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