Billion-dollar Medicare fraud case in Miami on the ropes

. . . for prosecutorial misconduct. However this case turns out, both sides have issues for the inevitable appeal.

https://www.miamiherald.com/news/local/article216589740.html

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.