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Telemedicine in Rural Communities: Navigating the Legal Issues in this New Frontier of Health Care Delivery

posted on Tue, Dec 8 2015 2:54 pm by Brittney Bauerly

Rural communities experience significant health disparities and face unique challenges regarding access to health care providers. Although a quarter of the U.S. population lives in rural areas, only ten percent of physicians practice in these rural areas. There are 2,157 Health Professional Shortage Areas in rural and frontier areas of all states and U.S. territories compared to 910 in urban areas. Transportation is a significant barrier to health care access in rural communities, and many rural residents have to travel great distances to reach a clinic or a hospital.

Telemedicine, the use of technology to deliver health care services from a distance, is one tool that can improve health care access in rural communities. Telemedicine can increase quality of care and reduce costs by reducing readmissions and unnecessary emergency department visits for rural communities. Telemedicine can allow timelier access to specialists and can bring specialized health care to remote areas of the country where specialty care was previously unavailable. Electronic communications can connect providers who serve in remote areas to create “virtual professional communities” to improve patient care. Mobile health technology can facilitate tracking of patient vital signs, can be used to communicate with patients in their homes, and can facilitate medication monitoring in infectious disease control. Telemedicine drones, currently under development, can extend the reach of providers and clinics by carrying medicine and medical supplies to remote areas.

While telemedicine can help reduce health care barriers in rural communities, providers face legal, regulatory, and practical challenges in extending services to rural areas through telemedicine applications. Although substantial progress has been made in removing barriers to the wider utilization of telemedicine, legal challenges remain.

Reimbursement

Lack of reimbursement for telemedicine services has been one barrier which has prevented providers from investing in these technologies. In recent years, however, telemedicine reimbursement by private and public payers has significantly expanded. Thirty-two states and D.C. have now enacted laws regarding private payer reimbursement for telemedicine. Forty-seven states and D.C. now have some form of telemedicine coverage in their Medicaid programs. Medicare covers a limited number of telemedicine services, subject to certain requirements on geography, practice setting, type of service, and eligible technology. For example, Medicare will reimburse for telemedicine services when the originating site is in a Health Professional Shortage Area, although the originating site must be a medical facility and the telemedicine consultation must occur via live video, among other requirements.

Professional Licensing

Most states require that a health care provider have a license to provide services in the state where the patient is located. Obtaining licensure in multiple states can be time-consuming and expensive. Some states offer a special telemedicine license to practice across state lines, but for such telemedicine licensing to work there must be cooperation among the states.

Medical Malpractice

Medical malpractice standards and regulations vary by state. The obligations of medical malpractice insurance carriers to cover out-of-state medical malpractice claims must be examined on a state-by-state basis. Some medical malpractice insurance carriers may assert that they are only required to cover claims against a provider when the provider performs medical services in the state where the provider is licensed. Providers practicing medicine across state lines must ensure that their malpractice liability insurance policy extends coverage to multiple states to avoid being subject to uninsured claims.

Data Privacy and Security

If the provider or organization is classified as a “covered entity” under HIPAA, the telemedicine application used must have settings that are HIPAA-compliant and are also compliant with state data practices statutes. The application used and the system in place must protect the privacy and confidentiality of patient information, and the system must also be secure.

FDA Regulations

If a mobile application meets the definition of a medical device under the Federal Food, Drug and Cosmetic Act, the mobile application may be subject to FDA regulations. However, the FDA has issued guidance stating that it intends to apply its regulatory oversight only to those medical applications that are medical devices and whose functionality could pose a risk to the patient’s safety if the application were to not function as intended.

Fraud and Abuse

Providers incorporating telemedicine into their business models must take care in ensuring that the model does not violate federal fraud and abuse laws, such as the Anti-Kickback Statute, the Stark Law, and the False Claims Act. The Office of Inspector General has issued advisory opinions addressing telemedicine-related fraud issues that may be helpful to providers.

Telemedicine has enormous potential to improve health care access and health outcomes in rural communities. However, successful implementation of rural telemedicine applications will require close attention to a myriad of evolving state and federal laws and regulations. If you have questions about telemedicine laws and regulations and their application to advance rural public health, please feel free to contact the Network for legal technical assistance.

This blog post was developed by Brittney Crock Bauerly, J.D., Staff Attorney for the Network for Public Health Law–Northern Region.

The Network for Public Health Law provides information and technical assistance on issues related to public health. The legal information and assistance provided in this post does not constitute legal advice or legal representation. For legal advice, readers should consult an attorney in their state.

Support for the Network is provided by the Robert Wood Johnson Foundation (RWJF). The views expressed in this post do not necessarily represent the views of, and should not be attributed to, RWJF.

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