Ten Lessons from Health Affairs

The esteemed health-policy journal Health Affairs has published its list of "Ten Lessons from COVID-19  Research Published in Health Affairs" (12/30/20). Number 10 shouldn't have surprised me, but it did:

1. Mandating face masks in public is associated with a decline in the daily COVID-19 growth rate.
2. COVID-19 emergency sick leave has reduced confirmed cases.
3. Increased testing and isolation may be the most effective, least costly alternative—in terms of money, economic growth, and human life—for controlling COVID-19.
4. Shelter-in-place orders reduce both daily COVID-19 hospitalizations and mortality growth rates within weeks of enactment.
5. Blacks and Hispanics are more likely to screen positive, be hospitalized, and die due to COVID-19 relative to non-Hispanic Whites.
6. Vaccine implementation, including the pace of vaccination and the percent of the population ultimately vaccinated, will contribute more to the success of vaccination programs than a vaccine’s efficacy determined in clinical trials.
7. Hospitals reinvented patient and staff support systems during the COVID-19 pandemic to better cope with trauma.
8. Expanded Medicaid coverage and insurance reimbursement for telehealth played a pivotal role in the rapidly increased use of these services during the pandemic.
9. The majority of school employees and school-age children live in households including at least one adult with increased risk for severe COVID-19, and about half of all school employees have increased risk themselves.
10. Unionized health care workers in nursing homes were associated with a decrease in COVID-19 mortality rates and greater access to personal protective equipment for workers.

I've been considering my coverage decisions for Health Law next semester, and unionization -- not much of a force in health-care settings in the South and Southwest -- seemed like an easy topic to cut. Now I am reconsidering that decision.

What to Expect in Year Two of the Pandemic

Ed Yong is widely regarded as the best journalist on the COVID-19 beat, and he's just published in The Atlantic (1/29/21 (free)) his projections for Year 2 of the current pandemic. This summary barely does justice to the full piece, which is rich in details and supporting references:

1. The vaccine rollout could be rocky.

“We are trying to plan for the most complex vaccination program in human history after a year of complete exhaustion, with a chronically underfunded infrastructure and personnel who are still responsible for measles and sexually transmitted diseases and making sure your water is clean,” [Kelly Moore of Vanderbilt University, who studies immunization policy,] said.

2. The virus could change.

What happens next with SARS-CoV-2 depends on how our immune systems react to the vaccines, and whether the virus evolves in response. Both factors are notoriously hard to predict, because the immune system (as immunologists like to remind people) is very complicated, and evolution (as biologists often note) is cleverer than you.

3. But expect some relief by the summer.

Many of the 30 epidemiologists, physicians, immunologists, sociologists, and historians whom I interviewed for this piece are cautiously optimistic that the U.S. is headed for a better summer. But they emphasized that such a world, though plausible, is not inevitable.

4. Still, this outbreak will leave long-term scars.

A pummeled health-care system will be reeling, short-staffed, and facing new surges of people with long-haul symptoms or mental-health problems. Social gaps that were widened will be further torn apart. Grief will turn into trauma. And a nation that has begun to return to normal will have to decide whether to remember that normal led to this.

National Academy of Medicine Webinar on Crisis Standards of Care

This looks like a good lineup of panelists asking (and I hope answering) the right questions:

As hospitals and other providers experience significant patient surge at a pivotal stage of the COVID-19 pandemic, the National Academy of Medicine and its partners have called on federal, state/territorial, and tribal leaders and private sector actors to shift to crisis standards of care.  Resource scarcities of available ICU beds, personnel, treatments, personal protective equipment, and vaccinations justify critical changes in health care delivery. Yet substantial legal and policy issues can stand as obstacles to implementation without real-time solutions.

In this session, Dr. Dan Hanfling, Professor James Hodge, and Research Scholar Jen Piatt will examine key legal issues underlying crisis standards of care. These include

•  concerns surrounding emergency declarations, 
• invocation, 
• duties to care, 
• inter-jurisdictional challenges, 
• discrimination, 
• licensure/scope of practice, 
• risks of liability, 
• documentation, and 
• mitigation. 

Potential solutions to real-time issues will be offered, including through direct questions among attendees and others. 

Date: 1/7/21
Time: 3:30-4:45pm EST

Registration -- free -- is here.

Lawrence Wright in The New Yorker: For now, the definitive history of the novel coronavirus in 2020

The newest print edition of The New Yorker (Jan. 4 & 11) features "The Plague Year," a 40-page article by one of the best writers on the planet, Lawrence Wright, telling the tale of our response to the coronavirus and COVID-19. The article fills nearly the entire issue, something The New Yorker has done only a few times in its history (e.g., John Hersey's "Hiroshima" and Rachel Carson's "Silent Spring"). Following on the publication of his pandemic-novel, The End of October -- a meticulously researched and prescient tale of a coronavirus from China that becomes a world-wide pandemic -- the Woodrow Wilson HS graduate and Austinite Wright has written a story as gripping as any thriller, with the added twist that it is all-too-tragically true.

Pres. Obama's Inside Story on the Rocky Road to Obamacare

Here's a story worth reading: how the U.S. got -- if not universal health care -- something close after a century of trying and failing. For fans of sausage-making, it's a fascinating glimpse inside the factory, excerpted in the 11/02/20 issue of The New Yorker. The general story is well-known, but it is worth remembering how close we came to not getting an Affordable Care Act at all. 

With "about six in ten of the public say[ing] they or someone in their household suffers from a pre-existing or chronic medical condition, such as asthma, diabetes, or high blood pressure," the most popular provision remains the prohibition against discrimination by health insurers based upon preëxisting conditions. (Kaiser, 12/18/20) And now that the wildly unpopular individual mandate has been rendered completely toothless by the tax reform legislation in 2017, the favorable-over-unfavorable gap in public opinion is 19%, the largest it's been since enactment. 

Top 10 Health Stories of 2020: Nearly All Are Healthlaw-Related

 From The Commonwealth Fund (more details are here):

1. "COVID-19 hits the United States." The greatest public health (and public health law) crisis in a century.
2. "Pandemic takes a devastating toll on health." Public health measures alone don't protect against the virus. Compliance matters. 
3. "Economic fallout." COVID-19 has put pressure on every level of government. Some performed brilliantly, a few failed miserably, and for the rest the report card was mixed. 
4. "FDA authorizes coronavirus vaccine and distribution begins." A stunningly successful public-private partnership produced unprecedented results, though Pfizer -- the first to get FDA approval -- turned down federal funding. 
5. "Dramatic leapfrogging in telehealth." Regulators at both the federal and state levels proved to be fairly nimble in providing authorization and reimbursement for greatly expanded telemedicine services. This is probably one of many developments that won't go away after the virus has been controlled. Telemedicine will be part of the "new normal."
6. "Racial injustice protests draw attention to health disparities." It's not as if there are plenty of federal and state laws on the books to deal with discrimination in health care, but health disparities remain. There's a lot more work to do on this front.
7. "The future of the Affordable Care Act is still unknown." It is, once again, in the hands of SCOTUS. Chief Justice Roberts was the architect (and principal author) of the Court's two previous encounters with potentially ACA-killing litigation. With a revised lineup of Justices, will he provide the saving grace in Texas v. U.S.?
8. "Medicaid expansion continues at a slow and steady pace." Three states voted to expand Medicaid eligibility pursuant to the ACA; twelve continue to impede the ACA's promise of expanded coverage at virtually no cost to the states. Texas -- with the largest number and percentage of uninsured citizens in the U.S. -- remains a notable holdout. Consider the billions of federal dollars Texas providers have been denied during the COVID-19 crisis, which has seen provider and after provider, especially in rural areas, close up shop
9. "Joe Biden is elected president." We will soon have a resident in the White House who isn't trying to hobble the ACA and cast doubt on the bona fides of public-health authorities at every turn. 
10. "Biden appoints new health care team." With a few exceptions, the Trump cabinet was filled with amateurs with either no experience or a predisposition to cut back on enforcement of federal programs or both. The new cabinet and sub-cabinet appointees look to reverse the trend. 

More on COVID-19 and Employer Mandates and more and more . . .

 

Morrison & Foerster LLP issued a report on Wednesday, 12/9/20, based on a survey of in-house legal professionals around the world. The top legal concerns that came out of the survey were: employment and labor, data security, and contract disputes. 

On the subject of vaccine mandates, the subject of my post yesterday, MoFo concluded: "“With one or more vaccines on the verge of being approved, some employers will undoubtedly mandate employee vaccines, either for altruistic reasons – they don’t want people to get sick at their place of business – or because they are worried about liability for workplace exposure to COVID-19. Other employers will take a different tack, merely encouraging vaccines.” The report concludes:

“Especially given that EEOC has said COVID-19 poses a direct threat to the health and safety of [employees] and the general public, I imagine that the EEOC may be warmer to the idea of employer mandates than during the 2009 H1N1 pandemic when it suggested employers consider simply encouraging employees to be vaccinated. The EEOC’s final position and those of other government agencies remain to be seen, but regardless of whether mandates are merely tolerated or actively encouraged, employers will still have to consider legally required reasonable accommodations on a case-by-case basis.”

 

COVID-19 Vaccine and Employer Mandates

Can employers require their employees to be vaccinated against the coronavirus

1. In an "employment-at-will" state, almost certainly yes. The employer can compel employees to do almost anything (as long as it is legal) or be fired.
2. Except: If the employees are unionized, their collective-bargaining contract may give them the right to refuse. Unionized workforces have been on the decline for a generation, though, so from a societal perspective this isn't nearly the factor it might have been over the past 4 decades.
3. Except: Under the Americans with Disabilities Act, if vaccination is medically contraindicated for an employee, the employer is probably required to accommodate that impairment.
4. Except: If the employee has a religious objection to vaccination, that may also need to be accommodated.
5. And finally: In light of a significant minority of Americans' hostility to mandates in general and mandated vaccination in particular, most employers will probably make vaccination voluntary, rather than risk creating a controversy among the workforce. 

Worth reading:

• U.S. employers could mandate a COVID-19 vaccine, but are unlikely to do so -experts (Reuters, 12/2/2020)
• As COVID-19 Vaccine Nears, Employers Consider Making It Mandatory (NPR, 11/25/2020)
• COVID-19 VACCINES: CONSIDERATIONS FOR US EMPLOYERS (Morgan Lewis, 11/09/2020)

Early Indications Are Leaning Toward a Favorable SCOTUS Decision for the ACA

One thing I learned as a Constitutional Law prof many years ago is to not give full faith and credit to the comments and questions of Justices during oral argument. Sometimes they are simply testing out ideas that they plan to write against when the dust settles. All that said . . . 

Early reports from today's oral argument in the Supreme Court suggest that Justices Sotomayor, Kagan, and Breyer may be joined by Chief Justice Roberts and Justice Kavanaugh in upholding the ACA against the attack mounted by 20 GOP-led states. Policy wonks decry the possibility that 20 million people in this country could lose their health insurance if the ACA is struck down, and millions more will lose coverage if other underwriting reforms go down the tubes, including the prohibition against discriminating on the basis of pre-existing conditions, the ban on annual and lifetime caps, and the option for children to be covered by their parents' health insurance until they turn 26. The Supreme Court doesn't get to make health policy, but consequences as Draconian as these have to figure into their reading of the law, especially in a case in which congressional intent controls the issues. 

There are two issues in play. The first is whether the individual mandate can survive Congress's decision in the 2017 tax law to reduce the penalty tax for failing to secure health insurance all the way down to $0. Without a tax, the plaintiffs have argued, the constitutional basis for the mandate disappears. Maybe. I seem to remember from Income Tax I (Summer 1975) that Congress has from time to time elected not to collect a tax, and the Court has upheld the regulation attached to the tax nonetheless. Even if I recollect incorrectly, it should be at least a close question whether Congress intended to wipe out the individual mandate when they reduced the tax. It seems supremely silly to me 

If the Court answers the first question in the affirmative, the second question shouldn't be close at all: whether the end of the individual mandate means the entire ACA should be tossed out as well. The question is one of severability, and it shouldn't even pass the smile test, although the district court and the Fifth Circuit opined that the ACA could not be saved if the individual mandate were taken out. 

Stay tuned . . . 

Everything You Wanted to Know About Liver and Lung Transplant Allocation Policies But Were Afraid to Ask

The Government Accountability Office has issued a detailed letter report on recent changes to the allocation policies for these two organs. Over the years, this has been a difficult subject to teach in my Bioethics & Law course. I hope this will be a good resource for anyone seeming an overview of the manner in which these scarce resources are allocated, as well as a brief summary of the responsibilities of HHS, HRSA, and UNOS in maintaining the national Oran Procurement and Transplantation Network.

President Maligns Physicians and Hospitals in Midst of Third Wave

Out on the campaign trail last week, Pres. Trump had this to say:

“[O]ur doctors get more money if somebody dies from covid.” 

“You know that, right?” Trump said at a Michigan rally on Friday. “I mean our doctors are very smart people. So what they do is they say, ‘I’m sorry, but everybody dies of covid.’” [Wash. Post, 11/3/2020]

The American Medical Association and American Hospital Association have branded this accusation "offensive" and "unfounded." The Washington Post article quotes Chip Kahn, a spokesman for the Federation of American Hospitals: "That would be fraud — and something the Department of Justice could prosecute. 'It’s unethical, it’s illegal and it’s inappropriate,' Kahn said.

There's no question that hospitals may be reimbursed for testing and treating uninsured COVID-19 patients. Three of the relief statutes passed by Congress in March provide for reimbursement at Medicare rates for these services. A few points deserve mention:

• There is no reimbursement under these laws if the patient is insured.
• Medicare payment rates are, on average, about half of the rates paid to hospitals by private insurance plans. It's quite possible that Medicare-level payments don't cover the hospitals' costs for treating these very expensive cases (though there are few things on the planet more complex than Medicare cost-accounting).
• Hospitals (and physicians) aren't getting rich off the pandemic. Quite the opposite: hospital layoffs and bankruptcies have increased under the financial strain experienced over the past 9 months.
• Many states prohibited elective procedures during a long period of the pandemic (and may do so again if the third wave -- or fourth wave -- is as horrific as Dr. Birks has predicted). These procedures are the day-in and day-out bread-and-butter sources of income that keep hospitals' balance sheets out of the red. Most health and hospital systems are struggling to keep going.
• There is no bonus for a COVID-related death. The "bonus" is that health care professionals (HCPs) experience increased exposure to infected patients and increased risk of becoming infected themselves. As a result 800 or more HCPs have died from COVID-19.
• As for the president's assertion that doctors and hospitals are gouging the system with false diagnoses of COVID-19: No comment.

 

"The Pandemic is Over?" The Mind Boggles

This nonsense didn't come from the Trump campaign. It wasn't uttered by one of the president's surrogates out on the campaign trail. And it wasn't insinuated into one of the vice-president's answers during last week's debate.

This came from the White House Office of Science and Technology Policy! Granted, they are part of the Executive Office of the White House, but their website offers this self-description: 

In 1976, Congress established the White House Office of Science and Technology Policy (OSTP) to provide the President and others within the Executive Office of the President with advice on the scientific, engineering, and technological aspects of the economy, national security, homeland security, health, foreign relations, the environment, and the technological recovery and use of resources, among other topics. [emphasis added]

So imagine the surprise when, according to The Washington Post, "the White House Office of Science and Technology Policy wrote that it considered 'ending the covid-19 pandemic' to be one of the president's major first-term accomplishments." More:

Four officials told The Daily Beast they viewed the White House statement as a personal slight and a public rebuke of their efforts to try and get control of the virus.

“It’s mind-boggling,” one official said of the White House’s assertion it had ended the pandemic. “There’s no world in which anyone can think that [statement] is true. Maybe the president. But I don’t see how even he can believe that. We have more than 70,000 new cases each day.”

Today's paper identified one source of the actual, true facts: HHS's Under-Secretary of Health and the administrations "testing czar," Adm. Brett Giroir, M.D. :

Data show a resurgence of the pandemic across the country, despite President Trump’s repeated claims to the contrary, Adm. Brett Giroir, the White House’s coronavirus testing czar, said Wednesday.

In a tweet Monday, Trump blamed the rise in novel coronavirus infections on increased testing. But in an interview, Giroir broke with the president and emphasized that the surge is real, citing climbing case numbers, hospitalizations and deaths across the country.

“It’s not just a function of testing,” Giroir said on NBC’s “Today” show. “Yes, we’re getting more cases identified, but the cases are actually going up. And we know that, too, because hospitalizations are going up.”

Reality check: The country is setting daily records of new cases, most recently 78,000-80,000 per day. And the Johns Hopkins Bloomberg School of Public Health's Vice-Dean Joshua Sharfstein says projections of 2,000 deaths per day are "not unrealistic."

Public-health law requires three things to work: truth, transparency, and trust. Anthony Fauci and Brett Giroir understand this. They are men of science. They hold (for the time being, anyway) two of the most critical public-health positions in the federal government. They can be trusted to tell us the truth. The Office of Science and Technology Policy, alas, cannot.

Lessons for the Next Pandemic—Act Very, Very Quickly (WSJ Covid Storm series)

This article (10-11-20) by Betsy McKay is the latest in the Wall Street Journal's excellent series, "The Covid Storm." It is a terrific "lessons learned" piece. Our political and public-health leaders need to be ready for the next outbreak in some very specific ways, and that begins with taking stock of where the system failed us this time around.  But as the novel coronavirus has taught us, it's not a question of if there's another pandemic, but when. Hundreds of thousands, if not millions, of lives hang in the balance. It will take real political will-power to marshal the resources needed to make the investments in public-health infrastructure.

Practical Strategies for Healthcare Providers to Limit Claims Involving Alleged Contraction of COVID-19 on Premises (Haynes and Boone Newsletter)

Haynes and Boone's recent newsletter on limiting COVID-19-related liability is a gold mine of practical analysis and advice. It is also a virtual roadmap of issues that I've covered in my first-year Torts class: negligence (esp. duty and causation), negligence per se, premises liability, medical malpractice, immunity statutes, express waivers of liability, and best practices for avoiding a direct corporate negligence claim, not to mention topics I couldn't get to in a four-hour course (including fraud and public nuisance).

Care at the End of Life

The New England Journal of Medicine just published an incredibly insightful and moving Perspective piece, "Learning About End-of-Life Care from Grandpa," by Scott Halpern.  https://www.nejm.org/doi/full/10.1056/NEJMp2026629?query=TOC (Oct. 21, 2020). It's about physician aid-in-dying and voluntarily stopping eating and drinking (VSED) and hospice and family and home. I can't recommend it strongly enough. Oh, and it's free.

As reported by the Fort Worth Star-Telegram, the Texas Supreme Court on Friday declined to review the order of the Second Court of Appeals (Fort Worth) in the Tinslee Lewis case. This keeps in place the court of appeals's order that requires Cook Children's Hospital to continue aggressive life support for the one-year-old pending a full trial on the merits of her mother's suit against the hospital. As Thad Pope points out, this case challenges the constitutionality of § 166.046 of the Texas Health & Safety Code, our so-called "futility provision" of the Texas Advance Directives Act. 

The briefs for and against the lower court's ruling, which -- though not disposing of the constitutionality question -- gave a very strong indication of its inclination to strike down the law, are here. It probably goes without saying, as someone who worked (with many others, including National Right Life and Texas Right to Life, before they changed their mind about the law) to draft this law more than 20 years ago, that I am persuaded by the briefs that argue to uphold the law, which passed both houses of the state legislature without a single nay vote.

Nicholas Kristof: On the Right Side of History

Kristof's column in today's N.Y. Times is well worth a read. He's probably right that the Court, with or without Amy Coney Barrett on it, is unlikely to snatch the ACA away from 20 million people who are insured because of the law. It's a life-line for millions:

Census data show that even before the Covid-19 pandemic the number of uninsured Americans had risen by 2.3 million under Trump — and another 2.9 million have lost insurance since the pandemic hit. Most troubling of all, about one million children have lost insurance under Trump over all, according to a new Georgetown study.

The argument against the ACA is so weak (despite persuading the trial judge and a majority of the 5th Circuit panel that have ruled against the ACA), "only a lawyer could make it with a straight face," wrote Ruth Marcus in the Washington Post earlier this week. (Been there, said that here, here, and here.)

Public-Health Experts Agree (More or Less): Covid Shutdowns Aren’t the Way to Go

Not, at least, for the looming “second wave.” Over the past week or two, articles have been popping up left and right with this message. Now the Wall Street Journal has published a good summary (10/13/2920) of the arguments pro and con. The emerging consensus is that many people are worn down by the earlier shutdowns and aren’t likely to comply with another round of broad closings. On that assumption, public-health experts claim it is preferable to push a less drastic (and more traditional) regime that takes less effort to follow and is less disruptive of daily living:

• mask
• wash hands and avoid touching your face
• observe social distancing (now thought to be 9', not 6')
• avoid large groups, particularly indoors.

Questions for Judge Amy Coney Barrett

Over at The Commonwealth Fund, health-law prof and ACA expert extraordinaire Tim Jost properly focuses not on whether CJ Roberts got it right when he upheld the individual mandate as a proper exercise of Congress's powers under the Taxing Clause of the Constitution (Judge Barrett has argued that he did not) or when he upheld access to ACA premium tax credits for individuals enrolled in insurance plans through the federal exchange (ditto). 

The issues presently before the Court in California v. Texas are (1) whether the individual mandate is unconstitutional now that Congress has zeroed out the tax penalty in the 2018 tax reform bill and, if so, (2) whether the individual mandate provision is severable from the rest of the ACA. The district court (N.D. Tx., Fort Worth Div.) and the Fifth Circuit both answered (1) yes and (2) no, meaning the whole ACA has to be thrown out. Texas v. California, which has been consolidated with California v. Texas, raises a third issue: Whether the individual and state plaintiffs in this case have established Article III standing to challenge the ACA's individual mandate. In the unlikely event that Judge Barrett isn't confirmed before the Court decides these cases, the standing issue could conceivably give a Court split 4-4 on the first two questions a way out. Lack of Article III standing requires dismissal of the case at the district court level, effectively nullifying the two lower-court decisions.

As Tim Jost writes, 

Though she could be asked about standing or the mandate’s constitutionality, questions for Judge Barrett should mainly focus on severability: How much, if any, of the ACA should be invalidated if the mandate is found unconstitutional? (It does not matter much if the unenforceable mandate is invalidated if the rest of the ACA remains in place.) Would she disturb the Court’s long-standing presumption of severability? Cases recently decided by the Court with majority opinions written by Chief Justice Roberts and Justice Kavanaugh reinforce the presumption that if a provision of a statute is found unconstitutional, as much of the rest of the statute as possible should be found severable and preserved. She should be asked if she agrees with this doctrine.

Severability goes to the heart of these two cases. It is nearly inconceivable that she would tip her hand on this issue during the hearings. Democrats will fume and threaten not to vote to confirm, but most of them weren't going to vote for her confirmation anyway, and Mitch McC has enough Republican votes lined up to confirm the judge without the Dems.

78% of Americans Believe Abortion Should be Legal "To Some Extent": Gallup Poll

For decades it seemed the numbers followed the "rules of 3's": 1/3 believed abortion should be legal, period; 1/3 believed it should be illegal, period; and 1/3 believed it should be legal under some circumstances, so a 2:1 ratio favoring legalization of abortion.

A Gallup poll released September 29 has revised numbers:

According to Gallup's May 2020 update on Americans' abortion views, 29% believe abortion should be legal "under any circumstances," 14% say it should be legal "under most circumstances" and 35% say it should be legal "only in a few circumstances." Meanwhile, 20% say it should be illegal in all circumstances.

That is a nearly 20% increase in support, to some degree or another, for legalized access to abortion. Roe v. Wade continues to be a lightning rod unto itself, garnering only 64% support (May 2018).