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

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

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

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

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

Trump and Cornyn Apparently Listen to the Same Morons

This was posted to Facebook and Twitter by President Trump's campaign: a clip of an interview Trump did Wednesday with Fox News in which he said children were “virtually immune” from the Covid-19 coronavirus. “[Children] don’t have a problem, they just don’t have a problem,” Trump said in the video as part of an argument for why schools should reopen. “It doesn’t have an impact on them. I’ve watched some doctors say they’re totally immune.” To their credit, both Facebook and Twitter took the posts down pursuant to their policy against pandemic-related misinformation. (For the record, non-pandemic misinformation is still okay.) And Twitter briefly suspended the campaign's access to Twitter.

Last month John Cornyn questioned whether children can get COVID-19 or even transmit the virus. Who are the experts these people are talking to? A call to a pediatric hospital ER would bring them up to speed. 

Or Google "children + COVID." The first link is to the CDC's page with the title "Help Stop Spread of COVID-19 in Children." Here's the first sentence on that page: "Based on available evidence, children do not appear to be at higher risk for COVID-19 than adults." It doesn't take a Ph.D. in epidemiology to parse this sentence. It doesn't say children are at no risk. It doesn't say they are at lower risk. It says that as far as we know they are at the same risk as adults. See also "Characteristics of COVID-19 in febrile infants 2 months of age and younger" in 2MinuteMedicine.com.

Misleading the public about the risk of COVID-19 is no small thing. It is a violation of a fundamental obligation our leaders have to BE USEFUL, especially during a damned pandemic. Misrepresentations are not useful. At a time when school districts across Texas and around the country are trying to figure out how to open safely, or if they can open at all, dismissing the risk to school children with phrases like "no impact" and "totally immune" is reckless and dangerous.

COVID-19 Evictions and Health

Health Affairs has posted an excellent blog piece: "When Storms Collide: Evictions, COVID-19, And Health Equity" (08/04/2020). 

The good news: Forty-three states and D.C. enacted COVID-era moratoriums on foreclosures and evictions. The federal government enacted its own moratorium.

The really bad news: The federal moratorium expired on Friday, July 31. All but nine states' moratoriums will expire by the end of October.

If the connection between having a home and health seems a little fuzzy, these four paragraphs are key (emphasis added):

"Just as the economic fallout of COVID-19 has increased the likelihood of evictions, evictions might also increase the risk of COVID-19 transmission in the short term. Households may be rendered homeless by eviction or will need to double up in shared space, resulting in diminished ability to socially distance and increased risk of COVID-19 transmission.

"However, the immediate health effects of eviction extend far beyond COVID-19 risk. For individuals and families who become homeless, especially those who become chronically homeless, the health risks have long been recognized. Mounting evidence suggests that psychosocial stress and material scarcity following an eviction may carry profound and lasting health consequences. Among adults, evictions have been associated with several interrelated conditions, including all-cause mortality, emergency department utilization, sexually transmitted infections, HIV-related treatment outcomes, drug use, exposure to violence, mental health hospitalization, suicides, and depression. Health conditions and high levels of health care costs also increase vulnerability to evictions in a manner that can perpetuate a longstanding cyclical pattern of economic and housing instability and poor health.  

"For children, experiencing evictions during the COVID-19 pandemic may cast a long shadow, impacting their health and well-being as adults. Children whose mothers experience evictions during pregnancy are more likely to be born with low birthweight or preterm than are children whose mothers are not evicted. In early childhood, evictions are associated with food insecurity and lead poisoning, which over time can compound and cause lasting deficiencies in children’s physical, mental, and emotional development.

"Evictions during COVID-19 are also likely to perpetuate and worsen racial health inequities at both individual and community levels. Structural racism drives inequities in labor and housing markets, resulting in increased risk of both COVID-19 and eviction for Black and Latinx individuals. Black and Latinx individuals are also more likely to live in communities characterized by high levels of eviction with important spillover effects on health."

 

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

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

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

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

Repeal and Replace (Redux and Redux and . . . )

The Washington Post has done a good job of summarizing the litany of promises made and then-candidate and now President Trump to replace the Affordable Care Act with the new and better national health plan. By my count, he has claimed on at least four occasions that a comprehensive plan was imminent. The time frames vary ("in two weeks," "maybe this Friday," etc.) but the brazenness of each claim does not. It's pretty clear there is no such a plan, there never was such a plan, and -- with three months left before the election -- there won't be such a plan. 

Instead, the administration nibbles away at this and that provision of the ACA, often with pushback from the federal courts. One last attempt to do away with the ACA is now in front of the Supreme Court (California v. Texas, No. 19-840), and Trump's DOJ has filed a brief in that case that argues for doing away with the ACA lock, stock, and barrel. The brief attempts to defend the indefensible -- a Fifth Circuit opinion that declared that Congress's intent when it repealed the penalty for the individual mandate was to repeal the entire ACA, although that is precisely what Congress neither did nor said.

Have IRBs Become Compliance Bureaucracies?

Professor Sarah Babb (Sociology Professor, Boston College) has a new book -- Regulating Human Research: IRBs from Peer Review to Compliance Bureaucracy (Standford Univ. P. 2020). It is reviewed well by Edward Dove (Lecturer in Health Law and Regulation, University of Edinburgh Law School) in Jotwell -- Health Law (6/9/2020). Dove's bottom line: "In sum, Babb’s book is a welcome addition to the scholarship on research ethics governance. For those interested in this area of health law, it is a must-read."

Dove's restatement of Professor Babb's thesis, based upon her experience on the B.C. IRB and extensive interviews, is this: 

IRBs have transformed since the late 1990s from committees of peer reviewers – fellow academics making ethical judgements on the basis of scholarly expertise, but paying little attention to the letter of the regulations—to “compliance bureaucracies,” wherein full-time IRB administrators do much of the heavy lifting, often behind the scenes. Babb defines compliance bureaucracy as “a nongovernmental office that uses skilled staff—compliance professionals—to interpret, apply, and oversee adherence to government rules” (P. 5.) In this transformed governance environment, faculty board members still participate in terms of voting on whether to approve a project or expedited research protocols, but their work is simply not possible without IRB staff. This transformation, Babb argues, was due primarily to the growth in IRB scrutiny in the late 1990s by the Office for Human Research Protections (OHRP), which is situated in the federal Department of Health and Human Services. In turn, there was consequential growth in funding from research institutions to invest in IRB administration to better manage the risk associated with OHRP audits and enforcement actions. IRBs today are led not by peer reviewers, then, but rather a professionalized service of research administrators who know the nuances of IRB management. 

Based upon my experience as a member of four IRBs over the past 35 years, Professor Dove 's thesis may be based upon a false dichotomy. While The Common Rule, which is based upon the Belmont Report, is indeed a thick (in all senses of the word) document that reflects the bureaucratic mind at work, much of this bureaucratese emanates from ethical concerns that are central to the IRB's mission. When are a research program's risks sufficiently low that the IRB can pass on the proposal without any review? Or with a mere "expedited review"? Protection of research subjects depends upon the answers to these questions, as well as others: 

• Does the research protocol focus on minors? Prisoners? Other "vulnerable" subjects? 
• If so, what additional safeguards need to be built into the review process to help ensure the subjects are treated ethically? 
• Is there some human research that just shouldn't be done? 
• Are the fundamental human rights of research subjects sufficiently protected by the design of the research and the disclosure of risks?

The bureaucratic Common Rule, and the professional staff that guides IRB members through the compliance process, is intended to provide consistent answers to questions such as these. Our experience in the United States during much of the 20th century gives little reason to believe researchers should be left to decide these questions for themselves. 

Dartmouth Atlas Project

This is a great source of data on all manner of health care topics: 

• COVID-19 data -- maps! (some of them time-lapsed) -- up-to-date within a few days
  
  
• Data through 2018 (I guess 2019 is still being processed)
• Medicare reimbursement, mortality, primary care access and quality measures, etc.
• Neonatal intensive care

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?

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

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.

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.

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.

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.

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).

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?