We know telemedicine is expanding, but are telemedicine prescription and distant diagnosis allowed under any given state legislative scheme? Sometimes the art of lawyering is the art of careful reading; and at other times it helps to get a regulator’s input, even informally.
Moving Into Telemedicine
For example, a physician client seeks attorney counsel to move from an exclusively brick-and-mortar practice to one in which the MD sees patient via an online or mobile platform, or even patients from different states. Typical legal questions are:
- Can I continue to see my in-state patients remotely (through the Internet or mobile device) while they travel here or overseas, or are living for months in their second home in another state?
- What if I want to open a second part of my practice that focuses on nutrition, lifestyle, functional medicine (but not primary care), habits and goals? Can I call this “health coaching” instead of “medicine?”
- What kinds of legal disclaimers should I use?
- What about lab tests and prescriptions? Is it legally necessary for my patients to fly in once a year to make this legitimate?
- What are my legal risks?
More often than not, the physician already has begun offering telemedicine services, and now wants to know how to do so within the rules–or at least in a way that minimizes legal risk.
To paraphrase a folk song (“Freedom’s just another word for nothin’ left to lose“), “compliance” is just another word for everything left to lose. Or in fancier terms, risk mitigation counts.
It’s Not About the Bike
It’s about the statute (if there is one).
Last year, Delaware enacted a telemedicine statute (Section 1769D of Title 24, Chapter 17 of the Delaware Code). At first glance, it looks very straightforward, but there are a few wrinkles.
First, the statute defines “telehealth” as the broad category in terms of method of delivery of healthcare services, and “telemedicine” as a subset in terms of clinical care.
(15) “Telehealth” means the use of information and communications technologies consisting of telephones, remote patient monitoring devices or other electronic means which support clinical health care, provider consultation, patient and professional health-related education, public health, health administration, and other services as described in regulation. (emphasis added)
(16) “Telemedicine” means a form of telehealth which is the delivery of clinical health care services by means of real time two-way audio, visual, or other telecommunications or electronic communications, including the application of secure video conferencing or store and forward transfer technology to provide or support healthcare delivery, which facilitate the assessment, diagnosis, consultation, treatment, education, care management and self-management of a patient’s health care by a health care provider practicing within his or her scope of practice as would be practiced in-person with a patient, legally allowed to practice in the state, while such patient is at an originating site and the health care provider is at a distant site.
Next, the statute goes through the requirements for practice. We change a few words here and there to make the meaning clearer, and add underscore, italics, and bold for emphasis.
Requirement of a Physician-Patient Relationship
Many telemedicine laws state that a physician must first establish a physician-patient relationship. But what does that mean?
- A “good faith” exam?
- Is that the same as an in-person visit?
- Does “face-to-face” mean physical, or virtual?
- When, if ever, can a physician-patient relationship be established online or through mobile devices?
Before getting there, Delaware provides that there are three situations in which the physician-patient relationship does not have to be first established before diagnosis and treatment. These are:
- Informal consultation performed by a physician outside the context of a contractual relationship and on an irregular or infrequent basis without the expectation or exchange of direct or indirect compensation.
- Furnishing of medical assistance by a physician in case of an emergency or disaster if no charge is made for the medical assistance.
- Episodic consultation by a medical specialist located in another jurisdiction who provides such consultation services on request to a licensed health care professional.
Next, Delaware states how a physician-patient relationship can be established.
The statute states that such a relationship can be established either in-person “or through other means” (i.e., online or through mobile devices), “including” these:
- A physician establishes a physician-patient relationship either in-person or through telehealth through means including:
(1) fully verifying and authenticating the location and, to the extent possible, identifying the requesting patient;
(3) obtaining appropriate consents from requesting patients after disclosures regarding the delivery models and treatment methods or limitations, including informed consents regarding the use of telemedicine technologies as indicated in subsection (b)(5);
(4) establishing a diagnosis through the use of acceptable medical practices, such as patient history, mental status examination, physical examination (unless not warranted by the patient’s mental condition), and appropriate diagnostic and laboratory testing to establish diagnoses, as well as identify underlying conditions or contra-indications, or both, to treatment recommended or provided;
(5) discussing with the patient the diagnosis and the evidence for it, the risks and benefits of various treatment options; and
(6) ensuring the availability of the distant site provider or coverage of the patient for appropriate follow-up care; and
(7) providing a written visit summary to the patient.
The first one (verifying and authenticating) makes more sense if, for example, the physician is located in a remote state (i.e., other than Delaware) and is working with a nurse in Delaware; in such case, the physician should verify the nurse’s identity and credentials.
An example would be if, for example, the physician is located in a remote state (i.e., other than Delaware) and is working with a nurse in Delaware; in such case, the physician should verify the nurse’s identity and credentials.
Standard of Care
Like many telemedicine statutes, Delaware’s telemedicine states that treatment and consultation recommendations made online, “including issuing a prescription via electronic means, are held to the same standards of appropriate practice (standards of care) as those in traditional (encounter in-person) settings.”
In addition, the physician must follow standard rules regarding:
- informed consent
- documentation and record-keeping
There also are requirements as to what the physician must do before making a diagnosis and rendering treatment. The physician must do one of the following:
(1) Provide an appropriate examination in-person;
(2) Have another Delaware-licensed practitioner at the originating (i.e., Delaware) site with the patient at the time of the diagnosis;
(3) Provide a diagnosis based on using both audio and visual communication; or
(4) Provide a service that meets standards of establishing a patient-physician relationship included as part of evidenced-based clinical practice guidelines in telemedicine developed by major medical specialty societies, such as those of radiology or pathology.
What’s tricky here is that, if the MD does not do an in-person examination, then the physician nonetheless can do an online or mobile exam, provided that:
- the diagnosis is based on using both audio and visual communication, and
- standard of care is satisfied.
This is more forward-thinking than many telemedicine statutes in other states.
Prescription: a special case
The statute is clear that:
- A physician may not prescribe solely in response to an Internet questionnaire, an Internet consult, or a telephone consult.
However, this does not mean that prescription can’t be made without a physical examination. Presumably,it can, so long as:
- a prior physician-patient relationship is established, using the criteria in the statute
- audio and visual are both used (or the other listed criteria are met)
- standard of care is met
the telemedicine method consists of more than a questionnaire or online or phone consult (for example, could also be based on review of lab tests).
The above is based on a careful read of the statute which, like much legislation, has several nested definitions.
Delaware, like other states, has built in some protections to ensure that physicians using telemedicine do so responsibly.
Given that the statute lays out these steps in some detail, practitioners should revise their consents to include relevant language showing that they have followed the order set out by law.
For practitioners using complementary, alternative, or integrative medical therapies, another important resource is the policy document by the Federation of State Medical Boards on Physician Use of Complementary and Alternative Medical Therapies.
Note that both reference acceptable medical practices, or some other way of flagging that standard of care is important.
Legal Compliance Requires Balance
Keep in mind that language is a balancing act: we want to have good disclosures, but also we do not want to flag something that could be seen as a violation of standard of care. Contact us to draft your consents or review your telemedicine practices for compliance.