HealthLawProf Blog

"Very Real Consequences" for Medicaid and Beyond

Back in January, I commented on the oral arguments in Armstrong v. Exceptional Child Center, the Medicaid reimbursement case that the Supreme Court decided yesterday.  I noted then that Justice Breyer seemed confused about Medicaid's operation; that Justice Kennedy appeared to be on the fence; and that the four dissenters from Douglas v. Independent Living Center appeared wedded their 2012 position that no private right of action is available under the Supremacy Clause.  Sure enough, the Court eliminated private enforcement of the Medicaid Act's payment adequacy provision ("30(A)") against non-compliant states.  This decision is a major victory for states, a questionable victory for the Obama Administration, and a potential defeat for access to care in the Medicaid program.

Justice Scalia authored the majority opinion (joined by Justices Thomas, Roberts, Alito, and Breyer), which began with an intentional description of Medicaid as a Spending Clause program.  Justice Scalia noted that states agree to spend federal funds "in accordance with congressionally imposed conditions."  The majority then effectively constructed a clear notice rule for the Supremacy Clause, indicating that the Supremacy Clause provides a "rule of construction" but does not "create a cause of action" unless Congress "permits the enforcement of its laws by private actors."  Although purporting to empower Congress, the majority actually limited the reach of federal legislation by requiring Congress to explicitly confer private rights of action under federal laws.  As a Brief by Former Administrators of HHS made clear (in Douglas and again in Armstrong), Congress and HHS rely on private actions to enforce the Medicaid Act, in part because the law has such a broad reach and the agency's staffing is so limited.  Contrary to the majority's bizarre characterization of private enforcement of federal laws as limiting, in the Medicaid context, private enforcement is critical for implementing the purposes of 30(A), which was written to ensure equal access to medical care for Medicaid beneficiaries.  30(A) requires on-the-ground observation for assessing states' payment adequacy, which HHS cannot do without the assistance provided by privately initiated enforcement actions.

The majority then cited Chief Justice Roberts' dissent in Douglas to support its position that Congress deliberately excluded private enforcement from the Medicaid Act.  This is simply not true. Congress did not "foreclose" or "exclude" private enforcement from the Medicaid Act, either in 1965 when Medicaid was enacted, or when 30(A) amended the Act.  In fact, Congress debated language that would have prevented providers and beneficiaries from seeking relief in federal court when states violate the Medicaid Act, but Congress never has added such language to the Medicaid Act.  Nevertheless, the majority concluded that the Secretary of HHS is solely responsible for enforcing 30(A) pursuant to her authority under 42 U.S.C. §1396c to withhold Medicaid funds from non-compliant states.  The Secretary is reluctant to withhold funds in Medicaid because such an act would harm beneficiaries, but the majority did not engage this quandary, instead deeming 30(A) judicially unmanageable, even though lower federal courts have guided states toward adequate payment decisions for years.  The majority also seems to be setting up HHS to fail; if the agency actually withheld Medicaid funding, the state might respond with a claim of coercion under NFIB v. Sebelius, thereby further undermining the program's operations.  (Justices Scalia, Thomas, Alito, and Kennedy would have struck down the Medicaid expansion in its entirety under the newly crafted doctrine of coercion in that case.)

The majority circled back to Medicaid's status as a spending program in Part IV of its opinion, which Justice Breyer did not join, and which may resurrect a theory of spending programs as being like contracts and unlike other federal laws.  Though the Court has long relied on the Pennhurst contract analogy for federal conditional spending programs, in some cases (e.g. Barnes v. Gorman), the Court has suggested that the "third party beneficiaries" of spending programs have no enforceable rights in those programs.  The majority opinion very briefly noted that "contracts between two governments" cannot be enforced by beneficiaries of those contracts - citing Justice Thomas's concurrence in PhRMA v. Walsh - as if the federal government and the states were co-equal sovereigns.  This dicta brings all Medicaid provider and patient actions into question, whether they are raised under the Supremacy Clause or section 1983, the other avenue for Medicaid private enforcement.  The majority thus opened the courthouse doors to further eroding of conditional spending statutes in the context of the Medicaid Act. [more after the jump]

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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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Will the Uninsured Become Healthier Once They Receive Health Care Coverage?

The Affordable Care Act might not bend the cost curve or improve the quality of health care, but it will save thousands of lives, as millions of uninsured persons receive the health care they need. At least that’s the conventional wisdom. But while observers assume that ACA will improve the health of the uninsured, the link between health insurance and health is not as clear as one may think. Partly because other factors have a bigger impact on health than does health care and partly because the uninsured can rely on the health care safety net, ACA’s impact on the health of the previously uninsured may be less than expected.

To be sure, the insured are healthier than the uninsured. According to one study, the uninsured have a mortality rate 40% higher than that of the insured. However, there are other differences between the insured and the uninsured besides their insurance status, including education, wealth, and other measures of socioeconomic status.

How much does health insurance improve the health of the uninsured? The empirical literature sends a mixed message. On one hand is an important Medicaid study. Researchers compared three states that had expanded their Medicaid programs to include childless adults with neighboring states that were similar demographically but had not undertaken similar expansions of their Medicaid programs. In the aggregate, the states with the expansions saw significant reductions in mortality rates compared to the neighboring states

On the other hand is another important Medicaid study. After Oregon added a limited number of slots to its Medicaid program and assigned the new slots by lottery, it effectively created a randomized controlled study of the benefits of Medicaid coverage. When researchers analyzed data from the first two years of the expansion, they found that the coverage resulted in greater utilization of the health care system. However, coverage did not lead to a reduction in levels of hypertension, high cholesterol or diabetes.

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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

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.

 

 

 

 

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. 

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.

 

Dartmouth Institute Publishes Atlas of Medicare Part D Areal Variations

The Dartmouth Institute has just published its Atlas of areal differences in utilization of prescription drugs by Medicare Part D recipients.  The Atlas--unsurprisingly but disturbingly--details significant differences.  Pharmaceutical interventions are classified as effective, discretionary (where there is diagnostic or therapeutic uncertainty), and likely to be harmful in the patient population at issue.  A caveat, however, is that the report measured prescriptions filled and thus may underestimate actual provider behavior.

An initial variation involved sheer numbers of prescriptions, with a high average of 63 per year in Miami and a low average of 39 per year in Colorado (overall, the average was 49 standardized 30 day prescriptions filled per year per Part D beneficiary).  In general, the Mountain West had the lowest prescription average and the Rust Belt and Appalachian states the highest.  These differences could not be explained primarily by overall burden of disease but instead appear to reflect variations in provider prescribing practices.  For example, the American Heart Association recommends use of beta blockers in heart attack patients for three years post-attack.  However, rates of prescriptions for these drugs in the first six months ranged from highs of 94% to lows of under 68%, and persistence in the next six months was only slightly lower, ranging from highs of 92% to lows of under 68%.  Variations in statin use were even greater, ranging from just over 91% in Ogden, Utah, to below 45% in Abilene, Texas.  Interestingly, there was little correlation between effective use of beta blockers and effective use of statins.

The other two therapies analyzed in the Atlas were treatment of diabetes and treatment of patients with fragility fractures.  Diabetic patients fared somewhat better than heart attack patients, albeit still with significant variations.  Osteoporotic patients, however, fared dismally, receiving a high of 28% and a low of 7% with filled prescriptions for drug to combat osteoporosis after fragility fractures in sites other than the hip (such treatment is recommended to decrease the risk of future hip fractures).

Most interesting of all, there was no correlation between drug expenditures and measures of effective care.  In other words, patients in some regions may be spending a great deal on their drugs (paid for under Part D), but receiving far less benefit that patients in other regions who spend a great deal less.

[LPF]

 

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.

Happy Exchange Day!

Despite best efforts to prevent the exchanges, or marketplaces, from going on line, today the exchanges have begun to do the work of facilitating a health insurance home for people in the United States.  If you live in a state that has declined to create its own exchange, then you should visit https://www.healthcare.gov/, the federal website for the federal health insurance marketplace.  Though there were reports of the site crashing, as of 3:00 this afternoon it seems to be working.  And, the site will guide you to your state's marketplace site, as necessary.  No need to rush though, as open enrollment lasts through March of 2014.

Many probably saw Governor Beshear's op-ed in the New York Times last week regarding the reasons that Kentucky has created its own state-based exchange (and will accept federal funding for the Medicaid expansion), here.  The commentary seems even more relevant in the wake of the House Republicans shutting down the federal government over health insurance.

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]

Our Not-So-Exceptional System of Employer-Sponsored Health Insurance

In yesterday's New York Times, Ross Douthat joined the chorus that criticizes employer-sponsored health care insurance. According to Douthat, this "unsustainable relic" is a "burden on businesses, a source of perverse incentives for the health care market and an obstacle to more efficient, affordable and universal coverage."

In fact, the United States is not unusual in the extent to which it relies on companies to fund health care coverage. Indeed, employers in France, Germany and Japan shoulder a higher percentage of their countries' national health spending than do U.S. employers. Government-run systems must find sources of funding for their programs, and employers are an obvious place to look.

To be sure, there are problems with employer-sponsored coverage, but the Affordable Care Act (ACA) takes care of a very important one. Employer-sponsored coverage has promoted "job lock" in the United States. Many would-be entrepreneurs have been reluctant to start their own companies because they would lose their employer-sponsored coverage and have to pay for insurance out of their own pocket. For people with pre-existing medical conditions, insurance might not be available. Under ACA, the new entrepreneur will be able to find an affordable health care plan on an insurance exchange.

The abandonment of employer-sponsored coverage would reduce the burden on businesses only if health care costs overall were lower under the replacement system. Many health care policy experts observe that costs are lower in government-run systems overseas because the governments can exercise greater negotiating leverage with doctors and hospitals than can insurance companies in the United States. In short, the high cost of U.S. health care and its burden on business seems to be not so much a problem of relying on employers rather than individuals to purchase coverage but a problem of relying on private insurers rather than government to operate the system.

[DO]

 

Conditional spending for the cause of public health

The Supreme Court decided Agency for International Development v. Alliance for Open Society International yesterday, a lower-profile case about unconstitutional conditions placed on federal funding.  My initial reaction is that the opinion can be read in at least two ways.  On the surface, this decision reads like the long line of First Amendment unconstitutional conditions cases such as Rust v. Sullivan and Legal Services Corp. v. Velazquez.  Chief Justice Roberts' majority opinion held that the "Leadership Act" could offer federal funding to eradicate HIV/AIDS throughout the world, and that funding can express discouragement of prostitution by refusing to allow the funds to be used for the promotion of prostitution, but the Court held that the conditions on the funds cannot go so far as to require the organizations using the federal funds to explicitly oppose prostitution.  (Fund recipients had expressed the fear that taking an overt stance against prostitution would harm their public health efforts by scaring those in the sex trade away from their doors.)  The majority's opinion is a non-controversial read of that line of cases and even attempts to make sense of the somewhat inconsistent application of the doctrine by describing the difference between "conditions that define the limits of the government spending program" and "conditions that seek to leverage funding to regulate speech outside of the contours of the program itself."  I don't necessarily buy this distinction.  After all, conditions by necessity define the contours of a program - unless they are nongermane, which seems to underly the Chief Justice's leveraging concept but was never explicitly stated.  But, it is one way to describe the differing outcomes in this line of cases that is worth considering.

But then I come to a second possible take: this case reiterates the Roberts Court's willingness to rein in congressional exercises of the spending power.  On the heels of NFIB v. Sebelius, the spending aspect of this case is notable, given that this is the second case in two years to express disapproval of conditions on federal spending.  Unlike NFIB, which created a novel coercion doctrine without contours, this decision tread familiar ground in its conclusion that conditions on spending cannot violate First Amendment rights.  However, even during oral arguments, there were shadows of the ACA controversy from last term.  And, although NFIB was not cited in the opinion, both the majority and the dissent (authored by Justice Scalia) contained familiar language about leveraging, coercion, and offers that can't be refused.  It is unclear why Justices Scalia and Thomas would uphold this condition on federal funding when they so readily and forcefully rejected the Medicaid expansion last year.  The simplest answer is probably that these justices have long rejected the unconstitutional conditions doctrine.  (Another possibility is that the dissenting justices agree with the policy of rejecting prostitution (see Justice Scalia's bizarre "free love" comparison) but disagreed with the policy of universal health coverage.)  

While the spending power is still robust, I am not sanguine about the conversation the Court is trying to have with Congress about the Spending Clause.  It will be interesting to see how the Court furthers this project in the same-sex marriage cases that are sure to be handed down next week.  If the cases turn on the doctrine of federalism, then read in combination, the Roberts Court may be continuing its adventures in the Federalism Revolution, once thought done and gone, and now revived through the spending power.

[NH]

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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