The last week has yielded significant progress in several states currently debating Medicaid expansion. Thirty-one states and DC have already expanded the program, made an option for states due to the Supreme Court’s NFIB v Sebelius decision. Many state legislatures are coming back into session from summer recesses bringing into focus discussions on the budget implications of Medicaid. Additionally, as we approach a looming Presidential election with expected high voter turnout, politicians have an opportunity to push for the expansion to gain support from certain stakeholders. While significant action is needed in each of these states before any Medicaid expansion legislation is passed or their governors act to implement their plans, it is worth keeping an eye on all of these states in the coming months.
Utah- It has been over a year and a half since Governor Herbert announced his support for Medicaid expansion. This week, details of the new plan, UtahAccess+, have been released. The plan, formulated by the Governor and Republican legislative leaders, is similar to the Healthy Utah plan that was passed the Utah Senate but was struck down in the House with the exception of the financing model which puts the burden on providers that would benefit from additional funds through expansion.
Louisiana- This is one of the more surprising states to appear on a list of upcoming states to expand Medicaid, however the tides may be shifting in this largely conservative state. Louisiana is in the process of electing a new governor as Presidential candidate Bobby Jindal is ineligible due to term limits. All four candidates have indicated some level of support for expansion (to varying degrees) since April. These candidates’ positions reflect the push by business groups in the state which have called for expansion, as well as the recent legislative change that gave the new governor the necessary state authority to expand in the first months in office.
As if the proposed revisions to the Common Rule weren’t enough to process, the Council for International Organizations of Medical Sciences (CIOMS) just released its proposed changes to the current CIOMS Ethical Guidelines for Biomedical Research (last revised in 2002). CIOMS invites public comments until March 1, 2016, at which point the CIOMS Working Group will process and review them and submit the final document to the CIOMS Executive Committee for approval.
According to CIOMS, most guidelines have been substantially revised in this draft, several have been merged, and new guidelines have been added. The proposal also merges the guidelines for biomedical research with those for epidemiological research, and the scope has been broadened from biomedical research to health-related research with humans.
A busy and exciting time in research ethics!
Our colleagues at PRIM&R (Public Responsibility in Medicine & Research) have compiled several resources to help those interested in the proposed changes to the Federal Policy for the Protection of Human Subjects, or the Common Rule. These include an NPRM Resources page, with a chart comparing the current Common Rule with the proposed changes by section, and other materials. PRIM&R has also recently released a freely available (till December 11, when it becomes available only to members) annotated version of the current Common Rule, which provides the regulatory text, hyperlinked to further information in the form of guidance, frequently asked questions, and regulatory resources from the Office for Human Research Protections.
PRIM&R will be blogging about the NPRM in the coming weeks, and we will cross-post here. Stay tuned.
For those trying to make sense of the NPRM, the Academic and Clinical Research Group at Verrill Dana has issued two very helpful resources:
- A redline of HHS’s current Common Rule regulations at 45 C.F.R Part 46, Subpart A against the proposed regulations in the NPRM.
- Several decision charts walking through the following issues:
- the scope of covered human subject research and clinical trials,
- the key definitions of “human subject” and “research,”
- the exclusions (and conditions for exclusion) from the proposed regulations, and
- the exemptions (and associated requirements) from the proposed regulations.
For those interested, the firm’s full client advisories on the NPRM are available here.
[Posted with Verrill Dana’s permission]
While the NPRM might do much to reduce the number of projects requiring IRB review, it would do little to improve the quality of review for those projects for which it is still required. This is a retreat from the more ambitious plans of the 2011 advance notice of proposed rulemaking.
[Cross-posted from Institutional Review Blog]
By Katherine Kwong
Drug prices have become a hot topic on the presidential campaign trail following recent stories such as the sudden spike in price from $13.50 to $750 for the parasitic infection treatment Daraprim. This story is the latest example of a growing number of complaints about steep increases and high prices for many drugs, including those used to treat multiple sclerosis and cancer, as well as commonly-used generic drugs used to treat everything from high cholesterol to bacterial infections.
In contrast with the Republican presidential candidates, who have generally not supported additional government regulation of drug pricing, Democratic presidential candidates responded to the Daraprim story by urging greater government action to lower drug costs.
Hillary Clinton cited Daraprim as an example when unveiling a proposal to cap drug costs to $250 per month, require pharmaceutical companies to spend a minimum amount on research and development, and allow Medicare to negotiate drug prices. She would also end tax credits for drug advertising to consumers and allow the importation of drugs from other countries.
Non-Human Primates in Research: Legal and Ethical Considerations
September 30, 2015, 12:00 PM
Wasserstein Hall, Room 1010
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA [Map]
Please join us for a discussion of critical legal, ethical, scientific, and social issues raised by research involving non-human primates, and the research centers that house them. What does the current regulatory structure require and permit, what gaps exist, what enforcement problems have arisen, and how are they being addressed at Harvard and elsewhere? How should scientific and medical interests be balanced against the interests of the animals, and how might the ethical and/or regulatory analysis differ depending on the type of primate involved? What trends are emerging with regard to funding, scientific approaches, and public opinion? Our panelists will address these questions and others in the course of a lively debate.
Panelists: Continue reading
From Troubled Teens to Tsarnaev:
Promises and Perils of Adolescent Neuroscience and Law
September 28, 2015, 4:00 – 5:30 PM
Wasserstein Hall, Room 1015
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA [Map]
Followed by the Petrie-Flom Center’s 2015 Open House reception in the HLS Pub (more information below)! Continue reading
The latest newsletter from the Yale Interdisciplinary Center for Bioethics is now available online. For an archive of past newsletters, please visit the Center’s website.
by Zachary Shapiro
While all scientific research produces data, genomic analysis is somewhat unique in that it inherently produces vast quantities of data. Every human genome contains roughly 20,000-25,000 genes, so that even the most routine genomic sequencing or mapping will generate enormous amounts of data. Furthermore, next-generation sequencing techniques are being pioneered to allow researchers to quickly sequence genomes. These advances have resulted in both a dramatic reduction in the time needed to sequence a given genome, while also triggering a substantial reduction in cost. Along with novel methods of sequencing genomes, there have been improvements in storing and sharing genomic data, particularly using computer and internet based databases, giving rise to Big Data in the field of genetics.
While big data has proven useful for genomic research, there is a possibility that the aggregation of so much data could give rise to new ethical concerns. One concern is that promises of privacy made to individual participants might be undermined, if there exists a possibility of subject re-identification.
Re-identification of individual participants, from de-identified data contained in genetic databases, can occur when researchers apply unique algorithms that are able to cross-reference numerous data sets with the available genetic information. This can enable diligent researchers to re-identify specific individuals, even from data sets that are thought to be anonymized. Such re-identification represents a genuine threat to the privacy of the individual, as a researcher could learn about genetic risk factors for diseases, or other sensitive health and personal information, from combing through an individual’s genetic information.
Medicaid is often thought of as a welfare program because of the essential role it plays in providing health insurance for low-income people. However, looks can be deceiving. In terms of scale and scope, Medicaid is rapidly becoming a powerhouse player in health care.
Medicaid enrollment is booming as a result of the Affordable Care Act (ACA): nearly 72 million people are enrolled in Medicaid and the Children’s Health Insurance Program (CHIP). To put this in perspective, about 55 million people are enrolled in Medicare and about 64 million in the UK’s NHS. Medicaid enrollment is likely to continue rising as more states contemplate expansion. As of this month, 30 states and the District of Columbia have expanded Medicaid under the ACA.
Size isn’t the only way Medicaid is changing. Unlike Medicare, Medicaid is a joint state and federal program, which means that states have a lot of latitude to innovate with both delivery and payment. The ACA has enhanced opportunity for reform through planned initiatives like the Center for Medicare and Medicaid Innovation (CMMI), and unexpected pathways, like negotiations around Medicaid expansion – these have yielded some of the most radical departures from the traditional public program paradigm, even in states that have not sought a “private option”
Come join our team!
The Public Health Law Research program is hiring legal research associates to work on our policy surveillance project. The legal research associate will conduct legal research using Lexis and Westlaw, build historical law using HeinOnline, and conceptualize legal domains for empirical research. The associate will also code law for the creation of quantitative legal datasets at LawAtlas.org, and write legal briefs and other materials for LawAtlas.org.
Learn more and apply today!
Two weeks ago, California’s legislature approved a bill that would make California the fifth, and largest state to approve assisted suicide. If Governor Jerry Brown signs the bill, California would join Oregon, Washington, Montana, and Vermont in permitting physicians to prescribe life-ending medications. California was one of 36 states that considered assisted suicide legislation this year. Though none of the bills have become law, the assisted suicide, or “Death with Dignity” movement seems to be gaining strength.
If assisted suicide becomes legal in California, whether and how patients will have access to assisted suicide is a different matter. Secobarbitol and pentobarbital are the most commonly used medications in assisted suicide. Pentobarbital, the cheaper of the two options and the preferred drug of choice, is facing a drug shortage. Pentobarbital is also used in capital punishment, and U.S. suppliers have stopped producing the drug because the suppliers did not want to be associated with lethal injection. The drug shortage has left some patients considering assisted suicide to go through back alleyways to obtain pentobarbital.
Indeed, the Death with Dignity movement is facing many of the same issues that state corrections agencies are facing in obtaining access to lethal drugs. None of the drugs used for assisted suicide or lethal injection are FDA-approved for a lethal purpose. Both groups have faced challenges in importing the drugs from other countries because FDA cannot accepting an imported drug if it appears to violate Food Drug and Cosmetic Act. Both groups have, in some cases, resorted to compounding pharmacies to manufacture lethal drugs from raw materials.
My last post presented the debate over force feeding hunger striking prisoners in Israel. This post will discuss another group subjected to the dramatic means of force feeding in extreme circumstances, Anorexia Nervosa patients (AN).
Although ethical justifications for force-feeding are similar for both Anorexics and Hunger strikers (save life), the legal framework is completely different in each context. Whereas hunger striking prisoners were dealt with via ad-hoc legislation meant to answer national security threats, AN patients are handled within the framework of mental health law. In the U.S., compulsory hospitalization of mental patients occurs through the state’s Civil Commitment Laws, which require dangerousness resulting from a mental illness to be evaluated by a psychiatrist.
Is the different legal attitude justified? How is it that the same act performed by prisoners is viewed as a political assertion but when done predominantly by adolescent middle-upper class girls, it is considered mental illness?
By Gregory M. Lipper
Thomas Jefferson famously said that “[i]t does me no injury for my neighbour to say there are twenty gods, or no god. It neither picks my pocket nor breaks my leg.” Note what Jefferson did not say: “my neighbor is entitled to pick my pocket and break my leg, so long as the government can refill my pocket and pay for a cast on my leg.”
But the latter formulation seemed to influence last week’s Eighth Circuit ruling that the Religious Freedom Restoration Act (RFRA) bars the government from implementing an accommodation for employers with religious objections to including contraception in their health plans. In my previous post, I explained why the Eighth Circuit reduced RFRA’s substantial-burden requirement to a mere formality, potentially subjecting any and every federal law or regulation to strict scrutiny. Once things get to strict scrutiny, the Eighth Circuit goes even further, suggesting that a federal regulation cannot be sustained if the government could, in theory, provide the benefit or service itself.
The Eighth Circuit first applied this approach to the process by which employers obtain the religious exemption. Under the current rules, an objecting organization need only send a written notice to the government and identify its insurance provider or third-party administrator; the government then works with the insurance provider or third-party administrator to arrange for the employees to receive the contraceptive coverage to which they are entitled by law.
The Eighth Circuit, however, reasoned that there is a less-restrictive alternative to requiring this information, since the government could identify the necessary insurance providers and third-party administrators on its own—well, maybe: “Even if the [third-party administrators] are not known, the government has not shown at this stage of the proceedings that the inconvenience of identifying the [third-party administrators] likely would create an administrative problem of sufficient magnitude to make its entire scheme unworkable.” According to the Eighth Circuit, then, no disclosure requirement can be sustained unless the government can prove that it would be unable to discover the information after its own investigation.
The internet (not just the health policy part of the internet!) is fascinated by today’s New York Times story about dramatic recent increases in the costs of many decades-old drugs. The story focuses on the case of Daraprim, the standard of care for treating the parasitic infection toxoplasmosis. Daraprim was recently acquired by a start-up, which then raised the drug’s price from $13.50 a pill to $750 a pill. Daraprim has been around for decades, and as the story notes, it’s just one of many recent examples of dramatic price increases for generic drugs, often after their acquisition by other companies (as in this case).
The article raises an enormous number of issues of interest to intellectual property and health policy scholars, both explicitly and implicitly, and other commentators have begun to canvass them. But I want to spend the rest of this blog post unpacking a single point made in the article, because it actually contains an enormous amount of complexity. As the author notes, “[the company’s] price increase could bring sales to tens or even hundreds of millions of dollars a year if use remains constant. Medicaid and certain hospitals will be able to get the drug inexpensively under federal rules for discounts and rebates. But private insurers, Medicare and hospitalized patients would have to pay an amount closer to the list price.”
The author is right that there’s one sense in which Medicaid and entities eligible for the 340B program (I assume this is what the author is referring to when he says “certain hospitals”) will be able to obtain this drug “inexpensively” – but there’s another sense in which they won’t be able to.
[Cross-posted from the Genomics Law Report blog]
By John Conley
Over the last five or so years my law practice has focused increasingly on privacy law, both domestic and international. In hindsight, this was a predictable outcome: as an intellectual property lawyer, many of my clients do business on the Internet or are engaged in scientific research and development, with many of the latter in the health care area. These are the very kinds of people who need to worry about privacy—of their customers, users, patients, and subjects. As they started on focusing on privacy concerns, these clients turned to their IP lawyers for help, and my Robinson Bradshaw colleagues and I have tried to stay ahead of their needs.
As a consequence of my growing privacy practice, I am regularly called on to give overviews to other lawyers as well as non-lawyers in the scientific and business communities. I thought it might be useful to devote a GLR post to a privacy law summary targeted at readers who conduct medical and other scientific research. Privacy law is a transnational mess, so this will be a bit longer than I’d like—my apologies, and please don’t shoot the messenger—but I’ll try to cut through the legal jargon.
Sources of Modern Privacy Law Continue reading
By Gregory M. Lipper
On Thursday, the Eighth Circuit all but assured that major parts of the Affordable Care Act will return to the Supreme Court’s chopping block. This time the issue is whether an accommodation—enabling religious objectors to opt out of offering contraceptive coverage to their employees—itself violates the Religious Freedom Restoration Act (RFRA). The Eighth Circuit ruled for the plaintiffs in Sharpe Holdings, Inc. v. U.S. Department of Health and Human Services, along with a companion case brought by Dordt College. The court concluded that the accommodation substantially burdened plaintiffs’ religious exercise and that the accommodation was not the least-restrictive means of ensuring that the plaintiffs’ employees had contraceptive coverage.
The Eighth Circuit’s substantial-burden ruling is unprecedented. Indeed, the contraception coverage cases appear to be the first time that exempted entities have sued to prevent the government from implementing a religious exemption. Like the other nonprofit organizations challenging the contraception regulations, the plaintiffs in this case are not required to cover contraceptives. All they have to do is provide written notice (to either their plan administrator or the Department of Health and Human Services) that they object to providing contraceptive coverage and wish to opt out. Once they provide that notice, the government arranges for the plan administrator to arrange for contraceptive coverage—at no charge to either the plaintiffs or their employees.
The plaintiffs insist that by opting out of providing contraceptive coverage, they “indirectly provide, trigger, and facilitate that objectionable coverage through the … accommodation process.” Every other federal appeals court to have addressed these challenges—even courts as conservative as the Fifth Circuit—has rejected this argument. Indeed, the plaintiffs are being asked to do what they have already done voluntarily: state, in writing, that they object to providing contraceptive coverage to their employees. And it is the HHS regulations, not the plaintiffs’ written notice, that facilitates the provision of contraceptive coverage to plaintiffs’ employees.
[cross-posted at Prawfsblawg]
By Jessie Hill
In this second post on the certiorari petition in Whole Women’s Health v. Cole, I want to consider the likelihood that the Supreme Court will take this case, and if it does, what it is likely to do with it.
I think it’s a very good bet that the Supreme Court will decide to hear this case this Term, perhaps in conjunction with one of the other cases that deals with admitting privileges laws – either Currier v. Jackson Women’s Health Organization, another admitting privileges case, in which the Fifth Circuit actually enjoined an admitting-privileges requirement that would have shut down the last remaining abortion clinic in Mississippi, or Planned Parenthood v. Van Hollen, in which the Seventh Circuit enjoined an admitting-privileges law. However, both of those cases are still at the preliminary-injunction stage, unlike Whole Women’s Health, which was rushed to trial on an expedited schedule. Still, SCOTUS has been holding onto the petition in Jackson Women’s Health Organization since the spring and may well decide to consolidate it with Whole Women’s Health. (No petition has yet been filed in Van Hollen, as that case is back in front of the district court and scheduled for trial.)
There are a lot of reasons for the Court to grant cert in at least one of these cases.