AstraZeneca in Major Dispute with U.S. Regulators

Anthony Fauci's Institute -- the National Institute of Allergy and Infectious Diseases (NIAID) -- issued a mind-blowing statement today:

Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.

It is almost (but not quite) inconceivable that AstraZeneca made an innocent error. The DSMB is accusing the firm of essentially "cherry-picking"  the data “most favorable for the study as opposed to the most recent and most complete.” (NY Times, 3/23) The DSMB's letter to the NIH and AstraZeneca stated that the efficacy rate of the firm's COVID-19 vaccine might be between 69% and 74%, rather than the 79% rate touted by AstraZeneca itself. Did AstraZeneca really think they could slip one past the regulators? And at what cost to its reputation? Not to mention at what cost to the worldwide public-health crisis, where mistrust of science and vaccine-skepticism don't need any more encouragement and support. 

From the Times article: “'Decisions like this are what erode public trust in the scientific process,' the board wrote." 

Medicaid Expansion in Texas: The Time is Now

The Legislature is back in session. A bill has been introduced to authorize Texas to accept the federal government's offer to pay for 90% of the cost of expanding Medicaid eligibility to include all Texans under the age of 65 (when Medicare kicks in) and whose income does not exceed 138% of the federal poverty level: HB 1730, introduced by Republican Representative Lyle Larson. Sen. Johnson's own companion bills are SB 118 and SB 119.

The case for expansion is made in a most compelling and entertaining video (10.5 minutes) by Senator Nathan Johnson (D-Dist. 16 (which covers a big chunk of Dallas)). Please watch it. Share it with your family. Send it to your friends. Get involved. We have already waited too long, left billions of federal dollars on the table, and worst of all, we've ignored the health care needs of 1 million Texans who would benefit from expansion. Let's make this happen this year.

And thanks to DFW Hospital Council CEO Stephen Love for passing the video on to me.

CDC's Guidance for "Fully Vaccinated People"

The guidance was issued earlier today, and you can read the whole document here. Meanwhile, here are the highlights:

Key Points

This is the first set of public health recommendations for fully vaccinated people. This guidance will be updated and expanded based on the level of community spread of SARS-CoV-2, the proportion of the population that is fully vaccinated, and the rapidly evolving science on COVID-19 vaccines.

For the purposes of this guidance, people are considered fully vaccinated for COVID-19 ≥2 weeks after they have received the second dose in a 2-dose series (Pfizer-BioNTech or Moderna), or ≥2 weeks after they have received a single-dose vaccine (Johnson and Johnson [J&J]/Janssen ).†

The following recommendations apply to non-healthcare settings.

Fully vaccinated people can:

Visit with other fully vaccinated people indoors without wearing masks or physical distancing

Visit with unvaccinated people from a single household who are at low risk for severe COVID-19 disease indoors without wearing masks or physical distancing

Refrain from quarantine and testing following a known exposure if asymptomatic

For now, fully vaccinated people should continue to:

Take precautions in public like wearing a well-fitted mask and physical distancing

Wear masks, practice physical distancing, and adhere to other prevention measures when visiting with unvaccinated people who are at increased risk for severe COVID-19 disease or who have an unvaccinated household member who is at increased risk for severe COVID-19 disease

Wear masks, maintain physical distance, and practice other prevention measures when visiting with unvaccinated people from multiple households

Avoid medium- and large-sized in-person gatherings

Get tested if experiencing COVID-19 symptoms

Follow guidance issued by individual employers

Follow CDC and health department travel requirements and recommendations

Free Webinar: Pres. Biden's First 100 Days of Health Policy

This looks like a good webinar:

Boston University's Center for Health Law, Ethics & Human Rights faculty discuss the first 100 days of President Biden’s term:

• Executive Orders,
• proposed bills, and
• other steps to tackle COVID, climate, and economic crises affecting health.

What has happened? What comes next? 

Thursday, March 11, 2021
1:00 - 2:30 p.m. EST

SPEAKERS
George Annas
Nicole Huberfeld
Wendy Mariner
Michael Ulrich

JOIN ZOOM MEETING
https://bostonu.zoom.us/j/93372687004?pwd=NXpoNm5wZW1YOEljeENyeWY2V3dVUT09

Meeting ID: 933 7268 7004
Passcode: 331167

"Governor Abbott Lifts Mask Mandate, Opens Texas 100 Percent" [source: Governor's website]

Yes, it's true. Governor Abbott (along with the Governor of Mississippi) has earned the title "Worst Public Health Decision Maker Still Holding Office in the U.S." with this announcement. The full text of Executive Order GA-34 is here.

Gov. Abbott offered remarks on his remarkable EO in Lubbock. Here is an annotated paragraph:

"With the medical advancements of vaccines and antibody therapeutic drugs, Texas now has the tools to protect Texans from the virus,” said Governor Abbott. 

You bet we have the tools. We simply have to use them. 

"Make no mistake, COVID-19 has not disappeared, but it is clear from the recoveries, vaccinations, reduced hospitalizations, and safe practices that Texans are using that state mandates are no longer needed."

Wow, that's a whopper. To borrow a line from Justice Ginsburg's dissent in Shelby County, in which the majority held that the Voting Rights Act's preclearance mechanism was no longer needed: "Throwing out preclearance when it has worked and is continuing to work to stop discriminatory changes is like throwing away your umbrella in a rainstorm because you are not getting wet." [Opinion, p. 33]

"Today's announcement does not abandon safe practices that Texans have mastered over the past year."

Another whopper. Texans haven't mastered safe practices and now we've been given a green light to abandon them altogether. 

"Effective next Wednesday [Mar. 10], all businesses of any type may open to 100% capacity." "This order ends the statewide mask mandate in Texas."

Abbott helpfully notes that anyone who wants to can wear a mask and businesses can self-limit their own capacity. That's the kind of right-thinking Texas policy that gave us ERCOT and the disaster of two weeks ago. We are going our own way and celebrating Texas independence. Wonderful spirit, but lots of people died. And lots of people are going to die of COVID-19 unnecessarily because of today's order. 

Stephen Love, the President/CEO of the Dallas-Fort Worth Hospital Council had this to say: 

"While we respect Governor Greg Abbott and realize he has faced enormous challenges with the COVID-19 pandemic and recent weather issues, we strongly disagree with removing the mandatory mask requirements. This decision will cause the community spread to increase, forcing our exhausted healthcare heroes to diagnose, treat and save the lives of newly infected patients. If the community spread increases, the risk of mutations will also increase, creating a new set of potentially dangerous challenges. If you truly want to honor our healthcare heroes, then continue to wear a mask! We ask Governor Abbott to please reconsider his decision."

Back to the governor: 

"Instead, it is a reminder that each person has a role to play in their own personal safety and the safety of others." 

Agreed. What the Executive Order ignores is that the state has a role to play, as well. And the governor has just abandoned that responsibility.

"With this executive order, we are ensuring that all businesses and families in Texas have the freedom to determine their own destiny."

And the destiny of all others -- family, workers, strangers -- with whom they come into contact. Gulp. 

COVID-19 Vaccination and Ethics: Stanford/AJOB Webinar

The American Journal of Bioethics and Stanford's Center for Biomedical Ethics (David Magnus & Bela Fishbeyn) on Feb. 16 put on an excellent panel discussion of the ethics of COVID-19 vaccination policies. It was a far-ranging discussion with knowledgeable participants and well worth watching.

Medicaid in Times of Crisis: A GAO Report (2 pp.)

It's short but sweet. The Government Accountability Office has issued GAO-21-343SP (02-17-2021), a nifty description and analysis of the role of the federal-state Medicaid program in times of crisis (e.g., epidemics and pandemics, economic recessions, natural disasters, and personal health crises). Specific examples over the past 15 years include Hurricane Katrina, the Great Recession, the opioid epidemic, and of course COVID-19. 

This is further proof, as if any were needed, that Texas's policy of not expanding Medicaid eligibility at largely federal expense isn't only hurting the indigent (and largely minority) individuals -- including millions of kids -- that legislators seem keen to punish for being, you know, indigent, nonwhite, and young. The policy is also depriving public-health officials of an important tool in times of great public need. 

COVID Vaccine and Health Equity: We have a long way to go

From Kaiser Health News (2/18/2021):

KFF has an updated analysis of state-reported data as of February 16, 2021 on COVID-19 vaccinations, cases, and deaths by race/ethnicity.

New to the analysis are comparisons of vaccination rates in each racial/ethnic group based on state-reported data of total people who have received at least one dose of the vaccine. Among just over half of states reporting data, the vaccination rate among White people is over three times higher than the rate for Hispanic people (10% vs 3%) and twice as high as the rate for Black people (10% vs. 5%). The vaccination rate for Asian people is closer to the rate for White people in most reporting states, although they are less likely to have been vaccinated in most reporting states.

Planned Parenthood, Medicaid Expansion, and Women's Health

We here in Texas are used to having Medicaid weaponized in all sorts of ways. Refusing federal dollars to fund eligibility expansion is a particularly cruel and punitive policy directed at over a million low-income individuals, many of whom are the same "essential workers" who are so praised by the policy-makers (who simultaneously deny them Medicaid coverage) for their sacrifices during the present pandemic. Without eligibility reform, Texas will continue to deny Medicaid coverage for a two-parent family of four that makes more than $285 per month. Think about that. A family with one bread-winner working for the federal minimum wage of $7.25/hour for 40 hours a week ($290) -- often at jobs where health insurance is either not available or not affordable -- makes too much for enrollment in Medicaid.

Another example of weaponization was pointed out in an op-ed in the New York Times (02-17-2021) by Dr. Samuel Dickman, an internist and the medical director for primary care at Planned Parenthood South Texas:

For the past several years, Texas politicians have worked to cut off Medicaid recipients’ access to the wide range of services offered by Planned Parenthood. Now, barring an extension of a state district court’s temporary block on their efforts, they may have gotten their way.

Gov. Greg Abbott, a Republican, and like-minded state officials targeted Planned Parenthood because it offers abortion services. But abortion services account for just a fraction of the care we provide, which means the consequences of a new policy would be far more sweeping.

If it goes into effect, this policy would block patients’ access to blood pressure checks, cancer screenings, birth control, S.T.D. treatment and other medical care routinely provided at Planned Parenthood health centers in Texas, where I serve as a medical director for primary care. Nationally these other essential services, not abortion care, account for 96 percent of Planned Parenthood’s patient visits; in Texas, for example, some 24,000 Medicaid patients received non-abortion care over the past four years.

 The aforementioned cruel and punitive nature of the proposed change should be obvious:

States’ denials of health care coverage, including Texas’ refusal to expand Medicaid, contributed to 461,000 excess deaths in 2018 that would have been averted if the United States had kept up with other wealthy countries, a tragedy documented in a report by my colleagues and me published this month in The Lancet.

It is also just bad policy. Not just bad health policy, which it obviously is, but bad fiscal policy as well. Untreated STDs will increase the cost of health care because of expensive later treatments. Forgone cancer screenings, untreated hypertension and a host of other chronic conditions only get more expensive the longer preventive care is postponed denied once Planned Parenthood is knocked out of the Medicaid program altogether. Gov. Abbott and his pals have to be stopped. If they aren't, any Medicaid expansion that Texas may stumble into (see yesterday's post) will leave these 24,000 women and many others in years to come out in the cold.

Medicaid Expansion: Biden's COVID Relief Proposal Includes a Cash Sweetener for Texas and 11 Other Holdouts

As reported by The Washington Post (02/16/21), the 5,593-page COVID relief bill supported by the Biden Administration contains a provision to increase Medicaid reimbursements by 5 percent for holdout states that finally do the right thing and expand Medicaid eligibility to 133 percent of the federal poverty line. Some excerpts from the Post's article:

Texas has more uninsured residents than any other state — partly because the massive state has spurned expansion. That means no Medicaid for most adults earning up to 133 percent of the federal poverty level (around $17,000 for a single person or $35,000 for a family of four). . . .

A coronavirus relief bill working its way through Congress and backed by President Biden includes a hefty incentive for states to expand Medicaid. If a state did so, the federal government would increase its Medicaid contribution to the state by 5 percent. The increased match rate would apply to everyone outside the expansion group and would last two years.

For Texas, that would mean nearly $6 billion extra dollars in Medicaid funds over two years. . . .

It appears that a handful of Republican legislators -- and even Governor Abbott -- may be warming to the idea of accepting billions of federal dollars in order to provide decent health care to over 5 million uninsured Texans (that's 17.7% of the population, more than double the national rate of uninsured (8.5%). 

This shouldn't even be debatable. But maybe, just maybe, the times (and the state) are a-changin'. San Antonio's Republican Representative Lyle Larson has introduced HB 1730, a bill "[r]elating to the expansion of eligibility for Medicaid to all persons for whom federal matching money is available." Fingers crossed.

Welcome to the Wacky World of Hospital Pricing Practices

Today's Wall Street Journal (02-12-21) has a good piece on the incredible range of charged prices for hospital services. We are accustomed to articles highlighting differences from region to region, rural vs. urban, and even within the same city. This article looks at the prices charged for the same procedure at a single institution:

When a woman gets a caesarean section at the gleaming new Van Ness location of Sutter Health’s California Pacific Medical Center, the price might be $6,241. Or $29,257. Or $38,264. It could even go as high as $60,584.

Sutter Health isn't doing anything illegal or even unique. It bills different amounts based on whether the patient is uninsured, insured, a subscriber to the Sutter Health HMO, or (worst-case scenario) out-of-network. There is a historical and economics-based rationale for the way serves are priced in the hospital's ChargeMaster and ultimately billed to patients and payers of various stripes. Unfortunately, the history and accounting rationales conspire to hurt the patients least able to protect themselves with health insurance, Health Savings Accounts, and the like. I hope everyone has a chance to read this article.

Biden Administration Reverses Trump's Position on ACA SCOTUS Litigation

No surprise here. Siding with Texas and other red-state AGs in their attempt to get the entire Affordable Care Act tossed was inconceivable. The paper of record has the details (02-10-2021). 

In a two-page letter from the Office of the Solicitor General makes two simple assertions, with which neither the trial court nor 5th Circuit agreed:

1. When in 2017 Congress reduced to zero the monetary penalty imposed by the ACA on individuals who failed to secure health insurance coverage (the individual mandate, or the "play or pay" provision), the mandate didn't become unconstitutional by implication. The lawful choice between buying insurance coverage and not buying insurance coverage remained.
   
   
2. Even if the the Court disagrees with ¶ 1 and strikes down the mandate, the mandate is severable from the rest of the ACA, meaning the other provisions of this massive statute are left in place.

 

"HHS Misused Millions of Dollars Intended for Vaccine Research, Emergency Preparedness" (HHS Special Counsel Report, 1/27/21)

 

This is distressing, both because the practice of siphoning these funds away from their intended use thwarts the intent of congressional appropriators and because the practice apparently started in the Obama administration. The generic issue of moving funds around from program to program is, of course, much older and more widespread than this one fund and the ten years that its funds have been raided. The first paragraph of the Special Counsel's news release tells the story:

​The U.S. Office of Special Counsel (OSC) today sent letters to the President and Congress alerting them that, over the last decade, the U.S. Department of Health and Human Services (HHS) misappropriated millions of dollars Congress intended to fund vaccine research and emergency preparedness for public health threats like Ebola, Zika, and COVID-19. A whistleblower alerted OSC to the misuse of funds appropriated to the Biomedical Advanced Research and Development Authority (BARDA) within HHS. OSC referred the allegations for investigation by the agency, which was conducted by HHS's Office of Inspector General (OIG). The investigation substantiated many of the allegations, finding that since at least fiscal year (FY) 2010, the Office of Assistant Secretary for Preparedness and Response (ASPR) misused funds appropriated for BARDA and failed to accurately report this mismanagement to Congress.  

The report contains evidence that ASPR used BARDA's research funds to pay for myriad unrelated expenses, including the removal of office furniture, administrative expenses, news subscriptions, legal services, and the salaries of personnel who did not work for BARDA. The report reveals that the practice of using BARDA funds for non-BARDA purposes was so common, there was even a name for it within the agency: “Bank of BARDA." HHS OIG determined that ASPR had “violated the Purpose Statute" and “potentially violated the Antideficiency Act."

How much money are we talking about here? Potentially a lot (except half a billion dollars in the scheme of the federal budget may not seem like much):

While the report does not contain a specific estimate for total funds misappropriated, it contains evidence that as recently as FY 2019, approximately $25 million was taken from BARDA's Advanced Research and Development (ARD) programs and improperly provided to ASPR. Moreover, from FY 2007 to 2016, ASPR's reporting to Congress failed to account for $517.8 million in administrative expenditures. The report found that “ASPR is unable to demonstrate that the[se] BARDA funds were used for their appropriated purposes." 

It is fairly common to move funds from one small program that no one cares that much about to another program that is facing a budget shortfall -- not any less illegal, but it is done. But this raid on the "Band of BARDA" hit the programs -- vaccine development and emergency preparedness -- that are central to the health of the public right now. I think this is a story that isn't going away anytime soon.

Beyond the Health Policy "Iron Triangle" of Cost, Quality, and Access"

 

There's a new article that builds on our experience with pandemic response to make the case for increasing emphasis upon health justice -- equity and public health. "Health Reform Reconstruction" is a free download on SSRN and is well worth the time to read and reflect on its message. Authors Lindsay F. Wiley, (American University - Washington, College of Law), Elizabeth Y. McCuskey (University of Massachusetts School of Law, Center for Health Law Studies), Matthew B. Lawrence (Emory University School of Law, Harvard University - Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics), and Erin C. Fuse Brown (Georgia State University College of Law) provide this Abstract:  

This Article connects the failed, inequitable U.S. coronavirus pandemic response to conceptual and structural constraints that have held back U.S health reform for decades – and calls for reconstruction. For more than a half-century, an intellectually cramped “iron triangle” ethos has constrained health reform conceptually. The iron triangle centered individual interests in access to, quality of, and cost of medical care, while marginalizing equity and public health. In the iron triangle era, reforms unquestioningly accommodated four entrenched fixtures of American law—individualism, fiscal fragmentation, privatization, and federalism—that distort and diffuse any reach toward justice and solidarity. The profound racial disparities and public health failures of the U.S. pandemic response in 2020 agonizingly manifested the limitations of pre-2020 health reform and demand a reconstruction. 

Health reform reconstruction begins with the replacement of the iron triangle era with a new era in which reforms aim to realize health justice. Health justice does not itself overcome the fixtures of American law that constrain reform and propagate subordination. But it reveals the importance of doing so, despite the fixtures’ stubborn legal and logistical entrenchment. Because health reformers can no longer accept any conceptual goal short of health justice, incremental reforms must be measured chiefly by whether they confront or accommodate individualism, fiscal fragmentation, privatization, and federalism in health care. Through an uncompromising conceptual aspiration and a method of confrontational incrementalism focused on dismantling the legal structures that stand in the way of health justice, health reform reconstruction is possible. The Article describes how health reform reconstruction can chart the path of legal change and reflects on the usefulness of its methodology of confrontational incrementalism in other fields which recognize the necessity of reconstructive reform, along with its near impossibility, such as policing and drug policy.

Expect state and local governments to re-impose more severe restrictions over the next few month

News from the COVI-19 front -- which is to say nearly everywhere -- is bad and getting worse. It took about 4 months for COV)D-related deaths in this country to hit 100,000, and another 4 months to hit 200,000. The next 100,000 deaths occurred in the space of approximately 12 weeks. And it took only a little over 4 weeks to move from 300,000 deaths to 400,000. (Source: WaPo reporting and Johns Hopkins University) In October, public health authorities were predicting there could be as many as 400,000 deaths before the pandemic is under control. We will hit 400,000 this week, and the death toll is still on the rise in 30 states. (AP, 1/18/21) 

The vaccination program should slow things down, but in addition to vaccine skepticism, the rollout has been agonizingly slow, poorly organized, and far from clearly marketed. Initial shots are supposed to have some effect, but it remains to be seen whether second shots will be available on-schedule. And in any event, masking and social distancing are still called for and will be for the foreseeable future. It's pretty clear that "pandemic fatigue" has set in, so these traditional public-health measures, which have been demonstrated time and again to be effective against the spread of respiratory viruses, are waning in effectiveness. 

Finally, there are now at least three mutations of the novel coronavirus that make the disease potentially more contagious than the original form of the virus. They have appeared in the United Kingdom, South Africa, and Brazil. (The Atlantic, 1/18/21) Our own genomic surveillance is pitifully inadequate to provide reliable data, but at least two of the variants (a fixed cluster of mutations, according to virologists) have appeared in this country.

As Dr. Fauci has explained, all of this adds up to a dismal winter season (CNN, 12/27/20) and a not-much-better spring, with growing pressure on governors and regulators to impose restrictions at least as severe as those in place last summer.

Lana Del Rey's eerie, conspiracy-laden music video and the death of Phil Spector

It's a pretty tune -- "Chemtrails Over the Country Club" -- accompanied by a spooky video with an apocalyptic conclusion to go along with it. The video features occasional flashes of those wispy white tracks produced by the hot vapors emitted by jet engines: "contrails" (short for "condensation trails" (a/k/a "vapor trails")).  It turns out contrails contribute significantly to global warming, so they are far from benign in and of themselves. But conspiracy theorists believe the jets are putting out trails of deadly chemicals ("chemtrails") for -- as described by Scientific American -- "a variety of nefarious purposes from weather modification, to human population control via sterilization, to even mind control." Ms. Del Rey is the queen of "heroin chic" and wears her infamous mesh face mask in this video, and if she is anyone's source of scientific information . . . well, I don't suppose they are also readers of Scientific American. This isn't the first nihilistic pop tune to come down the road, to be sure (I am old enough to remember 1965's "Eve of Destruction"), but I am suddenly  feeling very, very old. The high point of the video for me was the gorgeous cherry red Mercedes 540 K that she drives until (spoiler alert) she sets it on fire (undoubtedly a replicar, but still a work of art).

Speaking of the dark side of pop culture, Phil Spector died yesterday of COVID-19 while serving a prison sentence for the murder of an aspiring actress in his home in 2003 (NY Times, 1/17/20). He produced some of the most glorious pop and rock of the 1960s and 1970s, but his mind slipped into a very dark place over the next 30 years. Coincidentally, Hal Blaine, the drummer in Spector's heralded studio band, The Wrecking Crew, played on "Eve of Destruction." You can't make this stuff up.

Super-Spreader Events = Not-So-Happy New Year

Becker's CFO Report today reprinted this tale of woe (or woefully irresponsible behavior, that is): 90 people were arrested and another 900 were given warnings at super-spreader events on New Year's Eve. That's the bad news. The dark underbelly of this story is that you know these 1,000 miscreants were only the tip of the iceberg around the country. If you're looking for the reason we have 4.25% of the world population and 25% of the world's COVID-19 cases, this is it. Public health pronouncements (which are issued daily) and law enforcement efforts (already stretched thin) aren't the answer. The answer is voluntary compliance with common-sense precautions, and we are obviously not very good at that. 

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).