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
Wednesday, January 01, 2020
More on the Fifth Circuit’s partisan hatchet job in the ACA case
Monday, December 30, 2019
2019 - Going, going, gone . . .
First, on Dec. 18 (revised Dec. 20) the Fifth Circuit decided that the ACA's individual mandate was unconstitutional because, once Congress repealed the tax/penalty the mandate lost its constitutional footing. It's a mechanistic (which is to say either naive or political, and "naive" isn't a word lightly to be applied to these judges) performance. The court's reason tracks that of District Judge Reed O'Connor in his December 2018 opinion (which was roundly and soundly criticized): The Supreme Court's 2012 decision upholding the ACA for the most part (with the major exception of the Medicaid expansion provision) held that the Taxing Clause provided the necessary constitutional hook for the individual mandate. Take away the tax/penalty and you take away that hook, as Congress did in 2017 (Pub. L. No. 115-97, § 11081, 131 Stat. 2054, 2092 (2017); see also 26 U.S.C. § 5000A(c)), eff. January 2019. In the view of the Fifth Circuit majority, once there's no tax involved, the mandate is an act of pure coercion, to which the court takes objection. As Nick Bagley at Michigan has argued (see my next post), it's hard to see how taking away the tax/penalty makes the mandate more coercive than it was with the mandate (which the Supreme Court upheld in 2012).
Second, the Fifth Circuit's opinion (above) is notable for what it didn't do: It didn't affirm Judge O'Connor's conclusion that, because the individual mandate no longer has a constitutional basis, the entire ACA must be thrown out as well. Judge O'Connor's sweeping decision was based upon what he deemed to be the inseverability of the individual mandate from the rest of the ACA. Unfortunately, the appellate court didn't reverse Judge O'Connor on this point, even though this part of Judge O'Connor's opinion is worse than his analysis of the mandate question; rather, it merely remanded the case back to the judge for reconsideration. Katie Keith has a nice summary of the implications of this decision in Health Affairs.
Third, on the Medicaid expansion front, four more states came aboard in 2019 (more or less -- political and legal prospects are not crystal clear). This leaves 14 states that haven't adopted the expansion, leaving billions of federal dollars on the table that could be paying for low-income health care.
Fourth, litigation and growing uncertainty surround the formerly settled concept of "brain death." Thad Pope does a good job of following the developments over on the Medical Futility Blog.
Fifth, the Supreme Court will hear oral argument on March 4, 2020, in two abortion cases. This is from SCOTUSBlog:
June Medical Services LLC v. Gee, No. 18-1323 [Arg: 3.4.2020] |
Gee v. June Medical Services, LLC, No. 18-1460 [Arg: 3.4.2020] |
Wednesday, August 15, 2018
Physician-assisted suicide (or Aid-in-Dying) ain't easy
‘No One Is Ever Really Ready’: Aid-In-Dying Patient Chooses His Last Day
JoNel Aleccia, Kaiser Health NewsIn the end, it wasn’t easy for Aaron McQ to decide when to die.
The 50-year-old Seattle man — a former world traveler, triathlete and cyclist — learned he had leukemia five years ago, followed by an even grimmer diagnosis in 2016: a rare form of amyotrophic lateral sclerosis, or ALS.
An interior and urban designer who legally changed his given name, McQ had been in pain and physical decline for years. Then the disease threatened to shut down his ability to swallow and breathe.
“It’s like waking up every morning in quicksand,” McQ said. “It’s terrifying.”
Last fall, McQ decided to use Washington state’s 2009 Death With Dignity law to end his suffering. The practice, approved in seven states and the District of Columbia, allows people with a projected six months or less to live to obtain lethal drugs to end their lives.
Although the option was legal, actually carrying it out was difficult for McQ, who agreed to discuss his deliberations with Kaiser Health News. He said he hoped to shed light on an often secretive and misunderstood practice.
“How does anyone get their head around dying?” he said, sitting in a wheelchair in his Seattle apartment in late January.
More than 3,000 people in the U.S. have chosen such deaths since Oregon’s law was enacted in 1997, according to state reports. Even as similar statutes have expanded to more venues — including, this year, Hawaii — it has remained controversial.
California’s End of Life Option Act, which took effect in 2016, was suspended for three weeks this spring after a court challenge, leaving hundreds of dying patients briefly in limbo.
Supporters say the practice gives patients control over their own fate in the face of a terminal illness. Detractors — including religious groups, disability rights advocates and some doctors — argue that such laws could put pressure on vulnerable people and that proper palliative care can ease end-of-life suffering.
Thin and wan, with silver hair and piercing blue eyes, McQ still could have passed for the photographer’s model he once was. But McQ’s legs shook involuntarily beneath his dark jeans and his voice was hoarse with pain during a three-hour effort to tell his story.
Last November, doctors told McQ he had six months or less to live. The choice, he said, became not death over a healthy life, but a “certain outcome” now over a prolonged, painful — and “unknowable” — end.
“I’m not wanting to die,” he said. “I’m very much alive, yet I’m suffering. And I would rather have it not be a surprise.”
In late December, a friend picked up a prescription for 100 tablets of the powerful sedative secobarbital. For weeks, the bottle holding the lethal dose sat on a shelf in his kitchen.
“I was not relaxed or confident until I had it in my cupboard,” McQ said.
At the time, he intended to take the drug in late February. Or maybe mid-March. He had wanted to get past Christmas, so he didn’t ruin anyone’s holiday. Then his sister and her family came for a visit. Then there was a friend’s birthday and another friend’s wedding.
“No one is ever really ready to die,” McQ said. “There will always be a reason not to.”
Many people who opt for medical aid-in-dying are so sick that they take the drugs as soon as they can, impatiently enduring state-mandated waiting periods to obtain the prescriptions.
Data from Oregon show that the median time from first request to death is 48 days, or about seven weeks. But it has ranged from two weeks to more than 2.7 years, records show.
Neurodegenerative diseases like ALS are particularly difficult, said Dr. Lonny Shavelson, a Berkeley, Calif., physician who has supervised nearly 90 aid-in-dying deaths in that state and advised more than 600 patients since 2016.
“It’s a very complicated decision week to week,” he said. “How do you decide? When do you decide? We don’t let them make that decision alone.”
Philosophically, McQ had been a supporter of aid-in-dying for years. He was the final caregiver for his grandmother, Milly, who he said begged for death to end pain at the end of her life.
By late spring, McQ’s own struggle was worse, said Karen Robinson, McQ’s health care proxy and friend of two decades. He was admitted to home hospice care, but continued to decline. When a nurse recommended that McQ transfer to a hospice facility to control his growing pain, he decided he’d rather die at home.
“There was part of him that was hoping there were some other alternative,” Robinson said.
McQ considered several dates — and then changed his mind, partly because of the pressure that such a choice imposed.
“I don’t want to talk about it because I don’t want to feel like, now you gotta,” he said.
Along with the pain, the risk of losing the physical ability to administer the medication himself, a legal requirement, was growing.
“I talked with him about losing his window of opportunity,” said Gretchen DeRoche, a volunteer with the group End of Life Washington, who said she has supervised hundreds of aid-in-dying deaths.
Finally, McQ chose the day: April 10. Robinson came over early in the afternoon, as she had often done, to drink coffee and talk — but not about his impending death.
“There was a part of him that didn’t want it to be like this is the day,” she said.
DeRoche arrived exactly at 5:30 p.m., per McQ’s instructions. At 6 p.m., McQ took anti-nausea medication. Because the lethal drugs are so bitter, there is some chance patients won’t keep them down.
Four close friends gathered, along with Robinson. They sorted through McQ’s CDs, trying to find appropriate music.
“He put on Marianne Faithfull. She’s amazing, but, it was too much,” Robinson said. “Then he put on James Taylor for, like, 15 seconds. It was ‘You’ve Got a Friend.’ I vetoed that. I said, ‘Aaron, you cannot do that if you want us to hold it together.’”
DeRoche went into a bedroom to open the 100 capsules of 100-milligram secobarbital, one at a time, a tedious process. Then she mixed the drug with coconut water and some vodka.
Just then, McQ started to cry, DeRoche said. “I think he was just kind of mourning the loss of the life he had expected to live.”
After that, he said he was ready. McQ asked everyone but DeRoche to leave the room. She told him he could still change his mind.
“I said, as I do to everyone: ‘If you take this medication, you’re going to go to sleep and you are not going to wake up,’” she recalled.
McQ drank half the drug mixture, paused and drank water. Then he swallowed the rest.
His friends returned, but remained silent.
“They just all gathered around him, each one touching him,” DeRoche said.
Very quickly, just before 7:30 p.m., it was over.
“It was just like one fluid motion,” DeRoche said. “He drank the medication, he went to sleep and he died in six minutes. I think we were all a little surprised he was gone that fast.”
The friends stayed until a funeral home worker arrived.
“Once we got him into the vehicle, she asked, ‘What kind of music does he like?’” Robinson recalled. “It was just such a sweet, human thing for her to say. He was driving away, listening to jazz.”
McQ’s friends gathered June 30 in Seattle for a “happy memories celebration” of his life, Robinson said. She and a few others kayaked out into Lake Washington and left McQ’s ashes in the water, along with rose petals.
In the months since her friend’s death, Robinson has reflected on McQ’s decision to die. It was probably what he expected, she said, but not anything that he desired.
“It’s really tough to be alive and then not be alive because of your choice,” she said.
“If he had his wish, he would have died in his sleep.”
Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.
Tuesday, August 14, 2018
Billion-dollar Medicare fraud case in Miami on the ropes
https://www.miamiherald.com/news/local/article216589740.html
Saturday, July 28, 2018
First: smoke and mirrors. Followed by: pure bunkum.
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.
Wednesday, July 25, 2018
Why is this man smiling?
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!
Thursday, July 19, 2018
When futility itself is futile
Monday, July 16, 2018
Johnson & Johnson mega-verdict
"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.
Wednesday, July 11, 2018
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.
Friday, May 25, 2018
Hoping to visit this blog more than once every four years!
Wednesday, May 28, 2014
American University's 7th annual 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 . . . .
Friday, December 31, 2010
Sunday, September 27, 2009
Dallas Morning News' excellent series on health care costs (and other things that matter)
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
Patients' stories:
Regional disparities in Medicare spending: http://www.dartmouthatlas.org/interactive_map.shtm
High prices, red tape fuel popular Dallas doctor's move to Temple
Sunday, March 29, 2009
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.
Thursday, December 18, 2008
Dallas Morning News: series on palliative care
Wednesday, December 17, 2008
WSJ backs incentives for organ donation
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:
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: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.
- 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.
Friday, December 12, 2008
Vatican issues 3rd major bioethics pronouncement in 21 years
Wednesday, December 03, 2008
Cleveland Clinic addresses financial conflicts of interest head-on
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.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.