51 N.J.R. 934(a)

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

Reporter
51 N.J.R. 934(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 > CERTIFIED PSYCHOANALYSTS ADVISORY COMMITTEE

Administrative Code Citation

Proposed New Rules: N.J.A.C. 13:42A-8
Text

Telemedicine

Authorized By: Paul R. Rodriguez, Acting Director, Division of Consumer Affairs.

Authority: N.J.S.A. 45:14BB-12 and P.L. 2017, c. 117.

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

Proposal Number: PRN 2019-081.

Submit comments by August 16, 2019, to:

   Susan Rischawy, Acting Executive Director
   Certified Psychoanalysts Advisory Committee
   124 Halsey Street
   PO 45050
   Newark, New Jersey 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 Director of the Division of Consumer Affairs (Director) proposes new Subchapter 8 to effectuate the provisions of P.L. 2017, c. 117, for State-certified psychoanalysts.

N.J.A.C. 13:42A-8.1 sets forth that Subchapter 8 implements P.L. 2017, c. 117, and establishes that the subchapter applies to certified psychoanalysts. N.J.A.C. 13:42A-8.2 provides definitions for the terms used in Subchapter 8.

N.J.A.C. 13:42A-8.3 requires a State-certified psychoanalyst 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 State-certified psychoanalyst cannot provide services through telemedicine or telehealth and he or she would be required to advise the patient to receive services in-person. A State-certified psychoanalyst 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. 13:42A-8.4 establishes how a State-certified psychoanalyst will create a State-certified psychoanalyst-patient relationship prior to providing services through telemedicine or telehealth. A State-certified psychoanalyst must identify the patient and disclose his or her identity. Before a State-certified psychoanalyst 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 State-certified psychoanalysts 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 State-certified psychoanalyst will not have to establish a State-certified psychoanalyst-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 State-certified psychoanalyst is providing on-call or cross-coverage services.

N.J.A.C. 13:42A-8.5 permits a State-certified psychoanalyst 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 State-certified psychoanalyst-patient relationship with the patient or qualifies for an exemption to the State-certified psychoanalyst-patient relationship requirement. Prior to providing services, the State-certified psychoanalyst must determine the site at which the patient is located and record this in the patient's record. When a State-certified psychoanalyst provides services through telemedicine, he or she must use interactive, real-time, two-way communication technologies, which include a video component. A State-certified psychoanalyst 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 State-certified psychoanalyst may use interactive, real-time, two-way audio in combination with technology that permits the transmission of images, diagnostics, data, and medical information.

A State-certified psychoanalyst 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 State-certified psychoanalyst who provides services through telemedicine or telehealth will be required to provide contact information to a patient by which the patient can contact the State-certified psychoanalyst, or an alternative State-certified psychoanalyst, for at least 72 hours after the provision of services. A State-certified psychoanalyst must provide patients with records, or a summary of the record, upon request. State-certified psychoanalysts also must provide a patient's information to a patient's primary care provider or other health care or health care provider upon written request. State-certified psychoanalysts will be required to provide a referral for follow-up care when it is necessary.

N.J.A.C. 13:42A-8.6 requires State-certified psychoanalysts to maintain records of care provided to patients through telemedicine or telehealth. Such records must comply with the requirements in N.J.A.C. 13:42A-6 and all other statutes and rules governing recordkeeping, confidentiality, and disclosure. N.J.A.C. 13:42A-8.7 requires State-certified psychoanalysts 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. 13:42A-8.8 requires State-certified psychoanalysts 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. If a State-certified psychoanalyst becomes aware of a breach of confidentiality, he or she must report this as required by 45 CFR Part 164. State-certified psychoanalysts must provide patients with copies of privacy practices and obtain written acknowledgement of receipt from patients. The rule also requires State-certified psychoanalysts to provide patients with notice regarding telemedicine and telehealth which includes the risks and benefits of being treated through telemedicine or telehealth and information on how to receive follow-up care. State-certified [page=935] psychoanalysts 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 State-certified psychoanalyst will have to inform the patient of this and advise the patient that he or she should receive an in-person evaluation to meet his or her needs.

The Board has provided a 60-day comment period for this notice of proposal. Therefore, pursuant to N.J.A.C. 1:30-3.3(a)5, this notice is excepted from the rulemaking calendar requirement.

Social Impact

The Director believes the proposed new rules will have a positive social impact in that it will facilitate the use of communication technologies to provide services while protecting patients who receive such services through telemedicine or telehealth.

Economic Impact

The Director anticipates that the proposed new rules may have an economic impact on State-certified psychoanalysts who choose to provide services through telemedicine or telehealth. The proposed new rules require State-certified psychoanalysts to use communication technologies that provide for interactive, real-time, two-way communication that includes a video component. State-certified psychoanalysts may incur costs in obtaining such communication technologies. The Director does not anticipate that the proposed new rules will have any other economic impact.

Federal Standards Statement

Requirements in N.J.A.C. 13:42A-8.8 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 Director does not believe that the 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 State-certified psychoanalysts are individually certified 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 Director does not believe that State-certified psychoanalysts 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 State-certified psychoanalysts 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 State-certified psychoanalysts 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 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 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:

1. TELEMEDICINE
2. Purpose and scope
3. 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.
4. This subchapter shall apply to all persons who are certified by the Committee as psychoanalysts.
5. 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 information either to or from an originating site or to or from the State-certified psychoanalyst at a distant site, which allows for the patient to be evaluated without being physically present.

"Committee" means the Certified Psychoanalyst Advisory Committee.

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

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

"State-certified psychoanalyst" means an individual certified by the Director as a psychoanalyst.

"On-call" means a State-certified psychoanalyst is available, where necessary, to physically attend to the urgent and follow-up needs of a patient for whom the State-certified psychoanalyst 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 State-certified psychoanalyst 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 State-certified psychoanalyst, 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. Standard of care
2. Prior to providing services through telemedicine or telehealth, a State-certified psychoanalyst 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 State-certified psychoanalyst 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 State-certified psychoanalyst shall not provide services through telemedicine or telehealth.

[page=936] (c) A State-certified psychoanalyst who determines that services cannot be provided through telemedicine or telehealth pursuant to (b) above shall advise the patient to obtain services in-person.

1. A State-certified psychoanalyst 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.
2. State-certified psychoanalyst-patient relationship
3. Prior to providing services through telemedicine or telehealth, a State-certified psychoanalyst shall establish a State-certified psychoanalyst-patient relationship by:
4. Identifying the patient with, at a minimum, the patient's name, date of birth, phone number, and address. A State-certified psychoanalyst 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
5. Disclosing and validating the State-certified psychoanalyst's identity, license, and title.
6. Prior to an initial contact with a patient for the purpose of providing services to the patient using telemedicine or telehealth, a State-certified psychoanalyst shall review the patient's history and any available records.
7. Prior to initiating contact with a patient for the purpose of providing services through telemedicine or telehealth, a State-certified psychoanalyst 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 State-certified psychoanalyst shall make this determination prior to each unique patient encounter.
8. Notwithstanding (a), (b), and (c) above, service may be provided through telemedicine or telehealth without a proper provider-patient relationship if:
9. The provision of services is for informal consultations with another healthcare provider performed by a State-certified psychoanalyst outside the context of a contractual relationship, or on an irregular or infrequent basis, without the expectation or exchange of direct or indirect compensation;
10. The provision of services is during episodic consultations by a specialist located in another jurisdiction who provides consultation services, upon request, to a State-certified psychoanalyst in this State;
11. A State-certified psychoanalyst furnishes assistance in response to an emergency or disaster, provided that there is no charge for the assistance; or
12. A substitute State-certified psychoanalyst, who is acting on behalf of an absent State-certified psychoanalyst in the same specialty, provides health care services on an on-call or cross-coverage basis, provided that the absent State-certified psychoanalyst has designated the substitute State-certified psychoanalyst as an on-call State-certified psychoanalyst or cross-coverage service provider.
13. Provision of services through telemedicine or telehealth
14. As long as a State-certified psychoanalyst has satisfied the requirements of N.J.A.C. 13:42A-8.4, a State-certified psychoanalyst 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.
15. Prior to providing services through telemedicine or telehealth, a State-certified psychoanalyst shall determine the patient's originating site and record this information in the patient's record.
16. A State-certified psychoanalyst 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 State-certified psychoanalyst to see a patient and the patient to see the State-certified psychoanalyst during the provision of services.
17. A State-certified psychoanalyst providing services through telemedicine or telehealth may use asynchronous store-and-forward technology to allow for the electronic transmission of:
18. Images;
19. Diagnostics;
20. Data; and
21. Medical information.
22. If, after accessing and reviewing the patient's records, a State-certified psychoanalyst 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 State-certified psychoanalyst may use interactive, real-time, two-way audio in combination with asynchronous store-and-forward technology, without a video component.
23. During the provision of services through telemedicine or telehealth, and after the provision of services, a State-certified psychoanalyst, or another designated State-certified psychoanalyst, shall provide his or her name, professional credentials, and contact information to the patient. Such contact information shall enable the patient to contact the State-certified psychoanalyst 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.
24. Prior to providing services through telemedicine or telehealth, a State-certified psychoanalyst shall review any history or records provided by a patient as follows:
25. For an initial encounter with a patient, history and records shall be reviewed prior to the provision of services through telemedicine or telehealth; and
26. 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.
27. After the provision of services through telemedicine or telehealth, a State-certified psychoanalyst shall provide the patient, upon request, with his or her records created due to the services provided, or a summary of the record, as long as the summary adequately reflects the patient's history and treatment, unless otherwise required by law.
28. A State-certified psychoanalyst 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.
29. A State-certified psychoanalyst engaging in telemedicine or telehealth shall refer a patient for follow-up care when necessary.
30. Records

A State-certified psychoanalyst 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. 13:42A-6, and all other applicable State and Federal statutes, rules, and regulations for recordkeeping, confidentiality, and disclosure of a patient's record.

1. Prevention of fraud and abuse
2. In order to establish that a State-certified psychoanalyst has made a good faith effort to prevent fraud and abuse when providing services through telemedicine or telehealth, a State-certified psychoanalyst 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. 13:42A-8.4(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. Privacy and notice to patients
12. State-certified psychoanalysts 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.

[page=937] (b) A State-certified psychoanalyst 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.

1. State-certified psychoanalysts, 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.
2. State-certified psychoanalysts 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 State-certified psychoanalyst shall obtain a signed and dated statement indicating that the patient received this notice.
3. When telemedicine or telehealth is unable to provide all pertinent clinical information that a State-certified psychoanalyst exercising ordinary skill and care would deem reasonably necessary to provide care to a patient, the State-certified psychoanalyst 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.