with Alexandra Ellerbeck

Hitting rewind will be President-elect Joe Biden’s chief way of acting on health-care policy — at least for the next two years.

Biden appointees in the White House and federal health agencies are expected to unwind dozens of Trump administration regulations on Obamacare, Medicaid and abortion rights, turning back the page four years ago to the Obama administration’s vision of how government health programs should be run.

Regulatory actions and executive orders will be their chief pathway.

Biden will have no significant Senate majority to pass his more ambitious proposals, such as a public option. Yet after spending the 2020 campaign season promising to improve the nation’s health-care system, Democrats will be under heavy pressure to deliver.

“I think there is an incredibly strong message…that health care and drug pricing issues helped deliver the White House in 2020, so now you have to do something on these issues,” said Maura Calsyn, a health-policy expert at the liberal Center for American Progress. “There’s just no time to wait.”

Larry Levitt, executive vice president at the Kaiser Family Foundation:

Biden will bring back Obama alums to help steer the ship.

Democratic advisers told me they expect many old faces — mixed with some new ones — to return to top appointee slots at the Department of Health and Human Services and health adviser roles at the White House. The administration may especially focus on appointing doctors to key roles, given the severity of the coronavirus pandemic and the Trump administration’s shortcomings on that front.

“I do think there will be a course correction for wanting to have more scientists and doctors,” said Kavita Patel, who served in the Obama White House as a policy director.

Vivek Murthy, who served as surgeon general under President Barack Obama, is viewed as a top pick for HHS secretary, as well as New Mexico Gov. Michelle Lujan Grisham. 

Biden has already chosen Murthy to help lead his new coronavirus task force. The 13-member group will also be co-led by former Food and Drug Administration Commissioner David Kessler and Yale University’s Marcella Nunez-Smith. The members, who were announced this morning, include prominent bioethicist Zeke Emanuel and Rick Bright, a Trump administration whistleblower who alleged his early warnings about the pandemic were ignored.

For administrator of the Centers for Medicare and Medicaid Services — the mammoth subagency within HHS that oversees the federal health insurance programs — contenders could include North Carolina health secretary Mandy Cohen — who served at CMS during the Obama administration — and former Louisiana health secretary Rebekah Gee.

Christen Linke Young, who was a CMS deputy director, and Patel could also be in the mix for top HHS or CMS spots.

For Food and Drug Administration commissioner, Josh Sharfstein and Amy Abernethy are under consideration. Sharfstein was considered for the spot under Obama, but instead made principal deputy commissioner; Abernethy currently serves as the agency’s principal deputy commissioner of Food and Drugs.

And in the White House, Biden probably will surround himself with several Obama veterans, perhaps including Emanuel, former Ebola czar Ron Klain, former HHS secretary Sylvia Mathews Burwell and Andy Slavitt, who ran CMS in Obama’s second term.

Whoever is on the Biden team, they will be Obamacare champions.

One of the administration’s first moves is expected to be opening Healthcare.gov for a special enrollment period and reinstating advertising funds the Trump administration slashed — a move that deeply frustrated health-care advocates who watched with dismay as enrollment diminished each year.

“There is just a lot of cleanup to be done on Healthcare.gov and outreach and enrollment,” Calsyn said.

The Biden administration may also roll back Trump-era rules expanding the length of short-term health plans that are cheaper but also are exempt from the law’s full coverage requirements — plans critics feared might undermine the marketplaces and leave purchasers financially exposed. 

The new administration will also start putting its own mark on the individual marketplaces through regular, annual guidance CMS issues about how they should work. There are likely to be tweaks aimed at ensuring plans have comprehensive benefits, although the new administration probably won't reverse all the small changes made by the Trump administration.

It will be a distinct shift in tone toward the health-care law.

Trump, after trying and failing in 2017 to replace the ACA, argued he’d made the best of an otherwise bad law — a posture also taken by his top health officials. Long-standing GOP antagonism to the law put Trump appointees in the position of simultaneously trying to trim back the law while arguing they were still improving insurance opportunities for people.

But Biden, who served as vice president while the law was being written and passed, spent his campaign promising to amplify and expand Obamacare. That message is welcome for doctors, hospitals, insurers and other industry players who supported the Affordable Care Act’s passage and have watched in dismay as the nation’s uninsured rate inched back up after an initial plunge.

Biden’s win means “we get preservation and enhancement of ACA to ensure that the newly unemployed and anybody else who lacks insurance has access,” said Chip Kahn, president of the Federation of American Hospitals.

The Biden administration will try to ease the pathway to Medicaid for low-income Americans.

Allowing states to impose new types of requirements on Medicaid enrollment was one of the Trump administration’s most controversial health-care moves. The Centers for Medicare and Medicaid Services approved work or volunteer requirements in 12 states and allowed many others to collect premiums from enrollees or lock them out of coverage if they didn’t pay.

“You see all the work requirements getting shelved,” Slavitt told me. 

It’s not at all clear the Trump administration’s moves were legal; many of the new state requirements are caught up in litigation or didn’t attract much uptake from states to begin with. And its Medicaid philosophy diverged heavily from how the program has traditionally been viewed, with CMS Administrator Seema Verma regularly arguing it should nudge people out of poverty by incentivizing personal responsibility.

The new state requirements were approved through waivers, which are essentially permission slips from the federal government to states to modify their Medicaid programs in specific ways. 

So the new administration won’t be able to halt new Medicaid requirements right away.

“Even if Biden said Day 1 we’re eliminating all work requirements, it would take time,” Patel said.

But there are gradual things the new administration could do. 

It could issue its own guidance to state Medicaid directors, trying to nudge them away from requirements that Democrats view as onerous. It could stress that states can’t enact any changes that minimize eligibility or make it harder for people to access the program. And it could invite states to apply for waivers to expand services, such as for telehealth or behavioral health.

Don't forget about reproductive rights disputes.

The Biden administration will reverse Trump rules on abortion and birth control that had pleased conservatives.

Chief among these is changes to the Title X family planning program. Planned Parenthood left the program after the administration finalized rules banning grantees from referring women for abortions and requiring financial separation from facilities that provide abortions.

Biden appointees could scrap those new rules. The administration could also revert to narrower Obama-era rules on religious and moral exemptions for health-care providers and employers, which the Trump administration expanded. 

Ahh, oof and ouch

AHH: Pfizer's coronavirus vaccine appears more than 90 percent effective.

The company's front-runner vaccine showed high effectiveness in an interim analysis by an independent data monitoring committee that met yesterday, Carolyn Y. Johnson reports.

“The early look at the ongoing trial provides a decisive initial glimpse of the real-world performance of one of the four coronavirus vaccines in the last stages of testing in the United States,” Carolyn writes. “It is the strongest signal yet that the unprecedented quest to develop a vaccine that could help bring the pandemic to an end might succeed, breaking every scientific speed record.”

“I would say it’s a historical moment. Something like this has never happened before. First of all, the world was faced with such a terrible situation, the pandemic, and being able in such a short time to go through what usually takes many years,” Kathrin Jansen, head of vaccine research and development at Pfizer, said in an interview. “Hearing that at the interim analysis we are over 90 percent effective — it was almost stunning to hear.”

“In Pfizer’s 44,000-person trial, there have so far been 94 cases of covid-19…in people who were not previously infected,” Carolyn writes. “Fewer than nine of those cases were among people who received two shots of the vaccine, a strong signal of efficacy. The data is not yet published or peer-reviewed, and the company news release could not be presented to outside experts under the terms of an embargo.”

From Trump's ex-FDA head:

From a senior health editor at Bloomberg News:

OOF: Biden will urge governors to adopt mask mandates and encourage social distancing.

“Biden has laid out a far more muscular federal approach than Trump, saying he would urge state and local leaders to implement mask mandates if needed, create a panel on the model of President Franklin D. Roosevelt’s War Production Board to scale up testing and lay out detailed plans to distribute vaccines to 330 million people after they are greenlighted as safe and effective,” Yasmeen Abutaleb and Laurie McGinley report.

President-elect Joe Biden passed the threshold for electoral votes on Nov. 7. The Fix’s Amber Phillips analyzes pending shifts in Washington's balance of power. (The Washington Post)

“Biden’s goal, these people say, is to have people hear the same message from leaders at all levels of government and from members of both parties — something that has been lacking this past year as mask-wearing became a political flash point," Yasmeen and Laurie write. “Another thing that Biden can do without Congress is reverse Trump’s decision to withdraw from the World Health Organization — which has not yet been finalized — and begin holding briefings with government scientists and health experts, as he has repeatedly vowed to do. He also can implement mask mandates on all federal property."

But much of the success of Biden's public health initiatives will be determined by his ability to persuade a fractured nation, while his ambitions to ramp up testing and contact tracing and provide more economic stimulus will require money from Congress.

“With Trump sowing doubt about the election results, Biden officials are also preparing for Trump to block hundreds of Biden transition team members from gaining access to government resources as required by law,” Yasmeen and Laurie write.

Tom Inglesby, director of the Johns Hopkins Center for Health Security:

OUCH: Tomorrow the Supreme Court will hear yet another challenge to the Affordable Care Act’s constitutionality.

“A decision this term to strike down the entire ACA — unlike when justices upheld the law on different grounds in 2012 and 2015 — would upend the health-care system in ways that touch most people in the United States,” Amy Goldstein writes. “If the high court, with a newly strengthened conservative majority, were to overturn the law following this week’s oral arguments, health insurance would collapse for at least 23 million Americans."

The Supreme Court upheld the law’s individual mandate in 2012, ruling it constitutional under Congress’s authority to tax. But after Congress set the mandate penalty to $0 in 2017, a coalition of conservative states challenged the law, arguing that the 2012 ruling no longer applies when it comes to a penalty-less mandate and that the entire law should be struck down.

Even many conservative scholars find the argument weak, and during confirmation hearings for Amy Coney Barrett, some Republican senators dismissed the idea that the law was in jeopardy. Nevertheless, the challenge, which is supported by 18 Republican states and the Trump administration, seem to have convinced a federal district judge in Texas, who ruled to strike down the law in its entirety in 2018.

Congress could potentially make the whole lawsuit irrelevant by passing a law increasing the penalty to $1, although with control of the Senate still up in the air, it's unclear whether it would do so.

In the middle of a pandemic, the stakes are high. If the law is overturned, it could cast into doubt insurance for people with preexisting conditions. This could potentially affect hundreds of thousands of Americans who have contracted the coronavirus if covid-19, which sometimes causes lingering effects, is classified as a preexisting condition. 

The Supreme Court has been hearing oral arguments over teleconference during the coronavirus pandemic and broadcasting them live for the first time. Tomorrow's arguments will be aired on C-SPAN.

OUCH: Mark Meadows has covid-19, amid a fresh outbreak of coronavirus cases in the White House.

An administration official said that the White House chief of staff and at least five other aides have received positive coronavirus test results in the period around Election Day, Anne Gearan and Josh Dawsey report

“Meadows, who tested positive Wednesday, at first told others not to disclose his condition. But after his diagnosis became public late Friday, the official confirmed that a broader outbreak threatens to create a new crisis in the West Wing just as Meadows and other top aides are trying to help President Trump navigate a bitter loss at the polls to Democratic President-elect Joe Biden,” Anne and Josh write.

The latest outbreak is at least the third wave of infections to strike the White House. The first, which erupted in the days after a Sept. 26 Rose Garden ceremony honoring Supreme Court Justice Amy Coney Barrett, resulted in Trump testing positive and entering the hospital with covid-19. Two weeks later, at least five aides or advisers to Vice President Pence tested positive. But despite repeated infections, the White House has continued to ignore public health guidelines around the use of masks or social distancing.

“Meadows, for instance, has rarely worn a mask in public, has ridiculed Democratic governors for locking down bars, restaurants and other businesses and has fought with federal science advisers about the administration’s response to the pandemic,” Anne and Josh write. 

The White House has also faced criticism for failing to conduct contact tracing or genetic analysis that could determine the source and spread of the outbreaks. This pattern may be playing out again. The administration official told The Post that many White House staffers and Cabinet officers who had close contact with Meadows were kept in the dark about his infection.

The science of coronavirus

An early hypothesis suggested cytokine storms, a type of immune overreaction, fueled covid-19 deaths, but new studies cast doubt.

To many doctors the idea of cytokine storms made perfect sense: “Patients who died of Covid were found to sometimes have little or no virus in their bodies. Their immune systems got rid of it. But in doing so, the hypothesis went, their body’s defenses went rogue, spewing out powerful compounds — cytokines and other drivers of inflammation — that fatally damaged tissues and organs in a storm,” the New York Times’s Gina Kolata writes

Early reports from China and Italy suggested that one cytokine, interleukin-6, or il-6, was elevated among patients who fared poorly with covid-19 and that results were improved when patients were given drugs to block il-6.

"Now rigorous studies are failing to find that anti il-6 drugs are effective. Other studies are finding that il-6 levels are not even highly elevated in Covid patients compared to levels in other critically ill patients,” Kolata writes. “Three such studies, two published in JAMA Internal Medicine and one in the New England Journal of Medicine, found no evidence that a commonly used il-6 inhibitor, tocilizumab, a rheumatoid arthritis treatment, reduced the death rates in severely ill coronavirus patients.”

Not everyone is ready to dismiss the cytokine storm hypothesis. 

Randy Cron, a professor of pediatrics and medicine at the University of Alabama at Birmingham who studies cytokine storms, told NYT that hospitalized covid-19 patients do experience these immune reactions, even if they manifest differently from other viral infections. Randomized controlled trials could also help determine whether administering anti-il-6 drugs earlier or later during treatment provided beneficial.

One obstacle: there is no consistent or diagnostic criteria for cytokine storms. Even if they play a role in covid-19 deaths, it’s possible that il-6, one of hundreds of cytokines the body releases when it responds to an infection, is not a culprit. Other immune overreactions, including other chemicals that drive inflammation, could also explain some severe covid-19 cases and deaths. 

More in coronavirus

  • A record-breaking surge of coronavirus cases is sweeping the nation. “The country’s seven-day new case average was more than 100,000 for the first time. In five of the past seven days, more than 1,000 deaths were recorded,” The Post’s Robert Barnes writes.
  • New York City officials have been shutting down schools and businesses with “almost surgical precision,” using block-by-block infection data, The Post’s Ben Guarino reports. The policy has won praise among health experts and has helped avoid many blanket restrictions but is unpopular among many in the communities targeted for lockdowns.
  • The Department of Veterans Affairs is recruiting 8,000 volunteers for phase 3 clinical trials of at least four coronavirus vaccines. The news follows a Defense Department announcement in September that it was partnering with AstraZeneca to recruit volunteers for clinical trials. Both federal departments have experience in research, can tap into diverse populations and have a vested interest in the success of a vaccine, Kaiser Health News’s Patricia Kime reports.
  • In an op-ed in the New York Times, sociologist and writer Zeynep Tufekci argues that there would be no ethical or effective way to conduct randomized trials of mask-wearing but there is plenty of other data supporting mask use, from ecological studies comparing infection rates in different places to lab studies looking at the effectiveness of masks in blocking particles.

In her op-ed, Tufekci took issue with a tweet from Republican Sen. Rand Paul (R-Ky.) questioning the utility of masks:

  • The October jobs report shows that 2.2 million women had dropped out of the labor force as of October, compared to 1.5 million men. The disproportionate number of women leaving the workforce seems to be driven by more mothers staying home with kids who are in virtual schooling, The Post’s Heather Long reports.

Elsewhere in healthcare

An FDA advisory committee gave a thumbs down to new Alzheimer’s drug.

“An experimental drug designed to slow cognitive decline in those with Alzheimer’s disease ran into a buzz saw of skepticism Friday as government advisers said there was not enough evidence to show that the drug was effective. The reaction raised questions about whether the Food and Drug Administration would approve the drug, which would be the first new Alzheimer’s treatment in almost two decades,” The Post’s Laura McGinley reports.

Aducanumab targets amyloid beta, a protein that builds up in the brain and is considered a possible cause of Alzheimer’s. The medication does not cure or prevent Alzheimer’s but is instead aimed at slowing the progression of the disease for patients in the early stages. 

But members of the committee were critical of what they characterized as a “one-sided” and overly positive assessment from the FDA, pointing out that one study of the drug showed little benefit.

The advisory committee meeting included emotional testimony from desperate families and advocates who pleaded for approval of the medication. The Alzheimer’s Association, for instance, argued against requiring another late-stage trial, saying it could set the availability of the drug back by another four years.

The FDA said it would reach a decision about whether to approve the drug in March. The agency is not required to follow the counsel of its advisory committee, but it often does.

Sugar rush

In its cold open 12 hours after Joe Biden was declared president-elect, "Saturday Night Live" reimagined Biden's acceptance speech, played by Jim Carrey. (The Washington Post)