Friday, August 24, 2012
USA - A Closer Look at Telemedicine's Legal Issues
Five legal issues require scrutiny prior to launching a telemedicine program.
Doctors have been practicing some form of telemedicine since before the invention of the telephone. And while the communication technology has evolved—doctors can now conduct a video consultation with colleagues in the next county or on the next continent—laws governing these events have not kept up.
There is no universal law of telemedicine, and different states take significantly different approaches to regulating it. Consequently, jumping into telemedicine without first analyzing a few critical legal issues could have serious consequences.
Following are five of the most important legal issues facing health care providers who are contemplating telemedicine.
State Licensure and Credentialing of Physicians
Health care organizations and physicians contemplating a telemedicine arrangement face complicated licensure and credentialing issues because telemedicine often involves a doctor in one state consulting with a doctor who resides in a different state or even a different country. Licensing of physicians is a state government function, and each state develops its own rules regarding physician licensure. Unfortunately for telemedicine providers, states have not adopted a uniform approach to telemedicine.
Some states, such as California and Ohio, have created specific legislative provisions addressing telemedicine, while others, such as Indiana, have not addressed it at all. Therefore, depending on the locations of the providers and the patients in a telemedicine arrangement, the providers may need a special telemedicine certificate, may need to be fully licensed in certain states or may need to do something else entirely before providing any services.
Similar issues arise with respect to physician credentialing. For example, the Joint Commission has established credentialing standards specifically addressing telemedicine. They state that the place where the patient resides retains responsibility for “overseeing the safety and quality of services offered to its patients,” but may credential telemedicine providers at distant sites under certain conditions.
Both parties must analyze licensing and credentialing issues and plan their telemedicine arrangement to ensure they are able to comply with each state’s and accrediting agency’s requirements.
Liability for Patient Injuries
If a patient is injured after receiving telemedical care, who bears the liability for the harm? The patient’s primary care physician will likely be the main target of an action that alleges malpractice or other wrongdoing if a patient is harmed. However, a consulting specialist may also be implicated. Just because the specialist engaged in a limited consultation and never physically treated the patient does not eliminate the possibility of legal liability for patient harm. Some courts have held that a physician who merely consulted with another physician about an anonymous patient’s medical care will not be held liable for injuries the patient sustains while in the primary physician’s care. However, the potential liability of the consulting physician usually increases as the physician gets more involved in the patient’s care.
Traditionally, medical malpractice liability hinges on the existence of a physician-patient relationship. Most courts examine multiple factors to determine whether a physician-patient relationship was developed and will likely continue to do so in the telemedicine context. Courts look at whether the consulting physician met the patient, reviewed the patient’s medical records, knew the patient’s name, received a fee for the consultation or exerted control over the patient’s care. To protect themselves, both the primary care physician and the consulting specialist physician should analyze, individually, their potential liability before entering into a telemedicine arrangement.
FDA and State Regulations
Depending on the types of technology used and the services provided in a telemedicine arrangement, state and federal regulations may be implicated. For example, software and hardware used to practice telemedicine may be regulated by the U.S. Food and Drug Administration as medical devices. Providers using only a telephone or simple videoconference hookup may have little to worry about as far as FDA regulations are concerned, but parties developing new telemedicine technologies may unwittingly be creating a medical device strictly regulated by the FDA.
In addition to FDA regulations, telemedicine providers must also consider state regulations. Some states have instituted specific rules governing the use of the Internet, e-mail and similar technologies when treating patients. What is commonplace and accepted in one state may be illegal in another.
Telemedicine providers should analyze the FDA implications of their telemedicine arrangement and review each relevant state’s statutes and regulations concerning the use of Internet, e-mail and related technologies in the treatment of patients.
Security of Patient Health Information
Protecting the privacy of patient health information is a critical requirement for health care providers. Although HIPAA and state privacy laws are not necessarily different in the telemedicine context, telemedicine may create additional risks of inadvertent disclosure of patient health information. The security rule sets forth numerous provisions related to the use, maintenance and disclosure of electronic patient health information. State laws provide additional restrictions on the use of patient health information. In response, providers must implement appropriate safeguards to protect patient health information exchanged in a telemedicine arrangement, including computer security measures, business associate agreements and appropriate policies controlling the use and disclosure of patient health information.
Although telemedicine is gaining broader acceptance, not all telemedicine services are reimbursable. Through the Balanced Budget Act of 1997 and later the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000, Congress took steps toward reimbursing some telemedicine services, including telemedicine consultations for Medicare beneficiaries in rural areas that have a shortage of health professionals. Whether a particular telemedicine service qualifies for reimbursement, however, depends on the exact nature of the service and strict compliance with the Medicare regulations.
As with all things Medicare, failing to comply with the regulations when seeking reimbursement for telemedicine services or seeking reimbursement for non-reimbursable services can have devastating consequences. The Department of Health & Human Services’ Office of Inspector General has been aggressively prosecuting Medicare fraud and will not hesitate to impose significant criminal and civil penalties in appropriate circumstances.
Telemedicine can play a critical role in providing access to health care, especially in underserved areas. First, however, providers must take steps to ensure they are complying with federal and state laws and regulations as well as licensing and credentialing organizations’ requirements.
David D. Storey
David D. Storey is an attorney with Baker & Daniels, Fort Wayne, Ind.