The ACA’s Nondiscrimination Rule: Hobby Lobby 2.0?

Should healthcare providers, researchers, and insurers be able to engage in sex discrimination for religious reasons? HHS asked the public to weigh in on this question with regard to the ACA’s nondiscrimination provision.

The answer is no for three important reasons. First, the statute doesn’t allow additional exemptions. Not only is the text clear, but Congress also considered and rejected broader religious exemptions. Second, authorizing sex discrimination for religious reasons is bad health policy with damaging effects for women and LGBT people. Third (as I argued in separate comments with a group of law and religion scholars), granting religious exemptions here runs into constitutional limits set by the Establishment Clause.

Continue reading

The ACA’s Nondiscrimination Rule: Puzzling Misreading of the Statute

Like other healthcare civil rights statutes, the Affordable Care Act’s Section 1557 links nondiscrimination requirements to federal funding. Programs that receive “federal financial assistance” can’t discriminate against individuals based on their race, sex, age or disability. HHS has proposed to exclude Medicare Part B payments from “federal financial assistance.” As a result, physicians’ offices would be outside Section 1557’s reach. The statute, however, bars this puzzling and contradictory interpretation.

For almost fifty years, HHS has taken the position that Medicare Part B payments to physicians are “contracts of insurance.” Because previous civil rights statutes—like Title VI of the Civil Rights Act and the Rehabilitation Act—explicitly excluded “contracts of insurance” from the definition of “federal financial assistance,” physicians were exempted from compliance. Payments under Medicare Part B and other insurance contracts did not suffice to create nondiscrimination obligations.

HHS’s interpretation of Section 1557 would again exclude Medicare Part B payments from the ambit of “federal financial assistance.” But, this time, the statute doesn’t allow it. Section 1557 specifically states that federal financial assistance includes “contracts of insurance.” HHS can’t have it both ways, defining Part B as “contracts of insurance” when the statute excludes them and defining Part B as something else (it’s not clear what) when the statute includes contracts of insurance. The only permissible interpretation of Section 1557 means providers who participate in Medicare can’t discriminate.

In a series of posts this week, we’re blogging on the proposed HHS Nondiscrimination Rule. You’ll find our first post here. Look for our next posts on religious exemptions and remedies under Section 1557 later this week.

The Common Rule NPRM: Biospecimens

By: Academic and Clinical Research Group at Verrill Dana LLP

[Crossposted from the The Common Rule NPRM Blog Series on the Endpoints Blog]

As we previously announced, sixteen federal agencies, including the Department of Health and Human Services (“HHS”), recently published a Notice of Proposed Rulemaking (“NPRM”) in the Federal Register outlining changes to the existing regulations protecting human subjects (the “Common Rule”).  The Common Rule NPRM is the latest development since the Advanced Notice of Proposed Rulemaking (“ANPRM”) was published on July 26, 2011.  The Academic and Clinical Research Group (“ACRG”) will be publishing a series of topic-specific blogs in the coming weeks to assist institutions in digesting various aspects of the proposed regulations, preparing to submit any comments by the December 7, 2015 deadline, and grappling with implementation changes once the final rule issues.  We have also prepared an unofficial redline of the proposed changes against the existing regulations and a set of decision charts to assist with navigating the proposed revisions.

In this installment, we discuss the NPRM’s proposed changes to biospecimens research.  The NPRM did not back down from one of the more controversial aspects of the ANPRM, proposing a fundamental shift in the applicability of the human subjects protection framework to non-identified biospecimens research.  However, once the shock of the new definition of “human subject” wears off, the reality is that most of the changes codify how the research community has tried to apply the existing Common Rule to the challenging arena of biobanking, secondary research, and genomic and other “omics” research.  That said, many of the carve-outs (i.e., exclusions and exemptions) intended to balance this shift are more restrictive than at first they seem.

ACRG Rapid Rundown:  Six Things You Need to Know Continue reading

The ACA’s Nondiscrimination Rule: Kudos and Critiques

More than five years ago, Section 1557—a little known provision in the Affordable Care Act—promised to protect individuals from race, sex, age, and disability discrimination in health programs and activities that receive federal financial assistance. But until this fall, the Department of Health and Human Services (HHS) hadn’t offered any interpretation of what the nondiscrimination provision requires. Today, the comment period for the proposed rule closes, and HHS will set to work finalizing the Nondiscrimination Rule. Together with professors Jessica Roberts and Jessica Clarke and Yale Law students Elizabeth Dervan and Elizabeth Deutsch, I drafted lengthy comments on the proposed rule.  In a series of blog posts this week, we’ll explain what HHS got right, where its interpretation went wrong, and how it can provide clarity to healthcare programs and the public.

The ACA broke new ground in prohibiting sex discrimination in healthcare for the first time. Women and LGBT people face persistent and systemic discrimination at the hands of insurers, hospitals, and doctors. Women’s pain goes undertreated, and their heart attacks undiagnosed. Due in part to their capacity to become pregnant, women have largely been excluded from studies. More than half of LGBT people report facing discrimination in healthcare settings. Transgender men and women have encountered ridicule, refusals of treatment, and hostility in emergencies with fatal and near-fatal consequences.

The Affordable Care Act aims to change this. The Nondiscrimination Rule presents a historic opportunity for HHS to interpret sex discrimination broadly. In its proposed rule, HHS seems poised to take advantage of this opportunity by reaching pregnancy, sex stereotyping, and gender identity discrimination. To meet HHS’s goal of ensuring the most robust set of protections in current law, the final rule should also make clear that sexual orientation discrimination is sex discrimination.

Continue reading

Nevada’s $350,000 Cap on Noneconomic Damages Held Constitutional and Applicable Per Incident

By Alex Stein

Bad news for Nevada’s victims of medical malpractice. This state’s Supreme Court upheld the constitutionality of the $350,000 cap on noneconomic damages as limiting recovery for all kinds of victims and injuries. Tam v. Eighth Jud. Dist. Ct., — P.3d —- , 2015 WL 5771245 (Nev. 2015).  Moreover, the Court held that the cap applies per incident, which encompasses all mistakes that the doctor may have made in delivering a single treatment to a patient and all the victims of those mistakes (such as twins born with birth defects as a result of negligent prenatal care or delivery). For my discussion of the “per incident” and alternative approaches to caps, see here. Continue reading

Lecture Tomorrow, 11/10! Euthanasia in Belgium: The most recent legal developments and policy challenges

Euthanasia in Belgium: The most recent legal developments and policy challenges
November 10, 2015 11:00 AM – 12:15 PM

Conference Room, 1st floor
Center for Bioethics at Harvard Medical School
641 Huntington Ave., Boston, MA [Map]

A lecture by Sigrid Sterckx, Professor of Ethics and Political and Social Philosophy, Ghent University, Belgium; End-of-Life Care Research Group, Vrije Universiteit Brussel & Ghent University, Belgium; Bioethics Institute Ghent, Ghent University, Belgium.

In 2002, euthanasia by a physician (the intentional termination of a patient’s life at his or her request) was depenalized in Belgium for adults and emancipated minors. In 2014, the law was extended to competent minors, without an age limit. The frequency of performance of euthanasia is rising very rapidly, having more than doubled in the last five years (accounting for one death in twenty, about 8 per day in Flanders, the Dutch-speaking region). Moreover, although the prevalence of euthanasia remains highest in patients with cancer, a clear shift is visible in the characteristics of patients who request euthanasia and whose requests are granted. The largest increases are among women, and those aged 80 or older, with lower education levels, and those dying in nursing homes. Continue reading

‘The Week in Health Law’ Podcast

By Nicolas Terry

twihl 14x14

This week we are joined by Glenn Cohen, Professor of Law at Harvard Law School and Faculty Director of Harvard’s Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics, and Holly Fernandez Lynch, Executive Director of the PFC and member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), at the U.S. Department of Health and Human Services.

We discussed the NPRM on the Common Rule, summarized here and here. (Comments are due by December 7th.) Holly and Glenn offered perspectives on the nature and purpose of the proposed revision, and the bioethical aims it served, with a particular focus on the advancement of research. Frank focused on the practical implications for designing consent procedures for learning health care systems. Nic commented on the regulatory complexity arising out of the interaction of HIPAA and HSR protections of data. Podcast listeners will find themes in this episode also engaged in our conversations with Deirdre Madden and Michelle Meyer.

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 If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

CMS Issues Notice Regarding Barriers to HCV Treatment

By Dalia Deak

Yesterday, the Centers for Medicare & Medicaid Services (CMS) issued a notice that affirmed CMS’s commitment to provide prescription drugs to beneficiaries, specifically highlighting beneficiaries suffering from hepatitis C virus (HCV). The notice comes at a moment of heightened interest in the cost of prescription drugs (particularly on the federal level as an inquiry in the Senate has been initiated regarding rising drug prices).

In the statement, CMS:

  • Reminded the states of their obligation, under the terms of the Social Security Act, that Medicaid programs must cover prescription drugs for medically accepted indications if the manufacturer of the drug is a manufacturer with whom they have rebate agreements with;
  • Discussed the concern regarding costs of direct-acting antiviral (DAA) HCV drugs, emphasizing the role of competition and negotiation in bringing down the drugs’ prices;
  • Expressed concern regarding some states’ policies to restrict access to the DAA HCV drugs that may be contrary to their obligations under the Social Security Act;
  • Encouraged states to ensure that their policies do not unreasonably restrict coverage of effective treatment;
  • Reminded states that drugs available under the states’ fee-for-service programs must also be available to beneficiaries of Medicaid managed care organizations; and
  • Indicated that CMS will monitor state Medicaid policies for DAA HCV drug coverage to ensure that they are compliant with approved state plans, statutes, and regulations.

CMS also followed up its notice with a letter to the CEO of AbbVie asking for additional information regarding the types of value-based purchasing arrangements offered to payers and to state Medicaid agencies by December 31, 2015.

Continue reading

The Supreme Court and Contraceptive Coverage—Take 2

Supreme Court

Flickr/Creative Commons – Andrew Raff

by Gregory M. Lipper

Today the Supreme Court granted review in seven challenges to the accommodation offered to those with religious objections to the Affordable Care Act’s contraceptive coverage regulations. I won’t rehash my earlier posts about why I (and seven of eight federal appeals courts) think that these challenges, brought under the Religious Freedom Restoration Act, are bunk. For now, a few observations about the cases and today’s cert grants:

1. These cases involve challenges to a religious accommodation, not the coverage requirement itself. In Burwell v. Hobby Lobby Stores, the Supreme Court said that the government couldn’t enforce the contraceptive coverage regulations against for-profit corporations with religious objections. The Court pointed to a less-restrictive alternative: the accommodation, offered to nonprofit organizations, through which the organization submits a written objection and government arranges for the objector’s insurance company or plan administrator to provide the coverage at no cost to either the objector or its employees. The plaintiffs in these cases are challenging the accommodation itself. By analogy, this is like a conscientious objector challenging the process for opting out of the draft.

2. Oddly enough, Hobby Lobby didn’t officially resolve RFRA challenges to the accommodation. You might think that since the Supreme Court’s decision in Hobby Lobby pointed to the accommodation as the less-restrictive alternative, then the Court must have also made clear that the accommodation itself complied with RFRA. But the majority opinion did not do so. Instead, after pointing to the accommodation as a less-restrictive alternative, the majority said, “We do not decide today whether an approach of this type complies with RFRA for purposes of all religious claims.”

3. And/But: Justice Kennedy, the deciding vote in Hobby Lobby, suggested more clearly that the accommodation complies with RFRA. Although he joined the majority opinion, Justice Kennedy also wrote separately and appeared to bless the accommodation. Here’s what he said:

  • “That accommodation equally furthers the Government’s interest but does not impinge on the plaintiffs’ religious beliefs.”
  • “Yet neither may that same [free exercise] unduly restrict other persons, such as employees, in protecting their own interests, interests the law deems compelling. In these cases the means to reconcile those two priorities are at hand in the existing accommodation the Government has designed, identified, and used for circumstances closely parallel to those presented here.”

If Justice Kennedy holds to his view in Hobby Lobby, then the plaintiffs in these cases will probably lose.

4. Although the plaintiffs in these cases are nonprofit organizations, the result will affect employees of for-profit corporations. As instructed by the Supreme Court in Hobby Lobby, the government extended the accommodation to closely held for-profit corporations such as Hobby Lobby. But neither Hobby Lobby nor the other for-profit plaintiffs have said that they will accept the accommodation, and most of them are represented by the same organizations representing the nonprofit challengers to the accommodation. So if the Supreme Court doesn’t uphold the accommodation as applied to nonprofit organizations, employees of objecting for-profit corporations will almost certainly go entirely without contraceptive coverage as well.

5. “[Y]ou are not entitled to your own facts….” Today the Becket Fund, which represents Little Sisters of the Poor and several other plaintiffs, issued a press release entitled “High Court to decide if Government can force nuns to provide contraceptives.” This is false—full stop. Under the accommodation, contraceptives are provided by the employer’s insurance company or plan administrator; employers aren’t paying for the insurance coverage, let alone handing out the insurance coverage, let alone handing out contraceptives themselves. Whether or not you think that the accommodation resolves employers’ religious objections, it is simply not true that—as a matter of fact—objecting nuns are required “to provide contraceptives.” (This is not, I should add, the first time that the Becket Fund has made this claim in a press release.) I will be curious to see whether Becket Fund repeats this claim in its briefs to the Court.

Greg Lipper is Senior Litigation Counsel at Americans United for Separation of Church and State. You can follow him on Twitter at @theglipper.

REGISTER NOW! Specimen Science: Ethics and Policy Implications Symposium, with NEW Lunchtime Talk on “Biospecimens and the NPRM”

testtube_hand_bw_slideSpecimen Science: Ethics and Policy Implications
NEW Lunchtime Talk on “Biospecimens & the NPRM”
Monday,  November 16, 2015, 8:30 AM – 5:00 PM
8:30am-12:40pm: Austin Hall North (100);
12:40-5:30pm, Langdell Hall South, Room 272

Harvard Law School, Cambridge, MA [Map]

Many important advances in human health depend on the effective collection, storage, use, and sharing of biological specimens and their associated data.   However, recent controversies involving specimen-based research have raised important questions about ownership, data-sharing, privacy considerations, group harms, and standards for responsible specimen stewardship.

Please join us for a symposium to discuss the key ethical and policy issues raised by genetics and other research involving human biological materials, covering the entire trajectory from specimen source to new discovery.  The experts at this day-long event will cover key topics, such as historical, legal, and international perspectives; donor attitudes, researcher perspectives, and institutional considerations; broad vs. specific informed consent; privacy, ownership, and control; use of specimens collected through mandatory newborn screening; research with discrete and insular populations; and others.  Conference papers eventually will be published as an edited volume with a major academic press.


Continue reading

Finally, a Final Rule on Advance Care Planning

In a victory for common sense, good policy, and good care, reimbursement for end-of-life counseling was safely tucked into the 2016 Medicare Payment Rules issued by CMS last Friday. The calm adoption of advance care planning shows welcome progress from the “death panels” hysteria that plagued this sensible policy when it was first proposed six years ago. The list of advance care planning supporters is long, including: numerous physician organizations, the Centers for Disease Control and Prevention, the Institutes of Medicine, the American Hospital Association, and over 80 percent of Americans. So, what is advanced care planning and why does it matter?

Given the circus that originally surrounded it, people may be surprised to learn that this policy simply involves the addition of two billable codes to the Medicare Physician Fee Schedule. The first code, 99497, covers an initial 30-minute consultation on end-of-life planning, with a second, 99498, covering 30 additional minutes, if needed. Importantly, patients do not need to be seriously ill to access this benefit – a consultation can be scheduled at any time, for example, as part of an annual physical. During this meeting, patients discuss the kind of interventions they would want if they become critically ill, or as they approach the end of life. Such conversations enable collaboration between the patient, family, and medical team – it opens the door for an ongoing dialogue about priorities and goals of care (which may evolve over time).

Planning for the end of life matters because advances in medicine have created a dizzying array of interventions and palliative care options for people who are gravely ill. There are many clinical and psychosocial benefits to communicating one’s preferences around end of life care. In a September 2015 Kaiser Family Foundation poll, 89 percent of respondents said doctors should discuss end-of-life plans with patients – but only 17 percent had actually had such a discussion with their doctor. Formal recognition of the value of advance care planning is an important step in encouraging more patients and doctors to initiate the conversation.

The Ongoing Push for E-Cigarette Regulations

By Katherine Kwong

Last week, the American Academy of Pediatrics publicly joined the group of advocates for federal regulations on e-cigarettes. The AAP urged the government to ban the sale of e-cigarettes to everyone under age 21 and prohibit advertising to minors, and advocated for high taxes on e-cigarette products similar to those on other tobacco products. In its announcement, the AAP cited developing brains’ vulnerability to nicotine and the potential harms to long-term health as reasons for its recommendations to keep e-cigarettes away from youths. It also recommended that smoke-free laws governing secondhand smoke explicitly include e-cigarettes, saying, “[t]he aerosol emitted from e-cigarettes is not harmless; it contains a variety of toxic chemicals, including some carcinogens and significant amounts of nicotine.”

A recently released poll found that a majority of Americans (57%) believe e-cigarettes should be regulated like tobacco products, while less than 25% of respondents felt they should not be. The Food and Drug Administration proposed e-cigarette regulations in 2014, and recently sent the regulations to the Office of Management and Budget for review. While the final form of the regulations is still unknown, the proposal banned the sale of e-cigarettes to minors and required e-cigarette labels include a list of ingredients and a disclosure that they contain nicotine.

There is growing concern about the potential health risks posed by e-cigarettes. Advocates for restrictions on e-cigarettes have long warned that unregulated e-cigarettes frequently expose users to the harmful effects of nicotine, as well as toxic chemicals such as formaldehyde, benzene, and other carcinogens. There have also been warnings about the risk that e-cigarette use may lead to greater social acceptance of smoking and higher rates of tobacco use. (Despite frequent claims that e-cigarettes may help with smoking cessation, longitudinal studies consistently find no evidence that e-cigarette use increases quitting rates.) Anecdotal evidence has linked e-cigarette use to pneumonia and other lung problems. Forty percent of e-cigarette users reported having health concerns about their use.

Continue reading

The Good, the Bad, and the Ugly: Physician Coverage under the ACA

By Elizabeth Guo

A recent study in JAMA by Dorner, Jacobs, and Sommers released some good and bad news about provider coverage under the Affordable Care Act (ACA). The study examined whether health plans offered on the federal marketplace in 34 states offered a sufficient number of physicians in nine specialties. For each plan, the authors searched for the number of providers covered under each specialty in each state’s most populous county. Plans without specialist physicians were labeled specialist-deficient plans. The good: roughly 90% of the plans covered more than five providers in each specialty. The bad: 19 plans were specialist-deficient and 9 of 34 states had at least one specialty deficient plan. Endocrinology, psychiatry, and rheumatology were the most commonly excluded specialties.

Here’s where it gets ugly.

Excluding certain specialists from coverage can be a way for insurers to discriminate against individuals with certain conditions by excluding them from their plans. By excluding rheumatologists, insurers may prevent enrolling individuals with rheumatoid arthritis; by excluding endocrinologists, insurers may prevent enrolling individuals with diabetes. Individuals with chronic conditions need to see specialists more frequently than healthier adults, and how easily a patient with chronic conditions can see a specialist can affect his health care outcomes.

The study adds to the growing body of empirical research showing that even after the ACA, insurers may be structuring their plans to potentially discriminate against individuals with significant chronic conditions. In January, Jacobs and Sommers published a study showing that some plans were discriminating against patients with HIV/AIDS through adverse tiering by placing all branded and generic HIV/AIDS drugs on the highest formulary tier. Another study found that 86% of plans place all medicines in at least one class on the highest cost-sharing tier. These studies show that despite being on a health plan, individuals with certain chronic conditions may still have trouble accessing essential treatments and services. Continue reading

Introducing Blogger Robert Kinscherff


The Petrie-Flom Center is pleased to welcome Robert Kinscherff, PhD, JD to the Bill of Health as our newest contributor!

Robert Kinscherff is the 2015-2016 Senior Fellow in Law and Neuroscience at the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center. Dr. Kinscherff is a forensic and clinical psychologist and an attorney who has been on the faculty at William James College since 1999, where he is Associate Vice President for Community Engagement with oversight of key clinical service-providing programs. He is also Teaching Faculty in the Doctoral Clinical Psychology Program and for the Doctoral School Psychology Program at William James College, Faculty at the Center for Law, Brain and Behavior, and Senior Associate for the National Center for Mental Health and Juvenile Justice. He is a member of the Massachusetts legislative Special Commission on Sexual Offender Recidivism and designee member for the Administrative Office of the Juvenile Court for the legislative Committee to Develop an Evaluation Process in Cases of Homicide by Juveniles. Kinscherff has previously served as Assistant Commissioner for Forensic Mental Health (MA Department of Mental Health), Director of Juvenile Court Clinic Services (MA Trial Court), and Director of Adult Forensic Services (Psychiatry and Law Program, MGH). For over a decade, he taught classes at the intersection of law and psychology at Boston University Law School. For the American Psychological Association, he is a current member of the Board of Professional Affairs, and has served as Chair of the APA Gun Violence Policy Review Task Force, a past two-term Chair of the Ethics Committee (EC), Chair of the Committee on Legal Issues (COLI) and Member of the Committee on Professional Practices and Standards (COPPS). His research and professional practice areas include legal, ethical, and professional practice issues in clinical and forensic mental health practice, violence risk assessment and management, juvenile homicide, aggressive and sexually problematic behaviors among youth and adults with developmental or mental disorders, and severe and unusual forms of child maltreatment. His many publications include the co-authored book APA Ethics Code: Commentary and Case Illustrations (Washington, DC: American Psychological Association Press, 2009) and more recent publications on topics including mental health practice in juvenile justice contexts, special ethical and practice considerations in work with juvenile and violent offenders, and international human rights law implications for forensic psychologists of the 2012 US Supreme Court case of Miller v. Alabama regarding mandatory life imprisonment without possibility of parole for offenses committed as a juvenile.

Understanding “Lost Chances to Recover” (and Looney v. Moore)

By Alex Stein

My colleague, Professor Tony Sebok, drew my attention to an important recent decision, Looney v. Moore, 2015 WL 4773747 (N.Dist.Ala. 2015, by Chief United States District Judge Karon O. Bowdre). This decision adjudicated a textbook lost-chance case that involved the effects of oxygen saturation levels (SpO2) in premature infants with extremely low birth weights (ELBW). For any such infant, high SpO2 levels involved (among other complications) the risk of blindness caused by retinopathy of prematurity (ROP). On the other hand, low levels of SpO2 could lead to life-threatening neurodevelopmental impairments (NDI). The neonatologists’ customary practice was to maintain SpO2 levels in ELBWs between 85% and 95%. The effects of variations within that nationally accepted range were hitherto unknown.

To find out what those effects are, the defendants conducted a clinical trial. They divided the nationally accepted range of SpO2 levels into a high range (90%- 95%) and a low range (85%-90%). Infants whose parents agreed to participate in that trial—all having an extremely low birth weight—were randomly placed in either of the two groups. By making that division, the defendants tracked the infants’ rates of NDI, on one side, and ROP, on the other side.

Continue reading

TOMORROW, 11/4! Reflections in Honor of the Life and Influence of Professor Alan Wertheimer

Wertheimer_teaching_slideReflections in Honor of the Life and Influence of Professor Alan Wertheimer
November 4, 2015, 1:00 – 5:30 PM
Wasserstein Hall, Milstein West B (2019)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA [Map]

Please join us for an afternoon of reflection on the life, work, and enduring influence of Professor Alan Wertheimer (1942-2015). Professor Wertheimer was a leading philosopher of law and bioethics, making critical contributions to clinical research ethics; theories of coercion, undue influence, and exploitation; consent in a variety of contexts, and much more. This tribute event will feature leading scholars discussing and engaging with Professor Wertheimer’s many contributions, and exploring how he influenced their own work.

At the time of his death in 2015, Alan Wertheimer was Senior Research Scholar in the Department of Bioethics at the National Institutes of Health. 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 October. The selections feature topics ranging from the use of superlatives in cancer research, experience with the priority review voucher for neglected tropical and rare pediatric diseases, to a decision-making framework for gatekeepers of pragmatic clinical trials. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Abola MV, Prasad V. The Use of Superlatives in Cancer Research. JAMA Oncol. 2015 Oct 29. [Epub ahead of print].
  2. Downing NS, Krumholz HM, Ross JS, Shah ND. Regulatory watch: Characterizing the US FDA’s approach to promoting transformative innovation. Nat Rev Drug Discov. 2015 Oct 5. [Epub ahead of print].
  3. Ioannidis JP, Fanelli D, Dunne DD, Goodman SN. Meta-research: Evaluation and Improvement of Research Methods and Practices. PLoS Biol. 2015 Oct 2; 13(10):e1002264.
  4. Kesselheim AS, Maggs LR, Sarpatwari A. Experience With the Priority Review Voucher Program for Drug Development. JAMA. 2015 Oct 27; 314(16):1687-8.
  5. Kim C, Prasad V. Cancer Drugs Approved on the Basis of a Surrogate End Point and Subsequent Overall Survival: An Analysis of 5 Years of US Food and Drug Administration Approvals. JAMA Intern Med. 2015 Oct 19. [Epub ahead of print].
  6. Langedijk J, Ebbers HC, Mantel-Teeuwisse AK, Kruger-Peters AG, Leufkens HG. Licensing failure in the European decentralised procedure. Eur J Pharm Sci. 2015 Oct 19. [Epub ahead of print].
  7. Luo J, Kesselheim AS. Evolution of insulin patents and market exclusivities in the USA. Lancet Diabetes Endocrinol. 2015 Oct 6. [Epub ahead of print].
  8. Whicher DM, Miller JE, Dunham KM, Joffe S. Gatekeepers for pragmatic clinical trials. Clin Trials. 2015 Oct; 12(5):442-8.

House of Reps v. Burwell: A Case Worth Following

By Matthew Ryan, Harvard Health Law Society

With the final judgment in King v. Burwell this summer upholding federal subsidies for health insurance, many legal analysts believed that lawsuits against the Affordable Care Act had ended. But the House of Representatives had other plans. In July of 2014, the House of Representatives voted on partisan lines to sue President Obama for overstepping his constitutional bounds. The House alleged that the President did not faithfully execute the Affordable Care Act with regard to two executive actions. First, the Obama Administration authorized payments to insurance companies to assist with cost sharing. The House argued Congress never appropriated these funds. Second, the House alleged that the Obama Administration unlawfully delayed the employer mandate at a $12 billion cost to taxpayers.

In September, the United States District Court for the District of Columbia cleared a major hurdle for the House: the court granted standing to the plaintiffs for their challenge to the Administration authorizing cost sharing funds without Congressional appropriation. The court did not grant standing with regards to the employer mandate implementation. Continue reading

The Right to Health and Free Speech: Supreme Court of Argentina Rules Against Tobacco Advertising

by Martín Hevia (Universidad Torcuato Di Tella)

In 2006, Nobleza Piccardo, a main tobacco company in Argentina, had filed a claimed against the government of the Province of Santa Fe because a law sanctioned by the Provintial Congress completely banned the advertising and promotion of tobacco products in the Province (Santa Fe is one of the main Provinces of Argentina). Nobleza Piccardo argued that those restrictions infringed upon free speech and upon commercial freedom. It also claimed that, under the Argentine National Constitution, the Province is not allowed to pass legislation of that kind because the National Congress had already passed law 23.344, which regulated tobacco advertising (but did not ban it); once National Congress did so, Provintial Congresses cannot further legislate on the issue.

In its October 27 ruling, the Supreme Court held that nothing in the National Constitution provides National Congress with an exclusive power to legislate on health matters. Furthermore, Provintial legislation may complement federal legislation on the matter.

On the free speech and commercial freedom argument, the Court held that there is a tendency in other jurisdictions to restrict or even completely ban tobacco advertising. According to the Court, the restrictions established by the law are justified because they are proportionate to the public health concerns it wants to address; in addition, they follow internationallly accepted standards on the matter.

In his vote, Judge Lorenzetti, President of the Supreme Court, wrote that restricting tobacco advertising does not infringe upon free speech because tobacco advertising is not related to the working of republican and democratic institutions. Thus, Lorenzetti says, it would be wrong to analyze the restrictions established by the provintial law with the strict scrutiny test used in free speech cases. This claim, of course, is very important and will deserve much more discussion by the Supreme Court in future decisions. But the main teaching of the case is that, for the first time, the Supreme Court clearly states that tobacco control measures are a matter of human rights. This is, no doubt, a very important step.