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17 October 2017

Telemedicine Rules In D.C. Get Second Draft

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Foley & Lardner

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Telemedicine rules in the District of Columbia underwent a second round of revisions as the District of Columbia Department of Health issued a new set of proposed rules .
United States Food, Drugs, Healthcare, Life Sciences
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Telemedicine rules in the District of Columbia underwent a second round of revisions as the District of Columbia Department of Health issued a new set of proposed rules  . The newly-revised proposed telemedicine rules, issued in July, replace the Department's first draft of telemedicine regulations issued in early 2016, and incorporate comments submitted by a number of telehealth industry advocates. Other than a  2014 policy statement, the D.C. Medical Board's current laws are silent as to telemedicine practice.

Changes in the Newly Revised Telemedicine Rules

Based upon the review of the public comments and its Telemedicine Workgroup recommendations, the Board of Medicine amended its initial proposed regulations for greater clarity and to eliminate unnecessary barriers.  Here is a summary of the notable changes contained in the new rules:

  • Simplifying the definition of telemedicine by striking the following language: "Generally, telemedicine does not include an audio-only telephone conversations [sic], electronic mail, instant messaging conversations, or facsimile communications. Telemedicine typically involves the application of secure videoconferencing or store and forward technology to provide or support the delivery of healthcare by replicating the interaction of a traditional encounter in person between a licensee and patient."
  • Revising the modality required to create a valid physician-patient relationship via telemedicine in the absence of any prior in-person exam.
    • The prior rule stated, "the physician shall use real-time auditory communications or real-time visual and auditory communications to allow a free exchange of protected health information between the patient and the physician performing the patient evaluation."
    • The new proposed rule states "the physician may use real-time telemedicine to allow a free exchange of protected health information between the patient and the physician to establish the physician-patient relationship and perform the patient evaluation." (emph. added)
    • The new rules also tweak the definition of "real-time" to mean "a system in which information is provided in such a way as to allow near immediate feedback." The prior rule defined it as "simultaneously or quickly enough to allow two or more individuals to communicate."
  • Requiring the physician be licensed to practice medicine in DC if the patient is located in DC, and eliminating the requirement that the physician be licensed in both the jurisdiction in which the physician is physically located and where the patient is physically located.
  • Replacing the word "face-to-face" with the term "in-person" to better describe that the physician and patient are in the physical presence of each other.
  • Eliminating certain requirements that the physician create specific telemedicine written policies and procedures.
  • Eliminating proposed definitions for terms that were not used in the regulation (e.g., group practice, consultative service).

What Telehealth Providers Need to Know

Here are the key takeaways health care providers, hospitals, and start-up companies looking to enter the D.C. market should consider if the proposed telemedicine rules are implemented without further changes:

  1. The proposed rules define telemedicine as "the practice of medicine by a licensed practitioner to provide patient care, treatment or services, between a licensee in one location and a patient in another location with or without an intervening health care provider, through the use of health information and technology communications, subject to the existing standards of care and conduct."
  2. The rules are flexible on the modality and do not mandate the use of real-time audio-video technology for all telemedicine services.
  3. Valid Doctor-Patient Relationship.A physician may create a valid doctor-patient relationship via telemedicine, without the need for an in-person exam.  When doing so, the physician "may use real-time telemedicine to allow a free exchange of protected health information between the patient and the physician to establish the physician-patient relationship and perform the patient evaluation."  Real-time means a system in which information is provided in such a way as to allow near immediate feedback.
  4. Telemedicine Exams. In all telemedicine use cases, the physician must perform a patient evaluation to establish diagnoses and identify underlying conditions or contraindications to recommended treatment options before providing treatment or prescribing medication for a patient utilizing the appropriate standards of care, except when performing interpretive services. (Interpretive services are "official readings of images, tracings, or specimens through telemedicine" including "remote, real-time monitoring of a patient being cared for within a health care facility or home-based setting"). A D.C. licensed physician may rely on a patient evaluation performed by another D.C. licensed physician if the former is providing coverage for the latter.
  5. Informed Consent.The rules require the physician to obtain and document patient consent, except when providing interpretive services. Patients must be informed of alternate forms of communication between the patient and the physician for urgent matters.
  6. Physician Licensure. Physicians providing telemedicine to patients located in D.C. must hold an active D.C. medical license.
  7. Standard of Care.Under the rules, a physician using telemedicine is held to the same standard of care as when making medical decisions in an in-person encounter with a patient.
  8. The rules allow prescribing of medications via telemedicine without an in-person exam, provided the patient evaluation meets the guidelines and is within the standard of care.
  9. Medical Records.The physician must create and maintain adequate medical records of the encounter. The physician must comply with D.C. and federal laws and regulations governing the confidentiality and disclosure of medical records. All relevant patient-physician, 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.

We will continue to monitor the proposed telemedicine rules for when the final version is published.

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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