SCOTUS (7-2): Any company that wants to eliminate contraceptive coverage now gets a free pass to do so

You read that right. Whether the objection is based upon the religious beliefs of the owners of a closely-held corporation (Hobby Lobby, 2014) or is based upon the moral beliefs of a publicly-traded mega-corporation, the Trump Administration's rule exempting companies from the ACA's mandate for women's health services at a reasonable price has, at least for now, been upheld by the Supreme Court.

In Little Sisters of the Poor Saints Peter and Paul Home v. Pennsylvania, the Court held that the Health Resources and Services Administration -- which the ACA authorized to come up with a list of mandatorily covered FDA-approved drugs and devices -- was also given the power to decide who would be subject to the mandate as well as what the mandate covered. Five justices (Justice Thomas, who wrote the majority opinion, and the four conservative justices everyone assumed would vote to uphold the regulation) agreed that the ACA was clear that HRSA could decide both the who and what questions. Justice Ginsburg, joined by Justice Sotomayor, dissented on the ground that the ACA was clear that HRSA had delegated authority to decide only the what question, not the who question.

Neither the majority nor the dissent mentioned Chevron deference, but Justice Kagan's concurring opinion (joined by Justice Breyer) did. (In their previous lives, both Kagan and Breyer were prominent administrative-law scholars while on the Harvard Law School faculty.) As Kagan wrote, sometimes when she squints real hard, the ACA looks as though its delegation to HRSA is broad enough to include the who question. And other times, the ACA seems to delegate only the what question to HRSA. In other words, either choice would have been a reasonable one for HRSA, in which case Chevron requires deference to the choice made by the agency.

This decision is bad news for women, make no mistake about it. As Lourdes Rivera of the Center for Reproductive Rights stated, "Today’s ruling has given bosses the power to dictate how their employees can and cannot use their health insurance — allowing them to intrude into their employees’ private decisions based on whatever personal beliefs their employers happen to hold."

But this isn't the last word on the subject. The case now goes back to the trial court to decide a potentially dispositive question under the Administrative Procedure Act: Whether the Trump Administration's rule is arbitrary and capricious. Five justices (the liberal/moderates plus Chief Justice Roberts) have recently demonstrated a willingness to hold this Administration's feet to the APA's fire in a few big cases (the citizenship question on the census questionnaire, DACA), and Justice Kagan's concurrence devotes 3-1/2 of its 6-1/2 pages to an analysis of the ways in which the HRSA rule might fail the APA's "arbitrary and capricious" test. They include (bulleted points are quoted from Justice Kagan's opinion]:

• Most striking is a mismatch between the scope of the religious exemption and the problem the agencies set out to address. In the Departments’ [HRSA, which promulgated that rule, and the Departments of Health and Human Services, Labor, and the Treasury, which "incorporated" them] view, the exemption was “necessary to expand the protections” for “certain entities and individuals” with “religious objections” to contraception. 83 Fed. Reg. 57537 (2018). Recall that under the old system, an employer objecting to the contraceptive mandate for religious reasons could avail itself of the “self-certification accommodation.” Upon making the certification, the employer no longer had “to contract, arrange, [or] pay” for contraceptive coverage; instead, its insurer would bear the services’ cost. 78 Fed. Reg. 39874 (2013). That device dispelled some employers’ objections—but not all. The Little Sisters, among others, maintained that the accommodation itself made them complicit in providing contraception. The measure thus failed to “assuage[]” their “sincere religious objections.” 82 Fed. Reg. 47799 (2017). . . . Given that fact, the Departments might have chosen to exempt the Little Sisters and other still-objecting groups from the mandate. But the Departments went further still. Their rule exempted all employers with objections to the mandate, even if the accommodation met their religious needs. In other words, the Departments exempted employers who had no religious objection to the status quo (because they did not share the Little Sisters’ views about complicity). The rule thus went beyond what the Departments’ justification supported --raising doubts about whether the solution lacks a “rational connection” to the problem described. [emphasis added]
• And the rule’s overbreadth causes serious harm, by the Departments’ own lights. In issuing the rule, the Departments chose to retain the contraceptive mandate itself. See 83 Fed. Reg. 57537. Rather than dispute HRSA’s prior finding that the mandate is “necessary for women’s health and well-being,” the Departments left that determination in place. HRSA, Women’s Preventive Services Guidelines (Dec. 2019), www.hrsa.gov/womens-guidelines-2019; see 83 Fed. Reg. 57537. The Departments thus committed themselves to minimizing the impact on contraceptive coverage, even as they sought to protect employers with continuing religious objections. But they failed to fulfill that commitment to women. Remember that the accommodation preserves employees’ access to cost-free contraceptive coverage, while the exemption does not. See ante, at 5–6. So the Departments (again, according to their own priorities) should have exempted only employers who had religious objections to the accommodation—not those who viewed it as a religiously acceptable device for complying with the mandate. The Departments’ contrary decision to extend the exemption to those without any religious need for it yielded all costs and no benefits. Once again, that outcome is hard to see as consistent with reasoned judgment. [emphasis added]
• Other aspects of the Departments’ handiwork may also prove arbitrary and capricious. 
• For example, the Departments allow even publicly traded corporations to claim a religious exemption. See 83 Fed. Reg. 57562–57563. That option is unusual enough to raise a serious question about whether the Departments adequately supported their choice. [emphasis added]
• Similarly, the Departments offer an exemption to employers who have moral, rather than religious, objections to the contraceptive mandate. Perhaps there are sufficient reasons for that decision—for example, a desire to stay neutral between religion and non-religion. See 83 Fed. Reg. 57603–57604. But RFRA cast a long shadow over the Departments’ rulemaking, see ante, at 19–22, and that statute does not apply to those with only moral scruples. So a careful agency would have weighed anew, in this different context, the benefits of exempting more employers from the mandate against the harms of depriving more women of contraceptive coverage. In the absence of such a reassessment, it seems a close call whether the moral exemption can survive. [emphasis added]

We can only wait to see if the APA rides to the rescue one more time.

The Virus Rolls Along; Nurses are in Shorter Supply than Equipment

ICU beds and, just as critically, ICU personnel are at or near capacity in Florida, Texas, Nevada, and California. Two Texas counties are "urging" shelter in place. Houston is estimated to be 2 weeks from 100% capacity; the shortage is personnel, not beds. Dallas County had over 1,000 new cases yesterday, a new record for the third day in a row. And the experts tell us we are just at the beginning of this epidemic. See Becker's Hospital Review and the Dallas Morning News. The pandemic is going in the wrong direction, giving proof of Dr. Fauci's statement that we are still in the early phase of dealing with this outbreak.

The Republican members of Congress and the Texas legislature -- including Lt. Gov. Dan Patrick --  who resist orders to wear face masks in public as unconstitutional need to have an adult explain the constitution to them. The power of the state to impose mandatory public-health requirements on citizens was upheld in 1905 by a conservative Supreme Court of the United States in Jacobson v. Massachusetts. The Court agreed that an exception could be made when the public-health measure in question (smallpox vaccination) constituted a medical threat to an individual, but otherwise, reasonable public-health mandates do not violate the due process clause of the Constitution.

New FTC-DOJ Guidelines on Vertical Mergers

This is the first joint statement on vertical mergers in 36 years. Granted, the lion's share of healthcare mergers appear to be horizontal, not vertical, but Becker's Hospital Review cites the CVS acquisition of Aetna as a vertical merger that would have been reviewable under these new guidelines, issued June 30. Here's the PDF link.

Follow-up on Haavi Morreim's post re: triage protocols

This is from Kenneth Alan Totz, DO, JD, FACEP (reprinted with permission):

As an attorney and emergency physician practicing in Arizona, Texas, and Colorado, your bottom-line prediction is correct. It is not within our DNA to ration healthcare. Our medical community is extremely resourceful and generous sharing resources within the state and across state lines. If the patient reasonably needs something, we find a way to get it for them. On my last shift this week, I transferred a patient hundreds of miles away via fixed wing aircraft to get the ICU resources they needed. Our hospital had run out of remdesivir as well. This was an intubated 67 year old hispanic gentlemen with COVID with a history of diabetes, hypertension, hypercholesterolemia, and a prior coronary by-pass surgery. The discussion of this patient's comorbidities was never raised when deciding to push forward with advanced medical care. The states can enact rationing of resource protocols, but the physicians are not necessarily going to adhere to them. Just like the minority patients have a distrust of the healthcare system, the medical community has a general distrust that they will NOT be legally protected if these rationing algorithms need to be instituted. 

Triage Protocols and Disparate Racial Impact

Law and Medicine scholar Haavi Morreim recently posted an excellent analysis of the problem on a discussion list maintained by the American Health Law Association. I reproduce it here, with Haavi's permission:

Issues of triage and rationing in Covid-19 have been discussed extensively within the bioethics community.  One prominent protocol (adapted and/or adopted at many sites) aims to maximize lives saved, and also life-years saved; additionally it emphasizes transparency with both the community and the patient/family.  The authors of these protocols have strived mightily to achieve something intellectually satisfying, ethically excellent. 

A major flaw has been that, to maximize life-years saved, we look to co-morbidities.  So guess which communities have the highest rates of co-morbidity - - yes, it's minority communities.  Add to this the fact that the SOFA score these protocols use is well-acknowledged not to be highly accurate in predicting mortality ("yes we know, but it's the best we have").   

And now add in the huge mistrust that many minority communities have for the healthcare establishment.  At the front end, that mistrust has many in these communities reluctant to be tested at all (fear that "you're putting the virus on that swab so you can give me the disease" has been documented) - - and indeed, sometimes reluctant to seek regular care (my pediatrics colleagues find some of their minority mothers reluctant to accept routine vaccinations for their children, citing fear that the vaccines now have the virus inserted into them).   

And now add in transparency + that mistrust.  We're supposed to tell a minority family "your dad won't be intubated because he doesn't meet our criteria."  "Our criteria . . . " So we (the ones they mistrust) will supposedly assure them "our criteria" are racially neutral.  But in fact they are not.  Check out NEJM, online June 18:  Vyas et al, "Hidden in Plain Sight - Reconsidering the Use of Race Correction in Clinical Algorithms" (attached).  It has long been documented that racial minorities receive less care, on many fronts.  This piece explains part of the reason why.  Minority distrust of the healthcare system is not some sort of mindless, baseless paranoia. 

My prediction -- and what has actually happened, so far, across the country -- is that healthcare providers will not actually implement these protocols.  They will find another vent, split a vent 2 or 4 ways, retrain another nurse . . . do whatever it takes to avoid this sort of rationing.  And they will be right to do that.

Where is OSHA? AWOL, apparently

18,000 complaints from employees. 12,000 cases closed with no action. More noncompliance to come. No inspections. No enforcement actions. Nothing. Employees are dying in the name of limited government, combined with a delusional belief in voluntary compliance by employers. Secretary of Labor Eugene Scalia has their blood on his hands. "Shameful" doesn't begin to describe OSHA's abject failure to enforce guidelines. The story appeared in NPR's Weekend-Saturday show with Scott Simon, 7/4/2020.

Thanks to Feedspot

Proud to be listed in Feedspot’s list of top 75 health law blogs. See #17 in the list to the right.

Heading in the wrong direction

I have known Brett Giroir since he was a pediatric critical-care fellow at Childrens Medical Center (now Children's Health) in Dallas. He is a brilliant physician and a dedicated public servant, and his advice to the country should be heeded. He has announced his intention to leave his post later this summer, and it will be a loss for the nation. (Wash. Post, 7/2/20).

American Airlines is dropping the ball big-time

I fly American Airlines all the time. I suppose when this pandemic is over, I will fly American Airlines again. But they are acting totally irresponsibly  cramming passengers into middle seats, considering the many opportunities passengers have to lower or take off their masks during flight.

Medicaid Expansion in Oklahoma and North Carolina (sort of) -- What's Up, Texas?

From The Washington Post (6/30/20):

Oklahomans voted Tuesday to alter their state constitution to expand Medicaid over nearly a decade of opposition by Republican governors, making their state the first to widen the safety-net insurance program as the coronavirus pandemic steals jobs and health benefits. 

The expansion’s approval, by a slender margin, means that an estimated 250,000 additional Oklahoma residents will be eligible for the public insurance, including nearly 50,000 who have lost coverage as unemployment has soared this year.

And from  The Raleigh News & Observer (7/2/2020), news that the governor of North Carolina has signed a bill to create a private Medicaid managed care option sometime between now and July 2021. The devil's in the details, and Medicaid managed care is notoriously difficult to implement, but the move is being hailed as a first step toward Medicaid expansion.

Meanwhile Texas -- with the highest rate of uninsured persons in the country -- continues to freeze out 1 million people who would be covered if the state were to join 38 other states (including deep red Oklahoma) and expand eligibility requirements (with generous federal matching funds) pursuant to the Affordable Care Act. (Texas Tribune, 2/27/20).

Racism and COVID-19

It seems to be almost universally acknowledged that health disparities have been unveiled and exacerbated during this pandemic, and that the health disparities are the result of generations of disparities in economic opportunity, housing, education, and criminal justice, to name a few. "Systemic disparities" needs to be seen for what it is: a euphemism for widespread racism. This is the generating concept behind a discussion that is currently on-going at Health Affairs, the leading health policy journal in the U.S.:

COVID-19 has affected an estimated 10.7 million people, resulting in an estimated half a million deaths globally, including more than 128,000 deaths in the US. As the COVID-19 pandemic unfolds, stark disparities in infection and mortality risk along racial lines have emerged.  

Understanding and addressing racial disparities in COVID-19 requires attention to the root causes of health disparities—and, in particular, to the health impacts of racism. Racism, be it overt, structural, or environmental, is an undeniable part of the United States’ history and present.  

Writing on Health Affairs Blog, researchers and providers explore the intersections of racism, health disparities, and COVID-19.  

Dismantling health care inequities will require addressing the structural racism at the root of both COVID-19 disparities and the murders of George Floyd and other Black Americans, Alexander Bryan and coauthors write. 

Sandra Soo-Jin Lee and coauthors say the COVID-19 recovery phase presents “a rare and critical opportunity” to pursue audacious policies that dismantle structural inequities and address structural racism, including redirecting state spending on prisons to public health. 

Despite racism’s alarming impacts on health and health care, preeminent scholars and the journals that publish them, including Health Affairs, routinely fail to interrogate racism as a critical driver of racial health inequities, Rhea Boyd and coauthors write. 

Drawing lessons from Critical Race Theory, Michelle Morse and colleagues argue that the COVID-19 crisis offers a unique opportunity to mobilize US physicians to advocate for progressive social policies that dismantle structural racism and structure our society more equitably. 

Acknowledging the urgency of both health and racial justice in this moment, Sheila Foster and coauthors set forth a legal agenda to fight the health effects of racism in housing, policing, the environment, and other areas. 

As Health Affairs Editor-In-Chief Alan Weil wrote recently, the legacy of racism “is baked into our institutions, our thinking, and our policies.” Racism must be explored as a key driver of health outcomes and health disparities.  

Follow the conversation on Twitter @Health_Affairs. 

Public Health System in Tatters

 From Kaiser Health Network (KHN) and the Associated Press (AP):Hollowed-Out Public Health System Faces More Cuts Amid Virus

By Lauren Weber and Laura Ungar and Michelle R. Smith, The Associated Press and Hannah Recht and Anna Maria Barry-Jester 

The U.S. public health system has been starved for decades and lacks the resources necessary to confront the worst health crisis in a century. An investigation by The Associated Press and KHN has found that since 2010, spending for state public health departments has dropped by 16% per capita and for local health departments by 18%. At least 38,000 public health jobs have disappeared, leaving a skeletal workforce for what was once viewed as one of the world’s top public health systems. That has left the nation unprepared to deal with a virus that has sickened at least 2.6 million people and killed more than 126,000. 

 Here are six key takeaways from the KHN-AP investigation:

1. Since 2010, spending for state public health departments has dropped by 16% per capita, and for local health departments by 18%. Local public health spending varies widely by county or town, even within the same state.
2. At least 38,000 state and local public health jobs have disappeared since the 2008 recession, leaving a skeletal workforce in what was once viewed as one of the world’s top public health systems.
3. Nearly two-thirds of Americans live in counties that spend more than twice as much on policing as they spend on non-hospital health care, which includes public health.
4. More than three-quarters of Americans live in states that spend less than $100 per person annually on public health. Spending ranges from $32 in Louisiana to $263 in Delaware.
5. Some public health workers earn so little that they qualify for government assistance. During the pandemic, many have found themselves disrespected, ignored or even vilified. At least 34 state and local public health leaders have announced their resignations, retired or been fired in 17 states since April.
6. States, cities and counties whose tax revenues have declined during the current recession have begun laying off and furloughing public health staffers. At least 14 states have cut health department budgets or positions, or were actively considering such cuts in June, even as coronavirus cases surged in several states.

Nero + Fiddle = Covid-19 disaster

Trump and Pence know not what they say or do. And thousands of people are going to pay the ultimate price for their folly: 

Breaking News: Dr. Anthony Fauci warned the U.S. could see 100,000 new coronavirus cases a day, citing surges that put “the entire country at risk.” “It could get very bad,” he said.

Watch his Senate testimony live here.

Commentary on June Medical Services v. Russo

Today's three SCOTUSblog commentators aren't claiming "Victory" in yesterday's 5-4 ruling striking down Louisiana's patently unconstitutional abortion law: https://www.scotusblog.com/category/special-features/symposia-on-rulings-from-october-term-2019/symposium-on-the-courts-ruling-in-june-medical-services-v-russo/.

They're right to be worried. Justice Roberts made it perfectly clear that on the merits he believes Louisiana was within its rights to require doctors who perform abortions to have admitting privileges in a nearby hospital.

This, of course, is a position the Court rejected four years ago in Whole Women's Health, which involved a nearly identical Texas requirement (and from which CJ Roberts dissented). But doing the math in 2020, there are now five justices who believe Whole Women's Health was incorrectly decided. Chief Justice Roberts' concurring opinion yesterday was based on the slenderest of reeds -- stare decisis -- and, although it provided the fifth vote to doom the Louisiana law, clearly signaled that a majority of the Court is open to an interpretation of Casey's "undue burden" test that allows states to impose draconian and unjustifiable burdens on a woman's right to choose.

The Roe/Casey consensus hangs by the slenderest of threads.

One pill retails for $15.98 or $0.11: Who decides?

As if I needed more evidence of how messed up our health care system is. I went to the pharmacy this morning to pick up a 90-day supply of Xarelto, a blood thinner prescribed by my cardiologist. List price: $1,437.98. My co-pay: $430. That's steep, but it works out to $4.78/day to help prevent blood clots that could go to my heart, lungs, or brain.

The pharmacy tech took pity on me and said, "Let's see if we can get you a better price on that." Ten minutes later, he found a manufacturer's discount that's available for Blue Cross/Blue Shield subscribers, and now my co-pay (for this 90-day supply as well as each of the next three 90-day supplies): $10.00. That's not a typo; that's ten bucks.

Total one-year savings off the list price equals $5,711.92 (who pays that? people with no insurance, that's who), and total one-year savings off my co-pay amount equals $1,680 (and who pays that? my employer (SMU) and fellow BC/BS subscribers (or at least the ones in the SMU health plan). On a personal note, I really owe that Tom Thumb pharmacy tech. On a more meta level: Would anyone design a health care system this random and capricious?

Liability protection for employers in a post-pandemic world

The Washington Post has a piece on the split between GOP and Dem leadership in the US Senate over a proposed blanket immunity for employers whose employees become infected with the novel coronavirus. I am sure Dallas isn't alone in having restaurants (and other businesses?) whose owners are prohibiting the wearing of protective masks by their employees. Are they counting on the exclusive remedy under workers' comp to protect them from civil liability? I wouldn't.

A Victory for the ACA in the Supreme Court

The government suffered a loss today in its on-going battle to undo the Affordable Care Act through its "death by a thousand cuts" strategy. The case is MAINE COMMUNITY HEALTH OPTIONS v. UNITED STATES. (N.B. There is something strange and sad to say that the ACA won in the on-going war this administration has been waging to gut a law -- not a perfect law but nonetheless a transformative one that made health insurance available to millions of individuals and families formerly priced out of the system.) The issue was a fairly technical one, but it was decided on a basis that most first-year law students would grasp immediately: "shall" means "shall" and implied statutory repeals are highly disfavored. Only Justice Alito dissented, and that was on a totally separate ground: Assuming the Court was right in its statutory-interpretation analysis, it was wrong to conclude that a private right of action exists to allow insurance companies who lost money through their participation in the ACA marketplaces to sue the United States for a "bailout."

Smart comments on responding to the coronavirus pandemic

Words to the wise from Greg Mankiw: http://gregmankiw.blogspot.com/2020/03/thoughts-on-pandemic.html.

Covid-19 and politics

The New Yorker has a good piece online (not sure the link works for non-subscribers). I'd forgotten that VP Pence told Anthony Fauci on Friday that he needed to withdraw from his scheduled appearances on all five of the Sunday t.v. news programs. Wouldn't want the science of the coronavirus to get out ahead of the political posturing, eh, Mike?

Our patchwork "system" of health care

Here are the first three headlines from today's Becker's CFO Report:

1. CHS to end inpatient care at 2 Florida hospitals Full story
2. Texas health system files for bankruptcy, owes BCBS $29M  Full story
3. Children's Hospital of Philadelphia pumps $3.4B into expansion  Full story

Good summary of the ACA case now officially before the Supreme Court

From The New York Times

SCOTUS to review 5th Circuit's bizarro-world decision in the ACA case

From SCOTUSBlog:

California v. Texas
Docket No. 19-840

Issues: (1) Whether the individual and state plaintiffs in this case have established Article III standing to challenge the minimum-coverage provision in Section 5000A(a) of the Patient Protection and Affordable Care Act (ACA); (2) whether reducing the amount specified in Section 5000A(c) to zero rendered the minimum-coverage provision unconstitutional; and (3) if so, whether the minimum-coverage provision is severable from the rest of the ACA.

WaPo: The health care industry is letting surgeons behave like muggers

And we patients are expected to negotiate with them? Read on.

It’s not only surgeons, of course, but this Washington Post story lays out the problem pretty clearly. Surprise billing can happen whenever a cross-covering physician is out-of-network. A colleague checked before scheduling spine surgery to make sure the scheduled anesthesiologist was in-network. Absolutely, the office manager replied. Not so much the day of surgery, when a different — out-of-network — anesthesiologist was substituted in at the last minute. That’s how a $1500 bill became a $15,000 one.

There is only word for a fractured health care “system” this unresponsive to the needs of patients and the requirements of contract law: broken.

20 Democratic-led states ask SCOTUS to review the 5th Circuit's ACA opinion

The Washington Post was one of the first on this story, but there will be dozens more before the day is over. I'll track the best of the opinion pieces in future posts.

There's every reason to think the Supreme Court will decline the request: the decision wasn't final (there was a remand back to Dist. J. Reed O'Connor to reconsider the severability issue), there's no circuit conflict, and it would be a huge partisan issue during a presidential election year. On the other hand, four justices can grant review, so the five conservatives can't stop four more moderate-to-liberal justices from accepting review. Even if that happens, there are a number of obstacles between the grant and an opinion on the merits, including a DIG (dismissal as improvidently granted). Stay tuned . . .

Link to Professor Bagley‘s commentary on Fifth Circuit ACA opinion

His NEJM argument is laid out in The Atlantic: https://www.theatlantic.com/ideas/archive/2019/12/affordable-care-acts-unconstitutional-flaw/603871/.

More on the Fifth Circuit’s partisan hatchet job in the ACA case

University of Michigan’s Nicholas Bagley does a fine job of shredding the logic of the court’s opinion in an article posted online today by the New England Journal of Medicine. Good luck getting a copy if you're not a subscriber and don't have access through an institutional library. Try Googling; you might find a version online.

2019 - Going, going, gone . . .

It's been a while since I posted to this blog, but 2019 shouldn't come and go without some recognition of a few developments of note, not only for the year just ending but for 2020 (and beyond?).

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] Issue(s): Whether the U.S. Court of Appeals for the 5th Circuit’s decision upholding Louisiana’s law requiring physicians who perform abortions to have admitting privileges at a local hospital conflicts with the Supreme Court’s binding precedent in Whole Woman’s Health v. Hellerstedt.

Gee v. June Medical Services, LLC, No. 18-1460 [Arg: 3.4.2020] Issue(s): (1) Whether abortion providers can be presumed to have third-party standing to challenge health and safety regulations on behalf of their patients absent a “close” relationship with their patients and a “hindrance” to their patients’ ability to sue on their own behalf; and (2) whether objections to prudential standing are waivable – per the U.S. Courts of Appeals for the 4th, 5th, 7th, 9th, 10th and Federal Circuits – or non-waivable per the U.S. Courts of Appeals for the D.C., 2nd, and 6th Circuits.

Physician-assisted suicide (or Aid-in-Dying) ain't easy

This is a powerful piece (reprinted with permission) from the Kaiser Family Foundation:

‘No One Is Ever Really Ready’: Aid-In-Dying Patient Chooses His Last Day

JoNel Aleccia, Kaiser Health News
In 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.

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.