New Resource: BPCIA Legislative History Documents

The Petrie-Flom Center is pleased to announce the availability of a new resource on its website: the legislative history of the Biologics Price Competition and Innovation Act (BPCIA).  The BPCIA, passed as part of the Affordable Care Act (ACA), created a pathway for the approval of biosimilar products and awarded innovator biologic companies twelve years of exclusivity for their products.  Modeled after the Hatch-Waxman Act of 1984, which established our system of generic small-molecule drug approvals while simultaneously creating a five-year period of exclusivity for new drugs, consideration of the BPCIA’s history is often lost in the discussion over the ACA’s history as a whole.  This resource selects only those documents relating to the BPCIA and may thus prove particularly useful for scholars of FDA law.

This new resource comes at an opportune time, as the courts and Congress have both turned their focus to the provisions of the BPCIA.  In 2015, the Federal Circuit issued a divided opinion interpreting the BPCIA’s instructions to biosimilar and innovator drug sponsors, and that opinion has now been appealed to the Supreme Court.  Just last month, the Justices called for the views of the Solicitor General on this question, a step which may significantly increase the likelihood of an eventual cert grant.  At the same time, several members of Congress have introduced a bill that would decrease the BPCIA’s grant of exclusivity from twelve years to seven years, bringing it more in line with the five-year period in the Hatch-Waxman Act or seven-year period in the Orphan Drug Act.  The twelve-year period of exclusivity may have been the most contentious aspect of the BPCIA as passed, with even the FTC arguing strongly against such a lengthy period at the time.

Members of the public may also be interested in an article written by Professor Erika Lietzan and colleagues providing an excellent analysis of the BPCIA’s legislative history.

National Academies Report Recommends Withdrawing the NPRM and Calls for a New Belmont Report

[Crossposted from Ampersand – The PRIM&R Blog]

By Elisa A. Hurley

On June 29, the National Academies of Science, Medicine, and Engineering released Part 2 of their report, Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century. The report, written by the Committee on Federal Research Regulations and Reporting Requirements in response to a Congressional request, examines the impact of regulations and policies governing federally funded academic research in the United States. Part 1, released in September 2015, concluded that the continued expansion of federal regulations is “diminishing the effectiveness of the U.S. research enterprise, and lowering the return on federal investment in basic and applied research by diverting investigators’ time and institutional resources away from research and toward administrative and compliance matters” (xii). It made specific recommendations to reduce regulatory burden, and also recommended the creation of a “public-private Research Policy Board to streamline research policies.”

Part 2 concludes the analysis of regulations governing federally funded research and includes, in Chapter 9, a critical examination of the ethical, legal, and regulatory framework for human subjects research. The chapter begins by acknowledging that the research landscape has changed dramatically since the publication nearly 40 years ago of the Belmont Report, which established the three basic principles that provide the ethical foundation for the conduct of human subjects research in the United States. Changes in research methodologies and technologies, including comparative effectiveness research, research on de-identified biospecimens, observational studies of large datasets, cluster randomized trials, and research in emergency settings—as well as longstanding questions about the applicability to social and behavioral research of rules written for the biomedical research context—raise challenging questions about how to apply and balance the Belmont principles of respect for persons, beneficence, and justice across much of today’s research enterprise. Continue reading

Tort Reform in Oregon: Constitutional, After All?

By Alex Stein

Three years ago, Oregon’s Supreme Court voided the state’s $500,000 cap on noneconomic damages for medical malpractice for violating the constitutional guarantee that “In all civil cases the right of Trial by Jury shall remain inviolate” (Or. Const., Art. I, § 17, as interpreted in Lakin v. Senco Products, Inc., 987 P.2d 463, modified, 987 P.2d 476 (Or. 1999)). Klutschkowski v. Oregon Medical Group, 311 P.3d 461 (Or. 2013). This cap also clashed with “every man’s” right to “remedy by due course of law for injury done him in his person, property, or reputation” (Or. Const., Art. I, § 10, as interpreted in Smothers v. Gresham Transfer, Inc., 23 P.3d 333 (Or. 2001), and in Hughes v. PeaceHealth, 178 P.3d 225 (Or. 2008)). The Court reasoned that a person’s right to recover full jury-assessed compensation for injuries recognized as actionable in 1857, when Oregon adopted its constitution, cannot be abolished or abridged by statute or common law. For my discussion of the Klutschowski decision, see here. For my discussion of a similar entrenchment principle adopted by the Utah Supreme Court in Smith v. United States, 356 P.3d 1249 (Utah 2015), see here.

The Oregon Supreme Court has now changed this course in a long precedential decision, Horton v. Oregon Health and Science University, — P.3d —- 359 Or. 168 (Or. 2016). Continue reading

Mehrsa Baradaran on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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Listen here!

Our guest this week is Mehrsa Baradaran, J. Alton Hosch Associate Professor of Law at the University of Georgia. Author of the acclaimed book How the Other Half Banks, Baradaran described the increasingly difficult financial landscape for poorer Americans. We discussed the impact of inequality and financial exclusion on many aspects of health care finance, including providers’ collections policies, hospital-as-lender models, and high-deductible health plans. Baradaran offers many important insights on how new financial realities affect both monetary flows and consumer protection in health care.

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 Radio, Tunein 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

Trial by Fire: CRISPR takes the next step

CRISPR-Cas9 has drawn applause for being one of the biggest technological advancements in recent history, but it also raises important ethical issues. This technology, an efficient genome editing tool, is now taking its next big step: CRISPR might be going in for human trials for its potential use in fighting cancer (namely, by altering T-cells to treat cancer cells as “foreign bodies”). Trials have been proposed to be conducted at three sites over a period of two years. The Recombinant DNA Advisory Committee (RAC) at the NIH gave its unanimous approval for these trials earlier this week. Now permissions from FDA and Institutional Review Boards remain before this becomes a reality.

Whether or not the studies will get that approval is uncertain. The RAC already expressed concerns about conflict of interest, and the ghosts of the trial involving Jesse Gelsinger 17 years ago at UPenn have resurfaced.  There are also important questions about risks, uncertainty, and informed consent from the research participants.

The scientific community and regulators have been wary of the gravity of the implications of genome editing. When a Chinese study involving gene editing in human embryos was submitted for publication, there was a hue and cry over whether journals should accept it, given ethical concerns. Currently, there is a moratorium on altering DNA that will subsequently pass on to new generations. Even when the CRISPR technology was approved for editing human embryos in the UK, it was mandated that embryos be destroyed within fourteen days.

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The Reproductive Rights Case the Supreme Court Decided *Not* to Decide

By Dov Fox

The landmark abortion decision in Whole Woman’s Health v. Hellerstedt eclipsed quieter reproductive rights news out of the Supreme Court at the end of its term. It involves a couple’s claim that the Tennessee Supreme Court violated their equal protection rights by refusing to recognize “disruption of family planning as either an independent cause of action or element of damages.” You won’t have heard about this case. It wasn’t a merits judgment, but a decision not to decide. The Court’s denial of certiorari in Rye v. Women’s Care Center of Memphis has gone all but unremarked. It shouldn’t. This post lays out the arguments and why the Court (most likely) declined to hear it on appeal (without explaining its decision, as standard for cert denials). My updated article out in next year’s Columbia Law Review elaborates on the significance of professional wrongdoing that imposes, deprives, and confounds procreation in the face of people’s best efforts to plan a family.

The dispute arose during Michelle Rye’s third pregnancy. Rye has Rh negative blood, meaning that she produces antibodies that attack the blood cells of a Rh-positive fetus, potentially leading to serious harm in a born child. Doctors nowadays easily prevent this Rh-sensitization by injecting the pregnant woman with a compound called RhoGAM. But Rye’s doctor didn’t give her that injection. Now the couple couldn’t have more children of their own without risking serious health problems. Their Catholic faith took fetal testing and abortion off the table. They couldn’t even use birth control to prevent a risky pregnancy. Rye and her husband sued the doctor (who admitted negligence) for disrupting their family plans. Tennessee courts, all the way up to the state’s Supreme Court, rejected their claim. The courts held that the couple had not suffered the kind of injury that would support a legal cause of action. The Ryes’ petition to the U.S Supreme Court argued that the state Court’s refusal to recognize their claim denied them equal protection under the law. Continue reading

Whole Woman’s Health – Some preliminary thoughts on benefits, purposes, and fetal status

The Supreme Court’s decision in Whole Woman’s Health is sure to be dissected in the coming days, weeks, and months.  In the meantime, I wanted to quickly reengage the discussion about the status of the “purpose prong” of Casey and what, if anything, Whole Woman’s Health tells us about it.  While Justice Breyer’s analysis in the majority opinion does not seem to be couched expressly in terms of Casey’s purpose prong, the majority’s willingness to assess the applicable laws’ benefits may ultimately be purpose dressed in different clothing.  If there is not sufficient evidence of a law’s benefit, there could be a problem.

As a quick refresher, recall that Casey prohibits laws that have either the purpose or effect of placing a substantial obstacle in the path of a woman seeking an abortion of a nonviable fetus.  While most folks can readily associate Casey’s “undue burden” test in terms of abortion restrictions that have the effect of placing obstacles, Priscilla Smith and Caitlin Borgmann, have written about courts seemingly ignoring Casey’s other mandate that laws should not have the purpose of even trying to place such obstacles (regardless of whether they succeed in creating that effect).  This avoidance of the purpose prong coupled with great deference to the asserted justifications of the legislature (without the kind of benefits inquiry seen in Whole Woman’s Health) has historically led to many TRAP (targeted regulation of abortion provider) laws being upheld.

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The AMA Should Forget the Dickey Amendment — For Now

By Shailin Thomas

gunRecently, the American Medical Association (“AMA”) passed an emergency resolution at its annual conference declaring gun violence a public health crisis and calling for both restrictions on access to firearms and increased research into gun-related violence. In its announcement, the AMA noted that it plans to “actively lobby Congress to overturn legislation that for 20 years has prohibited the Centers for Disease Control and Prevention (CDC) from researching gun violence.”

The AMA’s decision to publicly take a strong stance on gun violence could have a substantive impact on the national conversation. The group represents one of the most powerful voices in health care policy. According to the Sunlight Foundation, the AMA is a “political powerhouse,” raising $1.3 million through its PAC during the 2014 election cycle and spending almost $22 million on lobbying in 2015 alone. To put that in perspective, the National Rifle Association — the nation’s foremost gun rights organization — spent $3.6 million on lobbying that year. Admittedly, the AMA — unlike the NRA — is a multi-issue organization, and it remains to be seen whether it will throw its financial heft behind this new position, but the fact that there is a powerful new party at the table has made some hopeful that members of Congress will start to think more seriously about finding ways to reduce gun violence. Continue reading

Whole Women’s Health, First Take: On the Major Victories and On Technocratic vs. Kulturkampf Approaches to Abortion Litigation at the Supreme Court

I have just made my way through all 107 pages of Whole Women’s Health v. Hellerstedt,  the Supreme Court’s decision this morning to invalidate Texas’ H.B. 2 admitting privileges and surgical center regulations as undue burdens on the abortion right. Full disclosure I filed an amicus brief arguing for this result.  The case was 5-3 with Justices Thomas, Alito, and Chief Justice Roberts in dissent.  I am sure I’ll have a lot more to say after I’ve read through the opinion 3 or 4 more times. Here’s what’s clear to me though even on a quick read.

First, this is a major victory for opponents of Targeted Regulation of Abortion Provider (TRAP) laws. Armed with this opinion they will have a much easier time in the lower courts challenging such laws. Among other things,  (1) the Court signals much less deference to legislatures than in Gonzales and prior cases (see p. 21 of Opinion); (2) the Court instructs that “The rule announced in Casey, however, requires that courts consider the burdens a law imposes on abortion access together with the benefits” conferred (p. 19) ; (3) the Court clarifies the “large fraction” language from Casey as to what is an undue burden in a way favorable to opponents of these regulations. Let me quote the majority here:

Casey used the language “large fraction” to refer to “a large fraction of cases in which [the provision at issue] is relevant,” a class narrower than “all women,” “pregnant women,” or even “the class of women seeking abortions identified by the State.” 505 U. S., at 894–895 (opinion of the Court) (emphasis added). Here, as in Casey, the rele- vant denominator is “those [women] for whom [the provi- sion] is an actual rather than an irrelevant restriction.” Id., at 895. (p.39)

Contrast that with Justice Alito’s long discussion in his dissent as to his understanding (with the pizzaz that shows why he is such a good writer) in a footnote:

The Court, by contrast, applies the “large fraction” standard without even acknowledging the open question. Ante, at 39. In a similar vein, it holds that the fraction’s “relevant denominator is ‘those [women] for whom [the provision] is an actual rather than an irrelevant re­ striction.’ ” Ibid. (quoting Casey, 505 U. S., at 895). I must confess that I do not understand this holding. The purpose of the large-fraction analysis, presumably, is to compare the number of women actually burdened with the number potentially burdened. Under the Court’s holding, we are supposed to use the same figure (women actually burdened) as both the numerator and the denominator. By my math, that fraction is always “1,” which is pretty large as fractions go.

Second, it is remarkable how differently these sets of opinions read from, let’s say, the gay marriage cases or even Gonzales v. Carhart. All the opinions, except perhaps Justice Ginsburg’s very short concurrence, are decidedly in the “technocratic” mode of writing as opposed to what we might call the “kulturkampf” mode that characterized much of Justice Scalia’s dissents on these kinds of issues. These opinion are written for lawyers not the public. I would have to do a proper count to be sure but it seems to me that something like 2/3 to 3/4 of the total pages of these set of opinions are devoted to issues that only lawyers will be able to engage in — res judicata/claim preclusion, severability, third-party standing, as-applied versus facial challenges, and the cogency of tiers of scrutiny.

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Introducing our 2016 Summer Student Bloggers

The Petrie-Flom Center is pleased to welcome Kelly Dhru and Shailin Thomas to Bill of Health as our 2016 Summer Student Bloggers!

Kelly Dhru - photo1 (2)Kelly Amal Dhru is an incoming LLM student at the Harvard Law School, and a 2016-17 Fulbright-Nehru Master’s Fellow in Public Health Law and Bioethics from India. Previously, Kelly has completed her BCL (Distinction) and MPhil in Law from University College, University of Oxford, where thesis focused on the gap between rights and duties in the context of laws preventing cruelty to animals. Kelly holds a law degree from Gujarat National Law University, and has been the Research Director at Research Foundation for Governance in India, where she has been involved in drafting laws relating to public health, bioethics and human rights. Kelly has been a research assistant for Public Health Law at King’s College London, taught the Law of Tort, Jurisprudence and Bioethics at the University of Oxford, and Ethics and Philosophy at Ahmedabad University in India. She is a co-founder and storywriter for Lawtoons: a comic series on laws and rights, and been involved spreading awareness about public health and human rights through the use of street theatre.

Thomas Shailin PhotoShailin Thomas is a second year law student in a joint MD/JD program between Harvard Law School and the New York University School of Medicine.  He received a B.S. from Yale University, where he studied cognitive neuroscience — exploring the anatomy and physiology underlying social phenomena.  His interests lie at the intersection of clinical medicine and the legal forces that shape it.  Prior to law school, Shailin worked on both the administrative and clinical sides of health care, and as a research associate at the Berkman Center for Internet & Society.  He is currently an affiliate of the Berkman Center and Outreach Editor for the Harvard Journal of Law & Technology.  A fervent proponent of privacy and freedom of expression, Shailin has also served on the Board of Directors of the American Civil Liberties Union of Connecticut.

Brexit: I woke up this morning and the world had changed

By John Tingle

I voted in the referendum yesterday along with many others. The referendum turnout was 71.8%, with more than 30 million people voting. It was the highest turnout in a UK-wide vote since the 1992 general election.

My area, Broxtowe in Nottingham where I live, voted to leave the EU, 54.6%, 35754 votes, remain 45.4% 29672 votes. I live in the East Midlands, Middle England. Deep regional divisions have been laid bare by this referendum. It was notable that London largely voted to stay in the EU whereas in my region there was a notable push to leave, 58.5%.The  referendum result shows British politics has, according to the Guardian newspaper, fractured beyond all recognition since the last referendum on Europe in 1975.

The issues around EU membership have been hotly debated and there was a high level of public interest in what went on. Immigration has been the dominant theme in many areas and health along with a number of other issues has also come up. At this moment we are in a post referendum, after shock stage and picking through the fallout to see what is happening and what is going to happen. People are happy, sad and anxious over the result.It was not that long after the vote was announced by the BBC that our Prime Minister David Cameron said he was going to stand down in October, that was a lot to take in so soon after the result. Looking at some of the posts on Facebook it is striking how many young people feel a sense of betrayal by the vote to leave the EU. Many seem to harbour a deep sense of resentment that they have been robbed of a future by an elder generation, it’s the baby boomers against the millennials. Continue reading

Deborah Lupton on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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Listen here!

This week our guest is Professor Deborah Lupton, one of the world’s leading digital sociologists. Her new book, The Quantified Selfis the basis of most of our discussion–and it has fascinating lessons for health care lawyers, providers, and patients.

Deborah joined the University of Canberra in early 2014 as a Centenary Research Professor associated with the News & Media Research Centre in the Faculty of Arts & Design. Her research and teaching is multidisciplinary, incorporating sociology, media and communication and cultural studies. Deborah has previously held academic appointments at the University of Sydney, Charles Sturt University and the University of Western Sydney.

Deborah is the author of 15 books and over 150 journal articles and book chapters on topics including the social and cultural dimensions of: medicine and public health; risk; the body; parenting cultures; digital sociology; food; obesity politics; and the emotions. She is an advocate of using social media for academic research and engagement, including Twitter (@DALupton) and her blog This Sociological Life.

Those interested in further exploring the social theory of digital selfhood may be interested in Frank’s piece, The Algorithmic SelfAnd for some forward-thinking reflections on new technologies of digital health, check out Nic’s recent post at Health Affairs on hearing aids and regualtory arbitrage.

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 Radio, Tunein 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

The Catch-22 of Bayh-Dole March-In Rights

Earlier today, the NIH rejected a request filed by consumer groups including Knowledge Ecology International (KEI) to exercise the government’s march-in rights on an expensive prostate cancer drug, Xtandi.  Xtandi costs upwards of $129,000 per year, and KEI had asked the government to exercise its rights under the Bayh-Dole Act, which specifies a range of conditions under which the government may require a patentholder to grant licenses on reasonable terms to others to practice the patent.  Specifically, 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).

For some time now, there has been debate over the question of whether high prices for pharmaceuticals are a sufficient trigger to invoke the use of march-in rights under these clauses of the statute.  I don’t take a position on that question here.  Instead, I want to ask whose responsibility it is to decide that question.  Congress has the legal right to do so, but it seems unwilling or unable to.  The agencies in question have recently declined to, even assuming they have the power to interpret the statute in that way.  And so we might look to the courts.  But there’s a puzzle here: it’s not clear that anyone can ask a court to decide whether high prices meet the statutory requirements unless an agency actually decides that high prices meet the statutory requirements.

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Implied Certification and Materiality Under the Civil False Claims Act

by Joan H. Krause

[Cross-posted from Hamilton and Griffin On Rights]

On June 17, the Supreme Court unanimously decided Universal Health Services v. United States ex rel. Escobar (UHS), holding that FCA cases may be predicated on “implied certifications” of compliance as long as the defendant knowingly violates a requirement it knows is material to the government’s payment determination. Because the First Circuit applied an incorrectly broad interpretation of materiality, however, the Justices nonetheless vacated the appellate judgment and remanded. While both parties quickly claimed victory, in reality the decision is likely to satisfy no one and to raise as many questions as it answers.

The case was filed by the parents of a young woman who died after receiving Medicaid-covered mental health treatment from a Massachusetts clinic that failed to satisfy state licensing and supervision regulations. Her parents alleged that the clinic’s MassHealth claims were fraudulent because, by filing for payment, the clinic had implicitly represented that it was in compliance with all relevant state requirements. A district court dismissed the suit but the First Circuit reversed, taking a very broad view of the scope of implied certification. On appeal, UHS asked the Court to reject the implied certification theory, arguing that a failure to disclose noncompliance should not be considered fraudulent in the absence of an affirmative duty to disclose. Respondents, supported by the United States as amicus curiae, countered that a defendant who knowingly bills the government for services without disclosing a failure to meet material conditions has submitted a false claim. While few observers expected the Court to entirely abolish implied certification, at oral argument the Justices appeared deeply divided as to the scope of the theory and the source of any limiting principle.

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Hearing Aids And The Sound Of Mobile Health Disruption

By Nicolas Terry

Business disruption, Christensen’s classic observation of disruptive technologies leveraged by market entrants attacking mainstream industry incumbents, has generally failed in health care. There are several reasons why innovative businesses harnessing modern technologies have found health care a difficult nut to crack. The most likely reason is that the misaligned incentives caused by third-party reimbursement discourage consumers from choosing new, lower-cost alternatives.

However, there are additional explanations. Sometimes the arcane, fragmented nature of health care proves to be a poor fit for technologies successfully implemented in other businesses. In other cases—think electronic health records—a lack of common data standards allows proprietary data formats to cause customer lock-in.

But, what is the impact of health care regulation? Beyond the traditional trope that regulation stifles innovation, how does health care regulation impact disruption? Recent developments in the markets for hearing aids suggest some answers and even a possible regulatory approach to the broader and burgeoning category of mobile health apps and wearables.…

Read the full post at the Health Affairs Blog!

Thoughtful CREATES Act May Help Speed Generic Drug Approvals

Earlier this week, a bipartisan group of Senators introduced the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, a bill designed to speed generic drug approvals (and thus lower drug costs) by removing a delaying tactic some branded drug companies use to impede the generic approval process.  Essentially, branded drug companies sometimes refuse to sell samples of their drugs to generic companies who want to come to market, preventing them (for at least a time) from performing the necessary bioequivalence testing and extending their market dominance.  Sometimes companies try to hide behind a regulatory program, Risk Evaluation or Mitigation Strategies (REMS), in claiming that they legally cannot provide such access.  Other times, such as in Martin Shkreli’s case, no such excuse exists and the company simply refuses to provide access.

These delaying tactics have received substantial attention from both scholars (Jordan Paradise’s work can be found here) and lawmakers.  This is Congress’ third attempt at addressing the situation, although as Ed Silverman helpfully notes at Pharmalot, the previous attempts would have only dealt with REMS delays, not Shkreli-like closed distribution systems.  By contrast, the CREATES Act would require brand-name companies to provide access to samples of their drugs, whether subject to a REMS or not, on “commercially reasonable, market-based terms” or face potential civil action from the generic drug company in question.  There’s already been a lot of commentary on the bill, including a particularly helpful blog post from Geoffrey Manne providing background on REMS abuses and on why antitrust law has not sufficed to solve the problem.  Here, I want to add two points that I haven’t yet seen in the discussion: one about drug shortages and another about remedies.

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California the latest to pass a Death with Dignity law, 5th in US

Medical personnel are trained to “first do no harm.” In end-of-life treatment, that simple directive can be difficult to interpret, and the legal landscape has evolved in the United States over the past 25 years. In 1990, the US Supreme Court ruled that physicians and other health care providers could withhold medical treatment at the direction of a patient or the patient’s directed agent.

Most recently, a movement to provide patients’ help in dying has been termed “death with dignity” and “assisted suicide.” Federal law does not currently address euthanasia or “mercy killings” in terminal patients who seek a physician’s aid to end their own suffering. Rather, the patient’s right to obtain a physician’s or other health care provider’s help to end their life is established by state law. Continue reading

Rachel Sachs on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week we spoke with Rachel E. Sachs, who will join the faculty of the Washington University in St. Louis School of Law in Fall 2016. Rachel earned her J.D. in 2013 magna cum laude from Harvard Law School, where she was the Articles Chair of the Harvard Law Review and a student fellow with both the Petrie-Flom Center and the John M. Olin Center for Law, Economics, and Business. Rachel has also earned a Master of Public Health from the Harvard School of Public Health. We focused on Rachel’s work on drug pricing and innovation for global health. As part of a broader academic agenda for developing access to knowledge, Rachel’s work illuminates the many trade-offs involved in optimizing innovation law. She has also illuminated the importance of “innovation beyond IP,” and the importance of legal synergies in accelerating or impeding innovation.

Listen here! 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 Radio, Tunein 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

General Medical Practice: Complaint Handling Issues

By John Tingle

There is a new report from Health Service Ombudsman (HSO) on GP (General Medical Practitioner) complaint handling and major failings are revealed. The HSO makes the final decisions on complaints that have not been resolved in England and lies at the apex of the NHS complaints system. The report reveals that some GP practices are failing to handle patient complaints properly. The report is based on evidence from HSO casework files and intelligence gathered by the Care Quality Commission (CQC) , NHS England and Healthwatch England. One hundred and thirty-seven closed complaint cases from November 2014 – November 2015 were analysed. General medical practice forms 90% of all NHS interactions with the general public.The quality of complaint handling by GPs was found to be highly variable:

“…over half of the cases were either good (46%) or outstanding (9%). However, over a third required improvement (36%) and a tenth were inadequate (10%) (p7).”

The report states that there are five areas where general practice has the most scope for improvement: Continue reading

Zika May Place Burden On Medicaid

Emma Sandoe, 2015-2016 Petrie-Flom Student Fellow

Full post at Health Affairs Blog.

Aedes_Mosquito_300x300Congress is currently debating the level of federal funding that should be made available to fight to reduce the spread of Zika. Administration officials working with local public health agencies on the ground have recently expressed fear that the funding levels are insufficient to prevent the disease from spreading. What is one overlooked concern? State budgets.

Medicaid is jointly funded by states and the federal government and serves as a key financer of health care services if Zika spreads across the country this summer. The Centers for Medicare and Medicaid Services (CMS) recently released a bulletin to state Medicaid Directors outlining how Medicaid funds can be used to both prevent the spread of Zika and treat people infected by the disease and infants born with microcephaly. With Medicaid covering roughly half of the births in America today, the program will finance many pregnancies potentially affected by Zika. […]

Read the full post at the Health Affairs Blog!