Authorized By: New Jersey State Board of Dentistry, Jonathan Eisenmenger, Executive Director.
Authority: N.J.S.A. 45:6-3 and 45:1-61 et seq.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2021-022.
Submit comments by May 14, 2021, to:
Jonathan Eisenmenger, Executive Director
New Jersey State Board of Dentistry
124 Halsey Street
PO Box 45005
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 New Jersey State Board of Dentistry (Board) proposes new Subchapter 9 to effectuate the provisions of P.L. 2017, c. 117.
N.J.A.C. 13:30-9.1 sets forth that Subchapter 9 implements P.L. 2017, c. 117 and establishes that the subchapter applies to a dentist or a dental hygienist. The section requires dentists and dental hygienists to hold a Board-issued license 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. 13:30-9.2 provides definitions for the terms used in Subchapter 9. The following terms are defined: "asynchronous store-and-forward," "Board," "cross-coverage," "distant site," "licensee," "on-call," "originating site," "proper licensee-client relationship," "telehealth," and "telemedicine."
N.J.A.C. 13:30-9.3 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. In addition, paragraph (b)1 provides that a licensed dental hygienist working under supervision is independently responsible for determining whether health care services can be provided through telemedicine or telehealth in a manner that is consistent with in-person standards of care.
N.J.A.C. 13:30-9.4 establishes how a licensee will create a licensee-patient relationship prior to providing services through telemedicine or telehealth. A licensee must disclose his or her identity and identify the patient. Before a licensed dentist can provide services through telemedicine or telehealth, he or she is required to review a patient's medical and dental history and any available dental records. The section requires licensed dentists to determine if services 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, the licensed dentist has to provide a patient with the opportunity to sign a consent form authorizing the release of dental records to the patient's primary care licensed dentist or other healthcare provider identified by the patient. A licensee will not have to establish a licensed dentist-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 a medical or dental specialist in another jurisdiction; services are related to dental assistance provided during an emergency or disaster without compensation; or a licensee is providing on behalf of and at the designation of an absent licensee in the same specialty on-call or cross-coverage services.
N.J.A.C. 13:30-9.5 permits a licensee to provide dental care services through telemedicine and to support and facilitate the provision of such 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 medical and/or dental 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 or dental information.
A licensed dentist is required to review a patient's medical history or medical or dental 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 licensed dentist who provides services through telemedicine or telehealth is required to provide contact information to a patient by which the patient can contact the dentist, or another designated licensee, for at least 72 hours after the provision of services. A licensed dentist must provide patients with dental records upon request and provide dental information to a patient's primary dental care provider or other health care provider, upon written request. A licensed dentist is required to provide a referral for follow-up care when it is necessary.
This section also requires a licensed dental hygienist, who engages in telemedicine or telehealth, and who practices dental hygiene under general supervision, to comply with the provisions at N.J.A.C. 13:30-1A.4, which set forth the scope of practice of and general requirements for dental hygienists working under general supervision.
N.J.A.C. 13:30-9.6 permits a licensed dentist to issue a prescription to a patient when services are provided through telemedicine or telehealth. A prescription cannot be issued based solely on the responses to an online questionnaire, unless the dentist has established a dentist-patient relationship with the patient. A licensed dentist is prohibited from issuing a prescription for a Schedule II controlled dangerous substance, unless the dentist has an initial in-person examination of the patient and sees the patient in-person at least every three months during the time the patient is prescribed the Schedule II controlled dangerous substance. The in-person examination requirement is established pursuant to P.L. 2017, c. 117, and is appropriate due to public safety concerns with Schedule II controlled dangerous substances.
N.J.A.C. 13:30-9.7 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. 13:30-8.7 and all other statutes and rules governing recordkeeping, confidentiality, and disclosure.
N.J.A.C. 13:30-9.8 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. 13:30-9.9 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 Federal regulations implement the privacy requirements of the Health Insurance Portability and Accountability Act of 1996 and protect the privacy of individually identifiable health information. Theprivacy 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, registrant, or other employee of the dentist becomes aware of a breach of confidentiality, he or she must report this as required 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.
As the Board has provided a 60-day comment period on this notice of proposal, 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. 13:30-9 impose the same standards for privacy of communications as are imposed at 45 CFR 160 and 164, which are incorporated by reference into the 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 8,690 dentists and 5,925 hygienists. As dentists are individually licensed by the Board under the Regulatory Flexibility Act (the Act), N.J.S.A. 52:14B-16 et seq., they may be considered "small businesses" for the purposes of the Act. Dental hygienists cannot be considered "small businesses" because they may not engage in independent practice.
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 dentists 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 dentists 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 dentists 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: