The Right to Health, the Affordable Care Act, and Non-Treaty Treaties (Part I)

Special guest post by Nicholas J. Diamond

The right to health has played a significant role in global health fora since the World Health Organization first identified the “enjoyment of the highest attainable standard of health” as a “fundamental right of every human being without distinction of race, religion, political belief, economic or social condition” in 1946. Twenty years later, the International Covenant on Economic, Social and Cultural Rights (ICESCR) would set out the right to health in a binding international instrument. Subsequent guidance in 2000 from the United Nations Committee on Economic, Social and Cultural Rights, referred to as General Comment 14, clarified the content of the right to health, as well as articulated four elements—availability, accessibility, acceptability, and quality—that constitute the right.

Despite widespread support in the international community, the U.S. has not ratified the ICESCR. Many have argued that the Affordable Care Act (ACA) is doubtless a significant step toward realization of the right to health in the U.S. Indeed, its design speaks directly, to varying degrees, to each of the four elements of the right to health. While I acknowledge the significance of the ACA in advancing the right to health in the U.S., there are at least three reasons to doubt its ability to fully advance the right. Continue reading

March-In Rights Alone Won’t Solve Our Drug Pricing Problems

By Rachel Sachs

On Monday, a group of over 50 members of Congress sent a letter urging the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) to use a little-known statutory provision to take action against high drug prices.  Their goal is laudable, and HHS and the NIH should certainly offer guidance in this area – but the existing law offers only a partial solution to the problem as the legislators describe it.

The members of Congress wrote to remind HHS and the NIH of a provision in the 1980 Bayh-Dole Act giving the government “march-in rights” to patents resulting from government-funded research.  More specifically, the statute spells out a range of conditions under which the government may require a patentholder to grant licenses on reasonable terms to others to practice the patent.  The government may require such a license where “action is necessary to alleviate health or safety needs which are not reasonably satisfied,” 35 U.S.C. § 203(a)(2), or where the benefits of the invention are not being made “available to the public on reasonable terms,” 35 U.S.C. § 201(f).  The legislators argue that many drugs today violate these conditions, as even many insured Americans cannot access prescription drugs without incurring significant financial harm.

Although the “march-in rights” provision has existed in the statute since 1980, it has never been exercised by the federal government, even when it has been specifically asked.  And some of these cases have been paradigmatic examples where “health or safety needs” are not being satisfied.  A December 2015 study notes that in Bayh-Dole’s history, there have only been five petitions requesting that the NIH exercise its march-in rights.  Three of those requests were based on high prices for drugs for HIV/AIDS and glaucoma, and one was based on a persistent drug shortage which may have caused the deaths of people with Fabry disease, a rare condition.  (The fifth petition involved a medical device under patent litigation at the time.)  The NIH denied each request.  Some scholars argued that if the NIH denied the Fabry disease petition, where Genzyme’s drug shortages lasted for multiple years and caused great suffering, possibly including death, there may be no circumstances under which the NIH would grant such a petition.

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Medicaid and Access to Health Care Services

Centers for Medicare and Medicaid Services Washington Headquarters

Centers for Medicare and Medicaid Services Washington Headquarters, Hubert H. Humphrey Building

Last week Health Affairs released a new article that surveyed low-income individuals in Kentucky and Arkansas, two states that expanded Medicaid coverage to all people under 138 percent of the federal poverty level in 2014. They survey, led by Harvard professors, Robert Blendon and Ben Sommers, found that people in these states reported lower rates of problems paying medical bills and forgoing care or prescriptions due to cost. Additionally, the number of people that reported seeing a physician for a checkup and management of chronic conditions increased in Kentucky and Arkansas. All of these responses are indicators of having access to health care.

The results seen in Kentucky and Arkansas are in stark contrast to the survey results in Texas, which has elected not to expand Medicaid coverage. Texas has seen no change in an individual’s ability to pay for medical services and an increase in people forgoing health care coverage. This comparison indicates that expanded Medicaid coverage improves a person’s access to medical care.

But this isn’t the first time Medicaid has been shown to score well in measures of access to health care services for low-income individuals. Contrary to the rhetoric of politicians and the logic that Medicaid’s low reimbursement rates mean people have fewer choices of physicians, evidence to date has suggested that some of these arguments may be exaggerated.

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Some Commentary on How to Think About Secondary Research with Biospecimens

The public comment period on the NPRM to revise the Common Rule has just closed, and now we wait to see what happens (if anything), and when.  One of the most controversial proposals in the NPRM would require at least broad consent for secondary research with biospecimens (i.e., research on specimens originally collected for another purpose, either clinical care or a different study), regardless of whether those specimens retain identifiers.  This is a substantial change from the status quo, which does not require consent for such research with de-identified specimens.  How should we feel about this status quo, and the proposed change?  My own view is that it’s really not so bad: the risks to individual research participants are quite low, and the current approach facilitates critically important scientific advancement.  There is certainly room for improvement, e.g., to impose punishment on those who would act to re-identify de-identified specimens without permission, to inform the public that such research takes place, and to educate them about its value, perhaps allowing those who still feel very strongly that they prefer not to be included an opportunity to opt-out.  But what has been actually proposed has more problems than what it would replace, and in fact, wouldn’t solve some of those it seems to be a response to.

Rebecca Skloot feels otherwise.  She is the author of a book called The Immortal Life of Henrietta Lacks, which chronicles the origin of one particularly important cell line – HeLa  – derived from cells that had been excised from Ms. Lacks in the course of a 1951 surgery to treat her cancer, and later used for research without her knowledge or permission.  Ms. Lacks was poor, uneducated, and black, and her descendants have also faced more than their fair share of adversity.  Ms. Skloot paints a compelling story of exploitation, but in my opinion, it is much more effective as a narrative about the horrible and enduring legacy of racism in this country than as proof that researchers who conduct secondary research with biospecimens without consent (as permitted under the current regulations, remember) or even without profit-sharing have behaved badly. After all, if individual risks are low and social benefits high – both true – then what’s the problem?  And it is far from clear that specimen sources deserve compensation for no other reason than that their discarded material actually proves valuable to scientists.  Nonetheless, the book has been used as a rallying cry by people from all walks of life who believe that they should be allowed to control whether, and potentially how, their specimens are used for research. Indeed, The Immortal Life of Henrietta Lacks is probably the single most important development that pushed the proposed revisions to the Common Rule forward, for the first time since they were released in 1991.

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Realizing the Potential of Accountable Health Communities

Michael Anne Kyle

The recent $157 million commitment from the Centers for Medicare and Medicaid Innovation (CMMI) for a new “Accountable Health Communities” test model is most welcome. This is major step for the agency in recognizing the significance of social determinants of health in improving outcomes and costs. A New England Journal of Medicine article accompanying the funding announcement does an excellent job of highlighting the extent to which social conditions affect health outcomes and costs.

The program will invest in 44 communities over five years in three progressively advancing tracks: “increasing awareness”, “providing assistance” and “aligning partners”. Evaluation (perhaps proof of concept is more apt) is an important aspect of the model: the goal is not only to find out whether social service linkages affect health outcomes, but what types of interventions work. The awareness and assistance tracks each involve randomizing patients to usual care or an intervention; in the case of awareness, this is information about relevant social services, and in the case of assistance, the patient is provided navigation to facilitate the connection. The alignment track provides navigation, and will not involve randomization; instead, outcomes in these communities will be measured against a matched control site.

The CMMI vision of AHCs (another new acronym, gulp!) reflects emerging trends in health care and antipoverty work. The funding announcement credits initiatives like Health Leads for inspiring the low-touch (e.g., awareness) pathways. The alignment track, meanwhile, aligns very nicely with the work of emerging Medicaid Accountable Care Organizations in states like Minnesota, Colorado, and New Jersey.

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The Impact of Genetic Testing on Children: What do we know, what’s missing?

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By: Claire E. Wakefield, Lucy V. Hanlon, Katherine M. Tucker, Andrea F. Patenaude, Christina Signorelli, Jordana K. McLoone and Richard J. Cohn

Genetics research often pushes the boundaries of science, and by the far-reaching nature of genetic information, pushes us out of our comfort zones to consider new psychosocial, ethical, and legal scenarios. Conducting genetic testing on children arguably pushes our boundaries most. Yet, there can be medical benefits for some children, who may then be offered tailored medical care to match their risks. Children can also be indirectly affected by genetic testing, when they learn genetic information about themselves because a family member has had a genetic test. Continue reading

Studies Find ACA Did Not Lead to Substantial Increases in Part-Time Employment

By Katherine Kwong

Analysts from all over the political spectrum have long suggested that the Affordable Care Act’s provisions could lead to a reduction in employment numbers. New research suggests that contrary to these expectations, the available data do not support claims that the ACA would lead to a substantial shift from full-time workers to part-time workers. The current evidence also does not support claims that there would be substantially more part-time workers and people leaving the workforce due to the ACA’s provisions expanding Medicaid eligibility.

Many politicians have specifically expressed concern that the ACA’s requirement that companies with 100 or more employees provide health insurance to employees working 30 or more hours per week would lead to companies shifting employees from full-time work to part-time. Republican presidential candidates including Ted Cruz and Donald Trump have stated that they believe Obamacare makes more workers part-time instead of full-time. While campaigning in Iowa, even Hilary Clinton said she believes the ACA created “some unfortunate disincentives that discourage full-time employment.” Continue reading

UPDATED AGENDA: Fourth Annual Health Law Year in P/Review, January 29!


UPDATED AGENDA: Fourth Annual Health Law Year in P/Review
January 29, 2016 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East C 
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

The Fourth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2015 and what to watch out for in 2016. The discussion at this day long event will cover hot topics in such areas as health insurance, health care systems, public health, innovation, and other issues facing clinicians and patients.

In addition to presenting at the conference, many of our speakers will write about their topics for a collaborative blog series that will begin in February 2016 on the Health Affairs Blog.

This year’s Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, the New England Journal of MedicineHealth Affairs, the Hastings CenterHarvard Health Publications at Harvard Medical School, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

Agenda Continue reading

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of December. The selections feature topics ranging from the timing of extensions in drug indications, to the FDA’s efforts to engage patients across the spectrum of medical product development, to the impact of medical schools’ industry interaction policies on resident behavior. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Dhruva SS, Prasad V. Application of Medicare’s New Technology Add-on Payment Program for Blinatumomab. JAMA Oncol. 2015 Dec 30:1-2. [Epub ahead of print].
  2. Hunter NL, O’Callaghan KM, Califf RM. Engaging Patients Across the Spectrum of Medical Product Development: View From the US Food and Drug Administration. 2015 Dec 15;314(23):2499-500.
  3. Langedijk J, Whitehead CJ, Slijkerman DS, Leufkens HG, Schutjens MD, Mantel-Teeuwisse AK. Extensions of indication throughout the drug product lifecycle: a quantitative analysis. Drug Discov Today. 2015 Dec 2. [Epub ahead of print].
  4. Neumann PJ, Cohen JT. Measuring the Value of Prescription Drugs. N Engl J Med. 2015 Dec 31;373(27):2595-7.
  5. Shaw DL, Ross JS. US Federal Government Efforts to Improve Clinical Trial Transparency with Expanded Trial Registries and Open Data Sharing. AMA J Ethics. 2015 Dec 1;17(12):1152-9.
  6. Treasure CL, Avorn J, Kesselheim AS. Do March-In Rights Ensure Access to Medical Products Arising From Federally Funded Research? A Qualitative Study. Milbank Q. 2015 Dec;93(4):761-87.
  7. Yeh JS, Austad KE, Franklin JM, Chimonas S, Campbell EG, Avorn J, Kesselheim AS. Medical Schools’ Industry Interaction Policies Not Associated With Trainees’ Self-Reported Behavior as Residents: Results of a National Survey. J Grad Med Educ. 2015 Dec;7(4):595-602.

Mind the Coverage Gap (A Look at Healthcare Sharing Ministries)

Painting of Christ healing the sick

Flickr/Creative Commons—Ted

By Gregory M. Lipper

The Wall Street Journal published a story earlier this week about an increase in the number of Americans enrolling in healthcare sharing ministries: faith-based alternatives to standard health insurance. According to the Journal, the number of participants in these ministries has grown from under 200,000, before the Affordable Care Act was enacted, to approximately 500,000 today. Under 26 U.S.C. § 5000A(d)(2)(B), participants in these ministries are exempt from the Act’s individual mandate, which requires most Americans to either obtain qualifying health insurance coverage or pay a tax.

As the Journal article makes clear, however, participants in healthcare ministries lack many of the protections otherwise provided to patients by the Affordable Care Act. For example,

  • Ministries often don’t cover preexisting conditions;
  • Ministries often don’t cover preventive care; and
  • Ministries often don’t cover contraception, maternity care, or mental-health care.

If and when coverage disputes arise, moreover, “[m]inistries generally don’t allow members to sue and require disagreements to be settled by arbitration and mediation.”

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Medical Malpractice in an Emergency Room. What Constitutes an “Emergency” Treatment?

By Alex Stein

Georgia’s Supreme Court has recently delivered an important decision interpreting the “emergency room” doctrine: Nguyen v. Southwestern Emergency Physicians, P.C., — S.E.2d —-, 2015 WL 6631964 (Ga. 2015).  Anyone interested in medical malpractice law should know about that decision. Continue reading

1/20/16: Register Now! A Conversation with Margaret Hamburg, FDA Commissioner 2009-2015

A Conversation with Margaret A. Hamburg, FDA Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), speaks during an interview in Washington, D.C., U.S., on Wednesday, May 28, 2014. A new program that lets drugmakers move more quickly through the approval process for breakthrough products may help lower the cost of life-saving treatments, Hamburg, the nation's chief drug regulator, said today. Photographer: Andrew Harrer/Bloomberg via Getty ImagesCommissioner 2009-2015
January 20, 2016 12:30 PM
Wasserstein Hall, Milstein East ABC (2nd floor)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Please join the Petrie-Flom Center for a conversation with former FDA Commissioner (and former New York City Health Commissioner), Dr. Margaret A. Hamburg, led by Peter Barton Hutt, former Chief Counsel to FDA and current Senior Counsel at Covington & Burling LLP and Lecturer on Law at HLS. Topics discussed will include FDA’s role and the changing scientific, legal, political, and economic landscape; the overlap of science, innovation, and cost regarding biomedical products; food safety and nutrition; challenges of globalization, and more.

Speakers:

  • Margaret A. Hamburg, Commissioner of the U. S. Food and Drug Administration, 2009-2015
  • Peter Barton Hutt, Covington & Burling and Harvard Law School

This event is free and open to the public, but seating is limited and registration is required. Register now!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund.

‘The Week in Health Law’ Podcast

By Nicolas Terry

twihl 14x14

This week we talked to Professor Mary Crossley of the University of Pittsburgh School of Law. Professor Crossley’s research has focused on issues of inequality in the financing and delivery of health care, encompassing topics ranging from an exploration of potential legal remedies for physician bias in medical treatment, to an examination of how recent trends in health insurance coverage function to discriminate against unhealthy people.

We focused on the “community benefit standard” for federal nonprofit status for hospitals. The ACA has imposed new requirements in this domain, including a Community Health Needs Assessment (CHNA). CHNA’s might spur hospitals to do more to address health disparities and improve quality. But what? And how?

In our lightning round, we discussed four recent developments in health law, including a  final rule issued by HHS with respect to HIPAA law enforcement exceptions related to reporting of “mental health prohibitors” for gun ownership to background check database; Changes to meaningful use in legislation introduced by Rob Portman; Charles Ornstein’s great work at ProPublica on HIPAA violations, and how massive health care bills still dog even insured patients;

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher RadioTunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Juvenile crime is down and high school graduation is up: Good news or distraction?

By Robert Kinscherff

At first glance it seems like unequivocal good news: Juvenile crime rates are at approximately the same levels as the early 1970’s and high school graduation rates have risen from 65 percent four years ago to 82 percent in 2013-2014.  But, a closer look suggests a different picture under the surface of this aggregate national data.

Overall rates of juvenile crime have diminished considerably since the high-water mark in the late 1980’s and early 1990’s but “hot spots” of violent crime by juveniles and young adults—especially gun violence—persistently burn in neighborhoods of large cities like Detroit, Chicago, Oakland, Cleveland, and Baltimore as well as in smaller cities like Flint (MI), New Haven (CT), Rockford (IL), Odessa (TX), and Springfield (MA), and in many rural areas with intractable high poverty rates and which have seen gang infiltration in recent years. Continue reading

Products Liability or Medical Malpractice? The Definition of a “Healthcare Provider”

By Alex Stein

Every defendant in a suit for medically inflicted injuries wants to be a “healthcare provider.” This status entitles the defendant to categorize the suit as “medical malpractice” and become eligible to special litigation advantages, which include shortened limitations and repose periods, dismissal of suits not verified by experts, and statutory caps on damages.

In Verticor, Ltd. v. Wood, — S.W.3d —- 2015 WL 7166024 (Tex.App.–Austin 2015), the manufacturer of Eclipse Shield – a spinal implant for fusion – claimed to be a “healthcare provider” for purposes of the Texas Medical Liability Act (TMLA). The purpose of this claim was to recharacterize the products liability action filed against Verticor into a “healthcare liability claim” that can proceed to court only upon showing of medical malpractice verified by an expert. To establish this claim, Verticor argued that it provides the Eclipse Shield “for, to, or on behalf of a patient during the patient’s medical care, treatment, or confinement” under its “device manufacturer” license. This service, explained Verticor, makes it a “healthcare provider.” Continue reading