United States: Ten Things To Know About Maryland's Proposed Telehealth Rules

The Maryland Board of Physicians evaluated, then tabled for further consideration, a set of new telehealth rules designed to expand the opportunities for hospitals and providers to deliver virtual care services in Baltimore and throughout the State.  The Board held a public hearing on January 24, 2018 to review proposed telehealth rules originally issued late last year. The new rules were influenced by the Washington, DC telemedicine rules, and incorporate comments submitted by a number of telehealth industry advocates, including the successful efforts of the folks at the Maryland Telehealth Alliance.

What Telehealth Providers Need to Know

While the Board did not finalize the proposed rules, the rules offer useful insight into the Board's priorities and its changing perspective to allow more robust and diverse applications of telehealth in Maryland.  The Board will likely prepare a new draft of the proposed rules, so there will be another opportunity for telehealth providers and advocates to contribute comments and make their voice heard.  In advance of that forthcoming draft, here are the key takeaways and insights health care providers, hospitals, and entrepreneurs in Maryland should know.

1. Revised Definitions. The rules replace the term "telemedicine" with "telehealth" and replace "physician" with "telehealth practitioner," a term defined as a Maryland licensed physician or licensed allied health practitioner performing telehealth services within their respective scope of practice. In addition, the Board replaced "face-to-face" with "in-person" to emphasize that face-to-face encounters  can be accomplished via telehealth, and to more clearly distinguish telehealth services from in-person services.

Insight: These revised definitions are beneficial to patients and providers alike because they acknowledge a broader use and scope of telehealth services, as well as telehealth services provided by non-physician health care professionals.

2. Expanded Modalities. The rules expand the definition of telehealth to expressly allow for additional  modalities of care, including asynchronous (store and forward) services and remote patient monitoring.

    • "Telehealth" means "the use of interactive audio, video, or other telecommunications or electronic technology by a licensed health care practitioner to deliver clinical services within the scope of practice of the health care practitioner at a location other than the location of the patient. It includes, but is not limited to: 1) interactive audio-visual synchronous encounters; 2) store-and-forward technology; 3) interpretive services; and 4) remote patient monitoring."
    • Telehealth does not include: a) an audio–only telephone conversation between a health care practitioner and a patient; b) an electronic mail message between a health care practitioner and a patient; or c) a facsimile transmission between a health care practitioner and a patient.
    • Remote patient monitoring means "the use of telehealth devices to collect medical and other forms of health data from patients that are securely provided to a telehealth practitioner in a different location for assessment, recommendation, and diagnosis."
    • Store and forward technology means "the asynchronous transmission of digital images, documents and videos electronically through secure means."
    • Interpretive services mean "reading and analyzing images, tracings, or specimens through telehealth or giving interpretations based on visual, auditory, thermal, ultrasonic patterns or other patterns as may evolve with technology."

Insight: These expanded definitions are helpful because they accommodate for new developments in technology and innovation in how healthcare services are (and will be) delivered. They also distinguish between asynchronous telehealth and interpretive services, which is typically a distinction made only by health plans and payers (e.g., under Medicare, radiology is technically considered a remote interpretive study and not a telehealth service). Yet, the proposed rules include "interpretive services" within the definition of telehealth services. From a rulemaking perspective, the Board might consider removing all references to interpretive services, or alternatively more clearly distinguishing that interpretive services are not subject to the various telehealth practice standards in the rule.

3. Telehealth practitioners must hold an active Maryland license if 1) they are physically located in Maryland; or 2) the patient is located in Maryland.

Insight: This requirement is atypical among States, as the majority generally require the practitioner to be licensed to practice in the State where the patient is located at the time of the telehealth encounter, not where the practitioner is located.

4. Standard of Care. A telehealth practitioner is held to the same standards of practice as those applicable in traditional health care settings and shall ensure that the quality and quantity of data and other information is sufficient in making medical decisions.

Insight: This is a sensible inclusion in the proposed rule, and is consistent with how the vast majority of States address telehealth-based services.

5. Valid Practitioner-Patient Relationship. The proposed rules imply that telehealth practitioners may create a valid practitioner-patient relationship via telehealth.

Insight: The Board should strongly consider adding the following explicit statement when preparing its next draft, consistent with many other States' approaches: "A telehealth practitioner may create a valid practitioner-patient relationship via telehealth."

6. Practice Standards. When initiating telehealth services through synchronous audio-visual communication a telehealth practitioner must:

    • Confirm whether the patient is in Maryland or outside of Maryland and identify the practice setting of the patient (i.e., where the patient is physically located);
    • Verify the identity of the patient through accepted patient identifiers;
    • For an initial patient-telehealth practitioner interaction, disclose to the patient the telehealth practitioner's name, location, medical specialty, and any other relevant credentials;
    • Identify any other individuals present at the telehealth practitioner's location;
    • Confirm there is no one in the patient's location who is not allowed to hear or share personal health information;
    • Inform the patient when the telehealth encounter is beginning and that sensitive medical information may be discussed; and
    • Have a contingency procedure of re-establishing electronic or other connection if communication is terminated.

Insight: The requirement to confirm the patient's identity is not unusual among State telemedicine practice rules, but the seven-element process enumerated in the Maryland proposed rules is not found in most other States.  In addition, the rule applies these requirements to providers "initiating telehealth services through synchronous audio-visual communication" but does not address asynchronous or other modalities of communication.  The next version of the proposed rule should consider eliminating some of these as explicit requirements and applying them equally to all modalities of telehealth treatment when appropriate (i.e., not applicable to interpretive services, but applicable to asynchronous telehealth).

7. Telehealth Exams. A telehealth practitioner must perform a patient evaluation adequate to establish diagnoses and identify underlying conditions or contraindications to recommended treatment options before providing treatment or prescribing medication, except when performing asynchronous telehealth services or remote patient monitoring. A telehealth practitioner may use a surrogate examiner, telehealth devices, live synchronous audio-visual communications, and other methods of performing a medical examination remotely, as well as a patient evaluation performed by another licensed health care practitioner providing coverage, if the evaluation is adequate to comply with the regulations.

Insight: The concept underpinning this provision is sensible and defers to the standard of care and the professional judgment of the treating practitioner.  It is unclear, however, why the rule does not apply those standards to asynchronous telehealth services or remote patient monitoring. Practitioners are capable of conducting patient evaluations via asynchronous modalities, and would be expected to do so prior to providing treatment or prescribing medication. The Board might consider revising the sentence for greater clarity as to what the Board expects of telehealth practitioners using asynchronous or remote patient monitoring technology.

8. Telehealth Prescribing. The rules allow prescribing of medications via telehealth without an in-person exam, provided the patient evaluation meets the guidelines and is within the standard of care.  However, a telehealth practitioner may not treat a patient or prescribe medication based solely on an online questionnaire.  In addition, a telehealth practitioner may not prescribe opioids through telehealth except: 1) for opioids used to treat opioid use disorder; (2) if the patient is in a "health care facility" as defined in Section 19-114 (d)(1) of the Health General Article; or 3) if the patient is in the presence of a licensed health care practitioner.

Insight: The provision banning treatment or prescribing based solely on an online questionnaire is consistent with the majority of States. The opioid language was the subject of considerable discussion at the Board's January 24, 2018 meeting, as the Board seeks to balance patient access to legitimate medical care with the current opioid crisis. If the Board were to revise this provision, it might consider using language contained in other state telemedicine prescribing rules, such as "A telehealth practitioner may prescribe controlled substances through the use of telehealth, subject to the applicable standard of care and state and federal laws. However, a telehealth practitioner may not prescribe through the use of telehealth any controlled substance for treatment of chronic nonmalignant pain." This approach not only mirrors other states, it restricts medically questionable prescribing while still allowing providers to use telehealth and controlled substances for specialties like addiction treatment, psychiatry, and emergencies.

9. Informed Consent. The rules require the telehealth practitioner to obtain and document the patient's oral or written consent to telehealth services. The telehealth consent must include the following:

    • A description of the telehealth modality used by the telehealth practitioner.
    • An acknowledgement that the telehealth practitioner may determine that telehealth is not clinically appropriate and request that a patient come for an in-person encounter.
    • A description of telehealth privacy risks, and the telehealth practitioner's data breach policy, including the requirement to timely inform the patient of a data breach and inform the patient of the steps being taken to remediate the problem.
    • A statement informing the patient that the patient may exclude anyone from any site during the telehealth service.
    • A statement informing patients that they can decline telehealth service at any time without affecting their right to future care or treatment and that the patients can terminate the telehealth encounter at any time.
    • An authorization to record the telehealth encounter and maintain and store the recording in accordance with medical retention requirements under state and federal law, if the practitioner records the telehealth encounter.

Insight: Telehealth informed consent rules, while well-intended, have been met with skepticism by some in the industry. This is due, in part, to the fact that it should be self-evident to the patient that the telehealth practitioner is not located in the same room as the patient. Some states have declined to impose telehealth informed consent requirements, or eliminated previously-existing requirements on the grounds they are unnecessary. As the Board considers its next draft, it is worth noting that the Maryland provisions would be among the most extensive telehealth consent requirements in the U.S. and it might be reasonable to trim them back or eliminate them entirely.

10. Medical Records; Privacy & Security Protocols. The telehealth practitioner must create and maintain adequate medical records of the encounter. The telehealth practitioner must comply with Maryland and federal laws and regulations governing the confidentiality and disclosure of medical records. All relevant patient-practitioner, communications, including those done via an electronic method such as email or other electronic messaging system, shall be documented and filed in the patient's medical record. The telehealth practitioner must have sufficient privacy and security measures through encryption, password protection, and other security measures to assure confidentiality and integrity of patient-identifiable information.  In addition, telehealth practitioners must establish and follow processes and procedures in the event of a data breach, to notify patients about the breach of their personal health records and or electronic synchronous communications.

Insight: These provisions are consistent with other state and federal laws, can be readily accomplished by most telehealth providers, and are a good addition consistent with the approaches other States have taken.

We will continue to monitor the proposed telehealth rules for developments in Maryland and across the United States.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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