By Geoffrey B. Davis What is telemedicine?
What exactly is telemedicine? Pretend you have a horrible headache and visit your family practice physician or walk-in clinic where you undergo a thorough examination. The physician becomes concerned with what she sees. Your provider recommends referral to a neurologist for a follow-up diagnosis and treatment plan. The problem is, you live in southern Indiana near Evansville, and I-69 is closed for its grand opening (remember, I said “pretend.”). But what if you didn’t need to worry about traveling to the nearest specialist (which depending where you live could be anywhere from a 45-minute drive to several hours) and your provider connected you directly to the neurologist via encrypted video conference where she conducts the consultation and, in the end, saves your life? That is telemedicine.
Standard of care and potential pitfalls
For many Hoosiers living in rural Indiana, obtaining access to high-quality health care has been a challenge. Yet, with the fairly recent advancements in telemedicine, Hoosiers who reside outside of the major metropolitan areas are receiving increased access to health care via not-so-new technology. Whether it be email, two-way video, smartphone or other wireless technology, this type of communication is now being classified as medical treatment and is filling the void for many who were previously unable to obtain routine medical treatment. Nonetheless, with the development of technology comes the potential for misuse and mistakes, which can result in complex and costly litigation. In addition to the risk of litigation, some opponents of telemedicine believe patients are less secure in their diagnoses or follow-up treatment and are more likely to be concerned that a doctor made an avoidable mistake that could have been prevented if the doctor and patient had met in person. Despite the advancements, health care providers practicing telemedicine still owe their patients the same duty of care as they would owe to those being seen in person, as the potential failure to diagnose, misdiagnosis or other medical negligence is likely to have the same impact on a patient’s life.
At present, telemedicine is used mainly by primary care and specialist referral services and for remote patient monitoring, consumer medical and health information, and general medical education for health care professionals. While these services offer a great outlet for high-quality health services for patients in outlying or rural areas, each health system and/or physician must be prepared to handle potential liability risks that accompany this evolving technology.
To help avoid costly litigation, health care providers can take some basic steps before the initial treatment to better protect themselves. The first inquiry sounds simple: Health care providers must check with their malpractice carriers to confirm that their existing coverage includes the added exposure associated with telemedicine. Failure to do so may leave a physician or hospital high and dry, defending a medical malpractice claim without insurance coverage.
In-person contact requirement
In addition to the insurance coverage issue, current Indiana law mandates “a documented patient evaluation, including history and physical adequate to establish diagnoses and identify underlying conditions or contraindications to the treatment recommended or provided, must be obtained prior to providing treatment, including prescriptions, electronically or otherwise.” 844 IAC 5-3-2. Although there is a current push in the Indiana General Assembly to remove the initial in-person contact requirement, as of today, it is still required.
Each health care provider must investigate interstate licensure issues, as it is possible a doctor may physically be located in one state and “treating” a patient in a different state via video conference. Failure to investigate this issue properly could also result in a licensure hearing before the state.
HIPAA compliance is another serious issue that must be properly addressed to avoid potential liability and litigation. As we have recently seen in Indiana, HIPAA violations are being prosecuted more frequently and have returned some sizable verdicts against the health care providers. Thus, the providers should take simple precautions to prevent such disclosures. If the electronic communication involves protected health information, the communication, including any video communication, must be encrypted. Any entity that stores the protected health information must sign a business associate agreement or appropriate written assurance. Today, there are many vendors who can provide simple and secure encrypted video conferencing as well as encrypted email and other forms of electronic communication.
Another consideration is the technology that is implemented to obtain proper reimbursement. Depending on the type of telemedicine being used, both hub and spoke sites must have the necessary equipment to ensure compliance. For example, Indiana Medicaid mandates the following: “(1) A hub site; (2) A spoke site; (3) An attendant to connect the patient to the specialist at the hub site; and (4) a computer or television monitor to allow the patient to have real-time, interactive and face-to-face communication with the hub specialist or consultant via interactive television technology.” This technology must meet generally accepted standards to allow the physician at the hub site to render medical decisions. As a condition of payment, Medicaid also mandates that the services between the hub and spoke sites are more than 20 miles apart. More information on Medicaid compliance can be found in the Indiana Health Coverage Programs Provider Manual.
In addition to having the necessary and proper equipment, staff training and integration of the new systems are other considerations the health care providers must not overlook. In fact, the General Assembly has established some requirements for the use of electronic communications. Specifically, health care providers must have “written policies and procedures for the use of patient-physician electronic mail.” 844 IAC 5-3. Thus, it is paramount that the health care networks have the proper policies in place to handle the simplest of electronic communications. Failure to address privacy, email administration, hours of operation, oversight and protocol for emergency situations could land a health care provider in serious trouble. The providers, whether RNs, LPNs, advanced practice nurses or physicians, must be properly trained on these policies and procedures relating to the intricacies of telemedicine in order to satisfy licensure requirements as the same standard of care will likely apply to practitioners who are using telemedicine as those practitioners treating patients in person.
Perhaps some of the largest holdups to the Indiana telemedicine explosion are the current laws regulating prescription practices. Presently, the Indiana Administrative Code “prohibits medical treatment, including the issuance of a prescription, based solely on an online questionnaire or consultation. Prior to providing treatment, including issuing a prescription through electronic means, a physician must conduct a documented patient evaluation, including a history and a physical evaluation.” Likewise, telemedicine presents certain hurdles for prescriptions of controlled substances and legend drugs. Under current law, except in an institutional setting, “a physician shall not prescribe, dispense, or otherwise provide, or cause to be provided, any legend drug that is not a controlled substance to a person who the physician has never personally physically examined and diagnosed.” 844 IAC 5-4-1. The handling of the regulatory issues has been one of the main barriers to the growth of telemedicine in Indiana.
Informed consent can also bring challenges. The appropriate informed consent from the patient must be obtained before a telemedicine appointment, and the written form should be maintained at both sites. As stated above, it is mandatory to offer the patient the option of an in-person visit when discussing an electronic meeting. The Indiana Administrative Code specifically addresses patient-physician email exchanges and dictates what must be contained in the consent form. Among other items, the consent must indicate what types of transmission will be permitted (e.g., prescription refills). There must also be an indication of the fees that will be assessed for online consultation or other electronic communication, as well as a statement to the patient that the physician’s email is not to be used in an emergency situation. 844 IAC 5-3-5.
Documentation is consistently one of the hot-button issues that gives rise to many medical negligence cases. And just as in a traditional setting, if the documentation is completed incorrectly, it could also lead to a reimbursement loss. Therefore, with the emergence of telemedicine, additional headaches will be created as additional documentation is required. Thus, if health care providers are unprepared, they may find themselves the target of unwanted litigation. Specifically, the documentation must be maintained at both the hub and the spoke locations to verify the services were actually provided. The documentation must also indicate the medical services that were rendered via telemedicine. In addition to these criteria, health care providers must include start and stop times of treatment and continue to document as they would in a traditional hospital or office setting. It must also be explained to the patient and documented that the patient was given the choice between a traditional office visit and a telemedicine visit. As we all have seen, if it is improperly charted or documented, litigation exposure is dramatically increased, as are defense costs.
As telemedicine increases in popularity, it is critical for health care providers to understand the risks when communicating with patients by electronic means, and it is imperative that physicians and hospital staff educate themselves on the perils of telemedicine in order to protect themselves from potential litigation – including loss of one’s license to practice medicine. That said, if these risks are properly identified and controlled, telemedicine is likely to expand and continue to provide life-changing health care for a large number of rural Hoosiers for years to come. In addition, recent developments in technology will allow health care professionals residing in different hospitals to share information and discuss patient issues as if they were together in the clinic room. For others, the hope is for additional remote patient monitoring that may reduce the need for outpatient visits and enable remote prescription verification and drug administration oversight, with the potential to reduce the overall cost of health care.•
Mr. Davis is an associate in the Indianapolis office of Hall Render Killian Heath & Lyman and is a member of the Defense Trial Counsel of Indiana. The opinions expressed in this article are those of the author.