Friday, July 31, 2020

In Texas, More People Are Losing Their Health Insurance as COVID Cases Climb

From a story by Ashley Lopez of Public Radio station KUT in Austin (and picked up by Kaiser Health Network):
Texas’ uninsured rate has been climbing along with its unemployment rate as COVID cases also surge in the state. Before the pandemic, Texas already had the highest rate and largest number of people without insurance among all states. And 20% of all uninsured children in the U.S. live in Texas.

The uninsurance problem has only gotten worse in Texas in 2020. According to recent data from Families USA, a consumer health advocacy group that supported the Affordable Care Act, 29% of Texas adults under 65 don’t have health insurance so far this year.

The group found that about 659,000 people in the state became uninsured between February and May as job losses soared. Texas is one of 13 states that has not expanded Medicaid under the ACA.
Thirty-seven states and D.C. have expanded Medicaid eligibility in response to a generous federal match under the ACA -- and that doesn't include Missouri, where voters are voting on Tuesday on Medicaid expansion. Texas is one of the holdouts, for reason that defy logic. We'll see if it continues to defy politics in November. In recent decades we've been a resolutely red state in statewide and presidential elections. Is this the year the politicians who have turned their backs on the poor and disabled individuals in this state are held to account for their heedless, heartless actions?

Thursday, July 30, 2020

Starr County, TX implements "crisis standard of care"

It's been reported that the only hospital in Starr County (on the southern border) will deny access to critical-care facilities based upon a patient's likelihood of survival. You can hear the desperation in this quote from the Starr County Judge (the highest executive official in the county), Eloy Vera:
“It is important that we all know the situation that we’re facing in the county, not only the community but the hospital is overwhelmed right now,” Vera said. “Our backs are to the wall.”
And from the County Health Authority, Dr. Jose Vazquez:
“We are not gods or anybody to make a decision for who should live or who should die. However, when you have a mass-casualty situation there are guidelines that makes you work in a more efficient manner and to help save the maximum number of people,” said Vazquez, who added in his entire career as a physician he has never experienced such a desperate mass medical situation. 
According to the Border Report:
Starr County has an eight-bed COVID-19 unit at its hospital, but currently there are 28 patients with three on ventilators and life support, including one in the emergency room. Vazquez said physicians will be using a mass-casualty treatment plan devised by physicians in North Texas to determine who gets treatment and who does not.

“The number of cases we see in the ER are growing every day; 50% of cases in the ER are COVID. The situation is desperate. We cannot continue functioning at Starr County Memorial Hospital the way things are going. The numbers are staggering,” Vazquez said. 

Haynes and Boone "Health Law Vitals": Almost All COVID-19 Almost All the Time

New issue of the firm's health-law newsletter includes the following:
  • COVID-19-Related Healthcare Fraud and Anti-Kickback Enforcement Focuses on Laboratory Testing
    • While the U.S. Department of Justice (DOJ) has identified and pursued a variety of fraud schemes and activities related to COVID-19 (such as sales of fake testing kits and PPE, price gouging, and fraudulent offers for free COVID-19 testing in order to obtain Medicare beneficiary information that is used to submit false medical claims), several recent cases involving laboratory testing demonstrate that this is a key area of healthcare fraud and anti-kickback enforcement during the pandemic
  • HIPAA Updates
    • OCR's HIPAA guidance for healthcare providers during the COVID-19 pandemic
  • HHS's extension of its Public Health Emergency
  • Detailed reporting instructions for recipients of Provider Relief Funds (PRF) will be released on August 17, 2020
  • Substance Abuse and Mental Health Services Administration (SAMHSA) announced the adoption of the revised Confidentiality of Substance Use Disorder Patient Records regulation, 42 CFR Part 2
  • Department of Justice updated its guidance regarding evaluation of corporate compliance programs
  • OCR resolved two religious freedom complaints related to COVID-19

Tuesday, July 28, 2020

After taking a week off from misleading the public about the coronavirus, Pres. Trump is at it again.

Public health law promotes public health, including public-health measures to combat threats to the health of the public. But what happens when the top federal executive-branch official -- someone whose public-health executive-branch agencies include the FDA, the CDC, the National Institute of Allergy and Infectious Disease, the Indian Health Service, and the Public Health Service, among many others -- is himself a threat to public health?

That's right, President Trump, I am talking about you.

After a week of acting and speaking fairly sensibly about the coronavirus and COVID-19, he's back at it again, today retweeting that hydroxychloroquine is an effective treatment for COVID-19. And, according to the Associated Press, "Trump also shared a post from the Twitter account for a podcast hosted by Steve Bannon, a former top White House adviser to Trump, accusing Fauci of misleading the public over hydroxychloroquine." This is the same nonsense that today got Twitter to limit Donald Trump Jr.'s Twitter access for 12 hours as a sanction for misleading the public about COVID-19.

One of my earlier posts analogized Trump to Nero, fiddling while Rome burned. A better analogy is  poring gasoline on the fire to make it worse.

Monday, July 27, 2020

Somnolescent state medical boards bear large responsibility for epidemic of opioid death and destruction

400,000 deaths (and counting. Many multiples of that number of lives ruined. A big part of the problem is a regulatory regime that seems not to be up to the task of policing prescription abuses by doctors (and other health care professionals working under their supervision and control). A recent article in the New York Review of Books -- "Licensed to Pill" by Rebecca Haw Allensworth -- starts with the story of a completely ineffectual Tennessee licensing board that allowed a physician involved in a criminal enterprise to push pills. It is a harrowing tale.

Granted, not all medical boards are created equal. Some have been more active than others in disciplining physicians who overprescribe. But the opioid crisis could not have reached the level it has without many boards failing in their responsibility to protect the public from unscrupulous physicians. This is occurring against a background of overregulating physicians who practiced evidence-based medicine to treat patients with medical problems other than addiction to opioids. Many doctors began avoiding pain management altogether because the regulatory environment was too hostile and the legal risk too great. Over time, state legislatures began enacting "intractable pain" laws that were intended to protect legitimate pain-control practices. Somehow, over the past two decades, the regulatory pendulum seems to have swung very farin the opposite direction.

Sunday, July 26, 2020

Artificial Intelligence-Assisted Conversational Agents in Health Care

"Clinical, Legal, and Ethical Aspects of Artificial Intelligence-Assisted Conversational Agents in Health Care": That's the title of a new, free Viewpoint article in JAMA (online only at this point).

If you've called the DMV, your cellphone service or cable tv provider, the complaint line of an on-line vendor, or other automated, disembodied telephone "presence," you know the drill:

  1. You are asked a question. 
  2. You respond. 
  3. You hear funny "sorting" noises. 
  4. You are asked another question. 
  5. Rinse and repeat. And repeat. And repeat.
Now imagine doing this when you call your doctor's office or local medical clinic.

Are there going to be problems with AI-assisted conversational agents (CA) in the health care setting? Oh, yeah. The authors of this paper list "considerations," and it's an impressive list:

  • Patient Safety
    • Who monitors the interactions between patients and CAs? Does monitoring occur 24 hours/day and 7 days/week or on another schedule?
    • Is there a rigorously tested escalation pathway to a human clinician? What scenarios have been configured to initiate the escalation pathway?
    • How well do CAs detect subtleties of language, tone, and context that may signal a risk for patient harm?
  • Scope
    • What kinds of clinical tasks should be augmented or automated by CAs and which should not? How much guidance is appropriate for CAs to provide to patients?
  • Trust and Transparency
    • Do clinicians trust CAs? Do patients? Should they?
    • To what degree do clinicians and patients need to understand the workings of CAs to use them effectively, intelligently, and ensure the appropriate amount of trust?
  • Content Decisions
    • What are the content sources for CAs that provide recommendations or guidance? 
    • Do the CArecommendations align with content sources and with supervising clinician recommendations?
  • Data Use, Privacy, and Integration
    • Who can access exchanges between patients and CAs? 
    • Who owns or controls the data? 
    • Will the data be stored or purged? 
    • If stored, for what purposes (eg, research, commercial use)?
    • Are conversations integrated into patients’ electronic health records (EHRs) or do they remain in each device? 
    • Can EHR data be integrated into CAs to better contextualize interactions?
  • Bias and Health Equity
    • Which patient groups are used to train algorithms? 
    • How representative are they? 
    • How do CAs evolve over time to reflect new user populations?
    • How do CAs handle accents and speakers of other languages? 
    • What about various health literacy levels and compliance with the Americans with Disabilities Act?
  • Third-Party Involvement
    • CAs should be protected against commercially motivated data sharing or marketing, while permitting referencing of evidence-based products and therapies. 
    • A balance is needed among commercial, technology leadership, and other incentives for CA developers and health care organizations
  • Cybersecurity
    • What if data, devices, or apps are hacked or monitored covertly and cause harm? 
    • Will CA conversation data be encrypted?
    • Are there restrictions on CA access? 
    • Is 2-factor authentication required? 
    • What are the trade-offs between sufficient security and convenient access?
  • Legal and Licensing
    • Who is accountable if CAs fail? The sponsoring health care organizations or clinicians? The CA vendors? All of the above?
    • What is the role of insurance in CA services?
    • Will there be required licenses or credentials for CAs similar to those required for clinicians?
  • Research and Development Questions
    • What approach or tone works best for patients? Human vs robotic, empathetic vs stoic, terse vs engaging, female vs male vs gender-neutral?
    • What are the most common questions or needs posed to CAs?
    • What do patients find most and least useful? What motivates patients to use CAs? What are differential discontinuation rates? Why do some patients stop using CAs? What other functions are requested, are viable, and are needed most? What are patient outcomes with CAs?
  • Governance, Testing, and Evaluation
    • How will decisions about CA selection, deployment, and use be governed? How will performance be tested and evaluated with actual patients before deployment?
    • What types of standard performance metrics and evaluations will be developed and implemented? How will desired outcomes and unanticipated or undesirable outcomes, including biases, be captured and assessed on an ongoing basis? How will these assessments be used to continue, suspend, or modify use of CAs?
    • How will hazards or anomalies be detected and addressed?
  • Supporting Innovation
    • How can development, testing, and introduction of promising boundary-pushing technologies be balanced with the need to protect patients and address the other issues listed here?
This is all pretty new stuff. The oldest source cited by the authors came out in 2014, and only a handful are specifically about CA in healthcare. This article is a good starting place for anyone who wants to catch up with what will be a fascinating innovative process.

Saturday, July 25, 2020

CDC Reverses Self on Guidelines for School Reopenings

The online N.Y. Times headline and teaser pretty much says it all:

C.D.C. Calls on Schools to Reopen, Downplaying Health Risks
    The agency’s statement followed earlier criticism from President Trump that its guidelines for reopening were too “tough.”

And ¶ 2 nails it:
The Centers for Disease Control and Prevention published the statement, along with new “resources and tools,” Thursday evening, two weeks after Mr. Trump criticized its earlier recommendations on school reopenings as “very tough and expensive.” 
Exactly how is this not a case of politics trumping (so to speak) science? The report does concede that individual communities may need to delay or cancel in-person classes, and the decision is theirs to make. Still, CDC has mishandled this issue, aided and abetted by the geniuses in the West Wing.


Primary Care on the Endangered Species List

The New Yorker's Clifford Marks has a new piece on the threat posed by COVID-19 to primary-care physician practices. As with the case of many cash-strapped hospitals whose bread-and-butter (mostly elective) procedures have dried up, primary-care physicians are being hit hard. From Marks's article:
“This is taking us down,” Jacqueline Fincher, an internist and the president of the American College of Physicians, told me. “We’re not going to have a vaccine and herd immunity for probably a year—so, is this sustainable for a year? The reality is, it’s probably not, certainly not for most small practices.” If many of them go out of business, the consequences for Americans’ health could be profound and enduring. What’s at stake is not just a pattern of health outcomes but the shape of the health-care system as a whole. The way that patients interact with their doctors and the path that American health care takes in the future may be about to shift. 

2nd Court of Appeals (Fort Worth) Rules in Tinslee Lewis Case

The 2nd Court of Appeals in Fort Worth ruled in the Tinslee Lewis case that (1) the actions of the private nonprofit pediatric hospital where pediatricians are treating Tinslee is a "state actor" and therefore (2) Tinslee's mother has pleaded a plausible due-process claim under the Constitution.

Note: The links below aren't working for me. If they are changed, I will update. Meanwhile, Thad Pope has posted the PDFs on his blog.

  • Majority opinion (pdf)
  • Dissenting opinion (pdf)
The dissenting opinion of Justice Gabriel is well worth reading. She correctly points out that the private, nonprofit pediatric hospital here was engaged in private conduct that did not give rise to any of the traditional circumstance that would turn private conduct into state action.

She also correctly takes the majority to task for writing a 150-page opinion that all but decides the merits of the constitutional due-process claim raised by Tinslee's mother. As Gabriel points out, the opinion goes far, far beyond the question presented to the court: 
The procedural posture of this case presents a very narrow question that is further limited
by the applicable abuse-of-discretion standard: Did Mother raise a bona fide issue as to whether CCMC—a private hospital—is a state actor that violated Mother’s due process rights, thereby showing a probable right to relief on her § 1983 claim? This is the operative question this court has been asked to answer; thus, our answer should be so limited. [Dissenting opinion of Justice Gabriel at 2]
Instead, the majority pretty definitively (and inappropriately) purports to decide the constitutional merits of the case, coming close -- according to Justice Gabriel -- to rendering an advisory opinion.

I may be biased. (Disclaimer: I helped to write the Texas Advance Directives Act in 1998-99, including the provision -- § 166.046 of the Tex. Health & Safety Code -- at issue in this case.) But I think Justice Gabriel nailed it. And "on the merits" of the due process argument, which the majority opinion all but decides for the benefit of the trial court on remand, I have three reactions. (1) The statute provides more due process than was ever available before TADA was enacted. (2) The claim that the statute does not provide for judicial review is correct as far as it goes, but this litigation is itself proof that judicial review is available under Texas law. (3) If more due process is required, the Legislature can fix the law with a few changes when it comes back into session in 2021.

Friday, July 24, 2020

Triage During a Pandemic and Exclusion Criteria for Drugs, Devices, or Services in Critically Short Supply

The Office of Civil Rights of US DHHS has ruled in two cases out of Pennsylvania (4/16/20) and Tennessee (6/26/20) that triage guidelines with explicit exclusion criteria violate the law. Most triage policies were written with exclusion criteria for a good reason: to provide objective, evidence-based criteria for allocating scarce medical resources. The rationale is to avoid ad hoc bedside decisions that might be discriminatory as well as to maximize the benefit of those scarce resources by directing them away from patients who are likely to die with or without them.

The message from OCR is that exclusion criteria have the potential to violate laws that OCR is tasked with enforcing federal civil rights laws, "including Section 504 of the Rehabilitation Act of 1973, Title II of the Americans with Disabilities Act, and Section 1557 of the Patient Protection and Affordable Care Act, among others."

I have been in conversations with care providers who interpret the OCR decisions to require an abandonment of exclusion criteria. I think that misinterprets the OCR position. What OCR seems to be against is a set of "blanket" exclusion criteria that apply across the board to all patients. This simply moves the decision making from the regional or hospital triage guidelines to the bedside. Wise hospital counsel should be encouraging individual departments (starting with critical care) to develop a checklist of comorbidities that need to be considered in situ -- taking into account all of the facts and circumstances of an individual patient's situation -- in making a decision to offer a scarce resource or to deny it.

Four executive orders on drug pricing = 1 campaign bragging point + no actual relief on prices

Pres. Trump issued four EOs today, ostensibly aimed at lowering drug prices, which are -- make no mistake about it -- outrageously overpriced. But other than giving his reelection campaign the ability to claim "Promise Kept," the orders really aren't going to do much. First, a quick summary from the Washington Post:

  • One of the executive orders aims to speed up the timeline for a proposal the administration introduced late last year to allow states, drug wholesalers and pharmacies to import certain drugs from Canada. Drug companies have pushed back fiercely on that proposal, arguing there is “no way to guarantee the safety of drugs that come into the country from outside the United States’ gold-standard supply chain.” The Canadian government also opposes the measure, warning that the drug supply for Canada’s 37 million residents cannot possibly fulfill the demands of the much larger U.S. market and that allowing importation would cause severe drug shortages for Canadians.
  • Another aims to tie some Medicare drugs’ prices to those paid in other countries with significantly lower list prices — a so-called “international pricing index.” The idea, which Trump called the “granddaddy of them all,” is anathema to most congressional Republicans, who see it as price fixing, as well as to the pharmaceutical industry.
  • The third proposal purports to end a widespread practice in which drugmakers give rebates to insurance middlemen in government programs such as Medicare. The administration’s goal is to channel that money to consumers instead. Trump killed the rule last year, which is favored by the drug industry, after initially embracing it when he saw projections showing it would raise Medicare premiums for many seniors.
  • The fourth proposal requires the provision of insulin and/or an EpiPen free through an existing program mandating pharmaceutical companies to provide steep discounts to thousands of hospitals and community health centers that serve large numbers of low-income patients. Drugmakers have targeted the program, known as 340B, arguing some facilities getting the discounts should not be eligible.
In addition to a built-in delay to August 25, in order to give Big Pharma a shot at them, it is unclear whether the Executive Orders have any effect other than to encourage DHHS to proceed with ongoing rulemaking proceedings under the Administrative Procedure Act. And whether the administration relies on the EOs or speeds up the administrative process, expect litigation to challenge these rules. The EOs have drawn criticism from both sides of the aisle in Congress, and even Margarida Jorge, campaign director for Lower Drug Prices Now, has dismissed them as a campaign stunt: “These Executive Orders are not about policy, they’re about politics. The only reason for President Trump’s rekindled interest in lowering drug prices is his dwindling poll numbers, and realization that our country’s senior citizens are abandoning him thanks to his bungled handling of the coronavirus crisis.”

Further evidence that this is not a serious attempt to accomplish anything concrete: As reported by Stat, "As of late Friday afternoon, the White House had not made public the text of Trump’s executive orders. And on a conference call with reporters following Trump’s announcement, health secretary Alex Azar provided little detail as to when and how each of the administration’s latest proposals would be implemented."

Teenagers & Long-Acting Reversible Contraception

The AAP's Committee on Adolescence has published its recommendations in a report -- "Long-Acting Reversible Contraception: Specific Issues for Adolescents" -- in the July 2020 issue of the journal Pediatrics. For those whose hair curls at the mention of adolescent sexuality, this report is going to set their hair on fire. It is, however, a balanced a well-reasoned report that covers the bases. A few highlights:

  • The long-acting reversible contraceptives (LARC) are one progestin subdermal implant (Norplant, I presume) and five IUDs. The report states that they "are all appropriate for use in the adolescent population."
  • "[R]ates of LARC use among sexually active adolescents remain low at 2% to 3%" (emphasis added).
  • Safety concerns, noncontraceptive uses of LARC, side effects, timing issues, and adolescents with physical and/or cognitive disabilities are discussed in detail.
I am not in a position to comment on the clinical analyses above. But the report goes on to discuss issues that are well within the scope of HealthLawBlog:
  • Consent, confidentiality, and cost concerns -- which are complex and intertwined with one another -- are discussed but remain far from resolved. It's not hard to see why these issues are a major obstacle to the use of LARC by minors, especially for purposes of contraception. For this discussion alone, the report is well worth reading.
For a quick overview, check out Contemporary Pediatrics (7/21/20).

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 preëxisting 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.

Thanks to Feedspot

Proud to be listed in Feedspot’s list of top 75 health law blogs. See #17 in the list to the right.

Friday, July 03, 2020

Heading in the wrong direction

I have known Brett Giroir since he was a pediatric critical-care fellow at Childrens Medical Center (now Children's Health) in Dallas. He is a brilliant physician and a dedicated public servant, and his advice to the country should be heeded. He has announced his intention to leave his post later this summer, and it will be a loss for the nation. (Wash. Post, 7/2/20).

American Airlines is dropping the ball big-time

I fly American Airlines all the time. I suppose when this pandemic is over, I will fly American Airlines again. But they are acting totally irresponsibly  cramming passengers into middle seats, considering the many opportunities passengers have to lower or take off their masks during flight.

Thursday, July 02, 2020

Medicaid Expansion in Oklahoma and North Carolina (sort of) -- What's Up, Texas?

From The Washington Post (6/30/20):

Oklahomans voted Tuesday to alter their state constitution to expand Medicaid over nearly a decade of opposition by Republican governors, making their state the first to widen the safety-net insurance program as the coronavirus pandemic steals jobs and health benefits. 
The expansion’s approval, by a slender margin, means that an estimated 250,000 additional Oklahoma residents will be eligible for the public insurance, including nearly 50,000 who have lost coverage as unemployment has soared this year.
And from  The Raleigh News & Observer (7/2/2020), news that the governor of North Carolina has signed a bill to create a private Medicaid managed care option sometime between now and July 2021. The devil's in the details, and Medicaid managed care is notoriously difficult to implement, but the move is being hailed as a first step toward Medicaid expansion.

Meanwhile Texas -- with the highest rate of uninsured persons in the country -- continues to freeze out 1 million people who would be covered if the state were to join 38 other states (including deep red Oklahoma) and expand eligibility requirements (with generous federal matching funds) pursuant to the Affordable Care Act. (Texas Tribune, 2/27/20).

Racism and COVID-19

It seems to be almost universally acknowledged that health disparities have been unveiled and exacerbated during this pandemic, and that the health disparities are the result of generations of disparities in economic opportunity, housing, education, and criminal justice, to name a few. "Systemic disparities" needs to be seen for what it is: a euphemism for widespread racism. This is the generating concept behind a discussion that is currently on-going at Health Affairs, the leading health policy journal in the U.S.:
COVID-19 has affected an estimated 10.7 million people, resulting in an estimated half a million deaths globally, including more than 128,000 deaths in the US. As the COVID-19 pandemic unfolds, stark disparities in infection and mortality risk along racial lines have emerged.  
Understanding and addressing racial disparities in COVID-19 requires attention to the root causes of health disparities—and, in particular, to the health impacts of racism. Racism, be it overt, structural, or environmental, is an undeniable part of the United States’ history and present.  
Writing on Health Affairs Blog, researchers and providers explore the intersections of racism, health disparities, and COVID-19.  
Dismantling health care inequities will require addressing the structural racism at the root of both COVID-19 disparities and the murders of George Floyd and other Black Americans, Alexander Bryan and coauthors write. 
Sandra Soo-Jin Lee and coauthors say the COVID-19 recovery phase presents “a rare and critical opportunity” to pursue audacious policies that dismantle structural inequities and address structural racism, including redirecting state spending on prisons to public health. 
Despite racism’s alarming impacts on health and health care, preeminent scholars and the journals that publish them, including Health Affairs, routinely fail to interrogate racism as a critical driver of racial health inequities, Rhea Boyd and coauthors write. 
Drawing lessons from Critical Race Theory, Michelle Morse and colleagues argue that the COVID-19 crisis offers a unique opportunity to mobilize US physicians to advocate for progressive social policies that dismantle structural racism and structure our society more equitably. 
Acknowledging the urgency of both health and racial justice in this moment, Sheila Foster and coauthors set forth a legal agenda to fight the health effects of racism in housing, policing, the environment, and other areas. 
As Health Affairs Editor-In-Chief Alan Weil wrote recently, the legacy of racism “is baked into our institutions, our thinking, and our policies.” Racism must be explored as a key driver of health outcomes and health disparities.  
Follow the conversation on Twitter @Health_Affairs. 

Wednesday, July 01, 2020

Public Health System in Tatters


 From Kaiser Health Network (KHN) and the Associated Press (AP):Hollowed-Out Public Health System Faces More Cuts Amid Virus
By Lauren Weber and Laura Ungar and Michelle R. Smith, The Associated Press and Hannah Recht and Anna Maria Barry-Jester 
The U.S. public health system has been starved for decades and lacks the resources necessary to confront the worst health crisis in a century. An investigation by The Associated Press and KHN has found that since 2010, spending for state public health departments has dropped by 16% per capita and for local health departments by 18%. At least 38,000 public health jobs have disappeared, leaving a skeletal workforce for what was once viewed as one of the world’s top public health systems. That has left the nation unprepared to deal with a virus that has sickened at least 2.6 million people and killed more than 126,000. 
 Here are six key takeaways from the KHN-AP investigation:
  1. Since 2010, spending for state public health departments has dropped by 16% per capita, and for local health departments by 18%. Local public health spending varies widely by county or town, even within the same state.
  2. At least 38,000 state and local public health jobs have disappeared since the 2008 recession, leaving a skeletal workforce in what was once viewed as one of the world’s top public health systems.
  3. Nearly two-thirds of Americans live in counties that spend more than twice as much on policing as they spend on non-hospital health care, which includes public health.
  4. More than three-quarters of Americans live in states that spend less than $100 per person annually on public health. Spending ranges from $32 in Louisiana to $263 in Delaware.
  5. Some public health workers earn so little that they qualify for government assistance. During the pandemic, many have found themselves disrespected, ignored or even vilified. At least 34 state and local public health leaders have announced their resignations, retired or been fired in 17 states since April.
  6. States, cities and counties whose tax revenues have declined during the current recession have begun laying off and furloughing public health staffers. At least 14 states have cut health department budgets or positions, or were actively considering such cuts in June, even as coronavirus cases surged in several states.