Authorized By: New Jersey State Board of Respiratory Care, Renee Clark, Executive Director.
Authority: N.J.S.A. 45:1-61 et seq., and 45:14E-7.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2021-025.
Submit comments by May 14, 2021, to:
Renee Clark, Executive Director
New Jersey State Board of Respiratory Care
124 Halsey Street
PO Box 45031
Newark, NJ 07101
or electronically at: http://www.njconsumeraffairs.gov/Proposals/Pages/default.aspx
The agency proposal follows:
Summary
P.L. 2017, c. 117, which was effective July 21, 2017, authorizes healthcare providers to engage in telemedicine and telehealth. The Board of Respiratory Care (Board) proposes new Subchapter 11 to effectuate the provisions of P.L. 2017, c. 117.
N.J.A.C. 13:44F-11.1 sets forth that Subchapter 11 implements P.L. 2017, c. 117 and establishes that the subchapter applies to persons who are licensed by the Board. The section requires a respiratory care practitioner to hold a license issued by the Board if they are physically located in New Jersey and are providing health care services by means of telemedicine or telehealth or if they are physically located outside of New Jersey and are providing health care services by means of telemedicine or telehealth to patients located in New Jersey. The section also clarifies that a healthcare provider in another state who uses communications technology to consult with a New Jersey licensee and who is not directing patient care will be deemed as not providing health care services in New Jersey and will not be required to obtain a license in New Jersey.
N.J.A.C. 13:44F-11.2 provides definitions for the terms used in Subchapter 11. The following terms are defined: "asynchronous store-and-forward," "Board," "cross-coverage," "distant site," "licensee," "on-call," "originating site," "proper licensee-patient relationship," "telehealth," and "telemedicine."
N.J.A.C. 13:44F-11.3 requires a licensee to determine whether he or she can provide services through telemedicine or telehealth consistent with the standard of care for such services when provided in-person. If such provision of services would not meet that standard, a licensee cannot provide services through telemedicine or telehealth and he or she would be required to advise the patient to receive services in-person. A licensee who provides services through telemedicine or telehealth will be held to the same standard of care and practice standards as are applicable when services are provided in-person.
N.J.A.C. 13:44F-11.4 establishes how a licensee will create a licensee-patient relationship prior to providing services through telemedicine or telehealth. A licensee must identify the patient and disclose his or her identity. Before a licensee can provide services through telemedicine or telehealth, he or she is required to review a patient's medical history and medical records, and any other relevant patient records including, but not limited to, educational, vocational, or social records. The section requires licensees to determine if service can be provided through telemedicine or telehealth with the same standard of care as if the services were provided in-person. This determination must be made prior to each unique patient encounter. Before providing services through telemedicine or telehealth, a licensee has to provide a patient with the opportunity to sign a consent form authorizing the release of medical records to the patient's primary care provider. A licensee will not have to establish a licensee-patient relationship if: services are provided as informal consultations, or on an infrequent basis, and there is no compensation for the services; services are part of episodic consultations by specialists in another jurisdiction; services are provided during an emergency or disaster without compensation; or a licensee is providing on-call or cross-coverage services.
N.J.A.C. 13:44F-11.5 permits a licensee to provide health care services through telemedicine and to support and facilitate the provision of health care services to patients through telehealth if he or she has established a licensee-patient relationship with the patient or qualifies for an exemption to the licensee-patient relationship requirement. Prior to providing services, the licensee must determine the site at which the patient is located and record this in the patient's record. When a licensee provides services through telemedicine, he or she must use interactive, real-time, two-way communication technologies, which include a video component. A licensee will not have to use technology that includes a video component if he or she determines, after reviewing a patient's records, that he or she can meet the standard of care for such services provided in-person without video. In such a situation, the licensee must use interactive, real-time, two-way audio in combination with technology that permits the transmission of images, diagnostics, data, and medical information.
A licensee is required to review a patient's medical history and records, and any other relevant patient records including, but not limited to, educational, vocational, or social records prior to an initial encounter with the patient and, for subsequent interactions, review the history and records either prior to, or during, interactions. A licensee who provides services through telemedicine or telehealth is required to provide contact information to a patient by which the patient can contact the licensee, or an alternative licensee, for at least 72 hours after the provision of services. A licensee must provide patients with their records upon request and provide the patient's information to a patient's primary care provider or other healthcare provider, upon written request. A licensee is required to provide a referral for follow-up care when it is necessary.
N.J.A.C. 13:44F-11.6 requires licensees to maintain records of care provided to patients through telemedicine or telehealth. Such records must comply with the requirements at N.J.A.C. 13:44K-10.1 and all other statutes and rules governing recordkeeping, confidentiality, and disclosure.
N.J.A.C. 13:44F-11.7 requires licensees to establish written protocols to prevent fraud and abuse. Such protocols must address: authentication of users, patients, and the origin of information; the prevention of unauthorized access to a system or information; system security; maintenance of documentation; information storage, maintenance and transmission; and verification of patient data.
N.J.A.C. 13:44F-11.8 requires licensees to establish privacy practices for electronic communications that comply with the standards at 45 CFR 160 and 164, which are incorporated herein by reference. These privacy practices must include measures to protect confidentiality and patient-identifiable information and transmissions must be protected by passwords, encryption, or other authentication techniques. If a licensee becomes aware of a breach of confidentiality, he or she must report this as pursuant to 45 CFR 164. Licensees must provide patients with copies of privacy practices and obtain written acknowledgement of receipt from patients. The section also requires licensees to provide patients with notice regarding telemedicine and telehealth that includes risks and information on how to receive follow-up care. Licensees must obtain a signed and dated statement from the patient recognizing receipt of this notice. If the provision of services through telemedicine or telehealth cannot provide all clinical information necessary to provide care, a licensee will have to inform the patient of this and advise the patient that he or she should receive an in-person evaluation to meet his or her needs.
The Board has provided a 60-day comment period for this notice of proposal. Therefore, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.
Social Impact
The Board believes the proposed new rules will have a positive social impact in that they will facilitate the use of communication technologies to provide health care services while protecting patients who receive such services through telemedicine or telehealth.
Economic Impact
The Board anticipates that the proposed new rules may have an economic impact on licensees who choose to provide health care services through telemedicine or telehealth. The proposed new rules require licensees to use communication technologies that provide for interactive, real-time, two-way communication that includes a video component. Licensees may incur costs in obtaining such communication technologies. The Board does not anticipate that the proposed new rules will have any other economic impact.
Federal Standards Statement
Requirements at N.J.A.C. 13:44F-11.8 impose the same standards for privacy of communications as are imposed at 45 CFR 160 and 164, which are incorporated by reference into the proposed new rule. There are no other Federal laws or standards applicable to the proposed new rules.
Jobs Impact
The Board does not believe that the proposed new rules will result in the creation or loss of jobs in the State.
Agriculture Industry Impact
The Board does not believe that the proposed new rules will have any impact on the agriculture industry in the State.
Regulatory Flexibility Analysis
Currently, the Board licenses approximately 3,570 respiratory care practitioners. If these licensees are considered "small businesses" within the meaning of the Regulatory Flexibility Act (the Act), N.J.S.A. 52:14B-16 et seq., then the following analysis applies.
The economic impact on small businesses will be the same as that imposed on all businesses as detailed in the Economic Impact statement. The Board does not believe that licensees will need to employ any additional professional services to comply with the requirements of the proposed new rules. The proposed new rules impose no reporting requirements but impose compliance and recordkeeping requirements upon licensees as detailed in the Summary above.
The proposed new rules will protect the health, safety, and welfare of patients who receive health care services through telemedicine or telehealth; therefore, no differing compliance requirements are provided to licensees based upon the size of a business.
Housing Affordability Impact Analysis
The proposed new rules will have an insignificant impact on the affordability of housing in New Jersey and there is an extreme unlikelihood that the proposed new rules would evoke a change in the average costs associated with housing because the proposed new rules concern the provision of health care services through telemedicine or telehealth.
Smart Growth Development Impact Analysis
The proposed new rules will have an insignificant impact on smart growth and there is an extreme unlikelihood that the proposed new rules would evoke a change in housing production in Planning Areas 1 or 2, or within designated centers, under the State Development and Redevelopment Plan in New Jersey because the proposed new rules concern the provision of health care services through telemedicine or telehealth.
Racial and Ethnic Community Criminal Justice and Public Safety Impact
The Board has evaluated this rulemaking and determined that it will not have an impact on pretrial detention, sentencing, probation, or parole policies concerning adults and juveniles in the State. Accordingly, no further analysis is required.
Full text of the proposed new rules follows: