51 N.J.R. 1088(a)

VOLUME 51, ISSUE 13, JULY 1, 2019
RULE PROPOSALS

Reporter
51 N.J.R. 1088(a)
NJ - New Jersey Register  >  2019  >  JULY  >  JULY 1, 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 > STATE BOARD OF MEDICAL EXAMINERS > STATE ACUPUNCTURE EXAMINING BOARD

Administrative Code Citation

Proposed New Rules: N.J.A.C. 13:35-9.21 through 9.28
Text

Acupuncture - Telemedicine

Authorized By: State Acupuncture Examining Board, ToniAnn Petrella-Diaz, Executive Director, and State Board of Medical Examiners, William Roeder, Executive Director.

Authority: N.J.S.A. 45:2C-3 and P.L. 2017, c. 117.

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

Proposal Number: PRN 2019-101.

Submit comments by August 30, 2019, to:

   ToniAnn Petrella-Diaz, Executive Director
   State Acupuncture Examining Board
   Division of Consumer Affairs
   124 Halsey Street
   PO Box 45002
   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 State Acupuncture Examining Board (Board) proposes new rules to effectuate the provisions of P.L. 2017, c. 117, for licensed acupuncturists.

N.J.A.C. 13:35-9.21 sets forth that the proposed new rules implement P.L. 2017, c. 117, and establishes that the rules apply to licensed acupuncturists. The rule requires acupuncturists to hold a Board issued license if they are physically located in New Jersey 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 rule clarifies that a healthcare provider in another state who uses communications technology to consult with a New Jersey acupuncturist 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. 13:35-9.22 provides definitions for the terms used in proposed new N.J.A.C. 13:35-9.21 through 9.28.

N.J.A.C. 13:35-9.23 requires an acupuncturist 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, an acupuncturist cannot provide services through telemedicine or telehealth and he or she would be required to advise the patient to receive services in-person. An acupuncturist 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. 13:35-9.24 establishes how an acupuncturist will create an acupuncturist-patient relationship prior to providing services through telemedicine or telehealth. An acupuncturist must identify the patient and disclose his or her identity. Before an acupuncturist can provide services through telemedicine or telehealth, he or she is required to review a patient's history and records. The rule requires acupuncturists 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. An acupuncturist will not have to establish an acupuncturist-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 an acupuncturist is providing on-call or cross-coverage services.

N.J.A.C. 13:35-9.25 permits an acupuncturist 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 an acupuncturist-patient relationship with the patient or qualifies for an exemption to the acupuncturist-patient relationship requirement. Acupuncturists are prohibited from providing services through telemedicine that involve a patient or other unlicensed person inserting needles into the body of the patient. Prior to providing services, the acupuncturist must determine the site at which the patient is located and record this in the patient's record. When an acupuncturist provides services through telemedicine, he or she must use interactive, real-time, two-way communication technologies, which include a video component. An acupuncturist 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 acupuncturist may use interactive, real-time, two-way audio in combination with technology that permits the transmission of images, diagnostics, data, and medical information.

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

N.J.A.C. 13:35-9.26 requires acupuncturists to maintain records of care provided to patients through telemedicine or telehealth. Such records must comply with the requirements in N.J.A.C. 13:35-9.16, and all other statutes, rules, and regulations governing recordkeeping, confidentiality, and disclosure.

N.J.A.C. 13:35-9.27 requires acupuncturists 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. 13:35-9.28 requires acupuncturists 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 [page=1089] 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 or other authentication techniques. If an acupuncturist becomes aware of a breach of confidentiality, he or she must report this as required by 45 CFR Part 164. Acupuncturists must provide patients with copies of privacy practices and obtain written acknowledgement of receipt from patients. The rule also requires acupuncturists to provide patients with notice regarding telemedicine and telehealth which includes the risks of using technology to provide services and information on how to receive follow-up care. Acupuncturists 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, an acupuncturist 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 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 acupuncturists who choose to provide services through telemedicine or telehealth. The proposed new rules require acupuncturists to use communication technologies that provide for interactive, real-time, two-way communication that include a video component. Acupuncturists 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 in N.J.A.C. 13:35-9.28 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 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 proposed new rules will have no impact on the agriculture industry in the State.

Regulatory Flexibility Analysis

Since acupuncturists are individually licensed by the Board 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 Board does not believe that acupuncturists 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 acupuncturists 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 acupuncturists 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.

Regulations

Full text of the proposed new rules follows:

1. ACUPUNCTURE

13:35-9.21    Telemedicine: purpose and scope

1. The purpose of N.J.A.C. 13:35-9.22 through 9.28 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.
2. These rules shall apply to all persons who are licensed by the Board as acupuncturists.
3. Pursuant to N.J.S.A. 45:1-62, an acupuncturist must hold a license issued by the Board 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 an acupuncturist 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.

13:35-9.22    Telemedicine: definitions
The following words and terms, when used in N.J.A.C. 13:35-9.21 and 9:23 through 9.28 and this section, shall have the following meanings, unless the context clearly indicates otherwise.

"Acupuncturist" means an individual licensed by the Board as an acupuncturist.

"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 acupuncturist at a distant site, which allows for the patient to be evaluated without being physically present.

"Board" means the Acupuncture Examining Board.

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

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

"On-call" means an acupuncturist is available, where necessary, to physically attend to the urgent and follow-up needs of a patient for whom the acupuncturist has temporarily assumed responsibility, as designated by the patient's primary acupuncturist 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 [page=1090] 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 an acupuncturist 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 acupuncturist, 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.

13:35-9.23    Telemedicine: standard of care

1. Prior to providing services through telemedicine or telehealth, an acupuncturist 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 an acupuncturist 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 acupuncturist shall not provide services through telemedicine or telehealth.
3. An acupuncturist 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. An acupuncturist 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.

13:35-9.24    Telemedicine: acupuncturist-patient relationship

1. Prior to providing services through telemedicine or telehealth, an acupuncturist shall establish an acupuncturist-patient relationship by:
2. Identifying the patient with, at a minimum, the patient's name, date of birth, phone number, and address. An acupuncturist 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 acupuncturist'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, an acupuncturist 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, an acupuncturist 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 acupuncturist shall make this determination prior to each unique patient encounter.
6. Notwithstanding (a), (b), and (c) above, service may be provided through telemedicine or telehealth without a proper provider-patient relationship if:
7. The provision of services is for informal consultations with another healthcare provider performed by an acupuncturist outside the context of a contractual relationship, or on an irregular or infrequent basis, without the expectation or exchange of direct or indirect compensation;
8. The provision of services is during episodic consultations by a specialist located in another jurisdiction who provides consultation services, upon request, to an acupuncturist in this State;
9. An acupuncturist furnishes assistance in response to an emergency or disaster, provided that there is no charge for the medical assistance; or
10. A substitute acupuncturist, who is acting on behalf of an absent acupuncturist in the same specialty, provides health care services on an on-call or cross-coverage basis, provided that the absent acupuncturist has designated the substitute acupuncturist as an on-call acupuncturist or cross-coverage service provider.

13:35-9.25    Telemedicine: provision of services through telemedicine or telehealth

1. As long as an acupuncturist has satisfied the requirements of N.J.A.C. 13:35-9.24, an acupuncturist 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. Notwithstanding (a) above, an acupuncturist shall not provide health care services through the use of telemedicine that involve a patient or other unlicensed person inserting needles into the body of the patient.
3. Prior to providing services through telemedicine or telehealth, an acupuncturist shall determine the patient's originating site and record this information in the patient's record.
4. An acupuncturist providing healthcare services through telemedicine shall use interactive, real-time, two-way communication technologies, which shall include, except as provided in (f) below, a video component that allows an acupuncturist to see a patient and the patient to see the acupuncturist during the provision of services.
5. An acupuncturist providing services through telemedicine or telehealth may use asynchronous store-and-forward technology to allow for the electronic transmission of:
6. Images;
7. Diagnostics;
8. Data; and
9. Medical information.
10. If, after accessing and reviewing the patient's records, an acupuncturist 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 (d) above, the acupuncturist may use interactive, real-time, two-way audio in combination with asynchronous store-and-forward technology, without a video component.
11. During the provision of services through telemedicine or telehealth, and after the provision of services, an acupuncturist, or another designated acupuncturist, shall provide his or her name, professional credentials, and contact information to the patient. Such contact information shall enable the patient to contact the acupuncturist 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.
12. Prior to providing services through telemedicine or telehealth, an acupuncturist shall review any history or records provided by a patient as follows:
13. For an initial encounter with a patient, history and records shall be reviewed prior to the provision of services through telemedicine or telehealth; and
14. 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.
15. After the provision of services through telemedicine or telehealth, an acupuncturist shall provide the patient, upon request, with his or her records created due to the services provided.
16. An acupuncturist 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.
17. An acupuncturist engaging in telemedicine or telehealth shall refer a patient for follow-up care when necessary.

13:35-9.26    Telemedicine: records
An acupuncturist 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. 13:35-9.16, and all other applicable State and Federal statutes, rules, and regulations for recordkeeping, confidentiality, and disclosure of a patient's record.
13:35-9.27    Telemedicine: prevention of fraud and abuse

1. In order to establish that an acupuncturist has made a good faith effort to prevent fraud and abuse when providing services through telemedicine or telehealth, an acupuncturist 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. 13:35-9.24(a)1;

[page=1091] 3. Authentication of the origin of information;

1. The prevention of unauthorized access to the system or information;
2. System security, including the integrity of information that is collected, program integrity, and system integrity;
3. Maintenance of documentation about system and information usage;
4. Information storage, maintenance, and transmission; and
5. Synchronization and verification of patient profile data.

13:35-9.28    Telemedicine: privacy and notice to patients

1. Acupuncturists 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.
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 and laboratory results must be password protected or protected through substantially equivalent authentication techniques.
3. An acupuncturist 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.
4. Acupuncturists, 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. Acupuncturists 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. An acupuncturist 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 an acupuncturist exercising ordinary skill and care would deem reasonably necessary to provide care to a patient, the acupuncturist 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.