First Circuit Upholds ACA’s Medicaid Maintenance-of-Effort Provision Against Constitutional Challenge

Last week, the First Circuit Court of Appeals upheld the ACA’s maintenance-of-effort provision against a constitutional challenge brought by the Maine Department of Health and Human Services. The court’s opinion has received relatively little media attention, but it should be of interest to all in the health policy space. Its post-NFIB v. Sebelius Spending Clause analysis will be relevant to scholars who are interested in King v. Burwell, challenging the grant of subsidies on health insurance exchanges run by the federal government. Its procedural posture will fascinate those who are interested in plural executive systems. And its fulsome discussion of the Medicaid program and its history will be of broader interest to health policy scholars.

States participating in Medicaid must agree to cover certain groups of people up to certain income thresholds, but states may choose to expand these groups in various ways. Relevant to this case, most states have increased the income thresholds for covering children or pregnant women through the SCHIP program (sometimes quite substantially), and some have extended SCHIP to include low-income 19- and 20-year-olds. Maine had done both, providing coverage to 19- and 20-year-olds since 1991. The ACA subsequently included a maintenance-of-effort provision (42 U.S.C. § 1396a(gg)), requiring states participating in Medicaid to maintain their eligibility standards through 2019. As such, in 2012 HHS denied Maine’s request to stop providing coverage to 19- and 20-year-olds.

Maine’s Department of Health and Human Services sought review in federal court. Maine’s executive branch was not united in this choice: the Attorney General declined to represent the state and even intervened on the side of HHS Secretary Burwell. This mirrors a phenomenon that was often observed in the context of the Medicaid expansion, in which several states whose Attorneys General joined the legal fight against the expansion in NFIB subsequently expanded anyway, as that separate power was exercised by Governors and legislatures.

Continue reading

“Proximate Cause” and the Patient Suicide Problem

By Alex Stein

This difficult problem and the underlying human tragedy have recently been adjudicated by the Supreme Court of Mississippi in Truddle v. Baptist Memorial Hosp.-Desoto, Inc., — So.3d —- (Miss. 2014).

A hospital patient suffering from a number of illnesses became agitated and aggressive. He took the IV out of his arm and attempted to leave the hospital. When nurses stopped him and forced him back to his room, he hallucinated that someone was trying to rape him. Despite these psychiatric symptoms, the patient was discharged and treated as an outpatient. During his outpatient treatment, he complained to his doctor that the medications he was taking “make him crazy.” Six days after his release from the hospital and two days after his last outpatient appointment, the patient barricaded himself in his bedroom and committed suicide.  Continue reading

Hospitable Hospitals and the True Cost of VIP Rooms

By Vadim Shteyler

Increasing hospitality in medical facilities is not a recent trend. We take for granted that modern hospitals offer clean sheets, towels, a plethora of toiletries, heated blankets, and many other amenities. Conversely, in the hospitals of decades past, many patients relied on family members to bring food and clean sheets. Rows of hospital beds in an open ward precluded privacy. Unhygienic conditions commonly resulted in rodent infestations. And paternalism in medicine was still the norm.

This trend towards hospitality has recently gained new momentum. As featured in a recent article in Kaiser Health News, dozens of hospitals have hired Chief Patient Experience Officers from customer service or hotel industries. Since 2012, when Medicare began penalizing hospitals for poor patient experiences, hospital efforts to improve patient satisfaction have grown. Some hospitals began mandating communication seminars, encouraging nurses to spend more face-to-face time with patients, and calling patients after discharge to follow-up on their recovery. The Affordable Care Act (ACA), further tying hospital reimbursements to patient surveys, has additionally promoted such changes.

A similar trend has arisen with the increased popularity of V.I.P. sections in many hospitals. Though the hospital construction boom is beginning to slow down, the resultant V.I.P. rooms remain. Lenox-Hill Hospital’s maternity suite in New York City, which received a lot of media attention after Beyonce gave birth there in 2012, is one of many luxurious suites across the nation. Some, offering personal shoppers, private chefs, and salon services, are priced upwards of $4,000. While nobody calls for a return to the hospitals of old, many feel suites such as these are excessive.  Continue reading

The Learned Intermediary Rule and Direct-to-Consumer Advertising

By Zachary Shapiro

In the field of pharmaceutical product-liability litigation, the Learned Intermediary Rule (LIR) is a defense doctrine for failure to warn claims, which has been adopted in 22 states, and applied in 48. The LIR means that if a pharmaceutical manufacturer that gives an adequate warning to a prescribing physician, the company has no corresponding duty to directly warn the patient.

This rule has been justified by the belief that the prescribing physicians is “in a superior position to impart the warning and can provide an independent medical decision as to whether use of the drug is appropriate for treatment of a particular patient.” Larkin v. Pfizer, Inc. 153 S.W.3d 758, 763-764 (Ky. 2004). Furthermore, historically, pharmaceutical manufacturers lacked effective means to communicate directly to patients. Courts did not want to extend liability when pharmaceutical companies were complying with FDA regulations regarding proper warnings to consumers. Finally, there was a belief that any direct warning would interfere with the doctor-patient relationship.  Continue reading

The Civil Rights Movement and the Blood Supply

By Emily Largent

This year marks the 50th anniversary of the Civil Rights Act of 1964, and this semester, I have been fortunate enough to take a class on the Civil Rights Movement with Professor Randall Kennedy.  This has prompted me to examine the influence of race on healthcare delivery in the 1940s, ’50s, and ’60s.  Racism infected all aspects of the healthcare system, including medical schools and schools of nursing, residencies and post-graduate training, professional societies for doctors and nurses, ambulance services, outpatient clinics, staff privileges at hospitals, hospital admissions, and medical research.  Doubtlessly, the color line in medicine compounded physical ills with emotional and dignitary harms.

I find the stories related to the segregation of the American blood supply during World War II to be particularly interesting because they show that discrimination was a national (i.e., not just a Southern) problem, and there is a small connection to Harvard Law School.  Speak Now Against the Day: The Generation Before the Civil Rights Movement in the South by John Egerton has proven to be an excellent source of information on this topic.

Blacks made contributions to the war effort in many capacities.  William H. Hastie, a graduate of Harvard Law School, took leave from his position as Dean at Howard University School of Law (HUSL) to accept an appointment as civilian aide to Secretary of War Stimson.  Charles R. Drew, a physician who had conducted pioneering research on typing, preserving, and storing blood for later transfusion, helped both Britain and the United States establish blood programs to support military operations. In February 1941, Drew was made medical director of the American Red Cross blood bank program.

Late in 1941, the surgeons general of the United States Army and Navy informed the Red Cross that only blood from white donors would be accepted for military use.  Although it had been conclusively proven that there were no racial differences in blood, the military yielded to prevailing social bias and heavy political pressure.  In January 1942, the War Department revised its position, agreeing to accept blood from black donors, though also insisting on rigid adherence to segregation of the blood supply.  The Red Cross not only accepted that decision but declared that it had no interest in trying to settle racial-social controversies.  Later, Red Cross officials “suggested that those who persisted in criticizing the policy were unpatriotically attempting to cripple the blood donor service and thus harm the war effort itself.”  Continue reading

Risk and Reform of Long-Term Care

By Allison Hoffman
[Cross-posted from Health Affairs Blog]

The 50th Anniversary of Medicare and Medicaid offers an opportunity to reflect on how U.S. social policy has conceived of the problem of long-term care.

Social insurance programs aim to create greater security—typically financial security—for American families (See Note 1). Programs for long-term care, however, have had mixed results. The most recent attempt at reform, which Ted Kennedy ushered through as a part of the Patient Protection and Affordable Care Act (ACA), called the CLASS Act, was actuarially unsound and later repealed. Medicare and especially Medicaid, the two primary government programs to address long-term care needs, are criticized for failing to meet the needs of people with a disability or illness, who need long-term services or supports. These critiques are valid.

Even more troublesome, however, long-term care policy, especially in its most recent evolution toward home-based care, has intensified a second type of insecurity for Americans. Continue reading

Article III Standing in Patent Law May Be Before the Supreme Court Soon

Who has standing to challenge a patent’s validity? And under what circumstances can Congress define an injury for the purpose of creating Article III standing? Those questions underlie a new petition for certiorari filed by Consumer Watchdog, who is asking the Supreme Court to reverse a Federal Circuit opinion holding that Consumer Watchdog lacked Article III standing to challenge a patent on embryonic stem cells.

Consumer Watchdog, a non-profit consumer organization, requested an inter partes reexamination of a patent on embryonic stem cells held by the Wisconsin Alumni Research Foundation (WARF), alleging that the patent should be invalidated on several grounds. After a lengthy administrative process, the Patent Trial and Appeal Board (PTAB) upheld the patent as valid. Consumer Watchdog subsequently appealed, under sections of the Patent Act that expressly permit third-party requesters (like Consumer Watchdog) in inter partes reexamination proceedings to appeal to the Federal Circuit if they are “dissatisfied” with the PTAB’s decision or if any “final decision [is] favorable to the patentability” of the claims in question. The Federal Circuit held that Article III’s case or controversy requirement imposes a separate, irreducible constitutional minimum requirement on standing — and that Consumer Watchdog hadn’t met that requirement.  Continue reading

Check out the latest news from the Petrie-Flom Center!

11-14 newsletter screenshot

Check out the November 14th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Protect Those Who Protect Our Food

Check out a new op-ed by our friends, Jacob E. Gersen and Benjamin I. Sachs at Harvard Law School!

CAMBRIDGE, Mass. — EVERY year, 5.5 million people are sickened by norovirus, a highly contagious gastrointestinal bug. According to the Centers for Disease Control and Prevention, norovirus is the leading cause of food-borne illness in the United States and is spread primarily by “infected food workers.” Last year cooks, waiters and other workers were involved in about 70 percent of the outbreaks.

This is just one example of the critical role that food workers play in our nation’s economic and public health systems. And yet, while we often tailor employment rules for work that has a special impact on the public, the law has yet to recognize food workers as a distinct class — an approach that harms consumers, the economy and the workers themselves.

Sick restaurant workers provide a particularly vivid example of the kind of legal reform that’s needed. Until recently, very few restaurant workers had the legal right to paid sick time, which meant that many of them went to work very ill (last week voters in Massachusetts and three cities passed paid-sick-leave laws). Federal law can fix this problem by requiring employers to provide their workers with paid time off. [...]

To read the full op-ed, please click here.

Health and Wealth

By David Orentlicher
[Cross-posted at Health Law Profs blog]

A number of studies have suggested that education, wealth, and other socioeconomic factors are more important than health care in promoting a person’s health. Earlier this week, NPR reported on a study of welfare payments that reinforces the link between income and health. Researchers studied children whose families received benefits through the Mothers Pension Program between 1911 and 1935. Compared to children in families that did not receive program benefits, the children of recipients lived longer, and their longer lives might reflect the fact that they stayed in school longer and earned higher incomes during their working days.

European Responses to the Ebola Crisis, Part I: Initiatives at the European Medicines Agency (EMA)

By Timo Minssen

The current Ebola outbreak already attracted much attention on “Bill of Health” resulting in some excellent blogs on a horrible topic.

While it is evident that the current health crisis requires both immediate responses and more sustainable changes in health care policy, research and regulation, medicines regulators are collaborating internationally to find innovative solutions enhancing evaluation of and access to potential new medicines to fight Ebola outbreaks. In a statement announced by the International Coalition of Medicines Regulatory Authorities (ICMRA) in September 2014, regulators around the world led by the FDA and the EMA have vowed to collaborate in supporting accelerated evaluation of experimental new drugs to treat Ebola virus infections and say they will encourage submission of regulatory dossiers. This clearly backs up the World Health Organization’s (WHO) decision to test experimental Ebola treatments in infected patients in the current outbreak region in West Africa and to speed up the development of vaccines.

In the following I would like to summarize and discuss some of the recent European responses to the current crisis starting with an overview on recent initiatives at the EMA.

Like its US counterpart, the EMA leads a close and consistent dialogue with public and private developers of Ebola products and spends much effort in reviewing available information on the various experimental Ebola treatments currently under development. These experimental drugs range from experimental antivirals or vaccines based on the adenovirus or stomatitis vaccine to experimental therapies based on mono- and polyclonal antibody technologies. One of these unapproved antibody combination drugs – MAPP Biologicals’  ZMapp – has already been used in some care workers affected by Ebola. Other experimental drugs that are currently reviewed by the EMA include Biocryst’s BCX 4430, Fab’entech’s Hyperimmune horse sera, Sarepta’s AVI-7537, Toyama Chemicals and MediVector’s Favipiravir and Tekmira’s TKM-Ebola.

Other companies such as Bavarian Nordic  and the Russian Mikrogen are close to follow.

In addition to monitoring experimental drugs and enhancing global collaboration, the European Medicines Agency has like the FDA initiated several activities in order to support and speed up the development of these drugs towards market approval.  Continue reading

What’s Wrong with Selling Organs (and a Taxonomy of Taboo Trade/Commodification Objections)

By I. Glenn Cohen

Many people – non-philosophers especially, but some philosophers as well – loosely use the term “commodification” as an objection to a “taboo trade”. By “taboo trade” I mean the sale of a good or service such as an organ, sperm, egg, surrogacy, prostitution, etc.

This is unhelpful since it means that people often talk past each other and substitute rhetoric for reason.

In my own work I have tried to disentangle various separate objections falling within this family. This is also important in determining what, if any, form of regulation might help combat or minimize the ethical concern. It is also important because it helps us see that some forms of regulation might improve matters as to one of the ethical objections while at the same time worsen matters as to another one of the ethical objections.

For this blog post I wanted to share my taxonomy of ethical objections drawn from a recent paper I did on objections to buying and selling organs and the potential ways various regulatory tools can and cannot be used to deal with them: Regulating the Organ Market: Normative Foundations for Market Regulation, 77 Law and Contemporary Problems (forthcoming Nov 2014)  In the paper itself it is set out more formally with supporting citations, here I present just excerpts more informally.

While I illustrate the taxonomy of arguments using the buying and selling of organs, in fact the same categories can be used for any taboo trade (prostitution, selling eggs, commercial surrogacy, etc):

1. Corruption

The basic idea behind what I have elsewhere called the “corruption” argument is that allowing a practice to go forward will do violence to or denigrate our views of how goods are properly valued. This argument is sometimes labeled the “commodification” argument, but because that term is also used in a way that encompasses some of the other arguments I discuss below, I prefer the more specific label of “corruption.” The American Medical Association, among others, has voiced this kind of objection in the domestic organ-sale context, suggesting paying kidney donors would “dehumanize society by viewing human beings and their parts as mere commodities.”

We can distinguish two subcategories of this objection, which I have elsewhere called “consequentialist” and “intrinsic” corruption. “Consequentialist corruption” justifies intervention to prevent changes to our attitudes or sensibilities that will occur if the practice is allowed —for example, that we will “regard each other as objects with prices rather than as persons.” This concern is contingent and to be successful must rely on empirical evidence, in that it depends on whether attitudes actually change. By contrast, “intrinsic corruption” is an objection that focuses on the “inherent incompatibility between an object and a mode of valuation.” The wrongfulness of the action is completed at the moment of purchase irrespective of what follows; the intrinsic version of the objection obtains even if the act remains secret or has zero effect on anyone’s attitudes.

2. Crowding Out  Continue reading

February 9-13, 2015: Visit Karolinska Institutet in Stockholm to Learn More About Biobanking

By Timo Minssen

The following information has been extracted from the webpage of the BioBanking and Molecular Resource Infrastructure of Sweden on the course Biobanking as a Resource for Biomedical Research, February 9-13, 2015 at Karolinska Institutet (Stockholm). 

Purpose and Goal

Biobanks constitute a powerful resource in medical research with access to millions of samples and associated data collected within health care and in specific research studies. New “omic-technologies” with high-throughput analytical platforms now permit large scale analyses without the need to wait for years while new samples are being collected.

However, successful research based on human biological samples and associated data requires applied knowledge about how the samples have been collected and processed. Standardized procedures, controlled pre-analytical variables and study documentation are key factors for the reliability and validity of the analytical findings.

This one week course addresses fundamental concepts in biobank infrastructures and biobank research, ethical and legal frameworks, technologies, sample analysis and practical considerations when new samples are to be collected.  Continue reading

Call for Proposals: The 2016 Brocher Foundation Residencies

By Timo Minssen

I have just been informed that a new call for proposals for the 2016 Brocher Foundation residencies has been launched. I can warmly recommend this splendid opportunity to any researcher or group of researchers in the fields of Bioethics, Medical Anthropology, Health Economics, Health Policy, Health Law, Philosophy of Medicine and Health, Medical Humanities, Social Science Perspectives on Health, Medical Ethics, or History of Medicine.

A grant by the Brocher Foundation enables international researchers to carry out their projects for a 1-4 month period at one of the most beautiful places in Europe. The Brocher Foundation’s seat is located in Switzerland at the shores of the beautiful Lake Geneva. The location is very close to the French border and to international organisations particularly relevant to the health sector, such as WHO, WTO, WIPO, UNHCR, ILO, WMA, ICRC, and others.

The following information has been extracted from the webpage of the Brocher Foundation:  Continue reading

HLS Health Law Workshop with Leemore Dafny

HLS Health Law Workshop: Leemore Dafny

November 10, 2014 5:00 PM
Griswold Hall, Room 110 (Harvard Law School)
1525 Massachusetts Ave., Cambridge, MA [Map here.]

Download the paper: “More Insurers Lower Premiums: Evidence from Initial Pricing in the Health Insurance Marketplaces” (co-authors, Jonathan Gruber and Christopher Ody)

Leemore Dafny is a Professor of Management and Strategy and the Herman Smith Research Professor in Hospital and Health Services at the Kellogg School of Management at Northwestern University. Her research examines competitive interactions among payers and providers of healthcare services, and the intersection of industry and public policy. Dafny’s work has been published in journals such as the American Economic Review and the New England Journal of Medicine, and featured in The New York Times, BusinessWeek, Bloomberg, and The Washington Post.

Current projects include studies of consolidation in the U.S. hospital industry and the kidney dialysis industry, organizational form of provider practices, copayment coupons for prescription drugs, and the implications of for-profit ownership of insurance companies.

Will the Real Evidence-Based Ebola Policy Please Stand Up? Seven Takeaways From Maine DHHS v. Hickox

By Michelle Meyer

Ebola pic

The case I mentioned in my last post, Maine Department of Health and Human Services v. Kaci Hickox is no more. Hickox and public health officials agreed to stipulate to a final court order imposing on Hickox the terms that the court had imposed on her in an earlier, temporary order. Until Nov. 10, when the 21-day incubation period for Ebola ends, Hickox will submit to “direct active monitoring” and coordinate her travel with Maine public health authorities to ensure that such monitoring occurs uninterrupted. She has since said that she will not venture into town or other public places, although she is free to do so.

In a new post at The Faculty Lounge,* I offer a detailed account of the case, which suggests the following lessons:

  1. As Hickox herself described it, the result of her case is a “compromise,” reflecting neither what Hickox nor what Maine initially wanted.
  2. That compromise was achieved by the parties availing themselves of the legal process, not through Hickox’s civil disobedience.
  3. The compromise is not easily described, as it has been, as a victory of science-based federal policy over fear-based state demagoguery. By the time the parties got to court, and perhaps even before then, what Maine requested was consistent with U.S. CDC Guidance, albeit a strict application of it. What Hickox had initially offered to do, by contrast, fell below even the most relaxed application of those guidelines, although by the time the parties reached court, she had agreed to comply with that minimum.
  4. The compromise applies only to Hickox, and was based on a stipulation by the parties to agree to the terms that the court had temporarily imposed after reviewing a limited evidentiary record. Additional evidence and legal arguments that the state might have raised in the now-cancelled two-day hearing could have resulted in a different outcome.
  5. A substantially different outcome, however, would have been unlikely under Maine’s public health statute. Indeed, it is not clear that Maine’s public health statute allows public health authorities to compel asymptomatic people at-risk of developing Ebola to do anything, including complying with minimum CDC recommendations.
  6. “Quarantine” is a charged, but ambiguous, term. It allows us to talk past one another, to shorthand and needlessly politicize a much-needed debate about appropriate policy, and to miss the fact that the CDC Guidance in some cases recommends what could be fairly described as a “quarantine” for people like Hickox and requires it for asymptomatic people with stronger exposure to Ebola (but who are still probably less likely to get sick than not).
  7. It’s not clear who has bragging rights to Ebola policy “grounded in science,” or what that policy looks like.

* The piece is quite long, and I cannot bear the fight with the WordPress formatting demons that it would require to cross-post it here.

Bioethics on the Ballot

In addition to the closely-watched senate and gubernatorial candidates, 146 ballot questions were up for vote yesterday in 42 states across the nation. Below is a review of the some of the most pressing bioethics issues on the docket and the latest information on what passed according to Politico’s Ballot TrackerContinue reading

The Constitutional Implications of Ebola: Civil Liberties and Civil Rights In Times of Health Crises

Join us for an important public forum:

Constitutional Implications of Ebola:
Civil Liberties & Civil Rights In Times of Health Crises

This public forum addresses the constitutional and public health implications of Ebola response in the United States.  According to state and federal laws, patient information is deemed private and is to be held in strict confidentiality.  However, in the wake of Ebola, well-established protocols to guard patient privacy have been neglected or suspended without public debate.  At this forum, a panel of experts raise questions not only about how to contain the disease, but also to what extent Americans value their healthcare privacy, civil liberties, and civil rights.  To what extent are Americans’ Ebola fears influenced by the origins of the disease?  What liberties are Americans willing to sacrifice to calm their fears?  How to balance the concern for public welfare with legal and ethical privacy principles?

Speakers: Reverend Jesse L. Jackson, Sr.;  Michele Goodwin, Chancellor’s Chair, UC Irvine School of Law;  Professor Andrew Noymer, UC Irvine School of Public Health; and Dr. George Woods, American Psychiatric Association.

This Forum intervenes in the current national and international discourse on Ebola by probing law’s role in addressing public health crises.  This forum is free and open to the public.

WHEN: Wednesday, November 19, 2014, 3.30pm-5.30pm

WHERE: University of California Irvine, School of Law; ROOM EDU 1111, 401 E Peltason Dr, Irvine, CA 92612

Call for Abstracts: 2015 Petrie-Flom Annual Conference – Law, Religion, and American Health Care

SCOTUSfrontThe Petrie-Flom Center invites abstracts for its 2015 Annual Conference: “Law, Religion, and American Health Care.” The conference will be held at Harvard Law School on May 8 and 9, 2014.

This conference, and anticipated edited volume, will aim to: (1) identify the various ways in which law intersects with religion and health care in the United States; (2) understand the role of law in creating or mediating conflict between religion and health care; and (3) explore potential legal solutions to allow religion and health care to simultaneously flourish in a culturally diverse nation.

For a full conference description, including the call for abstracts and registration information, please visit our website.

Abstracts are due by December 1, 2014. The conference seeks to address the following topics. Please note that this list is not meant to be exhaustive; we hope to receive papers related to the conference’s general theme, but not specifically listed here:  Continue reading

More on the Maine Ebola Order

By Nicolas Terry

Today’s order from Chief Judge LaVerdiere is available here. It removes restrictions on Kaci Hickox’s movements and essentially orders her to comply with the latest CDC guidelines that she was already following on a voluntary basis. According to this report the state troopers that had been posted outside her house have left. Two paragraphs at the end of the order are worth quoting in full.

First, we would not be here today unless Respondent generously, kindly and with compassion lent her skills to aid, comfort, and care for individuals stricken with a terrible disease. We need to remember as we go through this matter that we owe her and all professionals who give of themselves in this way a debt of gratitude.

Having said that, Respondent should understand that the court is fully aware of the misconceptions, misinformation, bad science and bad information being spread from shore to shore in our country with respect to Ebola. The court is fully aware that people are acting out of fear and that this fear is not entirely rational. However, whether that fear is rational or not, it is present and it is real. Respondent’s actions at this point, as a healthcare professional, need to demonstrate her full understanding of human nature and the real fear that exists.…

An interview with Ms Hickox suggested she was taking the judge’s advice, “I am sensitive… I don’t want to make anyone uncomfortable.” However, according to this recent report Governor LePage believes, “we don’t know what we don’t know about Ebola” and does not trust Ms. Hickox.