HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Monday, October 27, 2014

Hot off the press!

In this article, published today at the Illinois Law Review online, Jessica Roberts and I argue why the Medicaid expansion is a matter of social justice that must be taken seriously in the upcoming gubernatorial elections.  Here's the blurb from the journal:

On the doorstep of its fiftieth anniversary, Medicaid at last could achieve the ambitious goals President Lyndon B. Johnson enunciated for the Great Society upon signing Medicare and Medicaid into law in 1965. Although the spotlight shone on Medicare at the time, Medicaid was the “sleeper program” that caught America’s neediest in its safety net—but only some of them. Medicaid’s exclusion of childless adults and other “undeserving poor” loaned an air of “otherness” to enrollees, contributing to its stigma and seeming political fragility. Now, Medicaid touches every American life. One in five Americans benefits from Medicaid’s healthcare coverage, and that number soon will increase to one in four due to the Patient Protection and Affordable Care Act. Medicaid’s universalization reveals that the program can now be best understood as a vehicle for civil rights. ...

October 27, 2014 in Affordable Care Act, Coverage, Disabilities, Health Care Reform, Medicaid, Obama Administration, Politics, PPACA, Public Health | Permalink | Comments (0) | TrackBack (0)

Saturday, October 25, 2014

The Ebola "Czar"

In the wake of Craig Spencer’s decision to go bowling in Brooklyn, governors of three major states—Illinois, New Jersey, and New York—have imposed new Ebola quarantine rules that are inconsistent with national public health policy, are not likely to protect Americans from Ebola, and may compromise the response to Ebola in Africa, as health care providers may find it too burdensome to volunteer where they are needed overseas. Don’t we have an Ebola czar who is supposed to ensure that our country has a coherent and coordinated response to the threat from Ebola?

Of course, the term “czar” was poorly chosen precisely because Ron Klain does not have the powers of a czar. He will oversee the federal response to Ebola, but he cannot control the Ebola policies of each state. Unfortunately, on an issue that demands a clear national policy that reflects medical understanding, public anxieties will give us something much less desirable.

[cross posted at Bill of Health and PrawfsBlawg]

October 25, 2014 in CDC, Global Health, Policy, Politics, Public Health, Public Opinion, Science and Health | Permalink | Comments (0) | TrackBack (0)

Thursday, July 24, 2014

More on Halbig

Over at Balkinization, Abbe Gluck, Neil Siegel, and Joey Fishkin have excellent posts on what's wrong with the Halbig majority.  Abbe's is especially important given that the majority wrongly agreed with the complainants that the exchange is some kind of cooperative federlism program.  It's not.

July 24, 2014 in Affordable Care Act, Health Law, Politics, PPACA | Permalink | Comments (0) | TrackBack (0)

Wednesday, July 23, 2014

Circuit Split in One Day: Tax Credits, Halbig and King (or, The Latest ACA Headache)

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.

Continue reading

July 23, 2014 in Affordable Care Act, Constitutional, Health Care Reform, HHS, Medicaid, Politics, PPACA, States | Permalink | Comments (0) | TrackBack (0)

Monday, June 2, 2014

PCAST, Big Data, and Privacy

The President’s Council of Advisors on Science and Technology (PCAST) has issued a report intended to be a technological complement to the recent White House report on big data. This PCAST report, however, is far more than a technological analysis—although as a description of technological developments it is wonderfully accessible, clear and informative.  It also contains policy recommendations of sweeping significance about how technology should be used and developed.  PCAST’s recommendations carry the imprimatur of scientific expertise—and lawyers interested in health policy should be alert to the normative approach of PCAST to big data. 

Here, in PCAST’s own words, is the basic approach: “In light of the continuing proliferation of ways to collect and use information about people, PCAST recommends that policy focus primarily on whether specific uses of information about people affect privacy adversely. It also recommends that policy focus on outcomes, on the “what” rather than the “how,” to avoid becoming obsolete as technology advances. The policy framework should accelerate the development and commercialization of technologies that can help to contain adverse impacts on privacy, including research into new technological options. By using technology more effectively, the Nation can lead internationally in making the most of big data’s benefits while limiting the concerns it poses for privacy. Finally, PCAST calls for efforts to assure that there is enough talent available with the expertise needed to develop and use big data in a privacy-sensitive way.”  In other words:  assume the importance of continuing to collect and analyze big data, identify potential harms and fixes on a case-by-case basis possibly after the fact, and enlist the help of the commercial sector to develop profitable privacy technologies. 

The report begins with an extremely useful (and particularly frightening if you aren’t familiar with the internet of things) description of big data possibilities, now and in the near-term future.  The description emphasizes the distinction between data “born digital”—that is, created in digital form—and data “born analog”—arising from the characteristics of the physical world and then becoming accessible in digital form.  Data born analog are highly likely to contain more information than just that of particular digital interest; for example, surveillance cameras record everything that is occurring in a particular location, not just acts that are the target of surveillance.  But with analytics that allow data fusion, the combination of data sources may reveal new meanings, for example profiling individuals. Big data are high volume, high velocity, and high variety, an intersection that presents serious privacy challenges.

PCAST then attempts to anticipate the privacy harms that might be associated with big data collection and analysis.  The harms are in the main presented as byproducts of the benefits of developments of particular types of technologies.  The list is impressive, but may miss additional harms associated with the development of a big data world.  Here’s a table listing developments, benefits, and harms; I’ve marked with an asterisk benefits that I’ve reconstructed from what PCAST says but that PCAST does not state explicitly. 

Technological development

Benefit

Associated Harm

Digital communication

Social networking across geographical boundaries; social and political participation on a far larger scale

Shared pipelines and the possibility of interception

Virtual home

Ability to store, organize, and share personal records, e.g. cloud storage of photographs.

“Home as one’s castle” should extent to “castle in the cloud,” not currently protected

Inferred facts about individuals

Delivery of desired or needed services, e.g. targeted marketing

Inferences may be drawn about highly sensitive facts about the individual (e.g. sexual orientation)—facts of which the individual may not even be aware (e.g. early dementia)

Locational identification

Services such as navigation or routes, finding people or services nearby, avoiding hazards

Stalking and tracking

Personal profiles

Benefits of use of statistically valid algorithms

False conclusions about individuals may be drawn

Discovery of special cases that apply to individuals within a population

May allow tailoring of services to special cases—e.g. personalized medicine, instruction linked to learning styles*

Foreclosure of autonomy—individuals may not want to take the predicted path

Identification of individuals

May allow individuals to be warned or protected or otherwise benefited*

Loss of desired anonymity

PCAST intentionally omitted from this list desires that information be used fairly and that individuals know what others know about them or are doing with their information.  In the view of PCAST, neither of these “harms” can be sufficiently defined to enable policy recommendations.  Also omitted from this list are more overarching concerns such as effects on identity, security, stigmatization of groups, freedom of expression, or political liberty.

PCAST’s discussion of the current technologies of privacy protection is highly informative and readers with interests in this area would do well to read the report—I won’t summarize it here.  The report also debunks several standard methods for privacy protection:  notice and choice (a “fantasy”), de-identification (ineffective in light of the development of analytics enabling re-identification), and non-retention or deletion (hopeless given potential for copying including the creation of multiple copies at the point analog data become digital).

Instead, the report suggests several different approaches for protection against data misuse.  As a successor to notice/consent, PCAST recommends the development of “privacy preference profiles,” perhaps by third parties such as the ACLU or Consumer Reports; apps or other internet entities could then indicate whether their privacy policies comport with a profile specified by the consumer. Or, the profile developers might offer the service of vetting apps.  Ideally, technologies could be developed to perform the vetting automatically.  PCAST also recommends developing use controls associated with data collection, use, and subsequent transmission of data or uses.  Metadata might serve this purpose but there is clearly need for further development.  Another suggested strategy is audit capability as a deterrent to misuse.  Finally, PCAST suggests implementing the Consumer Privacy Bill of Rights through recognition of potential harmful uses of data.  Emphasis should be placed on development of best practices to prevent inappropriate data use throughout the data life cycle. 

Five major policy approaches (they are called recommendations, but they are far better characterized as general directions rather than specific recommendations) conclude the report.   They are:

            --attention should focus on uses of big data rather than collection and analysis

            --policies should not be stated in terms of technical solutions but in terms of intended outcomes  

            --the US should strengthen privacy-related research, including relevant social science informing successful application of technologies

            --the US Office of Science and Technology Policy should increase education and training efforts

            --the US should take international leadership by adopting policies that stimulate the development of privacy protective technologies.

These recommendations seem remarkably anodyne after the detailed discussion of technologies that preceded them.  Moreover, they are also preceded by some other, less anodyne policy observations (I found these quite troubling—for reasons I just begin to suggest parenthetically below):

            --basing policy on data collection is unlikely to succeed, except in very limited contexts (such as health information) where there may be possibilities for meaningful notice and consent.  (Why, I ask, is notice/consent the only way to approach collection practices?  What about other sorts of restrictions on collection? Or, is the thought that getting the data is both inevitable and desirable, no matter what the context?)

            --regulating at the moment individuals are particularized by analytics might be technically possible—but even so, it’s preferable to focus on harms downstream (Doesn’t this expose people to risks of harm, correctable only after the fact? Shouldn’t we consider building ways to detect and deter re-identification that could intervene before the harm occurs?)

            --drafting savvy model legislation on cyber-torts might help improve the current patch-work of liability rules for privacy violations (Why not a public law approach to violations rather than placing the onus on individual litigation?)

            --forbidding the government from certain classes of uses might be desirable, even if these uses remain available in the private sector (So is the government the only or even primary problem with big data use???)

Leslie Francis

           

 

 

 

 

 

 

 

June 2, 2014 in Innovation, Obama Administration, Policy, Politics, privacy | Permalink | Comments (0) | TrackBack (0)

Thursday, April 3, 2014

A Call out to the "Invicible" Young Adults--What You Don't Know About Childhood Diseases Could Prevent You From Having Any Children

 

One thing we’ve all heard during the discussion of the affordable care act is that young people don’t worry a lot about their health.  It’s therefore likely that few young adults ever think about whether or not they received adequate vaccination.

Perhaps if they better understood the consequences, they would do so.  What you've heard is true many childhood diseases are much more serious for adults than for children.    For a general overview look here.  Here’s some information about chickenpox.

Outbreaks of Mumps are being reported all over the country.  This week there are 116 cases in and near Ohio State University in Columbus. Fordham University in New York reported 11 in late February.   Just today, the NYC Board of Health reported 21 cases of Measels and Rubella (German Measels) isn't likely to be far behind.  These numbers may seem small—until you appreciate that Mumps used to be a very common childhood disease in the United States but is now very rare because of a highly effective vaccine. Unfortunately, many parents have chosen not to vaccinate their child against Mumps because of concerns about the MMR vaccine—that now turn out to be the result of fraudulent scientific data.       This piece put out by the Center for American Progress explains how states responding to political pressure from parents have been remarkably lax in enforcing mandatory vaccination laws for school children.  At this point, almost anyone with a concern to claim an exemption.  

So back to Mumps.  Few had heard of it, and no one knew what should really be the main attention grabber.   It can impair fertility—even to the extent of causing sterility.  There hasn't been a lot of research done recently and permanent sterility is rare- probably no more than 10%.  But why chance it when it can be prevented?  

And  that’s not the worst of it.   Measels and Rubella carry even greater risks for young adults.   A case of Rubella early in pregnancy caries with a 20% chance of serious birth defects.   The risk of permanent hearing loss after measels is highest in children under 5 and adults over 20

The good news on the public health front is that it’s never too late to be vaccinated.   And preventive vaccination (even for childhood diseases) is covered under the Affordable Act.  Young adults would be wise to look into their own vaccination status.  If pediatric records aren’t available, a blood test can measure antibodies that show the presence (or absence) of vaccination against many serious childhood diseases that are coming back to infect young adults.  But if vaccination laws continue to be lax, long after the reason for so many people's misgivings has turned out to be a fraud, we will not be able to get ahead of what should to everyone be a very frightening trend

April 3, 2014 in Affordable Care Act, CDC, Health Care, Policy, Politics, PPACA, Prescription Drugs, Prevention, Primary Care, Public Health | Permalink | Comments (0) | TrackBack (0)

Monday, March 24, 2014

Halbig, King, Coercion, and the ACA Tax Credit Ligitation

Tomorrow, the D.C. Circuit will hear oral arguments in Halbig v. Sebelius.  This is the litigation in which parties hostile to the ACA are challenging the IRS rule that makes tax subsidies available in federally run health insurance exchanges.  Abbe Gluck has posted a deconstruction of the challengers' legislative and historical arguments at Balkinization, including a new post this morning discussing factual and historical inaccuracies in the appellants brief.  I want to address one of those arguments here: the analogy that the health insurance exchanges are somehow like the Medicaid expansion ruled unconstitutionally coercive in NFIB v. Sebelius. This comparison is so far off the mark, it reveals the underlying goal, which is to test the breadth of NFIB's coercion holding at every opportunity and to challenge federal power writ large.

The ACA expanded Medicaid eligibility to everyone up to 133% of the federal poverty level, and the states challenged that expansion in NFIB on the theory that they could lose all of their funding under the terms of the Medicaid Act if states refused to expand. The Court found that the expansion of Medicaid was a change in "kind" rather than "degree" and that the funding for the "old Medicaid" program could not be jeopardized for state refusal to comply with the "new Medicaid" program as envisioned in the ACA. As I have written elsewhere, the Court's unconstitutional coercion analysis was full of holes. One of those holes was nonsensical statutory interpretation, namely that the Medicaid expansion was too different from the Medicaid Act for coercion analysis purposes, but that it was similar enough for purposes of limiting the Secretary's authority to withhold or withdraw state Medicaid funding. But, that authority was not in the ACA (contrary to popular perception), it was in the language of the original Medicaid Act. The new/old Medicaid distinction was statutorily nonsensical, and yet it led to a newly recognized coercion doctrine that limits Congress's power to influence state policy through federal spending.

The Halbig appellants want federal courts to engage in this new coercion analysis by virtue of similarly absurd statutory interpretation. They ask the D.C. Circuit to deem the federal exchange funding offered to states to be struck down as coercive; but, they argue it is coercive not because of the money offered to states to create exchanges, but rather because of the tax credits that would not be available to individuals in exchanges established by the federal government. This causal chain is too attenuated; the claim is basically that the states were influenced not by the federal offer of funds but by the unavailability of tax credits for their citizens in federal exchanges. If this indirect coercion were possible, it is hard to imagine that two-thirds of states would have rejected the option to run state exchanges. It also breaks the link between the federal funding, the condition, and the supposed coercion (which is really a germaneness problem). States do not receive insurance premium tax credits, individuals do. States were offered moderate sums to establish their exchanges, and the loss of that moderate sum did not change the state's status at all. The appellants have mischaracterized the nature of the funding and the result of state rejection of that federal funding.

In addition, this argument can easily be turned on its head. Consider, for example, the Amicus Brief for the Commonwealth of Virginia in King v. Sebelius, recently filed in the Fourth Circuit's version of this tax credit litigation. Virginia argues that it was not aware that its citizens would lose access to tax credits if it rejected the funding to create its own exchange, thereby creating the polar opposite clear notice problem because Virginia believed its citizens would still have access to affordable health insurance if they invited the federally run exchange into the state. (See Kevin Outterson's post on Virginia's brief at The Incidental Economist.)

Clearly, exchange funding is different from Medicaid conditional spending. The ACA offered money to persuade states to participate in the establishment of exchanges, but the federal government will proceed without the states in the effort to establish near-universal insurance coverage. Congress would have dismantled its own goal of near-universal insurance coverage if it denied tax credits in federally run exchanges. This is the hope of the Halbig challengers, that the D.C. Circuit will dismantle the ACA's tax credit structure for federal exchanges and gut access to health insurance. Unfortunately, if they succeed, real people will be harmed.

March 24, 2014 in Affordable Care Act, Health Care Reform, Health Reform, Policy, Politics, PPACA | Permalink | Comments (0) | TrackBack (0)

Friday, February 28, 2014

Continued Skepticism re "Wellness Programs"

A big part of the job of being a Health Law Prof is to help students understand the intersection of the many legal specialties that comprise the big tent of "Health Law."  Wellness Programs are a good way of doing that because one of the key features of the Affordable Care Act is the flexibility it provides employers to link the cost their employees pay for health insurance with the individual employee's participation in a company sponsored "welleness program."  Here's an article I wrote explaining how PPACA went about doing that.  Here's a link to the Department of Labor's summary of the current rules and a good overview by the law firm Nixon-Peabody.  This report from Rand is an overview of what these programs are and how companies have increasingly fallen in love with them.   At this point just about every insurance company is offering to create one--here's some information from Aetna.  

The problem is, there's very little evidence that these programs do anything to demonstrably improve health (whatever that may mean).  And quite a bit that they may promote many different kinds of social injustice.

 This article in the Harvard Business Review does a great job describing the kinds of programs that are now descending on employees and how they are creating disatsifaction without any scientifically supportable improvement in "health."

There is also a growing literature suggesting that these programs may disproportionately discourage workers who employers aren't that unhappy to see go--but might not legally be able to actually fire.  Here is some very interesting testimony by Jennifer Mathis Director of Programs, Bazelon Center for Mental Health Law
On Behalf of the Consortium of Citizens with Disabilities.

Michelle Mello at Harvard has coined the term "life-style discrimination" to describe the ways Wellness Programs may target individuals employers may perceive as undesirable because they are obese, smoke or have other non-job related characteristics.

Studying Wellness Programs--and the issues they raise--can be an accessible entry point for students who can easily be intimated by the regulatory complexity of health law and can also be a bridge to understanding how fundamentally the Affordable Care Act has affected the way health care will be paid for and delivered as our students begin their careers in advising those struggling to implement these new regulations.

 

 

 

 

February 28, 2014 in Access, Affordable Care Act, Consumers, Coverage, Disabilities, Effectiveness, Employer-Sponsored Insurance, Genetics, Health Care, Health Care Costs, Health Care Reform, Health Law, Health Reform, HHS, Insurance, Mental Health, Obesity, Policy, Politics, PPACA, Prevention, Public Health, Quality, Reform, Workforce | Permalink | Comments (0) | TrackBack (0)

Monday, January 20, 2014

Are We Misusing the "Brain Death" Diagnosis to Hurry Along Families?

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. 

January 20, 2014 in Bioethics, Children, Cost, End-of-Life Care, Health Care, Health Law, Hospitals, Politics, Public Health, Research, States | Permalink | Comments (0) | TrackBack (0)

Friday, January 17, 2014

IRS Rule Providing Tax Credits In Federal Exchanges Upheld

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.

January 17, 2014 in Affordable Care Act, Constitutional, Health Care Reform, Health Reform, HHS, Obama Administration, Politics, PPACA, States | Permalink | Comments (0) | TrackBack (0)

Friday, December 27, 2013

Republicans and Democrats on Health Care Reform: Not That Far Apart After All

Today’s New York Times describes the Republican Party’s search for an alternative to the Affordable Care Act (ACA). With millions of Americans about to receive their health care through ACA health insurance exchanges, GOP members of Congress recognize that reform rather than repeal is the more sensible strategy.

Interestingly, proposals by leading Republicans look very much like ACA and especially like the favored reform proposal of former Obama senior staffer, Ezekiel Emanuel. While Emanuel has embraced ACA’s individual mandate, his preferred approach to reform is a universal voucher for health care coverage (also discussed here). According to the Times, U.S. Representative Paul Ryan soon will release a revised version of a universal voucher that he and U.S. Senator Tom Coburn proposed in the past. The main difference between Emanuel’s voucher and the Ryan-Coburn voucher is in the amount of coverage. Emanuel would cover the full cost of an insurance plan with standard benefits (akin to the essential benefits requirement of ACA), while Ryan and Coburn pegged the value of a voucher at a fixed dollar amount, about 50-60 percent of the cost of a standard insurance policy. As with ACA, Ryan and Coburn would have established health insurance exchanges, required insurers to meet minimum standards and protected persons with pre-existing conditions from discrimination (though perhaps not to the degree that ACA protects them).

There are good reasons to prefer universal vouchers to ACA. When all Americans, rich and poor, are in the same program, the program works much better. Consider in this regard the differences between Medicare and Medicaid. ACA may promise nearly universal coverage, but persons at higher incomes still will receive their health care mostly through their employers rather than through ACA’s health insurance exchanges or the Medicaid expansion. That gives the political influential a much smaller stake in the success of ACA than they would have in a universal voucher program.

It’s not surprising that there is more agreement than disagreement on the specifics of health care reform. As many observers noted during the health care reform debate, the individual mandate for health care coverage began as a conservative alternative to Clinton health care, and Mitt Romney championed an individual mandate as governor of Massachusetts. As with immigration reform and other policy initiatives, the chief stumbling block to progress is not the lack of common ground but the strong political incentives for elected officials to pursue a policy of conflict.

[cross-posted at orentlicher.tumblr.com]

December 27, 2013 in Affordable Care Act, Health Care Reform, Politics, PPACA | Permalink | Comments (0) | TrackBack (0)

Tuesday, December 17, 2013

Get to Know the 9 ACA Exemptions-Health Care Sharing Ministries

Stacey Tovino, a rock-star health law professor and Lincy Professor of Law at the UNLV William S. Boyd School of Law and I were nearly knocked off our chairs at a presentation by Wellesley College Professor Charlene Galarneau, PhD on The ACA Exemption of Health Care Sharing Ministries at the ASBH- American Association of Bioethics and the Humanity’s annual Meeting last month.  If you are a health law professor (or hobbyist) and do not yet know what a Health Care Sharing Ministry is, prepare to be surprised.  It is NOT insurance but rather a non-binding agreement among people of faith to share their health care costs.  As the Alliance of Health Care Sharing Ministries explains, “A health care sharing ministry (HCSM) provides a health care cost sharing arrangement among persons of similar and sincerely held beliefs. HCSMs are not-for-profit religious organizations acting as a clearinghouse for those who have medical expenses and those who desire to share the burden of those medical expenses.”  It specifically does not provide the essential services of an ACA qualified plan.  Yet those without health insurance who are participating in one of these ministries are exempt from the obligation to purchase insurance or pay a penalty—even though it is highly likely that the cost of their care will fall on the community where they become sick and seek treatment.  Read more about it here and here.  Health Care Sharing Ministries are among the 9 exemptions in the Affordable Care Act, yet have not attracted significant attention.  Given their important role in exempting large numbers of people from the obligation of obtaining health insurance, they deserve a place, or at least a shout-out, in all of our classes.

 

December 17, 2013 in Access, Affordable Care Act, Coverage, Health Care, Individual Mandate , Policy, Politics, PPACA, Private Insurance, Public Health, Uninsured | Permalink | Comments (0) | TrackBack (0)

Wednesday, June 26, 2013

US v. Windsor: Some Constitutional Uncertainty, Many Healthcare Implications

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.

[NH]

June 26, 2013 in Aging, Constitutional, Health Law, HHS, Medicaid, Medicare, Politics, Spending, States, Unconstitutional | Permalink | Comments (0) | TrackBack (0)

Saturday, May 11, 2013

Remembering the Bad Old Days of HIV/AIDS Exceptionalism--and How News from Kansas, an HBO Documentary, and Dancing with the Stars Can Teach Students To See it When it Happens Again

 

The  controversy in Kansas over Sub HB 2183, which was passed into law on April 17th, 2013, puts me in mind of how difficult it is to explain the period of time when  "aids specific" laws emerged.  My purpose in highlighting this situation is not to get deeply involved in Kansas law or politics.  It is pull together some material that may be helpful for teaching public health law to students unaware of the lessons we have learned from the laws proposed, and passed, specifically in response to the emergence of HIV/AIDS during the 1980’s. Without an understanding of the fear and panic that accompanied a disease for which there was no test, no treatment, no vaccine and which quickly killed  young, healthy people within months of starting symptoms, it is easy to minimize the risk of such a thing happening today.

What Happened in Kansas

 As I understand it, Sub HB 2183 was presented as a statute similar to those in almost every state intended to protect first responders and others who face occupational exposure to infectious
diseases and pathogens.  It gives the State’s Department of Health the authority to develop a mechanism for mandatory testing or even isolation of the person who is the possible source of infection
if he is unable to give consent or if no surrogate decision maker can be found.  Time is of the essence in these situations and the goal is to provide prophylactic treatment as soon as possible—not to stigmatize the source of infection. 

 One of the effects of Sub HB 2183 was to eliminate a bill passed in 1986 which specifically prohibited the State from quarantining individuals based on a diagnosis of HIV/AIDS.  This led to concerns that people living with HIV/AIDS in Kansas would no longer be protected.   Ann Gotlib explains these concerns, and their historical context, clearly in IJFAB-the International Journal of Feminist Approaches to Bioethics

 In an open letter to concerned citizens, the Secretary of Kansas’ Department of Health & Environment explained that “This bill was never about isolation or quarantine related to persons with HIV infection.”  Instead, the bill “provides the authority for the secretary…to adopt administrative regulations for prevention and control of HIV in addition to the other specified infectious diseases under current law.”    He continues to explain that the Bill reflects an attempt to modernize an old statute from that era, KS 65001, that specifically prohibits the state from quarantining or isolating individuals diagnosed with HIV/AIDS.  

Without getting in to Kansas politics and law any deeper, KS 65001 is indeed is a good example of an “AIDS specific” law of that era in that it prohibits the State from quarantining individuals based on a diagnosis of HIV/AIDS.  Indeed, according to the Kansas Equality Coalition, the Bill passed based on a compromise that involved  creating “a list of diseases ‘not’ subject to quarantine, and to include HIV/AIDS in that list.” 

What Kansas Can Teach
Public Health Students Today

Whatever the motivation for the legislation or its effect on
the citizens of Kansas, the controversy  deserves attention and study just as would thediscovery of a “living fossil.”   It gives us direct access to studying the past.

For anyone else looking for ways to bring that time alive, here are a few words about my experience

Continue reading

May 11, 2013 in AIDS, Health Law, Personal Experience, Policy, Politics, Proposed Legislation, Public Health, Public Opinion | Permalink | Comments (0) | TrackBack (0)