HealthLawProf Blog

2012 All Over Again

In 2012, the Supreme Court heard two important Medicaid cases, one in January of 2012 pertaining to payment rates (Douglas v. ILC), and the other in March 2012 pertaining to the ACA's Medicaid expansion (NFIB v. Sebelius). In Douglas, the Court's majority deferred to HHS, allowing the agency to exercise primary jurisdiction over California's Medicaid payment rates and punting the question regarding Supremacy Clause actions by Medicaid providers against noncompliant states. And, in NFIB, the Court decided that Medicaid's modification under the ACA was not Medicaid enough for purposes of Spending Clause doctrine but was Medicaid enough for purposes of the remedy, which was to limit HHS's authority to terminate Medicaid funding for states that refused to expand Medicaid eligibility under the terms of the ACA.  Confused yet? So is the Court, and that's a potential problem. 

Fast forward to 2014, and the Court is once again hearing a Medicaid reimbursement rate case and an ACA case, in the same time frame as 2012, both of which could be very disruptive.  The Medicaid rate case is Armstrong v. Exceptional Child Center, and the weirdly confused oral arguments occurred today. The question the Court granted from the petition for certiorari was whether private parties can enforce the Medicaid Act's equal access provision ("30(a)") against a noncompliant state when HHS has not demanded compliance from the state through payment of adequate reimbursement rates. Armstrong may have far-reaching implications for the Medicaid program, for implied rights of action, and for federal courts' jurisdiction over Supremacy Clause actions, to name a few possible dimensions. Steve Vladeck, author of a very important amicus brief on behalf of former HHS officials, has posted about some of these issues.  Rather than re-hash his fine commentary, or Will Baude's pithy overview for SCOTUSblog this morning, I will quickly share some impressions of today's oral arguments.

First, the justices had no idea how Medicaid works, which matters quite a lot when it may be the vehicle for constitutional change. Justice Breyer, for example, did not appear to understand the difference between the state describing how it would set payment rates and the state actually setting the amount of money it would pay to reimburse health care providers for their services.  Here, Idaho created a methodology for rate setting that was approved by HHS, but then its legislature decided to use a different rate setting methodology tied to the state's budget. Breyer kept using the example of a doctor submitting a bill for $80 when all he could receive was $60, but the example was inapposite. Another minor example is that the prohibition against balance billing was news to the justices. Another example is Justice Alito's hypothetical about states that allow for medical marijuana being sued because feeral law does not permit possession of marijuana, which had no apparent relevance for the Medicaid preemption questions at hand.

James Piotrowski, on behalf of Exceptional Child Center tried to limit the conversation to whether the state actually followed the plan that CMS approved (which it appears Idaho did not). He also tried to explain why a broad-based Supremacy Clause/Spending Clause decision would be both unnecessary and dangerous, and he advocated for a limited ruling that would allow this set of plaintiffs to seek an injunction to force the state to abide by the reimbursement plan that HHS approved.  

The trouble is that the Solicitor General, as he did in 2012, promoted the view that no private rights of action should be permitted. Justices Sotomayor and Kagan quickly called out Mr. Kneedler on HHS’ deep disagreement with this position. Kneedler asserted that HHS does not want these private actions, even though HHS pointedly did not sign the SG's brief, and even though the amicus brief here and in Douglas on behalf of former HHS officials (of all political stripes) clearly explained that HHS both expects and needs private actions to occur. In both cases, the former HHS officials explained that the agency is so woefully understaffed and underfunded that it could never police all of the states' reimbursement rates on a claim by claim basis.

The four dissenters from Douglas were relatively quiet during oral arguments today. In 2012, the Chief Justice authored a dissent that would have denied private rights of action under 30(a) to force states to pay adequate payment rates for equal access to health care providers. I suspect that Roberts, Scalia, Alito, and Thomas remain in the same positions, unless they were convinced that Idaho should have just stuck to the plan and their legislature drove off the rails after CMS approved their rate setting methodology. The real question will be if Kennedy sees this action as some kind of affront to state sovereignty given his affinity for federalism resolutions. If so, then Supremacy Clause actions will be lost for 30(a) litigants, and states will run over Medicaid providers who cannot enforce the adequate payment language in the Medicaid Act. In the very moment that more and more states are negotiating Medicaid expansion under the power given to them by the Court in NFIB, this would be a dangerous precedent both theoretically and on the ground. More to come.

 

The Problematic Jurisprudence of Halbig v. Burwell

Like the recent Supreme Court decision in Hobby Lobby, the D.C. Circuit’s ruling earlier this week in Halbig v. Burwell is being hailed by conservatives and bemoaned by liberals as a death knell for Obamacare.  Unlike the decision in Hobby Lobby, however the D.C. Circuit’s ruling is not the end of the matter, and many liberals are finding hope in the ruling of the 4^th Circuit the same day, the probability of an en banc hearing in the D.C. Circuit, and the ultimate possibility of a favorable Supreme Court decision.  In an earlier post in HealthLawProf, I decided to take seriously the possibility of damage control from a limited reading of Hobby Lobby.  It is pretty much universally agreed—and I believe correctly—that it is not possible to do similar damage control by giving a limited reading to Halbig v. Burwell.  If the ruling stands, that tax subsidies are not available to people purchasing coverage through the exchanges in the states that are letting the federal government do the work, many important other provisions of the ACA will be untenable, including the penalties for large employers not offering insurance whose employees receive subsidies and likely the individual mandate itself.  But I think it is possible to undermine Halbig in a way not generally recognized by the liberal critics who argue (correctly) that the statutory provision at issue is ambiguous:  argue that the jurisprudence of the majority opinion in Halbig is internally inconsistent.  Here’s how.

Under D.C. Circuit precedent, the court must “uphold an agency action unless we find it to be ‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.’”  So, the question for the court was whether the IRS rule permitting individuals purchasing insurance through federally-run exchanges was arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.  In concluding that it was, Judge Griffith’s opinion for the court reasoned that it was not in accordance with law. That is, Judge Griffith found that there was no ambiguity in the relevant provision of ACA that permitted the IRS to interpret the statute as it did.   Here's where much of the criticism takes him on.  But there’s more to say.

In reaching the conclusion that the statutory language is not ambiguous, Judge Griffith purported to rely on a literalist approach to statutory interpretation.  But he did not in fact rely consistently on such an approach—nor could he have done so.  The problem is that in order to formulate the literalist question to answer, Judge Griffith had to resolve several issues in a manner that was not literalist at all.

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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.

The Debate over Laura's Law: The Challenge of Providing Appropriate Care to Individuals with a Mental Disability

One of the cruelest features of some mental disabilities is that they create a level of fear and suspicion that can make it difficult for individuals to seek or accept treatment.    The situation is even worse when there is no infra-structure of community mental health clinics that could help  build relationships of trust with healthcare providers.    The result is  our current situation where county jails are often the largest mental health providers in their communities. (not this phenomena is all that recent--I and many others have been writing about it for over ten years).

California's Laura Laws that provide mechanisms for mandatory outpatient treatment are one way of keeping people are a way of keeping people whose only crime is having an illness out of jail.   But as the current debate over their use shows, any kind of compelled treatment raises important concerns about respect for civil liberties.  Yet some advocates for the mentally ill are supporting the law's implementation because it provides funds for outpatient treatment that would otherwise be unavailable.

News of efforts to provide increased services to those with severe mental disabilities is always of interest--but this policy debate in California is especially so because the arguments on both sides--for providing treatment to those not seeking it--are compelling and thoughtful.

 

 

 

Using Fear of Lawyers to Train Medical Students is Costing a Lot of Money!

The running joke of the Disney Monsters,Inc. movies is that there really are monsters in little kids' closets, but they aren't dangerous.  Too often in medical education, lawyers and law suits are used as "monsters in the closet" to scare medical students into paying attention.  This, I suggest, has become very expensive.   A recent post in the Harvard Bill of Health blog by former medical student Deborah Cho quite accurately describes how little accurate information medical students get about the law--and how much they come to dislike and mistrust lawyers.   Although I haven't seen research tracking how often the phrase "or you will get sued" is used in instructing medical students, but based on my experience it may be among the most common phrases they hear.  Without even addressing the vast literature suggesting that postive instruction is at least as instructive as negative, I contend we just can't afford the malpractice bogeyman.

The question now is what can be done about?   Tort Reform won't solve this problem--because it will never eliminate the possibility of being sued.  But maybe a change in medical education will.   The first step towards change is to realize that words and attitudes matter--drumming in a constant fear of being sued cannot help but affect how doctors see their work.

 

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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.

 

 

 

 

The AOL Babies: Our Healthcare Crisis in a Nut

Where does one start with AOL CEO Armstrong's ridiculous and unfeeling justifications for changes in his company’s 401(k) plan. Cable TV and Twitter came out of the blocks fast with the obvious critiques. And the outrage only increased after novelist Deanna Fei took to Slate to identify her daughter as one of the subjects of Armstrong’s implied criticism. Armstrong has now apologized and reversed his earlier decision.

As the corporate spin doctors contain the damage, Armstrong’s statements likely will recede from memory, although I am still hoping The Onion will memorialize Armstrong’s entry into the healthcare debate (suggested headline, "CEO Discovers Nation's Healthcare Crisis Caused by 25 Ounce Baby”). But supposing (just supposing) your health law students ask about the story in class this week. What sort of journey can you take them on?

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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. 

Dynamic Medicaid Expansion

Yesterday's reports on the annual meeting of the Republican Governors Association indicated disarray over the Medicaid expansion, and an opinion piece in the NYT highlighted the common story that only half of states are expanding their Medicaid programs.  If CMS is counting, then this tally is correct, as the federal agency can only account for those states that have submitted the proper documentation for expansion.  But this is not the only way to consider the states' decisionmaking regarding the expansion.  I have just posted a short essay preliminarily detailing research I have performed over the last several months, which reveals that many states currently counted as "not participating" are acting to expand their Medicaid programs.  Here is the abstract:

In the run up to the ACA’s effective date of January 1, 2014, the sleeper issue has been the Medicaid expansion, even though Medicaid stands to cover nearly a quarter of the United States citizenry. While the national press has portrayed a bleak picture that only half of the states will participate, the Medicaid expansion is progressing apace. Though this thesis may sound wildly optimistic, it is more than predictive; it is empirically based. I have gathered data on the implementation of the Medicaid expansion during the crucial months leading up to the operation of the insurance provisions of the ACA, and it is clear that most states are moving toward expansion, even if they are currently classified by the media as “not participating” or “leaning toward not participating.” The data thus far reveals counterintuitive trends, for example that many Republican governors are leading their states toward implementation, even in the face of reticent legislatures and a national party’s hostility toward the law. Further, the data demonstrates dynamic negotiations occurring within states and between the federal and state governments, which indicates that the vision of state sovereignty projected by the Court in NFIB v. Sebelius was incorrect and unnecessary.

 

Resources for Learning About (and Tracking) Violations of Research Law and Ethics

Even health law professors who do not teach a class in research law may be asked to participate in their university's programs for training researchers.  Now that the government is back in business, this seemed like a good time to feature some resources to help bring you up to speed.  The information below focuses on some of the main Federal Government sources of not just information but very high quality educational material.  All of this information is accurate as of today--but any web resource can suffer from link rot, and a direct Google search should lead you to all of these sources and more.

The most general place to start is actually not in the Federal Government, but rather CITI on-line training resources.  Although today their website says that these materials are no longer available to the public for free, it is likely that anyone associated with an institution that conducts federally funded research is a subscriber.   The unavailability of CITI to the public is unfortunate, but the amount of training provided for free by the federal government is beyond the scope of any individual human's ability to absorb information--everything from this point on is free!

 The Federal Government's regulation of research misconduct, research integrity and protection of human and animal subjects of research (yes, all of these things are different) is scattered not just among the various entities sponsoring research, but also within agencies.  While all have adopted "The Common Rule" when it comes to humans, in fact there can be significant differences in policies and regulations (especially in situations not involving humans).  Here are some places to start looking. 

   The location of this information depends both on the kind of research and the source of funding.   For research funded by the department of health and human services (biomedical research primarily) the relevant agency is the Office for Research Integrity (ORI) which " oversees and directs Public Health Service (PHS) research integrity activities on behalf of the Secretary of Health and Human Services with the exception of the regulatory research integrity activities of the Food and Drug Administration" and this is the website that tracks cases they are and have investigated.

Here's a movie they produced on avoiding research misconduct.  It's available with  Spanish and  Chinese subtitles

If the research safety violations involves people, you need to go to the entity within HHS currently known as the Office for Human Research Protections (OHRP)(remembering the "s" at the end of "Protections" shows you to be an insider).  This is a vast repository of both reference material and current reports of active cases--you might want to look at this overview first.

If you are getting funding directly from the National Institutes of Health, you will want to check in with Human Subject Research Protections (HSRP) program (note the "s") and their rules and guidance.  More information to be found here.

NIH also sponsors its own Human Subject Research Protection Online Training.  Also available in Spanish.

Research under the supervision, although not necessarily funding, of the FDA is monitored its Bioresearch Monitoring (BIMO) program is a comprehensive program of
on-site inspections and data audits designed to monitor all aspects of the
conduct and reporting of FDA regulated research.   This is not to be confused with the FDA's Office of Criminal Investigations which has a broader scope and covers not just research but all FDA monitored activities.

Actually,  "all" is an understatment because Recalls, Market Withdrawals and Safety Alerts are tracked elsewhere and there may be some spillover. Ditto MedWatch: The FDA Safety Information and Adverse Event Reporting Program.  If the violations directly concern human safety you should check here and in general at the Center for Drug Evaluation and Research

 

The National Science Foundation (NSF) is another major source of information.  The research it sponsors differs from that sponsored by NIH because it extends far beyond biomedical activities.  Indeed, NSF is the place to look for information about social science or behavioral research.

Here's where to look for  human subjects.  For more general wrongdoing, consult the NSF Office of the Inspector General.

The National Academy of Engineering has devoted considerable resources to issues of research ethics, misconduct and integrity which are available in its online Ethics Center.  Texas Tech University also provides extensive resources in Engineering Ethics through the Murdough Center.

The Institute of Medicine is often asked by Congress to investigate issues in Biomedical and Health Research.

The Department of Energy is a major player in the field of research ethics/human subject protection (it does considerable nuclear and genetics research) and has many resources.

It's very hard to distinguish between "bioethical" issues and "legal" issues when it comes to research, so another very important source of information is the Presidenial Commission for the Study of Bioethics.  which recently put out a remarkable report on Human Subject Research Violations which took place during the 1940's in Guatemala. (spoiler, the U.S. Public Health Service was giving people syphillis).

In future posts, I will dig deeper and provide more governmental and private sector resources.

Federal-State Tensions in Fulfilling the ACA's Promises

[Cross posted today at Constitution Daily:]

The Affordable Care Act expresses many goals, but its heart is the desire to create a health insurance home for all Americans.  The American healthcare system historically exists at the pleasure of a number of stakeholders and is not a coherent whole. This lack of system is reflected in the consistent tensions that underlie American healthcare, most notably federal power versus state power; the collective versus the individual; and the individual versus the state.  In creating near-universal health insurance, the ACA has resolved one of those tensions, individual versus the collective, in favor of the collective.  To that end, the ACA eliminated many of the practices health insurers used to cherry pick policyholders, which excluded people who need medical care from their risk pools.  In so doing, the ACA represented a federal choice to make all people insurable, whatever their wealth, age, medical history, sex, race, or other distinguishing factor. 

Despite the redirection this leveling of the health insurance playing field represents, the ACA did not craft a coherent whole out of the American healthcare system.  Instead, the ACA remodels the preexisting, unstable healthcare system.  In building on the old foundation rather than starting anew, the law retained the historic role of the states in regulating medical matters.  To that end, the ACA urged the states to implement two key aspects of its insurance modifications: Health Insurance Exchanges and the expansion of the Medicaid program.  The federal government has the power under the Spending Clause to create a federally-run insurance mechanism, but it chose instead to employ cooperative federalism to keep states engaged in healthcare policymaking.  The trouble is that some states have not been cooperating with these central legislative goals.

 The Exchanges, or Marketplaces, are an instrument through which qualified private health insurance plans can be purchased by individuals or small businesses.  The states were offered federal funding to create their own state-run Exchanges, which were operative as of October 1, 2013 (Tuesday last week).  Many states created Exchanges, but many rejected them as an expression of their distaste for the ACA.  Predictably, many of the states that have refused to create their own Exchanges were the same states that challenged the constitutionality of the ACA.  While there is value in dissent, the states that refused to create Exchanges invited more federal power into the state, because rejecting the federal offer for funding to create a state-run Exchange did not halt Exchanges from coming into existence. Instead, the ACA tasked the federal government with operating Exchanges in states that did not create their own.  While expressing a desire to protect their state sovereignty, these states have invited federal authority into their borders.  Though the Exchanges at both the state and federal levels have experienced some technical glitches this week, it appears that many people are eager to purchase insurance through them and that they have been successful at doing so.  The states that rejected Exchanges have not stopped implementation of the law, but their actions have other notable ramifications.

The Medicaid expansion was designed to catch childless adults under age 65 and below 133% of the federal poverty level in Medicaid’s safety net.  As with other modifications to the Medicaid program over the years, the expansion added a new element to the Medicaid Act that states could reject, but they could lose all of their funding if they made that choice.  The day the ACA was signed into law, states challenged the expansion of the Medicaid program as unconstitutionally coercive.  They succeeded on this claim in NFIB v. Sebelius, and the Court rendered the expansion optional for states. Immediately pundits began to question whether the states would participate in the Medicaid expansion. 

Though national media tallies make it appear that just over half of the states are participating in the Medicaid expansion, in reality the number is and will be much higher.  In almost every state reported as “leaning toward not participating,” and in many states reported as “not participating,” some significant act has occurred to explore implementation of the Medicaid expansion.  Some states have special commissions or task forces researching expansion; some state governors have indicated a desire to participate and have included the expansion in the budget; some legislatures have held debate or scheduled it for the next session; and so on.  Though some states will not have their Medicaid expansions running by January 1, 2014, it seems very likely that most if not all states will participate in the expansion in the relatively near future.

 In the meantime, state non-cooperation will have a direct effect on some of the nation’s poorest citizens.  People from 100% to 400% of the federal poverty level are eligible to receive tax credits for purchasing insurance in the Exchanges.  In states with no expansion, people above 100% of the federal poverty level who would have qualified for Medicaid will still be able to obtain insurance through federal subsidies in the Exchanges.  But, people who are below 100% of the federal poverty level will be too poor for tax-credits and living in states that have not yet expanded their Medicaid programs, therefore they will not be able to enroll in Medicaid either.  These very low income people will not be penalized for failing to carry health insurance, but they will not have health insurance either.  These individuals will get caught in a health insurance black hole that exists in part because the Court allowed states to refuse Medicaid expansion and in part because of state resistance to partnering in the implementation of the ACA.   

State cooperation in the Medicaid expansion is even more important than state participation in the Exchanges, because many thousands of people may not get the access to health insurance that is the promise of the ACA.  The debate over the meaning of federalism that swirls around political and academic circles will have a direct and important effect on the people who can least afford it.  The good news for them is that Medicaid’s history indicates that all states eventually participate in the program and its amendments, but this week’s implementation of the Exchanges keeps access to medical care through health insurance tantalizingly out of reach.

The Journal of Legal Medicine Invites Article Submissions

The Journal of Legal Medicine invites submissions of articles addressing issues at the nexus of law and medicine.  The Journal also welcomes substantive reviews of new books that intersect legal and medical topics.  

The Journal of Legal Medicine, the flagship publication of the American College of Legal Medicine, is a peer-reviewed, professionally edited, academic journal, published and marketed by Taylor & Francis.  The Journal, which is published quarterly, has a national and international circulation. 

Author information for manuscript preparation and submission can be found at:  http://www.tandfonline.com/action/authorSubmission?journalCode=ulgm20&page=instructions#.Uicvtj8WmOg  

Manuscript submissions are accepted for consideration on an ongoing basis.  Submissions should be made electronically through ScholarOne, as described at the link above.

[KVT]

Faculty Fellowships in Public Health Law - Call for Applications

Faculty Fellowships in Public Health Law - Call for Applications

Applications are invited for 10 faculty fellowships in public health law education.

DESCRIPTION 

Georgia State University College of Law and its Center for Law, Health & Society are leading an initiative funded by the Robert Wood Johnson Foundation for a faculty fellowship program to promote public health law education. Ten faculty members from law schools or schools/programs of public health will be selected to participate in a yearlong fellowship program designed to foster innovations in educational programming (including clinical, externship, and other experiential learning) and to build a strong learning community among faculty who teach in the public health law field.  

All fellows, with their deans’ support, will design and implement a project for curricular change in public health law education at their home institutions. Each fellow will be paired with a faculty mentor in public health law. The fellows will begin their fellowship year by attending an intensive 10-day educational Summer Institute on July 16-26, 2014 in Park City,  Utah. Over the course of the academic 2014-2015 fellowship year, the fellows and their mentors will regularly share ideas, experiences and models for public health law teaching, providing opportunities for professional growth and leadership development. 

ELIGIBILITY

• Applicants must have a J.D. degree and be employed in a full-time faculty position at a law school or school/program of public health, or be a full-time faculty member affiliated with a law school or school/program of public health, with a tenure-track, tenured, clinical-track, joint, or comparable faculty appointment;

• Applicants must have at least three years of full-time teaching experience at a graduate- or professional-school level by July 2014; previous background in health care law, public health law, or related subjects is preferred;

• A dean’s transmittal letter of support for the proposal is required, as well as
two letters of reference. 

For the complete list of eligibility and selection criteria and to review the full Call for Applications, visit www.law.gsu.edu/PHLFellowship.  

HOW TO APPLY

•   The application period opens Tuesday, Sept. 3, 2013. The deadline for applications is Friday, Dec. 13, 2013. Letters of reference are due Friday, Dec. 6, 2013.

•   For instructions on how to apply and complete information about the program, download the full Call for Applications at www.law.gsu.edu/PHLFellowship.

 Questions? Contact Stacie Kershner, associate director for the Center for Law, Health & Society, at [email protected] or 404-413-9088. 

 

Useful Article on Human Rights and Reproduction in Europe

In an article just posted on SSRN, "Reproductive health information and abortion services: Standards developed by the European Court of Human Rights," International Journal of Gynecology and Obstetrics 122 (2013) 173–176, Johanna Westeson provides a useful account of three recent decisions by the European Court of Human Rights.  In light of the decisions, she also highlights the importance of the development of professional standards to the evolution of human rights norms.

In the first case, R.R. v. Poland, No. 27617/04, Eur. Ct. H.R.; 2011, the patient had been denied access to diagnosis of a genetic condition of her fetus until after the time at which abortion was legal in Poland.  The ECHR held that this was a violation of her right to information in the context of reproductive health care.  Westeson points out the importance in this decision of the existence of medical standards regarding rights of access to information about maternal and fetal health. In the second case, P & S v. Poland, App. No. 57375/08, Eur. Ct. H.R.; 2012, the patient was a 14-year-old rape victim, for whom abortion in Poland was legally permissible.  However, she was subjected to a variety of forms of humiliating treatment, including release of her confidential information to the press and removal from the custody of her supportive mother . The ECHR determined that her treatment had violated the right not to suffer inhuman and degrading treatment and the right to respect for private life of both the patient and her mother.  Here, Westeson emphasizes the importance placed by the ECHR on ethical standards for when and how conscientious objection by providers is permissible.  Westeson also notes the ECHR's decison not to address the claim that the failure to provide emergency contraception violated the adolescent's human rights, and suggests that if Poland had had clearer ethical standards about such contraception, the ECHR might have been willing to take up the question.

The final decision discussed by Westeson is A. B. & C. v. Ireland, App. No. 25579/05, Eur. Ct. H.R.; 2010, a case involving three Irish women who received abortions in the UK.  Abortion is illegal in Ireland except when the mother's life is at stake.  In the case of one of the women, a patient with a form of cancer that could not be safely treated during pregnancy, the ECHR concluded that her inability to determine whether her life was at stake, and thus the legality of an abortion in her case, violated her right to private life.  For the other women, not suffering from life-threatening conditions, the ECHR concluded that Ireland was justified prohibiting abortion given the deep moral views of the Irish people.  Westeson is critical of the court's refusal to conclude that there is a human right to abortion, failure to recognize that travelling abroad is not an option for many women and is degrading for others, and inability to recognize that life and health may be difficult to distinguish in the abortion context.  Had the WHO Safe Abortion Guidelines been available in 2010, Westeson hypothesizes, the ECHR might have had medical judgments to rely upon in reaching a conclusion that threats to the women's life and health cannot be easily distinguished.

Westeson's discussion is worth reading both as a useful summary of the cases and as suggestive of how evolving standards of medical ethics and practice can be useful to courts in dealing with complex human rights issues. 

[LPF]

Futility on the Boarder

 

 

This month's Hasting Center Report contains a case study written by me and by Dr. Craig Klugman considering both the practice of "deporting" indigent patients who lack legal immigration status and the ability of a medical center to withdraw life sustaining treatment against a family's wishes.

 

The article considers a scenario occuring in Texas which, of course, has a highly structured mechanism to refuse to follow an advanced directive if it means providing care which the hospital believes not productive.  However, the problem of how to assert the legal right not to have a DNR is one of growing in importance.

 

For example, organizations like the Texas Alliance for Life tried but failed this last legislative session to vote in laws that would bar physicans from writing DNR orders against a patient or her surrogate's objection.

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]

Robert Wood Johnson Foundation Makes Impressive Committent to Public Health Law

 

I am just back from Austin where I was privileged to attend the "launch" meeting of the Scholars in Residence Program, one of five fellowship programs funded by the Robert Wood Johnson Foundation in order to enhance and promote public health law.  This press release  put out by the Network for Public Health Law gives more detail on the scholars (I'm proud to say I'm one of them) and our projects.  They are:

Jennifer S. Bard, Alvin R. Allison Professor of Law and Director of the Health Law Program and JD/MD program at Texas Tech University School of Law, will explore the interface between property rights and public health needs relating to nuisance and disease-spreading insects such as bed bugs and mosquitos. She will work with the City of Lubbock, Texas.    

Alex Capron, University Professor at the University of Southern California and the Scott H. Bice Chair in Healthcare Law, Policy and Ethics at the Gould School of Law, will examine federal rules on human subjects research relating to the surveillance of pathogens and viruses. He will work with the Los Angeles County Department of Public Health.

Mary Crossley, Professor of Law and former Dean at the University of Pittsburgh School of Law, will identify innovative ways in which California health officials can use their legal authority to address the growing burden of chronic diseases through interventions targeting risk behaviors and social and economic factors that impact health. She will work with the San Francisco Department of Public Health.

Sharona Hoffman, Edgar A. Hahn Professor of Law and Professor of Bioethics at Case Western Reserve University, as well as Co-Director of the Law School’s Law-Medicine Center, will develop enforcement guidance for regulation of in-home care agencies in order to improve compliance and protect the well-being of the vulnerable individuals served by these agencies. She will work with the Oregon Health Authority in Portland.

Browne Lewis, Leon & Gloria Plevin Professor of Law and Director of the Center for Health Law & Policy at Cleveland-Marshall College of Law, will focus on current state and federal preemption issues regarding local government regulation of the labeling, marketing and sale of small cigars. She will work with both the Cleveland Department of Public Health and the Shaker Heights Department of Public Health.

Polly J. Price, Professor at Law at Emory University School of Law, will address the coordination of public health agencies in providing long-term tuberculosis therapy among migrants along the U.S. border with Mexico.  She will work with public health agencies in El Paso, Texas and Las Cruces, New Mexico.

 

 

The meeting gave the six scholars, their supervisors from health departments all over the country, project leader Professor Fran Miller, RWJ liason and senior program officer Angela K. Mcgowan and consultant Nancy Kaufman and the team from the Network for Public Health Law, Judy Schector and Jackie Rose (Sara Rohde stayed behind to keep things running) a chance to meet and learn about the exciting projects and plans.

If anyone is not yet familiar with the Network for Public Health Law or their work, take a minute right now to join (its free).   This is how it describes itself: "The Network for Public Health Law provides insightful legal assistance, helpful resources and opportunities to build connections for local, tribal, state and federal officials; public health practitioners; attorneys; policy-makers; and advocate."  And indeed the assistance it provides is remarkable--it has put together a group of experts available to answer, free of charge, public health law questions.

The Network is linked with an impressive array of other RWJ funded public health law programs specifically:

• The National Policy & Legal Analysis Network to Prevent Childhood Obesity (NPLAN), a project of ChangeLab Solutions, provides leaders in the childhood obesity prevention field with educational resources and technical assistance on legal issues related to policies to improve nutrition and physical activity.
• The Northwest Center for Public Health Practice (NWCPHP) promotes excellence in public health by linking academia and the practice community, including developing training materials for public health law professionals.
• The Public Health Law Association (PHLA), a non-profit membership organization, serves as a vibrant and active community of public health law practitioners and stakeholders and provides opportunities for all members to learn and share ideas, best practices and research on public health law.
• Public Health Law Research (PHLR) builds the evidence for and increases the use of effective regulatory, legal and policy solutions to protect and improve population health and the public health system.
• Tobacco Control Legal Consortium, America’s tobacco control legal network, provides technical assistance to support public health professionals, attorneys and advocates as they develop, implement, interpret and defend tobacco control policies.

In addition to the Scholars in Residence, RWJ has already launched the the Visiting Attorney Fellows Program

There is also an active, and free of charge, students network designed to support law students interested in public health.

In the fall, a program directed by Charity Scott, Catherine C. Henson Professor of Law and center director, and
Stacie Kershner (J.D. ’08), associate director at The Georgia State College of Law's Center for Law, Health and Society will start accepting applications for "an intensive summer institute, work on course development, and create and direct
externships, clinics and other experiential-learning opportunities in public
health law. Experienced faculty mentors will guide these efforts, which will be
supplemented with connections to resources and organizations focused on public
health law in the practice setting."

Anyone with an interest in using the law to protect the public's health should be closely following the RWJ Foundation's innovative programing.

 

Are Health Care Providers Deliberately Misunderstanding HIPAA--And if So What You Can Do About it?

Ever since HIPAA was implemented in 2002, it has been used by health care providers to make life more difficult for patients by preventing their family members from being with them in care areas and by refusing to share information with those the patient wants to be kept informed.   This has caught the interest of the U.S. House Energy and Commerce Sub-Committee  has been holding hearings into various consumer issues regarding HIPAA.  I think this review is long overdue--and that  HHS is well aware of how providers are misusing HIPAA. The problems are so prevalent that the HHS website actually has a myth-buster section. 

So what can a family do?  A good step is to be skeptical when told that something is being done "because of the law."  As I have explained again and again to health care providers and lawyers, “If you think something that a) the patient or his family wants or b) is in the best interests of his care is prohibited by HIPAA, you don’t understand HIPAA.”  Ask for clarification from the hospital's lawyer--will you get that person on first call?  Maybe not, but be persistent.

 Inform yourself on the HHS website.  There is also a very useful FAQ section that addresses questions like, “is it illegal for a family member to pick up a prescription for a patient” (no) and  It starts with an over-all statement of principle: “The Privacy Rule provides federal protections for personal health information held by covered entities, and gives patients an array of rights with respect to that information. At the same time, the Privacy Rule is balanced so that it permits the disclosure of personal health information needed for patient care and other important purposes.”

Moreover, there is no provision in HIPAA that requires or allows a health provider to step in as “guardian of privacy” for a patient who is not conscious or competent.  When there is an identifiable surrogate decision maker, that person can make any decision about disclosure that the patient could have made himself.   And, no, there need not be any written document expressly allowing sharing of information with the surrogate.  Moreover, if a person has legal authority to make medical decisions, then he is entitled to review the medical records so that the decision can be an informed one.

At this point, more than ten years later, it’s reasonable to wonder if some of these “misunderstandings” are fostered by the fact that they make things easier for the providers in that it limits time consuming questions—like, “why isn’t my mother receiving pain medication?”  or “what are our options for Mom’s care?”  Certainly the posts in this nursing blog suggests that’s the case.  Here’s my favorite from Ortho-RN, “We usually don't allow family in the recovery room... I don't feel it's a place where family belongs.. No privacy, totally in HIPPA violations. Families like to be nosey and watch other things, and things do not always go smoothley...” (sic) Here’s another insight into how  providers see their obligations

 A brief foray into common sense should demonstrate the absurdity of these restrictive interpretations.  The  premise should be that outside a few narrow health & safety exceptions,  no one other than the patient is in a better position to decide who can and cannot have information about the medical care being provided.  And keeping family members away because of the risk they will see "other patients" is an absurdity.  None of us have the right to receive health care in complete seclusion.  Maybe high profile patients can pay for private wings—but all of us are stuck with the reality that in going to receive health care we may well be seen by other people, including those who know us. Finally, health care providers themselves are not entitled to protection from the observations and questions of family and friends about the care of their loved ones.  Could there be times during an emergency when the team can't stop and talk.  Sure.  But if these would be reasonable requests for information from the patient, then they are reasonable from the people the patient trusts most to protect his interests. 

 

 

Lessons About Medical Error Learned Watching I Love Lucy.

It's no secret that the night staff of a hospital are both over-worked and over-tired.   Nor is it any secret that many medical errors occur at night.  But until we look at the totality of the human factors making up medical error, we are unlikely to make significant headway in addressing it.  A review of the literature suggests that the reason isn't a lack of understanding about the factors which cause human errors, it's concern about the cost of addressing them.

The authors of a recent study in the Journal of the American Medical Association titled, Relationship Between Occurrence of Surgical Complications and Hospital Finances conclude that not only aren’t hospitals doing all they can to reduce medical errors, they actually have no financial incentives to do so.  

I'd suggest that financial incentives are behind ineffective efforts to address the issues of staff over-work and the inherent dangers of intermittent shift work.

 It's no surprise that another widely reported recent study has found that reductions in the hours medical residents work has not resulted in increased patient safety.   The study authors conclude that this is because although residents worked less hours, they did not have a reduced work load.  So, like Lucille Ball in the chocolate factory, the trying to cram more work in the same amount of time increased resident error.  

The findings of that study need to be seen in combination with the vast amount of scientific research on the increase in errors caused during night shifts.   A recent study of nurses working night shifts showed that “on average, the error rate increase 6% after the second night shift in a row, 17% after the third successive night shift and an astounding 35% higher on the fourth night shift.”  See also this and this article by the Joint Commission.  Although no one disputes the reality that human beings perform best in the day time, every hospital must be fully staffed 24 hours a day.  The information is both anecdotal and research based.   But no one seems to be listening.

 An article in Nursing World  does an excellent job of using available research to describe the scope of the problem, but implies that it can be effectively addressed by nurses proactively paying more attention to their sleep patterns.  It advises nurses working the night shift to “take control of sleep.”  In fact the NSF “recommends that nurses wear wrap around sunglasses when driving home so the body is less aware that it is daylight.”    This advice ignores the scientific reality that humans are not as effective or alert at night as they are in the day time.  Nor does it consider the human reality that medical shift workers do not have the luxury of using their days to sleep.  Like everyone else living in a diurnal world, they must cope with the tasks of family and daily living.

 Techniques like wearing dark glasses may work in making a shift to a new rhythm--like travelling to another time zone.   But given the unlikeliness of medical staff to convert to a  permanent change in their circadian rhthyms, as if they were working in a submarine (and that doesn’t work very well either)  the answer is to address the reality that humans are less effective at recognizing problems and completing complex tasks at night.   But that’s not where the problem solving is going. 

Continue reading

Evidenced Based Practice: When will Law Catch up with Medicine?

 Two widely reported studies this week about bed rest for women at risk of preterm delivery and reduction of salt consumption in order to promote heart health highlight two things we don’t think about enough—that a lot of standard medical practices are without any foundation in science and a lot of legal ones probably are too.    However, medicine has more and more taken the public health approach of examining the practices of individual doctors to see how effective they actually are in the general population.    For example, it is old news that prescribing bed rest to pregnant women at risk of preterm delivery is not effective.  But what this Obstetrics & Gynecology study found that “activity restriction”, such as quitting work, is still prescribed to one at three women at risk for preterm delivery.  The accompanying “Bed Rest in Pregnancy: Time to Put the Issue to Rest” makes an ethical argument that continuing to prescribe bed rest in the absence of evidence of its effectiveness violates the principles of autonomy and beneficence.

The Institute of Medicine just issued this report Sodium Intake in Populations: Assessment of Evidence “found no consistent evidence to support an association between sodium intake and either a beneficial or adverse effect on most direct health outcomes other than some CVD outcomes (including stroke and CVD mortality) and all-cause mortality.”

We have similar research in law- a lot of it coming from the Empirical Legal Studies movement, including work done at the Center for Empirical Legal Research at Washington University Berkeley Emperical Legal Research , the Centre for Emprical Legal Studies at UCL (formerly known as University College London) among many others, but it is not as well funded or coming from as well established sources as the studies which attempt to find an evidence basis for medical practices.  The salt reduction report was commissioned by the Institute of Medicine   In contrast, the ACLU supports its empirical argument that the death penalty does not deter crime on an opinion survey of police chiefs.  Translating information from research scientists to practicing physicians is still a slow process,—but no one questions the underlying principle that medical practice should be based on scientific evidence.

Part of the issue is funding.   Medicine as a whole is in a constant quest to contain costs and stopping ineffective practices is an important component of that effort.    But beyond a small number of progressive funders like the Robert Wood Johnson Foundation, there isn’t a lot of demonstrable interest, the kind supported by funding studies, in law making bodies in finding out what legal practices work and what do not.   

 This isn’t a new observation.  Bryant Garth outlined the problem in 1997 when he explained the importance of more social science research into the foundational principles of practices civil procedure.   But the steady flow of studies questioning conventional wisdom coming from the medical field has, as yet, no real counterpart in the world of law making.

Of course there will always be the problem of knowing the unknowable.  But it would be interesting for law makers to consider taking a lesson from public health in challenging assumptions about the human body and mind or even more generally the physical world that underlie both common law and statutes.