First: smoke and mirrors. Followed by: pure bunkum.

The Trump administrations recent rulemaking for "association health plans" -- which allow small businesses and others to band together and purchase health plans -- has scored a rare hat trick:

First, the rules disappointed even some of its most ardent supporters by imposing limits that will increase employers' costs for too little in return.

Second, despite the administration's claim that AHPs will provide drastically improved coverage for far less cost than "the failed Obamacare, the exact opposite is true and always has been. The Democrats correctly label the AHPs "junk" that workers will find offers skimpy-to-no coverage for premiums that have been poured down the drain. This is precisely the problem that the ACA's minimum health benefits were intended to cure.

Third, President Trump is now hailing the AHP rule a raging success. At an Iowa roundtable with his HHS secreatry, Alex Acosta, the president had this to say:

“Alex, I hear it’s like record business that they’re doing,” Trump said of the plans, which aren't available for another five weeks. “We just opened about two months ago and I’m hearing that the numbers are incredible -- the numbers of people getting really, really good healthcare instead of Obamacare, which is a disaster.”

Sounds good, eh? The only glitch is that the plans won't be available for purchase until September. If there are "incredible" numbers in July, imagine how huge the sales will be when the plans actually become available in September.

Why is this man smiling?

The U. S. House of Representatives has once again voted against the ACA's tax on medical device manufacturers, after two previous postponements in assessing and collecting the tax, which was an important source of funding for the various subsidies in the ACA that needed to be financed. Repeal of the tax, which would take passage in the Senate and a presidential signature -- both seemingly likely with GOP control -- would be one more nail in the coffin of the ACA. Making matters worse, repeal of the tax has bipartisan support, thanks in large part to the industry's massive lobbying efforts since 2010. What is it that motivates legislators -- usually Republicans, but occasionally Dems as well -- to despise a law that has made health insurance (and thus health care) available to millions of fellow citizens who previously had none?

Lots of us who supported the ACA nearly a decade ago knew no law would be perfect. We also knew that experience with the consequences -- intended and otherwise -- would require near-constant revision. When it comes to health reform, there's no such thing as "one and done." But what is it about the poorest 10+% of the population getting health care that drives lawmakers from "fix it" to "kill it"? From a cost-benefit perspective, which should appeal to business-oriented (and -financed) legislators, our health care system ranks behind that of every other developed country in the world. Our administrative costs are many multiples of those of other nations. "Private profit above public welfare" is an old story, but when the result is avoidable morbidity and premature death for neighbors, we need a new narrative. The ACA was a step in the right direction, but try telling that to the political right!

When futility itself is futile

Medical futility represents a judgment that further treatment would not provide a benefit to the patient. (Set aside for present purposes the definitional and epistemological difficulties that sentence embodies.) Does futility itself have a limit, beyond which the judgment ceases to provide a benefit to the patient, family, even care providers? The authors of a recent article in the Journal of Medical Ethics argue that the Charlie Gard case is an example of just such a limit. https://jme.bmj.com/content/44/7/438.info

Johnson & Johnson mega-verdict

From Bloomberg Legal News:
     "Johnson & Johnson should ready itself for a flood of new lawsuits after a jury ordered the company to pay $4.69 billion to 22 women who blamed their ovarian cancer on asbestos in its talc products, legal experts say.

     "There are already more than 9,000 suits claiming talc-based baby powder causes ovarian and asbestos-specific cancers. That number is likely to jump in the wake of the Missouri jury’s decision, said Elizabeth Chamblee Burch, a University of Georgia law professor who teaches about mass-tort law.

     “'The floodgates were already open on this issue, but this verdict breaks the dam,' Burch said. Bloomberg News has the story."

Brett Kavanaugh is, by all accounts, a splendid fellow, as well as a well-credentialed appellate judge who -- in addition to being quite conservative -- is widely admired by his peers.


Some Democrats, still seething at the shabby treatment Chief Judge Merrick Garland (Chief Judge, mind you, of the same court upon which Judge Kavanaugh sits), are apparently inclined to vote against confirming Judge Kavanaugh on a sort of sauce-for-the-goose theory. CJ Garland is, if anything, even more experienced in all manner of government lawyering than is Judge Kavanaugh, and Leader McConnell's justification for denying President Obama his appointment barely passed the smile test (and wasn't much better when, years earlier, it had been proposed by Sens. Schumer and Biden). If the Democrats vote against Kavanaugh on this basis, it would be for a primarily institutional reason, not necessarily on the merits of the nominee. (Although it would be hard to argue that misgivings about Kavanaugh as a Supreme Court Justice would be irrelevant to such a vote.)

On the merits, though, opponents have been kicking up all kinds of dust. Kavanaugh, Trump, and Trump's press office insist that Roe v. Wade wasn't discussed before the nomination. Cynics might say that it didn't need to be in order for the president to know what he was getting. Maybe. Kavanaugh was one of 13 authors of a massive tome entitled The Law of Judicial Precedent in 2016, and by most accounts in that treatise, standard principles of stare decisis seem to support retention of the Roe precedent (at least as modified by the Webster case).

The argument I don't quite get is that Kavanaugh should be denied a seat on the Court because he would probably be an enemy of the Affordable Care Act. This argument seems to be based on a serious misreading of his dissent in the case that upheld the ACA in his court while a similar case was on its way to the Supreme Court, which also upheld the ACA the next year.

Two things are worthy of note: (1) His dissent was based upon the Anti-Injunction Act, which denies the federal courts jurisdiction to issue an order enjoining the assessment or collection of a tax. Challenges to a tax,  as a result, can only be brought after the tax has been paid. And in the case of the ACA, nobody had been assessed a penalty by the IRS for violating the individual mandate. (2) In the same opinion, Kavanaugh pointed out that if the penalty (which the Obama administration tried to sell to Congress as "not a tax") were re-enacted as a tax, it would have fallen comfortably within Congress's taxing and spending powers. In fact, that is precisely how Chief Justice Roberts managed the next year to uphold the individual mandate. Without waiting for Congress to re-enact anything, Roberts characterized the "penalty" (the actual term in the ACA) as a "tax" and upheld the constitutionality of the individual mandate on that basis. Far from being a foe, it is possible that Kavanaugh was instead throwing out a lifeline to the Court to save one of the most contentious (and probably the most reviled) provision of the ACA. [Postscript: The Washington Post's Colby Itkowitz and others agree with me on this.)

We will hear much about Judge Kavanaugh's record in the months that follow his nomination. The emerging picture is of a judge who supports executive power and frequently opposes what he regards as administrative agencies' "overreach." Both of these strands of his judicial philosophy (and, more broadly, of his theory of government) might lead him to be skeptical of Obama-era healthcare regulations and to be more favorably inclined toward Executive Orders that seek to cut back on key aspects of that law's implementation. EOs have turned out to be one of President Trump's favorite actions (despite his criticism during the 2016 campaign of Pres. Obama's use of EOs). His ACA-limiting EOs include Nos. 13765 and 13813.

If this is what opposition to Judge Kavanaugh comes down to, he should be confirmed. He's conservative, yes. And yes, he probably wouldn't have voted with the Roe majority in 1973 (which is not the same as saying he would vote to overrule it in 2018 or later). But he's getting a bum rap on his ACA vote. He's also superbly qualified in terms of education and experience.

And elections have consequences. The Republicans have the White House and Congress. If they want to solidify a conservative majority on the Court, one judicial appointment at a time, they can do that.

Hoping to visit this blog more than once every four years!

Just checking in. I am thinking about reactivating this site, now that I am teaching Health Law, Public Health Law & Ethics, and Bioethics on a somewhat regular basis.

American University's 7th annual Health Law & Policy Summer Institute

From Matthew W. Pierce, Associate Director of American University's Health Law & Justice Program, comes an announcement about the school's upcoming Health Law & Policy Summer Institute:

“American University Washington College of Law’s 7th annual Health Law & Policy Summer Institute will run from June 16 to June 28. The Institute’s flexible schedule includes day, evening, and  one online course. Faculty and guest lecturers bring tremendous experience, and courses are designed to combine both theory and practice so that participants gain a well-balanced understanding of each topic. All of the courses are open to law students and lawyers, and several are open to non-attorneys as well. This year’s courses focus on a variety of topics, including pharmaceutical law, bioethics, healthcare fraud and compliance, healthcare antitrust, and the economics of healthcare reform. To learn more about the Institute, please visit http://www.wcl.american.edu/health/institute/ or contact health@wcl.american.edu."

It looks like a terrific line-up of courses and knowledgeable speakers. Thank you, Matt, for bringing this to my attention.

P.S. As careful readers of this blog will no doubt have noticed, it's been four years since the last post to this blog. This one instance of breaking radio silence may (or may not) be the rebirth of this blog. Time will tell . . . .

It's obviously been a while since I posted to this blog. Between directing an ethics center and maintaining a pretty heavy teaching and consulting load, the blog simply took a back seat to more pressing concerns. Since September 2009, a lot has happened on the health law front (boy, is that an understatement!), and during the same time period I started experimenting with Facebook and Twitter as more efficient ways of posting about articles, reports, cases, and the like . . . easier and quicker to do with much less less fuss and muss. Also, I have a private blog for my Health Law and Bioethics classes over on WordPress, so tons of posts went up in the fall of 2009, the last time I taught Health Law, just not here on HealthLawBlog.

It's probably time to shut this blog down, but I will keep it on life-support for a little while longer. No posts, but the possibility of jump-starting the blog this summer.

Dallas Morning News' excellent series on health care costs (and other things that matter)

Hooray to the Dallas Morning News for its week-long series on health care and the systemic issues that have contributed to the crisis we are now in. Free registration may be required to view all of these articles. . . .

Sun., 9/27: High prices, red tape fuel popular Dallas doctor's move to Temple

Sun., 9/27: Focus on cost efficiency, quality pays off for Temple-based Scott & White Healthcare

Sun., 9/27: No country has perfect system, but there are lessons to learn

Wed., 9/23: Critics see home health care boom as wasteful, but others tout benefits

Tue., 9/22: Cost of Care: Medical imaging a growth industry, but some say unneeded scans increase expenses

Mon., 9/21: Cost of Care: Doctor-owned hospitals a lucrative practice, though opinions split on benefits

Mon., 9/21: Cost of Care: Baylor Medical Center at Frisco poised to net big payoff for doctor-investors

Sun., 9/20: Cost of Care: Dallas sees no relief in health care expenses as competition drives up costs

Sun., 9/20: Feeling no relief in Dallas: City outspends most on medical care

Sat., 9/19: Cost of Care: 'Vicious circle' of uninsured results in higher bills for health coverage, taxes in Dallas-Fort Worth

Patients' stories:

• David Null
• Amy Townsend
• Gail Penry
• Gwen & Alan Lummus
• Jose Rodriguez
  

Regional disparities in Medicare spending: http://www.dartmouthatlas.org/interactive_map.shtm

High prices, red tape fuel popular Dallas doctor's move to Temple

Good article in today's NY Times comparing the Obama health reform plan to the Massachusetts experience, including a nifty graphic that summarizes the similarities and differences nicely.

I think Obama's initial emphasis on cost-control is smart - it's by no means clear that the U.S. can afford universal coverage at this point, and even if we tried, the effort would be doomed if unsustainable cost increases aren't also addressed. But eventually, in order for cost control to work, 49 million or so uninsured are going to have to get coverage:

Universal coverage should itself bring down costs over the long run by preventing chronic disease and reducing the amount of non-urgent care provided in emergency rooms. But it requires increased government spending in the form of subsidies for those who cannot now afford coverage.

Obama is starting to address access by focusing on kids first, which is politically astute and humane, and he will presumably expand public programs and public subsidies for private insurance incrementally.

Dallas Morning News: series on palliative care

This is quite a remarkable series of articles on end-of-life care and in particular palliative care at Baylor University Medical Center. Short of watching the amazing 6-hour documentary by Frederick Wiseman ("Near Death"), this is as close as most of us will get to the true in-hospital experience until it happens to one of us or someone we love. All of the articles are collected in one place, along with interactive tools and videos: At the Edge of Life: Life and death in 21st century medicine. I hope these links will work for a long time; the information and insights in these articles will be invaluable for many years to come.

WSJ backs incentives for organ donation

I know it will not come as a surprise that the house organ for American capitalism thinks a market for buying and selling human organs would produce a better system than the one we have now (100,000 patients on waiting lists, four times as many as were on lists when the current system was enacted into law in 1984), but maybe -- this time, at least -- they're right. Today's opinion piece, "Wait-Listed to Death" (WSJ link, Yahoo! Buzz link), doesn't lay out the full argument in favor of allowing for a market to develop, but it does offer its support for a modest rewrite of the National Organ Transplant Act by Sen. Arlen Specter (R.-Pa.).

The Journal doesn't say much about Specter's bill, other than that it would retain the ban on valuable consideration being paid for organs and increase the criminal penalties for violating the prohibition (both of which contradict the Journal's call for a market), but they seem to think the bill is a step in the right direction. But Specter appears not to have introduced the bill yet, nor has he described it in remarks from the floor of the Senate or posted so much as an outline of it on his Senate web site.

A columnist at the N.Y. Sun, Diana Furchtgott-Roth,, claims to have seen the three-page bill, or a summary of it. On September 24 she wrote:

according to the bill's summary, it would "increase the supply of donated organs by clarifying the legality of both government incentives that honor the gift of life and payments associated with the screening, pretransplantation care, and follow-up care expenses incurred by living organ donors." Both states and charities would be allowed to pay these expenses.

Ms. Fuchtgott-Roth adds: "As states sort out these issues, there are a variety of ways that they could permit compensation, such as funeral expenses, payments to an IRA, tuition or tax credits, or health insurance. One potential benefit to encourage donations would be to put donors and their families at the top of the list to receive kidney donations from others, should a future need arise."

In a December 4 post on the Encyclopedia Britannica Blog, John J. Pitney, Jr., writes that Specter is circulating a draft of his bill, the Organ Donor Clarification Act of 2008. If anyone has a copy, I'd love to see the "clarifying" language.

Meanwhile, Sally Satel, M.D., a resident scholar at the American Enterprise Institute, has a book coming out next month -- When Altruism Isn't Enough -- in which she and others make the case for economic incentives to encourage organ donation. Here's the AEI website's blurb:

America faces a desperate organ shortage. Today, more than 78,000 people are waiting for a kidney transplant; only one in four will receive one this year, while twelve die each day waiting for help. Not surprisingly, many patients are riven to desperate measures to circumvent the eight-year waiting list--renting billboards, advertising in newsletters, or even purchasing an organ on the global black market. Altruism is an admirable but clearly insufficient motivation for would-be donors.

What can be done to solve the kidney crisis? Reward organ donors for their remarkable gifts. Noncash benefits to people who donate to a desperate stranger will motivate others to do the same, increase the national supply of kidneys, and reduce needless death and suffering. When Altruism Isn't Enough: The Case for Compensating Kidney Donors explores the key ethical, theoretical, and practical concerns of a government-regulated donor compensation program. It is the first book to describe how such a system could be designed to be ethically permissible, economically justifiable, and pragmatically achievable.

Altruism is a beautiful virtue, but relying on it as the sole impetus for organ donation ensures that thousands of people will continue to die each year while waiting for kidney transplants.

Sally Satel, MD, is a resident scholar at the American Enterprise Institute.

Contributors: David C. Cronin II, MD, Julio J. Elias, Richard A. Epstein, Michele Goodwin, Benjamin E. Hippen, MD, Elbert S. Huang, MD, Arthur J. Matas, MD, David O. Meltzer, MD, Sally Satel, MD, Mary C. Simmerling, James Stacey Taylor, Nidhi Thakur, Chad Thompson.

It's already on my list for 2009. For those who can't wait that long, AEI has some of her articles on the subject posted on their website:

• Satel & Benjamin Hippen, M.D., Forbes, Oct. 30, 2008
• Satel, Slate, August 18, 2008

Finally, let's recall that last December Congress itself amended the prohibition-of-organ-sales provision in the National Organ Transplant Act (42 U.S.C. 274e) to make it clear that the law doesn't prohibit paired organ exchanges (Pub. L. No. 110-144, 121 Stat. 1813). The amendment codified the conclusion of a DOJ Memorandum Opinion that paired organ exchanges are not a form of "valuable consideration" in violation of the Act. Although, with the amendment, the point is now moot, I disagreed with DOJ on this, although I approved its conclusion on pure policy grounds. (In brief, if B, the spouse of patient A , isn't a good match with A but is a good match for patient C, and C's spouse, D, is a match for patient A, and B agrees to donate a kidney to Patient C in return for D's promise to donate a kidney to patient A, I think the exchange of promises -- and certainly the exchange of kidneys -- is valuable consideration. Not that there should be anything wrong with that . . . . )

Whatever evil Congress had in mind when it enacted the prohibition, this couldn't have been it, but it does open the door ever so slightly to at least some kinds of valuable exchanges. Based on what I've read about Sen. Specter's bill-to-be, the states ought to be able to craft their own benefit packages to create incentives without risking the commodification of the body and coercing desperate poor people into donating their organ in order to put food on the table.

Vatican issues 3rd major bioethics pronouncement in 21 years

First, it was Donum Vitae (The Gift of Life) in 1987, followed by Evangelium Vitae (The Gospel of Life) in 1995. Now the Vatican has given us its third major pronouncement on bioethics in over 2 decades with Dignitas Personae (The Dignity of the Person), released today. The instruction was issued by the Congregation for the Doctrine of the Faith (formerly headed by Pope Benedict XVI) and (as the N.Y. Times put it) "carries the approval and authority of [the Pope]." In light of the Holy See's numerous lesser statements over the years, it comes as no great surprise that the document condemns the morning-after pill, the IUD, RU-486, the freezing of embryos (a common practice for couples who undergo in vitro fertilization), stem-cell research (if the stem cells were derived from embryos: stem cells from adults, cord blood, or fetuses who died of natural causes are okay), human cloning, and designer babies.

Cleveland Clinic addresses financial conflicts of interest head-on

Today's Times has an interesting piece on the Cleveland Clinic's new policy of

publicly reporting the business relationships that any of its 1,800 staff doctors and scientists have with drug and device makers.

The clinic, one of the nation’s most prominent medical research centers, is making a complete disclosure of doctors’ and researchers’ financial ties available on its Web site, http://www.clevelandclinic.org/.

It appears to be the first such step by a major medical center to disclose the industry relationships of individual doctors. And it comes as the nation’s doctors and hospitals are under mounting pressure to address potential financial conflicts of interest that can occur when they work closely with companies to develop and research new drugs and devices.

The public reporting will be pretty minimal, at least at first, but the Cleveland Clinic gets points for getting out in front on this issue. Expect other research/treatment centers to follow suit. Charles Grassley and his colleagues on the Senate Finance Committee will be going after academic medical centers and others to deal with financial conflicts openly, and major drug firms like Merck and Lillyhave already announced their intention to publicly disclose payments to physicians next year.

13-year-old refuses heart transplant

The story of Hannah Jones is provoking some strong reactions -- both positive and negative -- in the U.K. The 13-year-old girl has refused a heart transplant without which her doctors say she has only months to live. Hannah's reasoning: potentially lousy quality of life and the possibility that the anti-rejection medicine will trigger a relapse of the leukemia she's been treated for since she was five years old. Her parents supported her decision, which was initially challenged by the hospital and protective services, at least until the hospital dropped its legal challenge. The story is well reported in The Guardian.

Larry Gostin's "Public Health Law" text in new edition

The great just got better.

No public-health law library would be complete without Larry Gostin's Public Health Law -- Power, Duty, Restraint. Originally published eight years ago, PHL was always more than simply a good place to start your research: Gostin's opus had depth to match its breadth.

Well, now the second edition of PHL has been published by the University of California Press (it also sells for 10% off on Amazon.com and qualifies for Amazon Prime).

Described as "revised and expanded," the new volume more than lives up to its billing. With no apparent change in the size of the page or the font and typeface, the new edition weighs in at 767 pages, up nearly 300 pages over the original. The index -- already good -- has been improved, and the endnotes have nearly doubled in length.

The text has been reorganized in a more logical, thematically consistent manner, and there are new chapters on global health and administrative law and regulation.

On the basis of a quick review, I recommend the new edition without reservation.

Health insurers agree to drop pre-existing condition exclusion

You read that right. According to an article in today's New York Times, the two big health-insurance industry associations have agreed to enroll all applicants, regardless of pre-existing condition. The catch? They will only do so if Congress requires all citizens to have health insurance.

The industry's concern is pretty easy to understand: moral hazard. Without a requirement of universal participation, health individuals will have little or no incentive to have and pay for health insurance until they need it, with the assurance that after a serious accident or the diagnosis of a significant health condition they can't be turned down by a health insurer. The system works best, as one industry spokesperson made clear, when everyone's in, so that the healthy contribute to the payment of health-care costs for the sick and injured.

During the presidential campaign, Hillary Clinton favored universal mandatory coverage, while Barack Obama supported mandates only for children, preferring to wait until insurance was demonstrably affordable and available for all. Yesterday's announcement addresses the latter concern. All that's left (as if this were a small detail) is to ensure that insurance products are affordable -- AND to agree on a mechanism for ensuring universal participation in the insurance pool. These are far from small details, but at least the industry is showing some willingness to move in the direction of significant health-care reform.

Washington passes PAS ballot measure

The State of Washington became the second state in the U.S. to legalize physician-assisted suicide. Initiative 1000 passed 58-42, according to the Seattle Post-Intellgencer. The measure looks virtually identical to the Oregon Death With Dignity Act, which was enacted in 1997. The law becomes effective in 120 days after the Nov. 4 election: March 4.

It's a matter of time before PAS is legal in a majority of states: 20 years, probably sooner. This is a law that appeals to liberals and libertarian-minded conservatives. The Catholic church and reliably right-to-life groups will always be against it, but as the tidal wave of boomers crashes into their sixties and seventies, the call for legalization will become more incessant, and the Oregon (and soon the Washington) experience will provide the counterargument against those who (like me) worry about abusive practices and a decrease in the commitment to provide effective palliative care at the end of life. The record in Oregon puts the lie to both of those concerns.

Interesting report from The Commonwealth Fund:

More than two-thirds of respondents to the latest Commonwealth Fund/Modern Healthcare Health Care Opinion Leaders Survey believe the way we pay for health care in the United States must be fundamentally reformed. Fee-for-service payment--the most prevalent system throughout the country--is not effective in encouraging high-quality, efficient care, they say.

In the survey, there was strong support for a move away from fee-for-service payment toward bundled approaches--that is, making a single payment for all services provided to a patient during the course of an episode or period of time. Under fee-for-service, providers are reimbursed for individual services, like hospital stays and medical procedures, rather than for providing the most appropriate care for the patient over the course of an illness. This creates incentives for providing more technical and more expensive--but not necessarily more effective -- care.

When asked their opinions about policies for improving U.S. health system performance, 85 percent of survey respondents cited fundamental provider payment reform, including incentives to provide high-quality and efficient care over time, as an effective strategy.

Tax-exempt hospitals and "community benefit"

Excellent discusion by John Colombo over at Nonprofit Law Prof Blog, ostensibly about the recent GAO report, Nonprofit Hospitals: Variation in Standards and Guidance Limits Comparison of How Hospitals Meet Community Benefit Requirements (GAO 08-880), but also about current thinking as to whether nonprofit hospitals should be tax-exempt in the first place. His conclusion:

Though I've mellowed on that subject since writing my first article about tax exemption for nonprofit hospitals 20 years ago, when I read stories like this one in the Wall Street Journal (subscription required), detailing how Ascension Health is closing inner-city facilities that lose money in favor of massive investment in suburban hospitals that generate profits (complete with widescreen TV's in private rooms!), I begin to think that any hospital that (1) does not qualify as an educational organization (e.g., a university-affiliated teaching hospital) or (2) does not PRIMARILY serve the poor (an inner-city hospital or perhaps some rural hospitals that are the only source of health care services in their geographic area) ought to be denied exempt status. Let Ascension Health, which reported aggregate net operating revenues of over $500 million last year, pay taxes like any other big business. Which is what it really is.

Seton Hall Law Review Symposium

Preparing for a Pharmaceutical Response to Pandemic Influenza:
A Seton Hall Law Review Symposium

October 23-24, 2008
Seton Hall University School of Law
Newark, NJ

Co-Sponsored by
The Center for Health & Pharmaceutical Law and the
Gibbons Institute of Law, Science & Technology
at Seton Hall University School of Law
Newark, New Jersey

Seton Hall Law School’s Center for Health and Pharmaceutical Law, the Health Law & Policy Program, the Gibbons Institute of Law, Science & Technology, and the Seton Hall Law Review will host a symposium to examine the legal, ethical, and public policy issues related to developing a pharmaceutical response to an influenza pandemic. Panels will explore issues related to the development and approval of vaccines and antiviral drugs, both before and during a pandemic; the allocation of vaccines and antiviral drugs in situations of scarcity; and issues related to international equity.

The Symposium welcomes all students, faculty members, government officials, pharmaceutical industry representatives, healthcare professionals, and members of the general public.

Admission is free.

Register online at: http://law.shu.edu/pandemic.

Pay for the best care, save money

Cary Grant is supposed to have said it's cheaper in the long run to buy the best shoes possible -- they will hold up better, last longer, look better over time than the supposedly less expensive alternative. It turns out that health care may work the same way. Here are the opening paragraphs of a Bloomberg News story posted yesterday (and brought to my attention by a student in my health law class):

Ken Ferguson, 54, maintains the bulldozers and heavy trucks that haul coal at the Belle Ayr mine near Gillette, Wyoming. In return, his employer, Foundation Coal Holdings Inc., provides his family with the best medical care it can buy.

Ferguson's wife, Shanna, had her colon removed last year because of chronic inflammatory disease. Foundation sent her 700 miles away to the top-ranked Mayo Clinic in Rochester, Minnesota. The company covered the $85,000 bill for the operation and follow-up reconstructive surgery and even paid for Ken's motel.

"I was at the best place with the best doctors possible,'' said Shanna, 50. "And we saved money.''

So did Foundation. The coal producer says it has found an unconventional way to cut health costs: Seek out the nation's best care and give workers incentives to use it. About two-thirds of operations have proven to be cheaper at better-rated hospitals out of state. Even when the price was higher, the Linthicum Heights, Maryland-based company saved money by reducing misdiagnoses, complications and repeat procedures.

Health-care costs for an average employee at Foundation's two Wyoming mines have dropped about 5 percent a year since the program took full effect in 2005, while U.S. spending rose about 7 percent annually. As Foundation's Wyoming workforce grew, its total medical bills remained steady at about $5.5 million a year.

Insurer to pay $225M settlement in Medicaid coverage-denial suit

The Kaiser Network has picked up on a report from Reuters that Amerigroup has settled a qui tam whistleblower suit in which it was accused of denying coverage to Medicaid beneficiaries who were pregnant or had health problems. (Under the law, Amerigroup was obligated to provide coverage for a Medicaid enrollees.)

Amerigroup claims its enrollment practices were intended to meet the objections of state officials that it was enrolling too many women who were late in their pregnancies. A jury rejected that claim and found instead that the insurer had engaged in systemic and wide-ranging fraud. The settlement occurred while Amerigroup's appeal from the 2006 judgment for $334 million was pending. The qui tam relator, former Amerigroup employee Cleveland Tyson, will walk away with a cool $56.3 million, his share of the recovery under the federal civil False Claims Act.

Forget the legal niceties for just a moment. Set aside the company's self-serving statements about needing to put this matter behind them and to move for the good of the company and its shareholders. And postpone thoughts that this sorry episode is a staggering example of the internal conflict of interest that plagues all health insurers.

Think instead of the extent of the human misery Amerigroup caused by denying coverage under this corporate policy. After the judgment was reduced by $109 million as a result of the settlement, it was still the largest health fraud recovery in Illinois' history (see Ill. AG's news release), and deservedly so.

Pediatric DCD in the news

Today The Washington Post has an article -- Infant Transplant Procedure Ignites Debate -- that builds on yesterday's AP article about three cases in which infant hearts were harvested under a "donation after cardiac death" ("DCD") protocol, which all transplant centers are required by UNOS and HHS. The details of each center's protocol may vary.

On the crucial issue of how long to wait before death is declared following the removal of life support and the onset of pulselessness, the Children's Hospital of Denver team waited 75 seconds in two of the cases and 3 minutes in the third; most centers' protocols require either 2 minutes or 5. Part of the ethical debate turns on whether this is long enough to be assured that autoresuscitation won't occur, a key component in determining that the absence of cardiac function is total and irreversible. Not to put too fine a point on it, if autoresuscitation can't be ruled out, irreversibility can't be assured, and if the loss of cardiac function isn't irreversible according to reasonable medical standards, the infant donors can't really be said to have died.

A second part of the debate concerns the removal of hearts from patients who haven't been declared brain dead. Most protocols of which I am aware are limited to kidneys; some include other organs, but I am not aware of any others that permit the harvesting of thoracic organs, hearts in particular. Think about it: If the heart's ability to beat (which is in some sense "intrinsic" because it is not tied to brain function) is supposedly irreversible, how can that be true when the heart (in all three cases) is working perfectly well in other bodies three years later? Two conclusions seem inescapable: The donor babies were erroneously declared dead and the traditional "dead donor rule" was abandoned

The debate was prompted by one clinical report, three Perspective pieces, and an editorial in today's New England Journal of Medicine, plus a videotaped discussion among three ethicists. It's unusual for the NEJM to devote this must space to any single topic. Even more unususal -- and a sign of how seriously they take the issues raised by the clinical report -- is their decision to make all five pieces available in full text (rather than abstracts only) for free:

Clinical report:

• Pediatric Heart Transplantation after Declaration of Cardiocirculatory Death M. M. Boucek and Others
  FREE Full Text PDF

Perspectives:

• The Boundaries of Organ Donation after Circulatory Death
  J. L. Bernat
  FREE Full Text PDF Perspective Roundtable
• Donating Hearts after Cardiac Death — Reversing the Irreversible
  R. M. Veatch
  FREE Full Text PDF Perspective Roundtable
• The Dead Donor Rule and Organ Transplantation
  R. D. Truog and F. G. Miller
  FREE Full Text PDF Perspective Roundtable

Editorial:

• Cardiac Transplantation in Infants
  G. D. Curfman, S. Morrissey, and J. M. Drazen
  FREE Full Text PDF Perspective Roundtable

The video discussion is here (requires Flash), along with a transcript.

"For better or worse, for richer or poorer, in sickness and in health . . . "

How to pick a life partner, 2008-style: "Let's see. . . . Good personality? Check. Kind to small animals and young children? Check. Reasonably communicative and okay with intimacy? Check. Excellent health care insurance? DOUBLE CHECK!!" That's the message in yesterday's New York Times article, Health Benefits Inspire Rush to Marry, or Divorce.

It's a sign of the times. As HLS Prof. Elizabeth Warren has written, "Every 30 seconds in the United States, someone files for bankruptcy in the aftermath of a serious health problem." (See also her SSRN article on this topic.) Insurance coverage is no guarantee that a person won't financially devastated by illness:

Nobody's safe. That's the warning from the first large-scale study of medical bankruptcy.

Health insurance? That didn't protect 1 million Americans who were financially ruined by illness or medical bills last year.

A comfortable middle-class lifestyle? Good education? Decent job? No safeguards there. Most of the medically bankrupt were middle-class homeowners who had been to college and had responsible jobs -- until illness struck.

As part of a research study at Harvard University, our researchers interviewed 1,771 Americans in bankruptcy courts across the country. To our surprise, half said that illness or medical bills drove them to bankruptcy. So each year, 2 million Americans -- those who file and their dependents -- face the double disaster of illness and bankruptcy.

But the bigger surprise was that three-quarters of the medically bankrupt had health insurance.

How did illness bankrupt middle-class Americans with health insurance? For some, high co-payments, deductibles, exclusions from coverage and other loopholes left them holding the bag for thousands of dollars in out-of-pocket costs when serious illness struck. But even families with Cadillac coverage were often bankrupted by medical problems.

Too sick to work, they suddenly lost their jobs. With the jobs went most of their income and their health insurance -- a quarter of all employers cancel coverage the day you leave work because of a disabling illness; another quarter do so in less than a year. Many of the medically bankrupt qualified for some disability payments (eventually), and had the right under the COBRA law to continue their health coverage -- if they paid for it themselves. But how many families can afford a $1,000 monthly premium for coverage under COBRA, especially after the breadwinner has lost his or her job?

Often, the medical bills arrived just as the insurance and the paycheck disappeared.

Bankrupt families lost more than just assets. One out of five went without food. A third had their utilities shut off, and nearly two-thirds skipped needed doctor or dentist visits. These families struggled to stay out of bankruptcy. They arrived at the bankruptcy courthouse exhausted and emotionally spent, brought low by a health care system that could offer physical cures but that left them financially devastated.

Considering the overwhelming impact medical debt can have on other aspects of domestic life, is it any wonder that domestic life is occasionally getting bent in ways that are intended (regardless of the prospect for success) to keep the wolf from the door.

As the article points out, divorce is also an option that couples will consider in order to qualify one or the other of them for state-provided benefits. (This is an old Medicaid-planning device.) The example that is in the article is compelling:

Other couples, like Michelle and Marion Moulton, are forced to consider divorce so that an ailing spouse can qualify for affordable insurance.

Ms. Moulton, 46, a homemaker who lives near Seattle with her husband and two children, learned three years ago that she had serious liver damage, a side effect, she believes, of drugs she was once prescribed. She is trying to get on a transplant list, but the clock is ticking; her once slender body has ballooned, and her doctors say her liver could give out at any time.

Mr. Moulton, a self-employed painting contractor, maintains a catastrophic coverage plan for his family, but its high deductibles and unpredictable reimbursements have left them $50,000 in debt. Without better coverage, a transplant could add unthinkable sums.

Two years ago, Ms. Moulton looked into buying more comprehensive coverage through the Washington State Health Insurance Pool, a state-financed program for high-risk patients. She found the premiums unaffordable, but noticed that the state offered subsidies to those with low incomes. As their debts and desperation multiplied, it occurred to Ms. Moulton that divorcing her husband of 17 years would make her eligible for the subsidized coverage.

“I felt like I had done this to us,” she said. “We had worked hard our entire lives, and if this was all the insurance we had, we could become homeless. I just said, ‘You know, we really need to sit down and talk about divorce.’ ”

Mr. Moulton would not consider it — at first. “From a male point of view, you want to be able to fix things, you want to be able to provide,” he said.

“Then you start looking at what things cost and what someone with no assets can get in terms of funding, and you have to start thinking about it.”

The conversations ebbed and flowed with the family’s financial pressures. They talked about the effect on their children and where they might live. They weighed the legal and financial risks against the prospects of bankruptcy.

The debate continued until this summer, when Mr. Moulton’s father offered financial help. “I know we don’t take charity from anyone,” Mr. Moulton told his wife, “but I’m not going to divorce you and I’m not going to let you die.”

Though grateful for the lifeline, the couple remains unsettled by how close they came.

“Nobody should have to make a choice like that,” Ms. Moulton said. “What happened to our country? I don’t remember growing up like this.”

Good question. What happened to our country?

U.S. health care reform: can 8 out of 10 Americans be wrong?

The latest from The Commonwealth Fund is a report based upon a Harris Interactive survey that sought the opinions of a sample of 1,004 adults about our health care system. Here's a summary of the results:

Overall, the telephone survey of a representative sample of 1,004 adults age 18 and older reveals that the health care delivery system does not serve the public well — eight of 10 respondents say it needs to be fundamentally changed or completely rebuilt. Many adults experience difficulties accessing care and poor care coordination, and struggle with the administrative hassles and complexity of health insurance. In addition, the survey found that one of three adults has experienced inefficient or unnecessary care in the past two years. Adults want their health care to be more patient-centered and integrated, and see an important role for information technology and teamwork in improving care. Reflecting these shared concerns, there is strong support for the next president to address health care quality, coverage, and costs.

The data brief and data packs are all available here.

Congresswoman Slams Religious Right's Assault on Science's "Edgier" Side

Scientific American has an on-line interview with Colorado Rep. Diana DeGette, who recently published, "Sex, Science and Stem Cells: Inside the Right Wing Assault on Reason" (Congresswoman Slams Religious Right's Assault on Science's "Edgier" Side). Here's their intro:

Six-term Democratic Congresswoman Diana DeGette owns a dubious distinction: She is one of the two co-authors of the bill that garnered President George W. Bush's first-ever veto.

The subject of the legislation: embryonic stem cells. DeGette, who represents Colorado's 1st District—which includes Denver and its environs—is for them. The president isn't.

On July 19, 2006, President Bush ceremoniously vetoed the bill, the Stem Cell Research Enhancement Act of 2005, even though it had passed both the House and Senate by wide margins—though the gaps were not large enough to override a veto. When he signed the veto, the chief executive was surrounded by so-called "snowflake babies," kids born from discarded IVF (in vitro fertilization) embryos that other couples had "adopted" through a Christian agency. These children wouldn't exist, he said, if embryos were used for stem cell research.

These publicity stunts, according to DeGette, have helped kill a wide range of legislation on sex and reproduction: the plan B "morning after" birth control pill, the human papillomavirus vaccine (touted as the best method for preventing cervical cancer), and even sex education—many Republicans advocate abstinence-only instruction.

New Study Looks at Uninsurance Among Immigrants

New Study Looks at Uninsurance Among Immigrants

[from today's Kaisernetwork.org's Daily Health Policy Report]

Although U.S.-born residents still make up the majority of uninsured U.S. residents, the percentage of uninsured documented and undocumented immigrants is growing, according to a study released on Tuesday by the Employee Benefit Research Institute, the Kansas City Star reports. EBRI researchers analyzed U.S. Census data for the study and found that immigrants accounted for 18.8% of uninsured residents in 1994 and 26.6% in 2006, the last year in which data were available. According to the study, 12.3 million immigrants and 34.1 million U.S.-born residents were uninsured in 2006.

In 2006, more than 46% of noncitizen immigrants were uninsured, compared with 19.9% of immigrants who gained citizenship and 15% of U.S.-born residents. The study found several factors that contributed to the higher number of uninsured immigrants. Immigrants are more likely to take lower-wage job positions that typically do not offer health insurance benefits, according to the study. In addition, the Personal Responsibility and Work Opportunity Act of 1996 contributes to the figures because it mandates that documented immigrants live in the U.S. for five years before they become eligible for government-sponsored health care and other programs. The study also found that the longer immigrants lived in the U.S., the more likely they were to acquire health insurance.

According to the study, 58.7% of uninsured immigrants lived in California, Texas, Florida or New York. The study did not define whether an immigrant was documented or undocumented (Kansas City Star, 8/5). The study is available online (.pdf).

Latest health-related reports from GAO

Electronic Health Records: DOD and VA Have Increased Their Sharing of Health Information, but More Work Remains. GAO-08-954, July 28, 2008 (43 pages).
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-954

Emergency Preparedness: States Are Planning for Medical Surge, but Could Benefit from Shared Guidance for Allocating Scarce Medical Resources. GAO-08-668, June 13, 2008 (53 pages).
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-668

Hurricane Katrina: Trends in the Operating Results of Five Hospitals in New Orleans before and after Hurricane Katrina.
GAO-08-681R, July 17, 2008 (56 pages).
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-681R

Indian Health Service: IHS Mismanagement Led to Millions of Dollars in Lost or Stolen Property. GAO-08-727, June 18, 2008 (41 pages).
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-727

Indian Health Service: Mismanagement Led to Millions of Dollars in Lost or Stolen Property and Wasteful Spending. GAO-08-1069T, July 31, 2008 (10 pages).
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-1069T

Influenza Pandemic: Federal Agencies Should Continue to Assist States to Address Gaps in Pandemic Planning. GAO-08-539, June 19,
2008 (47 pages).
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-539

Long-Term Care Insurance: Oversight of Rate Setting and Claims Settlement Practices. GAO-08-712, June 30, 2008 (35 pages).
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-712

Long-Term Care Insurance: State Oversight of Rate Setting and Claims Settlement Practices. GAO-08-1016T, July 24, 2008 (19 pages).
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-1016T

Medicaid Home and Community-Based Waivers: CMS Should Encourage States to Conduct Mortality Reviews for Individuals with Developmental Disabilities. GAO-08-529, May 23, 2008 (49 pages).
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-529

Medicare Part B Imaging Services: Rapid Spending Growth and Shift to Physician Offices Indicate Need for CMS to Consider Additional Management Practices. GAO-08-452, June 13, 2008 (49 pages).
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-452

Medicare Part D: Complaint Rates Are Declining, but Operational and Oversight Challenges Remain. GAO-08-719, June 27, 2008 (34 pages).
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-719

Prescription Drugs: FDA's Oversight of the Promotion of Drugs for Off-Label Uses. GAO-08-835, July 28, 2008 (41 pages).
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-835

VA Health Care: Ineffective Controls over Medical Center Billings and Collections Limit Revenue from Third-Party Insurance Companies. GAO-08-675, June 10, 2008 (57 pages).
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-675

Veterans Affairs: Health Information System Modernization Far from Complete; Improved Project Planning and Oversight Needed.
GAO-08-805, June 30, 2008 (39 pages).
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-805

Veterans Health Administration: Improvements Needed in Design of Controls over Miscellaneous Obligations. GAO-08-1056T, July 31,
2008 (32 pages).
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-1056T

Texas Attorney General: Charitable Hospital Summit

For those interested in charity care and community benefits in Texas, the Texas Attorney General is hosting a "summit" on Tuesday, September 16, in Austin. The schedule looks pretty good, if a little basic, but it's the Attorney General's office, for crying out loud, and they do have enforcement authority for Health and Safety Code chapter 311 (though it would be nice to know whether the speakers include OAG personnel or members of the private bar):

8:30 AM - Charity Care and the Patient Panel Discussion
Correctly identifying and communicating with charity care patients and formulating effective charity care policies and procedures will maximize the effectiveness of nonprofit hospital charity care programs. This panel will offer options to better communicate with this patient population while educating hospitals on common pitfalls in charity care compliance, suggesting policies to improve documentation and exploring alternatives to help hospitals care for those in greatest need.

9:30 AM - Governance Best Practices
What is your governance strategy? As a board member do you routinely demand and receive specific documents? Do you have a financial management plan? This speaker will capsulize best practices for hospitals; discuss the leading governance trends with a focus on executive compensation; and offer guidance for implementing best practices to be a h5er [sic], healthier organization.

10:15 AM - Break

10:30 AM - Two Concurrent Breakout Sessions

1. What is The True "Cost" of Health Care?
The excessive cost of health care is a topic of considerable focus in America today. This presentation will explore the method of defining the actual "cost" of care through a review of variables used to account for specific costs while offering suggestions as to which of these variables should and should not be included in charity care cost determination.

2. Joint Ventures – Doctor-owned Hospitals Panel Discussion
Hospital-physician joint ventures are a major strategic focus of many nonprofit hospitals. Regardless of the configuration, such ventures can present legal and business risks while providing a healthy choice for both the patients and the hospital. This panel explores the pros and cons of these alternative joint ventures.

11:30 AM - Break

11:45 AM - Keynote Luncheon
The Honorable Greg Abbott, Attorney General of Texas

12:45 PM - Break

1:00 PM - Community Benefits Panel Discussion
In Texas, all nonprofit hospitals are required to prepare community benefit plans based on community needs. The plans must state how the identified community needs will be addressed. Frequently, hospitals do so without an adequate assessment of community needs, clear goals or a defined plan of action. This panel will provide solid "how to" steps to develop and implement a plan of action to enhance the benefits your organization provides within your communities.

1:45 PM - Break

2:00 PM - Health Insurance and its Role in Health Care Delivery and Charitable Hospitals Panel Discussion
Although the American health care system has been said to provide the best quality health care to the majority of our citizens, there is a growing disparity in access to health care because of soaring medical costs, rising insurance premiums, and long term health care insurance spirals. This is particularly true in Texas. This panel will discuss these issues and provide some innovative solutions to these critical concerns.

2:45 pm - Health Care Delivery Trends Panel Discussion
Health care delivery can come in a variety of shapes and sizes. This panel will address recent health care trends, such as retail clinics, and the effect these trends have on more traditional health care models. Are the new models providing a service that was missing in the health care arena? Are these models providing patients with convenient, transparent, affordable access to health care? Or is the retail clinic patient in jeopardy due to the lack of consistency that is offered in the family practice model? This panel will also address the structure, failures and successes of select international delivery models.

3:45 PM - Break

4:00 PM - New Federal Reforms for Charitable Hospitals
The IRS recently completed the largest overhaul of the Organization Exempt Form Income Tax Form 990 tax return in over 25 years providing additional requirements for nonprofit hospitals. Both the IRS and Congress are actively examining how nonprofit hospitals fulfill their public purpose warranting tax-exempt status. Commissioner Miller will give us an overview of how these changes will affect charitable hospitals in Texas.

What it means to be uninsured in America

The New York Times has an article (Millions With Chronic Disease Get Little to No Treatment) today about the most recent Annals of Internal Medicine survey (abstract) of just exactly what health care services the uninsured with chronic conditions aren't getting. Here's a brief excerpt:

The study, the first detailed look at the health of the uninsured, estimates that about one of every three working-age adults without insurance in the United States has received a diagnosis of a chronic illness. Many of these people are forgoing doctors’ visits or relying on emergency rooms for their medical care, the study said.

The report, based on an analysis of government health surveys of adults ages 18 to 64 years old, estimated that about 11 million of the 36 million people without insurance in 2004 — the latest year of the study — had received a chronic-condition diagnosis.

“These are people who, with modern therapies, can be kept out of trouble,” said Dr. Andrew P. Wilper, the study’s lead author. Therapies for someone with diabetes and hypertension “are routine and widely available, if you have insurance,” said Dr. Wilper, a medical instructor at the University of Washington in Seattle.

The most recent government estimate of the number of people in this country without health insurance is 47 million, which means that if the proportions found in the study have remained constant, there might be nearly 16 million people in this country with a chronic condition but no insurance to pay for medical care.

Nearly a quarter of the uninsured with a chronic illness who were surveyed said they had not visited a health professional within the last year. About 7 percent said they typically went to a hospital emergency room for care.

All hospitals have to pull their weight on uncompensated care

Tim Walters filed this op-ed piece Saturday in the Cleveland Plain Dealer: All hospitals have to pull their weight on uncompensated care. Seems MetroHealth, the nationally recognized public hospital in town, is in perilous financial condition. It is the largest provider of uncompensated health care in the state of Ohio, and if it goes under, Walters wonders what will happen to indigent patients whose medical home is MetroHealth, not to mention everyone in the community who relies on MetroHealth's unique capabilities (the area's only Level I trauma unit, trauma burn care, etc.).

Walters' answer: Before this happens, how about all the hospitals in the area stepping up to the line and shouldering their fair share of charity care? Of course, hospitals with emergency departments have their EMTALA obligation to screen and to stabilize, but the lion's share of ED admissions and nonemergency charity care is coming from MetroHealth, not University Hospitals (can you spot the ED -- or the maze you have to solve -- on their interactive map?) or the Cleveland Clinic (same question).

5th Circuit's decision in Poliner is out

Total win for Presbyterian/THR/
medical-staff docs. HCQIA immunity for money damages held to apply to emergency suspension decisions during the fact-investigation phase of the peer-review process. Judge Higginbotham's opinion for a unanimous panel is here. It looks bullet-proof to me . . . . Pretty amazing saga, which I am sure won't be over until there's a petition for reconsideration/rehearing en banc: from a $360-million jury verdict to a remitted judgment for $33 million (still amazing for peer-review case) to $0.

Trying to Save by Increasing Doctors’ Fees

Trying to Save by Increasing Doctors’ Fees

That's the headline in this morning's New York Times' story about health plans (including Medicare) that are going to try to gin up some extra compensation for primary and preventive care in the hope that it will reduce more costly acute care down the road. Could it be? The dawning of the Age of Common Sense? Stay tuned . . .

Making Malpractice a Criminal Matter

The Wall Street Journal's Law Blog has an entry today on a criminal case brought against a physician at the Harvard School of Public Health. The case is described a little more fully in the Boston Globe. According to the Globe story, the physician -- Dr. Rapin Osathanondh -- was performing an abortion on a 22-year-old woman who died during the procedure. Dr. Osathanondh was subsequently charged by the state medical board with unprofessional conduct, on the basis of these allegations:

The board alleged that Osathanondh had placed the patient under sedation without any means to monitor her heart rate, blood pressure, or the oxygen level of her blood. The board said the doctor had no qualified person assisting him while Smith was under anesthesia. The only other person in the room was an office worker who had no CPR or other training in lifesaving procedures.

The board added that Osathanondh "failed to timely initiate a call to 911," "failed to maintain an adequate airway," and "failed to adhere to basic cardiac life support protocol."

Osathanondh also allegedly made a variety of false statements to board investigators, telling them that he had administered Smith oxygen and monitored her oxygen levels and that his office worker was certified in lifesaving procedures. He allegedly tried to deceive investigators by expanding the size of his treatment room and bringing in new equipment, which he maintained was there at the time of the abortion.

While it is rare for allegations of medical malpractice to be channeled through the criminal justice system, it's not unheard of. There's a point at which ordinary negligence shades into gross negligence (which can still be handled in the tort system) and at which gross negligence evidences the kind of recklessness that qualifies as a criminal offense. I am not competent to have an expert opinion about what happened in this case, but the cries of outrage about this case resulting in a criminal prosecution are a bit overdrawn. Extreme negligence -- multiple departures and wild departures from the standard of care -- if proved, can properly be a matter for the criminal justice system whether the defendant is a nightclub owner who locks the fire exits (resulting in hundreds of deaths after a fire breaks out) or a member of the medical profession.