By Alex Stein
The Nevada Supreme Court has recently delivered an important decision that addresses the specificity requirement for affidavits of merit. Zohar v. Zbiegien, 334 P.3d 402 (Nev. 2014). Continue reading
The enormity of the tragedy in West Africa remains hard to appreciate even as Ebola begins to migrate into developed countries. In the U.S. mindless panic stoked by the 24 hour news cycle and fear-mongering politicians are not the only familiar phenomena. In important ways our “Ebola crisis” is only tangentially related to a malicious virus and has much more to do with the state of our health care system. Consider the following “Ebola issues”
Next week (on October 29) Medicare’s Office of Medicare Hearings and Appeals (OMHA) is holding another appellant forum to discuss the ongoing backlog of Medicare claims waiting for a hearing. In one sense, a lot has happened since the last forum in February (I covered that here): OMHA announced pilot projects to try statistical sampling and facilitated settlement in some cases (see here and here); CMS (effectively the “defendant” for settlement purposes in these appeals; functionally independent from OMHA) announced a willingness to settle a subset of pending inpatient hospital billing claims for 68 cents on the dollar (see Nick Bagley’s post at the incidental economist); the backlog came up at a couple congressional hearings; and two lawsuits were filed to challenge it, one by providers (see here) and another by beneficiaries (see here).
In another sense, not that much has happened. Unless Thursday’s forum brings big news—and I know that OMHA and CMS have been working hard on reforms so perhaps it will—there is still a big backlog of Medicare appeals, there is still not a resource fix in sight, and the influx of Medicare appeals seems to still far outstrip OMHA’s capacity to hold hearings.
In advance of the forum, I’m planning a series of posts offering my thoughts, such as they are, on where we are and where we are going. I invite anyone who disagrees or thinks I’ve gotten something wrong to post their own views in the comments. Or you can email me and I will look into sharing your thoughts as an independent posting. You can get all my posts on this subject, including new ones as they come in, by clicking here.
A caveat: I’m approaching these as blog posts—trying to get my educated thoughts based on everything I have read out in a timely way—but I might be missing something. If the upcoming forum or comments reveal that I am–I won’t be there in person but will be watching remotely–I will either post a general update or go add particular updates in the text of my posts as necessary.
And a disclosure: I’ve said this before but want to do it once more again before pontificating—I worked in government until a little over a year ago, so my views on these matters may be biased. (And of course I will not discuss anything I worked on.) But I’ve done my best to be objective.
Check out the October 17th 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.
By Kelsey Berry
The news media has been reporting on the role and means of one’s own death more frequently recently, buoyed along by manifestos (Ezekiel Emanuel’s “Why I Hope to Die at 75”, Brittany Maynard’s “Compassion and Choices” Campaign) that have caught the attention of a diverse audience. These declarations are perhaps more connected to one another than we may think.
Just last week on this blog, Lauren Taylor authored an excellent post on new public figure Brittany Maynard – the terminally ill 29-year old woman who relocated to Oregon for access to its death with dignity law, and to end her life with a prescription for a fatal medication. Maynard’s story seems to have struck a chord in part due to her youth. She is the youngest advocate currently featured on the website of Compassion and Choices, the largest organization advocating for end-of-life options in the US (the next youngest is 57 years old). She is also a well-educated, well-traveled, well-spoken individual, supported in her choices by her immediate family and physician. When Maynard states that the remainder of her life, if allowed to come to a natural end as a result of her cancer and without the help of medical intervention, will not be of value (and will actually be of great disvalue) to her, we are inclined to believe her evaluation – and perhaps even the normative implications that Maynard claims should follow.
Another public figure recently claimed that a particular part of life is not of (sufficient) value to him in order to keep living it, either. In September, Dr. Ezekiel Emanuel, director of the Clinical Bioethics Department at the U.S. National Institutes of Health and head of the Department of Medical Ethics & Health Policy at the University of Pennsylvania, published his essay “Why I Hope to Die at 75” in The Atlantic. The part of life he wishes to avoid? An old age marred by disability, functional loss, and relinquishment of the values and expectations of a younger individual. He proposes to adopt (for himself only) active rejection of life-sustaining and life-prolonging heath care, beginning at age 75. The effect? Ideally, death from infection untreated by antibiotics — it’s “quick and painless.” Continue reading
By Alexandra Gross
What does “access” really mean for the purposes of PPACA’s contraceptive coverage mandate?
For two years, I’ve been enrolled in Loyola University of Chicago’s Student Health Insurance Plan, provided through a Blue Cross Blue Shield Illinois (BCBSIL) PPO plan. During this time, I have had to pay out-of-pocket for my contraceptive method every month. As a student studying health law, I was aware of the ACA’s contraceptive coverage mandate, § 2713 of the Public Health Services Act, which requires non-grandfathered health insurance plans to provide access to a full range of Food and Drug Administration approved contraceptive methods without cost sharing. The contraceptive coverage mandate reflects Congress’ determination that “access to preventive services without cost sharing is necessary to achieve access to basic health care,” particularly for women, as they have unique health care needs. The contraceptive coverage mandate also states that plans and insurers may impose “reasonable medical management techniques” to control costs and promote efficient delivery of care. For example, plans may cover a generic drug without cost sharing, but impose cost sharing for the equivalent brand name drug. Even with the imposition of medical management techniques, I still could not figure out why every single woman I talked to who was on my plan had a copayment of twenty dollars or more a month.
My colleagues and I assumed our issues with contraceptives were a result of attending a religiously affiliated institution. We were wrong. Loyola has properly sought a religious exemption from providing contraceptive coverage and communicated to the students and employees that BCBSIL should be accommodating us directly, without Loyola’s involvement. However, in practice, the accommodation is failing the students and employees at Loyola University of Chicago. Continue reading
By Christine Baugh
The most recent issue of the Journal of Law Medicine and Ethics (generously made available for free by the American Society of Law Medicine and Ethics) included several articles examining state concussion laws. One theme that arose across the articles is that although concussion-related legislation is on the books in all 50 states and the District of Columbia, the extent to which it is creating an improvement in youth and adolescent athlete health outcomes is unclear.
In their article titled “State experiences implementing youth sports concussion laws: challenges, successes, and lessons for evaluating impact” Kerri McGowan Lowrey and Stephanie Morain interviewed stakeholders (e.g., officials at state departments of public health, state athletic associations) at a majority of states with concussion laws in order to understand how the laws had been implemented. Although previous research in the area (see, for example: Hosea Harvey’s piece in the American Journal of Public Health) presented concussion legislation as relatively homogenous, McGowan Lowrey and Morain’s approach provided critical insight. They found that while the state laws are relatively uniform in their construction, there is substantial variation in their implementation. In particular, McGowan Lowrey and Morain reported variation in compliance with the statutes, variation in how much stakeholders were included during formative stages in the legislation’s composition, and variation in what constituted concussion education.
In another article in the issue, my colleagues Emily Kroshus, Alexandra Bourlas, Kaitlyn Perry, and I specifically examined the concussion education and acknowledgement provisions of state concussion laws. This investigation was conducted in two parts: first we examined what the statute mandated and then we examined what the high school athletic association and/or department of education in that state actually provided for education. Similar to McGowan Lowrey and Morain, we found that implementation did not always match statute. In some promising cases the education provided exceeded the information minimally required by statute. In other situations, the concussion information was provided in such a way that it was required to be returned with a parent signature. In cases like this, compliance with one part of the statute (mandating acknowledgement of receipt of information) may have been compromising another (providing concussion education). Although the education and acknowledgement tenets were relatively similar across states, more heterogeneity was found in the implementation of these aspects of the statutes.
In general, these two studies suggest that the approach for examining statute, and particularly its efficacy, needs to be designed to address implementation stage information. Strict examination of the statutory language obscures critical implementation-level differences. These concussion-related statutes, enacted now in every state, are ostensibly supposed to reduce risk and improve athlete health outcomes. The extent to which they are reliably accomplishing this goal is unclear. What is clear is that implementation of the laws, and enforcement in cases where schools do not abide by statute, are necessary precursors to consistent efficacy. Although it is important that all states have taken steps toward protecting the health and safety of youth and adolescent athletes, approving a statute is not the final step toward this aim. Further research is needed to understand what health effects the current laws are having and critically where improvements can be made in this important area of public health law.
[This post reflects my own views only. It does not necessarily represent the views of the Petrie-Flom Center or the Football Players Health Study at Harvard University.]
Recent speculation about healthcare disruption seems to have moved away from HIT to mHealth (discussed here). Apple has fueled this trend with its launch of sensor-laden iPhones and the new Apple Watch, iOS 8’s Health app and the HealthKit API framework. The future, we are told, is in mHealth provided by our phones and wearables notwithstanding that we have yet to solve data protection and other issues associated with the new devices.
Over the last few days leaks have suggested that web behemoths Facebook and Google may have their own takes on the future of healthcare. Reuters reports that Facebook is doing, lets face it, what you would expect—creating online “support communities” for patients with similar conditions and diseases.and creating “preventative care” applications. Now, Engadget reports that Google is testing a new service that offers chats with doctors when a user searches for symptoms. The service seems related to Google Healthcare Helpouts, a video telemedicine platform that launched a year ago to some on-line speculation about healthcare disruption but which today seems limited to a small number of mostly non-physician therapists, family counsellors, coaches or other advisors.
By Lauren Taylor
29-year old Brittany Maynard has captured national headlines this week by publicly announcing her intention to end her own life on November 1st. She did so in an effort to raise funds for and awareness of the non-profit Compassion and Choices.
Maynard was diagnosed earlier this year with an aggressive brain cancer and has moved to Oregon for access to its death with dignity laws. Those laws have allowed her to be prescribed a fatal dose of medication by a physician to be taken at the time and place of her choosing. Maynard sees the prescription as a means of avoiding a potentially long, painful and de-humanizing decline in her health.
In light of Maynard’s case, virtually every major media outlet has featured a bit of medical ethics this week. Maynard’s own voice first appeared in People Magazine, announcing her intention to end her own life. Therein, Maynard is clear that she does not consider herself to be planning for suicide. Continue reading
My university has recently joined EdX and is offering four courses starting February 2015. I have had the privilege of being selected as one of the instructors. I, along with Alicia Pérez Blanco (a skillful intensive care physician, wonderful colleague and sharp bioethicist), will be teaching a course on the ethical and legal challenges of organ transplantation. This has been possible partly because both of us, at different moments, could benefit from the extraordinary resources and the intellectual environment of the Petrie Flom and the Division of Medical Ethics at Harvard, where I stayed during my sabbatical year in 2011-2012.
The course will be delivered in Spanish (we will vocalize with utmost care and speak very, very slowly, it will sound almost like English…) but we will provide exercises and reading materials in both languages. We will cover a lot of the hot topics (DCD, death determination, organs’ conscription, nudges in organ donation, opting-out, markets of organs, death penalty and organ donation, transplantation tourism, among others) and (hopefully) will have a lot of fun (in spite of the nature of the topic). We are very excited and, I have to confess, a bit anxious about the final result. For more information please visit the EdX official announcement.
By Zachary Shapiro
It seems like the debate over banning flights from West African Ebola stricken countries has become instantly political, with many Conservatives calling for a flight ban. See here. One author, in response to these calls, points to the history of Liberia’s relationship with the United States as a reason that the US should not consider a flight ban. Arguments against a flight ban that are not based on public health principles provide fodder for the talking heads and individuals who want to see this as a political issue.
The real question should be how much good a flight ban would do to halt the spread of Ebola to the United States. Many public health experts, from the CDC to the WHO, do not think a ban would make us safer.
Ebola is only contagious when the patient is symptomatic, and the first symptom is almost always a fever. If a patient does not have a fever, and is asymptomatic, they are not contagious. Thus they do not provide a serious risk of infecting other people, even in the confined quarters of an airplane. This makes temperature screening especially important. This easy screening tool is already in use at airports in Ebola affected Countries. Continue reading
By Emily Largent
Perhaps you already knew that October is National Breast Cancer Awareness Month. Did you also know that it is:
On top of that, we have (just to name a few): Mental Illness Awareness Week (Oct. 6-10); National Depression Screening Day (Oct. 9); Bone and Joint Health National Awareness Week (Oct. 12-20); World Pediatric Bone and Joint Day (Oct. 19); and World Psoriasis Day (Oct. 29). Background on what it takes to make it onto the H.H.S. Office of Disease Prevention and Health Promotion’s national health observances (NHOs) calendar can be found here.
These campaigns can have different goals: raising general awareness of a health need; changing behavior–for example, convincing individuals to change risky behaviors or to take steps toward disease prevention; soliciting donations for research; increasing early detection; enabling patient support groups; or influencing legislators and policy. It appears that NHOs can make a difference. They are not, however, free of controversy.
For example, a primary goal of National Breast Cancer Awareness Month (NBCAM) is to encourage regular breast examination so that cancer can be diagnosed at an early stage. It has been found that the NBCAM campaign was initially effective in increasing diagnoses, but the effect has diminished over time as the movement has matured, and it seems that the benefits of mammography screening programs have been overestimated. Unsurprisingly, it has been suggested that it is time for NBCAM to shift focus. Additionally, many have been critical of the commercialization of NBCAM (see, e.g., the NFL’s “A Crucial Catch” campaign).
What do you think of NBCAM? Of NHOs more broadly? Personally, I was surprised at how few of the October NHOs I was aware of, even though medical charity is a topic of personal and academic interest for me.
By Bob Bohrer
[Cross-posted on Pharmaceutical Policy.]
According to a story by Bronwyn Mixter in Bloomberg’s BNA BIOTECH WATCH, the FDA has received at least twenty-five IND’s for biosimilar development programs. Some quick perspective on that is appropriate. Twenty-five initial IND’s for the development of new small molecule drugs for cancer or autoimmune disease would face many years of clinical trials and long odds against approval (DiMasi et al estimated the approval rate at sixteen percent to nineteen percent). However in this “a little brave” and “a little new” world of biosimilar development, clinical development programs are likely to be much shorter in duration than development programs for new drugs or innovator biologics, and the success rates are likely to be very high, as I indicated in a pharmaceuticalpolicy.blogspot.com post of May 19th, 2014. The DiMasi study referenced above estimated the large molecule success rate at thirty-two percent; and, biosimilars are not only within that large molecule category, they are copies of drugs that have already been shown to be reasonably safe and effective. So it is very likely that we will see filings for the approval of more than twenty biosimilars in the next three years.
It will be very interesting to watch the rapidly developing biosimilar marketplace.
By Bob Bohrer
I have previously posted on pharmaceuticalpolicy.blogspot.com about the FDA’s proposed change to the rules for generic drug labels and an estimate of the liability costs that might be incurred by the generic drug industry as a result of the proposed change. The Generic Pharmaceutical Manufactuer’s Association lobbying efforts appear to have motivated Congressmen Steve Israel (D-NY) and Timothy Bishop (D-NY) to draft a letter to the FDA requesting changes to the proposed rule. A copy of the Congressmen’s letter to the FDA can be downloaded through this link.
SG Global Chat
Harvard Effective Altruism — Using Evidence and Reason to Maximize the Impact of Efforts to Make the World Better
October 8, 2014 12:30-1:20pm, Kresge G-2
Harvard Effective Altruism (HEA) is a student group at Harvard College and Harvard Business School. The group is dedicated to spreading the ideas of effective altruism to better the global community. Previous HEA speakers include Peter Singer, Nick Bostrom, Max Tegmark and Thomas Pogge. This year, HEA plans to became a Harvard University-wide student organization. Come to the first SG Global Chat of the year to hear more about HEA, the events the group has planned, and ways to get involved. Presented by Anders Huitfeldt (ScD Candidate in Epidemiology) and Eric Gastfriend (Student at Harvard Business School).
Light lunch provided. Any questions email studentgov at hsph.harvard.edu.
The piece was prompted by this week’s news of the white lesbian mother who sued a sperm bank for mixing up the sample she ordered with that from a black donor. The impulse to call one’s mixed-race child a “wrongful birth” gives reason, Dov argues, to rethink the racial preferences that we tend to accept without question; race-matching should be resisted for expressing the divisive notion that single-race families should be preferred to multiracial ones and that families should be set apart by race.
Amanda C. Pustilnik
I am excited to join the Petrie-Flom Center as the first Senior Fellow in Law & Applied Neuroscience. This fellowship is the product of an innovative partnership between the Petrie-Flom Center and the Center for Law, Brain and Behavior (CLBB) at Massachusetts General Hospital. This partnership aims to translate developments in neuroscience into legal applications, remaining sensitive to the normative dimensions of many – if not all – legal questions. The field of law & neuroscience is large and growing, addressing questions that intersect with nearly every area of law and a huge range of social and human concerns. CLBB is bringing together scientists, bioethicists, and legal scholars to look at questions ranging from criminal responsibility and addiction, to mind-reading and brain-based lie detection, to how the brain’s changes over our lifecourse affect our capacities to make decisions.
In the first year of this joint venture, we will be focusing on a set of issues with potentially huge implications for the law: The problem of pain. Pain is pervasive in law, from tort to torture, from ERISA to expert evidence. Pain and suffering damages in tort add up to billions of dollars per year; disability benefits, often awarded to people who suffer or claim to have chronic pain, amount to over one hundred billion annually. Yet legal doctrines and decision-makers often understand pain poorly, relying on concepts that are out of date and that can cast suspicion on pain sufferers as having a problem that is “all in their heads.”
Now, brain imaging technologies are allowing scientists to see the brain in pain – and to reconceive of many types of pain as diseases of the central nervous system. Brain imaging shows that, in many cases, the problem is literally in sufferers’ heads: Long-term pain changes the structure and function of the brain, perpetuating non-adaptive pain and interfering with cognitive and emotional function. Continue reading
By Diana R. H. Winters
[Cross-posted at HealthLawProf Blog.]
On Thursday, October 2, 2014, FDA released its “Summary Report on Antimicrobials Sold or Distributed in Food-Producing Animals” for 2012. The Report contains the depressing news that “domestic sales and distribution of medically important antimicrobials approved for use in food-producing animals increased by 16%,” between 2009 and 2012, though the percentage of those labeled solely for therapeutic use rose from 28% to 32%. The other 68% are labeled for just production (growth promotion) or production and therapeutic uses.
But why is that depressing, you may ask. Isn’t this exactly why FDA issued a final-guidance document and a draft rule in December 2013, both addressing its voluntary program with drug sponsors to decrease, and eventually end, the use of medically important antimicrobials for growth promotion in animal feed? Problem identified, solution initiated—right? If only it were that simple.
FDA has a long history of delay and intransigence on this issue. I have written about that history in the past, and do so again in this forthcoming article. In 2011, FDA was sued by a group of public interest organizations for its unwarranted delay, and a federal district court ordered the agency to begin proceedings to hold withdrawal of approval hearings for certain medically important antibiotics, hearings that it had originally called for in 1977. The Second Circuit reversed this decision in July of this year (NRDC v. FDA, 760 F.3d 151). Continue reading