51 N.J.R. 919(a)

VOLUME 51, ISSUE 12, JUNE 17, 2019
RULE PROPOSALS

Reporter
51 N.J.R. 919(a)
NJ - New Jersey Register  >  2019  >  JUNE  >  JUNE 17, 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 > NEW JERSEY BOARD OF MEDICAL EXAMINERS > GENETIC COUNSELING ADVISORY COMMITTEE

Administrative Code Citation

Proposed New Rules: N.J.A.C. 13:35-14.19 through 14.26
Text

Genetic Counselors -- Telemedicine

Authorized By: Genetic Counseling Advisory Committee, William Roeder, Executive Director.

Authority: N.J.S.A. 45:9-37.115 and P.L. 2017, c. 117.

Calendar Reference: See Summary below for explanation of exception to calendar requirement.

Proposal Number: PRN 2019-078.

Submit comments by September 16, 2019, to:

   William Roeder, Executive Director
   Genetic Counseling Advisory Committee
   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, which was effective July 21, 2017, authorizes healthcare providers to engage in telemedicine and telehealth. The Genetic Counseling Advisory Committee (Committee) proposes new rules to effectuate the provisions of P.L. 2017, c. 117, for licensed genetic counselors.

N.J.A.C. 13:35-14.19 sets forth that the proposed new rules implement P.L. 2017, c. 117, and establishes that the rules apply to licensed genetic counselors and person permitted to provide genetic counseling pursuant to N.J.A.C. 13:35-14.4. The rule requires genetic counselors 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 genetic counseling services by means of telemedicine or telehealth to patients located in New Jersey, except as provided by N.J.A.C. 13:35-14.5. The rule clarifies that a healthcare provider in another state who uses communications technology to consult with a New Jersey licensed genetic counselor, 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. 13:35-14.20 provides definitions for the terms used in proposed new N.J.A.C. 13:35-14.19 through 14.26.

N.J.A.C. 13:35-14.21 requires a licensed genetic counselor to determine whether he or she can provide genetic counseling 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 licensed genetic counselor cannot provide services through telemedicine or telehealth and he or she would be required to advise the patient to receive services in-person. A licensed genetic counselor 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. 13:35-14.22 establishes how a licensed genetic counselor will create a licensed genetic counselor-patient relationship prior to providing services through telemedicine or telehealth. A licensed genetic counselor must identify the patient and disclose his or her identity. Before a licensed genetic counselor 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 licensed genetic counselors 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. A licensed genetic counselor will not have to establish a licensed genetic counselor-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 licensed genetic counselor is providing on-call or cross-coverage services.

N.J.A.C. 13:35-14.23 permits a licensed genetic counselor 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 licensed genetic counselor-patient relationship with the patient or qualifies for an exemption to the licensed genetic counselor-patient relationship requirement. Prior to providing services, the licensed genetic counselor must determine the site at which the patient is located and record this in the patient's record. When a licensed genetic counselor provides services through telemedicine, he or she must use interactive, real-time, two-way communication technologies, which include a video component. A licensed genetic counselor 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 licensed genetic counselor may use interactive, real-time, two-way audio in combination with technology that permits the transmission of images, diagnostics, data, and medical information.

A licensed genetic counselor will be required to review a patient's 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 licensed genetic counselor who provides services through telemedicine or telehealth will be required to provide contact information to a patient by which the patient can contact the licensed genetic counselor, or an alternative licensed genetic counselor, for at least 72 hours after the provision of services. A licensed genetic counselor must provide patients with medical records upon request. A licensed genetic counselor also must provide a patient's information to a patient's primary [page=920] care provider or other health care provider upon written request. A licensed genetic counselor will be required to provide a referral for follow-up care when it is necessary.

N.J.A.C. 13:35-14.24 requires licensed genetic counselors to maintain records of care provided to patients through telemedicine or telehealth. Such records must comply with the requirements in N.J.A.C. 13:35-14.15 and all other statutes and rules governing recordkeeping, confidentiality, and disclosure. N.J.A.C. 13:35-14.25 requires licensed genetic counselors 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. 13:35-14.26 requires licensed genetic counselors to establish privacy practices for electronic communications that comply with the standards of 45 CFR Parts 160 and 164, which are incorporated 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. 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 licensed genetic counselor becomes aware of a breach of confidentiality, he or she must report this as required by 45 CFR Part 164. Licensed genetic counselors must provide patients with copies of privacy practices and obtain written acknowledgement of receipt from patients. The rule also requires licensed genetic counselors to provide patients with notice regarding telemedicine and telehealth that includes the risks of using technology to provide genetic counseling services and information on how to receive follow-up care. Licensed genetic counselors 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 licensed genetic counselor 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, pursuant to N.J.A.C. 1:30-3.3(a)5, this notice is excepted from the rulemaking calendar requirement.

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 genetic counseling services while protecting patients who receive such services through telemedicine or telehealth.

Economic Impact

The Committee anticipates that the proposed new rules may have an economic impact on licensed genetic counselors who choose to provide services through telemedicine or telehealth. The proposed new rules require licensed genetic counselors to use communication technologies that provide for interactive, real-time, two-way communications that include a video component. Licensed genetic counselors 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. 13:35-14.26 impose the same standards for privacy of communications as are imposed by 45 CFR Parts 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 licensed genetic counselors 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 licensed genetic counselors 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 licensed genetic counselors 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 licensed genetic counselors 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 genetic counseling 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 genetic counseling services through telemedicine or telehealth.

Racial and Ethnic Community Criminal Justice and Public Safety Impact

The Committee 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:

1. Telemedicine: purpose and scope
2. The purpose of N.J.A.C. 13:35-14.20 through 14.26 and this section 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.
3. This subchapter shall apply to all persons who are licensed by the Committee as genetic counselors or are permitted to provide genetic counseling pursuant to N.J.A.C. 13:35-14.4.
4. Except as provided in N.J.A.C. 13:35-14.5, a genetic counselor must hold a license issued by the Committee if he or she:
5. 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
6. Is located outside of New Jersey and provides health care services to any patient located in New Jersey by means of telemedicine or telehealth.
7. Notwithstanding N.J.S.A. 45:1-62, a healthcare provider located in another state who consults with a licensed genetic counselor 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.
8. Telemedicine: definitions

The following words and terms, when used in N.J.A.C. 13:35-14.19 and 14.21 through 14.26 and this section, 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 licensed genetic counselor [page=921] at a distant site, which allows for the patient to be evaluated without being physically present.

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

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

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

1. Telemedicine: standard of care
2. Prior to providing services through telemedicine or telehealth, a licensed genetic counselor 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.
3. If a licensed genetic counselor 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 licensed genetic counselor shall not provide services through telemedicine or telehealth.
4. A licensed genetic counselor who determines that services cannot be provided through telemedicine or telehealth pursuant to (b) above shall advise the patient to obtain services in-person.
5. A licensed genetic counselor 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.
6. Telemedicine: licensed genetic counselor-patient relationship
7. Prior to providing services through telemedicine or telehealth, a licensed genetic counselor shall establish a licensed genetic counselor-patient relationship by:
8. Identifying the patient with, at a minimum, the patient's name, date of birth, phone number, and address. A licensed genetic counselor 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
9. Disclosing and validating the licensed genetic counselor's identity, license, title, and, if applicable, specialty and board certifications.
10. Prior to an initial contact with a patient for the purpose of providing services to the patient using telemedicine or telehealth, a licensed genetic counselor shall review the patient's history and any available records.
11. Prior to initiating contact with a patient for the purpose of providing services through telemedicine or telehealth, a licensed genetic counselor 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 licensed genetic counselor shall make this determination prior to each unique patient encounter.
12. Notwithstanding (a), (b), and (c) above, service may be provided through telemedicine or telehealth without a proper licensed genetic counselor-patient relationship if:
13. The provision of services is for informal consultations with another healthcare provider performed by a licensed genetic counselor outside the context of a contractual relationship, or on an irregular or infrequent basis, without the expectation or exchange of direct or indirect compensation;
14. The provision of services is during episodic consultations by a medical specialist located in another jurisdiction who provides consultation services, upon request, to a licensed genetic counselor in this State;
15. A licensed genetic counselor furnishes medical assistance in response to an emergency or disaster, provided that there is no charge for the medical assistance; or
16. A substitute licensed genetic counselor, who is acting on behalf of an absent licensed genetic counselor, provides health care services on an on-call or cross-coverage basis, provided that the absent licensed genetic counselor has designated the substitute licensed genetic counselor as an on-call licensed genetic counselor or cross-coverage service provider.
17. Telemedicine: provision of services through telemedicine or telehealth
18. As long as a licensed genetic counselor has satisfied the requirements of N.J.A.C. 13:35-14.22, a licensed genetic counselor 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.
19. Prior to providing services through telemedicine or telehealth, a licensed genetic counselor shall determine the patient's originating site and record this information in the patient's record.
20. A licensed genetic counselor 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 licensed genetic counselor to see a patient and the patient to see the licensed genetic counselor during the provision of services.
21. A licensed genetic counselor providing services through telemedicine or telehealth may use asynchronous store-and-forward technology to allow for the electronic transmission of:
22. Images;
23. Diagnostics;
24. Data; and
25. Medical information.
26. If, after accessing and reviewing the patient's records, a licensed genetic counselor 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 licensed genetic counselor may use interactive, real-time, two-way audio in combination with asynchronous store-and-forward technology, without a video component.
27. During the provision of services through telemedicine or telehealth, and after the provision of services, a licensed genetic counselor, or another designated licensed genetic counselor, shall provide his or her name, professional credentials, and contact information to the patient. Such contact information shall enable the patient to contact the licensed genetic counselor 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.
28. Prior to providing services through telemedicine or telehealth, a licensed genetic counselor shall review any history or records provided by a patient as follows:
29. For an initial encounter with a patient, history and records shall be reviewed prior to the provision of services through telemedicine or telehealth; and
30. 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.

[page=922] (h) After the provision of services through telemedicine or telehealth, a licensed genetic counselor shall provide the patient, upon request, with his or her records created due to the services provided.

1. A licensed genetic counselor 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.
2. A licensed genetic counselor engaging in telemedicine or telehealth shall refer a patient for follow-up care when necessary.
3. Telemedicine: records

A licensed genetic counselor who provides services through telemedicine or telehealth shall maintain a record of the care provide to a patient. Such records shall comply with the requirements of N.J.A.C. 13:35-14.15, and all other applicable State and Federal statutes, rules, and regulations for recordkeeping, confidentiality, and disclosure of a patient's record.

1. Telemedicine: prevention of fraud and abuse
2. In order to establish that a licensed genetic counselor has made a good faith effort to prevent fraud and abuse when providing services through telemedicine or telehealth, a licensed genetic counselor must establish written protocols that address:
3. Authentication and authorization of users;
4. Authentication of the patient during the initial intake pursuant to N.J.A.C. 13:35-14.22(a)1;
5. Authentication of the origin of information;
6. The prevention of unauthorized access to the system or information;
7. System security, including the integrity of information that is collected, program integrity, and system integrity;
8. Maintenance of documentation about system and information usage;
9. Information storage, maintenance, and transmission; and
10. Synchronization and verification of patient profile data.
11. Telemedicine: privacy and notice to patients
12. Licensed genetic counselors 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 Parts 160 and 164, as amended and supplemented, which are incorporated herein by reference, relating to privacy of individually identifiable health information.
13. 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 e-mail, prescriptions, and laboratory results must be password protected, encrypted electronic prescriptions, or protected through substantially equivalent authentication techniques.
14. A licensed genetic counselor who becomes aware of a breach in confidentiality of patient information, as defined in 45 CFR 164.402, shall comply with the reporting requirements of 45 CFR Part 164.
15. Licensed genetic counselors, 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.
16. Licensed genetic counselors 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 licensed genetic counselor shall obtain a signed and dated statement indicating that the patient received this notice.
17. When telemedicine or telehealth is unable to provide all pertinent clinical information that a licensed genetic counselor exercising ordinary skill and care would deem reasonably necessary to provide care to a patient, the licensed genetic counselor 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.