HealthLawProf Blog

Replacing the Affordable Care Act?

With the future of the Affordable Care Act in doubt after last week’s hearing before the U.S. Supreme Court, Republican lawmakers are busily preparing back-up legislation. New options should not be necessary—the government should prevail against those challenging its interpretation of the Act’s premium subsidy provisions. But it is prudent to consider alternatives in the event that the Court rules against the government.

While most of the ideas being floated would do little to bring health care insurance to the uninsured, there is an option that really could expand access to coverage while also containing health care spending. And it could be attractive to Republicans and Democrats alike on Capitol Hill.

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Health Care Policy by Common Sense?

In announcing the federal government’s approval of Indiana’s Medicaid expansion, Governor Mike Pence invoked common sense in defending his insistence that beneficiaries shoulder a share of their health care premiums. According to Pence, “It’s just common sense that when people take greater ownership of their health care, they make better choices.”

But relying on common sense is not a good way to make health policy. Common sense leads people to incorrectly believe that they are more likely to catch a cold by going out in cold weather or to take megadoses of vitamins that provide no additional health benefit and can be toxic. Common sense also leads physicians down the wrong path. Because lowering blood sugar has been good for the health of diabetics, medical experts recommended tight control of blood sugar levels. But that resulted in an increased risk of death for many patients.

It turns out that our intuitions often lead us astray, making it important that we rely on data from scientific studies to distinguish between good and bad policies. And we know from the data to date that when the poor are required to pay for their health care, they may choose to forgo it, not only when care is not needed but also when it is needed.

Kudos to Governor Pence for bringing the Medicaid expansion to Indiana and for worrying about health care costs. It may turn out that Indiana's cost-sharing is low enough to avoid problems, but rather than trying to contain costs by discouraging patients from seeking too much care, we should try to discourage physicians from providing too much care. Physicians are better able than patients to distinguish between necessary care and unnecessary care.

[cross-posted at Bill of Health]

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.

 

Ebola: A Problem of Poverty rather than Health

Undoubtedly, the death toll in West Africa would be much lower if Guinea, Liberia, and Sierra Leone had better health care systems or if an Ebola vaccine had been developed already. But as Fran Quigley has observed, Ebola is much more a problem of poverty than of health. Ebola has caused so much devastation because it emerged in countries ravaged by civil wars that disrupted economies and ecosystems.

Ultimately, this Ebola epidemic will be contained, and a vaccination will be developed to limit future outbreaks. But there are other lethal viruses in Africa, and more will emerge in the coming years. If we want to protect ourselves against the threat of deadly disease, we need to ensure that the international community builds functioning economies in the countries that lack them.

Our humanitarian impulses in the past have not been strong enough to provide for the needs of the impoverished across the globe. Perhaps now that our self-interest is at stake, we will do more to meet the challenge.

[cross-posted at Bill of Health and PrawfsBlawg]

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]

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

           

 

 

 

 

 

 

 

FDA Regulation of E-Cigarettes—A Gateway to Teaching Administrative Law

 

It’s likely that most readers of this blog already know that the FDA just announced its intent to extend its regulatory powers to E-Cigarettes.   E-Cigarettes have proven to be a "high interest" topic in both my "Constitutional Issues in Health Law" and "Legal Issues in Human Subject Research Classes."  The struggle between the FDA and those it wishes to regulate raise questions about the powers of all three branches of Government.  It can serve as a proxy for all administrative agencies in an Admin Class or as a direct source of study in a public health, environmental or (of course) food & drug law class.

The FDA's current struggles include energy drinks, body building supplements and truth in calorie reporting (no more hiding calories by assuming unrealistic serving sizes).

But back to E-Cigarettes.  

Here is the text of the proposed rule.  And here is the Campaign for Tobacco-Free Kids’ list of reasons why the FDA is justified—and should—be able to do this.

The FDA’s relationship with regulating tobacco products has been a complicated one.  This book review by Margaret Gilhooley can bring you up to date on the history of FDA’s failed attempts to obtain jurisdiction.  It was not until June 22, 2009 that the FDA finally did get regulatory power when President Obama signed the Family Smoking Prevention and Tobacco Control Act (FSPTCA) that the FDA got any authority to regulate tobacco products—and that only through the filter (sorry) of protecting children.   And that still remains the outer limit—protecting children. 

So any regulation of E-Cigarettes has to be along the lines of making them less available to minors.  That’s why what sounds like a relatively weak reason—“even if they are harmless, they are a gateway for children to real cigarettes” is important because that is the statutory basis of the FDA’s power.  It’s not surprising that the FDA’s announcement has been met with immediate protest from Vapers.  New York’s ban (and remember, all the FDA’s done is to announce it intends to assert its authority to look into the product’s safety) has sparked considerable push-back based on issues of “personal liberty.” Apparently this anti-regulation movement is not restricted to the U.S.

   Vapers have had little success persuading cities to exempt e-cigarettes from public spaces, but they have been able to prevent outright bans and to allow the creation of “vaping lounges” –-the English majors among you know these better as modern day equivalent of a legal opium den—perhaps inhabited by today’s Keats, Shelleys and Coleridges.  We even have them in Lubbock.  

The FDA’s goal is to build on the actions of the cities that are equating e-cigarettes with “old style” tobacco to keep e-cigarettes as an “adults only” product.

 

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

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.

At the Intersection of Health Law and Civil Rights

 

Health Law Prof Extraordinaire  Nina Kohn of Syracuse University, now visiting at Maine, shared this link with me http://www.cbc.ca/thecurrent/episode/2014/03/11/why-are-family-members-being-banned-from-visiting-their-relatives-in-nursing-homes/ because of an experience I had involving the ICU staff when my mother was hospitalized last year and I expressed concern about emerging pressure sores from compression socks that were not being monitored.  I don't think this problem is unique to Canada.

I received wonderful help and advice from two very different groups--the National Center for Medicare Advocacy-a terrific resource for navigating a complex and often not very patient centered health care system--and Texas Right to Life which is promoting the Will to Live document as a counter to the assumption that the possession of an "advance directive" is the equivalent of a decision to forgo care in order to hasten death.

 

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.

 

 

 

 

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.

 

Disability Accommodation and Board Certification

Accommodations for people with disabilities in professions remains controversial.  In medicine as in law, courts defer to the judgments of professional organizations regarding appropriate qualifications.  An illustration is a recent district court ruling in Pennsylvania that it is not a reasonable accommodation to alter the multiple choice format for the examination for Board certification in pediatrics. Rawdin v. American Bd. of Pediatrics, 2013 WL 5948074 (E.D.Pa).  This decision is troubling both for its understanding of disability and for its deference to the board certification process.

According to the district court, Rawdin was "by all accounts, an excellent pediatrician."  Yet Rawdin had a cognitive disability resulting from earlier surgeries for a brain tumor--a disability that affected his ability to process remembered information out of context in a manner that would enable him to succeed on tests in the multiple choice format.  Despite several tries, Rawdin could not pass the board certification exam given by the American Board of Pediatrics (ABP).  Because of his failure to obtain Board certification, Rawdin was dismissed from his positions in the Neonatology Department of the Children's Hospital of Philadelphia (CHOP), where he had served for 5 years and become the Assistant Director of CHOP's nursery, held a faculty post, and was part of the Academic Clinician Track at the University of Pennsylvania School of Medicine.  Rawdin brought suit against the ABP under Title III of the ADA seeking alternative testing as an accommodation.  The district court held that Rawdin was not a person with a disability under the ADA (as amended by the ADAAA) and that, even if he qualified for statutory protection, the accommodation he sought was not reasonable because it would be a fundamental alteration of the ABP testing procedure.

The court's ruling against Rawdin rested primarily on the determination that his disability did not bring him within the statutory protection of the ADA.  As the case arose after the effective date of the ADAAA, the court applied the amendments' more expansive standard for determining disability.   The court agreed that Rawdin's memory processing difficulties are a mental impairment and that test taking is a major life activity. However, the court still concluded that Rawdin was insufficiently affected to meet the statutory standard, reasoning that his cognitive processing abilities were at least average for the general population and so his limitation was not substantial.  This comparison--between Rawdin's abilities and the general population, not between Rawdin's abilities had he not had the brain tumor and Rawdin's abilities as affected by the tumor and its treatment--was not changed by the EEOC in light of the ADAAA.   Interpretations such as this illustrate the irony of the ADA, even as amended by the ADAAA:  there are many who could work successfully or meaningfully access accommodations but who remain unprotected by the ADA even in its amended form.

Although the Rawdin court's determination that Rawdin did not warrant statutory protection was sufficient for its decision, the court also reached out to state that Rawdin's request to that the Board certification exam in essay form was not a reasonable accommodation.  In thus concluding, the court judged that the ABP was an academic institution and thus deferred to the ABP's claim that a multiple choice examination was the best way to assess competence in the field.  The court also concluded that developing a different exam would impose an undue hardship on the ABP.

The Rawdin court also chose to reach the issue of whether altering the format of the exam was a reasonable accommodation, even though it was unnecessary to its resolution of the case.  Deferential to the ABP as to an academic institution, the court concluded that its determination that changes in the exam format would lower standards should be respected.  The court also judged that the requested accommodation would be a fundamental alteration of the Board certification process. 

The decision's deference to professional determinations is not surprising.  However, if the court's description of Rawdin's excellence as a neonatologist is accurate, it illustrates the problematic costs of the ABP's approach.

[LPF] 

 

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. 

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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.  

 

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 17^th, 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

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