Surprise! The Doctors at Your In-Network Hospital Are Out-of-Network

Guest Post by Erin C. Fuse Brown

Nick Bagley has written a great post at the Incidental Economist responding to Elisabeth Rosenthal’s recent article in the NY Times on out-of-network emergency physician billing.  This phenomenon arises when a patient goes to an in-network hospital, but the physicians staffing the emergency room are out-of-network. As a result, patients get balance-billed by the out-of-network physicians for large amounts that are not subject to their deductible or out-of-pocket limits.  I wanted to pile on to the moral outrage and add some thoughts about legal solutions.

(1)   DOL and HHS should issue rules to include out-of-network physician services provided at an in-network facility (not just emergency rooms) in calculations of an individual’s out-of-pocket maximum.

Nick suggests that the Department of Labor require out-of-network emergency services to count toward the ACA’s out-of-pocket spending cap. HHS should do the same for plans sold on the Exchange. Emergency rooms are an easy target, because in an emergency most people have little choice but to go to the nearest ER or the one to which the ambulance delivers them. My 2-year old fell and hit her head when we were traveling out of town, and I can personally attest to the difficulty of trying to figure out whether the nearest ER is in-network even for a law professor who writes about the perils of balance billing.

However, the out-of-network doctor problem goes beyond emergency care. Even for non-emergencies, you could dutifully select an in-network hospital and in-network surgeon to perform your hip replacement or bypass surgery, but the anesthesiologist or the other physicians working on you may be out-of-network, and you would be stuck with a large out-of-network charge. So the regulatory solution must reach beyond emergency services.  Continue reading

Ebola Update: Why Don’t We Seem to Care?

By Deborah Cho

It’s been over half a year since the beginning of the current Ebola outbreak in West Africa, yet the number of cases and deaths from the disease continue to rise.  The total case count as of September 29, 2014 is 6,574 and total deaths are at 3,091.  Even so, the international response, as a whole, seems to be lacking.  As I lived near the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia this past summer, I was acutely aware of the Ebola epidemic’s magnitude while it had the media’s attention.  The attention given was similar to that given to a car accident on the side of a road as onlookers drive on by without stopping to offer help.  Unfortunately, it was quite clear that aid efforts were woefully inadequate and that the disease would continue to spread rapidly without a stronger response.  It seemed that though our curiosity about this virus was at an all-time high, our national concern for the epidemic and its casualties were extremely minimal other than in the brief moments when we were faced with prospect of flying in two of our own infected citizens.  Continue reading

Are we appropriately framing the risks of brain trauma in contact sports?

By Christine Baugh

The recent concussion and sport special issue of the Journal of Law Medicine and Ethics (generously made available free by the American Society of Law Medicine and Ethics: HERE), edited by new Bill of Health contributor David Orentlichter,  includes a number of important works discussing legal and ethical issues related to mild traumatic brain injury sustained through sport. One of the most thought provoking articles in the issue is a piece by Kathleen Bachynski and Daniel Goldberg titled Youth Sports & Public Health: Framing Risks of Mild Traumatic Brain Injury in American Football and Ice Hockey. This piece delves into the important issues of cultural and normative influences on the framing (and thus public understanding) of the risk of brain injury in sport. At the heart of the paper is the assertion that, “The framing of risk is not a neutral, apolitical enterprise,” and that in the United States and Canada highly influential institutional actors such as football and ice hockey leagues have played a formative role in the cultural valuation of the risks inherent in these activities.

Bachynski and Goldberg provide a variety of examples where the overarching questions such as “Are contact sports too risky?” or “What is an appropriate level of risk?” are deferred for easier alternatives. Addressing more focal issues are: State concussion laws which mandate secondary prevention measures, advancement in protective equipment which promises to mitigate risk of injury, rule changes made by sports leagues which aim to make inherently dangerous activities somewhat less dangerous. Rather than addressing the broader risk questions, the implicit assumption in these more focused efforts is that risks are acceptable as long as they are managed. Through what Bachynski and Goldberg assert are concerted efforts on behalf of major stakeholders (e.g., major sports leagues), this has been the predominant frame for risk assessment in contact sports.

Unfortunately, this method of framing risks is not without consequences. Bachynski and Goldberg argue that this framing may alter our understanding of the scope of the problem as well as the most appropriate interventions or solutions. This frame may also inappropriately downplay the need to address the broader moral, social, and political questions that arise from concussions in contact sports. For example, the authors pose the following question, “At what age can players consent to risks of head trauma and associated elevated risks of chronic degenerative neurological disease?”

Answering this question could require a complex weighing of the scientific evidence of the long-term risk of neurodegeneration and balancing it against a variety of factors such as the paternalistic desire to control the population’s ability to partake in self-injurious behavior and the need to protect an individual’s autonomy. (We do, after all, regularly let individuals partake in other dangerous activities—e.g., downhill skiing or driving a car.) We would need to think about questions such as: Should we treat the risk of brain injury differently than bodily injury? Should the risk of delayed or chronic injury be weighed differently given humans’ known difficulty in assessing risk in the distant future? What does scientific evidence have to say about the nature of the risk across age ranges? However, under the current framing these questions are not the ones being addressed. Bachynski and Goldberg’s article elucidates the first step toward addressing concussions from sport: appropriately framing the problem.

[This post reflects my own views only.  It does not necessarily represent the views of the Petrie-Flom Center or the Football Players Health Study at Harvard University.]

Conference on Digital Experimentation (CODE) at MIT Sloan

Screenshot 2014-09-30 18.19.55Another stop on my fall Facebook/OKCupid tour: on October 10, I’ll be participating on a panel (previewed in the NYT here) on “Experimentation and Ethical Practice,” along with Harvard Law’s Jonathan Zittrain, Google chief economist Hal Varian, my fellow PersonalGenomes.org board member and start-up investor Ester Dyson, and my friend and Maryland Law prof Leslie Meltzer Henry.

The panel will be moderated by Sinan Aral of the MIT Sloan School of Management, who is also one of the organizers of a two-day Conference on Digital Experimentation (CODE), of which the panel is a part. The conference, which brings together academic researchers and data scientists from Google, Microsoft, and, yes, Facebook, may be of interest to some of our social scientist readers. (I’m told registration space is very limited, so “act soon,” as they say.) From the conference website:

The ability to rapidly deploy micro-level randomized experiments at population scale is, in our view, one of the most significant innovations in modern social science. As more and more social interactions, behaviors, decisions, opinions and transactions are digitized and mediated by online platforms, we can quickly answer nuanced causal questions about the role of social behavior in population-level outcomes such as health, voting, political mobilization, consumer demand, information sharing, product rating and opinion aggregation. When appropriately theorized and rigorously applied, randomized experiments are the gold standard of causal inference and a cornerstone of effective policy. But the scale and complexity of these experiments also create scientific and statistical challenges for design and inference. The purpose of the Conference on Digital Experimentation at MIT (CODE) is to bring together leading researchers conducting and analyzing large scale randomized experiments in digitally mediated social and economic environments, in various scientific disciplines including economics, computer science and sociology, in order to lay the foundation for ongoing relationships and to build a lasting multidisciplinary research community.

The Father of Sunshine

Paul Thacker

By Christopher Robertson

Over at our sister blog for the Safra Center’s Institutional Corruption Lab, Paul Thacker has a great post about how the Physician’s Payments Sunshine Act came to exist. The new database created by the Act is just now going live, and its a good time to reflect on how we got here. Thacker was a staffer for Senator Chuck Grassley, and from that vantage, has rare insight into how the bill was conceived and how initial objections of Big Pharma were overcome. Thacker also outlines several complementary efforts, including pressure to reform NIH policies around conflicts of interest. That proposal went all the way to the White House, where it was gutted. Worth reading.

Tomorrow: Conversation with the HHS Office of the Inspector General

pills_white_closeup_slideA Conversation with the HHS Office of the Inspector General

Tuesday, September 30, 2014 12:00 PM – 1:00 PM

Wasserstein Hall, Room 3018, Harvard Law School, 1585 Massachusetts Ave.

Please join the Petrie-Flom Center for a conversation with the Boston office of the U.S. Department of Health and Human Services Office of the Inspector General (OIG), Office of Evaluation and Inspections.  OIG has for decades served as the foremost government watchdog of federal healthcare programs, overseeing Medicare, Medicaid, the Food and Drug Administration, the National Institutes of Health, and the Centers for Disease Control and Prevention.  Among other topics, the Boston office’s recent work has focused on the labeling of dietary supplements and human subjects protections, including the informational risks associated with biospecimen research and other topics.

Come hear about the work of the OIG, its role in the Department of Health and Human Services, and some of its current and past projects.  We will be joined by Joyce Greenleaf, MBA, Regional Inspector General, and Jessica Fargnoli, MPH, Program Analyst (biographical details below).  Matthew Lawrence will moderate.

Lunch and refreshments will be served.  Co-sponsored by the Petrie-Flom Center and Harvard Catalyst.

Colorado Personhood Version 4.0

By Jonathan F. Will
[Cross-posted at Hamilton and Griffin on Rights.]

This November citizens of Colorado will have an opportunity to vote on a proposed amendment (Amendment 67) to their state constitution that would define the words “person” and “child” in the Colorado Criminal Code and Colorado Wrongful Death Act to include “unborn human beings.”  Similar personhood measures were rejected by a margin of 3-to-1 by Colorado citizens in 2008 and 2010, and a proposal in 2012 failed to receive the requisite signatures to get on the ballot.  Is this version 4.0 all that different?

A New Strategy

In short, the language is different, but not in ways that ought to matter for those concerned about the implications for reproductive rights.  I was initially surprised that a fourth personhood proposal was able to secure enough signatures to get on the ballot when the third measure was not.  After speaking with a reporter from Colorado, it became clear that the strategy this time around was very different.

This most recent personhood effort rode the wave of momentum generated by the 2012 story of a Colorado woman, hit by a drunk driver, who lost her pregnancy in the eighth month of gestation (a boy she had named Brady).  At that time, Colorado did not have a law on the books that permitted the drunk driver to be prosecuted for the death of the fetus.  Amendment 67, advertised as “The Brady Amendment” was offered as a solution, and there was no trouble generating over 100,000 signatures.  Even without Amendment 67, Colorado has since passed a Crimes Against Pregnant Women Act, which criminalizes (with varying degrees of punishment) the termination of a woman’s pregnancy without her consent.  This new law does not define the fetus as a person, expressly permits women to choose to have abortions, and certainly is not considered to go far enough for those in favor of sweeping personhood measures.  Amendment 67 was thus still viewed to be necessary by some. Continue reading

Upcoming Event: Petrie-Flom Center Annual Open House

PFC_Logo_300x300Petrie-Flom Center Annual Open House

October 6, 2014, 5:30 PM – 7:00 PM

Harvard Law School
Wasserstein Hall, Milstein East B
1585 Massachusetts Ave, 2nd Floor, Cambridge, MA [Map]

Come learn more about what the Petrie-Flom Center does and how you can get involved at this gathering for faculty, colleagues, and students with shared interests in health law policy, biotechnology, and bioethics.  We will review our sponsored research portfolio, introduce our staff and fellows, describe various opportunities for students and others, and demonstrate key features on our website.  And of course, we’ll eat, drink, and be merry.  Hope to see you there!

The Open House reception will immediately follow the Legal and Ethical Issues in Healthcare Start-Ups Panel.

Vaccination Policy and Public Trust

By Kelsey Berry

The conflict between a physician’s dual roles as an agent of population health and an agent of his or her patient is exemplified in the classical debate about ethical vaccination policy. Whereas studies have demonstrated the role of vaccination in protecting public health at negligible risk to individuals, “vaccine hesitancy” and non-acceptance among parents has increasingly contributed to vaccination delay and refusal. Recent domestic measles outbreaks and increased numbers of reported infections in 2011 and 2013 gesture to the public health impacts of even small decrements in uptake, especially in a globalized setting where the infection can travel easily.[1]

The FORUM at Harvard School of Public Health recently hosted an event on vaccination, exploring through an expert panel the drivers of public perception about vaccination and ways of restoring public trust in vaccination. Panelists discussed the need for research into the values and concerns of those who exhibit vaccine hesitancy, and development of effective modes of communication, tailored to individuals’ concerns, that will allow trained physicians to effectively guide choice. Notably, the clinical encounter was brought up several times as fertile ground for both reestablishing trust and promoting vaccine uptake effectively.

Reestablishing public trust in public health interventions may be key to avoiding conflicts between physicians’ duties to both population health and patients/guardians. If the patient/guardian ultimately expresses support for vaccination, as a result of persuasive information supplied by the physician, the conflict seems to disappear. However, what about the case in which a patient expresses support for vaccination as a policy, but does not support the use of vaccination in the case of his or her own child (assuming for simplicity that there are no medical contraindications to vaccination in this child’s case)? This scenario brings out a possible duality in the held views of patient/guardians. There seem to be two competing views within one patient/guardian: first, the view that we as a society should promote population health through vaccination, and second the view that one’s own person/child should be exempt from vaccination. Continue reading

Medical Marijuana Delivery May Not Be As “Eazy” As It Seems

By Arielle Lusardi, BA, JD/MPH (’17)

As state medical marijuana laws proliferate throughout the country, companies are trying to secure their own piece of the action. In July 2014, a San Francisco-based start-up company, called Eaze, launched a mobile application that facilitates the delivery of medical marijuana in California. Continue reading

Being Blunt About Product Safety: The problems with the lack of uniformity in medical marijuana laws

By Holly Jones, BA, JD candidate

How can the federal government ensure consumer safety in an industry that distributes a substance the federal government classifies as an illegal drug? The federal government effectively banned the use of marijuana nationwide with the Controlled Substance Act of 1970, classifying marijuana as a Schedule I substance according. Regardless of this federal prohibition, 23 states and Washington, DC have legalized marijuana for medical use. A lack of federal legalization allows states to independently enact their own distinct medical marijuana laws.

In a dataset released yesterday on LawAtlas.org, the distinctions become clear — there are currently 24 variations of medical marijuana program product safety guidelines in the United States, some of which bear little, if any, resemblance to one another. While some states, like Connecticut and Massachusetts, provide incredibly comprehensive guidelines for their medical marijuana programs, others provide skeletal legislation and instead grant a great deal of autonomy to local jurisdictions.

While variation may allow researchers to more effectively evaluate the approaches, from a patient-safety perspective, uniformity has its advantages. Continue reading

A Lack of Pep for PrEP

By Emily Largent

The Kaiser Family Foundation (KFF) recently conducted a survey of gay and bisexual men in the U.S. focusing on attitudes, knowledge, and experiences with HIV/AIDS.  The survey results, released Thursday, can be found here.  I was most interested in the finding that only a quarter of those surveyed know about PrEP (pre-exposure prophylaxis).

PrEP (brand name Truvada) is a combination of two medicines (tenofovir and emtricitabine) that has, if taken consistently, been shown to reduce the risk of HIV infection in people who are high risk by up to 92%.  The FDA approved an indication for the use of Truvada “in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk” in 2012.  The U.S. Public Health Service released the first comprehensive clinical practice guidelines in May of this year. Continue reading

How much promise do safety-net ACOs really hold?

The Health Affairs blog recently published an important write-up of the status of safety net ACOs. Therein, authors James Maxwell, Michael Bailit, Rachel Toby and Christine Barron offer five “key observations regarding emerging safety-net ACOs and suggest broad policy implications” which are drawn from what appears to be a fairly extensive research project including “site visits and telephone interviews with 66 safety-net ACO leaders and state officials conducted over the last two years in 14 states.” Generally, they leave the reader with an optimistic impression of safety-net ACOs efforts to achieve population health – which contrasts with my previous post on Bill of Health.

In short, the authors offer the following observations:

  1. State policy is a key factor in the formation of safety-net ACOs.
  2. Both health policy experts and those involved in forming ACOs consider health homes, high-cost case management, and integrated behavioral health to be priority delivery system transformations for ACOs in the safety-net.
  3. It takes money to save money: upfront capital and financial flexibility are required for investment in delivery system transformations.
  4. Safety-net ACOs are adopting payment and delivery system transformations incrementally.
  5. Building on a long-standing recognition of how non-medical factors impact health outcomes and utilization, safety-net ACOs are addressing social determinants of health through community partnerships.

The entirety of the post is well-written and I encourage folks to check it out for themselves. My concerns about the ACO model do still largely hold, however. While the authors of this blog highlight four states (MA, OR, AL and MN) with policies on the books to encourage creativity in safety-net ACO design, that leaves 46 others without such supportive legislation. In short, I think we are still working at the margins here. Moreover, I worry that the authors have chosen a definition of ACO that goes well beyond what CMS considers to be an ACO and in so doing have spotlighted “bright lights” of the health care delivery landscape that may not have the metrics and results to support their claims at innovation. The authors offer us little information about what kind of improvements either in quality of care or health outcomes these safety-net ACOs have been able to achieve. (Meanwhile, CMS recently released the latest quality metrics on the Pioneer and Shared Savings ACOs they sanction and monitor.)

The bottom line is this: safety-net ACOs, like all ACOs, certainly hold promise. The question is whether we will translate this promise into systems-level change.

Job Opportunity: Tenure-Track Professor in Health Care Law

[View the original posting here.]

Creighton University School of Law invites applications for a lateral tenured or tenure-track professor in health care law to join our faculty in Fall 2015.  Applicants should have significant academic or practice experience in the business side of health care (e.g., the financing and regulation of health care, including but not limited to the Affordable Care Act).  Creighton University has seven health care schools on its campus, as well as a College of Arts and Sciences and a College of Business, and the Law School is particularly interested in establishing interdisciplinary programs with those schools for non-JD as well as JD students.  Candidates with experience in developing such programs are especially encouraged to apply.  Candidates should have excellent academic credentials and a proven record of (or demonstrated potential for) outstanding classroom teaching and scholarship.

Applicants should apply online to Eric Pearson, Chair of the Faculty Appointment Committee, Creighton University School of Law. Please include:

  • a cover letter explaining the candidate’s interest in the position and the contributions she or he contemplates to our mission and academic enterprise
  • a curriculum vitae
  • if available, course evaluations for prior teaching engagements
  • a representative example of scholarship and/or a research agenda.

Continue reading

Introducing Robin Pierce

Pierce_peopleRobin Pierce, JD, PhD, contributes to the HealthLawProf Blog, and is joining Bill of Health as a regular contributor.

Robin is Senior Law Associate with the Petrie-Flom Center for Health Law and Policy, Biotechnology and Bioethics at Harvard Law School. She was formerly on the faculty of Technische Universiteit Delft in The Netherlands where her work focused on the legal, ethical, and policy implications of advances in biotechnology, including policy issues in the integration of nanotechnology in health care, regulatory, policy, and ethical issues in governance of synthetic biology, and policy, legal, and ethical issues arising from advances in Alzheimer’s disease research, and neuroscience, in general. In 2014 Dr. Pierce was appointed Associate Editor for Science and Genetics with the Journal of Bioethical Inquiry. In 2010 she was appointed Programme Leader for the Kluyver Center program on Society and Genomics in The Netherlands. She has taught across disciplines including such courses as Remedies (law), Social Issues in Biology, Ethic, Legal, and Social Issues in the Life Sciences, Public Health Ethics, and the Development of Legal and Political Institutions.

Representative Publications:  Continue reading

9/29/14: HLS Health Law Workshop with Benjamin Roin

HLS Health Law Workshop: Benjamin Roin
September 29, 2014 5:00 PM
Griswold Hall, Room 110 (Harvard Law School)
1525 Massachusetts Ave., Cambridge, MA [Map here.]

Download the Paper: Solving the Problem of New Uses by Creating Incentives for Private Industry to Repurpose Off-Patent Drugs

Benjamin N. Roin is Assistant Professor of Technological Innovation, Entrepreneurship, and Strategic Management at the MIT Sloan School of Management and an associate member of the Broad Institute of MIT and Harvard. From 2010 to 2014, as a faculty member at Harvard Law School, Ben was Faculty Co-Director of the Petrie-Flom Center. Ben’s work focuses on entrepreneurship, intellectual property, and innovation policy.  His primary areas of research are patent law and biopharmaceutical innovation.

Lessons from Miss Idaho: Greater Acceptance of (but Not Necessarily Greater Access to) Diabetes Devices

By Kate Greenwood
[Cross-posted at Health Reform Watch]

Given the health law and policy topics that are this blog’s usual fare, some of you may have missed the fact that earlier this month the eighty-eighth annual Miss America pageant was held here in New Jersey, at Boardwalk Hall in Atlantic City. And you may have also missed it (I did) when, this past July, Miss Idaho, Sierra Sandison, a Type 1 diabetic, became a social and traditional media sensation after she competed in the swimsuit competition with her insulin pump clipped to her bikini bottom, visible for all to see. Sandison started a hashtag, #showmeyourpump, inspiring Type 1 diabetics from around the world to post photos of themselves with their pumps.

Although Sandison was the first contestant to compete in the Miss America pageant with her pump visible, she is not the first contestant with Type 1 diabetes, or the first to rely on a pump. In 1998, both Deana Herrerra, Miss New York, and Nicole Johnson, Miss Virginia, had the disease, and both relied on pumps to control it. Johnson went on to be crowned Miss America 1999, with a platform of diabetes awareness. Johnson explained to the Philadelphia Inquirer that, before getting the pump, “‘I stuck myself four or five times a day. I was getting scar tissue. I was feeling depressed, and I thought, `I’m never going to have an iota of freedom.'” Since getting the pump, Johnson said, “‘Now, I control the diabetes.”’

Sierra Sandison’s decision to wear her diabetes pump on her hip both contributed to and was the result of a trend toward greater acceptance of medical devices and our need for them. (As Miriam Tucker reported at NPR, “Amputees are increasingly using visible prostheses rather than covering them up. And the ostomy community has its own version of the ‘show me’ campaign.”) Nicole Johnson told Tucker that “‘Our culture seems to be more accepting today, as opposed to when I was diagnosed in 1993.'”

Perhaps unsurprisingly, the increase in acceptance has not translated into easy or uniform access to the medical devices that help diabetics manage their disease, including insulin pumps, insulin pens, and continuous glucose monitors. Continue reading

HHS Issues Guidance on Same Sex Spouses and HIPAA

By Leslie Francis

[Cross-posted at HealthLawProfs blog.]

Under HIPAA, patients’ spouses and other family members have certain rights to access health information. In an important guidance document in the wake of United States v. Windsor, the Office for Civil Rights (OCR) at HHS has clarified that “spouse” under HIPAA refers to legally married same-sex spouses, even if the individual is receiving services in a jurisdiction not recognizing same-sex marriage.  Continue reading