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).

Wall Street Journal: More Superb Reporting on The COVID Storm

Catching up with the most recent installments in the WSJ's excellent series, "The Covid Storm."

• "Why Did Covid Overwhelm Hospitals? A Yearslong Drive for Efficiency" (9/17/2020)
• "How South Korea Successfully Managed Coronavirus" (9/25/2020)
• "In a Year of Bad Days, This Was One of the Worst" (9/25/2020)
• "Why Hospitals Can’t Handle Covid Surges: They’re Flying Blind" (9/30/2020)
• "The U.S. Economy Was Laden With Debt Before Covid. That’s Bad News for a Recovery" (10/1/2020)
• "How New Jersey Nursing Home Suffered One of America's Deadliest Outbreaks" (10/6/2020)
• "Coronavirus Hit the U.S. Long Before We Knew" (10/8/2020)

For links to previous installments, search for "storm" in the right-hand nav bar.

Overturning the ACA Would Kick 12 Million Newly Enrolled Individuals Out of Medicaid: Kaiser Family Foundation Policy Paper

The ACA permitted states to expand eligibility for Medicaid enrollment to 128% of the federal poverty line. Twelve million people enrolled after their state took the federal government up on their offer to sweeten the deal by paying for 90% of the additional cost of covering these new enrollees (and even more that 90% in the early years). 

The ACA is currently being challenged in the Supreme Court, with oral arguments scheduled Nov. 10, one week after national election day. The Kaiser Family Foundation's policy paper explains that if the Supreme Court affirms the Fifth Circuit's decision and tosses out the entire ACA (on the basis of a specious severability argument), the result will be the rescission of federal permission to expand eligibility and the unavailability of federal funds to subsidize each state's expansion. (So far, 39 states have accepted the federal offer. Texas, with the most uninsured and highest uninsured rate in the country, has not.)

The result of overturning the ACA will be a Hobson's choice for expansion states: Either cut back the eligibility cutoff to the pre-ACA level: "income eligibility limits for parents were very low—typically just 64% of poverty, equating to less than $14,000 a year for a family of three in current dollars." Most states cannot self-fund the expansion, especially in light of the COVID-19-era hit to their budgets (on both the revenue and expenditure sides).

Add this effect to the loss of the ACA's broad range of insurance underwriting reforms --protection for patients with pre-existing conditions, the ability to keep a child on her parents' health insurance plan up to age 26, abolition of life-time and annual caps on coverage, elimination of the ability to rescind a policy simply because the insured has started submitting claims, etc. -- and the devastation will be all too real for tens of millions of Americans. 

Political Interference with FDA and COVID-19 Vaccine

The New York Times reports that the White House chief of staff and other "[t]op White House officials are blocking strict new federal guidelines for the emergency release of a coronavirus vaccine, objecting to a provision that would almost certainly guarantee that no vaccine could be authorized before the election on Nov. 3, according to people familiar with the approval process."

This is part and parcel of this administration's on-going politicization of public-health processes designed to promote the greatest good for the greatest number while minimizing harms to others. Put otherwise, the FDA's mandate is to regulate medical devices, drugs, and biologics (including vaccines) to promote their safety and efficacy. It's a balancing act, to be sure, but it's one that needs to be guided by evidence, not electoral politics. Shouldn't that be clear? Why isn't that clear to the White House's "top officials"? And where's the outrage? Are we (and by "we," I mean not only our political class but the rest of us as well) so inured to the utter predictability of this sort of dangerousness that we simply accept it as par for the course?

If they are successful, these "top officials" are going to expose the nation to the unnecessary risk of a vaccine that is not ready for prime time. And, sadly, it also negates the efforts of the tens of thousands of volunteers who have voluntarily taken on the risks of participation in clinical trials.

POSTSCRIPT: 6:00PM CDT

FROM THE NEW YORK TIMES:

BREAKING NEWS

The F.D.A. released stricter coronavirus vaccine guidelines that the White House had blocked. They make a vaccine by Election Day highly unlikely.

The new guidelines recommend gathering extra data about the safety of vaccines in the final stage of clinical trials, a step that would take time and make it highly unlikely that a vaccine could be authorized before Election Day, Nov. 3.

Common sense and decency prevail! 

Senate Report on Health Inequities and COVID-19

It's a report from the Democratic staff of the Senate Health, Education, Labor, and Pensions Committee: "COVID-19 & ACHIEVING HEAL TH EQUITY: Congressional Action Is Necessary To Address Racism And Inequality In The U.S. Health Care System" (Sept. 2020).

From the summary:

COVID-19 has had a disproportionate impact on Black people across urban, suburban, and rural communities. As of September 2020, Black people were nearly 3.5 times as likely to die from COVID-19 as white people when age is accounted for.

Latinx people have experienced some of the highest rates of infection from COVID-19 in the country. As of June 2020, counties where more than a quarter of the population is Latino saw infection rates increasing at higher rates than in counties with smaller Latino populations, and as of July 2020, the infection rate among Hispanic patients was more than three times the rate among white patients. Over the same time period, Hispanic patients were hospitalized at a rate that was more than four times higher than white patients, and COVID-19 accounted for approximately one in five deaths among Hispanic people.

Data are not consistently available from states for other minority groups, but what is known supports similar conclusions about the risk of serious COVID-related complications and death among Asians, Native Americans, and LGBTQIA+ individuals.

Contributing factors include underlying health conditions, a lack of adequate insurance, increased likelihood of exposure to COVID-19 at work, mistrust of the health care system based upon a history of racial bias and exploitation, present-day explicit and implicit bias in the health care system, underrepresentation of physicians of color, bias in medical research and pharmaceutical clinical trials, limited access of patients of color to high-quality medical care, and a long list of social determinants of health that have disproportionately disadvantaged persons of color.

This is an important report, and not only for the fifteen pages of endnotes. The report ends with thirty recommendations for congressional action. Ask your representative or senator if they've read the report. We all should. 

Leave it to Trump to Say the Exact Wrong Thing

  

President Trump announced his intention to leave Walter Reed at 6:30 this evening. Okay, it is not the standard of care, but it's common for VIPs to get inferior care because no one wants to tell them "no." But did he have to tweet this utterly inappropriate message?

"Don't be afraid of Covid"? Mr. President, 209,000 of your fellow citizens have died of this disease since January. And, according to an infectious-disease doctor at NYU who is quoted in the NY Times, there's a very real chance the president's medications have induced a false sense of euphoria and well-being:

“I think it would be disastrous to be in a situation where he gets really sick at the White House, and you’re having to emergency transfer him,” said Dr. Céline Gounder, a clinical assistant professor of medicine and infectious diseases at the N.Y.U. Grossman School of Medicine, who has been caring for Covid-19 patients. “To me, it’s not safe.”

Dr. Gounder also noted that dexamethasone can cause a sense of euphoria. Mr. Trump said in his tweet that he feels better than he has in 20 years.

“A lot of people will just feel really great. If you had any aches and pains, they will disappear. If you had a fever, that will disappear,” she said. “People can become somewhat manic, grandiose.” 

The Opposite of How Public Health is Supposed to Work

The staff of the Congressional Select Committee on the Coronavirus Crisis has issued a report on The Trump Administration's Pattern of Political Interference in the Nation's Coronavirus Response (10/2/2020). Coming from a committee with a majority of members of the Democratic caucus one month before the national election -- and with a title like that -- the political implications (and motivation) are hard to avoid. But . . . 

The public-health lesson should be clear to all. The administration -- at least within the White House -- has treated the pandemic like a political problem to be managed. And the political interference with public-health authorities has made COVID-19 far worse that it needed to be. 

Public health is a fragile enterprise. It always involves some interference in the lives and liberty of individuals, whether by encouragement or legal mandate. Widespread compliance requires understanding and trust. Mixed messages and blatant political manipulation of public-health authorities and the information they must convey undermine both public understanding and trust. It's as simple as that.

NY Times Op-Ed: Maybe Roe v. Wade Isn't Worth Fighting For Anymore

UC-Hastings law professor Joan Williams writes in today's NY Times ("The Case for Accepting Defeat on Roe," 9/29/2020) one of the best summaries of where the current abortion jurisprudence stands in 2020 and argues that reproductive-rights advocates may fare better with state legislatures than they have in the courts:

It’s true that abortion access is already abysmal. . . . Nearly 60 percent [of women seeking abortions] have already had one child and nearly half live below the poverty level; some fear they’ll be fired if they take time off, particularly if they need to make two trips, as they must in the 26 states with mandatory waiting periods.

The argument that the left has already lost the abortion fight reflects the fact that there’s no abortion clinic in 90 percent of American counties. This is the result of the highly successful death-by-a-thousand-cuts anti-abortion strategy, which has piled on restriction after restriction to make abortion inaccessible to as many American women as possible.

Prof. Williams isn't ready to give up on the fight to preserve Roe, though every year it seems to protect less and less of a woman's right to choose. She cites Justice Ginsburg's critique of Roe as support for a legislative strategy going forward:

So what should we do now? Often forgotten is that R.B.G. herself had decided that Roe was a mistake. In 1992, she gave a lecture musing that the country might be better off if the Supreme Court had written a narrower decision and opened up a “dialogue” with state legislatures, which were trending “toward liberalization of abortion statutes” (to quote the Roe court). Roe “halted a political process that was moving in a reform direction and thereby, I believe, prolonged divisiveness and deferred stable settlement of the issue,” Justice Ginsburg argued. In the process, “a well-organized and vocal right-to-life movement rallied and succeeded, for a considerable time, in turning the legislative tide in the opposite direction.” 

There's more to read and learn from Prof. Williams's insightful op-ed. I recommend it. 

KFF Report on Trump's Health Care Record

We can expect health care (and HC reform) to be a major policy focus of the fall presidential campaign. The president's record is long and complex, including (quoting a press blurb from the nonpartisan Kaiser Family Foundation):

his response to the COVID-19 pandemic, his early and ongoing efforts to repeal and replace the Affordable Care Act (ACA), his annual budget proposals to curb spending on Medicare and Medicaid, his executive orders and other proposals to lower prescription drug prices, and his initiative on hospital price transparency.

This is from an issue brief published by KFF  -- "President Trump's Record on Health Care" -- with all the details. It is the fairest and most comprehensive summary I've seen. 

The Case for the Saliva-Based Antibody Test, Rather than PCR Test, to Reopen Society Safely

Co-authors A. David Paltiel & Rochelle P. Walensky write in today's Health Affairs blog that we shouldn't be put off by the 30% false-negative rate of antigen testing (as compared to the PCR test, which is great at identifying the virus (sensitivity) but has a relatively high rate of specificity (it can be fooled into giving a positive result long after the virus has left the individual, and therefore long after the individual has ceased to be infectious). The key distinction pressed by the authors is "infection" vs. "infectiousness." Their claim is that the antigen test is pretty lousy as a test for the presence of the virus but actually quite good as a test for infectiousness. It's a pretty persuasive case for the rapid-return, inexpensive test, which has been touted by some, as well criticized by others. 

The authors state that the FDA has been slow to approve these tests. As far as I can tell from the FDA's "COVID-19 Emergency Use Authorization" page, that's true. The authors argue that the time has come to ask the FDA why it isn't moving faster on an EUA for this technology.

The Latest from The Atlantic's Ed Yong on Where We Are Headed with COVID-19

Yong is quite possibly the best journalist covering the pandemic beat -- knowledgeable about the science, perceptive in spotting trends. His latest article in The Atlantic (9/8/20) is a good example. It's also borderline apocalyptic: "America Is Trapped in a Pandemic Spiral." Did I say "borderline"? I meant "downright apocalyptic." Here's the article's subtitle: "As the U.S. heads toward the winter, the country is going round in circles, making the same conceptual errors that have plagued it since spring." 

If you want to read all of Yong's reporting (and by others on its staff) on the pandemic, The Atlantic has made all of its articles free at this link.

A Look at the Top-Down Management of the Coronavirus by Gov. Cuomo: WSJ's Series

The latest in the Wall Street Journal's series, "The COVID Storm," is critical of Governor Cuomo's insistence on controlling the shut-down and reopening of New York City, one of the hardest-hit cities in the United States. The article argues that the death toll didn't need to be as high as it was, if local authorities had been left to manage the crisis on their own.

$10,984 for a COVID-19 Antibody Test? Yes.

This is like one of those kid's puzzles -- Can You Spot the Errors in This Picture? -- with upside-down swings hanging up from tree branches and a man wearing unmatched socks. As reported by ProPublica, a part-time ER medical director walks into his employer's stand-along emergicare center to get a COVID-19 antibody test. There's no serious attempt to take a history and no physical exam, just a blood draw and results 30 minutes later.

The charge (100% of which was paid by the doctor's insurance company, a subsidiary of health insurance behemoth UnitedHealthcare): $10,984: $2,100 for the physician portion and $8,884 for the facility fee.

1. The facility advertises the price of an antibody test on its website: $75.

2. The insurer never blinked before paying the charges in full. 

3. The parent company of the insurer cleared $6.6 billion in net earnings in the second quarter of 2020. An $11,000 bill -- whether sent in error or because of a policy of price gouging -- may amount to a rounding error for the insurer's first hour of operations at the beginning of each quarter and just not worth the hassle to question the provider.

4. It's not as if UnitedHealthcare or its sub ends up footing the bill for these charges. They are paid by all of UHC's policyholders.

I am partial to Medicare opt-in for all in the hope that it will provide a reality check for providers and private insurers, whose business model is making lots of people rich off the most expensive system of health care in the world. According to the ProPublica article: "Medicare lists its payment at $42.13 for COVID-19 antibody tests." That's a reality check!

The ER doctor/patient responded to this episode with a letter of resignation: "I have decided I can no longer ethically provide Medical directorship services to the company . . . . If not outright fraudulent, these charges are at least exorbitant and seek to take advantage of payers in the midst of the COVID19 pandemic."

"‘Really Diabolical’: Inside the Coronavirus That Outsmarted Science": Latest in WSJ Series

Another good installment in the WSJ series, "The COVID Storm" (9/7/20). Here are the opening few paragraphs:

The new coronavirus is a killer with a crowbar, breaking and entering human cells with impunity. It hitchhikes across continents carried on coughs and careless hands, driven by its own urgent necessity to survive.

It has a gregarious side that makes it hard to resist. It loves a party. The persistent social climber claims its victims around the world by riding on moments of the most innocent of human interactions—a shared laugh, a conversation, an embrace. And it is a liar. SARS-CoV-2, which causes Covid-19, often misleads the body’s immune systems.

Taken on its own terms, SARS-CoV-2 is the infectious disease success of the past 100 years.

Sen. Cruz (+ 20) Makes a Move on Women's Health

Kudos to The Dallas Morning News for this article on the senator's letter urging the head of the FDA to pull Mifeprex (a/k/a mifepristone, RU-486, or "the abortion pill") from the market. The DMN story quotes the senator as saying "Pregnancy is not a life-threatening illness, and the abortion pill does not cure or prevent any disease. Make no mistake, Mifeprex is a dangerous pill." The story explains the background: 

As the COVID-19 pandemic limited access to in-person doctor appointments, abortion-rights advocates called for the FDA to alter its risk evaluation strategy for the pill, arguing that the policy, which required a woman be prescribed the pill in person, made it more difficult for a woman to acquire it. A federal judge suspended the rule in July.

The article offers this lesson in basic reproductive biology: 

Pregnancy can be especially deadly to Black and American Indian women. From 2011 to 2016, there were 42.4 deaths per 100,000 live births for Black non-Hispanic women and 30.4 deaths per 100,000 live births for American Indian and Alaskan Native non-Hispanic women.

The CDC reported in [2019] that since Mifeprex’s approval in 2000, there were 24 recorded maternal deaths associated with the drug.

The article ends with this great Twitter quote from Democratic congressional candidate (TX-4) Russell Foster: "If you dont have a uterus, you shouldn't have a say in a womans healthcare. You lack basic knowledge. Viagra doesnt prevent any disease but I'm sure you have a full bottle at home. Please stay out of women's healthcare decisions unless you want them to start legislating mens."

Wall Street Journal's Latest in "The COVID Storm" Series

The Wall Street Journal continues its excellent series with two new installments:

• "How Trump Sowed Covid Supply Chaos. 'Try Getting It Yourselves.’" (8/31/20)
• "How Coronavirus Overpowered the World Health Organization" ((8/28/20)

Links to all previous articles in this series are here.

Testing for the coronavirus and the CDC

On August 24 the CDC announced new recommendations for testing for the coronavirus. They said that there is no need for testing if someone is asymptomatic, even if that person has come into contact with someone who has the infection. 

Of course, this change serves the political goals of President Trump perfectly, since he has repeatedly asserted that with fewer tests the U.S. would have fewer cases. I have a granddaughter who loved playing a game where, if she closed her eyes, I would disappear. By the time she was four or five, though, she knew it was just a game and that I really didn't disappear. That lesson seems to have been lost on the president.

But back to the CDC. Adm. Brett Giroir (an old friend whose integrity I've never had reason to question) says there was no political pressure: "We all signed off on it, the docs, before it ever got to a place where the political leadership would have, you know, even seen it, and this document was approved by the task force by consensus." The medical community outside the CDC, however, has been pretty close to unanimous in rejecting this latest guidance. The former head of the CDC, Dr. Tom Frieden summed up the response from outside the Washington Beltway: the guidance change is "unexplained, inexplicable, probably indefensible.”

There are two competing narratives out there, and there is no reason both couldn't be be true. 

1. This is a politically driven change pushed by the White House, HHS, and political actors on the coronavirus task force to make the president look good. Brett Giroir denies this, though he has confirmed that once "the docs" signed off the change made its way into the political process. Sheryl Gay Stolberg of the NY Times reports that "[t]wo federal health officials said the shift came as a directive to the Atlanta-based C.D.C. from higher-ups in Washington at the White House and the Department of Health and Human Services." That still allow for the possibility that the politicos "directed" the CDC to make a change after it was presented to them by "the docs."
2. This new guidance is an attempt to ration tests, which are still drastically and acutely in short supply, to those who are most likely to be contagious. As has been reported throughout the summer, it can take days to get tested and weeks to get test results back due to the backlog in properly equipped testing facilities. 

But to say that asymptomatic individuals don't need to be tested masks the rationing effort with a veneer of pseudoscience that is being widely criticized. Asymptomatic individuals can still be infected and can spread the virus without knowing they are infected. Testing addresses that real risk. What we need is honesty about what's really going on.

Especially against a backdrop of on-again, off-again advice from the White House task force and CDC, this couldn't have been handled more ineptly. But it's not just the messaging that's off. Behind the altered guidance is the reality that our testing program, by any measure, has been a disaster.

The COVID Storm: three more Wall Street Journal articles

The Wall Street Journal continues to excel with its in-depth study of how we got to where we are today, what went right and what went wrong:

• What Derailed America’s Covid Testing: Three Lost Weeks (Aug. 18, 2020)
• Why Are There Still Not Enough Paper Towels? (Aug. 21, 2020)
• New Thinking on Covid Lockdowns: They’re Overly Blunt and Costly (Aug. 24, 2020) - by the inimitable Greg Ip

Previous articles in the series are here and here. 

". . . it illustrates that we are all connected "

From the Boston Globe (possible paywall protection): When Biogen held its meeting of the firm's international leaders in a Boston hotel in February, they apparently had no idea it would be a super-spreader event. Attendees congregated in meeting rooms, on escalators and in elevators, at cocktail receptions and meals. Masks and social distancing weren't much of a thing back then. Current estimates of the number of coronavirus infections in four easter Massachusetts counties that are traceable to that two-day event: 20,000. And that number could be too conservative an estimate.

The "connected" quote is in reference to the spread from the tony Marriott Long Wharf hotel to at least "122 people living in Boston-area homeless shelters and employees who work there, the study says. It’s unclear what path the virus took to get there."

Lesson learned? Not necessarily, as illustrated by last week's decision by a number of universities to cancel the return to on-campus classes after clusters of infections broke out among undergraduates (Inside Higher Ed, 8/25/20).

Declining life expectancy in the U.S. and legal determinants of health

It is well known that average life expectancy in this country declined from 2014-2017, followed by a slight (~1 month) increase in 2018 (CDC, Jan 2020), leaving the average still below its high in 2014. An important new article in JAMA (on-line and free) by Larry Gostin and co-authors James Hodge and Donna Levin consider "Legal Interventions to Address US Reductions in Life Expectancy." Here, in brief, is their case:

Age-based, geographic, and socioeconomic status disparities collectively diminish average life expectancy. Midlife “diseases of despair” (eg, suicides, drug overdoses, and alcohol-related conditions), firearm violence, and obesity also are contributing factors for reduced life expectancy, especially in rural counties, the industrial Midwest, and Appalachia. Life expectancy gaps among the richest and poorest 1% of the population are estimated to exceed 10 years for women and 14 years for men. Stated simply, poorer, less-educated individuals in the US live considerably shorter lives. This pattern of inequality has been highlighted further during the COVID-19 pandemic.

Among multiple causes, weak laws at all levels (federal, state/tribal, local) contribute to regional differences in life expectancy, suggesting a need for responsive legal reforms. Universal health coverage is vital, but “upstream” prevention aimed at known risk factors undergirded by law also contribute to increased life expectancy. Post–COVID-19 public health laws can address specific social determinants beyond the health sector—such as by focusing on connectedness, education, environment, housing, food, income, and transportation—and potentially narrow vast health equity gaps among underserved at-risk populations.

 

The COVID Storm: Part 2 of The Wall Street Journal Series on What Went Wrong

 

The second installment in the WSJ's series -- "China’s CDC, Built to Stop Pandemics Like Covid, Stumbled When It Mattered Most" -- focuses on the breakdown, primarily in surveillance, which didn't discover the outbreak in Wuhan until it had already started to spread to the rest of the world. The story in China is distressingly similar to the story in the U.S.: Public-health infrastructure was underfunded, understaffed, and degraded to the point that it couldn't do the job it was designed to do.

As expected, the writing is superb. Also as expected, the series is still behind a paywall. It's too bad. A lot of other news outlets are putting their COVID-19 coverage on-line for free as a public service. 

New Wall Street Journal Series: The COVID Storm

The first installment was in today's paper: "A Deadly Coronavirus Was Inevitable. Why Was No One Ready?" The series is off to a pretty strong start, with some useful historical data and trends, good stuff on SARS, lessons learned from EBOLA (not caused by a coronavirus, but a highly infectious disease), and a straightforward narrative describing the international response. 

Unfortunately, there are only a few paragraphs on the developments, historical and present-day, that produced a public-health disaster in the U.S. Maybe there will be more in subsequent articles. 

And the articles are behind a paywall. (Really, WSJ? Many papers and journals are making their COVID-related articles available for free because, you know, they are in the public interest). 

For now, I still highly recommend two articles by Ed Young in The Atlantic that I've mentioned previously (here and here). Yong is somewhat less diplomatic than the WSJ when it comes to describing the failures in policy and in practice during the first half of 2020, and I for one am grateful for his forthrightness.

Cruzan and the Right to Die -- SMU Law Review Symposium (Vol. 73, No. 1)

 I'm happy to report the publication of the SMU Law Review's Symposium, "Cruzan and the 'Right to Die'" in Vol. 73, No, 1 (2020). The authors who wrote for the Symposium are the thought leaders around the country. I want to thank them for their wonderful scholarship and urge everyone reading this to check out their articles.  (All are available in PDF from the link above.)

The motivating idea behind the Symposium was "where are we now, 30 years after the U.S. Supreme Court's decision in Cruzan? Here are our authors and their topics:

• Foreword: Cruzan and the “Right to Die”
  Thomas Wm. Mayo
  
  
• First Man and Second Woman: Reflections on the Anniversaries of Apollo 11 and Cruzan
  George J. Annas
  
  
• Cruzan’s Legacy in Autonomy
  Kathy L. Cerminara
  
  
• Remaking the “Right to Die”: Give Me Liberty but Do Not Give Me Death
  Janet L. Dolgin
  
  
• Beyond Cruzan: Dementia and the Best Interests Standard
  Rebecca Susan Dresser
  
  
• Cruzan and the Other Evidentiary Standard: A Reconsideration of a Landmark Case Given Advances in the Classification of Disorders of Consciousness and the Evolution of Disability Law
  Joseph J. Fins
  
  
• A History of the Law of Assisted Dying in the United States
  Alan Meisel
  
  
• Cruzan and Surrogate Decision-Making
  David Orentlicher
  
  
• Video Advance Directives: Growth and Benefits of Audiovisual Recording
  Thaddeus Mason Pope
  
  
• The Legacy of Cruzan: Balancing the Moral Agency of Surrogates and the State
  Margie Hodges Shaw, Timothy E. Quill, and Bernard L. Sussman

Can we finally put to rest the certifiably false assertions by Trump and Cornyn that children are immune to or not affected by the coronavirus? Positive cases in children (under the age of 19) increased by 97,000 in the last two weeks of July alone (WaPo, 8/10/20). It really doesn't matter whether increased testing or increased numbers of infections (or, most likely, some combination of the two) are behind this number. (A) The number disproves claims that kids are, by virtue of being kids, safe from infection. (B) The true number of positive cases is probably quite a bit larger than the reported number (which is true of all reported numbers).

Ed Yong (Atlantic writer) on KERA-FM's "Think"

Ed Yong, whose article in the September issue of The Atlantic I previewed in an earlier post, was recently interviewed by Krys Boyd on KERA-FM (8/11/20). Krys is a fabulous interviewer, and her one-hour session with Yong is a good example of her work. 

Yong's current piece focuses on the inadequacy of our response to the coronavirus. He and Krys mentioned his two-year-old article, also in The Atlantic, that predicted our inability to respond to a pandemic: "The Next Plague is Coming. Is America Ready?" (July/August 2018).The article pretty well nailed what came to pass, with the added factor -- now all too apparent -- of the total lack of coherent leadership from our president, which Yong details in the current article.

Both articles are indispensable reading (if you can get past the paywall). Also, Yong is a prolific writer and his Atlantic articles since January are worth checking out.

Long-term Health Care Costs for COVID-19

 

Even after the critical-care hurricane passes, we are looking at COVID-19-related thunderstorms for the years ahead.

 We are used to thinking about the impact of COVID-19 in light of short-term effects: hospital beds, ventilators, staffing, schools and businesses, local and national economy, etc. It makes perfect sense. These are the places and concerns where the pandemic first hits us. But researchers are starting to look at the longer-term effects, beginning with the health care needs of individuals with long-term and even permanent health problems as a result of their exposure to the novel coronavirus. 

Even after (that is, when and if) Reuters ran this story last week:

With mounting evidence that some COVID-19 survivors face months, or possibly years, of debilitating complications, healthcare experts are beginning to study possible long-term costs.

Bruce Lee of the City University of New York (CUNY) Public School of Health estimated that if 20% of the U.S. population contracts the virus, the one-year post-hospitalization costs would be at least $50 billion, before factoring in longer-term care for lingering health problems. Without a vaccine, if 80% of the population became infected, that cost would balloon to $204 billion.

This of course is on top of the year-in, year-out bill for health care B.C. (Before COVID-19). According to the Centers for Medicare and Medicaid Services, "U.S. health care spending grew 4.6 percent in 2018, reaching $3.6 trillion or $11,172 per person.  As a share of the nation's Gross Domestic Product, health spending accounted for 17.7 percent." 

If we're aiming for herd immunity without a vaccine available, 80% is a good number, but in terms of the human misery, economic dislocation, and impact on health care providers (institutional and individual), getting to 80% is a disaster. And $204 billion represents a 5.67% bump on top of the underlying 4.6% growth rate that is pretty much baked into our national health care costs. 

We may get a vaccine that will be at least partially effective, and we may get out the required hundreds of millions of doses (in this country along, let alone the billions needed worldwide). The infection rate, therefore, may be less than 80%. But a 20% infection rate still puts an enormous burden on the system, especially primary-care physicians and specialists including cardiologists, pulmonologists, endocrinologists, neurologists, and gastroenterologists. 

And that burden will not be shared equally by states and regions. Massachusetts has more physicians per capita than any other state. There may be shortages in the years ahead, but they are unlikely to be as severe as in states that already have physician and other health-provider shortages. Many of those states are in the South (including the the Southeast and Southwest), where restrictions have been lifted too broadly and too soon and where COVID-19 spikes have been the most pronounced since July. 

Determination of Brain Death/Death by Neurologic Criteria: The World Brain Death Project

Brain death/death by neurologic criteria (BD/DNC) is described in every jurisdiction in the U.S. as the irreversible cessation of all brain function, including that of the brain stem. The universal acceptance of this seemingly straightforward criterion masks an unsettling reality: "There are inconsistencies in concept, criteria, practice, and documentation of brain death/death by neurologic criteria (BD/DNC) both internationally and within countries." That's the opening salvo by an international, multidisciplinary group that has published its findings and recommendations in an important new paper in JAMA. 

As summarized by the panel: "This report provides recommendations for the minimum clinical standards for determination of brain death/death by neurologic criteria in adults and children with clear guidance for various clinical circumstances. The recommendations have widespread international society endorsement and can serve to guide professional societies and countries in the revision or development of protocols and procedures for determination of brain death/death by neurologic criteria, leading to greater consistency within and between countries."

In the same issue, Dr. Robert Truog at Harvard Medical School and Boston Children's provides a useful editorial on the report. His bottom line: loss of consciousness, loss of spontaneous respiratory drive, and the irreversibility of both conditions are the source of inconsistency and confusion. Research as to all three factors is desperately needed and devilishly difficulty to carry out. And even if that research is performed and is successful in establishing clinical criteria for their determination, much work will remain to be done, e.g.:

Bringing these recommendations to the entire international community will require a 2-pronged approach. First, evidence to support the existing tests needs to be bolstered, and this may require greater use of advanced neurodiagnostic techniques. A key question will be whether the whole-brain biological standard for defining BC/DNC will remain tenable, or whether this concept should be replaced by the values-based brainstem standard. Second, since much of the world does not have access to advanced technologies, the World Brain Death Project will need to focus on development and validation of tests that rely on the clinical examination and widely available diagnostic tools. This will be essential if the capacity for accurately diagnosing BD/DNC is to become accessible to all clinicians around the world.