Monday, November 9, 2020

Axios Vitals: The 3 questions that will determine the ACA's fate

1 big thing: The 3 questions that will determine the ACA's fate | Monday, November 09, 2020
 
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By Caitlin Owens ·Nov 09, 2020

Good morning. Yes, the election is mostly over. But never fear, the drama lives on: It's time for the Affordable Care Act to go back to the Supreme Court.

🚨 Tonight on our post-election "Axios on HBO" episode:

  • Valerie Biden Owens, the president-elect's adviser and sister, tells us how Joe Biden's upbringing drove his campaign thinking
  • House Republican Leader Kevin McCarthy talks about the future of the GOP and the "new power" of House progressives within the Democratic Party
  • House Majority Whip James Clyburn blames "sloganeering" like "defund the police" within the Democratic Party for Dem losses and discusses who he'd like for Biden's Cabinet
  • Rep. Ro Khanna tells Jonathan Swan that the House Democratic Caucus has "trust to build" after losing seats (clip)

Catch the show at 11:00pm ET/PT on all HBO platforms.

Today's word count is 1,217, or a 5-minute read.

 
 
1 big thing: The 3 questions that will determine the ACA's fate
Illustration of a caduceus with a gavel in the center.

Illustration: Aïda Amer/Axios

 

The Supreme Court will hear oral arguments Tuesday over the future of the Affordable Care Act — the third time in eight years the ACA has been on the brink of life or death at the high court, Axios' Sam Baker reports.

The big picture: For now, the smart money says that the court is likely to strike down what remains of the law's individual mandate, but is unlikely to go along with the argument — advanced by both red states and the Trump administration — that the whole law has to fall along with it.

  • But that conventional wisdom is based on a lot of guesswork. We'll get a clearer sense of the justices' thinking on Tuesday, and the answers to these three questions will give us a better sense of what's about to happen to 20 million people's health insurance.

1. Can the mandate survive? Probably not, but if it can, this case will be easier than almost anyone expects.

2. Whose intent matters? If the court strikes down the mandate, then the question turns to "severability" — how much of the rest of the ACA has to fall along with the mandate.

  • Severability is always a question of congressional intent. The courts try to figure out whether Congress still would have passed other provisions without the one the courts are striking down.

3. Who's going to save it? Blue states' argument is based on the kind of textualist, congressionally focused principles that often work with conservative justices. But for the law to survive, at least two Republican appointees have to cross over and vote with the court's liberals to save it.

  • Most observers expect Chief Justice John Roberts to be one of them. And there are reasons to believe he might find a second.

Go deeper.

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2. Biden signals the pandemic is a priority

President-elect Joe Biden is expected to name a 12-member coronavirus task force today, signaling that addressing the coronavirus will be the immediate priority for his transition, Axios' Hans Nichols reported this weekend.

  • The task force will be led by three co-chairs: former Surgeon General Vivek Murthy, former Food and Drug Administration Commissioner David Kessler and Marcella Nunez-Smith from Yale University.

The big picture: The U.S. recorded more than 100,000 coronavirus cases for the 5th day in a row yesterday, and it's likely that Biden will immediately inherit an out-of-control pandemic once he takes office.

Between the lines: Biden's transition website outlines his seven-point plan for addressing the pandemic, which includes many of the things public health experts say the federal government should have been doing all along.

  • But even if Biden is able to accomplish everything on this list, the real challenge will be convincing the millions of Americans who don't want to wear a mask or social distance that they should do so — a nearly impossible feat in today's polarized environment.

What we're watching: President Trump still occupies the Oval Office, and will hold enormous sway over a wide swath of the population even once he leaves.

  • That means that as we enter into what's looking more by the day like a very dark winter, what Trump says and does about the pandemic will matter a lot.
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3. Coronavirus digital immunity certificates
Illustration of a passport with a syringe on the cover

Illustration: Eniola Odetunde/Axios

 

Companies are preparing to design digital immunity certificates for COVID-19 that could be used when a vaccine is available, Axios' Bryan Walsh reports.

Why it matters: The vaccine won't roll out to everyone at the same time, so we need some way for those who have been immunized to easily demonstrate that they can safely return to work and travel. The easiest way might be a digital certificate that can be linked to a passport or even a mobile phone.

Background: The World Health Organization already issues paper "yellow cards" that act as an international certification of vaccination, primarily to be used when entering a country that has enhanced health risks to travelers.

  • But a paper certificate, as experts warned in a white paper released earlier this year, could be subject to fraud and would be too difficult to quickly scale up for hundreds of millions of people.
  • Digital certificates, though, could be rapidly and safely distributed and made easily verifiable at borders or even in businesses, says Lars Reger, CTO of the semiconductor company NXP, which makes biometric technology now used in some passports.

The catch: Some critics worry digital immunity certificates could cause discrimination between those who can show immunity and those who can't.

  • We also have to be sure those who receive such certificates really are immune, an immunological uncertainty that torpedoed earlier plans to issue certificates to those who had contracted the disease.
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A message from PhRMA

The key to developing more – and more effective – medicines
 
 

There are almost 7,000 new medications in development right now.

But to develop these treatments, biopharmaceutical companies must ensure their discoveries are protected.

IP can help lead to more effective treatments and cures.

 
 
4. A test of the FDA's reputation

An independent panel of medical experts overwhelmingly said last week there is not enough evidence for the Food and Drug Administration to approve Biogen's experimental Alzheimer's drug, aducanumab.

Why it matters: This is one of the most consequential drug evaluations in years, aside from pending coronavirus vaccines and drugs, Axios' Bob Herman reports.

  • The FDA is not required to follow the experts' recommendations, but bucking their advice and siding with Biogen's data-parsing would call into question the agency's standards and motives.

Between the lines: The FDA will make a final decision by March, and the clinical and financial stakes are enormous.

  • Alzheimer's affects more than 5 million Americans, and roughly 2 million of those have a mild version of the disease. There are no treatments that reverse the disease's cognitive decline.
  • Aducanumab, an IV medication, is expected to have a price of $50,000 per year. If the drug were approved and if only a fraction of Alzheimer's patients get the drug, Biogen would collect tens of billions of dollars in sales annually — which would easily rank aducanumab as the top-selling drug of all time and would increase the country's health care spending on its own.

The bottom line: Aducanumab currently does not meet the FDA's own standard of requiring two large, successful clinical trials, and many experts have said a third trial is needed for a drug of this importance, even though that comes with extra time and expense.

Go deeper: Biogen's Alzheimer's revival meets with skepticism

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5. 23 states set coronavirus records last week
Data: Compiled from state health departments by Axios; Map: Danielle Alberti/Axios

23 states set new highs last week for coronavirus infections recorded in a single day, according to the COVID Tracking Project (CTP) and state health departments. 15 states surpassed records from the previous week, Axios' Orion Rummler reports.

Why it matters: More states across the country are handling record-high caseloads than this summer.

Zoom in: Current ICU capacity in Colorado may be reached in late December, according to the latest modeling from the state's public health department.

  • Southwest and southeast Indiana have roughly 15% of ICU beds available, although the state overall has more than a quarter of its ICU beds open, the IndyStar reports.
  • In Michigan's rural Upper Peninsula, nearly all ICU beds across 15 hospitals were occupied as of Nov. 5, local outlet Bridge Michigan reports.
  • In Missouri and Kansas, hospitalizations continue to reach new highs, NPR's Kansas City station reports.

What they're saying: Illinois Gov. J.B. Pritzker (D) told reporters Thursday that "we are going to experience a surge in hospitalizations much higher than where we are now. And in some areas of our state that will mean that you'll run out of hospital beds, and nurses and doctors who can treat you," the Chicago Tribune reports.

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6. Catch up quick
Illustrated collage of a cut up coronavirus cell.

Illustration: Aïda Amer/Axios

 

New York Gov. Andrew Cuomo (D) said that Joe Biden's election victory could bring forth "a different tone" surrounding the coronavirus. "I think the political pressure of denying COVID is gone," Cuomo said on ABC's "This Week" Sunday.

White House chief of staff Mark Meadows has tested positive for the coronavirus, Bloomberg's Jennifer Jacobs first reported Friday night.

The Defense Department has deployed three U.S Air force Medical Specialty Teams to El Paso to help officials cope with a surge in coronavirus cases and hospitalizations, Texas Gov. Greg Abbott announced Friday.

The number of Americans receiving unemployment benefits continues to fall, but data from the Labor Department showed more than 1 million people filed for first-time jobless benefits for the 33rd week in a row, Axios' Dion Rabouin reports.

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Patents are crucial in developing new medicines
 
 

One reason so many COVID-19 vaccine candidates are in late stage clinical trials is because companies are able to share information around vaccine technology.

Our IP system – including patents – allows brand competitors and generic manufacturers to build on existing inventions.

 
 

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