Nevada man’s COVID-19 reinfection, the first in the US, is ‘yellow caution light’ about risk of coronavirus

https://www.yahoo.com/news/nevada-mans-covid-19-reinfection-223155707.html

COVID-19 reinfection: Nevada man is first confirmed American case

An otherwise healthy 25-year-old Nevada man is the first American confirmed to have caught COVID-19 twice, with the second infection worse than the first.

He has recovered, but his case raises questions about how long people are protected after being infected with the coronavirus that causes the disease, and potentially how protective a vaccine might be.

“It’s a yellow caution light,” said Dr. William Schaffner, an infectious disease expert at the Vanderbilt University School of Medicine in Nashville, Tennessee, who was not involved in the research.

Respiratory infections like COVID-19 don’t provide lifelong immunity like a measles infection. So, Dr. Paul Offit, an infectious disease expert at Children’s Hospital of Philadelphia, said he’s not at all surprised people could get infected twice with the coronavirus, SARS-CoV-2. 

It’s too soon to know whether the man from Washoe County, Nevada, who had no known health problems other than his double infection, was highly unusual or if many people could easily get infected more than once with SARS-CoV-2, Schaffner said.

“There’s hardly an infectious disease doctor in the country who hasn’t encountered a patient who thinks they’ve had a second infection,” he said. “Whether that’s true or not, we don’t know. There are lots of respiratory infections out there.”

How rare is he?

There have been at least 22 documented cases of reinfection worldwide since the start of the pandemic, but it’s unclear how many cases there have actually been, and how common it may be among people who don’t even know they’re infected.

“It could be a one in a million event, we don’t know,” said Akiko Iwasaki, an immunologist at Yale University and an investigator with the Howard Hughes Medical Institute, who wrote a commentary with the study.

With millions of people infected, it’s hard to know if case studies like the new one represent very rare events or the tip of an iceberg, she said. “It’s possible that the vast majority of people are completely protected from reinfection, but we’re not measuring them, because they’re not coming to the hospital.” 

Also, many people don’t know they are infected the first time, so it’s hard to say whether they’re getting re-infected.

In one of the recent cases, a Hong Kong man only knew he was reinfected because it was caught during a routine screening when he returned from outside the country, months after he had cleared an infection and tested negative. 

One reason there may not be more documented cases of reinfection: It’s tough to prove, said Mark Pandori, a pathologist at the University of Nevada, Reno School of Medicine, and senior author on the new study

His team coordinated early in the pandemic with members of the Washoe County Health District to look for repeat infections. They had the benefit of sequencing equipment on campus, as well as microbiologists, he said. And they got lucky finding someone who had been tested both times he was infected and cleared in between. 

Why his infection was worse the second time remains unclear, said Pandori, director of the Nevada State Public Health Laboratory. “I can’t tell you if it tells us anything in particular about the biology of this virus.”

The man caught a slightly different version of the virus the second time, according a genetic analysis of the man’s infections. It’s possible the second version was more dangerous, though there is no evidence of that, or that it was just different enough that his body didn’t recognize it, the paper said.

Implications for vaccination

Iwasaki said the study raises questions about how long immunity lasts after a natural infection. Protection with a vaccine is likely to be quite different, she said.

“Vaccines can be designed to induce much higher levels of antibody and much longer lasting immunity,” she said. Just because the natural infection doesn’t give you protection doesn’t mean the vaccines cannot. It’s a separate issue.”

Offit, also a vaccine expert at the Perelman School of Medicine at the University of Pennsylvania, said he expects protection from vaccines will likely last at least a year or two.

The protection provided by infection or vaccination isn’t 100% perfect until the day it disappears completely, he said. Instead, protection fades gradually, so someone exposed to a huge dose of the virus might get re-infected within months, while others could be protected for years, Offit said.

It’s also possible the Nevada man has an undiagnosed problem with his immune system. “He probably should be seen by an immunologist,” Offit said. 

The length of time an infection will be protective remains one of the key open questions about the virus.

Infected twice, two months apart

The Nevada man, considered an essential worker, started feeling ill in late March, with a sore throat, cough, headache, nausea and diarrhea. His workplace had been hit with an outbreak early in the pandemic, before safety measures like masks could be put in place, said Heather Kerwin, senior epidemiologist at the Washoe County Health District and a co-author on the paper. 

He went for testing on April 18 and his infection with the coronavirus was confirmed.

On April 27, he reported his symptoms had all resolved and he felt fine, but at the time, employees were required to test negative for COVID-19 twice before they would be allowed back to work, Kerwin said. So he remained isolated at home.

A month later, he began feeling poorly again. At the same time, there was an outbreak where one of his parent’s, also an essential worker, was employed, Kerwin said.

On May 31, he went to an urgent care center, reporting fever, headache, dizziness, cough, nausea and diarrhea. On June 5, he went to see a doctor who found his oxygen levels dangerously low and had him hospitalized. Again, the man tested positive for the virus, even though he still had antibodies to the virus in his bloodstream, Kerwin said.

Genetic differences between the viruses responsible for each of his infections suggested he was infected two separate times. The virus doesn’t mutate quickly enough within a single person to explain the differences between the two infections, the researchers found. 

A parent living with the man also caught COVID-19 and was diagnosed on June 5.

Mark Pandori, pathologist
Mark Pandori, pathologist

The paper reports it’s possible the man was reinfected because he was exposed to a higher dose of the virus the second time, perhaps from the family member.

His cough lingered and he suffered from shortness of breath and mental fog, and was on oxygen for six weeks after the second infection, Kerwin said. He has now fully recovered.

Reinfections imply so-called herd immunity cannot be obtained just through natural infection. If natural infection protects for only a few months, then it will be impossible for enough people to be protected simultaneously to reach herd immunity.

The moral of the case study, said co-author Pandori, is even people who already have been sick with COVID-19 need to protect themselves by wearing a mask, avoiding large gatherings, washing hands frequently and maintaining social distance.

“You’re not invulnerable to this,” Pandori said. “In fact, you could get it worse the second time.”

America’s most prestigious medical journal makes a political statement

https://mailchi.mp/45f15de483b9/the-weekly-gist-october-9-2020?e=d1e747d2d8

In Rare Step, Esteemed Medical Journal Urges Voters To Oust Trump | KPCW

For its first 208 years, the New England Journal of Medicine has never endorsed a political candidate. But this week the journal published an editorial outlining its political position in the upcoming Presidential election, signed unanimously by all editors who are US citizens.

The editors did not explicitly endorse former Vice President Biden, but rather offered a scathing condemnation of the current administration’s performance during the COVID pandemic: “Reasonable people will certainly disagree about the many political positions taken by candidates.

But truth is neither liberal nor conservative. When it comes to the response to the largest public health crisis of our time, our current political leaders have demonstrated that they are dangerously incompetent. We should not abet them and enable the deaths of thousands more Americans by allowing them to keep their jobs.” (Formally endorsing Biden last month, Scientific American also made the first political endorsement in its 175-year history.)
 
Much of the media coverage of the NEJM statement has centered on the question of whether medicine should involve itself in politics, or “live above it”

Medicine has been drawn into political disputes before, but now the nature of the involvement has changed. In the past, debates largely centered around regulation, payment or policy—but now the science itself has become a fundamentally political issue. 

The very nature of the coronavirus has become a matter of political belief, not just an indisputable scientific fact.

Public trust in both scientific institutions and the government, and their ability to work together, has been damaged. We fear this will lead to poorer health outcomes regardless of who wins the upcoming election.

Approaching a “new normal” for healthcare volumes?

https://mailchi.mp/45f15de483b9/the-weekly-gist-october-9-2020?e=d1e747d2d8

Eight months into COVID-19, national healthcare volumes are still lagging pre-pandemic levels. The graphic above shows highlights from Strata Decision Technology’s recent analysis of volume data from 275 hospitals nationwide between March and August, and reveals that inpatient, and especially emergency department, volumes are still well below 2019 levels. 

This isn’t surprising. Consumer confidence in healthcare facilities hasn’t changed much since April, with many still reporting feeling unsafe in emergency care and hospital settings. Even some outpatient providers are still seeing lags compared to last year.

While outpatient volume as a whole has rebounded, critical outpatient diagnostics, including mammographies and colonoscopies, are still down significantly, leading to reduced downstream oncology and surgical volume as well, at least in the short-term.
 
COVID-19 is also accelerating the outmigration of high-margin surgical procedures like total knee replacements. Comparing a two-week period in August to the same period last year reveals that inpatient knee procedures are down by nearly 40 percent, while similar outpatient procedures are up over 80 percent.

As Strata Executive Director Steve Lefar said in a recent conversation with Gist Healthcare Daily’s Alex Olgin, these data expose “an elasticity of demand the healthcare industry never even knew existed” and that “the demand curve for healthcare services may be permanently adjusted because people are just changing their behaviors.” 

While we expect volumes will ebb and flow over coming months in step with the local severity of COVID-19, health systems should plan for a longer-term “new normal” with volume below pre-pandemic levels.

A high-profile reminder of the importance of therapeutics

https://mailchi.mp/45f15de483b9/the-weekly-gist-october-9-2020?e=d1e747d2d8

Stemline Therapeutics Inc (NASDAQ:STML): What's The Other Side Of The  Story? - Market Exclusive

Along with the many political and public health questions raised by President Trump’s recent and very public bout with COVID-19 is the issue of when the public might have access to the same monoclonal antibody therapy that he received from doctors last week.

Having seen the President tout the benefits of Regeneron’s experimental antibody cocktail, COVID patients have reportedly been asking physicians about participating in clinical trials of the therapy, which is only available on a “compassionate use” basis outside of ongoing studies.

On Wednesday, Regeneron announced it had submitted a request to the US Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) for the treatment, claiming that early data from ongoing trials showed promise in moderating coronavirus symptoms.

Eli Lilly, which is developing a similar antibody therapy, also announced plans to apply for an EUA, saying its drug has shown the ability to reduce hospitalizations among those infected with the virus.

The US government has already paid Regeneron $450M to access up to 300,000 doses of the therapy, and on Friday a spokesman for the Department of Health and Human Services (HHS) said the government would acquire up to a million doses from Regeneron and Eli Lilly by the end of the year, which it will allocate to hospitals in a similar approach to the way it has distributed Gilead Science’s antiviral drug remdesivir, which the President was also given last week.
 
News on the availability of potentially effective therapies to mitigate the impact of COVID-19 is welcome, particularly as the timeline for COVID vaccines appears to be lengthening.

In guidance released this week, the FDA said it would require pharmaceutical companies to submit two months’ worth of data on vaccine safety and efficacy after patients received their final dose, as part of the EUA application process. The data requirement effectively means that, despite repeated promises from the White House, none of the vaccine candidates being developed will be available before the November 3rd Presidential election.

The head of the government’s vaccine program said separately this week that he expects data on vaccines being developed by Pfizer and Moderna to be available by December. As many have predictedit will take months beyond that for a safe and effective vaccine to be distributed and administered to a majority of Americans.

Challenges will abound: ensuring sufficient manufacturing capacity, managing a complex supply chain, setting up specialized distribution and vaccination centers, and tracking those vaccinated (especially if two shots will be required). A massive public education campaign will also be needed to overcome vaccine hesitancy and ensure widespread immunization. And all of that will take time, and money. 

President Trump’s recent and unfortunate illness underscores the importance of paying equal attention to the development of therapies and treatments—which are essentially a holding maneuver to get us through the coming winter and spring, and eventually to the promise of immunity that lies beyond.

Medical ethics in pandemic times

https://www.axios.com/medical-ethics-clinical-trials-pandemic-eb77f819-76f1-45b0-af8a-cf181bc1607b.html

The Importance of Medical Ethics | Medical Ethics – theMSAG

The COVID-19 pandemic is rife with scientific and medical uncertainty, including debates about the ethics of using experimental treatments.

The big picture: As the global pandemic continues, the tension between providing the best available care for patients and performing trials to determine whether that care is effective risks complicating the medical response.

The big question: Is it unethical to withhold a possible treatment from someone who instead receives a placebo, or to continue to administer that treatment without having collected data on whether it works?

Driving the news: President Trump received an experimental monoclonal antibody cocktail via expanded access or “compassionate use,” which allows someone to access a treatment outside of a clinical trial before it is approved, provided their doctor, the drug company and the FDA agree.

  • Experts say his subsequent claims of the treatment being a cure risks reducing enrollment in clinical trials, flooding companies with requests for access to a limited number of doses and creating false hope for patients.
  • And the president’s treatment raised questions about fairness — would other COVID-19 patients have similar access?
  • “It’s important that we not say the president got access to a beneficial experimental intervention because we don’t know if it is beneficial or if there are adverse events associated with it, says Alex John London, director of the Center for Ethics and Policy at Carnegie Mellon University. 

He and other ethicists say the president’s treatment highlights a broader question about the ethical obligation doctors have to the science needed to determine if those treatments are effective.

Between the lines: Offering patients experimental COVID-19 drugs via emergency use authorizations, expanded access programs and compassionate use can slow needed clinical trials.

  • Researchers have struggled to enroll people in clinical trials in which they may receive a placebo if patients can access a drug directly.
  • One example: “There’s been some hiccups with the expanded access use for convalescent plasma, because it was something that precluded people from enrolling in a randomized control trial, so it took longer, and we still don’t quite know how well convalescent plasma works,” says Amesh Adalja, an infectious disease physician and senior scholar at the Johns Hopkins Center for Health Security.

More than 100,000 COVID-19 patients at almost 2,800 U.S. hospitals received convalescent plasma from people who survived the virus and developed antibodies to it.

  • “It’s easy for people to say you enrolled 100,000 people, there should have been a trial. But a small number of those 2,800 hospitals would have been capable of doing those trials,” says the Mayo Clinic’s Michael Joyner, who leads the program.
  • There are now smaller trials taking place to answer questions about the effectiveness of plasma in treating the disease in different stages.
  • But if this happens again, Joyner says programs at academic medical centers should be peeled off earlier to form clinical trials run in parallel.

The gold standard for determining whether a treatment works is through randomized controlled trials in which people are randomly assigned to receive a treatment or to be in a control group.

  • In the uncertainty and urgency of a pandemic, some physicians argue randomizing people to receive a placebo goes against physicians’ ethics and that it is better to do something to help patients than do nothing.
  • “That’s a false dichotomy because the question is, what should we do?” says London.

From a doctor’s perspectiveit’s important to weigh the collective value of theearly drug data and the individual needs of the patient, Adalja says.

  • “I do think you have to be extra careful when you’re thinking about drugs that you don’t have strong randomized control trial data for, or the data is incomplete or inconclusive,” he adds.
  • “What people have to ask themselves is what constitutes evidence or proof and where do you want to make the bets in a pandemic?” says Joyner.
  • “There is a moral, legal and public health obligation to do those trials before people use those products,” says Alison Bateman-House, a professor of medical ethics at NYU’s Grossman School of Medicine who co-chairs an international working group on pre-approval access to treatments.
  • She says she understands the emotional pull on doctors to help patients whose health is quickly deteriorating, “but it is not evidence-based medicine.”

“There is no ethical obligation to give anyone an unproven substance.”

Alison Bateman-House, NYU Grossman School of Medicine

In a forthcoming paper, London argues that when medical professionals don’t have the knowledge they need to treat patients, it is their responsibility “to band together and run studies to get evidence to discharge [their] very ancient medical obligation.”

  • Medical ethics should be updated to include a responsibility to learn in the face of uncertainty, says London, who was part of a committee that called for research to be incorporated into the response to the Ebola outbreak in West Africa in 2014.
  • The U.K.’s large randomized RECOVERY trial is based in part on the Ebola experience, says London. “Because of it, we know dexamethasone is effective and hydroxychloroquine is not.”

What to watch: How the FDA’s handling of treatments during the pandemic influences other drugs and diseases once the pandemic ends.

The bottom line: “Medicine doesn’t have a good handle on uncertainty, and that is a problem,” says London.

Washington’s big contact tracing problem

Contact tracing grows across US | News, Sports, Jobs - The Vindicator

The D.C. Health Department is trying to jump-start contact tracing efforts around the White House’s coronavirus outbreak. Tracing has been inadequate so far even as cases spread deeper into the city, Axios’ Marisa Fernandez writes.

The big picture: The White House has decided not to move forward with recommended public health protocols of contact tracing and testing since President Trump tested positive for the virus. 

The state of play: Tracing has been done for people who had direct contact with Trump, White House spokesman Judd Deere told the Washington Post.

On Capitol Hill, there’s also no formalized contact tracing program in place, even as lawmakers themselves test positive.

  • Two infected staffers in Rep. Doug Lamborn’s (R-Colo.) office were told to not disclose to roommates they may have been exposed, WSJ reports.

The bottom line: The White House’s refusal to contact trace is “a missed opportunity to prevent additional spread,” Emily Wroe, a co-leader of a contact-tracing team at Partners in Health, told Nature.

COVID-19 sparks national security concerns with top brass in quarantine

COVID-19 sparks national security concerns with top brass in quarantine

COVID-19 sparks national security concerns with top brass in quarantine

The quarantining of most of the Joint Chiefs of Staff, coming on the heels of President Trump’s COVID-19 diagnosis, is raising fears that U.S. adversaries might seek to exploit a perceived weakness.

Few expect any sort of overt military action, but there are other ways to wreak havoc on the United States.

Chief among them is disinformation. Experts have been warning ever since Trump tested positive for the coronavirus last week that disinformation is likely to kick into overdrive.

Now, with six of the seven members of the Joint Chiefs of Staff waylaid at home, warnings are being amplified about the national security implications of the growing COVID-19 outbreak among U.S. leadership.

“All these kinds of things are just a huge distraction for us where our national security apparatus is consumed with matters domestic and internal,” former Director of National Intelligence James Clapper said at a Washington Post event after news broke of the Joint Chiefs quarantining. “So this is an ideal time for adversaries, particularly in adversary intelligence services, to look for ways to further confuse us, to distract us.”

Adding that “you can bet particularly our good friends the Russians are doing this,” Clapper warned of them “further sowing seeds of disinformation.” 

“They will appeal to all the various tribes and continue to capitalize on the polarization in this country,” he said. “So it is a vulnerable time, and it’s an opportunity for them while we’re not looking and not being alert to further sow seeds of disinformation, casting doubt, discord, distrust in the country.”

The quarantining of top military officers stems from the Coast Guard’s No. 2 admiral contracting COVID-19. The Coast Guard announced Tuesday that its vice commandant, Adm. Charles Ray, tested positive for the coronavirus on Monday after feeling mild symptoms over the weekend.

The test result came after Ray met with most of the Joint Chiefs of Staff at the Pentagon on Friday.

That put Joint Chiefs of Staff Chairman Gen. Mark Milley into quarantine, as well as the chiefs of the Army, Navy, Air Force, Space Force and National Guard. The vice chairman, Gen. John Hyten, was also in the meetings and is quarantining.

The only member of the Joint Chiefs who didn’t meet with Ray was Marine Corps Commandant Gen. David Berger, who was traveling.

Berger’s deputy, Gen. Gary Thomas, met with Ray instead and went into quarantine Tuesday. The Marine Corps announced Wednesday evening that he has tested positive for the virus.

Gen. Paul Nakasone, commander of U.S. Cyber Command and director of the National Security Agency, also met with Ray and went into quarantine.

It’s unclear exactly where Ray caught the virus, but his schedule within the incubation period included a visit to the White House, which is now considered the epicenter of a coronavirus outbreak that includes Trump himself.

Ray — along with Milley, Defense Secretary Mark Esper and other top defense officials — attended a White House ceremony for Gold Star families on Sept. 27.

The event happened the day after Trump announced he was nominating Amy Coney Barrett for the Supreme Court, a gathering for which several attendees have since been diagnosed with COVID-19.

Since Trump’s diagnosis, the Department of Defense has sought to allay any national security concerns.

When Trump’s positive test was first announced last week, the Pentagon insisted there has been “no change to DoD alert levels.”

After news broke Tuesday of the Joint Chiefs quarantining, chief Pentagon spokesman Jonathan Hoffman reiterated that “there is no change to the operational readiness or mission capability of the U.S. Armed Forces.”

“Senior military leaders are able to remain fully mission capable and perform their duties from an alternative work location,” Hoffman said in a statement.

The military chiefs are well-equipped to work from home, and besides Ray and Thomas, none have tested positive for the virus yet.

But the development has raised questions about whether adversaries will try to take advantage of the situation nonetheless.

After the military quarantines were revealed, House Armed Services Committee Chairman Adam Smith (D-Wash.) said “the national security implications of the president’s recklessness cannot be overstated” even though the military “can still operate while leadership is quarantined.”

“Since announcing that he tested positive for the virus, the president’s antics have been downright reckless and harmful,” Smith said in a statement. “Our adversaries are always looking for any weakness to exploit. President Trump’s pathetic attempts to exude strength aren’t fooling anyone — Americans know he is weak and so do those who wish us harm.”

Rep. Jackie Speier (D-Calif.), another senior member of the Armed Services Committee, questioned why so many senior military leaders were meeting in person in the first place, as well as attending a White House reception in which they were pictured maskless.

“What if the Joint Chiefs’ responsibilities cannot be done remotely while they are isolating?” Speier wrote in a series of questions on Twitter. “How many other senior military leaders have tested positive? Why weren’t we safeguarding the health of senior military leaders like the natural security asset that it clearly is?”

Barry Pavel, senior vice president and director of the Atlantic Council’s Scowcroft Center for Strategy and Security, stressed that there is “no degradation in operational command and control” from the Joint Chiefs quarantining.

But, he added, adversaries such as Russia and China could misperceive that the United States is distracted and decide to act. For example, he cited concerns about China moving against Taiwan or Russia trying to grab more territory.

Pavel also listed what he called Russia’s “non-kinetic war” against the United States in the cybersecurity, influence and disinformation realm.

“This is a KGB officer’s most wildest dream coming true almost on a daily basis,” he said. “And so I think it’s a big threat. Who knows what proportion of our current public divisions are sown by Russian influence and bots or are just part of our current division. I don’t know the answer to that question. But they’re certainly right now exploiting it.”

To diminish those concerns, Pavel said, the Pentagon should keep emphasizing its military readiness, as well as demonstrating it by taking actions like publicizing a previously planned exercise.

“It’s probably a good idea to keep repeating those messages,” he said, “to be reiterating those messages, sending them publicly, privately, by third parties and through various forms of military activity so adversaries have no misunderstanding about our readiness and capabilities despite the chairman being quarantined in his quarters.”

Cartoon – Anti-Science or Pro-Myth?

Twitter | Daily cartoon, Editorial cartoon, Cartoon

State autonomy versus a fundamental right: VP debate will spotlight divergent healthcare views

https://www.healthcarefinancenews.com/news/vice-presidential-debate-will-likely-spotlight-divergent-views-healthcare

Mike Pence and Kamala Harris take the debate stage Wednesday night. (Kamala (Harris photo by Ethan Miller; Pence photo by Joshua Roberts. Both Getty Images)

The undercurrent of the VP debate is the age and health of the two men vying for the presidency.

The two remaining presidential debates, scheduled for October 15 and 22, are in question due to President Trump’s positive COVID-19 and quarantine status, making the vice presidential debate this Wednesday at 9 p.m. even more important than VP debates of past elections.

The undercurrent in the debate consists of the ages of challenger Biden, who is 77 and turning 78 before the end of the year, and Trump, 74, who has been hospitalized for COVID-19 and was released from Walter Reed Army Medical Center on Monday afternoon. Trump has said he plans to debate Biden on October 15.

This VP debate is big, said Paul Keckley, a healthcare policy analyst and managing editor of the Keckley Report. 

“The reason is not so much the two are debating,” Keckley said. “We have a 77- year-old challenger and a 74-year-old incumbent. Voters are expecting the odds are one will become disabled and the vice president is going to step in. That’s the undercurrent of this debate.”

Healthcare is an obvious dominant theme Wednesday night beyond the health of the two men seeking the presidency. 

It is expected that Biden’s running mate, Kamala Harris will challenge Vice President Mike Pence on his role heading the coronavirus task force when close to 7.5 million people in this country have been infected with COVID-19 and more than 200,000 have died.

Pence will likely challenge Harris on her support for Medicare for All before she backtracked to support Biden’s public-private option for healthcare coverage.

Pence and Harris are expected to lay out the healthcare plans of their respective Republican and Democratic nominees less than four weeks before the election, in a way the lead candidates failed to get across during the first presidential debate that presented more chaos than clarity.

TRUMP AND BIDEN PLANS

Trump and Biden differ fundamentally on whether the federal government should be involved in the business of providing healthcare coverage.

Trump’s guiding principles rest on the pillar of state autonomy as opposed to a federalized healthcare system and Biden’s maxim that healthcare is a right, not a privilege. 

Trump believes that private solutions are better than government solutions, according to Keckley. He is much less restrained on private equity and the Federal Trade Commission’s scrutiny of vertical integration. States become the gateway to the market as private solutions are sold to states as innovation.

Trump’s other concept is that the door to engaging consumers in healthcare is price transparency. His view is that price transparency will spawn consumer engagement.

Centers for Medicare and Medicaid Services Administrator Seema Verma, who was appointed by Trump in 2016 based largely on the recommendation of Pence, is instituting a rule, starting January 1, 2021, requiring hospitals to have price transparency for 300 shoppable services. Hospitals are being required to make their contract terms with payer accessible.

This is separate from CMS’s interoperability rule aimed at payers that also goes into effect on January 1.

Trump believes healthcare is a personal responsibility, not a public obligation. To Trump, healthcare is a marketplace where there are winners and losers, according to Keckley.

Biden has a more developed policy platform on making healthcare a universal right, starting with strengthening the Affordable Care Act that was passed while Biden was vice president during President Barack Obama’s terms.

Biden wants to increase the eligibility for tax subsidies in the ACA up to 400% of the federal poverty level, which would expand access to subsidized health insurance.

He also wants to reduce the affordability threshold for employer insurance. Currently, if employees pay more than 9.7% of their adjusted income for their workplace coverage, they can seek a plan in the ACA marketplace. Biden would lower that eligibility for ACA coverage to 8.5%, opening the door for many more consumers to be insured through the ACA, at a lower cost.

Biden would also lower the age of eligibility for Medicare from 65 to 60.

For companies such as manufacturing and transportation, in which individuals can retire after 30 years of service, this lets them into the Medicare system earlier to fill that gap between retirement and Medicare eligibility.

Biden’s public option would create insurance plans that would compete with private plans. 

The other factor to watch on the Biden side, Keckley said, is his clear focus on equity and diversity in healthcare. 

AFFORDABLE CARE ACT

Biden wants to strengthen Obamacare while Trump is actively pursuing a repeal of the law through the Supreme Court. 

President Trump’s debate prep and the White House Rose Garden event announcing the nomination of Judge Amy Coney Barrett to replace the late Supreme Court Justice Ruth Bader Ginsburg, border on the definition of super spreader events.

The Justices, perhaps with the addition of Trump’s pick, Amy Coney Barrett, if there are enough Republican senators well enough and in attendance to vote for confirmation, are scheduled to hear oral arguments in the case brought by 18 GOP-led states on November 10, the week after the election.

Senators must be present to vote, and Republicans, who have a majority of 53 to 47 seats, need a four-vote majority. Two Republican senators – Susan Collins of Maine and Lisa Murkowski of Alaska – have said they wouldn’t vote on a nominee prior to the election. Vice President Mike Pence could cast the deciding vote in a tie.

Three Republican senators have tested positive for the coronavirus. Sens. Mike Lee of Utah and Thom Tillis of North Carolina, who sit on the Judiciary Committee, tested positive for COVID-19 days after attending the White House Rose Garden event on September 26. Republican Sen. Ron Johnson of Wisconsin is now the third to test positive, though he did not attend that event.

There was a lack of social distancing and mask wearing at both the Rose Garden nomination and at a meeting between Trump and staff for debate prep. Twelve people in Trump’s inner circle, including his wife Melania, former New Jersey governor Chris Christie and White House Press Secretary Kayleigh McEnany, have tested positive since attending.

Senate Majority Leader Mitch McConnell wrote in an email to GOP senators obtained by CNN that he needs all Republican senators back in Washington by October 19.

COVID-19

Trump announced in a tweet Monday that he would be leaving Walter Reed later in the afternoon, saying he felt “really good!” and adding, “Don’t be afraid of Covid. Don’t let it dominate your life. We have developed, under the Trump Administration, some really great drugs & knowledge. I feel better than I did 20 years ago!”

Trump has been criticized for leaving the hospital on Monday to take a drive-by ride to wave to supporters. Attending physician Dr. James Phillips called the action “insanity” and “political theater” that put the lives of Secret Service agents in the car with him at risk.

Trump has downplayed the virus in an effort to reopen the country and the economy, and has put the blame on China, where the coronavirus originated.

Trump told Biden during the debate, “We got the gowns; we got the masks; we made the ventilators. You wouldn’t have made ventilators – and now we’re weeks away from a vaccine.” 

Biden puts the blame squarely on Trump for delaying action to stop the spread.

Biden said during the debate: “Look, 200,000 dead. You said over seven million infected in the United States. We in fact have 5% or 4% of the world’s population – 20% of the deaths. Forty thousand people a day are contracting COVID. In addition to that, about between 750 and 1,000 people, they’re dying. When [Trump] was presented with that number he said ‘It is what it is’ – what it is what it is – because you are who you are. That’s why it is. The president has no plan. He hasn’t laid out anything.”

Biden said that back in July he laid out a plan for providing protective gear and providing money the House passed to get people the help they need to keep their businesses open and open schools. 

Under Trump’s Administration, Congress passed $175 billion in provider relief funds for hospitals, small businesses, individuals and others – $100 billion from the CARES Act and $75 billion from the Paycheck Protection Program and Healthcare Enhancement Act.

MEDICAID EXPANSION

CMS Administrator Seema Verma was healthcare advisor to Pence while he was governor of Indiana. Her consulting firm, SVC, Inc., worked closely with Pence to design Indiana’s Medicaid expansion under the Affordable Care Act. They developed a unique Medicaid expansion program called Health Indiana Plan 2.0, which mandated low income adults above the poverty level pay monthly premiums for their healthcare. 

Members who did not pay faced being disenrolled for six months. 

As administrator, Verma has initiated similar work requirements for Medicaid coverage nationwide.

While as governor Pence implemented Medicaid expansion, as vice president he has supported torpedoing the ACA, and has pushed the Graham-Cassidy plan for healthcare reform that would have replaced the ACA.

DRUG PRICES

Neither Trump nor Biden has taken on the pharmaceutical industry in a meaningful way, though both have voiced a strong belief that drug manufacturers are egregious to the system, according to Keckley.

“Both camps are saying, we’re really going to take them on,” he said. 

During the debate, Trump said he was cutting drug prices by allowing American consumers to buy drugs from Canada and other countries under a favored nation status. 

“Drug prices will be coming down, 80 or 90 percent,” Trump said during the debate, telling Biden he hadn’t done anything similar during his 47 years in government.

If Trump gets a second term, there will likely be more industry folks in his circle, following up on his first term of stacking his cabinet with business people.

Biden would be more likely to lean toward a blend of public health officials and industry executives. There would be more of a spotlight on wealth creation in healthcare and executive pay.

In the $1.1 trillion world of prescription drugs, the United States makes up 40% of the market. 

“We’re the hub of the prescription drug industry,” Keckley said. 

Cartoon – I’m DONE wearing a MASK

Editorial cartoon for June 19, 2020 | West Central Tribune