In 2017, the New Jersey legislature passed the New Jersey Telehealth and Telemedicine Act (codified at N.J.S.A. 45:1-61 et seq.), which established registration and reporting requirements for "telemedicine and telehealth organizations." After a multi-year wait for details regarding the registration process, the New Jersey Department of Health (NJ DOH) published a proposed rule in April 2020 that brought providers of telehealth services in New Jersey one step closer to the implementation and enforcement of the registration requirements. A final rule is expected by April 2021.
New Jersey providers are also expecting the publication of a proposed rule detailing the reporting requirements for registered organizations. While the coronavirus (COVID-19) public health emergency has led many states to implement waivers and other measures to allow for the expansion of remote healthcare services within their states, telehealth and telemedicine organizations operating in New Jersey should prepare to comply with additional requirements and the outlay of annual registration fees if the state finalizes the registration requirements as proposed.
Background: The 2017 Telemedicine and Telehealth Act
For purposes of the Act, a "telemedicine or telehealth organization" is defined as a corporate entity "that is organized for the primary purpose of administering services in furtherance of telemedicine or telehealth." The Act differentiates telemedicine from telehealth: "telehealth" is the use of information and communications technologies (including telephones, remote patient monitoring devices or other electronic means) to support clinical healthcare, provider consultation, patient and professional health-related education, public health, health administration and other services, whereas "telemedicine" is the delivery of healthcare services using electronic or technological means (not including the use, in isolation, of audio-only telephone, electronic mail, instant messaging, phone text or facsimile transmission) to "bridge the gap" between a healthcare provider located at a distant site and a patient located at an originating site.
In addition to establishing requirements for providers' use of telemedicine and telehealth, the Act requires telemedicine or telehealth organizations to register with the NJ DOH annually, and to submit annual reports to the NJ DOH that include data elements established by the NJ DOH commissioner and, at a minimum, the following de-identified encounter data:
- The total number of telemedicine and telehealth encounters conducted
- The type of technology utilized to provide services using telemedicine or telehealth
- The category of medical condition for which services were sought
- The geographic region of the patient and the provider
- The patient's age and sex
- Any prescriptions issued.
The Act did not establish any enforcement mechanism for the registration and reporting requirements, and because the NJ DOH has not yet implemented criteria for registering or reporting, New Jersey providers of remote health services have generally operated without regard to these statutory requirements.
Implementation of the Registration Requirement
The April 2020 proposed rule would implement the registration requirement for telemedicine or telehealth organizations and establish enforcement mechanisms available to the NJ DOH against any telemedicine or telehealth organization that fails to comply.
The proposed rule would require telemedicine and telehealth organizations to register with the NJ DOH on an annual basis prior to providing services in the state. Each year, applicants would need to submit an initial or renewal application along with a $1,500 application fee. This requirement would apply to all telemedicine or telehealth organizations operating in New Jersey regardless of whether the organization is operating as a "distant site, originating site, or both." Separate applications would be required for each "doing business as" name maintained by the organization that engages in telehealth or telemedicine in New Jersey.
The proposed rule would also authorize the NJ DOH to impose monetary penalties and/or suspend or refuse to issue or renew the registration of a telemedicine or telehealth organization if the organization fails to comply with the requirements of the Act, or if the NJ DOH determines that the organization poses a threat to the public health, safety or welfare.
What Happens Next?
The public comment period for the proposed rule concluded on June 19, 2020, and the NJ DOH will have until April 2021 to adopt a final rule. The NJ DOH will review the comments received in response to the proposed rule and may either issue a revised rule or adopt the proposed rule. The proposed rule does not address the annual reporting required by the Act. However, the NJ DOH reported in the preamble to the proposed rule that it was in the process of drafting a separate notice of proposal to implement the reporting requirement.
Originally published by Telehealth, 18 August 2020
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