Health care law (including regulatory and compliance issues, public health law, medical ethics, and life sciences), with digressions into constitutional law, statutory interpretation, poetry, and other things that matter
Here is The Commonwealth Fund's introduction to the new report (released today):
Part of the Fund’s ongoing series examining state health system performance, Advancing Racial Equity in U.S. Health Care: The Commonwealth Fund 2024 State Health Disparities Report evaluates states on 25 measures of health care access, quality, service use, and health outcomes for Black, white, Hispanic, American Indian and Alaska Native (AIAN), and Asian American, Native Hawaiian, and Pacific Islander (AANHPI) populations.
Among the key findings:
The health care divide is especially stark when it comes to premature deaths: American Indian and Black people die from preventable and treatable causes at substantially higher rates than other groups.
Disparities exist even in states that are otherwise considered high performing on health care.
Health care experiences for people of color vary widely across states. For example, health systems in South Dakota, North Dakota, and Alaska perform worst for American Indian people, while North Carolina’s health system performs best.
Find out where your state ranks, and how we can achieve more equitable health care systems in each state.
Once upon a time, the way health insurance worked was this: Patients with insurance were seen by their doctors, received prescriptions for medications, and got the surgeries and other procedures their doctors believed were justified. Under these "indemnity plans," after the fact, invoices were submitted to health insurance companies, and -- by and large -- the invoices were paid. Not necessarily in full -- there were deductibles that needed to be met each year and reductions in "reimbursement" for the patient's co-pay or co-insurance obligation. But coverage was seldom an issue. Insurance companies conducted retroactive reviews to determine that the service or item was "medically necessary and appropriate," but most claims for payment were approved most of the time.
Until they weren't.
As new technologies and high-priced drugs and devices drove up the cost of health care, insurers looked for ways to control the amounts they paid out in claims. Under the broad banner of "managed care," insurers instituted various reforms that fundamentally changed the delivery of health care goods and services.
One reform was to create panels or networks of approved providers, in exchange for which the insurance companies demanded deep discounts in physicians' fees and hospitals' charges. Patients who received their care -- even emergency care -- from providers who were "out of network" typically received no coverage for that care or reduced coverage, putting more of the cost of care on patients (i.e., the insurers' customers).
Another reform was the integration of health insurance and healthcare provider. The purest form of this were the HMOs. Some provided health care services to their insureds; others contracted with providers to diagnose and treat their insureds. In both instances, a single entity was financially (and legally and ethically) obligated to write health insurance policies and provide care (either directly or indirectly) to their insureds.
A third reform relates to the title of this post: prior authorization, to which I would add concurrent authorization. "Prior authorization" gives the insurance company up-front veto power over referrals to specialists or for hospitalizations, for prescriptions for drugs and devices, and for procedures (diagnostic (CT scans, e.g.) or treatment (including surgeries). "Concurrent authorization" gives insurance companies the same type of veto power throughout a course of treatment. This might be denial of a request for an MRI to see whether or how much a disease has progressed or denial of a request for an additional number of days of hospitalization to deal with post-procedure complications. And "retroactive review" -- which, under indemnity plans, were relatively benign efforts to determine medical appropriateness and necessity -- became a more rigorous process of "retroactive authorization."
Although managed care was originally justified as a necessary form of cost control, including screening insurance claims for those that were not for medically necessary appropriate care, managed care itself evolved into something that was increasingly regarded as abusive. The pattern of denying coverage for unarguably necessary and appropriate care produced a backlash over the past two decades, including legislative and regulatory reforms at the federal and state level to address the worst features of managed care.
A recent opinion video on the New York Times website (Mar. 14, 2024; subject to paywall) provides excellent evidence that insurance companies continue to use prior and concurrent authorizations to to delay or avoid altogether their contractual obligation to pay for care that is necessary and appropriate. (I can provide free access to eights readers of this post; if you want access, just let me know at tmayo@smu.edu.)
A handful of states have passed "gold card" laws that are intended to allow physicians who have successfully received prior authorizations to bypass that process altogether. According to the Texas Medical Association, two years after passage of the state's "gold card" law, "the Texas Department of Insurance (TDI) reports that only 3% of physicians and health care professionals have received gold cards because of the current eligibility threshold, which requires physicians to submit a minimum of five eligible prior authorization requests for a given health care service or medication within the six-month review period."
A federal version of the gold card law -- H.R. 4968, "Getting Over Lengthy Delays in Care As Required by Doctors Act of 2023" (or the "GOLD CARD Act of 2023") -- was referred last July 23 to the Subcommittee on Health of the House Ways and Means Committee, where it remains to this day. Even if it becomes law, exempts physicians from prior authorization requirements only under Medicare Advantage plans with respect to specific items and services if at least 90% of the physician's requests for such items and services were approved during the previous plan year. Outside of Medicare, patients and their providers would not be helped by the GOLD CARD Act.
The Commonwealth Fund just published "Automatic Enrollment in Health Insurance: A Pathway to Increased Coverage for People with Low Income" (March 11, 2023) by John Holahan, Michael Simpson, and Jason Levitis. By way of introduction, the Commonwealth Fund writes: "The number of uninsured Americans — more than 26 million — remains stubbornly high, despite the availability of free or low-cost health coverage to those with low incomes. But there is a pathway to coverage that could have a substantial impact on the uninsured rate: automatically enrolling people who qualify for no-cost coverage in either Medicaid or marketplace plans."
The basic model would expand upon existing law in a bold way:
The Inflation Reduction Act of 2022 eliminated marketplace premiums for eligible people with incomes below 150 percent of FPL. As a result, all individuals at that income level who live in states that have expanded Medicaid can now receive zero-premium coverage, unless they have an “affordable” offer from an employer or are excluded because of immigration status. If the remaining 10 states expanded Medicaid, or if eligible people with incomes below 100 percent of FPL in nonexpansion states were permitted to have subsidized coverage in the marketplace, then most legal residents with incomes below 150 percent of FPL could be covered with no premiums. Zero-premium coverage could also be extended to higher incomes, either through further enhancement of federal premium tax credits or by states adopting a Basic Health Program or adding state premium subsidies. [footnotes omitted]
Here's the Abstract:
Issue: The number of uninsured Americans remains stubbornly high, and many Americans do not obtain the coverage for which they are eligible — even when insurance is free.
Goal: To outline a system for automatically enrolling people with low incomes in health coverage and then model the impact on coverage and spending at the federal and state levels.
Methods: The Urban Institute’s Health Insurance Policy Simulation Model was used to analyze alternative auto-enrollment approaches. These include identifying uninsured individuals who are tax filers or recipients of the Supplemental Nutrition Assistance Program (SNAP), unemployment insurance, or Social Security and enrolling people who are eligible for free coverage.
Key Findings and Conclusions: We show results for the nation and for three states (California, Georgia, and Michigan). If all states adopted an auto-enrollment policy for those with incomes at or below 150 percent of the federal poverty level, 4.3 million uninsured people would be identified and enrolled. An additional 1.8 million would be “deemed” covered, either auto-enrolled through provider contact or contingently covered and thus protected from huge medical bills. Provider spending on uncompensated care would fall 32 percent, while federal spending would increase by $30.3 billion and state spending would increase by $7.7 billion per year.
The report discusses two implementation models: nationwide enrollment pursuant to federal legislation or, absent that, state-by-state legislative implementation.
It's hard to imagine either model would escape contentious litigation lasting years. Recall Chief Justice Roberts's opinion in the 2012 case of Sebelius v. NFIB, in which the individual mandate was deemed to exceed Congress's powers under the Commerce Clause:
The individual mandate, however, does not regulate existing commercial activity. It instead compels individuals to become active in commerce by purchasing a product, on the ground that their failure to do so affects interstate commerce. Construing the Commerce Clause to permit Congress to regulate individuals precisely because they are doing nothing would open a new and potentially vast do-main to congressional authority.
Make a change to these sentences and you have the essence of the brief we can expect from opponents of automatic enrollment:
The individual mandate, however, does not regulate existing commercial activity. It instead compels individuals to become active in commerce by enrolling them in a product, on the ground that their failure to do so affects interstate commerce. Construing the Commerce Clause to permit Congress to regulate individuals precisely because they are doing nothing would open a new and potentially vast do-main to congressional authority.
In Sebelius Roberts saved the individual mandate by characterizing the penalty for not purchasing health care coverage as a tax. It would be a real stretch to characterize a free insurance policy as an exercise of the Taxing Clause. Would it fly under the Spending Clause?
By way of counter-argument, don't we already have a nationwide automatic-enrollment scheme for Medicare Part A? Would a broader scheme be any different?
The Merger Guidelines apply equally to acquisitions, so it is natural to ask about the potential impact of the revised Merger Guidelines on the growing trend of hospital acquisitions of physician practices. That question is asked and expanded, if not quite answered, in the March 9 issue of the New England Journal of Medicine in a piece by Dhruv Khullar, M.D., M.P.P., Lawrence P. Casalino, M.D., Ph.D., and Amelia M. Bond, Ph.D.: "Vertical Integration and the Transformation of American Medicine," available for free here (HTML) and here (PDF).
The article identifies three broad areas of concern that will require a more nuanced approach fueled by a close factual inquiry in each case under review:
First, are the effects of vertical integration influenced by the form that the resulting health system takes? The Agency for Healthcare Research and Quality has defined a health system as an organization that has at least one hospital and at least one physician practice that provides comprehensive care, with the entities operating under common ownership or management. This broad definition is useful for systematically tracking growth in the number of health systems, but it masks tremendous heterogeneity in size, geography, not-for-profit versus for-profit status, provider specialties, and leadership structure. . . .
Second, how do practice acquisitions affect clinicians? Traditionally, antitrust agencies judging whether to challenge a proposed merger or acquisition have focused on prices paid by consumers. In recent years, however, they have started to take a more expansive view of potential benefits and harms. The new guidelines address the extent to which a merger lessens competition for workers and could result in lower wages, worse benefits, or poorer workplace conditions. Research on vertical integration in health care could examine its consequences for clinicians. Many clinicians may be satisfied after their practice is acquired; they may, for example, have an improved work–life balance, receive greater administrative support, and be relieved of managing the business-related aspects of medicine. Alternatively, they may work longer hours, have less autonomy and constrained job mobility, and experience more burnout or moral injury.
Third, and most important, when hospitals acquire practices, which patients benefit, and which are harmed? The effects of vertical integration are likely to vary depending on the medical and social needs of a health system’s patients. Patients who have multiple coexisting conditions and require frequent interactions with the health care system may be especially affected by changes in care protocols and referral networks after practice acquisitions. The types of practices that hospitals target also matters. The guidelines call attention to the potential for merged entities to limit access to products or services that rivals need to compete. It’s possible that in preferentially acquiring profitable practices, hospitals leave patients in poorly resourced practices worse off by weakening those practices’ leverage in negotiations with insurers, deprioritizing referrals for their patients, or hiring away their clinicians and staff. Future research could examine the effects of acquisitions not only on patients at practices that are acquired by hospitals, but also on patients at practices that, for whatever reason, are not.
The concluding paragraph summarizes the authors' concerns:
The rapid acquisition of physician practices by hospitals highlights an important tension in health care — between the possibility that integration can promote efficiency and improved quality and the concern that it distorts markets and can worsen health and financial outcomes. This tension reflects the conflicting values of coordination and competition. Resolving it — determining whether, how, and when regulators should act — will require a more nuanced understanding of the consequences of these acquisitions for patients, families, and clinicians.
Money's tight. Inflation seems to be stuck at a level that bothers voters -- R, D, and Ind alike. Worries that the Fed may back off a notch or two in its current rate-reduction program seems to have spooked the equities markets, and that's an unsettling development to tens of millions of workers and retirees whose retirement plans are in managed stock portfolios.
Add to all this a broadly shared view that out-of-pocket expenditures for health care are too high, according to polling done by the nonpartisan Kaiser Family Foundation. When registered voters were asked about their health-care concerns, these payments -- copays, coinsurance, deductibles -- were #1 by a lot:
This concern was shared across the political spectrum. As the KFF folks put it:
What this means is that affordability is now the theme that will resonate most with voters, whether candidates are talking about health on the campaign trail, or policymakers are advancing policy proposals. That doesn’t mean that other themes like “universal coverage” or health care as a “right” (if you lean liberal), or “choice” or “competition” (if you lean more conservative), don’t work with large segments of the population. But with 92% of the population now covered and so many people struggling with medical bills and medical debt, affordability is the big tent theme that will connect with the most Americans.
Reproductive rights will motivate large groups of voters to go to the poll. The issue polls well with Democrats, independents, and college-educated women, among others. It appeared to have an effect in 2023 elections, but its impact on 2024 remains to be seen.
To be clear, affordability of health care isn't simply a political issue. It has huge implications for access to health care, even among the 92% of Americans who have health insurance coverage, at least to the extent health care is postponed or not sought at all because of high cost-sharing obligations. Also, when care is postponed or passed up, that has an impact on quality of care, and reduced access and quality affect societal concerns with the justice and fairness of the health care delivery system that continues to price millions of covered individuals out of the market.
On Thursday (Dec. 7), I posted about a Catholic hospital system in California that has taken to suing patients for trespass when they refuse to leave the hospital after a discharge order has been written. I don't know how the suits will turn out (settled, is my guess), but there are factual disputes as to whether safe discharge locations (such as home, nursing home, intermediate care facilities) are available for patients who leave their hospital settings. The hospitals undoubtedly believe there are safe alternatives, so if there is no settlement, there will need to be a trial to resolve the factual disagreements. In short, it's a mess.
Another side of the same coin was highlighted by a different kind of story later in the week. Coming a $2.3 billion operating loss in 2022, Massachusetts General Hospital reported a $95 million operating revenue surplus for 2023 (Boston Globe, Dec. 8; paywall likely). Major contributors to the one-year turn-around: the last of the one-time COVID relief money and "a robust investment portfolio." In other words, this year's net revenue was not necessarily directly related to higher volumes and greater efficiencies in providing patient care, though the hospital did report an nearly $1 billion increase in revenue from patient activities year-over-year.
The financial picture could have been even better. According the the Globe story, "The system is treating fewer people than it would like to, largely because there is less capacity at nursing homes and rehabilitation facilities that would normally take discharged patients recovering from hospitalization" (emphasis added). The hyperlink is to a (June 12, 2023) report that over 1,000 patients in the Bay State remain "stuck" in hospitals because of the shortage of nursing homes and rehab facilities. But the main point of the Dec. 8 story is that hospitalizations are being limited at the front end at MGH, which means care is being delayed and even denied for lack of appropriate discharge options.
We refer incessantly to the "American health care system," but this is another reminder that the "system" is less than that. It's an agglomeration of disparate parts -- some public, some private, some for-profit, others nonprofit -- the locations and even existence of which are largely market-driven, which is often not the same as need-driven. The big players are in a fairly decent position to protect themselves, as the 2023 MGH numbers illustrate. But there are lots of smaller and rural providers that lack the resources and resiliency to weather large losses year after year. The outlook for them is grimmer than ever.
The Affordable Care Act was premised (correctly, IMHO) on the proposition that the private health insurance market could not operate in the public interest without a large dose of regulatory correction. Even the advances of the ACA -- as desirable and necessary as they were and are -- were delayed and reduced bu its opponents. From my Dec. 4 blog post:
As Abbe Gluck and two co-authors wrote in the Georgetown Law Journal in 2020, "[t]he ACA is the most challenged statute in American history." The authors cite more than 2,000 legal attacks, more than 70 GOP-led attempts in Congress to repeal or strip down the Act, and seven trips to the Supreme Court. Add to the story that "the statute has been rebelled against by the states charged with implementing it, sabotaged by the second President to administer it, and financially starved by Congress," and the story becomes one of "unprecedented statutory resilience."
Private health insurance is just one piece of the puzzle -- a very significant piece, but only a part of the story. If this country tried to get serious about organizing health care into a true system, the opposition would dwarf anything we saw from 2010-2020.
I once had a Health Law student who had been an HMO employee in a previous life. She was the one who answered the phone when a provider (hospital, clinic, physician, etc.) dialed 1-800 for pre-authorization for a procedure, hospitalization, or prescription item (medication, wheelchair, PT, etc.). Her standing order was simple: Always deny the request first time around. In Texas, we call that "bad faith claims handling" and it's a tort that can result in compensatory and punitive damages. So much for the deterrence effect of tort law!
A lot has changed in health care in the intervening two decades, byt "deny, deny, deny" is still with us. It's frustrating for policy holders (a/k/a patients and human beings), and it's aggravating for the providers. It's also a form of Russian roulette that results in dangerous delays in providing needed health care goods and services.
A recent article in Becker's CFO Report (Aug. 14, 2023) highlights the problem. As described by a hospital CEO with 37 years of experience in health care, bare-knuckle negotiations over reimbursement rates get all the media attention when providers and a payor appear to be at impasse and termination of the contract is a looming reality for thousands of patients whose providers are about to be "out of network." Reimbursement rates are the "above the surface" story in these negotiations, but eventually both sides compromise and crisis is averted.
The "below the surface" issues, though, have an outsized effect on providers. These issues stem from denials of payment for any of the myriad reasons insurers can cite: service or medication not covered, no pre-authorization or referral from a gatekeeper, DRG down-coding, difference in clinical judgment about medical necessity . . . . The list goes on. Here's the eye-popping heart of the article:
Data and numbers on denial rates are not easy to find, but some examination paints a picture rich with variation. An analysis of 2021 plans on Healthcare.gov conducted by KFF found nearly 17 percent of in-network claims were denied, with rates varying from 2 percent to 49 percent. The reasons for the bulk of denials are unclear. About 14 percent were attributed to an excluded service, 8 percent to lack of pre-authorization or referral and 2 percent to questions of medical necessity. A whopping 77 percent were classified as "all other reasons."
Adding to the inconsistency is the fact that health plan denial rates fluctuate year over year. In 2020, a gold-level health plan offered by Oscar Insurance in Florida denied 66 percent of payment requests; in 2021 it denied 7 percent.
And here's a refrain I hear from physician friends from all over:
"Nobody becomes a physician because they hope to feel like a cog in a factory," Michael Ivy, MD, deputy chief medical officer of Yale New Haven (Conn.) Health, told Becker's. "However, between meeting the demands of payers for referrals, denials of payment and increased documentation requirements in order to assure proper reimbursement and risk adjustment, as well as an increasing number of production metrics, it can be difficult not to feel like a cog."
As for the government's role in policing the conduct of these insurers:
Authors of the 2010 Affordable Care Act worried that provisions to expand health insurance access — such as barring health insurers' refusal to cover patients with preexisting conditions — could cause them to ratchet up other tactics to make up for the change. With this in mind, the law charged HHS with monitoring health plan denial rates, but oversight has been unfulfilled, leaving denials widespread.
When you consider insurance company profits and their executive salaries, it's apparent that the "middle men" in these transactions are getting rich at the expense of providers and patients alike. Where's a good, old-fashioned congressional or FTC hearing when you need one?
"Limiting Overall Hospital Costs by Capping Out-of-Network Rates" [Free Download] Annals of Health Law, Vol. 32, No. 2 (2023)
DAVID ORENTLICHER, University of Nevada, Las Vegas, William S. Boyd School of Law Email: david.orentlicher@unlv.edu
KYRA MORGAN, Nevada Department of Health and Human Services
BARAK D. RICHMAN, Duke University, School of Law, CERC, Stanford Univ. School of Medicine Email: richman@law.duke.edu
Abstract:
Contract theory offers a simple and wildly effective solution to surprise bills: Hospital admissions contracts are contracts with open price terms, which contract law imputes with market rates. This solution not only obviated the costly, time-consuming, and complicated (and still unimplemented) legislative fix in the No Surprises Act, but it also is a superior solution since it introduces superior incentives to disclose, compete, and economize.
Using data from the Nevada Department of Health and Turquoise Health, this paper explores the theory and empirics of employing contract law's solution to hospital surprise bills and its superiority over other legislative interventions.
In his State of the Union speech on Jan. 6, 1941, FDR famously offered up "the Four Freedoms" to explain why the United States was at war abroad and on a war footing at home. He introduced the Four Freedoms with this eerily familiar list of goals for the country:
[T]here is nothing mysterious about the foundations of a healthy and strong democracy. The basic things expected by our people of their political and economic systems are simple. They are:
Equality of opportunity for youth and for others.
Jobs for those who can work.
Security for those who need it.
The ending of special privilege for the few.
The preservation of civil liberties for all.
The enjoyment of the fruits of scientific progress in a wider and constantly rising standard of living.
These are the simple, basic things that must never be lost sight of in the turmoil and unbelievable complexity of our modern world. The inner and abiding strength of our economic and political systems is dependent upon the degree to which they fulfill these expectations.
Many subjects connected with our social economy call for immediate improvement.
As examples:
We should bring more citizens under the coverage of old-age pensions and unemployment insurance.
We should widen the opportunities for adequate medical care. [emphasis added -- this is a HealthLawBlog, after all]
We should plan a better system by which persons deserving or needing gainful employment may obtain it.
Then FDR got to the part of his speech that made it so enduring:
In the future days, which we seek to make secure, we look forward to a world founded upon four essential human freedoms.
The first is freedom of speech and expression--everywhere in the world.
The second is freedom of every person to worship God in his own way--everywhere in the world.
The third is freedom from want--which, translated into world terms, means economic understandings which will secure to every nation a healthy peacetime life for its inhabitants-everywhere in the world.
The fourth is freedom from fear--which, translated into world terms, means a world-wide reduction of armaments to such a point and in such a thorough fashion that no nation will be in a position to commit an act of physical aggression against any neighbor--anywhere in the world.
The public response? Crickets. Congress barely applauded. The next day most newspapers didn't even mention the “Four Freedoms.” Those who were still talking about the phrase in the weeks and months that followed did so to lambaste its “hollow, empty sound.” The government hired [E.B.] White and other A-list scribes to drum up some buzz, but White’s boss called his pamphlet “dull.” The “Four Freedoms,” in the words of one federal administrator, were a “flop.”
Ever the optimist, FDR concluded the list with this: "That is no vision of a distant millennium. It is a definite basis for a kind of world attainable in our own time and generation." Eighty-two years later the Four Freedoms are still aspirational, not real, for much of the world and for many of our fellow citizens.
If I have any recommendations for "must-read" sources of insight into the world of health care policy and law they would be the Kaiser Family Foundation (KFF) Health News website/homepage and the policy journal Health Affairs. Today KFF recapped its most popular Forefront articles (June 2023). Here's a summary:
The American Health Law Association (AHLA) wrapped up its annual meeting on June 28 with a presentation on hot topics. Speakers were from DHHS/OIG (Susan Edwards), DOJ (Kelley Hauser), and private practice (Scott Hasselman, Reed Smith).
According to Edwards, OIG plans to release a general Compliance Program Guidance (CPG) by the end of this year that will help providers develop and maintain an effective compliance program. OIG will then issue by the end of next year managed care and nursing facility CPGs, Edwards said.
The informative session also covered fraud issues related to the end of the COVID-19 public health emergency. Hauser, noting that fraud enforcement always lags behind implementation of new reimbursement, assured the audience that more enforcement actions would be coming. Hauser also said that given the sensitivity of the emergency funds, DOJ would likely look harder at use of the funds and will pursue enforcement actions even if the recovery is not a big dollar amount.
Edwards also mentioned the OIG final rule on information blocking that was released early on June 27 and noted that a separate rule that will apply to providers will list “disincentives” for information blocking.
Hauser reviewed recent fraud case law, such as the SuperValu case on scienter—if there’s evidence that a defendant is questioning the accuracy of certain statements or billing, you’re probably going to hear from DOJ.
The speakers also discussed the use of AI and questioned whether it could be used to create clinical notes. Hauser noted that the government is generally in favor of any technology that could improve accuracy and predicted that more widespread use of AI will likely lead to a certification process of some sort to ensure that such programs work as intended.
Each speaker then chose an emerging topic to discuss. Hauser picked parallel criminal and civil investigations, highlighting that such investigations are advantageous to the government and he has seen a steady increase in them during his tenure at DOJ.
Edwards talked about managed care oversight and its increasing importance amid explosive growth in managed care. And Hasselman highlighted the corporate practice of medicine doctrine (and here) and urged lawyers to be aware of it while structuring transactions.
I am not saying health insurers are evil. Or that their policies are evil. But their claims-handling practices are very often ill-advised, are calculated to maximize corporate revenues at the expense of the health of their insureds, and too often produce results that are, well, evil.
One of the defining characteristics of "managed care" -- which used to be this funky little thing over in the corner of our system of healthcare finance and delivery and now is everywhere -- is the notion of preauthorization by your insurance company before you can get almost anything: a visit to a specialist, hospitalization, a prescription drug, etc. The craziness that sometimes marks this process is hard to fathom (other than the aforementioned profit motive). Dr. Amy Faith Ho has taken this on over on Twitter and her posts are well worth following.
First, "innovation and access" is and always will be an important health law and policy topic. The testimony on May 10 covered Alzheimer's, cancer, FDA regulatory issues, Big Pharma R&D, and NIH research support. Important stuff.
Second, the blog post consists of summaries of testimony that were generated, in whole or in part, by ChatGPT. 'Nuff said? I could have waded through the testimony and written my own summaries or paid a research assistant to do the same. And I would certainly read the testimony if I were citing it, relying on it, etc. I am guess, though, that these summaries are serviceable enough as background reading (and a way of determining whether the testimony appears interesting enough to invest more of my time reading it).
These are the messages from Ed Yong's latest piece in The Atlantic: "It’s a Terrible Idea to Deny Medical Care to Unvaccinated People." To which I'd add:
4. Tort law will not support your decision. My first-year Torts students read a case in which the Tennessee Supreme Court reversed a trial court decision to allow the jury to compare the degree of fault of a hospital and two employees (whose provision respiratory support left the patient with permanent brain damage) with the degree of fault of the plaintiff (who had been driving with a blood alcohol level of .20% at the time of the accident). The American Law Institute's Third Restatement of Torts supports the rule that a patient's prior conduct (whether tortious or criminal) -- conduct that necessitate the medical treatment in issue -- does not diminish a health care provider's duty to treat or the duty to meet a professional standard of care. Restatement (Third) of Torts, Apportionment of Liability § 7, cmt. m (2000).
Yong concedes that this "debate" is theoretical:
Health-care workers are not denying care to unvaccinated patients, even though, ironically, many told me they’ve been accused of doing so by not prescribing ivermectin or hydroxychloroquine, which are ineffective against COVID but are often wrongly billed as lifesavers. Still, I ran this argument past several ethicists, clinicians, and public-health practitioners. Many of them sympathized with the exasperation and fear behind the sentiment. But all of them said that it was an awful idea—unethical, impractical, and founded on a shallow understanding of why some people remain unvaccinated.
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
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.
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.
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?”
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?
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.
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