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. 

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.

"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.

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.

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. 

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. 

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)

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. 

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.

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.

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.

 

Devastating Report on the U.S. Response to the Novel Coronavirus

Ed Yong has written the definitive story on the federal (non)response to the pandemic in The Atlantic: "How the Pandemic Defeated America" (Sept. 2020 issue; updated 8/4/2020). Yong's reporting is thorough, well-sourced, and fair and balanced, including this paragraph:

No one should be shocked that a liar who has made almost 20,000 false or misleading claims during his presidency would lie about whether the U.S. had the pandemic under control; that a racist who gave birth to birtherism would do little to stop a virus that was disproportionately killing Black people; that a xenophobe who presided over the creation of new immigrant-detention centers would order meatpacking plants with a substantial immigrant workforce to remain open; that a cruel man devoid of empathy would fail to calm fearful citizens; that a narcissist who cannot stand to be upstaged would refuse to tap the deep well of experts at his disposal; that a scion of nepotism would hand control of a shadow coronavirus task force to his unqualified son-in-law; that an armchair polymath would claim to have a “natural ability” at medicine and display it by wondering out loud about the curative potential of injecting disinfectant; that an egotist incapable of admitting failure would try to distract from his greatest one by blaming China, defunding the WHO, and promoting miracle drugs; or that a president who has been shielded by his party from any shred of accountability would say, when asked about the lack of testing, “I don’t take any responsibility at all.”

Yong's conclusion: What's unfolding before our eyes at this very moment was entirely "predictable and preventable." 

"Constitutional Norms for Pandemic Policy"

Here's a précis of an important paper by three professors at the University of Arizona College of Law (Toni Massaro, Justin R. Pidot, and Marvin Slepian). After all the dumb (mostly anti-mask and anti-shutdown) rhetoric about how constitutional rights don't go away in a pandemic, here's some common sense about how our present crisis fits into the constitutional scheme.

Arizona Legal Studies Discussion Paper No. 20-29 (free download)

The COVID-19 pandemic has unleashed a torrent of legal and political commentary, and rightly so: the disease touches every corner of life and implicates all areas of law. In response to the disease, governments, civic institutions, and businesses have struggled to protect public health, respect individual autonomy, and enable Americans to satisfy their elemental instinct to congregate with one another.

Public perceptions about the disease, and our responses to it, have substantially fallen along predictable ideological lines. For example, the willingness of individuals to social distance may indicate something about their risk tolerance, but also about their political affiliation. Our ability to launch a unified response to COVID-19 has, in other words, been affected by rifts that generally infect American political life. 

How we manage these divides over pandemic response matters, because the costs of disunity are high. Those who fear the risk COVID-19 poses to their lives depend on others to participate in mitigation efforts; those who fear the risk our response to COVID-19 poses to their livelihoods depend on others to willingly reengage in economic life. Common ground, while elusive, is essential to America’s response to this pandemic, and the next one that will surely follow. 

We argue that ingredients for consensus already exist, even if they are obscured by political and policy rancor. Americans share the common goal to safely return to families, jobs, schools, places of assembly, pubs, parks, and the myriad of other settings that make up human lives and we share a fidelity to basic constitutional legal norms that can inform how we safely return. 

This Essay identifies four constitutional principles to shape pandemic policies and enable them to garner broad public acceptance: substantive and procedural rationality, respect of fundamental liberties, equal treatment, and flexibility to enable government to nimbly and effectively address emergencies that threaten life itself. Fidelity to these norms is essential for all institutions, public and private, because reopening safely can occur only through the cooperation of private individuals, and individuals will cooperate only if they have confidence in the ability of institutions to protect safety, liberty, and equality.