Thursday, July 23, 2020

HHS OCR Guidance on Discrimination during COVID-19 Pandemic

The Office of Civil Rights in US DHHS has issued a guidance bulletin (7/20/20): "Civil Rights Protections Prohibiting Race, Color and National Origin Discrimination During COVID‐19: Application of Title VI of the Civil Rights Act of 1964." There's not much that is likely to be controversial or even surprising here. All services and programs should be offered on a basis that does not discriminate based race, color, or national origin. 

One bullet point may prove to be trickier: 
  • "Assign staff, including physicians, nurses, and volunteer caregivers, without regard to race, color, or national origin. Recipients should not honor a patient’s request for a same‐race physician, nurse, or volunteer caregiver" (emphasis added).
Some hospitals, or at least some departments (such as psychiatry) within hospitals, have accommodate patient requests after explaining the hospital/department policy of nondiscrimination, the reasons for the policy, and the reasons for the patient's request. Beyond that, what about a request for a caregiver who speaks the patient's language? If that is the equivalent of asking for a caregiver from a particular country, does that violate the OCR Guidance?

Wednesday, July 22, 2020

Dan Farber on the constitutional scheme during a pandemic

Professor Farber has hit the nail on the head. Constitutional rights aren't suspended during a pandemic, nor has SCOTUS endorsed a special "pandemic standard of review." As the Jacobson case amply demonstrates, courts should apply the usual due-process standard of review, taking into account the special circumstances confronting state and local governments when contagion hits their communities.

The Long Shadow of Jacobson v. Massachusetts: Epidemics, Fundamental Rights, and the Courts
20 Pages Posted: 29 Jun 2020 Last revised: 7 Jul 2020
Daniel A. Farber
University of California, Berkeley - School of Law

Date Written: June 25, 2020
AbstractWhen emergency health measures have impinged on constitutional rights, judges have often turned to a 1905 Supreme Court case decision, Jacobson v. Massachusetts, which upheld a state law requiring smallpox vaccination.  
Courts are all over the map on how to apply Jacobson.. Some have viewed Jacobson as providing a special constitutional standard during epidemics. As this paper shows, history doesn’t support that view. Other judges have used “business as usual” constitutional analysis that ignore the crisis conditions under which the government must contend with today.  
During a pandemic, the government confronts a fast-changing situation presenting risks of catastrophic loss of life, under conditions of uncertainty. Similar conditions prevail in national security cases. There, courts apply the normal constitutional tests but give extra deference to the government. Many though not all of the reasons are similar to the coronavirus situation. The lesson would be to utilize the usual tests, but with allowances for the government’s need to take precautionary actions despite high uncertainty.

Health Affairs Blog: ACA Litigation Roundup

Katie Keith has finished an extremely useful three-part review of recent PPACA-related litigation:

  • Part I (July 20): "This post summarizes the recent Affordable Care Act-related Supreme Court decisions and the latest in California v. Texas. A second post will discuss the status of long-standing ACA-related lawsuits and highlight newer lawsuits over ACA implementation. A third post will focus on the resolution of lawsuits over unpaid risk corridors payments."
  • Part II (July 21): "This post covers a decision from the Court of Appeals for the Second Circuit holding that New York is preempted from making changes to ACA-governed risk adjustment transfers and a decision from the Court of Appeals for the Ninth Circuit holding that the ACA prohibits discrimination in plan benefit design under Section 1557 of the ACA."
  • Part III (July 22): "In April 2020, the Supreme Court ruled that insurers were entitled to more than $12.2 billion in unpaid risk corridors payments. This post summarizes the latest on risk corridors litigation in the wake of that ruling. Two prior posts focused on other recent ACA-related Supreme Court decisions and ACA lawsuits in the lower courts."

Tuesday, July 21, 2020

"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.

Sunday, July 19, 2020

Herd immunity explained

Here's a GAO Report (GAO-20-646SP, July 7) that provides a relatively nontechnical but still useful introduction to herd immunity.

Welcome to the President's New New Fantasyland

There's so much in a Fox interview that aired today, but here are some of the COVID-19 highlights (or, if you will, lowlights):
  • "'No country has ever done what we've done in terms of testing. We are the envy of the world,' he said."
  • "Trump downplayed the recent rise in national case numbers, claiming that it is the result of increased testing, with the implication that it is not a true rise in the severity of the pandemic, a claim that leading health experts have disputed."
  • "'I guess everybody makes mistakes,' the president said, then added, 'I'll be right eventually. I will be right eventually,' referring to his past prediction that the virus would eventually go away.

    "'It's going to disappear and I'll be right,' he said."
  • "'I think we have one of the lowest mortality rates in the world,' Trump said, offering White House statistics that differed from the ones [interviewer Chris] Wallace cited [that we have the seventh-highest mortality rate in the world]."
  • "The Trump administration announced that they are supporting a lawsuit to overturn ObamaCare. When asked why he would oppose something that people are relying on during a pandemic, Trump said he will be replacing it soon, and is 'signing a health care plan within two weeks.'" I am sure that's news to Mitch McConnell and the rest of the GOP majority in the Senate, let alone Speaker Pelosi and the rest of the House of Representatives.

Take away the stitch in time . . .

. . . and kill nine? This makes no sense. From The New York Times (7/18/20):
The White House is pushing to eliminate billions for coronavirus testing and tracing from a relief proposal drafted by Senate Republicans.
The draft suggested allocating $25 billion to states for testing and contact tracing, as well as almost $10 billion to shore up the Centers for Disease Control and Prevention and $15 billion to bolster the National Institutes of Health, according to a person familiar with the tentative plans, who cautioned that the final dollar figures remained in flux. 
The Trump administration has instead pushed to eliminate all of those funds and has also called for cutting billions of dollars set aside for the Pentagon and the State Department to help counter the outbreak and potentially distribute a vaccine at home and abroad.

A city with 85 hospitals, Houston has a COVID-critical shortage: nurses

The New Yorker has a fine piece on this problem. The focus is on Houston, but virtually every large city has the same problem: plenty of PPE, at least some ICU bed and ventilator capacity, but not nearly enough trained nurses to staff the sick and very sick COVID-19 patients.

Saturday, July 18, 2020

Playing politics with H1N1 vs. COVID-19 testing . . .

. . . and misleading the public in the process. Pres. Trump is trying to score points on VP Biden by calling out Obama and Biden for the CDC's decision to stop receiving test data during the H1N1 outbreak. FactCheck.org reports that the two viruses are too different to make the comparison valid. No surprise, I suppose, but playing politics with a pandemic simply undermines the public-health enterprise at a time when public-health expertise, not bluff and bluster, is desperately needed.

Friday, July 17, 2020

D.C. Circuit Drives Another Nail into the ACA's Coffin

Ok, that may be a bit hyperbolic, but it's still not good news for Obamacare.

Early on in the Trump administration, the Departments of Treasury, Labor, and HHS rules that short-term limited-duration health insurance plans should be available without complying with various underwriting rules that would otherwise be required by the ACA. These are cheap policies that don't cover very much. Once upon a time, they were designed for an initial coverage period of up to six months and were intended to provided "gap" coverage for individuals who were between real health insurance plans. The 2017 rule, however, allows these all-but-worthless plans to be sold for an initial period of three years and to serve as the primary health coverage provided by employers. It doesn't take a genius to figure out what the Trump administration had in mind: provide employees with the option of low-cost alternative to more expensive (and better) health plans and they will probably take it.

Today the D.C. Circuit in a 2-1 decision upheld the rule. You can read the opinions in Association for Community Affiliated plans v. U.S. Department of Treasury here. The majority opinion is pretty depressing. Judge Judith W. Rogers -- one of the few bright lights left on the D.C. Circuit Court of Appeals -- dissented in an opinion that really should have been a majority opinion. Her introductory paragraph says it all:
Today the court upholds a Rule defining “short-term limited duration insurance” (“STLDI”) to include plans that last for up to three years and function as their purchasers’ primary form of health insurance, in stark contrast to the gap-filling purpose for which such plans were created. Because STLDI plans are exempt from the requirements of the Patient Protection and Affordable Care Act (“ACA”), insurers offering them can cut costs by denying basic benefits, price discriminating based on age and health status, and refusing coverage to older individuals and those with preexisting conditions. As a result, they leave enrollees without benefits that Congress deemed essential and disproportionately draw young, healthy individuals out of the “single risk pool” that Congress deemed critical to the success of the ACA’s statutory scheme. 42 U.S.C. § 18032(c)(1). The Supreme Court has instructed courts to interpret the ACA’s provisions in a manner “consistent with . . . Congress’s plan.” King v. Burwell, 135 S. Ct. 2480, 2496 (2015). Because the Rule flies in the face of that plan by expanding a narrow statutory exemption beyond recognition to create an alternative market for primary health insurance that is exempt from the ACA’s comprehensive coverage and fair access requirements,
I respectfully dissent.
I hope the en banc court takes this up, or that SCOTUS will fix it, but I am not holding my breath. Perhaps a new administration in 2021 will get this right.

Tuesday, July 14, 2020

Hospitals ordered to bypass CDC with Covid data & report it to HHS

The NY Times reports that the Trump administration is moving the locus of hospital reports from the CDC (one of the agencies least under the president's thumb) to HHS (one of the most political agencies). This is not how public health is supposed to work. There is a legitimate fear that HHS will manipulate the data to fit the White House’s political message. This battle will be won only once the public believes in its public health institutions. That requires accuracy, transparency, and accountability. CDC is the best we have at the federal level, and HHS simply has not earned that degree of public trust.

Pandemic kills off health insurance coverage for 5.4 million



The heartlessness of this administration's position, which offers no alternative to the ACA, borders on depravity. The ACA works. Granted, it's not perfect and hasn't been since Day One. Like every other health care plan in the world, the ACA needs to be regularly tweaked to respond to conditions on the ground. But undoing a healthcare program 10 years later, despite substantial public support for it, is the equivalent of using a stick of dynamite to smooth out the edges of a rough plank.

This is the biggest reduction in coverage in our history, according to the NY Times (7/13/20). Meanwhile, back in Washington, Trump's Justice Department filed a brief in the Supreme Court that asks the Court to wipe out the ACA, which would potentially result in:
  • millions more being thrown out of the insurance market, 
  • pulling the rug out from under states that took the U.S. at its word and expanded Medicaid eligibility on the basis of a generous federal match, as well as
  • the reversal of such popular policies as:
    • coverage for children until age 26, 
    • protection against discrimination based upon preĂ«xisting conditions, 
    • annual and lifetime caps on coverage, and 
    • rescissions triggered by the filing of claims. 

Thursday, July 09, 2020

CDC sticks to its guns on guidelines for school reopenings

Trump doesn't like the draft guidelines and tweeted that he'd be meeting with the CDC (followed by three, count 'em, three exclamation points). Pence said revised guidelines would be out next week. Betsy DeVos emphasized how important it was for all school kids to be in class five days a week this fall. And, against all this political posturing unsupported by not one lick of science, CDC Director Robert Redfield said today that [1] the guidelines are what they are; [2] CDC is planning to provide additional information on how best to implement the guidelines; and [3] best of all, each school district will need to decide for itself when and how to open up based upon conditions on the ground. CDC hasn't exactly covered itself in glory during this pandemic, but this is a welcome show of spine by a federal official who could be fired by Trump in a nonce. Good work, Dr. Redfield.

Tim Jost's summary of the Supreme Court's decision on contraceptive coverage and the ACA

Tim is (or ought to be) everybody's go-to ACA scholar.

His short piece for the Commonwealth Fund is a masterpiece in concision.

Wednesday, July 08, 2020

SCOTUS (7-2): Any company that wants to eliminate contraceptive coverage now gets a free pass to do so

You read that right. Whether the objection is based upon the religious beliefs of the owners of a closely-held corporation (Hobby Lobby, 2014) or is based upon the moral beliefs of a publicly-traded mega-corporation, the Trump Administration's rule exempting companies from the ACA's mandate for women's health services at a reasonable price has, at least for now, been upheld by the Supreme Court.

In Little Sisters of the Poor Saints Peter and Paul Home v. Pennsylvania, the Court held that the Health Resources and Services Administration -- which the ACA authorized to come up with a list of mandatorily covered FDA-approved drugs and devices -- was also given the power to decide who would be subject to the mandate as well as what the mandate covered. Five justices (Justice Thomas, who wrote the majority opinion, and the four conservative justices everyone assumed would vote to uphold the regulation) agreed that the ACA was clear that HRSA could decide both the who and what questions. Justice Ginsburg, joined by Justice Sotomayor, dissented on the ground that the ACA was clear that HRSA had delegated authority to decide only the what question, not the who question.

Neither the majority nor the dissent mentioned Chevron deference, but Justice Kagan's concurring opinion (joined by Justice Breyer) did. (In their previous lives, both Kagan and Breyer were prominent administrative-law scholars while on the Harvard Law School faculty.) As Kagan wrote, sometimes when she squints real hard, the ACA looks as though its delegation to HRSA is broad enough to include the who question. And other times, the ACA seems to delegate only the what question to HRSA. In other words, either choice would have been a reasonable one for HRSA, in which case Chevron requires deference to the choice made by the agency.

This decision is bad news for women, make no mistake about it. As Lourdes Rivera of the Center for Reproductive Rights stated, "Today’s ruling has given bosses the power to dictate how their employees can and cannot use their health insurance — allowing them to intrude into their employees’ private decisions based on whatever personal beliefs their employers happen to hold."

But this isn't the last word on the subject. The case now goes back to the trial court to decide a potentially dispositive question under the Administrative Procedure Act: Whether the Trump Administration's rule is arbitrary and capricious. Five justices (the liberal/moderates plus Chief Justice Roberts) have recently demonstrated a willingness to hold this Administration's feet to the APA's fire in a few big cases (the citizenship question on the census questionnaire, DACA), and Justice Kagan's concurrence devotes 3-1/2 of its 6-1/2 pages to an analysis of the ways in which the HRSA rule might fail the APA's "arbitrary and capricious" test. They include (bulleted points are quoted from Justice Kagan's opinion]:
  • Most striking is a mismatch between the scope of the religious exemption and the problem the agencies set out to address. In the Departments’ [HRSA, which promulgated that rule, and the Departments of Health and Human Services, Labor, and the Treasury, which "incorporated" them] view, the exemption was “necessary to expand the protections” for “certain entities and individuals” with “religious objections” to contraception. 83 Fed. Reg. 57537 (2018). Recall that under the old system, an employer objecting to the contraceptive mandate for religious reasons could avail itself of the “self-certification accommodation.” Upon making the certification, the employer no longer had “to contract, arrange, [or] pay” for contraceptive coverage; instead, its insurer would bear the services’ cost. 78 Fed. Reg. 39874 (2013). That device dispelled some employers’ objections—but not all. The Little Sisters, among others, maintained that the accommodation itself made them complicit in providing contraception. The measure thus failed to “assuage[]” their “sincere religious objections.” 82 Fed. Reg. 47799 (2017). . . . Given that fact, the Departments might have chosen to exempt the Little Sisters and other still-objecting groups from the mandate. But the Departments went further still. Their rule exempted all employers with objections to the mandate, even if the accommodation met their religious needs. In other words, the Departments exempted employers who had no religious objection to the status quo (because they did not share the Little Sisters’ views about complicity). The rule thus went beyond what the Departments’ justification supported --raising doubts about whether the solution lacks a “rational connection” to the problem described. [emphasis added]
  • And the rule’s overbreadth causes serious harm, by the Departments’ own lights. In issuing the rule, the Departments chose to retain the contraceptive mandate itself. See 83 Fed. Reg. 57537. Rather than dispute HRSA’s prior finding that the mandate is “necessary for women’s health and well-being,” the Departments left that determination in place. HRSA, Women’s Preventive Services Guidelines (Dec. 2019), www.hrsa.gov/womens-guidelines-2019; see 83 Fed. Reg. 57537. The Departments thus committed themselves to minimizing the impact on contraceptive coverage, even as they sought to protect employers with continuing religious objections. But they failed to fulfill that commitment to women. Remember that the accommodation preserves employees’ access to cost-free contraceptive coverage, while the exemption does not. See ante, at 5–6. So the Departments (again, according to their own priorities) should have exempted only employers who had religious objections to the accommodation—not those who viewed it as a religiously acceptable device for complying with the mandate. The Departments’ contrary decision to extend the exemption to those without any religious need for it yielded all costs and no benefits. Once again, that outcome is hard to see as consistent with reasoned judgment. [emphasis added]
  • Other aspects of the Departments’ handiwork may also prove arbitrary and capricious. 
    • For example, the Departments allow even publicly traded corporations to claim a religious exemption. See 83 Fed. Reg. 57562–57563. That option is unusual enough to raise a serious question about whether the Departments adequately supported their choice. [emphasis added]
    • Similarly, the Departments offer an exemption to employers who have moral, rather than religious, objections to the contraceptive mandate. Perhaps there are sufficient reasons for that decision—for example, a desire to stay neutral between religion and non-religion. See 83 Fed. Reg. 57603–57604. But RFRA cast a long shadow over the Departments’ rulemaking, see ante, at 19–22, and that statute does not apply to those with only moral scruples. So a careful agency would have weighed anew, in this different context, the benefits of exempting more employers from the mandate against the harms of depriving more women of contraceptive coverage. In the absence of such a reassessment, it seems a close call whether the moral exemption can survive. [emphasis added]
We can only wait to see if the APA rides to the rescue one more time.

Monday, July 06, 2020

The Virus Rolls Along; Nurses are in Shorter Supply than Equipment

ICU beds and, just as critically, ICU personnel are at or near capacity in Florida, Texas, Nevada, and California. Two Texas counties are "urging" shelter in place. Houston is estimated to be 2 weeks from 100% capacity; the shortage is personnel, not beds. Dallas County had over 1,000 new cases yesterday, a new record for the third day in a row. And the experts tell us we are just at the beginning of this epidemic. See Becker's Hospital Review and the Dallas Morning News. The pandemic is going in the wrong direction, giving proof of Dr. Fauci's statement that we are still in the early phase of dealing with this outbreak.

The Republican members of Congress and the Texas legislature -- including Lt. Gov. Dan Patrick --  who resist orders to wear face masks in public as unconstitutional need to have an adult explain the constitution to them. The power of the state to impose mandatory public-health requirements on citizens was upheld in 1905 by a conservative Supreme Court of the United States in Jacobson v. Massachusetts. The Court agreed that an exception could be made when the public-health measure in question (smallpox vaccination) constituted a medical threat to an individual, but otherwise, reasonable public-health mandates do not violate the due process clause of the Constitution.

Saturday, July 04, 2020

New FTC-DOJ Guidelines on Vertical Mergers

This is the first joint statement on vertical mergers in 36 years. Granted, the lion's share of healthcare mergers appear to be horizontal, not vertical, but Becker's Hospital Review cites the CVS acquisition of Aetna as a vertical merger that would have been reviewable under these new guidelines, issued June 30. Here's the PDF link.

Follow-up on Haavi Morreim's post re: triage protocols

This is from Kenneth Alan Totz, DO, JD, FACEP (reprinted with permission):
As an attorney and emergency physician practicing in Arizona, Texas, and Colorado, your bottom-line prediction is correct. It is not within our DNA to ration healthcare. Our medical community is extremely resourceful and generous sharing resources within the state and across state lines. If the patient reasonably needs something, we find a way to get it for them. On my last shift this week, I transferred a patient hundreds of miles away via fixed wing aircraft to get the ICU resources they needed. Our hospital had run out of remdesivir as well. This was an intubated 67 year old hispanic gentlemen with COVID with a history of diabetes, hypertension, hypercholesterolemia, and a prior coronary by-pass surgery. The discussion of this patient's comorbidities was never raised when deciding to push forward with advanced medical care. The states can enact rationing of resource protocols, but the physicians are not necessarily going to adhere to them. Just like the minority patients have a distrust of the healthcare system, the medical community has a general distrust that they will NOT be legally protected if these rationing algorithms need to be instituted. 

Triage Protocols and Disparate Racial Impact

Law and Medicine scholar Haavi Morreim recently posted an excellent analysis of the problem on a discussion list maintained by the American Health Law Association. I reproduce it here, with Haavi's permission:
Issues of triage and rationing in Covid-19 have been discussed extensively within the bioethics community.  One prominent protocol (adapted and/or adopted at many sites) aims to maximize lives saved, and also life-years saved; additionally it emphasizes transparency with both the community and the patient/family.  The authors of these protocols have strived mightily to achieve something intellectually satisfying, ethically excellent. 
A major flaw has been that, to maximize life-years saved, we look to co-morbidities.  So guess which communities have the highest rates of co-morbidity - - yes, it's minority communities.  Add to this the fact that the SOFA score these protocols use is well-acknowledged not to be highly accurate in predicting mortality ("yes we know, but it's the best we have").   
And now add in the huge mistrust that many minority communities have for the healthcare establishment.  At the front end, that mistrust has many in these communities reluctant to be tested at all (fear that "you're putting the virus on that swab so you can give me the disease" has been documented) - - and indeed, sometimes reluctant to seek regular care (my pediatrics colleagues find some of their minority mothers reluctant to accept routine vaccinations for their children, citing fear that the vaccines now have the virus inserted into them).   
And now add in transparency + that mistrust.  We're supposed to tell a minority family "your dad won't be intubated because he doesn't meet our criteria."  "Our criteria . . . " So we (the ones they mistrust) will supposedly assure them "our criteria" are racially neutral.  But in fact they are not.  Check out NEJM, online June 18:  Vyas et al, "Hidden in Plain Sight - Reconsidering the Use of Race Correction in Clinical Algorithms" (attached).  It has long been documented that racial minorities receive less care, on many fronts.  This piece explains part of the reason why.  Minority distrust of the healthcare system is not some sort of mindless, baseless paranoia. 
My prediction -- and what has actually happened, so far, across the country -- is that healthcare providers will not actually implement these protocols.  They will find another vent, split a vent 2 or 4 ways, retrain another nurse . . . do whatever it takes to avoid this sort of rationing.  And they will be right to do that.

Where is OSHA? AWOL, apparently

18,000 complaints from employees. 12,000 cases closed with no action. More noncompliance to come. No inspections. No enforcement actions. Nothing. Employees are dying in the name of limited government, combined with a delusional belief in voluntary compliance by employers. Secretary of Labor Eugene Scalia has their blood on his hands. "Shameful" doesn't begin to describe OSHA's abject failure to enforce guidelines. The story appeared in NPR's Weekend-Saturday show with Scott Simon, 7/4/2020.