Telehealth is expanding rapidly outside of the U.S. in both developed and developing countries. Not surprisingly, the expanded use of telehealth presents many of the same regulatory and reimbursement challenges abroad that it does here in the U.S. One region in particular that has taken steps to expand telehealth across borders is Europe, where in an effort to confront the legal issues raised by telehealth, the E.U. has removed and revisited existing regulations. The E.U. has also issued guidance through the European Commission (an institution that is responsible for ensuring that E.U. law is applied and adhered to by all Member States and therefore a key player in regulating the use of telehealth), regarding how best to comply with the regulations in place. In order to provide timely and effective guidance on rapidly evolving technologies, the Commission publishes staff working documents which interpret the law and provide compliance guidance, but are not legally binding themselves. One such document is the “Commission Staff Working Document on the applicability of the existing E.U. legal framework to telehealth services”, dated June 12, 2012. The Document provides guidance on how to comply with E.U. law, but for those in the U.S., reading this guidance also brings to light where the E.U. and the U.S. diverge with respect to key legal issues such as licensure and reimbursement.
Licensure
Under the existing framework, the Europeans have done a good job providing expanded access to care and have accomplished this at least partially through their licensure rules. The licensing structure in the E.U. is similar to the one in the U.S., wherein each individual state is tasked with licensing requirements and enforcement. However, the E.U. system differs where cross-border healthcare, such as telehealth, comes into play because of what is called the “country-of-origin principle”. This principle, a component of the eCommerce Directive (enacted by the E.U. in 2000 to set up an Internal Market framework for electronic commerce and to provide legal certainty for business and consumers), is the key difference between the U.S. and the E.U. regarding licensure issues. Under the “country-of-origin principle” a service provider in the E.U. is practicing medicine legally if he or she complies with the licensure requirements in his or her own Member State and treats the patient from within his or her Member State. This is true regardless of whether the patient is located in another Member State and irrespective of the requirements in that other Member State.
The “country-of-origin principle” is the exact inverse of how licensure works in the U. S. Within the U.S., the doctor must be licensed in the same state as the patient he is treating regardless of whether the treatment is via telehealth. This restricts patients’ access to doctors who are not licensed in their states and impedes access to cutting-edge technology such as remote monitoring. To change the licensure requirements in the U.S. and make telehealth more accessible, there would need to be changes at the state level across the country, or a federal licensure law would need to be adopted.
Reimbursement
A clear formula for how a provider would get paid for telehealth services, how much he or she would be paid, and what procedures he or she would get paid for, is crucial to the development of new health technology and the future practice of telehealth in the U.S. and in the E.U. In the U.S., Medicare reimbursement has not kept up with the times. However, about a third of the states have adopted legislation known as telehealth parity statutes which require private insurers to cover telehealth services if they would otherwise cover in-person provided services. In these states, as well as states without telehealth parity statutes, many health plans are beginning to cover telehealth services.
In the E.U., there is a Directive (Article 3(d) of Directive 2011/24/EU) on the application of patients’ rights in cross-border healthcare stating that cross-border health care services utilizing telehealth or other types of eHealth services must be reimbursed if the individual or patient resides in a country that reimburses the eHealth service. This is extremely positive for individuals residing in countries that reimburse telehealth services, as they will be reimbursed if they decide to utilize telehealth services. However, those individuals whose home countries do not reimburse for telehealth are barred from access to these technologies or doctors in other countries unless they are willing to pay out of pocket. One example of this is Germany, where the costs of telehealth are only reimbursed by health insurers in exceptional cases. As a rule, patients have to pay for such health services out of their own pockets. Other countries like France reimburse several categories of telehealth services at the same levels as traditional in-person services. French Social Security will pay for some telehealth services including teleconsultation (physicians conduct consultation remotely), teleexpertise (physicians solicit advice from peers), telemonitoring (physicians monitor remotely patient data), and teleassistance (physicians can assist nurses or other medical personnel in the completion of medical acts). In the Netherlands, phone and e-mail consultations are reimbursed via fixed prices by health insurance companies. Although the E.U. has yet to present a harmonized reimbursement picture, in countries like Sweden and the U.K. small telehealth projects are publicly funded. It seems the authorities are still testing the waters before fully committing.
The different approaches taken by the E.U. and the U.S. partially reflect the different health care systems in place as well as the differences in legal structures between the two. On the one hand, the U.S. has struggled with its fragmented approach. On the other hand, Europe, known for its heavy regulation, has embraced a less regulated path in terms of licensure to make way for the expansion and adoption of telehealth into mainstream medical practice. Yet in terms of reimbursement, both the U.S. and the E.U. are struggling with limited reimbursement capability. Regulators, whether in the U.S. or in the E.U., are often criticized for not keeping up with rapid innovation. That is also true for payors.
Oftentimes when public authorities are slow to take action, the industry and the patients themselves will adopt innovative products and technologies. It will not be long before both the U.S. and the E.U. will be forced to see the value of telehealth and to understand that earlier development of health technology and improved incorporation of telehealth into accepted medical best practices is crucial to broader access and better health care.