51 N.J.R. 714(a)

VOLUME 51, ISSUE 10, MAY 20, 2019
RULE PROPOSALS

Reporter
51 N.J.R. 714(a)
NJ - New Jersey Register  >  2019  >  MAY  >  MAY 20, 2019  >  RULE PROPOSALS  >  LAW AND PUBLIC SAFETY -- DIVISION OF CONSUMER AFFAIRS

Interested Persons Statement

INTERESTED PERSONS
Interested persons may submit comments, information or arguments concerning any of the rule proposals in this issue until the date indicated in the proposal. Submissions and any inquiries about submissions should be addressed to the agency officer specified for a particular proposal.
The required minimum period for comment concerning a proposal is 30 days. A proposing agency may extend the 30-day comment period to accommodate public hearings or to elicit greater public response to a proposed new rule or amendment. Most notices of proposal include a 60-day comment period, in order to qualify the notice for an exception to the rulemaking calendar requirements of    N.J.S.A. 52:14B-3. An extended comment deadline will be noted in the heading of a proposal or appear in a subsequent notice in the Register.
At the close of the period for comments, the proposing agency may thereafter adopt a proposal, without change, or with changes not in violation of the rulemaking procedures at    N.J.A.C. 1:30-6.3. The adoption becomes effective upon publication in the Register of a notice of adoption, unless otherwise indicated in the adoption notice. Promulgation in the New Jersey Register establishes a new or amended rule as an official part of the New Jersey Administrative Code.

Agency


LAW AND PUBLIC SAFETY > DIVISION OF CONSUMER AFFAIRS > BOARD OF MEDICAL EXAMINERS > HEARING AID DISPENSERS EXAMINING COMMITTEE

Administrative Code Citation

Proposed New Rules: N.J.A.C. 13:35-8.21 through 8.28
Text

Telemedicine
Authorized By: Hearing Aid Dispensers Examining Committee, William Roeder, Executive Director.
Authority: P.L. 2017, c. 117 (N.J.S.A. 45:9A-7).
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2019-056.
Submit comments by July 19, 2019, to:
   William Roeder, Executive Director
   Hearing Aid Dispensers Examining Committee
   140 East Front Street, 2nd Floor
   PO Box 183
   Trenton, New Jersey 08625
   or electronically at: http://www.njconsumeraffairs.gov/Proposals/Pages/default.aspx.

The agency proposal follows:

Summary
P.L. 2017, c. 117, effective July 21, 2017, authorizes healthcare providers to engage in telemedicine and telehealth. The Hearing Aid Dispensers Examining Committee (Committee) proposes new rules to effectuate the provisions of P.L. 2017, c. 117 for licensed hearing aid dispensers described below.

N.J.A.C. 13:35-8.21 sets forth that the proposed new rules implement P.L. 2017, c. 117 and establishes that the rules apply to licensees. The rule requires hearing aid dispensers to hold a Committee-issued license if they are physically located in New Jersey or if they are physically located outside of New Jersey and are providing services by means of telemedicine or telehealth to patients located in New Jersey. The rule clarifies that a healthcare provider in another state who uses communications technology to consult with a New Jersey licensee, but who does not direct 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. 13:35-8.22 provides definitions for the terms used in proposed new rules N.J.A.C. 13:35-8.21 through 8.28.

N.J.A.C. 13:35-8.23 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. 13:35-8.24 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. The rule requires licensees 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 has to 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. 13:35-8.25 permits a licensee to provide services through telemedicine and to support and facilitate the provision of services to a patient 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 may use asynchronous store-and-forward technology for certain electronic transmissions. 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 may use interactive, real-time, two-way audio in combination with technology that permits the transmission of images, diagnostics, data, and medical information.

A licensee will be required to review a patient's medical history and 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 will be 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 medical records upon request. A licensee also must provide a patient's information to the patient's primary care provider or other health care provider upon written request. A licensee will be required to provide a referral for follow-up care when it is necessary.

N.J.A.C. 13:35-8.26 requires licensees to maintain records of care provided to patients through telemedicine or telehealth. Such records must comply with the requirements in N.J.A.C. 13:35-8.16, and all other statutes and regulations governing recordkeeping, confidentiality, and disclosure.
N.J.A.C. 13:35-8.27 requires licensees to establish written protocols to prevent fraud and abuse. Such protocols must address: identification 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. 13:35-8.28 requires licensees to establish privacy practices for electronic communications that comply with the standards of 45 CFR 160 and 164, which are incorporated 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 required by 45 CFR 164. Licensees must provide patients with copies of privacy practices and obtain written acknowledgement of receipt from patients. The rule also requires licensees to provide patients with notice regarding telemedicine and telehealth that includes risks of using technology to provide services 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 Committee 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 Committee believes the proposed new rules will have a positive social impact in that they will facilitate the use of communication technologies to provide services while protecting patients who receive such services through telemedicine or telehealth.

[page=715] Economic Impact

The Committee anticipates that the proposed new rules may have an economic impact on licensees who choose to provide services through telemedicine or telehealth. The proposed new rules requires 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 Committee does not anticipate that the proposed new rules will have any other economic impact.
Federal Standards Statement

Requirements in N.J.A.C. 13:35-6B.9 impose the same standards for privacy of communications as are imposed by 45 CFR 160 and 164, which are referred to in the rule. There are no other applicable Federal laws or standards.

Jobs Impact

The Committee does not believe that proposed new rules will result in the creation or loss of jobs in the State.

Agriculture Industry Impact

The proposed new rules will have no impact on the agriculture industry in the State.

Regulatory Flexibility Analysis

Since licensees are individually licensed by the Committee under the Regulatory Flexibility Act (Act), N.J.S.A. 52:14B-16 et seq., they may be considered "small businesses" for the purposes of the Act.

The economic impact on small businesses will be the same as that imposed on all businesses as detailed in the Economic Impact statement. The Committee 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 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 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 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 services through telemedicine or telehealth.

Racial and Ethnic Community Criminal Justice and Public Safety Impact

The Director 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.

Regulations

Full text of the proposed new rules follows:

13:35-8.21    Telemedicine: purpose and scope

1. The purpose of N.JA.C. 13:35-8.21 through 8.28 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.
2. N.J.A.C. 13:35-8.21 through 8.28 shall apply to all persons who are licensed by the Committee to fit and dispense hearing aids.
3. Pursuant to N.J.S.A. 45:1-62, a hearing aid dispenser must hold a license issued by the Committee if he or she:
4. 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
5. Is located outside of New Jersey and provides health care services to any patient located in New Jersey by means of telemedicine or telehealth.
6. Notwithstanding N.J.S.A. 45:1-62, 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 and will not be required to obtain licensure in New Jersey in order to provide such consultation.

13:35-8.22    Telemedicine: definitions

The following words and terms, when used in N.J.A.C. 13:35-8.21 through 8.28, 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.

"Committee" means the Hearing Aid Dispensers Examining Committee.

"Cross-coverage" means a licensee who engages in a remote medical 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 a person who has been duly issued a license to fit and dispense hearing aids in accordance with N.J.S.A. 45:9A-1 et seq., and this subchapter.

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

"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 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.

13:35-8.23    Telemedicine: standard of care

1. 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.
2. If a licensee determines, either before or during the provision of 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.
3. 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.
4. A licensee 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 [page=716] held to the same standard of care or practice standards as are applicable to in-person settings.

13:35-8.24    Telemedicine: licensee-patient relationship

1. Prior to providing services through telemedicine or telehealth, a licensee shall establish a licensee-patient relationship by:
2. Identifying the patient with, at a minimum, the patient's name, date of birth, phone number, and address. A licensee 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
3. Disclosing and validating the licensee's identity, license, title, and, if applicable, specialty and board certifications.
4. Prior to an initial contact with a patient for the purpose of providing services to the patient using telemedicine or telehealth, a licensee shall review the patient's history and any available records.
5. Prior to initiating contact with a patient for the purpose of providing services through telemedicine or telehealth, a licensee shall determine whether he or she 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. The licensee shall make this determination prior to each unique patient encounter.
6. Prior to initiating contact with a patient, a licensee shall provide the patient the opportunity to sign a consent form that authorizes the licensee to release records of the encounter to the patient's primary care provider or other health care provider identified by the patient.
7. Notwithstanding (a), (b), and (c) above, service may be provided through telemedicine or telehealth without a proper provider-patient relationship if:
8. The provision of services is 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;
9. The provision of services is during episodic consultations by a specialist located in another jurisdiction who provides consultation services, upon request, to a licensee in this State;
10. A licensee furnishes assistance in response to an emergency or disaster, provided that there is no charge for the assistance; or
11. A substitute licensee, who is acting on behalf of an absent licensee in the same specialty, provides health care services on an on-call or cross-coverage basis, provided that the absent licensee has designated the substitute licensee as an on-call licensee or cross-coverage service provider.

13:35-8.25    Telemedicine: provision of services through telemedicine or telehealth

1. As long as a licensee has satisfied the requirements of N.J.A.C. 13:35-8.24, 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.
2. 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.
3. A licensee providing healthcare services through telemedicine shall use interactive, real-time, two-way communication technologies, which shall include, except as provided in (e) below, a video component that allows a licensee to see a patient and the patient to see the licensee during the provision of services.
4. A licensee providing services through telemedicine or telehealth may use asynchronous store-and-forward technology to allow for the electronic transmission of:
5. Images;
6. Diagnostics;
7. Data; and
8. Medical information.
9. If, after accessing and reviewing the patient's 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 in (c) above, the licensee may use interactive, real-time, two-way audio in combination with asynchronous store-and-forward technology, without a video component.
10. During the provision of services through telemedicine or telehealth, and after the provision of services, a licensee, 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.
11. Prior to providing services through telemedicine or telehealth, a licensee shall review any history or records provided by a patient as follows:
12. For an initial encounter with a patient, history and records shall be reviewed prior to the provision of services through telemedicine or telehealth; and
13. For any subsequent interactions with a patient, history and records shall be reviewed either prior to the provision of services through telemedicine or telehealth or contemporaneously with the encounter with the patient.
14. After the provision of services through telemedicine or telehealth, a licensee shall provide the patient, upon request, with his or her records created due to the services provided.
15. A licensee shall provide, upon a patient's written request, the patient's information to the patient's primary care provider or to other health care providers.
16. A licensee engaging in telemedicine or telehealth shall refer a patient for follow-up care when necessary.

13:35-8.26    Telemedicine: 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 of N.J.A.C. 13:35-8.16, and all other applicable State and Federal statutes and regulations for recordkeeping, confidentiality, and disclosure of a patient's record.

13:35-8.27    Telemedicine: prevention of fraud and abuse

1. 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:
2. Authentication and authorization of users;
3. Authentication of the patient during the initial intake pursuant to N.J.A.C. 13:35-8.24(a)1;
4. Authentication of the origin of information;
5. The prevention of unauthorized access to the system or information;
6. System security, including the integrity of information that is collected, program integrity, and system integrity;
7. Maintenance of documentation about system and information usage;
8. Information storage, maintenance, and transmission; and
9. Synchronization and verification of patient profile data.

13:35-8.28    Telemedicine: privacy and notice to patients

1. Licensees who communicate with patients by electronic communications other than telephone or facsimile shall establish written privacy practices that are consistent with Federal standards under 45 CFR 160 and 164, which are incorporated herein by reference, as amended and supplemented, relating to privacy of individually identifiable health information.
2. Written privacy practices required by (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.
3. A licensee who becomes aware of a breach in confidentiality of patient information, as defined in 45 CFR 164.402, shall comply with reporting requirements of 45 CFR 164.
4. 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.
5. 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 [page=717] 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.
6. 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 evaluation reasonably able to meet the patient's needs.