PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:
Proposed Action:
Addition of Part 596; and repeal of section 599.17 of Title 14 NYCRR.
Statutory authority:
Mental Hygiene Law, sections 7.09 and 31.04
Subject:
Telepsychiatry Services.
Purpose:
Establish basic standards to approve telepsychiatry in certain OMH-licensed programs; repeal unnecessary existing provisions.
Text of proposed rule:
1. Section 599.17 of Title 14 NYCRR is repealed.
2. A new Part 596 is added to Title 14 NYCRR to read as follows:
Part 596
TELEPSYCHIATRY SERVICES
§ 596.1 Background and intent.
(a) Telepsychiatry is defined as the use of two-way real-time interactive audio and video equipment to provide and support mental health services at a distance. Such services do not include a telephone conversation, electronic mail message or facsimile transmission between a clinic and a recipient, or a consultation between two professional or clinical staff.
(b) Telepsychiatry can be beneficial to a mental health care delivery system, particularly when on-site services are not available or would be delayed because of distance, location, time of day, or availability of resources. The benefits of telespsychiatry can include improved access to care, provision of care locally in a more timely fashion, improved continuity of care, improved treatment compliance, and coordination of care.
(c) The Office of Mental Health supports the use of telepsychiatry as an appropriate component of the mental health delivery system to the extent that it is in the best interests of the person served and is performed in compliance with applicable federal and state laws and regulations and the provisions of this Part in order to address legitimate concerns about privacy, security, patient safety, and interoperability.
§ 596.2 Legal base.
(a) Section 7.09 of the Mental Hygiene Law grants the Commissioner of Mental Health the power and responsibility to adopt regulations that are necessary and proper to implement matters under his or her jurisdiction.
(b) Sections 31.02 and 31.04 of the Mental Hygiene Law authorize the Commissioner of Mental Health to set standards of quality and adequacy of facilities, equipment, personnel, services, records and programs for the rendition of services for persons diagnosed with mental illness, pursuant to an operating certificate.
§ 596.3 Applicability.
(a) The provisions of this Part shall apply to any provider licensed pursuant to Article 31 of the Mental Hygiene Law who has been authorized by the Office under this Part to include the use of telepsychiatry as a means of rendering licensed services, provided, however, that telepsychiatry shall not be utilized in Personalized Recovery Oriented Services (PROS) programs subject to Part 512 of this Title or Assertive Community Treatment (ACT) programs approved pursuant to Part 551 of this Title.
(b) The provisions of this Part do not apply to telehealth services subject to regulations of the Department of Health at 18 NYCRR Section 505.38, provided, however, nothing in this Part shall be deemed to restrict the ability of providers under the jurisdiction of the Office from contracting for telehealth services delivered in accordance with such regulations.
§ 596.4 Definitions. For purposes of this Part:
(a) Distant or “hub” site means the distant location at which the practitioner rendering the telepsychiatry service is located at the time the services are provided.
(b) Encounter means a telepsychiatry event involving patient contact, whereby the care of the patient is the direct responsibility of both the originating (spoke site) provider and the distant (hub site) provider.
(c) Encryption means a system of encoding data on a Web page or email where the information can only be retrieved and decoded by the person or computer system authorized to access it.
(d) Hospital means an inpatient facility licensed by the Office under Article 31 of the Mental Hygiene Law or a ward, wing, unit or other part of a hospital as defined in Article 28 of the Public Health Law which is operated as a part of such hospital for the purpose of providing services for persons with mental illness pursuant to an operating certificate issued by the Office.
(e) Office means the Office of Mental Health.
(f) Originating or “spoke” site means the site where the patient is physically located at the time mental health services are delivered to her/him by means of telepsychiatry.
(g) Nurse practitioner in psychiatry means a person currently certified as a nurse practitioner with an approved specialty area of psychiatry (NPP) by the New York State Education Department or who possesses a permit from the New York State Education Department.
(h) Physician means a psychiatrist currently licensed to practice medicine in New York State who (i) is a diplomat of the American Board of Psychiatry and Neurology or is eligible to be certified by that Board, or (ii) is certified by the American Osteopathic Board of Neurology and Psychiatry or is eligible to be certified by that Board.
(i) Practitioner means a physician or nurse practitioner in psychiatry who is providing telepsychiatry services from a distant or hub site in accordance with the provisions of this Part.
(j) Provider of services means a provider of mental health services licensed pursuant to Article 31 of the Mental Hygiene Law.
(k) Qualified mental health professional means a practitioner possessing a license or a permit from the New York State Education Department who is qualified by credentials, training, and experience to provide direct services related to the treatment of mental illness and shall include physicians and nurse practitioner in psychiatry, as defined in subdivisions (e) and (f) of this Section, as well as the following:
(1) Creative arts therapist: a person currently licensed as a creative arts therapist by the New York State Education Department or who possesses a creative arts therapist permit from the New York State Education Department.
(2) Licensed practical nurse: a person currently licensed as a licensed practical nurse by the New York State Education Department or who possesses a licensed practical nurse permit from the New York State Education Department.
(3) Licensed psychoanalyst: a person currently licensed as a psychoanalyst by the New York State Education Department or who possesses a permit from the New York State Education Department.
(4) Licensed psychologist: a person currently licensed as a psychologist by the New York State Education Department, or who possesses a permit from the New York State Education Department and who possesses a doctoral degree in psychology, or an individual who has obtained at least a master's degree in psychology who works in a federal, state, county or municipally operated clinic.
(5) Marriage and family therapist: a person currently licensed as a marriage and family therapist by the New York State Education Department or who possesses a permit from the New York State Education Department.
(6) Mental health counselor: a person currently licensed as a mental health counselor by the New York State Education Department or who possesses a permit from the New York State Education Department.
(7) Nurse practitioner: a person currently certified as a nurse practitioner by the New York State Education Department or who possesses a permit from the New York State Education Department.
(8) Physician: a person currently licensed as a physician by the New York State Education Department or who possesses a permit from the New York State Education Department.
(9) Physician assistant: a person currently registered as a physician assistant by the New York State Education Department or who possesses a permit from the New York State Education Department.
(10) Registered professional nurse: a person currently licensed as a registered professional nurse by the New York State Education Department or who possesses a permit from the New York State Education Department.
(11) Social worker: a person who is either currently licensed as a licensed master social worker or as a licensed clinical social worker (LCSW) by the New York State Education Department, or who possesses a permit from the New York State Education Department to practice and use the title of either licensed master social worker or licensed clinical social worker.
(l) Telecommunication system means an interactive telecommunication system that is used to transmit data between the originating/ spoke and distant/ hub sites.
(m) Telepsychiatry means the use of two-way real-time interactive audio and video to provide and support clinical psychiatric care at a distance. Such services do not include a telephone conversation, electronic mail message, or facsimile transmission between a provider and a patient or a consultation between two physicians or nurse practitioners, or other staff, although these activities may support telepsychiatry services.
§ 596.5 Approval to Utilize Telepsychiatry Services.
(a) A provider of services must obtain prior written approval of the Office before utilizing telepsychiatry services.
(b) Approval shall be based on receipt by the Office of the following:
(1) Sufficient written demonstration that telepsychiatry will be used for assessment and treatment services consistent with the provisions of this Part, and that the services are being requested because they are necessary to improve the quality of care of individuals receiving services;
(2) Submission of a written plan to provide telepsychiatry services that satisfies the provisions of this Part and includes:
(i) confidentiality protections for persons who receive telepsychiatry services, including measures to ensure the security of the electronic transmission;
(ii) informed consent of persons who receive telepsychiatric services;
(iii) procedures for handling emergencies with persons who receive telepsychiatric services; and
(iv) contingency procedures to use when the delivery of telepsychiatric service is interrupted, or when the transmission of the two-way interactions is deemed inadequate for the purpose of service provision.
(c) Requests for approval to offer telepsychiatry services shall be submitted to the Field Office serving the area in which the originating/spoke site is located. If both sites are licensed by the Office, then the request for approval shall be submitted by the originating site. Such Field Office may make an on-site visit to either or both sites prior to issuing approval.
(d) The Office shall provide its approval to utilize telepsychiatry services in writing. The provider of services must retain a copy of the approval document and shall make it available for inspection upon request of the Office.
(e) Failure to adhere to the requirements set forth in this Part may be grounds for revocation of such approval. In the event that the Office determines that approval to utilize telepsychiatry services must be revoked, it will notify the provider of services of its decision in writing. The provider of services may request an informal administrative review of such decision.
(1) The provider of services must request such review in writing within 15 days of the date it receives notice of revocation of approval to utilize telepsychiatry services to the Commissioner or designee. The request shall state specific reasons why such provider considers the revocation of approval incorrect and shall be accompanied by any supporting evidence or arguments.
(2) The Commissioner or designee shall notify the provider of services, in writing, of the results of the informal administrative review within 20 days of receipt of the request for review. Failure of the Commissioner or designee to respond within that time shall be considered confirmation of the revocation of deemed status.
(3) The Commissioner’s determination after informal administrative review shall be final and not subject to further administrative review.
§ 596.6 Requirements for Telepsychiatry Services.
(a) General requirements.
(1) The distant/ hub site practitioner must:
(i) possess a current, valid license to practice in New York State;
(ii) directly render the telepsychiatry service;
(iii) abide by the laws and regulations of the State of New York including the New York State Mental Hygiene Law and any other law, regulation, or policy that governs the assessment or treatment service being provided; and
(iv) exercise the same standard of care as in-house delivered services; and
(v) be enrolled in the Medicaid program.
(2) The distant/hub practitioner and originating/spoke site provider of service must not be terminated, suspended, or barred from the Medicaid or Medicare program.
(3) If the originating/spoke site is a hospital, the distant/hub practitioner must be credentialed and privileged by such hospital, consistent with applicable accreditation standards.
(4) Telepsychiatry services must be rendered using an interactive telecommunication system.
(5) A notation must be made in the clinical record that indicates that the service was provided via telepsychiatry and which specifies the time the service was started and the time it ended.
(6) Telepsychiatry services provided to patients under age 18 may include staff that are qualified mental health professionals, as such term is defined in this Part, in the room with the patient. Such determinations shall be clinically based, consistent with clinical guidelines issued by the Office.
(7) For the purposes of this Part, telepsychiatry services shall be considered face-to-face contacts when the service is delivered in accordance with the provisions of the plan approved by the Office pursuant to Section 596.5 of this Part.
(8) Culturally competent interpreter services shall be provided in the patient’s preferred language when the patient and distant/hub practitioners do not speak the same language.
(9) The practitioner providing telepsychiatry services at a distant/hub site shall be considered an active part of the patient’s treatment team and shall be available for discussion of the case or for interviewing family members and others, as the case may require. Such practitioner shall prepare appropriate progress notes and securely forward them to the originating/spoke provider as a condition of reimbursement.
(10) Telepsychiatry services shall not be used:
(i) for purposes of ordering medication over objection or restraint or seclusion, as defined in section 526.4 of this Title; or
(ii) to satisfy any specific statutory examination, evaluation or assessment requirement necessary for the involuntary removal from the community, or involuntary retention in a hospital pursuant to any of the provisions of Article 9 of the Mental Hygiene Law. Physicians conducting such examinations, evaluations or assessments may only utilize telepsychiatry on a consultative basis.
(b) Protocols and Procedures. A provider of services approved to utilize telepsychiatry services must have written protocols and procedures that address the following:
(1) Informed Consent: Protocols must exist to afford persons receiving services with the opportunity to provide informed consent to participate in any such services by utilizing telepsychiatry. Patients shall be advised of their right to refuse these services and to be apprised of the alternatives to telepsychiatry services, including any delays in service, need to travel, or risks associated with not having the services provided by telepsychiatry.
(i) The patient must be provided with basic information about telepsychiatry and shall provide his or her informed consent to participate in services utilizing this technology.
(ii) For patients under age 18, such information shall be shared with and informed consent obtained from the patient’s parent or guardian.
(iii) The patient has the right to refuse to participate in telepsychiatry services, in which case evaluations must be conducted in-person by appropriate clinicians.
(iv) Telepsychiatry sessions shall not be recorded without the patient’s consent.
(2) Confidentiality: Protocols and procedures should be maintained as required by Mental Hygiene Law Section 33.13 and the Health Insurance Portability and Accountability Act (HIPAA) at 45 CFR Parts 160 and 164. Such protocols shall ensure that all current confidentiality requirements and protections that apply to written clinical records shall apply to services delivered by telecommunications, including the actual transmission of the service, any recordings made during the time of transmission, and any other electronic records.
(i) All confidentiality requirements that apply to written medical records shall apply to services delivered by telecommunications, including the actual transmission of the service, any recordings made during the time of transmission, and any other electronic records.
(ii) The spaces occupied by the patient at the originating/spoke site and the practitioner at the distant/hub site must meet the minimum standards for privacy expected for patient-clinician interaction at a single Office of Mental Health licensed location.
(3) Security of Electronic Transmission: All telepsychiatry services must be performed on dedicated secure transmission linkages that meet minimum federal and state requirements, including but not limited to 45 C.F.R. Parts 160 and 164 (HIPAA Security Rules), and which are consistent with guidelines of the Office. Transmissions must employ acceptable authentication and identification procedures by both the sender and the receiver.
(4) Psychiatric emergencies: Protocols should exist to address psychiatric emergencies, which may override the right to confidentiality to require the presence of others if, for instance, an individual receiving services is suicidal, homicidal, dissociated, or acutely psychotic during the evaluation or treatment service. In general this individual should not be managed via telepsychiatry without qualified mental health professionals present at the originating/spoke site, unless there are no adequate alternatives and immediate intervention is deemed essential for patient safety. All telepsychiatry sites must have a written procedure detailing the availability of in-person assessments by a physician or nurse practitioner in an emergency situation.
(5) Prescribing medications via telepsychiatry: Procedures for prescribing medications through telepsychiatry must be identified and must be in accordance with applicable New York State and federal regulations.
(6) Procedures for first evaluations for involuntary commitments: Under New York State law, physicians must conduct first evaluations for involuntary commitments of individuals. If these evaluators want additional consultation before rendering their decision, they may obtain consultation from psychiatrists via telepsychiatry. The responsibility for signing the commitment papers remains with the physician who actually conducted the evaluation of the individual at the facility, not the psychiatrist who provided the telepsychiatric consultation.
(7) Patient rights: Patient rights policies must ensure that each individual receiving telepsychiatry services:
(i) is informed and made aware of the role of the practitioner at the distant/hub site, as well as qualified professional staff at the originating/spoke site who are going to be responsible for follow-up or on-going care;
(ii) is informed and made aware of the location of the distant/hub site and all questions regarding the equipment, the technology, etc., are addressed;
(iii) has the right to have appropriately trained staff immediately available to him/her while receiving the telepsychiatry service to attend to emergencies or other needs; and
(iv) has the right to be informed of all parties who will be present at each end of the telepsychiatry transmission.
(8) Quality of Care: All telepsychiatry sites shall have established written quality of care protocols to ensure that the services meet the requirements of New York state and federal laws and established patient care standards. A review of telepsychiatry services shall be included in the provider’s quality management process.
(9) Contingency Plan: All telepsychiatry sites must have a written procedure detailing the contingency plan when there is a failure of the transmission or other technical difficulties that render the service undeliverable.
(c) Guidelines of the Office. The Office shall develop guidelines to assist providers in complying with the provisions of this Part and in achieving treatment goals through the use of telepsychiatry. The Office shall post such guidelines on its public website.
§ 596.7 Reimbursement for Telepsychiatry Services.
(a) The originating/spoke site where the patient is admitted is the only site authorized to bill Medicaid for telepsychiatry services.
(b) Under the Medicaid program, telepsychiatry services are covered when medically necessary and when provided under the following circumstances:
(1) the person receiving services is physically located at the originating/spoke site and the practitioner is physically located at the distant/hub site;
(2) the person receiving services is present at the originating/spoke site during the telepsychiatry encounter or consultation;
(3) the physician/nurse practitioner is not conducting the telepsychiatry encounter consultation at the originating/spoke site;
(4) the request for telepsychiatry services and the rationale for the request are documented in the individual's clinical record;
(5) the clinical record includes documentation that the telepsychiatry encounter or consultation occurred and that the results and findings were communicated to the requesting provider of services;
(6) the practitioner at the distant/hub site is:
(i) licensed in New York State;
(ii) practicing within his/her scope of specialty practice;
(iii) enrolled in New York Medicaid;
(iv) affiliated with the originating/spoke site facility; and
(v) if the originating/spoke site is a hospital, is credentialed and privileged at the originating/spoke site facility, and is in compliance with regulations of the Department of Health, where applicable.
(c) If the person receiving services is not present during the provision of the telepsychiatry service, the service is not eligible for Medicaid reimbursement and remains the responsibility of the originating/spoke facility.
(d) The following interactions do not constitute reimbursable telepsychiatry services;
(1) telephone conversations;
(2) video cell phone interactions;
(3) e-mail messages.
(e) The originating/spoke site may bill for administrative expenses only when a telepsychiatric connection is being provided and a physician or nurse practitioner is not present with the patient at the time of the encounter.
(f) Reimbursement for services provided via telepsychiatry must be in accordance with the rates and fees established by the Office and approved by the Director of the Budget.
(g) If all or part of a telepsychiatry service is undeliverable due to a failure of transmission or other technical difficulty, reimbursement shall not be provided.
§ 596.8 Contracts for the Provision of Telepsychiatry Services.
(a) Nothing in this Part shall be deemed to prohibit a provider of services from providing assessment and treatment services, consistent with applicable regulations of the Office, as a distant/hub site via telepsychiatry pursuant to contract with an originating/spoke site provider that is not licensed or operated by the Office, but which is enrolled in the Medicaid program.
(b) Although prior approval of the Office is not required before entering into such contracts, notice of such contracts or agreements shall be provided by the distant/hub provider of services within 30 days after execution of such contract to the Field Office serving the area where such provider of services is located.
(c) Reimbursement for telepsychiatry service shall be pursuant to such contracts and are not separately billable by the distant/hub site.
(d) Providers of service shall not engage in distant/hub telepsychiatric services that violate the provisions of paragraph (10) of subdivision (a) of Section 596.6 of this Part.
Text of proposed rule and any required statements and analyses may be obtained from:
Kim Breen, NYS Office of Mental Health, 44 Holland Avenue, Albany, NY 12229, (518) 474-1331, email: regs@omh.ny.gov
Data, views or arguments may be submitted to:
Same as above.
Public comment will be received until:
45 days after publication of this notice.
Regulatory Impact Statement
1. Statutory authority: Sections 7.09 and 31.04 of the Mental Hygiene Law grant the Commissioner of Mental Health the authority and responsibility to adopt regulations that are necessary and proper to implement matters under his or her jurisdiction.
2. Legislative objectives: Articles 7 and 31 of the Mental Hygiene Law reflect the Commissioner’s authority to establish regulations regarding mental health programs.
3. Needs and benefits: Technology has made it possible to increase access to health care, including behavioral health care, by utilizing secure interactive communications. Telepsychiatry is the use of electronic communication and information technologies to provide or support clinical psychiatric care at a distance. Telepsychiatry is appropriate in situations where on-site services are not available due to distance, location, time of day, or availability of resources. The many advantages offered through telepsychiatry have led to a rapid expansion of such programs across New York State and the rest of the country. While clinical practice standards are developing along with this proliferation, OMH regulations currently address the use of telepsychiatry only in OMH licensed clinics. These amendments are intended to establish basic standards and parameters to approve the use of telepsychiatry by providers licensed pursuant to Article 31 of the Mental Hygiene Law that choose to offer this services; however, telepsychiatry shall not be utilized in Personalized Recovery Oriented Services (PROS) programs subject to Part 512 of this Title or Assertive Community Treatment (ACT) programs approved pursuant to Part 551 of this Title. This regulatory proposal also serves to repeal the telepsychiatry provisions found in 14 NYCRR Section 599.17 because they will be unnecessary upon promulgation of these amendments.
4. Costs: Costs to implement telepsychiatry, in general, are significantly offset by the cost savings that can result from its use, in terms of commuting time, cost of fuel, losses due to “no show” appointments, and number of appointments that can be booked per day. Specifically:
(a) cost to State government: There are no new costs to State government as a result of these amendments.
(b) cost to local government: There are no new costs to local government as a result of these amendments.
(c) cost to regulated parties: For providers that wish to offer these services (which includes any provider licensed pursuant to Article 31 of the Mental Hygiene Law with the exception of PROS and ACT program providers), the minimum requirements for an Internet-based solution are approximately $120 for a Webcam and then a WebEx end user license. Software licensing cost can vary, depending on the number of users at a site.
5. Local government mandates: The provision of this service is not required. These regulatory amendments will not involve or result in any additional imposition of duties or responsibilities upon county, city, town, village, school, or fire districts.
6. Paperwork: For providers that wish to provide this service, written plans must be submitted for approval by the Office.
7. Duplication: These regulatory amendments do not duplicate existing State or federal requirements.
8. Alternatives: OMH has been granting regulatory waivers in accordance with 14 NYCRR Part 501 to providers that have wished to provide telepsychiatry services. OMH could continue to grant such waivers on an ad hoc basis; however, given the interest in, and advantages to, this service, OMH wishes to advance these amendments to establish basic standards for the provision of telepsychiatry services to ensure quality and efficacy.
9. Federal standards: There are currently no federal standards specific to the provision of in-state telepsychiatry. However, the regulatory amendments conform to the minimum standards of the federal government with respect to the privacy and security of transmissions of protected health information (45 C.F.R. Parts 160 and 164, or HIPAA). In addition, the regulatory amendments are consistent with the definition of “telemedicine” issued by the Centers for Medicare and Medicaid Services (42 U.S.C. §§ 1395m(m)(1), 42 C.F.R. § 410.78(a)(3)).
10. Compliance schedule: The amendments would be effective upon adoption.
Regulatory Flexibility Analysis
The amendments to 14 NYCRR Part 596 are intended to establish basic standards and parameters to approve the use of telepsychiatry in certain OMH-licensed programs that choose to offer this service. The provision of telepsychiatry services is not required, and the amendments themselves do not create new local government mandates. As a result of this rule making, the regulations with respect to telepsychiatry will be located in a new Part, specifically 14 NYCRR Part 596; therefore, the existing telepsychiatry provisions in 14 NYCRR Section 599.17 must be repealed to avoid confusion to providers of service. As there will be no adverse economic impact on small businesses or local governments as a result of these amendments, a regulatory flexibility analysis is not submitted with this notice.
Rural Area Flexibility Analysis
The amendments to 14 NYCRR Part 596 are intended to establish basic standards and parameters to approve the use of telepsychiatry in certain OMH-licensed programs that choose to offer this service. The provision of telepsychiatry services is not required. As a result of this rule making, the regulations with respect to telepsychiatry will be located in a new Part, specifically 14 NYCRR Part 596; therefore, the existing telepsychiatry provisions in 14 NYCRR Section 599.17 must be repealed to avoid confusion to providers of service. The proposed rule will not impose any adverse economic impact on rural areas; therefore, a Rural Area Flexibility Analysis is not submitted with this notice.
Job Impact Statement
The amendments to 14 NYCRR Part 596 are intended to establish basic standards and parameters to approve the use of telepsychiatry in certain OMH-licensed programs that choose to offer this service. The provision of telepsychiatry services is not required. As a result of this rule making, the regulations with respect to telepsychiatry will be located in a new Part, specifically 14 NYCRR Part 596; therefore, the existing telepsychiatry provisions in 14 NYCRR Section 599.17 must be repealed to avoid confusion to providers of service. Because it is evident from the subject matter that there will be no adverse impact on jobs and employment opportunities as a result of these amendments, a Job Impact Statement is not submitted with this notice.
