New Jersey Regulations
Department of Law and Public Safety/Division of Consumer Affairs/Board of Dentistry
Vol. 53, No. 06, New Jersey Register 2021-03-15 pp.406-409
PUBLICATION DATE: 03/15/2021
ACTION DATE: 03/10/2021
COMMENT DEADLINE: 05/14/2021
PUBLICATION TYPE: Register
DOCUMENT NUMBER: PRN2021022

LAW AND PUBLIC SAFETY

(a)

DIVISION OF CONSUMER AFFAIRS

STATE BOARD OF DENTISTRY

Telemedicine and Telehealth

Proposed New Rules: N.J.A.C. 13:30-9

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:

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.

SUBCHAPTER 9. TELEMEDICINE AND TELEHEALTH

13:30-9.1 Purpose and scope

(a) The purpose of this subchapter is to implement the provisions of P.L. 2017, c. 117 (N.J.S.A. 45:1-61 et seq.), which authorizes healthcare providers to engage in telemedicine and telehealth.

(b) This subchapter shall apply to all persons who are licensed by the Board.

(c) Pursuant to N.J.S.A. 45:1-62, a dentist or dental hygienist must hold a license, as applicable, issued by the Board, if he or she:

1. Is located in New Jersey and provides health care services to any patient located in or out of New Jersey by means of telemedicine or telehealth; or

2. Is located outside of New Jersey and provides health care services to any patient located in New Jersey by means of telemedicine or telehealth.

(d) Notwithstanding N.J.S.A. 45:1-62 and (c) above, a healthcare provider located in another state who consults with a licensee in New Jersey through the use of information and communications technologies, but does not direct patient care, will not be considered as providing health care services to a patient in New Jersey consistent with N.J.S.A. 45:6-1 et seq., and will not be required to obtain licensure in New Jersey in order to provide such consultation.

13:30-9.2 Definitions

The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.

"Asynchronous store-and-forward" means the acquisition and transmission of images, diagnostics, data, and medical information either to or from an originating site or to or from the licensee at a distant site, which allows for the patient to be evaluated without being physically present.

"Board" means the New Jersey State Board of Dentistry.

"Cross-coverage" means a licensee engages in a remote dental evaluation of a patient, without in-person contact, at the request of another licensee who has established a proper licensee-patient relationship with the patient.

"Distant site" means a site at which a licensee is located while providing health care services by means of telemedicine or telehealth.

"Licensee" means an individual licensed by the Board.

"On-call" means a licensed dentist is available, where necessary, to physically attend to the urgent and follow-up needs of a patient for whom the licensed dentist has temporarily assumed responsibility, as designated by the patient's primary care licensed dentist or other health care provider of record.

"Originating site" means a site at which a patient is located at the time that health care services are provided to the patient by means of telemedicine or telehealth.

"Proper licensee-patient relationship" means an association between a licensee and patient, wherein the licensee owes a duty to the patient to be available to render professional services consistent with his or her training and experience, which is established pursuant to the requirements at N.J.A.C. 13:30-9.4.

"Telehealth" means the use of information and communications technologies, including telephones, remote patient monitoring devices, or other electronic means, to support clinical health care, provider consultation, patient and professional health-related education, public health, health administration, and other services in accordance with the provisions of P.L. 2017, c. 117 (N.J.S.A. 45:1-61 et seq.).

"Telemedicine" means the delivery of a health care service, including supportive mental health services, using electronic communications, information technology, or other electronic or technological means to bridge the gap between a health care licensee who is located at a distant site and a patient who is located at an originating site, either with or without the assistance of an intervening licensee, and in accordance with the provisions of P.L. 2017, c. 117 (N.J.S.A. 45:1-61 et seq.). "Telemedicine" does not include the use, in isolation, of audio-only telephone conversation, electronic mail, instant messaging, phone text, or facsimile transmission.

13:30-9.3 Standard of care

(a) Prior to providing services through telemedicine or telehealth, a licensee shall determine whether providing those services through telemedicine or telehealth would be consistent with the standard of care applicable for those services when provided in-person.

(b) If a licensee determines, either before or during the provision of health care services, that services cannot be provided through telemedicine or telehealth in a manner that is consistent with in-person standards of care, the licensee shall not provide services through telemedicine or telehealth.

1. A licensed dental hygienist working under supervision shall be 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.

(c) A licensee who determines that services cannot be provided through telemedicine or telehealth pursuant to (b) above shall advise the patient to obtain services in-person.

(d) A licensed dentist who provides a diagnosis, treatment, or consultation recommendation, including discussions regarding the risk and benefits of a patient's treatment options, through telemedicine or telehealth shall be held to the same standard of care or practice standards as are applicable to in-person settings.

(e) A licensed dental hygienist who provides an assessment, treatment, or consultation recommendation, including discussions regarding the risk and benefits of a patient's treatment options, through telemedicine or telehealth, shall be held to the same standard of care or practice standards as are applicable to in-person settings.

13:30-9.4 Licensee-patient relationship

(a) Prior to providing services through telemedicine or telehealth, a licensee shall establish a licensee-patient relationship by:

1. Identifying the patient with, at a minimum, the patient's name, date of birth, phone number, and address. A licensed dentist may also use a patient's assigned identification number, Social Security number, photo, health insurance policy number, or other identifier associated directly with the patient; and

2. Disclosing and validating the licensee's identity, license, title, and, if applicable, professional certifications.

(b) Prior to initiating contact with a patient for the purpose of providing services to the patient using telemedicine or telehealth, a licensed dentist shall:

1. Review the patient's medical and dental history and any available dental records;

2. Determine as to each unique patient encounter whether the licensee will be able to provide the same standard of care using telemedicine or telehealth as would be provided if the services were provided in-person; and

3. Provide the patient the opportunity to sign a consent form that authorizes the licensed dentist to release dental records of the encounter to the patient's primary care licensed dentist or other healthcare provider identified by the patient.

(c) Notwithstanding (a) and (b) above, health care services may be provided through telemedicine or telehealth without a proper licensed dentist-patient relationship if the provision of health care services is:

1. For informal consultations with another healthcare provider performed by a licensee outside the context of a contractual relationship, or on an irregular or infrequent basis, without the expectation or exchange of direct or indirect compensation;

2. During episodic consultations by a medical or dental specialist located in another jurisdiction who provides consultation services, upon request, to a licensee in this State;

3. Related to dental assistance provided in response to an emergency or disaster, provided that there is no charge for the dental assistance; or

4. Provided by a substitute licensee acting on behalf, and at the designation of, an absent licensee in the same specialty on an on-call or cross-coverage basis.

13:30-9.5 Provision of dental care services through telemedicine or telehealth

(a) As long as a licensee has satisfied the requirements at N.J.A.C. 13:30-9.4, a licensee may provide health care services to a patient through the use of telemedicine and may engage in telehealth to support and facilitate the provision of health care services to patients.

(b) Prior to providing services through telemedicine or telehealth, a licensee shall determine the patient's originating site and record this information in the patient's record.

(c) A licensee providing healthcare services through telemedicine shall use interactive, real-time, two-way communication technologies, which shall include, except as provided at (e) below, a video component that allows a licensee to see a patient and the patient to see the licensee during the provision of health care services.

(d) A licensee providing services through telemedicine or telehealth may use asynchronous store-and-forward technology to allow for the electronic transmission of:

1. Images;

2. Diagnostics;

3. Data; and

4. Medical or dental information.

(e) If, after accessing and reviewing the patient's medical and/or dental records, a licensee determines that he or she is able to meet the standard of care for such services if they were being provided in-person without using the video component described at (c) above, the licensee may use interactive, real-time, two-way audio in combination with asynchronous store-and-forward technology, without a video component.

(f) Prior to providing services through telemedicine or telehealth, a licensed dentist shall review any medical history or medical or dental records provided by a patient as follows:

1. For an initial encounter with a patient, medical and dental history and dental records shall be reviewed prior to the provision of health care services through telemedicine or telehealth; and

2. For any subsequent interactions with a patient, medical and dental history and dental records shall be reviewed either prior to the provision of health care services through telemedicine or telehealth or contemporaneously with the encounter with the patient.

(g) During and after the provision of health care services through telemedicine or telehealth, a licensed dentist, or another designated licensee, shall provide his or her name, professional credentials, and contact information to the patient. Such contact information shall enable the patient to contact the licensee for at least 72 hours following the provision of services, or for a longer period if warranted by the patient's circumstances and accepted standards of care.

(h) After the provision of health care services through telemedicine or telehealth, a licensed dentist shall, consistent with N.J.A.C. 13:30-8.7(e), provide the patient, upon request, with his or her dental records reflecting the services provided.

(i) A licensed dentist shall provide, upon a patient's written request, the patient's dental information to the patient's primary dental care provider or to other health care providers.

(j) A licensed dentist engaging in telemedicine or telehealth shall refer a patient for follow-up care when necessary.

(k) A licensed dental hygienist who engages in telemedicine or telehealth and who practices dental hygiene under general supervision shall comply with the provisions at N.J.A.C. 13:30-1A.4.

13:30-9.6 Prescriptions

(a) A licensed dentist shall not issue a prescription based solely on responses provided in an online questionnaire, unless the licensee has established a proper licensed dentist-patient relationship pursuant to N.J.A.C. 13:30-9.4.

(b) A licensed dentist shall not issue a prescription for a Schedule II controlled dangerous substance, unless the licensed dentist has had an initial in-person examination of the patient and a subsequent in-person visit with the patient at least every three months for the duration of the time the patient is prescribed the Schedule II controlled dangerous substance.

13:30-9.7 Records

A licensee who provides services through telemedicine or telehealth shall maintain a record of the care provided to a patient. Such records shall comply with the requirements at N.J.A.C. 13:30-8.7, and all other applicable State and Federal statutes, rules, and regulations for recordkeeping, confidentiality, and disclosure of a patient's dental record.

13:30-9.8 Prevention of fraud and abuse

(a) In order to establish that a licensee has made a good faith effort to prevent fraud and abuse when providing services through telemedicine or telehealth, a licensee must establish written protocols that address:

1. Authentication and authorization of users;

2. Authentication of the patient during the initial intake pursuant to N.J.A.C. 13:30-9.4(a)1;

3. Authentication of the origin of information;

4. The prevention of unauthorized access to the system or information;

5. System security, including the integrity of information that is collected, program integrity, and system integrity;

6. Maintenance of documentation about system and information usage;

7. Information storage, maintenance, and transmission; and

8. Synchronization and verification of patient profile data.

13:30-9.9 Privacy and notice to patients

(a) Licensed dentists who communicate or who have staff communicate with patients by electronic communications other than telephone or facsimile shall establish written privacy practices that are consistent with Federal standards pursuant to 45 CFR 160 and 164, which are incorporated herein by reference, relating to privacy of individually identifiable health information.

(b) Written privacy practices required pursuant to (a) above shall include privacy and security measures that assure confidentiality and integrity of patient-identifiable information. Transmissions, including patient email, prescriptions, and laboratory results must be password protected, encrypted electronic prescriptions, or protected through substantially equivalent authentication techniques.

(c) A licensee, registrant, or other employee of the dentist who becomes aware of a breach in confidentiality of patient information, as defined at 45 CFR 164.402, shall comply with the reporting requirements at 45 CFR 164.

(d) Licensees, or their authorized representatives, shall provide a patient, prior to evaluation or treatment, with copies of written privacy practices and shall obtain the patient's written acknowledgement of receipt of the notice.

(e) Licensees who provide services through telemedicine or telehealth, or their authorized representatives, shall, prior to providing services, give patients notice regarding telemedicine and telehealth, including the risks and benefits of being treated through telemedicine or telehealth and how to receive follow-up care or assistance in the event of an adverse reaction to the treatment, or in the event of an inability to communicate as a result of a technological or equipment failure. A licensee shall obtain a signed and dated statement indicating that the patient received this notice.

(f) When telemedicine or telehealth is unable to provide all pertinent clinical information that a licensee exercising ordinary skill and care would deem reasonably necessary to provide care to a patient, the licensee shall inform the patient of this prior to the conclusion of the provision of care through telemedicine or telehealth and shall advise the patient regarding the need for the patient to obtain an additional in-person medical evaluation reasonably able to meet the patient's needs.