Thursday, April 17, 2014
Guest Blogger Professor Gaia Bernstein: Direct to Consumer Genetic Testing and the Over-Production of Genetic Information
23andMe, 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.
Tuesday, April 15, 2014
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.
Guest Blogger Professor Deborah L. Forman: Introducing The ABA's Draft Model Act Governing Assisted Reproductive Technology Agencies
The 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.
Friday, April 11, 2014
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!
Thursday, April 10, 2014
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.
Wednesday, April 9, 2014
No, not those rankings that law professors love to hate, the rankings published by the (former) magazine that shall not be named. I’m talking about the County Health Rankings, released on March 26th. For the fifth year, the Robert Wood Johnson Foundation has partnered with the University of Wisconsin Population Health Institute to crunch data from across 29 health-linked factors to give counties a snapshot of their residents’ health, relative to other counties in their state. They’ve included several new factors this year, including housing, transportation, and access to mental health providers.
The County Health Rankings differ markedly from the most well-known law school rankings. The methodology and underlying data are transparent. Counties are not surveyed on their opinions of how healthy other counties are. And counties are not ranked higher if they spend more per resident on health.
The Rankings reinforce several messages that seem just now to be sinking in with the American public. Social, economic and environmental factors are as important in determining health as insurance status and medical care received. Where you live can matter as much to your health as how you live. While many of us are used to bemoaning the racial and ethnic health disparities that doggedly persist in the U.S., we may be less aware of striking geographic disparities that these rankings illuminate. According to the County-by-County Blog, “The Rankings show us that people living in the least healthy counties have twice the premature death rates than those living in the healthiest counties. There are also twice as many children living in poverty and teen births in the least healthy counties as in the healthiest counties.” And while some counties have one mental health provider for every 72 residents, some have only one mental health provider per 55,989 residents. My jaw dropped when I read that.
Tuesday, April 8, 2014
The Affordable Care Act might not bend the cost curve or improve the quality of health care, but it will save thousands of lives, as millions of uninsured persons receive the health care they need. At least that’s the conventional wisdom. But while observers assume that ACA will improve the health of the uninsured, the link between health insurance and health is not as clear as one may think. Partly because other factors have a bigger impact on health than does health care and partly because the uninsured can rely on the health care safety net, ACA’s impact on the health of the previously uninsured may be less than expected.
To be sure, the insured are healthier than the uninsured. According to one study, the uninsured have a mortality rate 40% higher than that of the insured. However, there are other differences between the insured and the uninsured besides their insurance status, including education, wealth, and other measures of socioeconomic status.
How much does health insurance improve the health of the uninsured? The empirical literature sends a mixed message. On one hand is an important Medicaid study. Researchers compared three states that had expanded their Medicaid programs to include childless adults with neighboring states that were similar demographically but had not undertaken similar expansions of their Medicaid programs. In the aggregate, the states with the expansions saw significant reductions in mortality rates compared to the neighboring states
On the other hand is another important Medicaid study. After Oregon added a limited number of slots to its Medicaid program and assigned the new slots by lottery, it effectively created a randomized controlled study of the benefits of Medicaid coverage. When researchers analyzed data from the first two years of the expansion, they found that the coverage resulted in greater utilization of the health care system. However, coverage did not lead to a reduction in levels of hypertension, high cholesterol or diabetes.
Monday, April 7, 2014
Associate Professor Ann Marie Marciarille posted the following: The New Hampshire Solution, Who Is Wasting What?, Teeth-Whitening at the Supreme Court, and Five Hundred Word Book Review: REINVENTING AMERICAN HEALTH CARE by Ezekiel Emanuel.
Michael Frakes, The Surprising Relevance of Medical Malpractice Law, 81 U. of Chi. L. Rev. (Forthcoming 2014).
David Orentlicher, Health Care Reform and Efforts to Encourage Healthy Choices by Individuals, N. Carolina L. Rev. (Forthcoming).
As abortion clinics close in Texas and the Supreme Court ponders whether the contraceptive mandate in the ACA infringes the religious freedom of Hobby Lobby, women’s reproductive rights have come under attack from another quarter—unwed fathers. Last Fall, Olympic-champion skier Bode Miller succeeded in wresting custody of his infant child from the mother after a New York magistrate determined Sarah McKenna had engaged in “misconduct” by daring to move to New York to complete her education while pregnant with Miller’s child. Although the decision was subsequently overturned, the mother lost custody for several months. More recently, a New Jersey man sued for the right to attend his child’s birth after the mother, his estranged ex-fiancée, objected to his request to be notified when she went into labor and barred him from the delivery room. (Plotnick v. DeLuccia, N.J. Super. Ct. Ch. Div., No. FD-16-00008-14, 11/19/13, released 3/10/14.)
Thursday, April 3, 2014
A Call out to the "Invicible" Young Adults--What You Don't Know About Childhood Diseases Could Prevent You From Having Any Children
One thing we’ve all heard during the discussion of the affordable care act is that young people don’t worry a lot about their health. It’s therefore likely that few young adults ever think about whether or not they received adequate vaccination.
Perhaps if they better understood the consequences, they would do so. What you've heard is true many childhood diseases are much more serious for adults than for children. For a general overview look here. Here’s some information about chickenpox.
Outbreaks of Mumps are being reported all over the country. This week there are 116 cases in and near Ohio State University in Columbus. Fordham University in New York reported 11 in late February. Just today, the NYC Board of Health reported 21 cases of Measels and Rubella (German Measels) isn't likely to be far behind. These numbers may seem small—until you appreciate that Mumps used to be a very common childhood disease in the United States but is now very rare because of a highly effective vaccine. Unfortunately, many parents have chosen not to vaccinate their child against Mumps because of concerns about the MMR vaccine—that now turn out to be the result of fraudulent scientific data. This piece put out by the Center for American Progress explains how states responding to political pressure from parents have been remarkably lax in enforcing mandatory vaccination laws for school children. At this point, almost anyone with a concern to claim an exemption.
So back to Mumps. Few had heard of it, and no one knew what should really be the main attention grabber. It can impair fertility—even to the extent of causing sterility. There hasn't been a lot of research done recently and permanent sterility is rare- probably no more than 10%. But why chance it when it can be prevented?
And that’s not the worst of it. Measels and Rubella carry even greater risks for young adults. A case of Rubella early in pregnancy caries with a 20% chance of serious birth defects. The risk of permanent hearing loss after measels is highest in children under 5 and adults over 20.
The good news on the public health front is that it’s never too late to be vaccinated. And preventive vaccination (even for childhood diseases) is covered under the Affordable Act. Young adults would be wise to look into their own vaccination status. If pediatric records aren’t available, a blood test can measure antibodies that show the presence (or absence) of vaccination against many serious childhood diseases that are coming back to infect young adults. But if vaccination laws continue to be lax, long after the reason for so many people's misgivings has turned out to be a fraud, we will not be able to get ahead of what should to everyone be a very frightening trend
Cigarette taxes have proved to be an effective strategy to reduce smoking, so one might think (as many experts do) that soda taxes would be an effective strategy to reduce obesity. Consumption of soft drinks seems to be an important risk factor for obesity, and people are sensitive to the price of their colas.
Moreover, soda taxes reflect the lessons of behavioral economics. People often over-indulge in activities that provide short-term gratification but impose significant harm in the long-term. Imposing a tax on unhealthy drinks supplies an immediate disincentive to the consumption of those drinks and can overcome the difficulty people have in postponing gratification.
However, two new articles in Health Economics question the effectiveness of soda taxes. One study based on UK data, the other on US data, come to the same conclusion--we should not expect much of an impact from taxes on sugary soft drinks. It seems that raising taxes on some beverages simply results in consumers switching to other beverages and replacing the forgone calories with other calories. And to make things worse, beverage taxes often are regressive.
The news is disappointing and adds to a growing list of disappointing policies for weight loss. Under the Affordable Care Act, for example, restaurants must disclose calorie information to customers. With better information, diners would know which salads really are healthy and which others are not. But researchers have not found mandates for calorie disclosure by restaurants (as in New York and Seattle) to be effective.
Legislative fixes for obesity are tempting and probably necessary. But lawmakers need to take better account of medical understanding before they act.
[cross-posted at PrawfsBlawg and orentlicher.tumblr.com]
Wednesday, April 2, 2014
The Affordable Care Act (ACA) seems to be gaining steam. After a rocky start in October, the new health insurance exchanges reached the government's enrollment goal of 7 million. As ACA's provisions continue to take effect, its status should solidify and transform the U.S. health care system in important ways.
Yet there also are reasons to be cautious about ACA's long-term prospects. The Act's basic framework may not have taken sufficient account of the lessons from history. After watching health insurers torpedo the Clinton plan in 1994, President Obama took care to secure support for ACA from the insurance industry, as well as drug companies, physicians, and other important interest groups. But there may have been more important lessons from the country's history with other public benefit programs, including Medicare, Medicaid, and food stamps.
As NPR and the New York Times reminded us with their ACA updates last week, federal-state partnerships can have serious drawbacks compared to programs operated by the federal government. Some states effectively meet the needs of their residents, but others do not. Just as Texas had the highest percentage of uninsured people under pre-ACA health care, Texas continues to lag other states under ACA in terms of access to health care coverage. Similarly, when states were responsible for setting eligibility standards for food stamps, the program reached counties with only 59 percent of the U.S. population. After a decade of state oversight, Congress established uniform eligibility standards.
Benefit programs also fare better when they are perceived by the public as having been earned. Medicare and Social Security have enjoyed strong support because they are funded in part by payroll deductions. Medicaid, on the other hand, with its funding from general revenues, often is viewed as providing handouts.
Guest Blogger Associate Professor Ann Marie Marciarille: Five Hundred Word Book Review: REINVENTING AMERICAN HEALTH CARE by Ezekiel Emanuel
The best joke in Zeke Emanuel’s new book is told near the beginning but referenced throughout, which makes the joke yet richer and more multi-layered by the book’s dense 349 page end. It goes like this: There are two people who actually understand the American health system, and both Victor Fuchs and Alain Enthoven are 90 and 83 years of age, respectively. I don’t care if Zeke Emanuel wrote the joke himself because what he did write is the book that should make all of us a little less fearful in light of these truths.
The best parts of Reinventing American Health Care might really be seen as two shorter books, intertwined. Several chapters, particularly the descriptive chapters in Part I on the American Health Care System could be a standalone book as a primer on the American health care system or what the anthropologist Clifford Geertz described as “thick description.” More than an entry level overview of the status quo, these chapters (particularly Chapter Two on Financing Health Care) represent something I might assign to my health law students. The second book on the process of health care reform up to the present might be called “How the Sausage Got Made” and essentially offers a standalone account of the history of health care reform – real and attempted – in the United States.
HealthLawProf Blog is excited to welcome the third of our three guest bloggers for April, Professor Mary Crossley:
Mary Crossley is a Professor of Law at the University of Pittsburgh School of Law, where she teaches courses on Bioethics, Health Law, Health Care & Civil Rights, Family Law, and Torts. Widely recognized for her scholarship in disability and health law, Professor Crossley has written broadly on issues of inequality in health care financing and delivery and has published articles in numerous law journals, including Columbia Law Review, Iowa Law Review, and Notre Dame Law Review. Crossley was appointed Dean and Professor of Law at the University of Pittsburgh School of Law in 2005 and served as Dean from 2005-2012, focusing her leadership on initiatives relating to curricular reform, innovation programming, and promoting diversity. In 2013 she was selected as a Robert Wood Johnson Foundation Public Health Law Scholar in Residence.
HealthLawProf Blog extends a warm welcome to the second of our three guest bloggers for April, Professor Gaia Bernstein:
Professor Gaia Bernstein specializes in law and genetics, reproductive technologies, information privacy, intellectual property and family law. Her scholarship looks at the inter-relations between technology, law and society, examining the dissemination and adoption processes of new technologies, including both medical and communications technologies. Professor Bernstein's scholarship has been published in leading law reviews including the Vanderbilt Law Review, the Boston University Law Review, the Washington Law Review and the U.C. Davis Law Review. Her work has been selected to the Stanford-Yale Junior Faculty Forum and received extensive media coverage.
Professor Bernstein has joined the Seton Hall faculty in 2004 and in 2009 was named the Margaret Gilhooley Research Fellow. Prior to joining the Seton Hall faculty, Professor Bernstein was a fellow at the Engelberg Center of Innovation Law & Policy and at the Information Law Institute at the New York University School of Law. Her degrees include: a J.S.D. from the New York University School of Law, an LL.M. from Harvard Law School, a J.D. (Intellectual Property concentration with Honors) from the Boston University School of Law, and a B.A. in Psychology and Political Science (magna cum laude) from Tel Aviv University. Professor Bernstein practiced law at Skadden, Arps, Slate, Meagher & Flom LLP in New York and at S. Horowitz & Co. in Israel.
HealthLawProf Blog is very pleased to welcome the first of our three guest bloggers for the month of April, Professor Deborah L. Forman:
Deborah L. Forman is Professor of Law at Whittier Law School, in Costa Mesa, California, J. Allan Cook & Mary Schalling Cook Children’s Rights Scholar. Professor Forman earned her J.D. from Stanford Law School. She joined Whittier in 1990 and served as Director of the Whittier Law School Center for Children’s Rights from 1999-2007. Her courses include Family Law, Contemporary Problems in Family Law, and Torts. Professor Forman is the author of Every Parent’s Guide to the Law (Harcourt Brace 1997) and numerous articles. Her scholarship today focuses primarily on assisted reproduction. Professor Forman also serves as Of Counsel to the International Fertility Law Group, where she specializes in counseling physicians on informed consent issues and drafting forms that reflect the unique issues faced by fertility clinics and their patients.
Tuesday, April 1, 2014
Julian Savulescu, Dominic Wilkinson, A Costly Separation between Withdrawing and Withholding Treatment in Intensive Care, 28 Bioethics 127 (2014).
Wendy A Rogers, Christopher Degeling, Cynthia Townley, Equity Under the Knife: Justice and Evidence in Surgery, 28 Bioethics 119 (2014).
Erik Malmqvist, Are Bans on Kidney Sales Unjustifiably Paternalistic?, 28 Bioethics 110 (2014).
Monday, March 31, 2014
Deborah Tuerkheimer, Flawed Convictions: 'Shaken Baby Syndrome' and the Inertia of Injustice: Introduction, Oxford University Press, (Forthcoming 2014).
Rebecca Dresser, Building an Ethical Foundation for First-in-Human Nanotrials, 40 J. of Law, Med. & Ethics 802 (2013).
Jennifer A. Chandler, Legally-Coerced Consent to Treatment in the Criminal Justice System, Homes, Jacob and Perron eds. Power and the Psychiatric Apparatus, Ashgate Publishing Ltd. (Forthcoming 2014).
Charity Scott, Ethics Consultations and Conflict Engagement in Health Care, 15 Cardozo J. of Conflict Resolution 363 (2014).[KVT]