that there will be much more intensified effort to flatten the curve before a vaccine comes into play.”
Career scientists at the Centers for Disease Control and Prevention could re-emerge as a leading voices on responding to Covid-19. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases, held weekly press calls and frequent appearances in the early days of the outbreak but later adopted a lower profile.
FDA on Vaccine Path
One thing that won’t change is the Biden administration’s efforts to speed a Covid-19 vaccine to market. Dehoney expects the administration to take an active role in distributing the vaccine once it becomes available. State public health officials complained that under Trump, they received little guidance as to how to prepare to dole out the vaccine.
Officials heading up Operation Warp Speed, the government initiative to fund drugmakers with promising vaccine candidates, say an administration change won’t derail their work.
Biden said one of his first appointments will be for a supply commander who tracks coronavirus testing and equipment shortages. But it’s not clear if that would be an FDA appointment, and Biden hasn’t specified if he’ll boot FDA Commissioner Stephen Hahn during the pandemic response. Other FDA staffers closer to the vaccine authorization process, like Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, joined the agency before the Trump administration.
The FDA will likely continue on the same path it’s been on for roughly a year: preparing to authorize a Covid-19 vaccine. Much of the timeline is out of the FDA’s hands as regulators wait for vaccine manufacturers to send them applications. Agency officials like Marks expect to have more than one vaccine on the market eventually. The first vaccine candidates will likely be given an emergency authorization for use, which will require the manufacturers to continue to feed data to the agency on the vaccine’s efficacy and potential side effects.
Even after the initial green-light for the first vaccine, agency officials will still have their hands full with other vaccine applications. They’ll also have to make decisions on whether certain vaccines could work well in populations under-represented in clinical trials, like children or pregnant women. Post-marketing safety analysis will likely take up much of the agency’s time in the winter and spring.
Although Covid-19 has cast a pall on all federal agencies since March, the FDA still has to negotiate the terms for the law that authorizes drug and device agreements. Those agreements outline what fees the FDA will collect from device and drugmakers and the FDA’s priorities for the next four years.
The current agreement expires in September 2022, and the final draft for the next one beginning in 2023 is due March 21, 2021—when the agency will theoretically be busy assisting with Covid-19 vaccine distribution. Impending deadlines for both drug and device agreements will likely put the agency under even more strain. Staffers are already working at “breakneck speeds,” Hahn said at a public meeting in October.
The National Institutes of Health largely enjoys bipartisan support in both Congress and the White House. President Barack Obama’s appointment of Francis Collins in 2009 moved swiftly through the Senate, and Trump decided to keep him at the urging of key health Republicans in late 2016.
If Collins is reappointed by Biden, it would be an unsurprising but unprecedented move, making him the only NIH director to work through three administrations since that post became a presidential appointment in 1974. Collins told Bloomberg Law last year he doesn’t plan to be a lifelong NIH director, but he would like to see a universal flu and HIV vaccine come to fruition before he leaves.
Biden has made medical research a priority, particularly cancer research and the Cancer Moonshot, which aims to double the rate of progress in treatments and prevention.
Both the CDC and the NIH rely heavily on discretionary funding from Congress. It’s unclear what Biden’s election means for shoring up additional funding for both agencies, although Biden’s pledge to support science indicates he’ll back robust funding. The NIH estimates it’s lost about $10 billion in research due to Covid-19—nearly a quarter of its budget—and CDC said it needs about $6 billion to distribute a Covid-19 vaccine.
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