HealthLawProf Blog

Dying in the US--still problematic

Today is Halloween, all Hallows Eve, the eve of All Saints Day.  And last night, my father-in-law died peacefully at the age of 96.  So I thought, amidst all the turmoil of death panels, that it might be useful to call attention to the continuing evidence that hospice is underutilized in the US, that changes in the hospice benefit found in the Affordable Care Act may not help, and that the controversy over physician-assisted suicide continues. 

One of the persistent problems with hospice in the US has been its utilization too little and too late.  Joan Teno among others has studied the use of hospice extensively. According to one of her most recent papers, "It Is “Too Late” or Is It? Bereaved Family Member Perceptions of Hospice Referral When Their Family Member Was on Hospice for Seven Days or Less" (Teno et al.2012), http://dx.doi.org/10.1016/j.jpainsymman.2011.05.012, of the over 1.4 million patients receiving hospice care each year in the US, 34.4% are enrolled for seven days or less and over half for less than 30 days.  In many of these cases, the study found, earlier referral would not have been possible because either the patient refused hospice or the patient's downhill course was quite rapid. But in other cases, the late referral was attributed to poor provider-patient communication or to a failure in prognosis, both long-standing problems in US health care.  The study concludes that many patients do not receive the full benefits of hospice services and that there is also need for better end of life services for those patients who receive hospice for only a very short period.

So what might ACA do?  The flip side of the criticism that hospice referrals come too late is that they come too early or for patients who do not qualify because of financial incentives created by the Medicare hospice benefit, as the Medicare Payment Advisory Commission (MedPAC) argued in a report in 2009. Section 3132 of ACA, in response, requires a face-to-face encounter with the patient by either a physician or a nurse practitioner prior to hospice re-certification after 180 days and each subsequent recertification. After delaying implementation of this requirement, CMS announced that it would expect full compliance after the second quarter of 2011, http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Downloads/f2f_listserv.pdf.  A particularly difficult aspect of this requirement is its application to patients who have received earlier hospice services, as admitting hospices must consider the patient's earlier receipt of hospice services and may have difficulty in getting the required information. The Center for Medicare Advocacy raises the concern that this may limit hospice access, albeit possibly improving the quality of care for those who do receive services,http://www.medicareadvocacy.org/2011/01/20/new-hospice-regulations-are-a-mixed-bag-for-beneficiaries-seeking-high-quality-end-of-life-care/ .

In Massachusetts, voters will address a ballot measure allowing physicians to prescribe lethal medication to certain terminally ill patients.  If the Death with Dignity measure (Question 2, http://ballotpedia.org/wiki/index.php/Massachusetts_%22Death_with_Dignity%22_Initiative,_Question_2_(2012)) passes, Massachusetts will join Oregon and Washington in permitting the practice.  Current polling suggests that the measure is ahead but that support for it is slipping.  In a recent New York Times opinion piece, Ezekiel Emanuel argued that the debate is confused and that while it might benefit those with money and the ability to control their lives, it might also put those who are more vulnerable at risk, http://opinionator.blogs.nytimes.com/2012/10/27/four-myths-about-doctor-assisted-suicide/.  Whether risks to the vulnerable are merely hypothetical or actual remains controversial, however; see my colleague Margaret Battin's analysis of the evidence from the Netherlands and Oregon, arguing that the risks are largely hypothetical,http://jme.bmj.com/content/33/10/591.abstract; the most recent report from the Netherlands also indicates that use of the practice remains stable with a decrease in the frequency in which life was ended without an explicit patient request, doi:10.1016/S0140-6736(12)61484-6.

To me, it is a shame that careful consideration of how best to support patients and their families in dying as they would wish, including with physician aid, has been caught up in concerns about costs, in political cross-fire, and in ideology.  Joan Teno's call for integrated support systems, whether within or outside of hospice, is an important one.  Fortunately, even though my father-in-law declined too precipitously for hospice to be a possibility for him, we received a great deal of support from the skilled nursing facility where he was a patient.  But the evidence remains compelling that in the US this is too often not the experience of patients and their families at the end of life.

[LPF]

 

 

 

 

Physician Aid in Dying

While It is not surprising to see Ezekiel Emanuel reject physician aid in dying (which he and others describe as physician-assisted suicide), it is surprising to see some of his arguments. For example, he argues that a right to assisted suicide lacks mass appeal because only a fraction of people actually exercise the right in Oregon or other countries where it is legal. But the benefits of a right to aid in dying extend far beyond those who exercise it or seriously consider it during their dying process. For anyone who develops a serious illness and worries that suffering might become intolerable at some point, a right to aid in dying can provide important reassurance.

Emanuel also worries that the poor and poorly educated dying patient will be abused by a right to aid in dying. But the evidence from Oregon after about 15 years of aid in dying does not indicate abuse of vulnerable populations. Indeed, the risk of abuse is far greater from a right to have life-sustaining treatment, which can be exercised by others on behalf of mentally incapacitated patients, than from a right to aid in dying, which must be exercised by competent patients.

[DO]

Physician Assisted Suicide

Coverage of the Massachusetts initiative from NPR is here and from TIME, here. In an op-ed in today's New York Times, here, Ezekiel Emanuel argues:

Instead of attempting to legalize physician-assisted suicide, we should focus our energies on what really matters: improving care for the dying — ensuring that all patients can openly talk with their physicians and families about their wishes and have access to high-quality palliative or hospice care before they suffer needless medical procedures. The appeal of physician-assisted suicide is based on a fantasy. The real goal should be a good death for all dying patients.

[NPT]

Follow up On Fungal Meningitis Outbreak

For those following the investigation of the meningitis outbreak the Massachusetts Department of Public Health has issued a preliminary report which links the outbreaks to apparently unsterile conditions at the New England Compounding Center (NECC).  Meanwhile, confirmed cases continue with the latest being identified in South Carolina.   Most recently, the CDC reports that the death toll is now 24.  The CDC now believes that “patients are most at risk for developing fungal meningitis within the first 6 weeks (42 days) after receiving their last injection in the back (epidural or paraspinal) with contaminated steroid medication from the New England Compounding Center.”  The blog Pharma Watchdog continues to monitor this and other pharmaceutical related legal issues.    If this case has sparked particular interest for someone not already involved in teaching public health law, the American Public Health Association has some terrific resource material on Public Health Law in general.  

Concluding with more on the topic of public health, this weekend marks the beginning of the APHA’s annual meeting which takes place this year in San Francisco.  As always, the law section is offering a plethora of high quality programs.  I will be there and look forward to seeing other health law profs.

JSB

Care for Vulnerable Populations

The Commowealth Fund has released a short video, here, on the subject of Improving Care for Vulnerable Populations.They also have more information, including a classroom-friendly chartpack on Care for Low-Income Populations here. [NPT]

And now, the important stuff...

If you tend to cure your mid-semester slump by increased chocolate consumption, here's a study to back you up.  A study published recently in the New England Journal of Medicine found "There was a close, significant linear correlation (r=0.791, P<0.0001) between chocolate consumption per capita and the number of Nobel laureates per 10 million persons in a total of 23 countries."  The study concludes:

Chocolate consumption enhances cognitive function, which is a sine qua non for winning the Nobel Prize, and it closely correlates with the number of Nobel laureates in each country. It remains to be determined whether the consumption of chocolate is the underlying mechanism for the observed association with improved cognitive function.

Enjoy!

[NH]

Medicare Reportedly Settles on Coverage for Rehabilitative Services

For many years, Medicare has refused to pay for physical or occupational therapy unless patients could show "improvement."  Although this policy is a cost-saver, it has devastating effects on patients for whom these therapies are critical to maintaining current levels of functioning or preventing declines.  The "benefits" of care extend far beyond "improvement."

Over the years, there have been some changes.  For example, many local Medicare carriers routinely denied ANY physical therapy to patients with a diagnosis of Alzheimer's disease, apparently on the theory that people with declining cognitive capacities cannot benefit from the service.  Leslie Fried, an lawyer at the ABA's Commission on Law and Aging (at the time the Commission on the Legal Problems of the Elderly) and partially funded by the Alzheimer's Association, took on these policies, http://www.alz.org/professionals_and_researchers_insurance_and_coverage.asp.  A photograph of President Reagan leaving physical therapy after his hip replacement (and long after the public announcement of his diagnosis of Alzheimer's) helped her to get Medicare to change such across-the-board denials.  However, the overall policy that patients must show "improvement" continued.  The Medicare Part B manual (current as of spring, 2012), reads:  "Rehabilitative therapy includes recovery or improvement in function and, when possible, restoration to a previous level of health and well-being. Therefore, evaluation, re- evaluation and assessment documented in the progress report should describe objective measurements which, when compared, show improvements in function or decrease in severity or rationalization for an optimistic outlook to justify continued treatment."

This policy was challenged in federal district court in Vermont by lawyers at the Center for Medicare Advocacy.  The Obama administration reportedly agreed earlier this week to settle the case, by stating in the Medicare manual that coverage for rehabilitative services:  "does not turn on the presence or absence of a beneficiary's potential for improvement from the therapy, but rather on the beneficiary's need for skilled care." News reports indicate that Medicare is describing this as a "clarification" of existing policy.  If it is such a clarification--and the language quoted above from the current manual would suggest it is far more than that--it is a welcome one, with the potential to benefit many Medicare recipients with chronic or disabling conditions.

[LPF] 

Health Affairs on Comparative Effectiveness Research

In the effort to promote higher-quality, lower-cost health care, the Affordable Care Act rightly emphasizes comparative effectiveness research. Studies often demonstrate that different treatments are effective for a medical problem without telling us which treatment is best. More studies comparing different treatments can make for better medical decisions. The current issue of Health Affairs includes a number of helpful articles on the challenges to implementing an effective comparative effectiveness research policy.

[DO]

Naomi Schoenbaum: The Single Word That Could Make or Break Obamacare

Naomi Schoenbaum, Associate Professor of Law, George Washington University Law School has written a very interesting essay for The Atlantic on the implications of labeling the health care mandate a tax or a penalty. Below is an excerpt. The entire essay is here.

Obamacare has been one of the yardsticks of Obama's term in office and one of the touchstones of the 2012 election. Last night's presidential debate was no exception, with health care reform mentioned at least half a dozen times. But an important piece of the discussion has been missing: is the health care law a tax or a penalty?  

It turns out how Americans perceive the health care mandate could affect whether they end up purchasing health insurance at all, and therefore whether the law achieves what it was meant to do. During the next four years, the way the president chooses to frame the law will have a large impact on its policy future. 

[KVT]

Position Announcement: University of Georgia Law School - Medical-Legal Partnership Clinic

The University of Georgia School of Law seeks a tenure-track assistant professor to serve as the director of a to-be-created Medical-Legal Partnership (MLP) Clinic, beginning the 2013 – 2014 academic year. Job expectations include both clinical work and the production of academic scholarship. 

On the scholarship side, the director must be able to satisfy all the standards applicable to other members of the tenure-track faculty, including the production of first-rate scholarship published in major law reviews. 

On the clinical side, the successful applicant will be responsible for establishing partnership(s) with medical providers in the community to house the new MLP Clinic.  The goal of the MLP Clinic is to provide legal services to underserved individuals receiving treatment from the medical provider.  Responsibilities include managing the partnership relationship, teaching the classroom component of the Clinic, and supervising student legal work in the Clinic. 

Finally, the director will teach a related doctrinal course. 

Applicants must possess a J.D. or equivalent law degree and must be a member of the Georgia Bar or willing to become a member as soon as practical following appointment.  Applications should include a cover letter, resume or CV, description of scholarly research agenda, existing scholarship and references.  The University of Georgia is an equal opportunity employer and strongly encourages candidates from diverse backgrounds to apply. 

Contact:  Professor Erica Hashimoto, University of Georgia, School of Law, Herty Drive, Athens, GA 30602. (706) 542-5098, [email protected]

[KVT]

Worth Reading This Week

• Tim Jost, The Internal Revenue Service’s Implementation and Administration of the Democrat’s Health Care Law, SSRN/Hastings Center Report
• Leslie Francis, When Patients Interact with EHRs: Problems of Privacy and Confidentiality, SSRN/Houston Journal of Health Law and Policy
• Ernest Young, Sorrell v. IMS Health and the End of the Constitutional Double Standard, SSRN/Vermont L.Rev.
• Michelle Mello & Glenn Cohen, The Taxing Power and the Public's Health, NEJM

[NPT]

Tools for Teaching the Fungal Meningitis Outbreak

I’m sure many of us are talking about the contaminated steroid injections which have spread a fungal form of meningitis Exserohilum rostratum across the country.   The CDC, which as is usually the case is doing an excellent job of providing clear and current information,  reports that as of “October 17, 2012, a total of 47 patients have laboratory-confirmed fungal meningitis.”  They offer some reassuring information—that “this form of fungal meningitis is not contagious”  and some scary information—that  there are 257 cases and ten deaths in 15 states and that incubation periods last up to a month.  

The most recent legal news is that the pharmacy was visited
earlier this week by the FDA’s criminal investigative unit and that the first law suit has already been filed in Minnesota Federal District Court by a woman who received a vaccine from the pharmacy but who does not know yet if she has meningitis.

The incident provides an opportunity to watch these two agencies work quickly with local health departments in reaction to a crisis.  The FDA estimates “that approximately 14,000 patients may have received injections with medication from three implicated lots of methylprednisolone and nearly 97% of these patients have been contacted for further follow-up.”  This is a copy of the letter they have received.

Since I don’t teach Public Health Law until next semester, I’ve used the event as an in-class exercise in Torts.  I showed a brief video clip on the story and asked the students to consider what kinds of information they could collect to prove standard of care should they be hired by either a patient or the pharmacy.  I was very pleased that they developed a list
that included things like consulting pharmacists who might be expert witnesses as well as researching the existence of laws controlling lab safety.

This story is, of course, a moving target and is likely to serve as a rich source of teaching material as details emerge.  In the larger picture, it should raise awareness about the growing problem of both adulteration and contamination of pharmaceuticals.  The Economist publisheda very interesting piece this week, Bad Medicine, The World’s Drug Supply Is Global. Governments Have Failed To Keep Up, that puts the issue in a global context.  

JSB

Continue reading

Better, Simpler Disclosure

This is an apt answer to the question: "What would an ideal food label look like?:"

Even the simplest information — a red, yellow or green “traffic light,” for example — would encourage consumers to make healthier choices. That might help counter obesity, a problem all but the most cynical agree is closely related to the consumption of junk food.

Of course, labeling changes like this would bring cries of hysteria from the food producers who argue that all foods are fine, although some should be eaten in moderation. To them, a red traffic-light symbol on chips and soda might as well be a skull and crossbones. But traffic lights could work: indeed, in one study, sales of red-lighted soda fell by 16.5 percent in three months.

Having recently spent time at a roundtable with transparency advocates (including one author of this excellent book), I can attest to the fact that only the clearest signals tend to get through the noise of an era of information overload.  

[FP]

 

Misuse of federal Medicaid funding

Recommended reading regarding Governor Romney's gaming of Medicaid funding:

http://www.bostonglobe.com/opinion/2012/10/12/podium-medicaid/X5KHn9vVJjfRPgDAtxku3M/story.html?s_campaign=8315

This week's edition of ACA Challenges

Earlier this week, Jonathan Adler wrote in the National Review Online that challenges to the individual mandate were just beginning. 

And today, Oklahoma's September challenge to the ACA is making headlines.  As I have described before, one of the new theories by which Jonathan Adler and the Cato Institute are seeking to thwart the ACA is by challenging the IRS rule that permits tax subsidies in exchanges created by the federal government, which Cato claims is not supported by the text of the ACA.  (State exchanges are supposedly the only avenue for obtaining tax subsidies for private insurance purchases.)  Oklahoma has brought this challenge to life in federal district court, and Cato's interest in this and other challenges was apparently reiterated by Professor Adler during a Cato-organized panel on Wednesday.

Also earlier this week, MedPage tallied the number of contraception coverage-related complaints at 35.  One such challenge was rejected earlier this month by the Eastern District of Missouri, but that does not seem to have thwarted the pile-on, which is evidenced by a new complaint filed in the District Court for the District of Columbia.

[NH]

Marijuana initiatives in the upcoming election

In a year of a presidential election, initiatives are likely to get lost in the shuffle unless they have implications for the race at the top--as did the state efforts to ban same-sex marriage did some years ago. This election season features a number of efforts to legalize marijuana. 

Several of these would legalize possession of small amounts of marijuana, whether or not for medical use.  Colorado Amendment 64 is a constitutional amendment to legalize possession of less than an ounce of marijuana by state residents over the age of 21, http://ballotpedia.org/wiki/index.php/Colorado_Marijuana_Legalization_Initiative,_Amendment_64_(2012).  Oregon Measure 80, the Oregon Cannabis Tax Act, would legalize growing and selling marijuana, http://www.oregonlive.com/politics/index.ssf/2012/07/marijuana_legalization_measure.html.  Washington I-502 would create exceptions to state law enforcement for adults possessing less than an ounce of marijuana.  Growers and sellers would be required to obtain state licenses, and sales would be taxed--with revenue going to state drug prevention programs.It would also establish a 5 nano-gram/millileter of blood limit for adults driving and a zero tolerance policy for those under 21, http://www.huffingtonpost.com/2012/10/15/dea-drug-czars-states-leg_n_1967363.html.

Massachusetts has a medical marijuana statute on the ballot, which would eliminate state civil or criminal penalties for medical use of marijuana.  It would also create state-regulated centers and in certain hardship cases allow patients to grow their own marijuana for personal use, http://ballotpedia.org/wiki/index.php/Massachusetts_Medical_Marijuana_Initiative,_Question_3_(2012)  In Arkansas, the Arkansas Medical Marijuana Act (Issue 5) would suspect state penalties (including those relating to licensure) for qualifying patients with debilitating illnesses, establish a system of dispensaries, and permit locations to enact zoning restrictions.

Unusual lineups are emerging with respect to these efforts.  In Washington, the sheriff of King County (Seattle) has endorsed the initiative.  Although the initiative is supported by groups seeking to legalize marijuana, it is opposed by groups supporting Washington's existing medical marijuana law.  In Colorado, religious groups are reportedly divided, law enforcement opposes the measure, and the NAACP favors it.  There are appeals to states' rights conservatives to support the measures, too. 

There are some signs that controversy over these measures is spilling over into the presidential race, especially in Colorado.  Opponents of the measures are calling on Attorney General Holder to come out against them.

[LPF]

 

New Scholars in Residence Program – A New Pilot Program for Public Health Lawyers

With funding from the Robert Wood Johnson Foundation, the Network for Public Health Law and the Foundation are establishing Scholars in Residence – a new pilot program for public health lawyers. The flyer for the Program is here.

Scholars in Residence is an exciting new opportunity for six public health law scholars who want to bring their expertise to the front lines of public health practice. The scholars will be affiliated with a host site such as a state, local or tribal health department for six months, including a minimum of one month on-site that may be completed during a sabbatical, a non-teaching semester or during the summer. Working with a mentor, Scholars in Residence participants will be able to shape their experience and develop a project that brings their unique expertise to a problem or issue confronting the host site. A full description of this program is available here.  

Each scholar will receive a stipend of $34,000. The stipend will cover the fellowship award and all related expenses, including travel to and lodging at the host site, travel to and lodging at two required meetings – an orientation session in June 2013 and a graduation celebration in December 2013 - plus any additional direct costs incurred related to this program.

Professor Fran Miller of Boston University School of Law serves as the Faculty Lead for the Scholars in Residence program.

This pilot project will start recruiting in fall 2012 with the residency beginning in June 2013. Please contact Judy Schector for more information.

[KVT]

Picking up Technical Knowledge

As I teach in some technical fields, I often get questions from students about “how much tech do I need to know to succeed in this field?” For example, the Health Law Survey includes many complex medical situations; my seminar Health Information, Privacy, and Innovation covers standards for certifying “meaningful use” of health information technology; and even the intro to IP course tends to include some forbidding patent cases in it. I think this advice from Michal Tsur and Leah Belsky is reassuring:

[S]uccessful tech companies require a variety of skillsets – from design and community management to operations and business development- both at the entry level and in leadership positions. Significant technical skills can also be learned both on the job and outside of traditional academic education. Take Marissa Mayer vs. Sheryl Sandberg. While Mayer, the current CEO of Yahoo may have graduated Stanford with a CS degree, Sandberg, Facebook’s COO, rose through the business ranks at Google, gaining enough product knowledge on the job to become one of the leading operators and innovators in the space.

Having just reviewed the offerings at Coursera this fall, I can definitely vouch for the idea that many tech skills are “on offer” outside the classroom. I’ve also heard from former students who picked up some tech management skills; for example, one learned software programming skills in order to deal with the massive paperwork in a litigation involving many small disputes. I’m also hoping to teach law students how to work with computer scientists and quantitative analysts in a spring course titled “Data Analysis and Advocacy,” which I’ll be co-teaching with a professor from my university’s Department of Mathematics and Computer Science. I know that Michigan State & Daniel Katz have really blazed a trail here; I’m hoping to apply some computational legal studies ideas in courses on health and IP law. If anyone has any suggestions on doing so, I’d love to hear them.

[FP]

X-Posted from Madisonian.

Media on Health Care Round-up

For some interesting recent articles in the media on health care topics, see

The Ups and Downs of Electronic Medical Records

Will Pay for Performance Backfire?

Health Care as Income for the Poor

Before a Wave of Meningitis, Shots Were Tied to Risk

Poking Fun at My Patients

[DO]

The DOMA petition you should be following

You may be thinking "DOMA? Hello, this is HEALTH LAW."  Please stick with me for a moment.  The Supreme Court appears to be collecting petitions for certiorari regarding the Defense of Marriage Act, likely to determine which circuit's decision is the best vehicle for considering the constitutionality of this federal law.  One such petition results from the First Circuit's decision in Massachusetts v. Department of Health and Human Services/Hara v. Office of Personnel Management, which held that section 3 of DOMA violated the Fifth Amendment's Equal Protection Clause.  The court reasoned that promoting marriage is not rationally related to denying federal benefits to same-sex couples, thereby avoiding the creation of a new category of suspect class.  The twist is that the state of Massachusetts also claims that section 3 of DOMA, which denies federal economic benefits to same-sex couples, exceeds Congress's Spending Clause authority and infringes the state's 10th Amendment rights.  While the First Circuit did not agree with the state on these points, it did incorporate federalism concerns into its Equal Protection Clause analysis by noting that states traditionally have defined marriage, therefore the federal government cannot protect the state of Massachusetts from its own definition of marriage by promoting heterosexual marriage.

The implications of Massachusetts v. DHHS, should it be the petition that is granted, are potentially far-reaching.  Even without the overlay of this litigation, DOMA affects federal healthcare programs.  For example, a gay spouse who did not work outside the home could not obtain spousal benefits from Social Security or automatically receive Medicare Part A benefits.  If the individuals in a same-sex marriage are treated separately for Medicaid accounting purposes, an elderly gay spouse could be vulnerable if his partner is in nursing home care that results in impoverishment because the spouse living at home could lose the family home rather than being protected in the way that heterosexual spouses are.  This is part of Massachusetts' original claim, that it could lose its Medicaid funding entirely for allowing gay couples, legally married in the state, to qualify as spouses for Medicaid purposes.

So, this litigation may have significant healthcare implications because Massachusetts pushed the spending power and Tenth Amendment aspects of the First Circuit's opinion harder after NFIB v. Sebelius was decided, even though it won on Fifth Amendment grounds.  Thus, if the Supreme Court grants this petition, it could clarify the spending and federalism points made in the Medicaid portion of NFIB, which held that the ACA's expansion of Medicaid was unconstitutionally coercive and rendered the expansion effectively optional for states.  The irony of this case is that Massachusetts seeks to preserve its traditional prerogative in an area that is generally reserved to the states - family law - which could place the conservative-leaning justices in a tough spot (for instance, Justice Scalia is a firm believer in protecting the states through the Tenth Amendment, but he also does not believe that same-sex marriage is permissible let alone constitutionally protectable).  The Court could be inclined to soften its protective states' rights stance if it wants to avoid supporting same-sex marriage.  Likewise, a consequentialist decision could result in the Court retreating from limits placed on the spending power in NFIB by allowing Congress to regulate marriage through section 3 of DOMA.  But, if the Court stays true to the spending power limits and strong federalism principles articulated in NFIB, then it would have to strike down DOMA and allow same-sex couples to be counted as married in programs such as Medicare and Medicaid.  Stay tuned...

[NH]