The Delaware Board of Medicine recently enacted new regulations pertaining to telemedicine and telehealth. As we previously reported, the new regulations are intended to clarify the language in Delaware’s Medical Practice Act, which imposes certain practice standards for what constitutes an appropriate patient diagnosis and treatment via telemedicine, including the allowable modalities and when an in-person examination is required. The new regulations add Rule 19.0 to Chapter 1700 of the Code of Delaware Regulations and became effective June 11, 2018.

Telemedicine advocates and interested parties should review the new regulations and ensure their practices adhere to these new provisions.

What is the Current Law on Telemedicine Practice in Delaware?

Current Delaware law requires a physician to establish a valid physician-patient relationship “either in-person or through telehealth.”  (“Physicians who utilize telemedicine shall, if such action would otherwise be required in the provision of the same service not delivered via telemedicine, ensure that a proper physician-patient relationship is established either in-person or through telehealth …”).  In connection with the establishment of a physician-patient relationship, the physician must adhere to the following:

• Fully verifying and authenticating the location and, to the extent possible, identifying the requesting patient;
• Disclosing and validating the provider’s [physician’s]identity and applicable credential or credentials;
• 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 paragraph (b)(5) of the statute;
• 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;
• Discussing with the patient the diagnosis and the evidence for it, the risks and benefits of various treatment options;
• Ensuring the availability of the distant site provider or coverage of the patient for appropriate follow-up care; and
• Providing a written visit summary to the patient.

Moreover, subsection (h) of the law states that physicians using telemedicine technologies to provide medical care to patients located in Delaware must, prior to a diagnosis and treatment, fulfill at least one of the following:

• An appropriate examination in-person;
• Have another Delaware-licensed practitioner at the originating site with the patient at the time of the diagnosis;
• The diagnosis must be based using both audio and visual communication; or
• The service 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.

How Do the New Regulations Change Telemedicine Practice in Delaware?

The Board’s proposed regulations stated that a “remote, audio-only examination” is not an “appropriate in-person examination” as that term is used in statutory section 1769D(h)(1).  After receiving public comment, the Board changed the statutory reference in the rule from section 1769D(h)(1) to section 1769D(b)(4).  The change was made after the Board became aware that, “despite the clear language of the statute, certain interest groups were opining that the requirement that a physician using telemedicine technologies to provide medical care to patients located in Delaware must first provide one of four options, including ‘an appropriate examination in-person,’ as that term is used in 24 Del.C. § 1769D(h)(1) did not actually require an in-person examination as an option.”  Namely, some groups were apparently arguing that a statutory requirement of an “in-person exam” can be accomplished via an audio-only exam.

The Board’s intent in doing so was to make clear that, under Delaware law and regulation, a remote, audio-only examination cannot be used to establish a valid physician-patient relationship. In drafting the regulatory language, the Board may have inadvertently injected some confusion because the term “in-person examination” referenced in the new regulation Section 19.1 does not actually exist in the cross-referenced statutory Section 1769D(b)(4). Moreover, Sections 1769D(b) and 1769D(h)(3) expressly permit the creation of a valid physician-patient relationship via telemedicine without an in-person exam (i.e., a diagnosis “based using both audio and visual communication”), subject to the standard of care.

In any event, providers and telemedicine companies should focus on these top four takeaways of the final rules:

1. Audio-Only Modality Not Sufficient for First Exam. A remote, audio-only examination is not an “appropriate in-person examination” as that term is used in section 1769D(b)(4).  In other words, despite any technical qualms with the regulation’s language, the Board’s interpretation and intent appear to be that a remote, audio-only examination cannot be used to establish a valid physician-patient relationship.
2. Provider-Patient Relationships. To create a valid physician-patient relationship using audio and visual communications pursuant to section 1769D(h)(3), the audio and visual communications must be live, real-time communications. Namely, it cannot be audio-video recordings subsequently transmitted asynchronously to the distant site telemedicine physician.
3. Acceptable Clinical Practice Guidelines. “Major medical specialty societies” as the term is used in section 1769D(h)(4) means specialty societies that are members of the Council of Medical Specialty Societies.  This further defines the term to minimize confusion and impose restrictions on which organizations constitute a major medical specialty society for purpose the statute.
4. Prescribing Opioids via Telemedicine. No opioid prescribing is permitted via telemedicine with the exception of addiction treatment programs offering medication assisted treatment that have received a Division of Substance Abuse and Mental Health (DSAMH) waiver to use telemedicine through DSAMH’s licensure or renewal process as outlined in 16 DE Admin. Code 6001 (Substance Abuse Facility Licensing Standards Sec. 4.15).  All other controlled substance prescribing utilizing telemedicine remains held to the same standards of care and requisite practice as when prescribing via in-person visits.