Information Blocking and Interoperability

By Nicolas Terry

The “Cromnibus” spending bill signed by the President on December 16 rightly upset Senator Warren and not just for providing luxury cars to a feckless Congress. However, in general the bill ignored healthcare. There was no new money for those ACA “villains” CMS and IRS and only a little more for NIH (resulting in net reductions all around given inflation). Of course constituencies have to be pandered to, so there was a symbolic $10 million cut from the moribund IPAB. Meanwhile, the CDC did well, HRSA picked up a few telemedicine dollars, but ONC didn’t get everything it wanted. However, look closer and it seems that during the convoluted legislative process someone threw a meaty wrench into the gears of an already flailing meaningful use program.

As I have discussed at length here and here the meaningful use subsidy program for EHRs may have delivered hundreds of thousands of mediocre electronic health records systems into provider offices but has failed to deliver effective data sharing. ONC knows this is an issue, is aware of and discussed the JASON report, has its own “10-year vision” and emphasizes interoperability in its recently released Health IT Strategic Plan (Disclosure: I serve on the HIT Committee Consumer Workgroup, but these views are mine alone). But, some kind of showdown has been brewing for a while. Have the HITECH billions been wasted? Was the regulatory problem in meaningful use or in certification? Are the HIT developers to blame or health care providers? (Answer: Yes). And, the AMA being “appalled” aside, what happens now that the meaningful use carrots have begun morphing into sticks? Continue reading

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

PFC_Banner_DrkBlue

Check out the December 19th 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.

Featured in this edition:

Harvard Law School 2013-05-03 Petrie-Flom Center Food ConferenceOutbreak: Developing New Medical Products for Epidemics, A lecture by Peter Hutt                                                                                                            Thursday, January 15, 2015, 12:30pm                           Hauser Hall 102,                                                   1575 Massachusetts Avenue, Cambridge, MA

The recent outbreak of Ebola has called attention to the substantial difficulties associated with developing and testing new products for time-sensitive epidemics. What are the legal, ethical, and economic barriers to getting essential treatments and preventative measures from the lab into the hands of patients – and how can they be overcome?

Please join the Petrie-Flom Center for a discussion of these issues by Peter Barton Hutt, Partner at Covington & Burling, LLP, and Lecturer on Law at HLS. Rachel Sachs, Petrie-Flom Center Academic Fellow, will respond.

For more on news and events at Petrie-Flom, see the full newsletter.

Access to Drinking-Water as a Fundamental Human Right

by Martín Hevia

Access to drinking-water is obviously necessary to lead a healthy life. However, in Latin America, many lack access to this vital resource.

Very recently, in December 2, the Argentine Supreme Court discussed the legal status of access to drinking-water in the Argentine legal system (the case is “Kersich, Juan Gabriel y otros c/Aguas Bonaerenses y otros s/amparo”). The Argentine Constitution does not explicitly recognize a right to have access to drinking-water. The Court discussed the claim of citizens of 9 de Julio against “Aguas Argentinas,” which was allegedly providing water with levels of arsenic higher than those allowed by Argentine law. In deciding the case, with the vote of 4 of the 5 Supreme Court judges, the Court reached two important conclusions.

First, invoking General Comment 15 on the right to water of the UN Committee on Economic, Social, and Cultural Rights, the Court concluded that Access to drinking water is a fundamental human right: it is necessary to lead a life with dignity, as well as necessary to fulfill other human rights, mainly, the right to health. The Court also invoked human rights treaties incorporated to the Argentine Constitution such as the Convention on the Rights of the Child - its Article 24.2.c mandates providing clean drinking water to combat disease.

Second, the Court held that the provision of drinking-water is a community interest. Thus, the right to access to drinking water is a “collective right” (the Spanish term is “derecho de incidencia colectiva”): drinking water is one of the elements of the environment, which is collective good under Section 41 of the Argentine National Constitution.

Although the Court discussed the particular claim of the inhabitants of 9 de Julio, and it ordered lower courts to analyze again the case on the basis of the aforementioned two conclusions, it is worth asking about the legal implications of this decision for the Argentine legal system. The decision of the Court expressly recognizes access to drinking water a collective constitutional right. This means that, from now on, inhabitants of Argentina will be able to file collective claims to demand both the Federal and the Provintial States that they make access to drinking-water a priority. Not doing so will entail not taking the Constitution seriously.

Worth Reading This Week

By Nicolas Terry

Debate over Resident Duty Hours

by Vadim Shteyler

On the wards, resident duty hour restrictions were a frequently recurring topic of heated discussion. Effective July 1, 2011, the Accreditation Council for Graduate Medical Education (ACGME) implemented new limitations on resident work hours for all ACGME-accredited residency training programs, furthering the existing limitations from 2003 reform. Current policies restrict workweeks to 80 hours. Residents must get at least four days off every four weeks. Shifts are reduced from 30 consecutive hours to 16 consecutive hours for first-year residents and to 24 hours for all other residents. First-year interns must have eight hours off between shifts. And residents after 24-hour call must have at least 14 hours off.

Proponents argue that exhaustion contributes to medical errors, such as the death of Libby Zion (whose tragedy prompted the conversations and the policies limiting duty hours). Longer hours can lead to poorer quality of life, ultimately harming patient care. And inefficiencies in the more frequent handoffs are reasons to focus attention on handoffs rather than lengthen shifts.

Opponents have an unlikely ally, many residents and physicians. During my rotations, many argued that fewer hours on the wards translates to less real-life patient exposure and under-preparedness for independent practice. Continue reading

The Constitutionality of Damage Caps in Pennsylvania

By Alex Stein

In its recent decision, Zauflik v. Pennsbury School Dist., — A.3d —- (Pa. 2014), the Supreme Court of Pennsylvania upheld the constitutionality of the statutory $500,000 cap on tort compensation payable by the local government. This decision was delivered in a case involving a student who lost her leg in an accident in which a school bus accelerated out of control onto a sidewalk and struck her (along with other nineteen students). The jury awarded the student $14,036,263.39 ($338,580 for past medical expenses, $2,597,682 for future medical expenses, and $11.1 million for past and future pain and suffering), but the court reduced the award to $500,000.

In affirming that ruling, the Pennsylvania Supreme Court rejected a number of constitutional challenges against the statutory cap. Continue reading

How Should the FDA Regulate Fecal Transplantation Safely and Effectively?

Last week’s issue of the New Yorker featured a terrific article about fecal microbiota transplantation, or FMT.  Much of the article focused on OpenBiome, a nonprofit stool bank spun off from MIT that screens donors, processes samples, and ships them to hospitals around the country.  For those who are unfamiliar with FMT, it is a startlingly effective treatment for recurrent C. difficile infection.  C. diff infections have become among the most common hospital-acquired infections in the United States, causing more than 300,000 hospitalizations and 14,000 deaths annually.  And unfortunately, many of these infections are resistant to antibiotics, with resistance rates rising rapidly.  But FMT may provide a way forward: a recent randomized trial (antibiotics versus antibiotics plus FMT) was stopped early, when 94% of patients in the FMT group were cured, as compared to roughly 30% of those in the antibiotics groups.

Coincidentally, I’ve been working with OpenBiome over the past few months on an interesting question that the New Yorker article touched on only briefly: how should the FDA regulate FMT to best ensure its safety and efficacy?  At present, the FDA is proposing to regulate FMT as a biologic drug.  However, many (including OpenBiome’s co-founder, Mark Smith) have argued that it ought to be regulated like human tissue, which from a scientific standpoint it resembles more closely than it does a small molecule drug, given the challenge of characterizing stool’s active ingredients and providing consistency across batches.  OpenBiome’s Policy Director, Carolyn Edelstein, and I are currently working on a paper examining the pluses and minuses of the FDA’s current approach.  I want to briefly summarize a few key points of our paper here, but essentially we argue that classifying FMT as a drug is simultaneously underregulatory and overregulatory.  Our primary goal is to ensure that patients have access to safe, effective treatments – and that means the FDA should be more involved in regulating some aspects of FMT, and less involved in others.

Continue reading

The ACA’s Cerberus

By Kelsey Berry

Following the Midterm Elections, the fate of the Affordable Care Act in a Republican-controlled Congress has been much speculated about. Jonathan Oberlander just published a piece in the New England Journal of Medicine arguing that we should be less concerned about Congress, and more concerned about the Supreme Court’s potential to shake the foundations of the law.

Congress, he claims, may be wary to threaten popular provisions of the health care law now that many constituents have benefited from them. Even if ACA beneficiaries may not recognize that they are benefiting from the contentious law, the very methods available to Congress to dismantle the law — i.e., chipping away at specific provisions — may produce greater awareness of the law’s contents and even provoke opposition toward efforts to undermine it. Moreover, Obama’s veto power may keep the law stable enough through 2 more years of implementation that by the time we risk having a Chief Executive who opposes the law, the law’s benefits will be more entrenched and successes more obvious, further straining repeal or dismantle efforts. In short, it looks to Oberlander as if the core of the law (if not some of the peripheral provisions) is safe from Congressional action, and potentially even getting safer.

Continue reading

Worth Reading This Week

By Nicolas Terry

The Right to Try Meets the Reality of Drug Approval

By Joan H. Krause

[Cross-posted at HealthLawProf Blog]

Whether it be a social media campaign to convince a company to provide an experimental anti-viral drug to a young cancer patient suffering from a life-threatening infection or the debate over appropriate treatment for high-profile Ebola cases, access to potentially life-saving but unapproved medications remains a controversial issue. Two recent articles, published on the same day, illustrate the difficulty of trying to balance desperate patients’ willingness to try unproven therapies with the very real concerns faced by manufacturers undergoing the drug approval process. The first was a Kaiser Health News article describing the passage of “Right to Try” laws in five states. The second was a brief note in the Los Angeles Business Journal that shares of CytRx Corporation, a biopharmaceutical R&D company, had fallen 9% after the company announced that the FDA had placed a partial clinical hold on its clinical trials after a patient’s death.

Right to Try laws are designed to give patients who have exhausted all other treatment options the right to access investigational medications, devices, and biological products that have met Phase I safety milestones. Right to Try legislation has been enacted in Colorado, Louisiana, Michigan and Missouri, and voters recently approved it by initiative in Arizona. The laws are based on model legislation drafted by the Goldwater Institute, which issued a detailed report on the issue in February 2014. While prohibiting states from blocking patient access to such medications, however, the model legislation does not require manufacturers to provide the products, nor does it require insurance companies to cover the costs. Continue reading

Clinical Trials Regulation in India

An op-ed from our friends Mark Barnes and Barbara Bierer at Harvard’s Multi-Regional Clinical Trials Center on recent legal changes to India’s clinical trial requirements, arguing that using the clinical trial context to promote a social or political policy agenda in India may sacrifice scientific integrity in the service of social justice.  A quick snippet:

The overbreadth of these requirements, and how poorly tailored they are to achieve the specific goal of protecting clinical trial participants from risks directly caused by trials themselves, leaves one wondering whether the regulatory authorities fully comprehend the clinical trial process and the nuances of complex medical and biological processes. One further wonders whether what animates these measures may be less a concern for specific justice in individual cases than the goal of righting social wrongs and achieving social justice, unrelated to but prompted by clinical trial experiences. Achieving social justice and a more just allocation of social resources may be completely laudable – even desirable – as social or political policy, but unconsciously using the clinical trial context to promote this agenda threatens to corrupt science and to undermine health, with results that may create more social distress than social justice.

Read the full piece here.

And more commentary from MRCT on this issue:

Dec 8-10: Seminar Series on Social Medicine in South Africa

By Kelsey Berry

The Harvard School of Public Health Department of Global Health and Population (GHP) is hosting what promises to be a fascinating 2-seminar series on Monday Dec 8 and Wednesday Dec 10 entitled: “A Practice of Social Medicine: South Africa and Beyond.” This event should be of interest to those thinking about models for Universal Health Coverage, community-based approaches to health, history and sociology of medicine and health care delivery, and population-level ethics.

The series will feature Professor Shula Marks, Emeritus Professor, University of London, and Fellow of the British Academy.

A word from the organizers: For just over a decade in the mid-twentieth century, perhaps somewhat surprisingly, South Africa was widely acknowledged as being in the forefront of progressive thought in health care delivery, its distinctive social conditions and developed medical practice making possible an experiment in social medicine with far-reaching implications.  These two lectures trace the story to its South African roots in the 1930s and 1940s, its propagation via the subsequent diaspora of progressive physicians, and its links to kindred developments throughout the world.  Its vision of a community-based, equitable, effective, inclusive, low cost approach to health emphasizing prevention and education may offer a distinctive model for Universal Health Coverage.

*The first lecture South Africa’s Experiment in Social Medicine, 1940-1960: A Model to the World? will be held on Monday December 8th, from 4:30pm to 6:00pm in HSPH Building 1, Room 1208.

*The second lecture Social Medicine in South Africa, 1960s to the Present will be held on Wednesday December 10th, from 4:30pm to 6:00pm in HSPH Building 1, Room 1208

For non-Harvard affiliated attendants, please email mclark@hsph.harvard.edu to arrange for access to the buildings in advance.

Do hospitals have a role in population health?

Population health advocates have identified health care providers, and hospitals in particular, as key allies in the effort to create better health and longer lives for Americans nationwide. Despite a growing interest in “community-based’ models of care, hospitals remain the most visible component of the US health care system. What’s more, hospitals are where the money, not to mention many of leading brains and cultural authority, reside. Of the 17.4% of GDP that the United States invests in health care, roughly 30% goes to hospitals – more than any other spending category. Hence why people interested in population health wish to have hospitals on board as they aim to address the always-challenging social, behavior and environmental determinants of health.

But the question remains open: do hospitals really have a role in the pursuit of population health?  Continue reading

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

By Rachel Sachs

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