By Christine Baugh
Between 2009 and 2014 all U.S. States and the District of Columbia implemented concussion legislation. Generally modeled after Washington State’s Zachery Lystedt Law, most of these statutes require that youth and adolescent athletes are provided with information about concussions prior to sports participation, that they are removed from play if they are suspected of having sustained a concussion, and that they receive clearance from a medical professional prior to returning to sports participation. One of the main purposes of the Zachery Lystedt Law, and presumably those laws modeled after it, is to prevent the catastrophic neurological injury that can occur when a youth athlete returns to play too quickly following a concussion.
Gibson and colleagues recently published their study “Analyzing the effect of state legislation on health care utilization for children with concussion,” in JAMA Pediatrics. This study compared concussion care utilization for adolescents age 12 to 18 in states with and without concussion legislation using an insurance claims database. After controlling for potentially confounding factors such as median income and number of insured individuals per state, Gibson et al. found that states that had implemented concussion legislation had increased concussion care utilization (92% increase) compared to those without legislation (75% increase). The increases in care utilization were driven primarily by increases in visits to the doctor’s office and to a neurologist, not through increases in emergency department care, which the authors described as encouraging.
By Ameet Sarpatwari and Aaron S. Kesselheim
The Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital Department of Medicine and Harvard Medical School invites its 2015 round of applications for postdoctoral fellows in pharmaceutical law and health services research. Current fellows have studied FDA regulation, patents and drug access and costs, and competition in the therapeutic marketplace. Other areas of focus include intellectual property, ethics, and comparative effectiveness, as well as the development, approval, and evidence-based use of drugs, devices, vaccines, procedures, and diagnostics.
Applications are invited from researchers with doctoral degrees (J.D., M.D., Ph.D., Pharm.D., or equivalent) or who will complete such training by July 2015. Fellows will have an appointment at Harvard Medical School, receive close mentorship from faculty members in the Division, and engage in one or more projects intended to start their careers in law and public health research. Fellowship length will vary depending on the candidate (min: 1 year).
The deadline is February 20, 2015. To apply, please send to firstname.lastname@example.org: (1) a CV, (2) a writing sample, and (3) a cover letter describing your past work, ideas for the kind of research you’d like to do in the fellowship, and career goals.
The FDA’s public workshop on their draft guidance framework for the regulation of laboratory-developed tests (LDTs) continued yesterday, featuring sessions on three additional issues: 1) notification and adverse event reporting, 2) public procedures for classification and prioritization, and 3) quality system regulation.
Many issues that had been raised during Thursday’s sessions reappeared in the context of these new subjects. Commenters considered whether and when laboratories should be able to submit one (rather than many) LDT notifications and/or registrations, the relationship between clinical use and risk classification, and the need to be sensitive to the diversity of LDTs and their providers in formulating the final guidelines. Other, more legal aspects were also raised again, including concerns about redundancy between FDA regulations and those already promulgated by the Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendments, whether the FDA possesses the legal authority to regulate most LDTs, and whether the FDA is required to proceed by notice-and-comment rulemaking rather than acting through the guidance process. (Litigation is almost certain to arise on these last two topics, about which I’ll have more to say in future posts.)
But I want to briefly highlight one theme that cropped up on both days more frequently than I had anticipated: the role of insurers and insurance reimbursement. Panelists considered whether insurers or other payers should have a seat at the table when advisory committees are convened to classify and prioritize LDTs for review. They discussed the effect of FDA approval on insurance coverage, debating whether the proposed regulations would increase or decrease access to FDA-approved LDTs. But most importantly (at least in my view), they explicitly considered the way in which increased FDA regulation would combine with decreasing insurance reimbursement to decrease incentives for innovation in diagnostic testing.
Happy New Year! Check out the January 9th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.
Featured in this edition:
Outbreak: Developing New Medical Products for Epidemics, A lecture by Peter Hutt Thursday, January 15, 2015, 12:30 PM Hauser Hall 102, 1575 Massachusetts Avenue, Cambridge, MA
The recent outbreak of Ebola has called attention to the substantial difficulties associated with developing and testing new products for time-sensitive epidemics. What are the legal, ethical, and economic barriers to getting essential treatments and preventative measures from the lab into the hands of patients – and how can they be overcome?
Please join the Petrie-Flom Center for a discussion of these issues by Peter Barton Hutt, Partner at Covington & Burling, LLP, and Lecturer on Law at HLS. Rachel Sachs, Petrie-Flom Center Academic Fellow, will respond.
For more on news and events at Petrie-Flom, see the full newsletter.
Over the past several months, I’ve been blogging (here, here, and here) about the FDA’s recent forays into regulating laboratory-developed tests (LDTs). Since the release of the draft guidance framework in October, serious arguments have been made on opposing sides of the issue, and industry groups have made additional moves in opposition to the proposed regulation. And now, today (and tomorrow), the FDA is holding a public workshop on their draft guidance framework, focusing on a wide range of issues.
Today’s workshop featured sessions on three main issues: 1) labeling considerations, 2) clinical validity and intended use, and 3) categories for continued enforcement discretion. Many commenters simply presented the unique concerns of their organization and urged the FDA to consider them in finalizing the guidelines, which was helpful when it did seem as if the draft guidance may have insufficiently considered the needs of a particular set of laboratories, such as public health laboratories that focus on testing for infectious diseases like Ebola and chikungunya (about which I’ve also blogged, here and here).
More helpful, though (at least in my view), were the comments of those who sought to provide concrete recommendations for the FDA on the basis of 1) the policy concerns they saw underlying the guidance and 2) the practical effects of implementation that they foresaw. I’ll illustrate with an example, which hopefully will display the complexity inherent in even the simplest questions that the FDA must answer here.
By Emily Largent
Generally speaking, law school goes more smoothly when the law student is caffeinated. Consider that Justice Elena Kagan was known at Harvard Law School as the “coffee dean” for instituting free coffee for students (and, as an aside, expects to be known as the “frozen yogurt justice” for bringing frozen yogurt to the SCOTUS cafeteria).
Last year, the deaths of Logan Stiner and James Wade Sweatt drew attention to another place where caffeine intersects with the law: the regulation (or lack thereof) of powdered caffeine by the FDA. Both men died after ingesting powdered caffeine. One teaspoon of powdered pure caffeine is roughly equivalent to 25 cups of coffee. Manufacturers encourage consumers to take between 1/16 and 1/64 teaspoon (see, e.g., here), though measuring such minute amounts with common kitchen tools may be impossible. On it’s blog, FDA observes that the people most drawn to powdered pure caffeine are “children, teenagers, and young adults.” It is not clear how common it is for individuals to overdose on caffeine powder, as the cause of death may be listed as “heart attack” in many cases.
By David Orentlicher
[Cross-posted at Health Law Profs.]
With Harvard professors protesting their increased responsibility for health care costs, we are seeing just the most visible aspect of the recurring cycle described in “Tragic Choices.” As Guido Calabresi and Philip Bobbitt observed in that book, society tries to defuse societal conflict by hiding its rationing choices through implicit forms of rationing. Thus, for example, health care insurers relied on managed care organizations in the 1990’s to contain health care costs with the premise that managed care would preserve health care access and quality while squeezing the fat out of the health care system.
But after a time, the public realizes what’s going on and rebels against the implicit rationing policy. Hence, managed care’s effective cost containment strategies, such as limited networks of physicians or primary care gatekeeping, were dumped, and health care costs began to climb again.
What did health care insurers turn to after abandoning serious managed care? Shifting more of the costs of health care to patients through higher deductibles and higher copayments. Insurers didn’t need to identify limits on their coverage because individuals would respond to their higher out-of-pocket costs by hesitating to seek care. Costs would be contained by “market forces” rather than rationing. But the Harvard professors and other Americans are now rebelling against the shifting-of-costs policy, just as Calabresi and Bobbitt predicted in 1978. (Indeed, they even included the shifting of costs as an example of an implicit rationing strategy.) Continue reading
Actavis is back in the spotlight regarding its allegedly anticompetitive behavior. Last month, the U.S. District Court for the Southern District of New York issued an injunction against Actavis and its subsidiary, Forest Laboratories LLC based on the New York Attorney General’s “product hopping” suit.
The suit concerns Actavis’ attempt to extend monopoly protection for its drug Namenda. Namenda is one of only a few FDA approved drugs to treat Alzheimer’s disease, and the only approved drug in a class of medications that act on the glutamatergic system by blocking NMDA receptors. Namenda is also Actavis’ largest revenue generating drug; it brought in $1.5 billion in sales last year. Unfortunately for Actavis, Namenda’s patent protection is due to expire in 2015. Once the patent protection for Namenda has expired, Actavis should ordinarily expect to see a dramatic reduction in sales revenue, as much as 90% in the first year, as consumers switch to a lower-cost generic version.
Physician and bioethicist Carla C. Keirns described the potentially dangerous impact of medicalization on her own childbirth in the Narrative Matters section of Health Affairs this month. A segment of that writing was reproduced in the Washington Post yesterday.
In each piece, Keirns outlines the challenges she faced in vaginally delivering her son in a hospital environment that seemed committed to performing a caesarian section. Particularly given Keirns’ expertise in and familiarity with health care, the lack of patient-centered care in the story is striking. Several staff suggested that surgery was a foregone conclusion while others appeared unprepared for her son’s long-awaited arrival.
By Ameet Sarpatwari and Aaron S. Kesselheim
Each month, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital/Harvard Medical School reviews the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.
Below are the abstracts/summaries for papers identified from December. The selections feature topics ranging from access to clinical trials data, to pharmacy-based interventions to reduce primary medication non-adherence, to the impact of out-of-pocket spending caps on the non-elderly with private group health insurance. A full posting of abstracts/summaries of these articles may be found on our website.
- Bonini S, Eichler HG, Wathion N, Rasi G. Transparency and the European Medicines Agency—sharing of clinical trial data. N Engl J Med. 2014 Dec 25;371(26):2452-2455.
- Fischer MA, Choudhry NK, Bykov K, Brill G, Bopp G, Wurst AM, Shrank WH. Pharmacy-based interventions to reduce primary medication nonadherence to cardiovascular medications. Med Care. 2014 Dec;52(12):1050-1054.
by Martín Hevia
In 2015, the Argentine Supreme Court is to hear a case involving the right to die, death with dignity, and informed consent. Because of a car accident in the Province of Neuquén, M.D., the patient, has been in a permanent, irreversible, vegetative state for 18 years. His sisters and curators have requested the discontinuation of the vital supportive measures which maintained M.D alive in an artificial way.
This will not be the first time that the Supreme Court hears a case of death with dignity. In 2012, the Court heard the case of Albarracini Nieves, who was unconscious when admitted to a hospital in Buenos Aires. The physicians established that a blood transfusion was necessary. But, as Albarracini belonged to the cult “Jehovah’s Witnesses”, he had had made a statement before a public notary in 2008 where he expressed he would not accept any blood transfusions even if his life were in danger. His father requested a cautionary measure that would order the transfusion to be practiced. The first instance court admitted the solicited measure, considering that although Albarracini had expressed that he refused an eventual transfusion, he was not “in a condition to make decisions with full discernment.”The case then reached the Supreme Court, which argued that there were no reasons to doubt over the current validity of Albarracini’s expression of will and that there was no evidence that he would not have considered the significance of his decision.The Court argued that “…this Court has clearly established that Article 19 of the National Constitution grants the sphere of freedom, within which he can freely adopt fundamental decisions about himself without any State or third parties interference, as long as those decisions do not violate third parties’ rights.”The Court stated that“The possibility of accepting or refusing a specific treatment, or selecting an alternative form of treatment, is part of self-determination and personal autonomy; that patients have the right to choose options according to their own values or points of view, even when they may seem irrational or imprudent, and that free choice must be respected.”
The M.D. case is different in that it is difficult to prove the patient’s will – unlike in the Albarracini Nieves case – because there is not a patient’s written statement on whether it is appropriate for him to continue or not certain medical treatment to keep him alive. The Superior Court of Justice of the Province of Neuquén has decided on the case invoking the 2009 Patients´ Rights Act: according to this law, the sisters have standing to grant informed consent in the name of their brother.
The Supreme Court and Argentine lower courts have interpreted the National Constitution and concluded that it grants patients a wide range of autonomous choice as regards their autonomy, reflected in their right to refuse medical treatment. On that basis, the Supreme Court will probably confirm the decision of the lower court.
By Nicolas Terry
Health reform may have signaled the shift from hospital-based “sick” care to primary care and “wellness” but the ACA failed to provide a detailed roadmap. All we know for sure is that primary care (PC) will be hugely important. Increasingly it also seems that it will look quite different. “Old” PC is being battered; Medicaid primary care physicians (PCP) saw their the two-year ACA bonuses expire in December, the OIG just reported that way too many Medicaid-listed doctors are not taking new patients, and the coverage-doesn’t-equal-access mantra is born out by persistent reports of PCP shortages. If PC as we have known it is not going to step up to the plate, what is the “new” model and who will end up owning it?
The ACA gave hospitals both good (fewer uninsureds in ERs, Medicaid expansion) and bad news (fewer profitably occupied beds because of HAC and readmission penalties). Not surprisingly there was a sharp increase in hospitals buying PCP practices. In part this was just hospitals following the money as usual, looking to roll these practices into their new ACOs. But, longer term strategies also persisted, such as strengthening networks, intercepting patients before they turn up in ERs, and creating local or regional dominant positions. Smaller PCP practices have also been more willing to sell as they faced financial regulatory disincentives (such as meaningful use penalties) if they continued as independents.
However, we are seeing hospitals doing more than increasing the number of hospital-based clinics. Many are also opening their own free-standing urgent care clinics, the “new” PC. There are several models, including full ownership as with the Intermountain Healthcare group or, perhaps for those late to the game, strategic partnerships with urgent care specialists like Premier Health or MedSpring. Continue reading
By Deborah Cho
We’ve come a long way in the area of mental health over the past several years. Notably, the Mental Health Parity and Addiction Equity Act of 2008 did great work to place mental health on more equal footing with physical health in the health insurance arena. Still, there is much work to be done to raise awareness and decrease stigma so that treatment is sought appropriately.
A few weeks ago, I was speaking with a physician about some of the difficulties in addressing mental health with his patients. He expressed disappointment at a recent conversation he had with a patient who refused to take his psychiatric medications. As the physician recounted the story to me, he was frustrated with his patient’s misconception that “successful people don’t have mental health problems.” Even worse, that misconception seemed to imply that in order to be successful, when one does have a mental health issue it is better to suffer through it than it is to seek help. At the time, hearing this story was particularly upsetting for me as a law student because I felt that we were receiving and even propagating a similar message during a rather remarkable final examinations period.
A couple weeks ago the Financial Times ran a book review (behind a pay wall) by Mark Vandevelde of Cass Sunstein’s “Valuing Life: Humanizing the Regulatory State” (linked here). The book review carries the tagline “Beware the paternalist in libertarian garb.” I happen to have read the book and, since the Financial Times beat me to the job of reviewing, I thought I would use the holiday lull to review the review.
In short, for reasons I explain in perhaps too much detail below, the review misses the mark in a way foreshadowed by the tagline. The review takes issue with Sunstein the libertarian paternalist, the Sunstein who advocated a class of choice-respecting regulations in his book “Nudge.” But “Valuing Life” is not “Nudge”; it is about the nitty-gritty of how we quantify the costs and benefits of all sorts of regulations, not the desirability of any particular sort of regulation (or even regulation in general). On the latter topic Sunstein has much to say in his book, Vandevelde’s review not so much.
by Zachary Shapiro
This is the first post of two that will discuss the use of neuroimaging in the courts. The first piece will talk about a few promising avenues of future research, while the second piece will discuss some of the pitfalls.
Mapping the brain is the next great frontier for scientific research. The recent decision by President Obama to initiate the Brain Activity Map, directing federal funding to a project with the aim of creating a working “map” of the human brain, highlights how our understanding of the brain will increase in the coming years. As our understanding of the brain increases, many institutions will face difficult questions about how such understanding should change long held practices. An excellent example of an institution that has been, and will continue to be, shaped by advances in neuroimaging is the American criminal justice system.
Neuroimaging initially was deployed as a way to detect anatomical abnormalities, such as tumors and strokes, in the brain. The rise of functional neuroimaging, using modalities such as fMRI, PET Scans, and EEGs, has allowed scientists to begin to picture how the brain works in real time. As the field advances, neuroimaging is finding applications in areas that seem to be totally separate from medicine.
Neuroimaging has already made its way into the courtroom, and theoretical and immediate uses abound, especially for criminal law. Criminal law traditionally focuses on the mens rea, or guilty mind, of the defendant. Theoretically, neuroimaging could help us understand the complex neurological pathways that produce certain behaviors, while determining what factors are at play in a given “guilty mind.”
By Alex Stein
Cefaratti v. Aranow, — A.3d —- (Conn.App. 2014) is a textbook decision on the “continuous act” exceptions to the statute of repose. This decision of the Connecticut Appeals Court draws an important – but oft-missed – distinction between “continuous wrong” and “continuous treatment.”
Back in 2003, the plaintiff underwent open gastric bypass surgery in an attempt to cure her morbid obesity. Her follow-up treatment and monitoring took place between 2004 and the summer of 2009. All these procedures have been carried out by the same surgeon, the defendant, at a hospital in which he had attending privileges as an independent contractor.
The plaintiff testified at her deposition that on each of her post-operative visits, she told the defendant that she was experiencing abdominal pain. In August 2009, after being diagnosed with breast cancer by another physician, the plaintiff had a CT scan of her chest, abdomen, and pelvis, which revealed the presence of a foreign object in her abdominal cavity. This object was a surgical sponge that the defendant negligently left when he operated the plaintiff in 2003. Following that discovery, the plaintiff filed a malpractice suit against the defendant. Continue reading
By Nicolas Terry
The “Cromnibus” spending bill signed by the President on December 16 rightly upset Senator Warren and not just for providing luxury cars to a feckless Congress. However, in general the bill ignored healthcare. There was no new money for those ACA “villains” CMS and IRS and only a little more for NIH (resulting in net reductions all around given inflation). Of course constituencies have to be pandered to, so there was a symbolic $10 million cut from the moribund IPAB. Meanwhile, the CDC did well, HRSA picked up a few telemedicine dollars, but ONC didn’t get everything it wanted. However, look closer and it seems that during the convoluted legislative process someone threw a meaty wrench into the gears of an already flailing meaningful use program.
As I have discussed at length here and here the meaningful use subsidy program for EHRs may have delivered hundreds of thousands of mediocre electronic health records systems into provider offices but has failed to deliver effective data sharing. ONC knows this is an issue, is aware of and discussed the JASON report, has its own “10-year vision” and emphasizes interoperability in its recently released Health IT Strategic Plan (Disclosure: I serve on the HIT Committee Consumer Workgroup, but these views are mine alone). But, some kind of showdown has been brewing for a while. Have the HITECH billions been wasted? Was the regulatory problem in meaningful use or in certification? Are the HIT developers to blame or health care providers? (Answer: Yes). And, the AMA being “appalled” aside, what happens now that the meaningful use carrots have begun morphing into sticks? Continue reading