Advance Directives: 1. Do They Work? 2. Is There Something Better?

Answers:

1. Not particularly well, except in the few cases where they do.

2. Talking is an essential, and often overlooked, aspect of advance care planning. In my talks to community groups, my advice is this: If you were forced to choose between executing the documents (e.g., living will, medical power of attorney) and discussing your values and preferences with family and physicians, you should choose the latter. Checking off a few boxes and affixing your signature to a document is seldom the panacea we think it will be. Of course, it's a false choice and you can do both.

3. Essential reading: (a) An essay in the Jan. 3 New York Times by physician Daniela Lamas. (2) A balanced and fair piece in Kaiser Health News this morning (reprinted with permission):

A New Paradigm Is Needed: Top Experts Question the Value of Advance Care Planning

Judith Graham January 6, 2022

For decades, Americans have been urged to fill out documents specifying their end-of-life wishes before becoming terminally ill — living wills, do-not-resuscitate orders, and other written materials expressing treatment preferences.

Now, a group of prominent experts is saying those efforts should stop because they haven’t improved end-of-life care.

“Decades of research demonstrate advance care planning doesn’t work. We need a new paradigm,” said Dr. R. Sean Morrison, chair of geriatrics and palliative medicine at the Icahn School of Medicine at Mount Sinai in New York and a co-author of a recent opinion piece advancing this argument in JAMA.

“A great deal of time, effort, money, blood, sweat and tears have gone into increasing the prevalence of advance care planning, but the evidence is clear: It doesn’t achieve the results that we hoped it would,” said Dr. Diane Meier, founder of the Center to Advance Palliative Care, a professor at Mount Sinai and co-author of the opinion piece. Notably, advance care planning has not been shown to ensure that people receive care consistent with their stated preferences — a major objective.

“We’re saying stop trying to anticipate the care you might want in hypothetical future scenarios,” said Dr. James Tulsky, who is chair of the department of psychosocial oncology and palliative care at the Dana-Farber Cancer Institute in Boston and collaborated on the article. “Many highly educated people think documents prepared years in advance will protect them if they become incapacitated. They won’t.”

The reasons are varied and documented in dozens of research studies: People’s preferences change as their health status shifts; forms offer vague and sometimes conflicting goals for end-of-life care; families, surrogates and clinicians often disagree with a patient’s stated preferences; documents aren’t readily available when decisions need to be made; and services that could support a patient’s wishes — such as receiving treatment at home — simply aren’t available.

But this critique of advance care planning is highly controversial and has received considerable pushback.

Advance care planning has evolved significantly in the past decade and the focus today is on conversations between patients and clinicians about patients’ goals and values, not about completing documents, said Dr. Rebecca Sudore, a professor of geriatrics and director of the Innovation and Implementation Center in Aging and Palliative Care at the University of California-San Francisco. This progress shouldn’t be discounted, she said.

Also, anticipating what people want at the end of their lives is no longer the primary objective. Instead, helping people make complicated decisions when they become seriously ill has become an increasingly important priority.

When people with serious illnesses have conversations of this kind, “our research shows they experience less anxiety, more control over their care, are better prepared for the future, and are better able to communicate with their families and clinicians,” said Dr. Jo Paladino, associate director of research and implementation for the Serious Illness Care Program at Ariadne Labs, a research partnership between Harvard and Brigham and Women’s Hospital in Boston.

Advance care planning “may not be helpful for making specific treatment decisions or guiding future care for most of us, but it can bring us peace of mind and help prepare us for making those decisions when the time comes,” said Dr. J. Randall Curtis, 61, director of the Cambia Palliative Care Center of Excellence at the University of Washington.

Curtis and I communicated by email because he can no longer speak easily after being diagnosed with amyotrophic lateral sclerosis, an incurable neurologic condition, early in 2021. Since his diagnosis, Curtis has had numerous conversations about his goals, values and wishes for the future with his wife and palliative care specialists.

“I have not made very many specific decisions yet, but I feel like these discussions bring me comfort and prepare me for making decisions later,” he told me. Assessments of advance care planning’s effectiveness should take into account these deeply meaningful “unmeasurable benefits,” Curtis wrote recently in JAMA in a piece about his experiences.

The emphasis on documenting end-of-life wishes dates to a seminal legal case, Cruzan v. Director, Missouri Department of Health, decided by the Supreme Court in June 1990. Nancy Cruzan was 25 when her car skidded off a highway and she sustained a severe brain injury that left her permanently unconscious. After several years, her parents petitioned to have her feeding tube removed. The hospital refused. In a 5-4 decision, the Supreme Court upheld the hospital’s right to do so, citing the need for “clear and convincing evidence” of an incapacitated person’s wishes.

Later that year, Congress passed the Patient Self-Determination Act, which requires hospitals, nursing homes, home health agencies, health maintenance organizations and hospices to ask whether a person has a written “advance directive” and, if so, to follow those directives to the extent possible. These documents are meant to go into effect when someone is terminally ill and has lost the capacity to make decisions.

But too often this became a “check-box” exercise, unaccompanied by in-depth discussions about a patient’s prognosis, the ways that future medical decisions might affect a patient’s quality of life, and without a realistic plan for implementing a patient’s wishes, said Meier, of Mount Sinai.

She noted that only 37% of adults have completed written advance directives — in her view, a sign of uncertainty about their value.

Other problems can compromise the usefulness of these documents. A patient’s preferences may be inconsistent or difficult to apply in real-life situations, leaving medical providers without clear guidance, said Dr. Scott Halpern, a professor at the University of Pennsylvania Perelman School of Medicine who studies end-of-life and palliative care.

For instance, an older woman may indicate she wants to live as long as possible and yet also avoid pain and suffering. Or an older man may state a clear preference for refusing mechanical ventilation but leave open the question of whether other types of breathing support are acceptable.

“Rather than asking patients to make decisions about hypothetical scenarios in the future, we should be focused on helping them make difficult decisions in the moment,” when actual medical circumstances require attention, said Morrison, of Mount Sinai.

Also, determining when the end of life is at hand and when treatment might postpone that eventuality can be difficult.

Morrison spoke of his alarm early in the pandemic when older adults with covid-19 would go to emergency rooms and medical providers would implement their advance directives (for instance, no CPR or mechanical ventilation) because of an assumption that the virus was “universally fatal” to seniors. He said he and his colleagues witnessed this happen repeatedly.

“What didn’t happen was an informed conversation about the likely outcome of developing covid and the possibilities of recovery,” even though most older adults ended up surviving, he said.

For all the controversy over written directives, there is strong support among experts for another component of advance care planning — naming a health care surrogate or proxy to make decisions on your behalf should you become incapacitated. Typically, this involves filling out a health care power-of-attorney form.

“This won’t always be your spouse or your child or another family member: It should be someone you trust to do the right thing for you in difficult circumstances,” said Tulsky, who co-chairs a roundtable on care for people with serious illnesses for the National Academies of Sciences, Engineering and Medicine.

“Talk to your surrogate about what matters most to you,” he urged, and update that person whenever your circumstances or preferences change.

Most people want their surrogates to be able to respond to unforeseen circumstances and have leeway in decision-making while respecting their core goals and values, Sudore said.

Among tools that can help patients and families are Sudore’s Prepare for Your Care program; materials from the Conversation Project, Respecting Choices and Caring Conversations; and videos about health care decisions at ACP Decisions.

The Centers for Disease Control and Prevention also has a comprehensive list of resources.

We’re eager to hear from readers about questions you’d like answered, problems you’ve been having with your care and advice you need in dealing with the health care system. Visit khn.org/columnists to submit your requests or tips.

Subscribe to KHN's free Morning Briefing.

Bad news for transgender kids: Genecis program is no more

A story in the Dallas Morning News (Dec. 6) by reporters Marin Wolf and Lauren McGaughy provides extremely useful details and context for the decision to shutter the Genecis ("Gender Education and Care, Interdisciplinary Support") program that was jointly run by UT-Southwestern Medical Center and Children's Health. Transgender and gender-diverse minors will now have a harder time than ever getting "health care, including mental health counseling and hormone therapy":

Last month, the hospitals said they would no longer be taking on new patients for hormone or puberty suppression therapy. They also removed all online references to the program, saying the care previously provided through the program will now be managed and coordinated through different specialty departments at the two hospitals.

According to the DMN article, the Genecis clinic was "the only program specifically for transgender children living in Texas and its surrounding states."

UT-Southwestern hasn't commented on the decision to shutter Genecis, but others haven't been so reticent. The article quotes Steve Rosenthal, medical director of the child and adolescent gender center for the University of California, San Francisco Benioff Children’s Hospitals: “It almost goes without saying that this seems inequitable and flatly wrong. Where are these patients going to go? And what’s the reason you’re not going to do it anymore?”

Texas and Mississippi Abortion Laws: A "Lack of Empathy and Hubris"

SCOTUS holds oral argument this morning in the Mississippi case that involves a law that bans abortions after 15 weeks of pregnancy, and the Court has granted review of SB 8, the Texas law that effectively bans abortions after 6  weeks. Prof. Michele Goodwin's guest essay in yesterday's New York Times is an apparently much-needed reminder just how stunted, myopic, and lacking in moral imagination is the world view of legislators in states like Michigan and Texas. Prof. Goodwin describes being 12 years old and pregnant after her father's repeated sexual assaults. She says the abortion she obtained saved her life. And for the record, SB 8 contains no exception for rape or incest.

Billions (and Chevron?) at Stake in SCOTUS's Medicaid Case

It's a health-law-heavy docket this year over at SCOTUS. Next up for oral argument (Nov. 29) is Becerra v. Empire Health Foundation (No. 20-1312; SCOTUSBlog summary). The case involves the somewhat mind-numbing question of how to calculate the "Medicare fraction," one of two ratios that, when combined, determine whether a hospital is entitled to supplemental Medicare reimbursement adjustments  as a Disproportionate Share Hospital (DSH) -- that is, a hospital that provides care to a large number of low-income patients. A 2004 change in the calculation of the Medicare fraction resulted in higher DSH payments to some hospitals and lower payments to others. The other fraction is the "Medicaid fraction."

This is a statutory-interpretation question: do the phrases “entitled to benefits under [Medicare] part A” [42 U.S.C. § 1395ww(d)(5)(f )(vi)(I)] and "eligible for medical assistance under [Medicaid]" [42 U.S.C. § 1395ww(d)(5)(f)(vi)(II)]. Professor Alison K. Hoffman does a nice job unpacking the issues over at the Commonwealth Fund's blog.

HHS's merits brief makes a strong pitch for Chevron deference. With the conservatives on the Court grousing about Chevron for the past decade or two, it will be interesting to see how far the government is pushed on that point during oral argument.

SCOTUS Grants Cert. in Three Health Law Cases

From SCOTUSBlog (with additional cites and links):

Ruan and Kahn

In Ruan v. United States (20-1410; opinion below) and Kahn v. United States (21-5261; opinion below) the justices agreed to decide whether a doctor who has the authority to prescribe controlled substances can be convicted for unlawful distribution of those drugs when he reasonably believed that his prescriptions fell within professional norms. The question came to the court in April in the case of Xiulu Ruan, an Alabama doctor who specialized in pain management. The government contended that the doctor had prescribed medicine outside the standard of care – for example, prescribing opioids when physical therapy or a detox facility would have been more appropriate. Ruan countered that he had always acted in good faith, making individual assessments of what each patient needed.

The second case came to the court in July. The doctor in that case, Shakeel Kahn, argued that he did not know that his patients were abusing or selling the medicine that he prescribed for them — primarily opioids. He was sentenced to 25 years in prison. The justices granted both cases and consolidated them for one hour of oral argument.

Marietta Memorial Hospital (20-1641; opinion below)  

The justices also will weigh in on a dispute filed by DaVita, the country’s largest dialysis provider, over the interpretation of the Medicare Secondary Payer Act, which bars health plans from considering whether an individual is eligible for Medicare benefits because they suffer from kidney failure. A health plan also cannot provide different benefits to such individuals than they provide to others covered by the plan. After the U.S. Court of Appeals for the 6th Circuit ruled that the Marietta Memorial Hospital health plan discriminates against patients with kidney failure by providing less coverage for dialysis, the plan came to the Supreme Court, which granted its petition for review on Friday.

Vaccines and Religious Exemptions

Prof. Wendy Parmet had an excellent guest column in the NY Times on 10/31 concerning religious exemptions from vaccination mandates during a pandemic. She points out that the Supreme Court has been pretty consistent since 1905 that medical exemptions -- based upon legitimate medical evaluations -- are legitimate (and may be required by the Constitution -- I think they are), but that until the past year, the Court was clear that religious exemptions are not required by the Constitution. A handful of cases from the Court's "shadow docket" suggest majority support for religious exemptions. As a public-health scholar, Parmet sees this trend as not only worrying but potentially deadly.

Friday's decision to allow Maine's vaccination mandate to remain in effect was not as hopeful a sign as one might expect. Parmet explained that three justices supported a religious exemption as a First Amendment requirement, which turns a century of public-health rulings on their head. Two other conservatives voted with the liberals on process grounds (another shadow docket decision), which suggests there might be five votes for a constitutionally required religious exemption from vaccination mandates. 

How to Save a Quarter-Trillion Dollars a Year in Health Care (Hint: It's Not as Easy as It Sounds)

The consulting firm McKinsey & Co. has a new report (full, executive summary) that identifies the sorts of administrative simplification that together could save the health care system $265 billion annually. As illustrated by a Perspectives piece in the October 20 issue of JAMA, that sum "would be more than 3 times the combined 2019 budgets of the National Institutes of Health ($39 billion), the Health Resources and Services Administration ($12 billion), the Substance Abuse and Mental Health Services Administration ($6 billion), and the Centers for Disease Control and Prevention ($12 billon)." As Everett Dirksen and Charlie Halleck might have said back in the day, a quarter-trillion here and a quarter-trillion there, and pretty soon you're talking about real money.

So, if administrative simplification is such a good idea and the benefits are so patently obvious, why has it not happened already? McKinsey identifies the types of changes that would need to be made. Some are changes that could happen within individual organizations (assuming regulators and private accreditation agencies were on-board). Other changes would need to be implemented between organizations (same assumptions and assuming public and private antitrust enforcement would permit it). And, finally, there are market failures that will require "seismic" interventions at the industry level -- "including the necessary decision-makers and influencers from both the public and private sectors for a given intervention" (emphasis added).

By comparison, the interventions introduced by the Affordable Care Act look downright modest. But the question remains: Can we really afford to continue to pay one trillion dollars every four years for nonbeneficial administrative waste?

Teenaged and pregnant in Texas after SB8

In yesterday's N.Y. Times, columnist Michelle Goldberg has a powerful up-ed describing the situation created by SB 8 -- Texas's so-called "heartbeat bill" -- for pregnant minors in Texas who seek an abortion. The situation is beyond grim. 

On top of totally unconstitutional legal and practical barriers that all Texas women face (until a federal judge enters a TRO, hopefully soon): imagine being 16, finding out you're pregnant, and then (unless your parents are on-board) needing to deal with the mechanics of a judicial-bypass process while the clock is ticking, all before detection of a so-called fetal (not really a fetus) heartbeat (not really a heartbeat, more like electrical signals from the precursor to the heart). Hard to imagine. But let's face it, moral imagination is not a strong suit for the GOP legislators (and AG and Governor) who dreamed up this scheme.

Unvaccinated patients added $5.7 billion to June-August healthcare expenditures

It's not surprising, but it is still staggering. As reported by Health Affairs: "A surge in COVID-19 hospitalizations among people who have not been vaccinated in August is adding billions of dollars in preventable costs to the nation’s health-care system. The analysis estimates that the preventable costs of treating unvaccinated patients in the hospitals now stand at an estimated $5.7 billion." The full Peterson-KFF report is here.

The latest surge: It's real and it was avoidable

Paul Krugman's N.Y. Times newsletter today (not posted yet, but it should be soon) has two altogether unsurprising but very revealing graphs that neatly summarize where we are with the latest surge in COVID-related deaths:

The delta variant is everywhere, but not every country is experiencing the surge that we are. Something other than infectivity is at work here. As Krugman points out, "the systematic refusal to get vaccinated, refusal to wear masks, etc., is very clearly tied to the unique way that common-sense public health measures have been caught up in the culture war. . . . According to a recent NBC poll, 91 percent of Biden voters have been vaccinated but only 50 percent of Trump voters. Or look at death tolls: Blue states look more like Canada or Germany than like Florida or Texas".

Can anyone seriously doubt that the non-policies of Govs. DeSantis and Abbott are unnecessarily killing people in their states?

DFW's COVID-19 Hospitalizations Have Tripled in the Past Month

This is today's dispatch from Steve Love, the CEO of the Dallas-Fort Worth Hospital Council:

We have 1,126 COVID-19 patients in our hospitals in TSA-E which is an increase from 1046 yesterday and we are sorry to see this number spike over 1,100 COVID-19 hospitalized patients. This represents 8.28 percent of bed capacity and 23.91 percent of adult ICU patients which means we are approaching one in four of our adult ICU patients has COVID-19. Tarrant county has 401, Dallas 336, Collin 162, Denton 53, Hunt 28, Grayson 30 and Rockwall 35. As we have said before, the majority of the patients are not vaccinated. As a point of reference, we had 387 COVID-19 patients in the hospitals on June 25 so as you can tell, our hospitalizations have increased significantly in 30 days. Currently, we have 118 available adult staffed ICU beds . We have 135 adults on ventilators.

As nearly as anyone can tell, with the exception of a relative handful of "breakthrough" infections among the fully vaccinated (to be expected, because no vaccine is 100% effective), this increase is almost entirely among the unvaccinated population. 

I am not inclined to be judgmental when it comes to choices people make for themselves, but refusing vaccination puts family and loved ones and the rest of the community at increased risk, and as the above numbers indicate, stress the critical care capacity to the detriment of other patients who also need treatment. Without a truly compelling reason (e.g., a validated medical reason) to skip vaccinations, failing to be vaccinated at this point is simply incomprehensible. And compelling reasons do not include cost (it's free), inconvenience (shots are available everywhere), or doubts about efficacy and safety (both of which have been amply demonstrated by the millions of individuals who have been vaccinated after the FDA granted emergency approval). 

Massive HHS settlements & judgments in 2020 for false and fraudulent claims

The gory details are contained in a report of the Inspector General released this month. Becker's Hospital CFO Report has a summary (emphasis added): 

HHS' watchdog agency, the Office of Inspector General, recovered $3.1 billion in false and fraudulent claims in 2020, according to a July report. 

OIG won or negotiated more than $1.8 billion in judgments and settlements in 2020, which, combined with efforts from previous years, led to 2020's $3.1 billion recovery. Of the $3.1 billion, $2.1 billion was transferred to the Medicare Trust Fund, and $128.2 million in Medicaid funds was transferred to the Treasury. 

A total of 440 people were convicted of healthcare fraud and related crimes in 2020, the OIG said. The Department of Justice opened 1,148 healthcare fraud investigations in 2020, according to the report.

Even after teaching health law (including fraud and abuse) for 33 years, I am still gobsmacked by the amount of thievery and other forms of law-breaking that goes on in the healthcare industry. I am reminded of Willie Sutton's reported response to a reporter's question why he robbed banks: "Because that's where the money is."  The health care sector represents 18% of GDP, more than defense and all levels of education combined. Yep, that's where the money is all right.

 

Atul Gawande Nominated for Global Health Role at USAID

Good news for fans of Atul Gawande (books: Amazon author's page) who will be pleased to know Pres. Biden has nominated the author/surgeon/health policy wonk to be  assistant administrator of the United States Agency for International Development's Bureau for Global Health. One of the hottest pandemic-related issues confronting the developed world is how to meet the need for vaccines and vaccination resources (human and otherwise) in the 90% of the world that is less than 10% immunized. It's an enormous challenge and one that falls squarely within Dr. Gawande's portfolio (assuming Senate confirmation).

The High Costs of Non-Beneficial Treatments in the ICU

Thad Pope has a useful post on this subject. There are direct medical costs (estimated at $2,700/day (Ottawa study) to $4,000/day (UCLA study)), but equally if not more concerning "may be (a) the opportunity cost when other patients are denied ICU care, (b) moral distress of the nursing staff, and (c) suffering inflicted on the patient." 

None of this seems to matter to the legislators in Texas who try, every legislative session, to gut the provisions of the Texas Advance Directives Act that were added in 1999 to deal with disputes over medically inappropriate treatment. The provisions are at Tex. Health & Safety Code § 166.046. The purpose of the law was to provide a nonjudicial mechanism for resolving these disputes. The key provision is in subsection (d), which -- after reasonable efforts over a 10-day period to find a provider willing to provide the treatment requested by the surrogate decision-maker fail to identify a provider willing to accept transfer of the patient -- permits the disputed treatment to be withheld or withdrawn.

The objectors in the legislature want to replace that 10-day process with a provision that requires the health care providers to "treat until transfer." This benign-sounding idea would mean that, in the vast majority of cases in which no transferee provider can be found, medically inappropriate treatment must be provided until death occurs, which may be months or even years later. A current example is the Tinslee Lewis case in Fort Worth, which has been in litigation for over two years. According to a motion filed by defendant Cook Children's Hospital, 

a review of Tinslee’s case was initiated by third-party administrator Aetna’s Special Investigative Unit, which has requested all of Tinslee’s records. The Special Investigative Unit’s mandate under Medicaid regulations is to investigate “waste, abuse, and fraud,” the motion says.

“In Cook Children’s experience, such reviews are often precursors to efforts to deny payment or even claw back funds previously paid,” the motion said.

Happy Independence Day (almost)

Today (July 5th) is the day of the federal holiday celebrating the Second Continental Congress's adoption of the text of the Declaration of Independence on July 4th, which set out the argument for independence from "the state of Great Britain," which independence was actually declared by vote of the same Congress on July 2nd with the adoption of  the Lee Resolution (a/k/a the Resolution of Independence) with New York abstaining. My best friend from law school, Frank, insists that July 2 is or at least ought to be the true Independence Day, and in that belief he is joined by many others, not least of whom was John Adams, who wrote to his wife Abigail on July 3: "The second day of July, 1776, will be the most memorable epoch in the history of America. I am apt to believe that it will be celebrated by succeeding generations as the great anniversary festival."

For 32 years, NPR staff (news readers, correspondents, commentators) have read the Declaration of Independence during the Morning Edition show closest to the 4th of July. Pretty much in Frank's honor (and out of respect to John Adams), this year the date for the reading fell on Friday, the 2nd of July. For many years, the readers included Bob Edwards, Red Barber, and "Kim Williams of Missoula, Montana," whose distinctive voices and personalities were represented long after their departure from NPR (Bob) and the land of the living (Red and Kim). 

This year was a little different, with a disclaimer that noted the hypocrisy of drafters and signers: "It famously declares 'that all men are created equal' even though women, enslaved people and Indigenous Americans were not held as equal at the time." So the Declaration remains an aspirational document for a country this is still reckoning with the long-term effects of its past. 

It remains, for all its limitations, the founding document that added philosophy and history to the political message of the Lee Resolution. It provided an outline for large parts of the original Constitution and the Bill of Rights. And for all sorts of reasons it is well worth reading at least once a year to remind us not only of the founders who "mutually pledge[d] to each other [their] Lives, [their] Fortunes and [their] sacred Honor" but also of the work left to be done to achieve its goals.

New Book: A political history of the Affordable Care Act

There is one scholar whose knowledge and understanding of the PPACA is second to none: Tim Jost. His book review of Jonathan Cohn's The Ten-Year War in the June 2021 issue of Health Affairs has sent me directly to the bookstore to buy my copy. Here are two key excerpts:

One of the main messages of The Ten Year War, Jonathan Cohn’s excellent history of the Affordable Care Act (ACA), appears in the final chapter: “The Affordable Care Act is a highly flawed, distressingly compromised, woefully incomplete attempt to establish a basic right that already exists in every other developed nation. It is also the most ambitious and significant piece of domestic legislation to pass in half a century—a big step in the direction of a more perfect union and a more humane one as well.”

Cohn has produced the most readable and comprehensive history of the ACA yet available—a must-read for anyone who wants to understand this history.

Looking forward to reading (and reviewing) this book! 

SCOTUS grants review in 4 health law cases

The 2021 Term will be a lively one for health lawyers in light of yesterday's grant of four petitions for review (two Medicare cases, one Medicaid case, and a PPACA case that doesn't involve a challenge to the constitutionality of the law):

• American Hospital Association v. Becerra, No. 20-1114, a challenge to a Department of Health and Human Services rule that cut Medicare reimbursement rates for prescription drugs for hospitals that participate in a program for underserved communities. The U.S. Court of Appeals for the District of Columbia Circuit ruled that the reimbursement cut was a reasonable interpretation of the Medicare statute; the justices on Friday agreed to weigh in on whether that deference is appropriate in this case. The court also asked both sides to discuss whether the challenge is barred by a provision of federal law that limits judicial review of certain Medicare-related calculations.
• Gallardo v. Marstiller, No. 20-1263, in which the court will decide whether a state Medicaid program can get reimbursed for past medical expenses that it has paid by taking money from a settlement or jury award that is intended to compensate for future expenses.
• Becerra v. Empire Health Foundation, No. 20-1312, a dispute over how to calculate additional payments under the federal Medicare program for hospitals with a large number of low-income patients.
• CVS Pharmacy v. Doe, No. 20-1374, in which the court will consider whether the Rehabilitation Act, which bars discrimination on the basis of disability by any program or activity receiving federal funding, and the Affordable Care Act allow plaintiffs to bring claims alleging that a policy or practice disproportionately affects people with disabilities.

CMS Proposes Final Interim Rule to Implement the No Surprises Act

Surprise medical bills are horrific events for patients and their families, throw insurance underwriting into disarray, and create or reinforce barriers to entry into the medical-industrial complex. The federal No Surprises Act (a relatively small part (32 pages) of H.R. 133, the 2,124-page Omnibus Reconciliation Act of 2021) was supposed to address the problem, but the new law needed a regulation to implement it. That rule -- in the form of a 411-page "interim final rule" with a request for comments -- dropped today.  CMS has provided a reasonably helpful fact sheet if you don't have time to wade through the rule's preamble. The rule is supposed to have an effective date of January 1, 2022, but don't be surprised if that date gets bumped. This rule will undoubtedly attract a ton of comments. The comment period closes 60 days after publication of the interim final rule in the Federal Register.

Grand Jury Declines to Indict Houston Doctor Accused of Stealing COVID Vaccine

As reported by The NY Times, The Associated Press, KHOU-TV, the Houston Chronicle, and Forbes, Dr. Hasan Gokal will not be indicted by the Harris County grand jury on charges that he stole vials of COVID-19 vaccine for family and friends. His defense consisted of the following:

1. The doses were about to be destroyed due to nonuse and aging.
2. It was his duty as a physician -- and one employed by the Harris County health department -- to maximize health and protect life.
3. Allowing the doses to be destroyed would have been a violation of his professional duties and sacred oath.

In short: "In an interview with The Associated Press, Gokal, 48, said when he was confronted with the possibility that a life saving vaccine could be lost, he made the decision to find eligible people late at night who could be given the expiring doses."

Although Harris County Public Health fired Gokal over the incident, the defense worked with the Texas Medical Board, which dismissed charges against him, as well as with a Harris County Court-at-Law Judge, who dismissed the theft charges against him. Prosecutors then turned to the grand jury, which rejected the case on June 30.

I'm searching for the right analogy to capture what was wrong with the prosecutor's case. Is this an "inverse Jean Valjean" situation, where the loaf of bread (vials of vaccine) would have been stolen not to feed Gokal's family (though his wife did get one of the doses) but the family of others? 

It's difficult to criticize Gokal's action if [1] the vaccine was going to be destroyed unless he acted, [2] noöne would be harmed if he did act (so this is not a variation on The Trolley Problem), [3] 9 otherwise at-risk individuals acquired some protection from infection at a time (late December 2020) when COVID-19 was still running rampant, and [4] Gokal himself wasn't responsible for creating the dilemma in the first place. 

Hospitals Now Employ 50% of all U.S. Physicians

Once upon a time, it was a virtually universal no-no for a corporation or other lay entity or person to own, or even have an ownership interest in, a physician's practice. There were various rationales for the so-called "corporate practice prohibition," including:

• only natural persons could meet the requirements for medical licensure,which ruled out corporations, trusts, partnerships, etc.
• a corporate or other lay owner created at least the potential for dual loyalties, putting doctors in the impossible position of choosing between his or her patient and corporate overlords; and
• allowing non-physicians to get in on a medical practice's action represented an unseemly commercialization of medical practice.

Not all states bought into the corporate practice prohibition. Some did, at least formally, but in many states the prohibition was under-enforced, to say the least. By the 1990s about a dozen states still recognized and enforced the prohibition, some with more or less enthusiasm than others.

Over time a couple of things changed. First and foremost, the three rationales for the prohibition -- always somewhat sketchy -- became increasingly suspect.

Second, state legislatures, and occasionally state supreme courts, created exceptions to the prohibition, allowing corporate ownership, for example, by nonprofit hospitals or by staff-model HMOs. Texas -- often cited as having one of the strongest corporate practice prohibition doctrines, even created the "5.01(a)" workaround, now codified at Texas Occupations Code §§ 162.001-.006. This law allows for the creation of a "certified nonprofit organization" -- subject to a plethora of requirements and limitations -- created to employ physicians to carry on the practice of medicine. And pursuant to Texas's Business Organizations Code, nonprofit corporations may have one or more "members" [§§ 22.151 et seq.]. This opened the door for certified nonprofits to have as their sole member a hospital or health care system that, in turn, provided much of the working capital and assets for the medical practice. Call it "virtual ownership" of medical practices.

As it turned out, many of the single-member 501(a)'s weren't very good investments for the hospitals, not even for those hospitals who were willing to lose some money as an investment in future referrals by the doctors who were employed by the 5.01(a). Not to mention that intentionally losing money in support of a medical practice that employs physicians who refer patients to the hospital raises questions under federal and state fraud and abuse laws and (if the hospital is tax-exempt) under § 501(c)(3) of the Internal Revenue Code (see IRS Gen. Couns. Mem. 39,862: "We question whether the Service should ever recognize enhancing a hospital's market share vis-a-vis other providers, in and of itself, as furthering a charitable purpose").

All of this is to say, today's news (Becker's Hospital CFO Report, 6/29/21) that hospitals employ 50% of U.S. physicians and that percentage continues to increase at a fast clip is further evidence of the break from past understandings of the corporate practice prohibition. May it rest in peace.

SCOTUS Rejects Red States' Challenge to ACA

In a 7-2 decision (majority opinion by Justice Breyer, dissent by Justice Alito), the Supreme Court today tossed out the suit filed by Texas plus other states and two individuals, not on the merits but for lack of standing. 

Basic standing analysis requires a direct harm to the plaintiff that is [1] traceable to an unlawful action or provision of law and is [2] redressable if a court were to give the plaintiff the relief it seeks. The majority opinion concluded that -- even if it agreed that the individual mandate lost its constitutional moorings when in 2017 Congress zeroed out the tax for noncompliance -- the only burdens (i.e., "harms") the plaintiffs could point to were the costs of complying with the presumptively lawful parts of the ACA that remained on the books. It is hard to see how future plaintiffs would be able to overcome the standing hurdle created by this opinion.

As the dissent points out, 

Today’s decision is the third installment in our epic Affordable Care Act trilogy, and it follows the same pattern as installments one and two. In all three episodes, with the Affordable Care Act facing a serious threat, the Court has pulled off an improbable rescue.

None of this is to say that challenges to the ACA on other grounds can't or won't be brought, but opponents are running out of constitutional theories. Indeed, the Court has already granted cert. in two ACA cases for the 2021 Term (Nos. 20-429 and 20-539), and there are 6 more ACA cases listed for the Court's next conference.  See Nos. 20-219, 20-1162, 20-1200, 20-1374, 20-1432, and 20-1536. All 8 cases are statutory-interpretation cases and none challenge the constitutionality of the ACA or any part of it. 

Surprise billing: It's still a thing

From the Kaiser Family Foundation's news service:

In Alleged Health Care ‘Money Grab,’ Nation’s Largest Hospital Chain Cashes In on Trauma Centers

After falling from a ladder and cutting his arm, Ed Knight said, he found himself at Richmond, Virginia’s Chippenham Hospital surrounded by nearly a dozen doctors, nurses and technicians — its crack “trauma team” charged with saving the most badly hurt victims of accidents and assaults. But Knight’s wound, while requiring about 30 stitches, wasn’t life-threatening. Hospital records called it “mild.” Nevertheless, Chippenham, owned by for-profit chain HCA Healthcare, included a $17,000 trauma team “activation” fee on Knight’s bill, which totaled $52,238 and included three CT scans billed at $14,000. His care should have cost closer to $3,500 total, according to a claims consultant which analyzed the charges for KHN. (KHN, Richmond Times-Dispatch)

The federal No Surprises Act (signed Dec. 27, 2020) was supposed to curb billing abuses. The KHN link has an exhaustive analysis of the problem, but it doesn't say whether Mr. Knight's trip to the ER was before or after the effective date of the new law. (And the Richmond Times-Dispatch link didn't work for me; I've included it here in case it works for you.) 

 

Public Health: The Neglected Infrastructure Crisis

Dr. Anne Schuchat's June 10th NY Times op-ed is a must-read for any and all who want to understand the importance of investment in public health resources as part of our renewed interest in rebuilding the nation's infrastructure. Published upon the eve of her retirement as second-in-command at the CDC after 33 years of public service. It's a great essay that celebrates public service as a career path. It's also a scary-as-hell depiction of the sorry state of public health in this country. Here's an example: 

The Covid-19 pandemic is not the first time the U.S. public health system has had to surge well beyond its capacity, but with the worst pandemic in a century and, initially, a heavily partisan political context, the virus collided with a system suffering from decades of underinvestment. A recent report from the National Academy of Medicine revealed that state and local public health departments have lost an estimated 66,000 jobs since around 2008. [emphasis added]

We cannot count on a once-in-a-century cycle of pandemics. There is every reason to believe that all countries -- the more economically developed chief among them -- are susceptible to increasingly frequent outbreaks. 

It's time to wake up and get prepared for when not if. 

SCOTUS still has to decide a big ACA case

On November 10, 2020, the Supreme Court heard oral argument (recording, transcript) in the two cases that will again decide the fate of the Affordable Care Act (ACA): Texas v. California, 19-1019, and California v. Texas, 19-840. Only two cases argued earlier in the Term remain undecided, and as we move into the last month before the Court's summer recess, timing alone suggests the ACA cases are proving to be highly contentious within the Court.

I have a hard time believing the Court will affirm the Fifth Circuit and the District Court and toss out the entire ACA on the specious ground that Congress wouldn't want the ACA to survive without the individual mandate. The premise -- that there is no longer an individual mandate -- flies in the face of the fact that the ACA still contains the individual mandate. The penalty for not purchasing health-insurance coverage was reduced to $0 in the 2017 tax reform law, which renders the mandate a somewhat toothless requirement, But even before 2017, the IRS's collection tools under the ACA were quite limited, which rendered the individual mandate one of the most under-enforced requirements in the United States Code.

Even if the Court agrees that the individual mandate is no more, however, the idea that the Court would go along with tossing out the entire ACA is mind-boggling. That would mean:

• no more prohibition against pre-existing condition exclusions
• no more prohibition against arbitrary and discriminatory rescissions
• no more family coverage for children up to age 26
• the reintroduction of annual and lifetime caps on coverage
• no more Medicaid expansion funds (raising a serious question about the status of funds for the 39 states that have expanded eligibility based on a promise of a generous (read: massive) federal subsidy)
• the elimination of federal insurance exchanges and possibly state exchanges, too
• the elimination of premium tax credits for low-income households
• the elimination of subsidies for out-of-pocket expenditures
• the elimination of what amounts to a cap on the amount insurers can spend on items other than health-care claims (accompanied by a premium rebate when non-health-care expenditures exceed the permitted amount)
• and on and on and on.

None of these practical effects has a doctrinal role in deciding whether the individual mandate is "severable" from the rest of the ACA, in which case the Fifth Circuit should be reversed. Similarly, consistent and growing public support for the ACA since late 2016 has no doctrinal significance. The question instead is whether Congress would want the entire ACA to go away if the individual mandate were to fall. 

What I thought would be an easy question is taking the Court a very long time to work out. If Lyle Denniston, who's been covering the Court for over 60 years, is concerned about what is going on with these cases, we all should be.

COVID-19 at the Intersection of Criminal Justice Reform and Public Health

Interesting new piece is Proceedings of the National Academy of Sciences (PNAS): "Carceral-community epidemiology, structural racism, and COVID-19 disparities" by Reinhart and Chen. They report on a Cook County study and offer the following summary and recommendation:

As jails and prisons remain leading sites of COVID-19 outbreaks, mass incarceration poses ongoing health risks for communities. We investigate whether short-term jailing of individuals prior to release may drive COVID-19 spread. We find that cycling individuals through Cook County Jail in March 2020 alone can account for 13% of all COVID-19 cases and 21% of racial COVID-19 disparities in Chicago as of early August. We conclude that detention for alleged offenses that can be safely managed without incarceration is likely harming public safety and driving racial health disparities. These findings reinforce consensus among public health experts that large-scale decarceration should be implemented to protect incarcerated people, mitigate disease spread and racial disparities, and improve biosecurity and pandemic preparedness.

The full article is well worth a close read. 

Texas Blows it Again on Medicaid Expansion

Health Affairs has posted a nice summary of the Biden Administration's attempt to entice the hold-out states to expand Medicaid pursuant to the ACA (though it unfortunately has absolutely no relevance to Texas -- read on):

In the newest addition to our “Eye On Health Reform” series, Katie Keith covers the American Rescue Plan Act, which was signed into law by President Joe Biden in March.

Keith explains that the legislation temporarily expands the Affordable Care Act’s premium tax credits and increases federal financial incentives for holdout states to expand their Medicaid programs. Keith also explores enrollment trends in states that use HealthCare.gov, current ACA litigation, and ACA guidance from the Biden administration.

I wrote about an earlier plan to pay hold-outs on Feb. 16, back when the prospects for expansion in Texas seemed, if not bright, at least alive. By my count there were five House bills, two Senate bills, four House Joint Resolutions, and three Senate Joint Resolutions that would have authorized (or required) Texas to take advantage of the federal dollars that would become available if Texas were to expand Medicaid eligibility to 138% of the federal poverty limit. Would it be cynical of me -- or simply realistic -- to report that every single one of these proposals died in committee? Every one! What is there to say other than it really sucks to be poor and live in Texas, where the legislature seems determined to keep a minimum level of health care out of reach for five million of its citizens.

For the record, here are the links to the bills and JRs, along with the names of co-sponsors:

HJR 9, 23, 24, 86
SJR 11, 14, 15
HB 143, 398, 513, 1730, 4406
SB 38, 119

"What Has President Biden Done in Health Care Coverage in His First 100 Days?"

There is a new Commonwealth Fund report by Tim Jost and Mark Regan looks at executive orders, legislation, and litigation in the Biden Administration's first 100 days. The focus is on strengthening and expanding the ACA and Medicaid, largely (but not entirely) by undoing the damage wreaked by the previous administration, which seemed hell-bent on increasing the sum total of human misery across the board.

AstraZeneca in Major Dispute with U.S. Regulators

Anthony Fauci's Institute -- the National Institute of Allergy and Infectious Diseases (NIAID) -- issued a mind-blowing statement today:

Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.

It is almost (but not quite) inconceivable that AstraZeneca made an innocent error. The DSMB is accusing the firm of essentially "cherry-picking"  the data “most favorable for the study as opposed to the most recent and most complete.” (NY Times, 3/23) The DSMB's letter to the NIH and AstraZeneca stated that the efficacy rate of the firm's COVID-19 vaccine might be between 69% and 74%, rather than the 79% rate touted by AstraZeneca itself. Did AstraZeneca really think they could slip one past the regulators? And at what cost to its reputation? Not to mention at what cost to the worldwide public-health crisis, where mistrust of science and vaccine-skepticism don't need any more encouragement and support. 

From the Times article: “'Decisions like this are what erode public trust in the scientific process,' the board wrote." 

Medicaid Expansion in Texas: The Time is Now

The Legislature is back in session. A bill has been introduced to authorize Texas to accept the federal government's offer to pay for 90% of the cost of expanding Medicaid eligibility to include all Texans under the age of 65 (when Medicare kicks in) and whose income does not exceed 138% of the federal poverty level: HB 1730, introduced by Republican Representative Lyle Larson. Sen. Johnson's own companion bills are SB 118 and SB 119.

The case for expansion is made in a most compelling and entertaining video (10.5 minutes) by Senator Nathan Johnson (D-Dist. 16 (which covers a big chunk of Dallas)). Please watch it. Share it with your family. Send it to your friends. Get involved. We have already waited too long, left billions of federal dollars on the table, and worst of all, we've ignored the health care needs of 1 million Texans who would benefit from expansion. Let's make this happen this year.

And thanks to DFW Hospital Council CEO Stephen Love for passing the video on to me.

CDC's Guidance for "Fully Vaccinated People"

The guidance was issued earlier today, and you can read the whole document here. Meanwhile, here are the highlights:

Key Points

This is the first set of public health recommendations for fully vaccinated people. This guidance will be updated and expanded based on the level of community spread of SARS-CoV-2, the proportion of the population that is fully vaccinated, and the rapidly evolving science on COVID-19 vaccines.

For the purposes of this guidance, people are considered fully vaccinated for COVID-19 ≥2 weeks after they have received the second dose in a 2-dose series (Pfizer-BioNTech or Moderna), or ≥2 weeks after they have received a single-dose vaccine (Johnson and Johnson [J&J]/Janssen ).†

The following recommendations apply to non-healthcare settings.

Fully vaccinated people can:

Visit with other fully vaccinated people indoors without wearing masks or physical distancing

Visit with unvaccinated people from a single household who are at low risk for severe COVID-19 disease indoors without wearing masks or physical distancing

Refrain from quarantine and testing following a known exposure if asymptomatic

For now, fully vaccinated people should continue to:

Take precautions in public like wearing a well-fitted mask and physical distancing

Wear masks, practice physical distancing, and adhere to other prevention measures when visiting with unvaccinated people who are at increased risk for severe COVID-19 disease or who have an unvaccinated household member who is at increased risk for severe COVID-19 disease

Wear masks, maintain physical distance, and practice other prevention measures when visiting with unvaccinated people from multiple households

Avoid medium- and large-sized in-person gatherings

Get tested if experiencing COVID-19 symptoms

Follow guidance issued by individual employers

Follow CDC and health department travel requirements and recommendations

Free Webinar: Pres. Biden's First 100 Days of Health Policy

This looks like a good webinar:

Boston University's Center for Health Law, Ethics & Human Rights faculty discuss the first 100 days of President Biden’s term:

• Executive Orders,
• proposed bills, and
• other steps to tackle COVID, climate, and economic crises affecting health.

What has happened? What comes next? 

Thursday, March 11, 2021
1:00 - 2:30 p.m. EST

SPEAKERS
George Annas
Nicole Huberfeld
Wendy Mariner
Michael Ulrich

JOIN ZOOM MEETING
https://bostonu.zoom.us/j/93372687004?pwd=NXpoNm5wZW1YOEljeENyeWY2V3dVUT09

Meeting ID: 933 7268 7004
Passcode: 331167

"Governor Abbott Lifts Mask Mandate, Opens Texas 100 Percent" [source: Governor's website]

Yes, it's true. Governor Abbott (along with the Governor of Mississippi) has earned the title "Worst Public Health Decision Maker Still Holding Office in the U.S." with this announcement. The full text of Executive Order GA-34 is here.

Gov. Abbott offered remarks on his remarkable EO in Lubbock. Here is an annotated paragraph:

"With the medical advancements of vaccines and antibody therapeutic drugs, Texas now has the tools to protect Texans from the virus,” said Governor Abbott. 

You bet we have the tools. We simply have to use them. 

"Make no mistake, COVID-19 has not disappeared, but it is clear from the recoveries, vaccinations, reduced hospitalizations, and safe practices that Texans are using that state mandates are no longer needed."

Wow, that's a whopper. To borrow a line from Justice Ginsburg's dissent in Shelby County, in which the majority held that the Voting Rights Act's preclearance mechanism was no longer needed: "Throwing out preclearance when it has worked and is continuing to work to stop discriminatory changes is like throwing away your umbrella in a rainstorm because you are not getting wet." [Opinion, p. 33]

"Today's announcement does not abandon safe practices that Texans have mastered over the past year."

Another whopper. Texans haven't mastered safe practices and now we've been given a green light to abandon them altogether. 

"Effective next Wednesday [Mar. 10], all businesses of any type may open to 100% capacity." "This order ends the statewide mask mandate in Texas."

Abbott helpfully notes that anyone who wants to can wear a mask and businesses can self-limit their own capacity. That's the kind of right-thinking Texas policy that gave us ERCOT and the disaster of two weeks ago. We are going our own way and celebrating Texas independence. Wonderful spirit, but lots of people died. And lots of people are going to die of COVID-19 unnecessarily because of today's order. 

Stephen Love, the President/CEO of the Dallas-Fort Worth Hospital Council had this to say: 

"While we respect Governor Greg Abbott and realize he has faced enormous challenges with the COVID-19 pandemic and recent weather issues, we strongly disagree with removing the mandatory mask requirements. This decision will cause the community spread to increase, forcing our exhausted healthcare heroes to diagnose, treat and save the lives of newly infected patients. If the community spread increases, the risk of mutations will also increase, creating a new set of potentially dangerous challenges. If you truly want to honor our healthcare heroes, then continue to wear a mask! We ask Governor Abbott to please reconsider his decision."

Back to the governor: 

"Instead, it is a reminder that each person has a role to play in their own personal safety and the safety of others." 

Agreed. What the Executive Order ignores is that the state has a role to play, as well. And the governor has just abandoned that responsibility.

"With this executive order, we are ensuring that all businesses and families in Texas have the freedom to determine their own destiny."

And the destiny of all others -- family, workers, strangers -- with whom they come into contact. Gulp. 

COVID-19 Vaccination and Ethics: Stanford/AJOB Webinar

The American Journal of Bioethics and Stanford's Center for Biomedical Ethics (David Magnus & Bela Fishbeyn) on Feb. 16 put on an excellent panel discussion of the ethics of COVID-19 vaccination policies. It was a far-ranging discussion with knowledgeable participants and well worth watching.

Medicaid in Times of Crisis: A GAO Report (2 pp.)

It's short but sweet. The Government Accountability Office has issued GAO-21-343SP (02-17-2021), a nifty description and analysis of the role of the federal-state Medicaid program in times of crisis (e.g., epidemics and pandemics, economic recessions, natural disasters, and personal health crises). Specific examples over the past 15 years include Hurricane Katrina, the Great Recession, the opioid epidemic, and of course COVID-19. 

This is further proof, as if any were needed, that Texas's policy of not expanding Medicaid eligibility at largely federal expense isn't only hurting the indigent (and largely minority) individuals -- including millions of kids -- that legislators seem keen to punish for being, you know, indigent, nonwhite, and young. The policy is also depriving public-health officials of an important tool in times of great public need. 

COVID Vaccine and Health Equity: We have a long way to go

From Kaiser Health News (2/18/2021):

KFF has an updated analysis of state-reported data as of February 16, 2021 on COVID-19 vaccinations, cases, and deaths by race/ethnicity.

New to the analysis are comparisons of vaccination rates in each racial/ethnic group based on state-reported data of total people who have received at least one dose of the vaccine. Among just over half of states reporting data, the vaccination rate among White people is over three times higher than the rate for Hispanic people (10% vs 3%) and twice as high as the rate for Black people (10% vs. 5%). The vaccination rate for Asian people is closer to the rate for White people in most reporting states, although they are less likely to have been vaccinated in most reporting states.