The Iowa Board of Medicine (IBM), at its April 3, 2015 meeting, approved a final rule setting forth disciplinary standards applicable to physicians who use telemedicine in diagnosing and treating patients located in Iowa.
That rule also includes standards and prohibitions that all physician licensees must comply with in providing patient care whether by telemedicine or not. The adopted Rule will be published in the April 29 Iowa Administrative Bulletin and then reviewed by the legislature’s Administrative Rules Review Committee at a time yet to be set. The rule is slated to go into effect on June 3, 2015.
The IBM, in the final rule, made several changes to its proposed telemedicine practice rule. Those changes reflect the IBM’s responses to public comments on its originally noticed proposed rule and its next draft. Changes, for the most part, bring clarity to the rules and their expectations.
The final rule primarily addresses requirements for physicians who use telemedicine. Those requirements are substantial. Failure to satisfy any of these requirements subject the physician using telemedicine to IBM discipline. Failure to comply with the rules also might be claimed by plaintiffs alleging medical negligence in the delivery of telemedical care.
It is critical that physicians using telemedicine understand the IBM’s substantial expectations of them. The fact that a hospital or other telemedicine site ordinarily is operationally responsible for certain of the IBM’s proposed requirements (i.e., equipment compliance with safety codes, HIPAA privacy and security compliance), standing alone, does not relieve the telemedicine physician from assuring compliance with such requirements as set forth in the IBM’s telemedicine rule. The final rule made changes to reflect this concern, yet physicians continue to face discipline for non-compliance on each of the final rule requirements.
The following is a summary of the IBM’s final rule. Click here to read the final rule.
The IBM defines telemedicine by clarifying what telemedicine means and includes as well what it does not include for purposes of this rule.
- Telemedicine means the practice of medicine using electronic audio-visual communications and information technologies or other means, including interactive audio with asynchronous store and forward transmission, between a physician licensee in one location and a patient in another location with our without an intervening health care provider. Telemedicine includes store-and-forward technologies, remote monitoring, and real-time interactive services, including tele-radiology and tele-pathology.
- Telemedicine does not include the provision of medical services only through an audio-only telephone, email messages, facsimile transmissions, mail service, or any combination thereof.
For physicians using telemedicine, the rule makes it clear that –
- Physicians using telemedicine will be held to the same standards of care and professional ethics as physicians using traditional in-person encounters with patients.
- Physicians using telemedicine must do so within the physician’s scope of practice and the physician’s education, training, experience, ability, and licensure/certification.
- Physicians using telemedicine in the diagnosis and treatment of a person located in Iowa must have an active Iowa medical license consistent with federal and state law (unless an exception to licensure already provided in the IBM’s licensure rules applies) regardless of the in-state or out-of-state site from which the physician provides those telemedicine services.
- Physicians using telemedicine must utilize evidence-based telemedicine practice guidelines and standards of practice to the degree they are available.
Physicians using telemedicine must establish a valid physician-patient relationship with the person who receives telemedicine services. For purposes of this rule —
- The physician-patient relationship begins when 1) a person with a health-related matter seeks assistance from a physician; 2) the physician agrees to undertake diagnosis and treatment of that person; and 3) the person agrees to be treated by the physician even if there has not yet been an in-person encounter between the physician and that person.
- A valid physician-patient relationship may be established in one of three ways: 1) an in-person encounter with an in-person medical interview and physical exam where standards of care would require an in-person encounter; 2) consultation with another physician or other health care provider who has an established relationship with the patient and who agrees to participate in or supervise the patient’s care; or 3) a telemedicine encounter if standards of care do not require an in-person encounter and consistent with evidence-based telemedicine practice guidelines.
- An “in-person encounter” is defined to mean the physician and the patient are in the physical presence of each other and in the same physical location during the physician-patient encounter.
Further, physicians using telemedicine must –
- Ensure that systems are in place to ensure that non-physician health care providers whom the physician relies upon or delegates to in the provision of a telemedical service are qualified and trained to provide such service within the non-physician’s scope of licensed practice; further, the physician must be available either in-person or electronically to consult with non-physician health care providers, particularly in the event of an injury or an emergency in the course of telemedicine service delivery.
- Verify the identity of the patient receiving the telemedicine services and ensure the patient can verify the identity, licensure status, certification and credentials of all health care providers involved in providing the telemedical service prior to the provision of that care.
- Ensure the patient is interviewed to collect the patient’s relevant medical history, receives a physical examination when medically necessary, sufficient for diagnosis and treatment prior to providing treatment via telemedicine, including issuing a prescription electronically or otherwise. The medical interview and physical examination need not be in-person if the telemedical encounter is sufficient to establish an informed diagnosis as though the medical interview and physical exam had been performed in-person. A static Internet questionnaire alone cannot suffice for the medical interview and physical exam prior to treatment, including issuing a prescription either electronically or otherwise. “Static” is defined in the rule.
- Ensure that patient informed consent is provided, including consent for the use of telemedicine, and that such consent is timely documented in the patient’s medical record.
- Identify and provide the patient’s medical record to the patient’s treating physician and/or medical home, when available and medically appropriate, where in-person medical services can be delivered in coordination with the telemedicine services the patient receives.
- Have access to or adequate knowledge of local medical resources for appropriate follow-up care.
- Refer a patient receiving telemedical services to an acute care facility or emergency department in the event of an emergency or for the safety of the patient.
- Ensure complete, accurate, and timely medical records, as appropriate, including notation of when telemedicine is used and other matters set forth in the rule, and, further, ensure that the patient and other health care providers have timely access to such information and that the patient, upon request, receives a timely summary of each telemedical encounter.
- Ensure that all telemedicine encounters comply with HIPAA privacy and security measures. Written protocol must be established and periodically reviewed, addressing measures specified by the IBM in its proposed rule to assure the confidentiality and integrity of patient-identifiable information.
- Equipment and technology used in the telemedical encounter must comply with safety laws and codes and are of sufficient quality/size/resolution/clarity to safely and effectively provide the telemedicine service.
- Ensure that information is disclosed to the patient re: the type of services to be provided via telemedicine; contact information, identity and credentials of all health care providers involved in the provision of the telemedical service; limitations, if any, on drugs and services as provided via telemedicine; fees/costs sharing if different than in an in-person encounter; financial interests, if any; limitations on the use of the telemedicine technology; and other information as detailed in the proposed rule.
- Ensure the patient’s ability to amend their patient information, to provide feedback on the quality of the telemedical encounter, and to register complaints.
For all physicians, whether in the course of using telemedicine or otherwise, the final rule –
- Sets forth several circumstances under which standards of medical care may not require a physician licensee to personally examine a patient. Circumstances include where the physician prescribes medications on a short-term basis for a new patient and has scheduled or is in the process of scheduling an appointment to personal examine the patient; call or cross-coverage situations in which a physician licensee is taking call or is covering for the other physician licensee who has an established physician-patient relationship with the patient; situations in which the patient has been examined in person by an advanced registered nurse practitioner or physician assistant or other licensed practitioner with whom the physician licensee has a supervisory or collaborative relationship; and other circumstances set forth in the rule.
- Prohibits physician licensees from prescribing based solely on an Internet request or an Internet questionnaire. An internet questionnaire is defined to mean a static questionnaire provided to a patient to which the patient responds with a static set of answers, in contrast to an adaptive, interactive and responsive online interview.
- Prohibits physician licensees from prescribing based solely on a telephonic evaluation for any person absent a valid physician-patient relationship.
See our page dedicated to Telemedicine for all related articles.