INTERVIEW: I. Glenn Cohen, Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School

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[email protected] http://petrieflom.law.harvard.edu/ About I. Glenn Cohen I. Glenn Cohen is professor of Law at Harvard Law School, and director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. He is one of the world’s leading experts on the intersection of bioethics (or medical ethics), and the law, as well as health law. He also teaches civil procedure. Prior to becoming a professor, he served as a law clerk to Judge Michael Boudin of the U.S. Court of Appeals for the First Circuit, and as a lawyer for U.S. Department of Justice, Civil Division, Appellate Staff, where he handled litigation in the Courts of Appeals and in the U.S. Supreme Court. He was selected as a Radcliffe Institute Fellow (2012-2013) and by the Greenwall Foundation to receive a Faculty Scholar Award in Bioethics. He also leads the Ethics and Law initiative as part of the multi-million dollar NIH-funded Harvard Catalyst for The Harvard Clinical and Translational Science Center program. Professor Cohen is the author of more than 80 articles and chapters, and his award-winning work has appeared in leading legal law review journals, including: Stanford, Cornell, and Southern California; medical journals including the New England Journal of Medicine, and JAMA; bioethics journals including the American Journal of Bioethics, the Hastings Center Report; and for public health, the American Journal of Public Health. He is the editor of The Globalization of Healthcare: Legal and Ethical Issues (Oxford University Press, 2013) and the author, editor or co-editor of six other books already published or in production. His newest book, Patients with Passports: Medical Tourism, Law, and Ethics, is now available from Oxford University Press http://www.amazon.com/Patients-Passports-Medical-Tourism-Ethics/dp/0199975094 . The Press has allowed him to post the first two chapters of the book, containing the book’s introduction and the most up to date and complete data on the medical tourism industry online for free download: http://ssrn.com/abstract=2514371 . About Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School was founded in 2005 through a generous gift from Joseph H. Flom and the Carroll and Milton Petrie Foundation, with the goal of promoting interdisciplinary analysis and legal scholarship in these fields. The Center is not an advocacy organization, but rather is dedicated to the unbiased analysis of pressing questions facing health policymakers. The future promises to raise new and fascinating issues that will make these interdisciplinary analyses all the more important. Scientific advances are pushing the boundaries of existing thinking on everything from what defines a human life to what constitutes an ethically tenable area of research, as well as raising complex issues about the appropriate role of intellectual property. At the same time, transformations in healthcare financing and business practices, changes in the role of health law, and the growing realization that the environment’s direct link to human health has upset traditional professional and market paradigms. The founding vision of the Petrie-Flom Center is to promote scholarly inquiry that breaks away from existing disciplinary lines and brings the totality of these disciplinary methodologies under its compass to inform policy. To achieve this goal, the Center fosters a community of leading intellectuals, practitioners and policymakers from a variety of backgrounds and at all stages in their careers. Medical Travel Today (MTT): Give our readers some background on your newest book: Patients with Passports: Medical Tourism and Law and Ethics. I. Glenn Cohen (IGC): Before this publication, I spent a great deal of time as an academic bystander in the medical travel space. To enhance my knowledge about the industry, I began to attend FAM tours and regional meetings, and engage in conversations with health geographers, lawyers and medical travel enthusiasts. As I gradually expanded my background, I realized there are many unanswered inquiries around the legal and ethical issues of the industry – which is what motivated me to author this piece. MTT: Give us a preview of the contents. IGC: The first 260 pages of the book are devoted to the legal side of medical travel, and the latter half pinpoints the borders of medical travel legality or illegality. The initial half details medical tourism as it is most widely known: patients traveling for high-quality, affordable and legal treatment services in a foreign location. The second portion of the book addresses consumers traveling to foreign locations to seek illegal treatments, which may include: abortion, assisted suicide, stem cell therapy that is not yet approved by the FDA, reproductive technology, etc. The book begins with my attempt to gather all of the medical travel data that is currently available, but more broadly encompasses the nature of the industry, i.e., popular treatment destinations, pricing, etc. Unfortunately, the majority of data available on the industry is more hype than fact, with only estimates available for public review. The initial section details quality, and in particular, the way information is and is not available, as well as the travel of pathogens between locations, multi-drug resistant bacteria, and more. In this era of Ebola, we are very much aware of the way the law does, or does not, generate incentives to provide information to patients and insurers who need to make a medical decision. MTT: Does the book address legal liability and other aspects of insurance? IGC: Yes, and it includes when one can sue a medical practice if involved in medical travel, and how treating destination hospitals can protect themselves against legal action. In the third chapter of the first half of the book, I discuss private health insurance in the U.S., employers that utilize a medical travel benefit in their plans, what law governs whether insurers can offer incentives and coverage, the liabilities an insurer or employer face, and plan design. Next, it focuses on public health insurance, especially in the E.U., issues regarding prior authorization, and when home countries must reimburse others. I also briefly make a suggestion that Medicaid and Medicare should provide coverage which enables medical tourism, and examine the way in which one U.S. government plan allows portable coverage – the TRICARE policy for military veterans who retire abroad. The final chapter in the first half of the book glances at the effects of medical tourism on destination countries, examines the existing empirical literature on the positive and negative effects of the industry, and questions what our obligations are to these countries. MTT: Do you focus on Americans traveling outside of the country? IGC: Americans are my primary focus, but I am also interested in inbound medical tourism, inter- European medical tourism, and Middle Eastern medical tourism. MTT: How would you characterize the current volume of medical travelers? IGC: The destinations where you will find the best data comes from places such as Malaysia, where the government collects the data. When it comes to Americans traveling for care, the Affordable Care Act (ACA) has slightly changed the composition in terms of who is engaging in medical travel. As an increasing number of individuals are getting insurance, and therefore gaining healthcare coverage, the number of individuals traveling and paying out-of-pocket is decreasing. On the other hand, I see a growing number of employers and insurers opting for a medical travel benefit, and sending employees and their dependents to a number of different locations. We must not forget about the undocumented aliens in America who are omitted from participating in the exchanges – these individuals are major medical travel enthusiasts, often forced to pay out-of-pocket. MTT: Will the growth of U.S. domestic travel have an impact on the outbound market? IGC: Yes, the growth of U.S. domestic travel for medical services will have some impact on the outbound market, but the price differentials in the U.S. are not large enough to be in competition with the price differentials in the international market. When patients travel within the U.S. it’s more often than not based on quality, accessibility or specialty care, rather than cost. Most of the outbound medical travel in the U.S. is based on price competition or “price shopping” because an insurer has issued a check. MTT: Which treatments seem to be the most popular among patients traveling internationally? IGC: I see a lot of patients traveling for heart bypasses and valve replacements, hip replacements, knee replacements, spinal fusions, hip resurfacing, gastric bypasses and mastectomies. Dental procedures, including crowns, teeth whitening and implants, have become quite attractive to medical travelers, as well. Lastly, cosmetic surgeries are prevalent among medical travelers – breast augmentations, rhinoplasties, etc. MTT: Do you see a definite move toward bundled pricing, including revisions, readmissions or any problematic outcomes? IGC: Certainly as the market becomes more competitive between countries, bundled pricing will be marketed as a selling point. Patients seem to find bundled pricing attractive, but the actual percentage of individuals who utilize this approach is unknown at this point. For me, a more attractive approach encompasses legal liability, which bundles a form of insurance which provides coverage for medical malpractice and doesn’t require the traveler to return abroad to take legal action if necessary. This makes it an easier process going forward with your medical malpractice lawsuit. MTT: What does that legal realm of medical travel consist of now? IGC: I always tell individuals, “If you go abroad for medical travel and treatment goes wrong, your ability to recover in the court is very, very weak.” On one hand, it is very unlikely you will be able to sue international facilities or providers in a U.S. court, and if one does sue them, they would be governed by a medical malpractice law, that by American standards, merits lower remuneration. It would be a totally different experience to filing a medical malpractice claim with a law firm like Noll Law Office in the US. If you look at the medical malpractice law in Thailand, or Malaysia, or Mexico, the kind of recoveries you see Americans making, in terms of top dollars, are almost nonexistent. If one has to sue an international facility or provider in a foreign court, they are in an even worse position because there is a major delay in many of the court hearings for medical malpractice action -local officials and doctors must testify. If the medical malpractice ends in death, this could also be brought to up against the doctors in question, since the family and loved ones are likely to seek help from a law firm similar to Valiente Mott who might be able to help with their case. This might be different if medical malpractice happens overseas; however, so seek legal advice would be advised. There is only one published decision I’ve ever seen about a case that went to trial and had a decision, and the fact pattern is very unlike medical tourism. As I recall it involved someone in police/prison custody. Either people are discouraged from taking legal action, or in many cases, foreign hospitals have a strong public relations team to settle the cases quickly and quietly. Most facilities are unwilling to provide data on adverse events, which makes it hard to tell if we are not seeing lawsuits because there are not a lot of errors, or because patients think it’s too hard to win. MTT: Have you interviewed employers in different countries that are concerned with liability? IGC: I’ve talked with a number of employers who are very interested in the medical travel industry as a whole. First, employers must make sure the Employee Retirement Income Security Act (ERISA) interacts with state insurance law in a way that allows them to build medical travel into their plans. The ERISA preemption states that if you are a self-insured employer you can virtually avoid the majority of state level regulation of health insurance, which is good news because that regulation will often make medical tourism legally problematic. Many employers are more concerned with the way medical travel looks from a public relations perspective rather than a cost-savings standpoint. Since the ACA requires all Americans to have health insurance, many employers are under pressure to find affordable plans, leading to medical travel. MTT: Do you think the medical travel market will explode or grow steadily? IGC: Personally, I believe it is a watershed moment for the industry when ABC News produces a positive story on a company that gives it’s employed individuals the option of traveling to Costa Rica for care. The initial media coverage on medical travel was very negative, and now, coverage is based on curiosity and interest. Employers are still trying to resume balance after the implementation of the ACA, but I do believe that this is an industry that will grow steadily, especially on the insurance side. MTT: When choosing locations, hospitals and providers outside the U.S., is there any value to an accreditation program? Is Joint Commission International (JCI) still the benchmark? IGC: Yes, JCI and its accreditation standards still seem to be the benchmark for institutions. For international facilities, collaborating with well-known U.S. institutions seems to be a marketing tactic, as well. If you observe the way JCI accredits, it’s really a process-based accreditation system, rather than an outcome-based system, and just because those requirements have been met doesn’t guarantee that the morbidity and mortality rates will be excellent. The reason I would rather travel to a JCI -ccredited institution is because, to me, it means that the destination country picked this institution to be its flagship – it has invested a lot of time and resources to ensure positive publicity. A portion of my book argues that we still need a plan to push facilities to disclose more data, regardless of accreditation. MTT: What are your thoughts on patients traveling to the U.S. for treatment? IGC: Again, the data is not great, but I do believe most people see the growth of outbound medical tourism, and in particular, inter-regional tourism. Post 9/11 and post-9/11 security has turned some of the Arab world away from seeking medical treatment in the U.S. There has been a rise in the number of individuals traveling for care from one middle-income country to another, but if these individuals want the best cancer treatment or high-tech surgery, they will travel to the U.S. regardless. MTT: Are U.S. hospitals marketing more aggressively to attract foreign patients? IGC: Marketing plans are definitely in place, but hospitals are in a much more competitive situation now than they were five or 10 years ago. Again, the growth of outbound medical tourism from the U.S., and elsewhere in the world, has allowed facilities in Malaysia, Korea, Singapore, Thailand and others to look attractive to patients now, but may not have been viable 10 years ago. MTT: Do you see potential for a medical travel benefit to be incorporated into Medicare, Medicaid and/or Workers’ Compensation? IGC: I would think Workers’ Compensation might be the easiest to incorporate a medical travel benefit, in part because it is mostly state law, not federal. Medicare is completely federal, and Medicaid is joint federal and state. But to be honest this is not an area I have studied so I would want to research more before giving a firm answer. As I mention in my book, the one place government will pay for medical travel is the retirement plan for individuals who serve in the military – the Tricare plan. If you are an individual who retires abroad, the U.S. government will cover your healthcare and pay for it with U.S. federal government dollars. MTT: What are the less common procedures that people travel abroad for? IGC: I call this “circumvention tourism” because people are trying to circumvent domestic rules. Many individuals travel, particularly to China, for stem cell therapy, in an effort to curb conditions ranging from Autism to impotence to Down-Syndrome. We have very little evidence that stem cells are useful outside of areas such as blood source human stem cells. There have been documented cases where some children have developed brain tumors, and there’s very little regulation and disclosure about what type of stem cell is being used during treatment. There are many reasons to be concerned with this practice, but on the other hand, despite the serious risks, I’m very sympathetic to these situations – especially with parents who have terminally ill children. MTT: What are your thoughts on the negativity around surrogacy? IGC: I believe there are two sets of issues around surrogacy. One issue is the exploitation of surrogates in the developing world and whether they are really being exploited or treated appropriately. The other issue is about the recognition of children born abroad. Parents are now faced with great immigration difficulties when they try to bring the child back to their home country, and that is a concern that many parents haven’t fully wrapped their heads around. I would advise anybody who is considering traveling abroad for surrogacy, or any reproductive technology, to meet with a family law expert who can handle a case like this to guarantee they will be able to bring their child home.

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