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.
Reimbursement
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.
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