HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Thursday, May 8, 2014

Guest Blogger Professor Nadia Sawicki: "Sanitizing” Lethal Injection

NNSawicki Loyola photo 2012Oklahoma’s botched execution of Clayton Lockett has brought increased attention to an issue that I have been concerned with for years – the increased “medicalization” of legally sanctioned executions, and, in particular, the role that medical professionals and the scientific community play in this process.

 Until the 20th century, most executions were conducted publicly – execution was a communal ritual that served as a means of catharsis. But the American execution process has, over time, become less visible, and, as a consequence, subject to less public oversight.  I believe that the movement of the capital punishment process “behind the curtain,” both literally and figuratively, should trouble death penalty opponents and supporters alike.

 The standard lethal injection protocol used throughout the United States was developed in 1976 by Dr. Jay Chapman, Oklahoma’s state medical examiner, and Dr. Stanley Deutsch, chair of the Oklahoma Medical School anesthesiology department.  Without testing or research, they settled on a three-drug protocol for executing prisoners – sodium thiopental, a short-acting barbiturate; pancuronium bromide, a paralytic; and potassium chloride, which stops the heart.  Until recently, this was the combination used in every state.

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May 8, 2014 | Permalink | Comments (0) | TrackBack (0)

Monday, May 5, 2014

Guest Blogger Professor Jonathan Todres: Health Care and Human Trafficking

Todres JonathanHuman trafficking inflicts significant physical, mental, and emotional harm on its victims.  The health consequences are dramatic and, in some cases, even life threatening. Victims and survivors of human trafficking confront a range of health issues from physical injuries and sexually transmitted infections to PTSD, depression, anxiety and other illnesses. 

Although human trafficking has received increased attention in recent years, responses to the problem remain rooted primarily in criminal justice frameworks. Law enforcement is necessary but not sufficient.  Health care professionals can play a key role in addressing human trafficking. 

Victims of human trafficking present at a wide range of health care facilities, including hospital emergency departments, community health centers, primary care clinics, school clinics, specialty clinics (e.g., obstetrics/gynecology, psychiatry), health department clinics, dental clinics, and other service providers.  In an article on sex trafficking of children and adolescents published last month in the New England Journal of Medicine, Ellen Wright Clayton and I wrote that health care professionals can help identify at-risk and exploited youth, provide needed treatment to survivors, and ensure that these individuals are connected with appropriate services. These roles apply not only to assisting individuals trafficked into the sex trade but also in identifying and responding to labor trafficking victims. Recent research has reinforced the need to recognize and respond to all forms of trafficking. Labor trafficking, which frequently has been overlooked, implicates numerous industries and businesses, including hospitality and tourism, agriculture, construction, mining, fisheries, domestic service, hair and nail salons, and many others.  

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May 5, 2014 | Permalink | Comments (0) | TrackBack (0)

Guest Blogger Professor Thomas (Tim) Greaney: Antitrust and the Physician Land Rush

GreaneyTimFor a number years, beginning well before the enactment of the Affordable Care Act, hospitals around the country have been engaged in a land rush.  The target has not been real estate, but doctors.  The number of physicians employed by organizations associated with hospital systems now exceeds 50 percent and in some specialties like cardiology the figure may be over 75 percent.  Much of the post-ACA hiring has involved primary care physicians, a phenomenon explained by the importance of nonspecialists in forming accountable care organizations and serving as the vehicle for referrals in the brave new world of integrated delivery and bundled payment.

The fiscal case for the land rush is not exactly clear, at least in the short run.  The median loss for hospitals employing a physician in 2012 was $176,463 and Moody’s  considers physician employment “a principal driver of hospitals’ margin pressure.”  However, many hospitals, fearful of being left out and losing revenues from referrals, lab work and profitable specialty service lines, are eagerly buying up physician practices.  Likewise physicians are also consolidating, especially in the form of large, single-specialty groups.

What have the antitrust enforcers had to say about physician consolidation?  Until recently, not much.  In fact, neither the FTC or DOJ had ever litigated a physician merger case and only a handful of states had done so.  However, in 2012 the FTC signaled its interest in the issue, challenging and settling by consent decree a hospital’s acquisition of two competing cardiology practices in Reno, Nevada. Somewhat controversial was the FTC’s decision not to insist on undoing the acquisitions (which enabled the hospital to employ 88 percent of the cardiologists in the market), but instead only requiring that a number of physicians be released from their non-compete agreements, presumably freeing them to practice independently or affiliate with another hospital.

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May 5, 2014 | Permalink | Comments (0) | TrackBack (0)

Sunday, May 4, 2014

Introducing Guest Blogger Professor Nadia Sawicki

HealthLawProf Blog is excited to welcome the third of our four guest bloggers for May, Professor Nadia Sawicki:  

NNSawicki Loyola photo 2012Professor Sawicki is a faculty member at Loyola University Chicago School of Law's Beazley Institute for Health Law and Policy.  Her current research focuses on issues relating to informed consent, particularly inreproductive and end-of-life care contexts; government speech in the public health arena; and professional discipline by state medical boards. An expert in both health law and bioethics, she is drawn to areas of conflict between law and ethics - including the government's use of persuasion, physicians' professional responsibilities when they act on behalf of the state, conscientious objection by medical providers, and the law's recognition of rights to recovery for invasion of contested interest.

May 4, 2014 | Permalink | Comments (0) | TrackBack (0)

Introducing Guest Blogger Professor Jonathan Todres

HealthLawProf Blog extends a warm welcome to the second of our four guest bloggers for May, Professor Jonathan Todres:

Todres JonathanJonathan Todres is Associate Professor of Law at Georgia State University College of Law. He researches and writes on a range of issues related to children’s rights and child wellbeing. His current research focuses in particular on trafficking and related forms of exploitation of children, economic and social rights issues, and legal and cultural constructs of childhood. Jonathan serves as a regular advisor to non-governmental organizations working on children’s rights issues. He also served recently on an Institute of Medicine and National Research Council study committee on commercial sexual exploitation and sex trafficking of minors in the United States (the committee published its final report in September 2013). He received his B.A. (International Development) from Clark University and his J.D. from Columbia Law School and served as a U.S. Peace Corps volunteer in Thailand. You may view his research on his SSRN page: http://ssrn.com/author=239725

 

May 4, 2014 | Permalink | Comments (0) | TrackBack (0)

Introducing Guest Blogger Professor Thomas (Tim) Greaney

HealthLawProf Blog is very pleased to welcome the first of our four guest bloggers for the month of May, Professor Thomas (Tim) Greany:

GreaneyTimProfessor Greaney is Chester A. Myers Professor of Law and Director of the Center for Health Law Studies at Saint Louis University School of Law.  He is co-author of the nation’s leading health law casebook, Health Law: Cases, Materials and Problems (7th edition) and a Treatise and Hornbook on health law, the new edition of which will be published in the Fall. He has published over 60 articles and chapters concerning antitrust law and health care law and policy and has testified on these issues before the Judiciary Committee of the House of Representatives and Federal Trade Commission. 

Before joining the Saint Louis University faculty, he served as an Assistant Chief in the Department of Justice Antitrust Division, supervising health care antitrust litigation. He has also been a Fulbright Fellow studying European Community competition law in Brussels, Belgium; and has been a visiting scholar at Université Paris Dauphine, Paris, France, Seton Hall University, and the University of Minnesota. Professor Greaney was named as Jay Healy Health Law Professor of the Year by the American Society of Law, Medicine and Ethics in 2007. 

Professor Greaney received his B.A magna cum laude from Wesleyan University and his J.D. from Harvard Law School.

 

May 4, 2014 | Permalink | Comments (0) | TrackBack (0)

Guest Blogger Professor Mary Crossley: Understanding and Influencing Our Health Choices

Crossley MaryPerhaps it’s because reading stories about behavioral economics makes me feel better about the irrational things I do on a regular basis, but it seems that stories and research reports about the potential value of behavioral economics for health policy and public health are appearing with increasing frequency. I don’t claim to be a highly sophisticated consumer of this literature, nor do I claim to have rigorously tracked the frequency of references to behavioral economics in the health literature. (But apparently I have been reading enough empirical scholarship that I know an author is expected to state caveats about her findings.) 

In any event, three items that I’ve read recently have me pondering the value of this literature. 

In April, a Robert Wood Johnson Foundation-sponsored research program with the long-winded name “Applying Behavioral Economics to Perplexing Health and Health Care Challenges” issued a Progress Report on the results of studies in its initial funding cycle.  The program (which explicitly cites to Richard Thaler and Cass Sunstein’s 2008 book Nudge: Improving Decisions about Health, Wealth, and Happiness) looks for solid evidence that behavioral economics techniques can in fact have a positive effect on health-related behaviors. Although RWJF finds behavioral economics approaches sufficiently promising to fund research investigating them, the recent Progress Report was no pep rally.  It stated that the results of the Round 1 studies have been mixed, in terms of finding that behavioral economics-inspired interventions can successfully lead to positive changes in health-related behavior. Notwithstanding these mixed results, the program’s director reported being encouraged, since the point of funding this research is to learn what sorts of “choice architecture” interventions actually influence behavior and why. 

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May 4, 2014 | Permalink | Comments (0) | TrackBack (0)

Guest Blogger Professor Deborah Forman: Egg Banking

Forman DeborahI was flipping through the most recent issue of Fertility & Sterility, the journal put out by the American Society for Reproductive Medicine (ASRM), when I came across an ad for the Fairfax EggBank.  One of the largest sperm banks in the country has apparently expanded into the egg banking business.  The ad was yet another reminder how constantly evolving technology raises new legal questions and sometimes resolves old ones.  

Back in 2007, when I began assisting fertility doctors with their consent forms, I recall considering the special language that would be necessary to address egg freezing, as it was still considered experimental at the time.  No more.  In 2013, the ASRM released a “Practice Committee Opinion” declaring that oocyte cryopreservation would no longer be considered experimental. With advances in the oocyte cryopreservation technique (using vitrification—a quick-freezing process), the rates of success for those using frozen eggs were comparable to those using fresh. 

How does the establishment of egg freezing as an accepted practice change the legal landscape for individuals and couples using assisted reproduction?  Until now, most patients using assisted reproduction have been offered the option of embryo cryopreservation.  The fate of unused embryos maintained in storage has posed dilemmas for patients and, in some cases, has led to litigation when couples divorce.  I have discussed the issues raised in these cases in depth in two recent articles, Embryo Disposition, Divorce & Family Law Contracting: A Model For Enforceability and Embryo Disposition And Divorce: Why Clinic Consent Forms Are Not The Answer.  Although legal theories have varied, courts have shied away from allowing one party to later use the embryos without the other’s consent.  

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May 4, 2014 | Permalink | Comments (0) | TrackBack (0)

Saturday, May 3, 2014

Why Sen. Elizabeth Warren's Memoir is of Special Interest to Health Profs

I'm a guest over at prawfsblog this month--come visit-and my posting today was about why law professors should be interested in Sen. Elizabeth Warren's new memoir.  You can read the whole pitch below--it includes that it's a funny, warm, well-written and interesting account of a remarkably successful career.  I also noted how important her efforts at fixing student loan debt are as a platform on which to build needed change in higher education.  Finally, she has very interesting things to say about balancing work and family as well as going beyond the classroom to help the individuals affected by the law she studied.   At a recent executive board meeting of the AALS Section on Law, Medicine and Health Care, current chair Dr. Ani Satz noted that there are not many mechanisms for recognizing that kind of service.  (side note--consider yourself warmly invited to the terrific panels our chair elect, Dr. Thad Pope, has organized for us to present and co-sponsor, more information to come).

But for a health prof audience, I'd also point out that she discusses her empirical work (with a team of top social scientists--she didn't do the math herself) that finally demonstrated the major flaw in our employer based health insurance system.  Medical bills turned out to be the leading cause of bankruptcy--and very often among families already insured.  Either their insurance was inadequate (maybe we should get these folks together with the people who are upset they can't keep their "old" plans) or, worse, their illness meant they could no longer work.  Whether the debt came directly from medical bills or from using credit cards and home equity loans to pay the bills--the results were equally catastrophic.

That this actually happens--that medical bills are a leading cause of bankruptcy--is as far as I know not currently disputed.  But I'd be remiss in this context not to point out that as part of the opposition research arising from her running to Senate-the Breitbart blog has made available a series of angry accusations from the 1990's of misconduct about that study.

 It will be a while before we see if the Affordble Care Act is going to do much to fix this problem--and predictions are mixed.  See this as opposed to this.   There's a federal study finding bankruptcies down in Massachusetts following Romneycare.   Common sense suggests that changes like no exclusions for pre-existing conditions and the lift of lifetime caps will make things better (for people with plans bound by those provisions).

But although certainly not usually described as such, Sen. Warren is, if not a Health Law Prof, certainly one whose work is very important to us. 

 

May 3, 2014 in Affordable Care Act, Blog, Consumers, Coverage, Employer-Sponsored Insurance, Health Care Reform, Insurance, PPACA, Proposed Legislation, Reform, Research, Research Ethics, State Initiatives, Workforce | Permalink | Comments (0) | TrackBack (0)

Wednesday, April 30, 2014

Guest Blogger Gaia Bernstein - Patients: the New Unexpected Players in Patent Litigation

Bernstein GaiaWhen people think about patent litigation they think about patent owners, they think about savvy technological competitors – they do not think about patients. For sure, everyone realizes that patients have strong interests in patented products, such as drugs or medical tests. And all agree that the goal of the patent system is to encourage innovation and eventually benefit patients. But, no one thinks of patients as active players in the patent playfield.

It is time to change the way we view patent litigation. In my article: The Rise of the End User in Patent Litigation, which is forthcoming in the Boston College Law Review, I show that end users are playing an increasingly growing role in patent litigation. End users are those who use patented technologies for personal consumption or in business. End users do not manufacture or sell patented technologies. Patients are prominent among these end users. 

Patients were among the plaintiffs suing to invalidate Myriad Genetics’ patents on several breast cancer genetic mutations in order to increase public access to the genetic tests. The tests at that time cost around $3000. The Supreme Court decided the case – Association for Molecular Genetics v. Myriad Genetics – in 2013. Patients also repeatedly challenge settlement agreements  -- called pay for delay agreements – between manufacturers of patented drugs and generic manufacturers. Under these agreements, patented drug manufacturers compensate generic manufacturers not to enter the market to the detriment of patients who now cannot benefit from lower priced drugs. And, in another example, a group of Fabry disease patients asked the National Institute of Health (”NIH”) to use its march-in power to grant licenses to other producers to address manufacturing problems at the patent owner’s facilities that caused a shortage of the patented drug. When the NIH refused the patients filed suit for damages against the patent owner and others in federal court.

My article shows that end users, including patients, are unique players in the patent playfield.  First, they lack the technological expertise that is critical in patent cases, where showing patent invalidity or non-infringement depends on sophisticated technological understanding of the patented invention and any competitive products. Second, they are usually unaware of the existence of the patented technology until later in the life of the patent, when the technology achieves mainstream adoption. Because of that they are limited in their ability to use the less expensive Patent Office procedures in lieu of litigation. Third, they are usually (although not in cases of patients of chronic diseases) one-time players and would prefer to settle with patent owners than endure the exorbitant costs of patent litigation.

Since patients, like other end users of patented technologies, are uniquely situated, they tend to be at a disadvantage compared to the traditional players of the patent playfield – the patent owner and her competitors.  My article argues for the need for procedural reforms to place patients, among other end users, on equal footing in patent litigation.  For more on ways to address the imbalance – see my follow up post.

-Guest Blogger Gaia Bernstein

[cross posted on Health Reform Watch]

April 30, 2014 | Permalink | Comments (0) | TrackBack (0)

Tuesday, April 29, 2014

Registering for Organ Donation--How Much Does It Matter?

All of those efforts to persuade people to authorize postmortem organ donation seem to be paying off. Whether one gives consent when renewing a driver's license or by signing up at Donate Life America, the results are impressive. In 2012, 45 percent of American adults were included in state organ donation registries, and 40 percent of organ donations after death came from these "designated donors." That's a more than doubling of the 19 percent rate of designated donors among posthumous organ donors in 2007.

But the increase in donor designation has not translated into a meaningful increase in organ transplantation. There were 22,053 transplants from 8,085 deceased donors in 2007 and 22,187 transplants from 8,143 deceased donors in 2012.

Why hasn't donor designation translated into more organs? Is it because organ procurement organizations would have obtained consent from family members anyway for individuals who registered for donation? A survey of organ procurement organizations suggests strong agreement between registered donors and their families. Or maybe family wishes matter more than the decedent's wishes despite legal rules that recognize the priority of the decedent's wishes. Or perhaps other factors are hiding the effect of donor designation. Maybe it's too soon to see an effect from donor designation. It will be interesting to see how the data play out over the next few years.

[cross-posted at PrawfsBlawg and orentlicher.tumblr.com]

April 29, 2014 | Permalink | Comments (0) | TrackBack (0)

Saturday, April 26, 2014

Published This Week

Guest Blogger Professor Mary Crossley: Health Reform and the Mission of Nonprofit Hospitals

Crossley1Ever since 1969, when the IRS established the “community benefit” standard for hospital tax exemption, nonprofit hospitals have been able to achieve federal tax exemption without any precise accountability for the benefits they provided. The ACA’s passage, however, ushered in significant changes to federal tax-exemption standards for hospitals.  The new § 501(r) of the Internal Revenue Code requires hospitals to take numerous measures, including establishing written financial assistance policies, limiting the amount charged to patients eligible for financial assistance, and limiting their use of “extraordinary collection actions” against patients. These requirements responded to concerns about how some purportedly “charitable” hospitals treated uninsured patients and, more generally, hospitals’ lack of transparency regarding indigent care.  They stop well short, however, of requiring hospitals to provide any particular quantum of free care to patients unable to pay.

Section 501(r) also incorporates a different tack, requiring that at least once every three years, a hospital conduct a “community health needs assessment” (CHNA) and adopt an “implementation strategy” to respond to the needs identified by the assessment. The needs assessment requirement is novel as a matter of federal tax policy, but is similar to mandates previously existing in a number of states.

As announced in the statute and fleshed out in Proposed Regulations issued by the IRS in April 2013, the CHNA requirement entails a series of steps.  In identifying and prioritizing community health needs, a hospital must take into account “input from persons who represent the broad interests of the community served by the hospital facility, including those with special knowledge of or expertise in public health.” Once the assessment is completed, the hospital must make a report on it “widely available to the public” and adopt an “implementation strategy” to meet the community health needs it identified. Finally, it must report to the IRS how it is “addressing the needs identified” and “a description of any such needs that are not being addressed together with the reasons why such needs are not being addressed.”  As a result of this new requirement, sometime in the past few years most of the nearly 3000 nonprofit hospitals in the US have completed their inaugural CHNA.

The CHNA requirement reflects a conceptual shift in the quid pro quo required of hospitals in return for the substantial financial benefit of federal tax exemption. In responding to the long-standing community benefit standard, hospitals mostly simply did what hospitals traditionally do (i.e., provide emergency and acute care services to patients), but provided those services for some patients who were uninsured and unable to pay and for patients whose insurance didn’t pay enough to fully cover the cost of hospital care (e.g., Medicaid and Medicare). Today, by contrast, the CHNA requirement calls for hospitals to look beyond the acute care needs of their patients and to assess and respond to the health needs of their community.

It’s not entirely clear, though, what that change will mean in practice and how meaningful hospitals’ community-oriented activities will be. Without a doubt, the specific steps that the ACA and the Proposed Regulations establish for conducting a CHNA are more definite than IRS guidance under the community benefit standard. But when it comes to substance – what needs to identify and prioritize, how to respond to those needs, and how to evaluate the impact of a hospital’s response – hospitals are left with a great degree of leeway.  One concern is that a hospital could simply jump through the hoops of completing the CHNA process, but then prioritize needs in a way that is hospital-centric (rather than community-centric) and fail to evaluate seriously the impact of its activities.

Hospitals’ reluctance to do more than the law clearly requires is understandable, because some hospitals may see efforts to address community health needs – rather than the health needs of hospital patients – as lying outside their mission. For example, the mission statement of one nonprofit hospital (pulled from the web) states: “The mission of ___ is to provide competent, innovative, and accessible emergency and acute care services for the residents of ____. We are caring people operating an extraordinary community hospital.” This hospital’s mission clearly is to provide traditional hospital services to people in a particular community, but such a hospital may need to enlarge its articulated mission in order to encompass community health needs.

Nudging hospitals toward a deeper understanding of and greater responsibility for health in the communities they serve could prove to be an important component in health reform’s attempt to shift our country’s orientation from a system that responds to ill health to a system that promotes good health. But it may not be an easy process for many hospitals, as they are called on to re-examine their missions and to adapt their own conceptions of their roles in the community.

-Guest Blogger Professor Mary Crossley

April 26, 2014 | Permalink | Comments (0) | TrackBack (0)

tenBroek Symposium and Supported Decisionmaking

Every year, the National Federation of the Blind sponsors a symposium on the legal rights of people with disabilities.  Named in honor of Jacobus tenBroek, the symposium brings together legal scholars, disability rights lawyers, lawyers from many federal agencies, and many others from disability rights organizations, to discuss current developments in disability law.  As might be expected for a symposium named after Dr. tenBroek, the symposium emphasizes the right to be in the world. The full description of the symposium can be found here.  Two themes from the symposium might be of particular interest to health lawyers.

First, Olmstead-type litigation is alive and well, in two directions.  One of the most exciting developments is the use of Olmstead to challenge sheltered workshops that provide people with disabilities the "opportunity" to work for sub-minimum wages in working conditions that may be substandard and in jobs that may be boring at best.  On April 8, 2014, the Department of Justice entered into a settlement agreement with the state of Rhode Island to the effect that the state's system of sheltered facilities violated Olmstead's integration mandate.  The DOJ has also intervened in a class action in Oregon challenging that state's sheltered workshops, Lane v. Kitzhaber, 841 F.Supp. 2d 1199 (D. Or. 2012).  This use of Olmstead to challenge settings for individuals who are not institutionalized is a tremendous development.  More traditional Olmstead suits and continuing as well: for example, challenges in both Florida and Texas to nursing home rather than community based placements for children and adults with intellectual disabilities.  

In another direction, however, so-called "reverse"-Olmstead litigation represents efforts to keep institutions available for those who might want to continue to live in them; litigation in progress includes Carey et. al. v. Christie-1:12-cv-02522-RMB-AMD-(D.N.J. 2012) and Sciarrillo ex rel. St. Amand v. Christie, 2013 WL 6586569 (2013).  The theory of this litigation is the second prong of the Olmstead integration mandate:  that the individuals do not oppose the community placement.  Litigants seek to turn this into a positive right to remain institutionalized, a contention that courts have rejected to date.

Another major development concerns supported decisionmaking.  tThe Convention on the Rights of Persons with Disabilities (CRPD) Article 12 provides for full legal personhood for people with disabilities.  Guardianship and other forms of rights-deprivation fly in the face of this mandate.  "Supported" decisionmaking--a methodology that enables people with disabilities to work with others to make their decisions, in a manner that enables rather than taking away rights--is a means to achieve such legal personhood.  In a landmark Virginia case last fall, Jenny Hatch, a person with Down syndrome, won the right to supported decision making despite her parents' efforts to protect her by imposing guardianship.  Proponents of supported decisionmaking are developing model support agreements and are planning evidence-based work about the effects of different mechanisms.   Information about the Jenny Hatch litigation and associated efforts can be found here.

[LPF]

April 26, 2014 | Permalink | Comments (0) | TrackBack (0)

Friday, April 25, 2014

FDA Regulation of E-Cigarettes—A Gateway to Teaching Administrative Law

 

It’s likely that most readers of this blog already know that the FDA just announced its intent to extend its regulatory powers to E-Cigarettes.   E-Cigarettes have proven to be a "high interest" topic in both my "Constitutional Issues in Health Law" and "Legal Issues in Human Subject Research Classes."  The struggle between the FDA and those it wishes to regulate raise questions about the powers of all three branches of Government.  It can serve as a proxy for all administrative agencies in an Admin Class or as a direct source of study in a public health, environmental or (of course) food & drug law class.

The FDA's current struggles include energy drinks, body building supplements and truth in calorie reporting (no more hiding calories by assuming unrealistic serving sizes).

But back to E-Cigarettes.  

Here is the text of the proposed rule.  And here is the Campaign for Tobacco-Free Kids’ list of reasons why the FDA is justified—and should—be able to do this.

The FDA’s relationship with regulating tobacco products has been a complicated one.  This book review by Margaret Gilhooley can bring you up to date on the history of FDA’s failed attempts to obtain jurisdiction.  It was not until June 22, 2009 that the FDA finally did get regulatory power when President Obama signed the Family Smoking Prevention and Tobacco Control Act (FSPTCA) that the FDA got any authority to regulate tobacco products—and that only through the filter (sorry) of protecting children.   And that still remains the outer limit—protecting children. 

So any regulation of E-Cigarettes has to be along the lines of making them less available to minors.  That’s why what sounds like a relatively weak reason—“even if they are harmless, they are a gateway for children to real cigarettes” is important because that is the statutory basis of the FDA’s power.  It’s not surprising that the FDA’s announcement has been met with immediate protest from Vapers.  New York’s ban (and remember, all the FDA’s done is to announce it intends to assert its authority to look into the product’s safety) has sparked considerable push-back based on issues of “personal liberty.” Apparently this anti-regulation movement is not restricted to the U.S.

   Vapers have had little success persuading cities to exempt e-cigarettes from public spaces, but they have been able to prevent outright bans and to allow the creation of “vaping lounges” –-the English majors among you know these better as modern day equivalent of a legal opium den—perhaps inhabited by today’s Keats, Shelleys and Coleridges.  We even have them in Lubbock.  

The FDA’s goal is to build on the actions of the cities that are equating e-cigarettes with “old style” tobacco to keep e-cigarettes as an “adults only” product.

 

April 25, 2014 in Constitutional, Drug and Device, Environmental Health, FDA, Food, Obama Administration, Policy, Proposed Legislation, Public Health, Public Opinion, State Initiatives | Permalink | Comments (0) | TrackBack (0)

Thursday, April 17, 2014

Guest Blogger Professor Gaia Bernstein: Direct to Consumer Genetic Testing and the Over-Production of Genetic Information

Bernstein23andMe, the Internet genetic testing company, which offered genetic testing for health conditions and ancestry, has received extensive publicity in recent months. In November 2013, the FDA ordered 23andMe to stop marketing its health-related genetic test results to customers because their product is a “device”, which requires FDA approval. In its letter to 23andMe the FDA focused on the harms of consumers’ interpretation of genetic test results without the appropriate medical guidance.

And for sure, consumers’ independent interpretation of genetic results is potentially harmful. But, another important concern not addressed by the FDA is the need to regulate and constrain the production of genetic information in the first place – at the time that a consumer decides which tests to take. Direct to consumer genetic testing companies, like 23andMe, usually offers a battery of multiple tests that the consumer purchases without careful selection of what information is desirable to her. And, although genetic information can help improve and control health outcomes, not all genetic information is made equal and not all tests results are similarly desirable for all people. In my essay Direct to Consumer Genetic Testing: Gatekeeping the Production of Genetic Information, I discuss the problem of indiscriminate production of genetic information and argue for the need for a medical gatekeeper not just for the interpretation of genetic test results but earlier on to guide consumers through the selection of tests.

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April 17, 2014 | Permalink | Comments (0) | TrackBack (0)

Tuesday, April 15, 2014

The Delay of ICD-10

As part of the “Protecting Access to Medicare Act of 2014,” Congress provided that DHHS may not set ICD-10 as the code standard before October 15, 2015.  October 15, 2014 had been the day set by DHHS for ICD-10 implementation.  For health care systems that have invested a great deal in being ready for the shift from ICD-9 to ICD-10 in 2014, the delay is likely to be a costly one.  Estimates range as high as $6.6 billion. 

"ICD" stands for the "International Classification of Diseases"; a common classification system enables standardized billing, care comparisons, and a common framework within which to observe public health trends.  ICD-10, copyrighted by the WHO, has been in development for over 30 years.  It was endorsed by the World Health Assembly in 1990 and first used in WHO member states as early as 1994.  It was field tested by the American Hospital Association and the American Health Information Management Association over 10 years ago and has been in use in Europe for at least 10 years.  The original federal rule requiring ICD-10 codes was promulgated in 2009, for an original implementation date of 2013. 

So why the delay? Many physicians, especially physicians in smaller offices, are concerned about the cost and time involved in learning a new way to code.  They claim that a shift from only 13,000 to over 68,000 codes is unwieldy and unnecessary. They also point out that the WHO is expected to release ICD-11 in the next several years and ask whether it might not be just as well at this point for the US to move straight to ICD-11 when it is available.

But there is much to lose by Congress’s concession to strong lobbying from physician groups.  ICD-10 contains more fine grained diagnoses,  is based on understandings of disease that are rooted in at least more contemporary science than ICD-9, and encompasses new technologies that remain unaccounted for in ICD-9.  It allows for better comparative and public health data.  This is not an issue just for techies. Congress’s capitulation is yet another illustration of why quality and cost effectiveness in US health care are so difficult to achieve.

[LPF]

April 15, 2014 | Permalink | Comments (0) | TrackBack (0)

Guest Blogger Professor Deborah L. Forman: Introducing The ABA's Draft Model Act Governing Assisted Reproductive Technology Agencies

FormanThe use of assisted reproductive technology to create families is often described as collaborative reproduction.   Intended parents, gamete donors and surrogates can all play a role in the process.  Assisted reproduction typically involves collaboration among various professionals as well, including physicians, mental health professionals, attorneys and, increasingly today, agencies.  

Agencies typically act as facilitators; they recruit egg donors and surrogates, screen candidates for physical and mental suitability, and match donors and surrogates with intended parents. The terms of a particular egg donation or surrogacy may be negotiated by the agency, though they are ultimately reviewed and memorialized by attorneys representing the parties.  If the match is successful and a pregnancy results, agencies continue to play a role supporting the relationship, ensuring payments are made, and assisting in resolution of any disputes that arise.  In other words, agencies occupy a very important position in the collaborative reproduction process; their conduct can make or break the experience for the participants. 

A high quality agency can provide invaluable service to its clients.  Unfortunately, unscrupulous agencies, those that fail to adhere to ethical principles, and those that are merely incompetent, can wreak havoc on the lives of surrogates, donors and intended parents, causing financial losses and emotional harm.  In one well-publicized case, the owner of a California surrogacy agency, Surrogenesis, embezzled $2 million dollars from intended parents.

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April 15, 2014 | Permalink | Comments (0) | TrackBack (0)

Friday, April 11, 2014

The Game of Succession

It is almost always dramatic when a well-known figure resigns. So it was this week, one leader gone and another swiftly nominated. Almost inevitably the process and new nominee were subject to conservative sniping. Then, Secretary Sebelius resigned! While the press suggested a tainted legacy, the opposition began to salivate over further damaging health reform during the succession hearings. Nominee Burwell has impeccable credentials, even if being a "manager's manager" may work better as alliteration than a call to arms. Of course, the list of ACA tasks to get right over the next couple of years is daunting and goes well beyond leading a team of web developers. The administration has flagged some of the most controversial parts of the law by delaying them and things will likley be more difficult the second time around. However, the greatest expectation of the nominee is highlighted in the White House press release, "Sylvia was confirmed unanimously by the Senate to lead the OMB less than a year ago, and has a record of building bipartisan consensus to get things done." Here's to optimism!

April 11, 2014 | Permalink | Comments (0) | TrackBack (0)

Thursday, April 10, 2014

Health Insurance, Socioeconomic Status, and Health

Earlier this week, I wrote about the link between health insurance and health and suggested that socioeconomic factors such as education and wealth can be much more important for health than access to health care. There are some interesting studies in this area.

For example, researchers looked at health outcomes in England under that country’s National Health Service (NHS) and found that the higher the socioeconomic status of a person, the lower the death rate. People in the highest civil service grade for government employees had a mortality rate about half that of people in the lowest civil service grade, even though they all had good access to health care. In addition, the gap in mortality rates among men in England by socioeconomic status has actually widened over time since the introduction of the NHS in 1948.

Or consider an interesting policy experiment in Canada during the 1970s. For four years, the province of Manitoba guaranteed a minimum annual income for all residents of Dauphin, a small, rural city. Health status improved significantly. When Dauphin residents were compared with residents of other rural communities in Manitoba, the data showed that while people in Dauphin were more likely to be hospitalized before implementation of the minimum income program, the gap in hospitalization rates disappeared by the end of the program. The decline largely occurred for hospitalizations that tend to be sensitive to levels of income security.

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April 10, 2014 | Permalink | Comments (0) | TrackBack (0)