The Record-Breaking Resolution of a Groundbreaking Fraud Investigation

By Zack Buck

After more than four years of investigation, and 70 separate agreements, the Department of Justice (DOJ) announced news Friday of a massive $257 million settlement, covering a record-breaking 457 hospitals, for the alleged fraudulent placement of implantable cardioverter defibrillators (ICDs) between 2003-2010. I have previously written about the twists and turns of this particular nationwide investigation—the most prominent example of the medical necessity-based health care fraud investigations—herehere, and here.

Why ICDs initially caught the attention of the DOJ seemed to be the fact that ICDs are highly expensive—costing Medicare about $25,000 per implantation—and, following a whistleblower’s lawsuit in 2008, the DOJ commenced a review of “thousands” of ICD placements nationwide. As I have written about before, hospitals across the country—including renowned hospitals such as the Cleveland Clinic—were included in the initial review, but not all of ended up on the settlement list (a full list of settling hospitals is available here).

Although the full details of the settlement have not yet been made public, there seems to have been a difference between all of the hospitals that placed ICDs outside of Medicare’s timing guidelines and those that the DOJ felt were particularly egregious (apparently less than half of the hospitals on the original investigation list ended up as part of this settlement). This is important because it may indicate a difference—in the DOJ’s thinking—between Medicare’s coverage standard, and its “medical necessity” standard for purposes of fraud enforcement.

Continue reading

Monday, 11/2, HLS Health Law Workshop with Jaime King and Erin Fuse Brown

HLS Health Law Workshop: Jaime S. King and Erin Fuse Brown

November 2, 2015, 5:00 PM
Lewis International Law Center, Room 214A
1557 Massachusetts Ave, Cambridge MA 02138

Download the paper: “State Options for Managing the Double-Edged Sword of Vertical Health Care Integration”

Jaime S. King is a Professor of Law and the Associate Dean and Co-Director of the UCSF/UC Hastings Consortium on Science, Law and Health Policy, the Executive Editor of The Source on Healthcare Price and Competition, and the Co-Director of the Concentration on Law and Health Sciences. In 2015, she also received the UC Hastings Foundation Faculty Award for Outstanding Scholarship.

King’s research examines some of the most complex challenges facing the U.S. healthcare system. An advocate for health reform, King focuses on the drivers of healthcare costs, with a special interest in market consolidation and efforts to improve transparency in healthcare pricing. In conjunction with Consortium Senior Fellow, Anne Marie Helm, she founded The Source on Healthcare Price and Competition, a multi-disciplinary web-based resource for information and analysis about healthcare cost and competition.

King’s scholarship also examines questions of individual autonomy and the states’ police power. Specifically, she focuses on medical decision making and constitutional and regulatory questions regarding reproductive genetic testing. Currently, she is collaborating with UCSF faculty to examine the legal and ethical implications of conducting whole genome sequencing on newborns. Continue reading

How does the Bipartisan Budget Bill change Social Security Disability Benefits?

On Tuesday, details of the new Bipartisan Budget Bill, a bill negotiated between Congress and the White House, were released. This bill funds the government for two years and extends the debt ceiling, two important budgetary moves Speaker Boehner promised to leave his successor with a clean slate. Less reported is that this bill makes some small but important changes to our nation’s two largest budgetary social programs, Medicare and Social Security. But the changes made to Social Security Disability Insurance eligibility extend beyond that program and will be important for state Medicaid agencies and for low-income people with disabilities.

What is the Social Security Disability Trust Fund?

Not part of the original Social Security Act, the Disability Insurance (SSDI) benefit was added in 1957. As of 2014 there were 10.9 million Americans receiving this benefit totaling $141 billion or 4% of the federal budget. In the last Trustees report for the projected future cost of the SSDI program, the trustees projected the exhaustion of the trust fund in 2016. This would mean that the nearly 11 million beneficiaries would see their benefits cut by 19% next year because incoming tax revenue would only be able to cover about 80% of the benefits.

Continue reading

23andMe Releases Transparency Report About Law Enforcement Requests for Customers’ Data

By Katherine Kwong

The direct-to-consumer genetic testing company 23andMe was widely discussed in the news recently after it announced it would resume providing health information to customers. Less widely reported was another important announcement: for what appears to be the first time, 23andMe has released a public report about the number of requests it has received from law enforcement seeking its customers’ genetic information. According to the Transparency Report, 23andMe has received four requests for user data from law enforcement, with five different affected users.

Although 23andMe has thus far successfully fought off all of the law enforcement requests for its users’ data, there has long been concern about the potential release of 23andMe’s customers’ information to law enforcement. The 23andMe Privacy Statement states, “23andMe will preserve and disclose any and all information to law enforcement agencies” when it believes it is required to do so. Even though 23andMe has not yet disclosed any of its users’ information, the day may soon come when it is required to do so. That disclosure could have significant impacts for not only users who consented to the use of their data, but for users’ families, who may be implicated through familial DNA searches.

Continue reading

‘The Week in Health Law’ Podcast

By Nicolas Terry

twihl 14x14

This week we interview Christy Ford Chapin, author of  Ensuring America’s Health: The Public Creation of the Corporate Health Insurance System (Cambridge University Press, 2015). Chapin is an assistant professor of twentieth-century political history at the University of Maryland, Baltimore County, and a visiting scholar at Johns Hopkins. Her interests include political, business, and economic history as well as capitalism studies. Chapin has won numerous wards including a Miller Center for Public Affairs Fellowship and a John E. Rovensky Fellowship in American Business and Economic History.

Our discussion’s themes included “everything old is new again:” it turns out that many au courant cost-cutting ideas were part of health policy discourse in the 1960s, 50s, and even 40s. We also explored the validity of the conventional wisdom on the rise of employer-sponsored insurance. And we considered what health policy might look like, if it were better informed by history.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy.

Subscribe at iTunes, listen at Stitcher RadioTunein and Podbean, or search for The Week in Health Law in your favorite podcast app.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Hormonal Treatment to Trans Children – But what if?

A few weeks ago I ran across this BuzzFeed post, telling the story of Corey Mason, a 14 year old male to female Trans teenager who was filmed getting her first pack of estrogen hormones. Her mom Erica, who uploaded the video to Facebook and YouTube, spurred a social-media discussion on the topic of hormonal treatment for Trans children and youth.

Erica said the vast majority of reactions were very supportive. On the other hand, different views and opinions were put on the table as well, even from people who ally completely with Trans identity politics.  One of them, a Trans woman, said she fears from rushing (perhaps gay) teenagers into irreversible treatments, as most Trans kids “GROW OUT OF IT”. Aoife commentThis position was also taken by Alice Dreger, a Bioethicist and a historian writing on Intersex issues, in describing the uneasy choice between the two models available at the moment: On the one hand you have the ‘therapeutic model’ offering mental health support to the Trans person and/or family, to help ease up the tensions caused by gender identity dysphoria (GID). This model aims to relax the dysphoria and so avoids any medical irreversible interventions. On the other hand, you have the ‘accommodation model’ asserting there’s nothing wrong with the trans person and/or his/her family, and so offers medical interventions to accommodate it.[1]

Continue reading

Our Curious Medicare Vaccine Reimbursement System

By George Maliha, Harvard Health Law Society

As flu season begins, we are bombarded by ubiquitous reminders to get our flu shot. So, it is a good opportunity to reflect on how we provide vaccines to our fellow citizens 65 and older. By law, Medicare Part B covers 4 preventive vaccines (flu, two pneumococcal, and hepatitis B for medium-to high-risk patients). Part D picks up the rest, namely shingles, TDaP, and any other commercially available vaccine. But, that’s where the trouble begins.

When Congress passed Part D, the vaccines recommended for those 65 or older were basically covered by Part B. Now, they aren’t. In 2006, the zoster (or shingles) vaccine came onto the market. In 2010, the recommendations for the TDaP (the P for pertussis or whooping cough being the most relevant here) changed to include the elderly.

But, so what, they’re still covered, right? Continue reading

China to Reform Review and Approval Process for Drugs and Medical Devices

China’s Standing Committee of the National People’s Congress (NPC), the country’s legislature, will hold a meeting from October 30 to November 4 to review the authorization of the State Council, the central government, to carry out a pilot program that will introduce market authorization holder of drug (MAH) system and reform the drug registration system. On August 9, the State Council issued the Opinions on Reforming Review and Approval Process for Drugs and Medical Devices (RAP Opinions). Since several key reform measures initiated by the RAP Opinions involve amendments to China’s Drug Administration Law, the State Council must receive the authorization of the NPC. If the authorization is approved by the NPC, the reform of China’s RAP will be accelerated.

The direct pressure for reform comes from the very serious backlog for RAP in China. As of August, there was a backlog of 21,000 applications, and large backlogs have appeared repeatedly in the past decade. For example, there was a backlog of 17,000 in 2005 and a backlog of 27,000 in 2008. These backlogs attract more and more criticism, both from companies and patients. Patients, unable to benefit from a new drug, especially those made by foreign companies and that have proven successful and effective in other territories, have suffered. Some patients have to either rely on  smuggled drugs or conduct expensive medical tourism. Now, the State Council seems determined to reform the broken RAP system completely, with the following key reforms:

Continue reading

Introducing New Blogger Peng Zhao

Zhao_peopleThe Petrie-Flom Center is pleased to welcome Visiting Scholar Peng Zhao to the Bill of Health as our newest contributor, who will blog primarily about China’s drug and food law and regulatory policy.

Peng Zhao earned his BA (2003), MA (2009), and PhD (2009) in law from the China University of Political Science and Law (CUPL, Beijing). He serves as associate professor of law and vice director of the Center for Government Reform and Development at CUPL. Peng’s research and teaching interests include food law, administrative law, and risk regulation theory. He has authored more than a dozen articles on food law and risk regulation theory, and is now presiding over two research projects sponsored by the Chinese central government on these two fields. Peng is a director and member of the Chinese Association of Administrative Law, and deputy secretary general of a committee affiliated with this organization which focuses on legal issues on governmental regulation. Peng has also participated actively in professional service activities. He had served as member of an expert commission for the National Health and Family Planning Commission on amendments to Chinese Food Safety Law, and currently is serving as advisor to the Ministry of Science and Technology on amendments to Chinese regulation of laboratory animal management. In addition, Peng was recently recognized by CUPL students as one of the Top Ten Popular Teachers at CUPL from 2013 to 2015.  Continue reading

Monday, 10/26, HLS Health Law Workshop with Adam Kolber

HLS Health Law Workshop: Adam Kolber

October 26, 2015, 5:00 PM
Lewis International Law Center, Room 214A
1557 Massachusetts Ave, Cambridge MA 02138

Download the paper: “Two Views of First Amendment Thought Privacy”

Adam Kolber is a Professor of Law at Brooklyn Law School. He writes and teaches in the areas of health law, bioethics, criminal law, and neurolaw and is affiliated with the Law School’s Center for Health, Science, and Public Policy and the Center for Law, Language & Cognition. In 2005, he created the Neuroethics & Law Blog and, in 2006, taught the first law school course devoted to law and neuroscience. He has also taught law and neuroscience topics to federal and state judges as part of a MacArthur Foundation grant. Professor Kolber has been a visiting fellow at Princeton University’s Center for Human Values and at NYU Law School’s Center for Research in Crime and Justice. His work has been frequently discussed in the media, including the New York Times, Wall Street Journal, and USA Today.

Kolber began his academic career on the faculty of the University of San Diego School of Law. Before that, he clerked for the Honorable Chester J. Straub of the U.S. Court of Appeals for the Second Circuit and practiced law with Davis Polk & Wardwell in New York. He graduated Order of the Coif from Stanford Law School, where he was an associate editor of the Stanford Law Review. Prior to law school, he was a business ethics consultant at PricewaterhouseCoopers.

Among his recent publications, Kolber has written “Unintentional Punishment,” 18 Legal Theory 1 (2012); “The Experiential Future of the Law,” 60 Emory Law Journal 585 (2011); “The Subjective Experience of Punishment,” 109 Columbia Law Review 182 (2009); “The Comparative Nature of Punishment,” 89 Boston University Law Review1565 (2009); and “A Limited Defense of Clinical Placebo Deception,” 26Yale Law & Policy Review 75 (2007).

UDI Adoption: A Necessary Step Towards Better Care for Patients with Implanted Devices

By Dalia Deak

In the United States, though many millions of individuals live with implanted devices, it may shock you to know that it is easier to recall tainted dog food than it is to recall a faulty pacemaker. This is due in large part to the lag of the medical device world behind most other industries in the implementation of a standardized system that can uniquely identify and track medical devices as they move through the supply chain to a patient. Such an identification system has existed for most products since stores implemented the UPC and Congress mandated that drugs be labeled with the National Drug Code, both of which were introduced in the early 1970s.

To remedy this lag, Congress, in FDAAA of 2007, tasked the FDA with the creation of a unique device identification (UDI) system. In 2013, FDA published a Final Rule regarding manufacturer labeling of UDIs, to be rolled out by class in the coming years. While the establishment of such a system would certainly constitute an important step forward, another number on a label will do little to enhance patient safety on its own. Rather, the value of UDIs is in the uptake of the identifier at each point in a medical device’s life—from manufacturer to distributor to provider to patient to payer (see this report I co-authored on this very issue). Continue reading

IU Fairbanks School of Public Health seeks Center for Health Policy Director

I’m pleased to share with my Bill of Health colleagues that my home department, the Department of Health Policy and Management at the Indiana University Richard M. Fairbanks School of Public Health in Indianapolis, is seeking a Director for its Center for Health Policy.

The full announcement can be found here.

This is a great opportunity for a senior researcher interested in joining a rapidly growing and dynamic department sitting at the center of a health sciences campus that includes the following collaborators:

as well as strong relationships with a large health care system, a progressive public hospital, and local, state, national, and international NGOs and agencies.

Introducing the Harvard Health Law Society

10689774_809751895714130_4010610321675415773_nThe Harvard Health Law Society (HHLS) is a student organization at Harvard Law School, dedicated to exploring issues at the intersection of health and law while connecting students and experts for active engagement. It is made up of students at Harvard Law, as well as other Harvard students, interested in health policy, health care law, biotechnology, bioethics, health and human rights, and a range of other health and law topics.

We are excited to announce that, as part of an ongoing collaboration with the Petrie-Flom Center, members of the Health Law Society will be contributing bloggers this year. Our first two bloggers will be:

Matt Ryan photo_HLS

Matthew Ryan

HLS Class of 2017

 

 

HHLS Blogger Goerge Maliha

George Maliha

HLS Class of 2018

 

 

Welcome to Bill of Health, HHLS!

Public Safety and Public Health

This morning I saw an announcement about a new initiative called “Law Enforcement Leaders to Reduce Crime and Incarceration” and thought it was an important thing to share on this blog. This alliance consists of 120 top current/former police commissioners and prosecutors, including both district attorneys and state attorneys general. These law enforcement leaders have come together to influence legislation and public opinion around mass incarceration. Their first project: supporting the Sentencing Reform and Corrections Act of 2015, a bipartisan bill currently moving through the Senate. This issue matters because there are currently over 2.2 million people in American prisons and jails.

The United States incarcerates more of its citizens than any other nation on earth, and by a disturbing margin: we have just 5 percent of the world’s population, but 20 percent of the world’s prisoners. What’s more, our prison population has grown by over 500 percent since 1978. At any given moment, one in 35 Americans is in prison, on parole, or on probation.

Why is criminal justice a health policy issue? Well, there are many reasons, but let’s start with the fact that the largest mental health provider in the United States is the Cook County Jail. This does not reflect well on our criminal justice policy or our health policy.

Continue reading

Worth Reading This Week

By Nicolas Terry

EVENT (11/12-13): The New Health Care Industry – Integration, Consolidation, Competition in the Wake of the Affordable Care Act

SolomonConfLogoThe New Health Care Industry: Integration, Consolidation, Competition in the Wake of the Affordable Care Act

Thursday, November 12 Center Launch, Celebratory Reception with speaker Kathleen Sebelius — former Secretary, Health and Human Services 4:00–6:30pm
Friday, November 13 Inaugural Conference 8:30am–5:00pm
Attendance to both events it free, but registration is required.

This conference marks the launch of the new Solomon Center for Health Policy and Law at Yale Law School. The Solomon Center is the first of its kind to focus on the governance, business, and practice of health care in the United States. This conference will mark the first under the Center, which will focus on bringing together leading experts and practitioners from the public and private sectors to address cutting-edge questions of health law and policy. Continue reading

Seeking Applicants! Executive Director, Solomon Center for Health Law and Policy at Yale Law School

Sterling_Law_Building,_YaleSolomon Center for Health Law and Policy at Yale Law School: Executive Director

The Yale Law School is delighted to announce the launch of the Solomon Center for Health Law and Policy, an exciting new Center at Yale Law School dedicated to training the next generation of health law leaders—academics, CEOS, lawyers, and government officials—and having an impact today on the most important health care issues.

The Solomon Center is seeking applications for the position of Executive Director. The Solomon Center coordinates a diverse program of activities that serve students and scholars at Yale and contribute both locally and internationally to the study of health law—with a particular focus on health governance, industry and the practice of medicine. Continue reading

Pre-Approval Access Symposium: Can Compassion, Business, and Medicine Coexist?

Dates: October 28 – 29, 2015
Location: The New York Academy of Sciences, 7 World Trade Center, NYC
Presented by: NYU School of Medicine and the New York Academy of Sciences
Event URL: www.nyas.org/CompassionateUse

Explore challenges surrounding pre-approval access to investigational medicines through a series of debates featuring prominent representatives of governments, pharmaceutical companies, patient groups, NGOs, and foundations in this two-day colloquium.

Agenda topics include:

  • Perspectives from Patient Advocates on Compassionate Use and Expanded Access
  • The Case of Josh Hardy and Social Media’s Impact
  • Lessons Learned from the Ebola Virus Epidemic on Compassionate Use during a Crisis
  • Key Issues from Stakeholders’ Perspectives When Considering a Compassionate Use Request
  • Legislative or Regulatory Changes on Compassionate Use and Expanded Access

Continue reading