One of the workshops at the World Medical Tourism Congress focused on the legal issues surrounding Medical Tourism. The Legal Workshop addressed liability, business challenges, tax issues, clinical trials, and cross-border hospital affiliations. Scott Edelstein, Esq. with Squire, Sanders, and Dempsey, L.L.P. (SSD) focused on the best way to structure your medical tourism program while protecting your organization.
Michael Kosmas, Esq. (SSD) presented on the Legal and Business Challenges in international mixed-use projects. The issues and emerging destinations of clinical trials was discussed in detail by Maureen Bennett, Esq. (SSD). Paul Gallese, Esq., from Alvarez & Marsal addressed practical strategies in developing cross-border hospital affiliations, and in finale, Michael Meissner, Esq. (SSD) spoke about tax issues related to management, operation and development of foreign facilities by US hospitals.
We had the opportunity to interview Scott Edelstein and Maureen Bennett from Squire, Sanders, and Dempsey, L.L.P. regarding medical tourism and how they are involved. “As a law firm, there are a lot of legal issues involved in establishing a medical tourism program.
These come from a variety of sources ranging from health insurers, to providers, to medical tourism agencies, and vendors. All of these sources are grappling with a number of legal issues that are relatively unique and new, because the industry is so new,” reports Edelstein.
According to Edelstein, SSD has a unique vantage because they work in all regions. “We have the largest global practice in healthcare issues and we are able to represent a number of countries as we have attorneys on the ground in each region. We have seen what the issues are. There is a massive migration of patients traveling to seek medical care. We have started seeing a larger amount of the uninsured in the US, topping 50 million and with it, seeing more US citizens going overseas.”
Bennett tells us that one of the ways Squire, Sanders and Dempsey first got involved in medical tourism was through life science companies. “Because we have a very active practice in Europe, Asia, and Latin America, we came to medical tourism as a global firm, through clinical trial related work.
Although medical tourism encompasses different things; life sciences is seeing some value in having dedicated centers in certain parts of the world, with more and more trials being done outside the US and more joint ventures and collaborative relationships developing.”
Bennett further says, “Under a narrow definition of medical tourism, clinical trials do not come to mind. The trends in clinical trials are a subset of medical tourism. Some of the reasons as to why Life Science companies are very interested in doing trials abroad are with a view to commercialization. It is an open and important requirement in order to obtain approvals if a U.S. company wants to market in the European Union or China.
A measure of prudence to have test results on local populations in a country that a company is looking to market its products. All those are reasons why we are seeing an increase in clinical trials abroad. There are so many technical specialists in so many different countries; the availability and presence of key knowledge leaders is global.”
“Just as we have seen in other areas; having competition for medical services has to provide better services for consumers,” comments Bennett. “Another question is that of insurance; there are a large number of insurance companies attending the Congress meeting. When we find major insurance companies present that adds to the credibility of a destination of services that is being offered.”
Edelstein also comments on quality. “The issue of quality is very important to insure that patients are receiving good quality of care. Guidelines and parameters should follow. Quality is an issue that we have not been able to compare apples to apples. We have not been able to compare the U.S. with overseas providers,” he said.
“Not to suggest that the best and highest quality care is here in the U.S..; but we should be mindful of the facts,” advises Bennett. “The MTA is working on identifying metrics, but so much is based on voluntary reporting. Accuracy of information is an issue,” reports Edelstein, who is on the MTA’s advisory board.
Licensing may also be an issue. Patients need to be aware that practitioners they see are not licensed as in their home country; so the standards of care may be different, as with quality differences as well and informed consent could be another issue. “For example, we are pushing very hard to inform patients of risks involved,” says Edelstein. “Finally, there are risks in medical tourism, involving travel and different methodologies for treatment and diagnoses.
Informed and contained consent needs to be addressed along with post care procedures. There is some reluctance in the provider community to provide post care after the patient has been treated by someone else.” Bennett recommends, “It is important to have an understanding of where the risks and legal rights might be; so that any prudent consumer who might ask about the levels of protection if they seek services elsewhere will be aware of these risks.”
One emerging solution to post care involves interest between providers in setting up affiliations. “For example, an overseas provider affiliating with a U.S. center can establish similar credentials and requirements. Overall, I have not seen horror stories on botched surgeries. There has not been much publicity of negative outcomes when we consider the numbers of people going overseas,” reports Edelstein.
In conclusion, Bennett states, “We would stress that just like everything else in the world is becoming global; if we are talking about the possibility of achieving greater quality of life; and an extension of life; one can only assume the sky is limit in terms of developing this area. After all, nothing is more vital than to keep ourselves healthy and alive. And having alternatives and choice is a very positive message.”
“What we see the MTA arranging with the Congress meeting, is an opportunity for the exchange of ideas. It is an opportunity to provide practical approaches as to issues that many are dealing with. And it is through this exchange of ideas that will drive growth in the medical tourism industry,” comments Edelstein.
“Personally, I have a real passion in this area. I believe the healthcare system is broken and medical tourism is one of the ways of addressing these issues. However, I do not think it’s the final answer. What we are seeing from an advocacy standpoint is that medical tourism may ultimately create enough awareness such that legislators recognize our system is broken. Medical tourism may be the catalyst for ultimately fixing the healthcare system.”