(a) Utilization review shall be conducted by:

1. (1) Administrative personnel trained in the principles and procedures of intake screening and data collection, provided however, that administrative personnel shall only perform intake screening, data collection and non-clinical review functions and shall be supervised by a licensed health care professional;
2. (2) A health care professional who is appropriately trained in the principles, procedures and standards of such utilization review agent; provided, however, that a health care professional who is not a clinical peer reviewer may not render an adverse determination; and
3. (3) A clinical peer reviewer where the review involves an adverse determination.

(b)

1. (1) A utilization review agent shall make a utilization review determination involving health care services which require pre-authorization and provide notice of a determination to the insured or insured's designee and the insured's health care provider by telephone and in writing within three business days of receipt of the necessary information, or for inpatient rehabilitation services following an inpatient hospital admission provided by a hospital or skilled nursing facility, within one business day of receipt of the necessary information. The notification shall identify: (i) whether the services are considered in-network or out-of-network; (ii) whether the insured will be held harmless for the services and not be responsible for any payment, other than any applicable co-payment, co-insurance or deductible; (iii) as applicable, the dollar amount the health care plan will pay if the service is out-of-network; and (iv) as applicable, information explaining how an insured may determine the anticipated out-of-pocket cost for out-of-network health care services in a geographical area or zip code based upon the difference between what the health care plan will reimburse for out-of-network health care services and the usual and customary cost for out-of-network health care services.
2. (2) With regard to individual or group contracts authorized pursuant to article thirty-two, forty-three or forty-seven of this chapter or article forty-four of the public health law, for utilization and review determinations involving proposed mental health and/or substance use disorder services where the insured or the insured's designee has, in a format prescribed by the superintendent, certified in the request that the proposed services are for an individual who will be appearing, or has appeared, before a court of competent jurisdiction and may be subject to a court order requiring such services, the utilization review agent shall make a determination and provide notice of such determination to the insured or the insured's designee by telephone within seventy-two hours of receipt of the request. Written notice of the determination to the insured or insured's designee shall follow within three business days. Where feasible, such telephonic and written notice shall also be provided to the court.

(c)

1. (1) A utilization review agent shall make a determination involving continued or extended health care services, additional services for an insured undergoing a course of continued treatment prescribed by a health care provider, or requests for inpatient substance use disorder treatment, or home health care services following an inpatient hospital admission, and shall provide notice of such determination to the insured or the insured's designee, which may be satisfied by notice to the insured's health care provider, by telephone and in writing within one business day of receipt of the necessary information except, with respect to home health care services following an inpatient hospital admission, within seventy-two hours of receipt of the necessary information when the day subsequent to the request falls on a weekend or holiday and except, with respect to inpatient substance use disorder treatment, within twenty-four hours of receipt of the request for services when the request is submitted at least twenty-four hours prior to discharge from an inpatient admission. Notification of continued or extended services shall include the number of extended services approved, the new total of approved services, the date of onset of services and the next review date.
2. (2) Provided that a request for home health care services and all necessary information is submitted to the utilization review agent prior to discharge from an inpatient hospital admission pursuant to this subsection, a utilization review agent shall not deny, on the basis of medical necessity or lack of prior authorization, coverage for home health care services while a determination by the utilization review agent is pending.
3. (3) Provided that a request for inpatient treatment for substance use disorder is submitted to the utilization review agent at least twenty-four hours prior to discharge from an inpatient admission pursuant to this subsection, a utilization review agent shall not deny, on the basis of medical necessity or lack of prior authorization, coverage for the inpatient substance use disorder treatment while a determination by the utilization review agent is pending.

4. (c-1) A utilization review agent shall grant a step therapy protocol override determination within seventy-two hours of the receipt of information that includes supporting rationale and documentation from a health care professional which demonstrates that:

   1. (1) The required prescription drug or drugs is contraindicated or will likely cause an adverse reaction by or physical or mental harm to the insured;
   2. (2) The required prescription drug or drugs is expected to be ineffective based on the known clinical history and conditions of the insured and the insured's prescription drug regimen;
   3. (3) The insured has tried the required prescription drug or drugs while under their current or a previous health insurance or health benefit plan, or another prescription drug or drugs in the same pharmacologic class or with the same mechanism of action and such prescription drug or drugs was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event;
   4. (4) The insured is stable on a prescription drug or drugs selected by their health care professional for the medical condition under consideration, provided that this shall not prevent a utilization review agent from requiring an insured to try an AB-rated generic equivalent prior to providing coverage for the equivalent brand name prescription drug or drugs; or
   5. (5) The required prescription drug or drugs is not in the best interest of the insured because it will likely cause a significant barrier to the insured's adherence to or compliance with the insured's plan of care, will likely worsen a comorbid condition of the insured, or will likely decrease the covered individual's ability to achieve or maintain reasonable functional ability in performing daily activities.
   6. (c-2) For an insured with a medical condition that places the health of the insured in serious jeopardy without the prescription drug or drugs prescribed by the insured's health care professional, the step therapy protocol override determination shall be granted within twenty-four hours of the receipt of information that includes supporting rationale and documentation from a health care professional demonstrating one or more of the standards provided for in subsection (c-1) of this section.
   7. (c-3) Upon a determination that the step therapy protocol should be overridden, the health plan shall authorize immediate coverage for the prescription drug prescribed by the insured's treating health care professional.

(d) A utilization review agent shall make a utilization review determination involving health care services which have been delivered within thirty days of receipt of the necessary information. * (e) Notice of an adverse determination made by a utilization review agent shall be in writing and must include:

1. (1) the reasons for the determination including the clinical rationale, if any;
2. (2) instructions on how to initiate standard appeals and expedited appeals pursuant to section four thousand nine hundred four and an external appeal pursuant to section four thousand nine hundred fourteen of this article; and
3. (3) notice of the availability, upon request of the insured, or the insured's designee, of the clinical review criteria relied upon to make such determination. Such notice shall also specify what, if any, additional necessary information must be provided to, or obtained by, the utilization review agent in order to render a decision on the appeal. * NB Effective until March 21, 2024 * (e) (1) Notice of an adverse determination made by a utilization review agent shall be in writing and must include:
4. (i) the reasons for the determination including the clinical rationale, if any;
5. (ii) instructions on how to initiate standard appeals and expedited appeals pursuant to section four thousand nine hundred four and an external appeal pursuant to section four thousand nine hundred fourteen of this article; (iii) notice of the availability, upon request of the insured, or the insured's designee, of the clinical review criteria relied upon to make such determination. Such notice shall also specify what, if any, additional necessary information must be provided to, or obtained by, the utilization review agent in order to render a decision on the appeal; and
6. (iv) for an adverse determination related to a step therapy protocol override request, information that includes the clinical review criteria relied upon to make such determination and any applicable alternative prescription drugs subject to the step therapy protocol of the utilization review agent.
7. (2) A utilization review agent may provide notice of an adverse determination related to a step therapy protocol override determination electronically pursuant to subsection (i) of this section, including by electronic mail or through the health care plan's member portal and provider portal. An electronic notice of such an adverse determination may meet the requirements of subparagraph (iv) of paragraph one of this subsection by linking to information posted on the website of the health care plan. * NB Effective March 21, 2024 * (e-1) Notice of an adverse determination made by a utilization review agent in relation to a step therapy protocol override determination request shall be made in writing to the insured or the insured's authorized representative and the insured's prescribing health care professional as defined in subsection (f) of section forty-nine hundred of this chapter, and shall include:
8. (i) the reasons for the determination including the clinical rationale, if any;
9. (ii) instructions on how to initiate standard and expedited appeals pursuant to section four thousand nine hundred four of this article and an external appeal pursuant to section four thousand nine hundred fourteen of this article;
10. (iii) information that includes: any applicable alternative covered medications; the clinical review criteria relied upon to make such determination; and any additional necessary information that must be provided to, or obtained by, the utilization review agent in order to render a decision on the appeal;
11. (iv) the provisions of this section shall be satisfied by making such information available electronically on a formulary website, on the member portal and/or provider portal of the insurer's, the health maintenance organization's website, or the website of an organization subject to article forty-three of this chapter, provided that the member consents to receiving the information electronically. * NB Effective and Repealed March 21, 2024
12. (f) In the event that a utilization review agent renders an adverse determination without attempting to discuss such matter with the insured's health care provider who specifically recommended the health care service, procedure or treatment under review, such health care provider shall have the opportunity to request a reconsideration of the adverse determination. Except in cases of retrospective reviews, such reconsideration shall occur within one business day of receipt of the request and shall be conducted by the insured's health care provider and the clinical peer reviewer making the initial determination or a designated clinical peer reviewer if the original clinical peer reviewer cannot be available. In the event that the adverse determination is upheld after reconsideration, the utilization review agent shall provide notice as required pursuant to subsection (e) of this section. Nothing in this section shall preclude the insured from initiating an appeal from an adverse determination.
13. (g) Failure by the utilization review agent to make a determination within the time periods prescribed in this section shall be deemed to be an adverse determination subject to appeal pursuant to section four thousand nine hundred four of this title, provided, however, that failure to meet such time periods for a step therapy protocol as defined in subsection (g-9) of section forty-nine hundred of this title or a step therapy protocol override determination pursuant to subsections (c-1), (c-2) and (c-3) of this section shall be deemed to be an override of the step therapy protocol.
14. (h) The superintendent, in conjunction with the commissioner of health, shall develop standards for prior authorization requests to be utilized by all health care plans for the purposes of submitting a request for a utilization review determination for coverage of prescription drug benefits under this article. The department and the department of health, in development of the standards, shall take into consideration existing electronic prior authorization standards including National Council for Prescription Drug Programs (NCPDP) electronic prior authorization standard transactions.
15. (i) A utilization review agent shall have procedures for obtaining an insured's, or insured's designee's, preference for receiving notifications, which shall be in accordance with applicable federal law and with guidance developed by the superintendent. Written and telephone notification to an insured or the insured's designee under this section may be provided by electronic means where the insured or the insured's designee has informed the utilization review agent in advance of a preference to receive such notifications by electronic means. A utilization review agent shall permit the insured and the insured's designee to change the preference at any time. To the extent practicable, such written and telephone notification to the insured's health care provider shall be transmitted electronically, in a manner and in a form agreed upon by the parties. The utilization review agent shall retain documentation of preferred notification methods and present such records to the superintendent upon request.