Tuesday, November 25, 2014
Guest Blogger Associate Dean and Professor of Law Joan H. Krause: The Complicated Relationship Between Integration and Health Care Fraud
On October 17, CMS announced a one-year extension of the interim final rule on Final Waivers in Connection With the Shared Savings Program. The interim rule, published on November 2, 2011, established waivers of the Stark self-referral prohibitions, the Anti-Kickback Statute, and some civil monetary penalties provisions for certain entities participating in the Medicare Shared Savings Program (MSSP) created by the Patient Protection and Affordable Care Act. Per the interim rule, HHS was required to consider comments and publish a final rule within three years; that deadline has now been extended until November 2, 2015. In announcing the delay, CMS explained that feedback from the initial stages of the MSSP suggested that modifications were necessary before the waiver rule could be finalized.
Monday, November 24, 2014
I'm editing the newsletter for the AALS Section on Law, Medicine and Health Care. I'd love to get news from folks who are AALS members--or news from others that might be relevant to AALS members. I've asked for replies by December 20th, so I can get the newsletter out before the AALS meeting in January.
You can send me all that good stuff here: https://www.surveymonkey.com/s/XWKYJVY
On Friday, November 21, 2014, House Speaker John Boehner, on behalf of the GOP-run House of Representatives, filed a lawsuit alleging that the Obama administration abused executive power with respect to the Affordable Care Act (ACA). The suit, filed against the secretaries of the Treasury and HHS and their respective departments, makes two central claims: one, that the White House acted unlawfully by twice delaying the implementation of the employer mandate and two, that the funds tied to the ACA’s cost-sharing program were not authorized by Congress.
In the recent midterm elections, Tennesseevoters approved a ballot measure thatstripped protection for abortion rights from the state constitution. Legislators have wasted no time in proposing new bills to restrict access to abortion. Tennessee state representative Rick Womick, a Republican, has quickly filed an anti-abortion bill that would impose mandatory ultrasounds and waiting periods for women seeking abortion care. Abortion providers already routinely perform an ultrasound as part of pre-procedure abortion care and give the woman the option to view the ultrasound image—a step that rarely changes a woman’s mind about choosing abortion. The crucial difference between general medical practice and the proposed Tennessee legislation (which is similar to mandatory ultrasound laws in other states), is that the law forces the woman to either view the image or listen to a description of the image regardless of her wishes. Abortion foes push mandatory ultrasound legislation to shame and demean women seeking abortion care.
AALS Annual Meeting Program: An Examination of Patient Dumping By Hospitals After Thirty Years of EMTALA
The Section on Law and Mental Disability is very pleased to announce the exciting panel An Examination of Patient Dumping By Hospitals After Thirty Years of EMTALA.
Our speakers will be:
1. Martin Castro, Chair of the U.S. Commission on Civil Rights;
2. Hernan Vera, President & CEO, Public Counsel (the largest pro bono law firm in the country);
3. Richard Elliott, M.D., PhD., Professor and Director, Professionalism and Medical Ethics, Mercer University School of Medicine (a nationally recognized forensic psychiatrist specializing in EMTALA and mental health disabilities);
4. Katharine Van Tassel, Director of the Public Health Law & Science Center and Health Law Programs and Professor of Law, University of Akron School of Law; and,
5. Moderator Barry Kozak, Director, Elder Law Programs, The John Marshall School of Law.
This panel will be presented on Saturday, January 3, 2015 from 1:30 to 3:15 p.m. at the AALS Annual Meeting. Our co-sponsors are the Section on Law, Medicine and Healthcare, the Section on Disability Law and the Section on Civil Rights.
Here is the description:
The Emergency Medical Treatment and Active Labor Act of 1986 (EMTALA) was designed to ensure equal access to emergency treatment by hospitals and to stop the practice of "patient dumping." Patient dumping occurs when patients needing emergency care— typically uninsured, disabled, and minority individuals— are transferred, prematurely discharged, or are denied treatment altogether. Thirty years after EMTALA was passed, patient dumping is still occurring. And healthcare delivery has changed dramatically, with stunning advances in medical science and the advent of major, national movements toward evidence-based medicine care and systems-based quality improvement.
Have these sweeping changes left EMTALA behind, so out of touch with current practice that it is now harming, rather than helping, equal access to emergency care? What impact will the Affordable Care Act have on EMTALA? What impact is EMTALA having on the push for community-based services, the growing use of telemedicine, medical repatriation and the number of the mentally disabled in prisons? This panel will address these questions and others while analyzing a forthcoming report of the U.S. Commission on Civil Rights on EMTALA. The panel will also share teaching materials on covering EMTALA in doctrinal courses.
The Report of the U.S. Commission on Civil Rights on EMTALA and Patient Dumping was released in September of 2014 and can be found here.
The law of informed consent has been the subject of scholarship for many years, and with good reason. Informed consent is central to the physician-patient relationship, emphasizing patient autonomy. The springboard for the doctrine may have been Canterbury v. Spence, 464 F.2d 773 (D.C. Cir. 1972). Canterbury speaks to the intent of informed consent to apply to a specific treatment or therapy which is recommended for a specific diagnosis.
My most recent law review article, to appear in the Wayne Law Review, addresses the expansion of informed consent to a doctrine of full disclosure, requiring the physician to disclose the differential diagnosis and various tests/treatments to explore the differential diagnosis. The paper focuses on the experiences in Wisconsin, Washington State and Alaska.
Friday, November 21, 2014
Southern Illinois Health Care/Southern Illinois University Medical Legal Partnership Master of Laws Fellowship
Through the generosity of Southern Illinois Healthcare (SIH), lawyers can apply to receive a Master of Laws degree (LLM) in Health Law and Policy from the Southern Illinois University School of Law, while working with Land of Lincoln Legal Assistance Foundation as a SIH/SIU Medical Legal Partnership LLM Fellow. The Southern Illinois Medical Legal Partnership, founded in 2002 as one of the first in the nation, is a nationally award-winning rural collaboration, working with over 18 medical partners in 10 counties. The SIH/SIU MLP LLM Fellow will gain an in depth understanding of the policies and regulations that affect the health care industry, while receiving practical experience eliminating barriers to health care by integrating legal assistance into the medical setting. The Fellowship is for one year, from the Fall 2015 semester through the Summer 2016 semester.
Cassandra Burke Robertson, Private Ordering in the Market for Professional Services, 94 B.U. L. Rev. 179 (2014).
Marc A. Rodwin, Compensating Pharmaceutical Injuries in the Absence of Fault, 69 Food & Drug L.J. 447 (2014).
Michael L. Perlin, Meredith Schriver, 'You Might Have Drugs at Your Command': Reconsidering the Forced Drugging of Incompetent Pre-Trial Detainees from the Perspectives of International Human Rights and Income Inequality, SSRN.
Tuesday, November 18, 2014
Guest Blogger Associate Dean and Professor of Law Joan H. Krause - United States v. Nayak: The Application of Honest Services Mail and Wire Fraud to the Health Care Industry (Part II)
In a prior post, I discussed the Seventh Circuit’s decision in United States v. Nayak, one of the first major “honest services” mail and wire fraud cases to arise since the Supreme Court decided Skilling v. United States in 2010. In Skilling, the Court found clear Congressional intent to limit honest services prosecutions to “offenders who, in violation of a fiduciary duty, participated in bribery or kickback schemes.” (Skilling at 407, emphasis added) As I warned in a 2012 article, the Court’s focus on bribery and kickback activity within the context of a fiduciary duty might have wide-ranging consequences in the health care field given the nature of the physician-patient relationship.
The structure of honest services cases differs from that of more traditional forms of mail and wire fraud, which usually involve perpetrators who defraud victims of money or property. In contrast, these “intangible rights” cases eliminate the requirement that the victim suffer a financial loss to the perpetrator. Nonetheless, such fraud is actionable only when the perpetrator in fact owes a heightened duty to provide “honest services” to the victim. While Skilling grounded that duty in a fiduciary relationship, the majority offered little guidance as to which aspects of the relationship were most important. As Justice Scalia noted in his concurrence: “None of the ‘honest services’ cases . . . defined the nature and content of the fiduciary duty central to the ‘fraud’ offense. There was not even universal agreement concerning the source of the fiduciary obligation – whether it must be positive state or federal law . . . or merely general principles, such as the ‘obligations of loyalty and fidelity’ that inhere in the ‘employment relationship.’” (Skilling at 416-17)
In a recent New York Times editorial, Lynn Paltrow and Jeanne Flavin bring to light the chilling reality of the criminalization of pregnant women in the United States. Stories of prosecutions of pregnant women in other countries, such as El Salvador, have received significant attention. Yet, similar stories within our own borders remain under the radar even while we constantly debate the issue of abortion.
As Paltrow and Flavin point out, the push to restrict women’s access to abortion and expand rights for fetuses impacts more than just those women specifically seeking abortion care. Anti-abortion measures threaten the rights of all pregnant women, even those who want to be pregnant. As Paltrow and Flavin’s peer-reviewed study on criminal prosecutions of pregnant women demonstrates, prosecutors and judges have relied on anti-abortion reasoning to arrest, detain, and force medical treatment on pregnant women who suffered from miscarriages, depression, or simply wanted to make their own medical decisions about how to proceed with childbirth.
Monday, November 17, 2014
Commentators have been weighing in since the Supreme Court decided it would hear King v. Burwell, the case challenging the ability of millions of Americans to receive subsidies to purchase health insurance on federally operated Exchanges under the ACA. Debate swirls over whether a decision striking down these subsidies will gut the ACA or not, but at the very least a ruling in favor of the petitioners would have grave consequences for ACA and the millions that currently receive these subsidies.
There is, however, more at stake in the King case than the ACA. If the Court takes this opportunity to cut down the ACA, it does so at the cost of the principle of separation of powers and the Supreme Court’s institutional legitimacy and credibility.
Guest Blogger Assistant Professor Jessica L. Roberts: Healthism? The EEOC, Employer Wellness Programs, and Discrimination on the Basis of Health Status
Not too long ago, the Department of Labor championed employer wellness programs as vehicles for both promoting public health and cabining health-care spending. Yet judging from recent litigation, the Equal Employment Opportunity Commission (EEOC) feels less sanguine about the potential effects of these kinds of initiatives.
On October 27, 2014, the EEOC filed a complaint against Honeywell, Inc., alleging that the company violated the Americans with Disabilities Act and the Genetic Information Nondiscrimination Act by requiring employees (and their spouses in the case of family coverage) to undergo biometric testing—i.e., measuring employees’ heights, weights, and waist circumferences and screening their blood pressure, cholesterol, and glucose levels—in conjunction with its employer-provided health benefit plan. The EEOC maintained that, despite Honeywell’s protestations to the contrary, failing to take these tests would incur significant penalties, thereby making participation in the wellness program not truly voluntary. It asked the Minnesota Federal District Court for a temporary restraining order and a preliminary injunction enjoining Honeywell from imposing penalties on employees and their spouses who opted out of testing. Just last week, on November 3, the judge denied the request.
HealthLawProf Blog is very pleased to welcome our fifth guest blogger for the month of November, Assistant Professor of Law Jessica L. Roberts. The following is her short bio:
Jessica L. Roberts is an Assistant Professor of Law at the University of Houston Law Center where she teaches Foundational Issues in Health Law, Disabilities & the Law, and Genetics & the Law. Professor Roberts is a pioneer in the area of discrimination on the basis of health-related information. Her work has appeared, or is forthcoming, in the William and Mary Law Review, the Iowa Law Review, the Minnesota Law Review, the Vanderbilt Law Review, the Notre Dame Law Review, the University of Illinois Law Review, the University of Colorado Law Review, the American Journal of Bioethics, and the Journal of Law and the Biosciences. She is a graduate of the University of Southern California and the Yale Law School.
Friday, November 14, 2014
Guest Blogger Assistant Professor Marc D. Ginsberg: Admissibility of Forensic Autopsy Reports in Homicide Prosecutions
Law and medicine are center stage in a controversy percolating in the state and federal courts concerning the admissibility of forensic autopsy reports in homicide prosecutions when the examining pathologist (who performed the autopsy and prepared the report) is unable to testify at trial. At issue is the intersection of hearsay and the Confrontation Clause. Since Crawford v. Washington, 541 U.S. 36 (2004), the courts have been attempting to define “testimonial” hearsay, which, despite the application of a recognized exception to the hearsay rule, no longer trumps the Confrontation Clause. Crawford changed the standards announced in Ohio v. Roberts, 448 U.S. 56 (1980).
Thursday, November 13, 2014
Megan S. Wright, Christopher T. Robertson, Heterogeneity in IRB Policies with Regard to Disclosures About Payment for Participation in Recruitment Materials, 42 J. of Law, Med. & Ethics 375 (2014).
I. Glenn Cohen, Regulating the Organ Market: Normative Foundations for Market Regulation, 77 L. & Contemp. Probs. 101 (2014).
Anna B. Laakmann , The Hatch-Waxman Act's Side Effects: Precautions for Biosimilars, Loyola of Los Angeles L. Rev. (Forthcoming).
HealthLawProf Blog would like to thank our wonderful October guest blogger, Research Fellow and Lecturer in Law Tara A. Ragone. Here is a short recap of her posts:
Continued Debates regarding Antitrust Concerns and Professional Licensing Boards, State Quarantines: Balancing Public Health with Liberty Interests, Valuable Internet Resource Focused on Healthcare Cost Containment and Competition, and Experimenting with Transparency and Decision Support to Inform Health Plan Selection.
A number of studies have suggested that education, wealth, and other socioeconomic factors are more important than health care in promoting a person’s health. Earlier this week, NPR reported on a study of welfare payments that reinforces the link between income and health. Researchers studied children whose families received benefits through the Mothers Pension Program between 1911 and 1935. Compared to children in families that did not receive program benefits, the children of recipients lived longer, and their longer lives might reflect the fact that they stayed in school longer and earned higher incomes during their working days.
[cross-posted at Bill of Health]
Tuesday, November 11, 2014
Guest Blogger Professor Jean Macchiaroli Eggen - In Honor of Veterans Day: Resolving the Complex Legal Issues of the Iraq and Afghanistan Burn Pit Litigation
Every war results in battlefield casualties and injuries. Every war also results in unanticipated health consequences to military service personnel, persons assisting the military, and civilians. In recent history, the Vietnam War was marked by the short- and long-term health consequences of Agent Orange; the 1991 Gulf War left veterans returning home manifesting symptoms of the mysterious “Gulf War Syndrome;” and the ongoing wars in Iraq and Afghanistan have resulted in the adverse health effects of exposure to fumes from burn pits and other environmental contaminants. The burn pits are open areas in which trash, discarded munitions, and other materials were burned – usually by private contractors working under contract for the U.S. Government – before troops moved out of the area. The term is also used generally to encompass the separate water treatment activities of the contractors. The list of illnesses alleged to be caused by these exposures includes various cancers, cardiac conditions, and numerous other organ conditions as well as generalized symptoms. The U.S. Department of Veterans Affairs has set up a health registry for veterans and current servicemembers who were deployed in the Middle East.
Guest Blogger Professor Maya Manian: The 2014 Midterm Elections and Access to Reproductive Healthcare
The Republican landslide in the 2014 midterm elections signals difficult times ahead for securing women’s access to reproductive health care. The conservative wave in state legislatures after the 2010 midterm elections led to an onslaughtof anti-abortion legislation, the effects of which continue to be felt today. For example, sweeping anti-abortion legislation in Texas has shut down over half the state’s abortion clinics so far, leaving many Texas women hundreds of miles from the nearest clinic.
Reproductive health care access—especially access to abortion and contraception—now faces threats from multiple levels of government. First, increasingly conservative state legislatures will continue assailing abortion access with legislation claiming to protect women’s health, such as admitting privileges requirements, that in fact serve no health-protective purpose and instead aim at shuttering abortion clinics. In one of the most heavily fought voter initiatives this election cycle, Tennesseevoters approved a ballot measure thatstripped protection for abortion rights from the state constitution. The measure will unleash anti-abortion forces in the state legislature, who are poised to enact new laws hindering access to abortion care. Of course, state laws will still be subject to scrutiny under the federal constitution in the federal courts—and this is where the Republican takeover in the U.S. Senate comes into play.
HealthLawProf Blog is very pleased to welcome our fourth guest blogger for the month of November, Professor of Law Maya Manian. The following is her short bio:
Maya Manian, professor of law at the University of San Francisco School of Law and a visiting scholar at the Columbia Law School Center for Gender and Sexuality Law for the 2014-2015 academic year, focuses her research on access to reproductive healthcare and explores the relationship between reproductive rights and gender equality. She publishes and presents regularly on abortion rights and related constitutional issues. Her publications include "Lessons from Personhood’s Defeat: Abortion Restrictions and Side Effects on Women’s Health" (Ohio State Law Journal, 2013); "Functional Parenting and Dysfunctional Abortion Policy: Reforming Parental Involvement Legislation” (Family Court Review, 2012); “The Irrational Woman: Informed Consent and Abortion Decision-Making” (Duke Journal of Gender Law & Policy, 2009); “Rights, Remedies, and Facial Challenges” (Hastings Constitutional Law Quarterly, 2009); and “Privatizing Bans on Abortion: Eviscerating Constitutional Rights Through Tort Remedies” (Temple Law Review, 2007). She previously served as a Blackmun Fellowship Attorney at the Center for Reproductive Rights in New York City, where she was a visiting scholar for a series of events during the 2011–2012 academic year. Professor Manian received her undergraduate degree from the University of Michigan and her law degree magna cum laude from Harvard Law School, where she served on the Harvard Law Review.