Thursday, July 31, 2014
On July 29, 2014, the U.S. Court of Appeals for the Fifth Circuit issued an as-applied ruling in a case involving Mississippi’s statute requiring that all physicians affiliated with a Jackson clinic providing abortion services have admitting and staff privileges at local hospitals. All local hospitals were unwilling to grant privileges to two of the clinic’s physicians who were involved most directly in abortion services because of the nature of their practices. Had the state’s statute been enforced, the clinic—Mississippi’s only facility offering abortion services—would have been ordered to close.
Mississippi’s argument was that ordering the clinic to close would not impose an undue burden on Mississippi women’s constitutional rights because women would be able to travel to nearby states for abortion services. The Fifth Circuit reasoned to the contrary: “Mississippi may not shift its obligation to respect the established constitutional rights of its citizens to another state. Such a proposal would not only place an undue burden on the exercise of the constitutional right, but would also disregard a state's obligation under the principle of federalism—applicable to all fifty states—to accept the burden of the non-delegable duty of protecting the established federal constitutional rights of its own citizens.” Jackson Women’s Health Organization v. Currier, 2014 WL 3730467 (July 29, 2014).
Wednesday, July 23, 2014
This has been cross-posted for a more general audience at ACSblog. Though it contains more background than most healthlawprof readers will need, analysis comes after the jump.
The D.C. Circuit held in Halbig v. Burwell that the IRS cannot provide tax credits to individuals who purchase private health insurance in states with federally-run insurance exchanges, potentially depriving millions of middle and low income Americans access to affordable health insurance. Improbably, while the blogosphere lit up, the Fourth Circuit held in King v. Burwell that the IRS properly interpreted the Affordable Care Act (ACA) to provide tax credits in all exchanges whether run by a state or the federal government. Members of the Obama Administration immediately declared they will seek rehearing by the D.C. Circuit en banc. The standard of review for petitions for rehearing is rigorous, but given the importance of the case, and the new circuit split, rehearing is conceivable. Further, it is not unreasonable to anticipate that the Supreme Court ultimately will grant a petition for certiorari in either or both of these cases. If it is upheld, Halbig could be the most damaging decision in the ACA litigation wars yet. For those not mired in the details of the ACA and its ongoing legal challenges, here’s why.
The ACA attempts to create near-universal insurance coverage by making Americans insurable and by commanding insurers to play by uniform rules. The ACA was created because, in 2008, one in five Americans did not have health insurance coverage. To make this number tangible, imagine everyone you know with blue eyes… and now imagine they do not have health insurance. That’s how many were uncovered, and the lack of coverage was just about that random too. In the United States, if you don’t have health insurance, you don’t have access to consistent healthcare. The ACA has clear goals, but it is a muddy scrum of legislative drafting that never underwent a conference committee process, and that imprecision has facilitated the litigation in these cases.
To avoid adverse selection (the problem of free riding), the ACA requires Americans to carry minimum essential coverage or face a tax penalty (upheld in NFIB v. Sebelius); however, if insurance premiums would cost more than 8% of an individual’s income, then no tax penalty will be assessed. To facilitate health insurance coverage, the ACA created health insurance exchanges, also called marketplaces, where individuals and small groups can purchase health insurance that provides standardized benefits without exclusions for preexisting conditions and other disequalizing prohibitions. People who earn 100-400% of the federal poverty level are eligible for federal tax credits that assist in paying premiums for private insurance on the exchanges (“premium assistance tax credits,” codified at 26 U.S.C. 36B), increasing substantially the number of people who can afford to purchase private health insurance.
States were given a choice to create exchanges with federal funding under ACA section 1311, and if they opted not to, then the federal government would create “such” exchange in the state under ACA section 1321. Sixteen states and D.C. created their own exchanges before January 1, 2014, so currently two-thirds of states have federally-run exchanges. This landscape is shifting slightly as some states’ exchanges fail and they move to federal mechanisms, while other states are still eyeballing the federal money available until 2015. What matters here is that the majority of exchanges were federally-run on the day that Halbig was decided.
Monday, January 20, 2014
What are We Learning About Brain Death from the McMath and Munoz cases?
By Jennifer S. Bard, J.D., M.P.H., Ph.D.
With the understanding that this is one of those topics that health law professors are supposed to know something about, here is a quick update of what’s going on. Along with my own views about the possible misuse by hospitals of declaring brain death in what are really medical futility cases.
Jahi McMath, age 12, in California who lost consciousness after a routine tonsillectomy and Marlize Munoz, age 32 in Texas who collapsed on her kitchen floor have both become involuntary public figures as their families struggle to make sense of both their medical conditions, which are complex, and of the laws which have declared them both legally dead based on a lack of brain activity. In legal terms, a person declared “brain dead” has the same status as any other dead person. Each state is entitled to make its own decision of whether or not to adopt a brain death statute. California’s and Texas’ are similar in that they require the “complete cessation” of all brain activity. The declaration of death is, in all states, a legal act. Most hospitals have a policy similar to this one which set criteria and require the participation of at least two doctors. A declaration of death cuts off any rights of the individual. The family of someone declared dead is no longer a surrogate decision maker. Rather, they have something like property rights to the disposal of the remains. More pointedly, a declaration of death ends all eligibility for medical insurance, including Medicaid and Medicare. If a family decides to release the organs for donation, their host becomes not a patient but rather a “heart beating organ donor.”
When a family wants to donate their loved one’s organs, a declaration of brain death is helpful mechanism for doing so. Indeed, a series of high profile cases involving anencephalic infants in the 1990s pointed out the frustrations of parents who wanted to donate their children’s organs but could not because they retained minimal brain function. However, there is never any legal need for a declaration of brain death in order for a family to withdraw life sustaining treatment. In 1993 bioethicist Robert Veatch wrote an important article in the Hastings Center Report in which he pointed out that “no one really believes that literally all functions of the entire brain must be lost for an individual to be dead.” And indeed, no one really believes that a piece of paper converts a warm, breathing body from alive to dead.
Many families in the McMath’s situation would have, even in their shock, heeded the doctors advice and stopped treatment. Although we do not, yet, know what actually happened, I suggest that it is possible that cases like the McMath’s can arise when hospitals and doctors seek to pressure families into withdrawing treatment by, essentially, taking away their right to receive care. This can be a lot more direct than the often times consuming and complex process of withdrawing "futile" care. Indeed, in the actual absence of all brain function there are no interventions that can replace the complex functions of the human brain and deterioration and decay are inevitable.
Although it is easy enough to say that Jahi’s family’s refusal to accept reality stems from ignorance or grief, it is not fair, as some have done, to call them crazy for mistrust of a diagnoses that is based in theory, not reality. Jahi may be irrevocably brain injured, but there are increasing signs that she may indeed have some brain function. Her thrashing movements may be reflex, not purposeful—but corpses do not have reflexes. This week, neonatologist Dr. Paul Burn notes, without citation so we do not know if it is true, that Jahi, has regained sufficient hypothalamus function to regulate her own body temperature. A corpse does not regulate its own body temperature.
This is not to suggest that the doctors are wrong about the amount of brain damage she has sustained or her chances of even retaining a sliver of consciousness—but that is not the same as “complete cessation” of all brain activity.
In contrast to the case in California, Marlize’s family, in Texas, want to let her go. The hospital is invoking a provision of the Texas Advanced Directives Act law which prohibits a hospital from withdrawing life sustaining treatment from a pregnant women. It may be, as bioethics experts law Tom Mayo at SMU explain, that this law does not apply after a declaration of death, but only when the mother is in a permanent coma. But, again, this points out the limits of using the legal concept of brain death to describe the medical condition of any particular person. Marlize may well be dead, but her fetus certainly is not. But until Marlize’s family gets clarification in the case it has filed in Tarrant County, or, ultimately, the Texas Supreme Court this distinction does not change their situation.
So where does that leave a health law professor? One of the reasons brain death is so hard to define is that we know relatively little about how the brain works. As the American Academy of Pediatrics Guidelines Determination Of Brain Death In Infants And Children,“ No randomized control trials examining different strategies regarding the diagnosis of brain death exist.” It even seems increasingly likely that we are not even sure where all of what we consider to be brain function happens—it turns out-—as folk wisdom has always believed—that a lot of it may happen in our guts. .
It may be that these two cases spur changes to the law—although other equally publicized situations have not-but for teaching purposes they both are helpful in exposing law students to how much we actually do not know about the human body and, especially, our brains.
Wired Magazine, in August 2011, ran a fascinating article called, “7 Creepy Experiments That Could Teach Us So Much (if they weren’t so wrong). These “7 Creepy Experiments” include some truly creepy things like using “a synthetic virus” to insert into an embryonic cell a “reporter” gene (green fluorescent protein, for example) in order to track embryonic development throughout the life cycle or deliberately separating twins at birth in order to study them.” I use it in my Human Subject Research Law class to get students thinking about the limits of consent, but more generally it and these cases tell us something about the reality that we need to make and enforce law in the face of limited information.
Friday, January 17, 2014
On Wednesday, Judge Friedman (U.S. District Court, District of Columbia) granted summary judgment to Secretary Sebelius in Halbig v. Sebelius (2014 WL 129023). Individual plaintiffs and small businesses, supported by the Cato Institute, Competetive Enterprise Institute, and others, challenged the availability of tax credits in federally-run Health Insurance Exchanges as exceeding the IRS's administrative authority. The court found that the statute, Congress's intent, and the legislative history of the Affordable Care Act supported the IRS's regulations. Thus, tax credits will be available in Exchanges whether the insurance is purchased on an exchange created by a state or an exchange created by the federal government standing in the state's shoes. The opinion engaged in careful statutory analysis and found the first part of the Chevron test answered the legal questions the plaintiffs presented (though a footnote provided a quick second step analysis anyway). Professor Gluck called this decision a big win for the ACA given that Chevron deference was not necessary in the court's analysis, and the court's methodical statutory analysis is certainly persuasive. (Professor Bagley posted a similarly sanguine analysis here.) By all accounts, this decision is a win for the Obama Administration.
This solid decision ought to end this frivolous litigation, but the plaintiffs have already stated that they will file an appeal. As I discussed here and here, even though these challenges have no statutory traction, the plaintiffs are financially well supported, and they have the means to continue pressing their theories up the federal court ladder. And, the political climate inspires unhappy policy losers to pursue their desired outcome through the judicial branch when they have lost in the legislative and executive branches. Although the decision in NFIB v. Sebelius allowed the ACA to move forward, it opened the courthouse doors to litigation such as this, which pushes legal reasoning in directions that would not have been considered serious before the successes of the NFIB litigation. While I do not believe that Halbig et al. have a real case for preventing tax credits in federally-run exchanges, that will not necessarily prevent another federal court from finding a differently.
Tuesday, October 1, 2013
Despite best efforts to prevent the exchanges, or marketplaces, from going on line, today the exchanges have begun to do the work of facilitating a health insurance home for people in the United States. If you live in a state that has declined to create its own exchange, then you should visit https://www.healthcare.gov/, the federal website for the federal health insurance marketplace. Though there were reports of the site crashing, as of 3:00 this afternoon it seems to be working. And, the site will guide you to your state's marketplace site, as necessary. No need to rush though, as open enrollment lasts through March of 2014.
Many probably saw Governor Beshear's op-ed in the New York Times last week regarding the reasons that Kentucky has created its own state-based exchange (and will accept federal funding for the Medicaid expansion), here. The commentary seems even more relevant in the wake of the House Republicans shutting down the federal government over health insurance.
Friday, September 27, 2013
Big news in the world of ACA implementation: CMS approved Arkansas' proposed waiver for an alternative mechanism for Medicaid expansion, which is to be called the Arkansas Health Care Independence Program. Arkansas proposed a premium assistance program, wherein newly eligible Medicaid beneficiaries will obtain insurance through the Arkansas health insurance exchange by receiving financial assistance for premium costs. This will place the new Medicaid population in qualified health insurance plans, i.e. private health insurance, which is administratively more expensive than government-sponsored insurance, but it may help to deal with the problem of "churn" between Medicaid and Marketplace-based private insurance.
CMS's approval of Arkansas' Medicaid demonstration program is significant for a number of reasons, but here I'd like to focus on what I think is one of the biggest: this waiver approval will pave the way for other states that are "undecided" to finally declare their intent to expand their Medicaid programs. I believe this will happen relatively quickly, because most states are already working on expansion. You would not think this is true from the national media's reporting on the Medicaid expansion. If you have been following any of the many color-coded maps depicting the five possible categories of expansion (expanding, not expanding, leaning toward expanding, leaning toward not expanding, and alternative model), you would think that just over half of the states are participating in the Medicaid expansion. The national media has gotten this story wrong, because they do not pick up on the negotiations, investigations, committees, special commissions, and other ways in which the "leanging toward not participating" states are actually exploring how they can expand their Medicaid programs. To understand how dynamic the state decision making is, you have to track the local newspapers that follow every move of the state legislatures and their conversations with their governors (which I have been doing all summer).
After NFIB v. Sebelius was decided, I wrote that most states would still expand their Medicaid programs. It appears that most states are now working toward Medicaid expansion in some form. In future posts, I will explain this dynamic federalism story in more detail. For today, I will emphasize that CMS has opened the door to more state waivers, which will lead to more states expanding their Medicaid programs. Though I am not necessarily on board with federalism by waiver, espcially given states' history of waiver mistakes and failures, I do think that in this instance, alternative expansion is better than no expansion. Otherwise, many of our poorest citizens will be left out of the attempt at national insurance coverage, not paying a penalty, but not having access to much-needed healthcare either.
Wednesday, June 26, 2013
The Court's decision striking down section 3 of DOMA in United States v. Windsor was unsurprising, yet still a relief to many. Section 3 defined marriage for federal statutory purposes to mean only marriage between one man and one woman. Based on the late March oral arguments in Windsor, as well as Justice Kennedy's majority opinions in Lawrence v. Texas and Romer v. Evans, the common wisdom was that federalism would be the prevailing reasoning because the states historically have governed family law matters, including marital status. One of Justice Kennedy's projects has been revitalization of the Court's enforcement of federalism to protect the states, especially as a method to protect individual liberties (see, e.g., Bond v. United States).
And so it was. Justice Kennedy provided both structural and substantive reasons for striking down section 3 of DOMA. From a structural perspective, Justice Kennedy's majority emphasized traditional state dominion over marriage, writing: "By history and tradition, the definition and regulation of marriage ... has been treated as being within the realm of the separate States." Though the opinion walked right up to the federalism line, it stopped short of holding that DOMA exceeded congressional authority or violated the Tenth Amendment. Instead, the majority moved forward on substance and held that the federal government cannot take away the marriage right and its attendant societal status once conferred by the states. To do so was a violation of gay couples' liberty and dignity. The Court also hinted at an equal protection analysis, condemning Section 3 as creating second class marriages in states that recognize same-sex unions. The majority applied only rational basis review, rather than heightened scrutiny, holding that DOMA was motivated by anti-gay animus and served no legitimate governmental purpose.
Neither the federalism, nor the equal protection, nor the due process analysis was either complete or clear cut, and each opens more questions than it closes. For example, Justice Kennedy views the experiment of the states to protect individual liberty, and here, it happens that twelve states do protect liberty, more than the federal government. But, this view of federalism's aspirational work does not address the 37 or so states that do not protect the liberty interests of their gay citizens from state discrimination let alone the federal government's limited view of gay rights. And, this reversion to assessing traditional state law domains does not advance modern conceptions of federalism that acknowledge most state law is ineffibly intertwined with federal law by virtue of statutory interconnectedness, conditional spending, or other cooperative federalism mechanisms. Instead, Justice Kennedy seemed to be reaching back to the dual sovereign model of doctrinal federalism.
Fortunately, this regressive model of federalism does not seem to hinder the work that Windsor is likely to do with regard to DOMA's far-reaching effects on healthcare. For example, marital status influences not only access to affordable private health insurance (which is usually easier and cheaper through marriage), but also qualification for the Federal Employees Health Benefits Program as well as Social Security, the gateway for Medicare at age 65. Section 3 also affected Medicaid enrollment and spend-down requirements for the elderly entering nursing homes. The Medicaid/DOMA issue was presented to the Court in a petition for certiorari that the Court has not granted or denied yet. Back in October, I highlighted the First Circuit's decision in Massachusetts v. Department of Health and Human Services, which was mentioned in passing by Justice Kennedy as a case that would suffer vacatur if the Court dismissed for lack of standing. It seems fair to read approval of the First Circuit's decision into Kennedy's cite, which makes me think the Court will not grant the petition.
In addition to public and private health insurance issues, some healthcare delivery issues are likely to be resolved by Windsor as well. For example, many stories have detailed how hospitals have turned away same-sex partners under the guise of HIPAA privacy. Other tales have highlighted how substituted decision-making at the end of life can devolve to estranged family members when same-sex partnerships are not recognized as giving the gay spouse decisional authority that would ordinarily be given without a second thought to a heterosexual spouse. Doctors' offices have refused to recognize same-sex spouses as parents of children who need medical attention. And, care for infants of same-sex couples may become easier now that the Family Medical Leave Act will apply to same-sex marriages. It seems that the federal recognition of gay marriage that will flow from Windsor will be beneficial in many healthcare situtations, even in states that do not recognize same-sex marriage. Federal agencies have much work to do interpreting the word marriage in the coming days, but it seems that these decisions will facilitate a more functional approach to families' experiences in the healthcare system.
Thursday, June 13, 2013
For those of you who thought we could forget about ongoing ACA litigation, here's a little update: the issue of premium assistance through tax credits for insurance purchased in federal exchanges is alive and well. The plaintiffs in the recently filed Halbig v. Sebelius claim that the ACA does not permit tax credits in federally run exchanges (opponents state that this is merely a statutory oversight, as I wrote in September.) A nice summary of the ongoing litigation on this issue was published yesterday on California Health Line.
These challenges seem to reveal the angst that the ACA is producing as the January 1, 2014 deadline creeps nearer. They also seem to reveal the upside-down federalism occuring in the states that have rejected the state-based exchanges. Those states have exercised their sovereign prerogative, but they are also inviting more federal power into the state, which aggrandizes federal power. Though I don't think these cases have a strong chance of success, if the plaintiffs are successful, undoubtedly we'll see more testing of the fence by states and private litigants.
Monday, June 10, 2013
Although it's probably true that with some imagination every Supreme Court decision could be related back to some aspect of Health Law, today's Post (which, yes, was supposed to be up Friday) is intended to highlight the as yet unreleased Supreme Court decisions of particular interest to Health Law. We don't know exactly which cases will be announced but Scotus believes this will
happen on Thursday June 13th--and they will be "live-blogging" starting "shortly before" 10 AM EST in anticipation of the announcements-- but we do know which ones are left.
Below is an email I sent out today to both our Health Law Certificate Students here at Texas Tech School of Law and to the students enrolled in my new class Constitutional Issues in Health Law. As a side note, I would certainly be interested in hearing from anyone who is/has taught this particular class. My model for it is the one taught by Mary Anne Bobinski when she was at the University of Houston Law Center.
Here, in relevant part, is what I sent out:
" Unlike last year where everyone was a health care lawyer and had something to say about National Federation of Independent Business v. Sebelius (the Affordable Care Act decision) (me included), the cases yet to be decided are not all waving the banner "Health Law"--but are likely to have significant impact in the practice of health law. There are so many sources of information about these cases and what they mean that it would almost be impossible to give a complete list.
Each decision will be posted almost immediately to the Supreme Court's website--and what I recommend is that you read it yourself--and then compare it to the press coverage! CNN will long remember this episode and Jon Stewart's take on it!
Also, it is never possible to avoid the "spin" that anyone describing an issue inevitably puts on it. I've included information when an organization or media outlet has created clarifying material but at this point. Here's an NPR Overview and one from Fox News.
Here are the cases (with parentheticals from Scotus):
Association for Molecular Pathology v. Myriad Genetics Inc.("whether human genes are patentable")
("Whether the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of
2003, 22 U.S.C. § 7631(f), which requires an organization to have a policy explicitly
opposing prostitution and sex trafficking in order to receive federal funding to provide HIV
and AIDS programs overseas, violates the First Amendment. (Kagan, J., recused.)")
("Whether the First Circuit Court of Appeals erred when it created a circuit split and held – in
clear conflict with this Court’s decisions in PLIVA v. Mensing, Riegel v. Medtronic, and
Cipollone v. Liggett Group – that federal law does not preempt state law design-defect
claims targeting generic pharmaceutical products because the conceded conflict between
such claims and the federal laws governing generic pharmaceutical design allegedly can be
avoided if the makers of generic pharmaceuticals simply stop making their products.")
The press is most interested in Hollingsworth v. Perry “gay marriage” and Fisher v. University of Texas (“affirmativeaction” )cases—and we should be interested too. In Hollingsworth because it is possible (although not certain) that the court will add to our understanding of the Constitutionality of statutes (like the one in Texas) which only allow a married couple consisting of a man and a woman to enter into a binding contract with a surrogate mother. It may also change the ability of physicians in states to refuse to treat patients on the basis of sexual orientation, gender identity or any other factor not currently required by Federal Law or a previous decision of the Supreme Court. LAMBDA Legal has put together an infographic for those wanting to get up to speed quickly.
And in Fisher because it may well affect medical school admissions even though it is a case about undergraduates.
There are also some cases involving important employment law issues—which are often the biggest part of a health lawyer’s case load.
You may not want to be poised at your computer 10 AM Thursday EST to hear what decisions the court is releasing—but you will certainly want to read them for yourself when they are available online.