§ 4902 — Utilization review program standards

§ 4902. Utilization review program standards. (a) Each utilization\nreview agent shall adhere to utilization review program standards\nconsistent with the provisions of this title which shall, at a minimum,\ninclude:\n (1) Appointment of a medical director, who is a licensed physician;\nprovided, however, that the utilization review agent may appoint a\nclinical director when the utilization review performed is for a\ndiscrete category of health care service and provided further that the\nclinical director is a licensed health care professional who typically\nmanages the category of service. Responsibilities of the medical\ndirector, or, where appropriate, the clinical director, shall include,\nbut not be limited to, the supervision and oversight of the utilization\nreview process;\n (2) Development of written policies and procedures that govern all\naspects of the utilization review process and a requirement that a\nutilization review agent shall maintain and make available to insureds\nand health care providers a written description of such procedures\nincluding procedures to appeal an adverse determination together with a\ndescription, jointly promulgated by the superintendent and the\ncommissioner of health as required pursuant to subsection (e) of section\nfour thousand nine hundred fourteen of this article, of the external\nappeal process established pursuant to title two of this article and the\ntime frames for such appeals;\n (3) Utilization of written clinical review criteria developed pursuant\nto a utilization review plan;\n (4) Establishment of a process for rendering utilization review\ndeterminations which shall, at a minimum, include: written procedures to\nassure that utilization reviews and determinations are conducted within\nthe timeframes established herein; procedures to notify an insured, an\ninsured's designee and/or an insured's health care provider of adverse\ndeterminations; and procedures for appeal of adverse determinations\nincluding the establishment of an expedited appeals process for denials\nof continued inpatient care or where there is imminent or serious threat\nto the health of the insured;\n (5) (i) Establishment of a written procedure to assure that the notice\nof an adverse determination includes:\n (A) the reasons for the determination including the clinical\nrationale, if any;\n (B) instructions on how to initiate standard and expedited appeals\npursuant to section four thousand nine hundred four of this article and\nan external appeal pursuant to section four thousand nine hundred\nfourteen of this article; (C) notice of the availability, upon request\nof the insured or the insured's designee, of the clinical review\ncriteria relied upon to make such determination;\n (D) what, if any, additional necessary information must be provided\nto, or obtained by, the utilization review agent in order to render a\ndecision on appeal; and\n (E) for an adverse determination related to a step therapy protocol\noverride determination, information that includes the clinical review\ncriteria relied upon to make such determination and any applicable\nalternative prescription drugs subject to the step therapy protocol of\nthe utilization review agent.\n (ii) A utilization review agent may provide a notice of an adverse\ndetermination related to a step therapy protocol override determination\nelectronically pursuant to subsection (i) of section four thousand nine\nhundred three of this title, including by electronic mail or through the\nhealth care plan's member portal and provider portal. An electronic\nnotice of such an adverse determination may meet the requirements of\nclause (E) of subparagraph (i) of this paragraph by linking to\ninformation posted on the website of the health care plan;\n (6) Establishment of a requirement that appropriate personnel of the\nutilization review agent are reasonably accessible by toll-free\ntelephone:\n (i) not less than forty hours per week during normal business hours to\ndiscuss patient care and allow response to telephone requests, and to\nensure that such utilization review agent has a telephone system capable\nof accepting, recording or providing instruction to incoming telephone\ncalls during other than normal business hours and to ensure response to\naccepted or recorded messages not less than one business day after the\ndate on which the call was received; or\n (ii) notwithstanding the provisions of subparagraph (i) of this\nparagraph, not less than forty hours per week during normal business\nhours, to discuss patient care and allow response to telephone requests,\nand to ensure that, in the case of a request submitted pursuant to\nsubsection (a) of section four thousand nine hundred three of this title\nor an expedited appeal filed pursuant to subsection (b) of section four\nthousand nine hundred four of this title, on a twenty-four hour a day,\nseven day a week basis;\n (7) Establishment of appropriate policies and procedures to ensure\nthat all applicable state and federal laws to protect the\nconfidentiality of individual medical records are followed;\n (8) Establishment of a requirement that emergency services rendered to\nan insured shall not be subject to prior authorization nor shall\nreimbursement for such services be denied on retrospective review;\nprovided, however, that such services are medically necessary to\nstabilize or treat an emergency condition.\n (9) When conducting utilization review for purposes of determining\nhealth care coverage for substance use disorder treatment, a utilization\nreview agent shall utilize an evidence-based and peer reviewed clinical\nreview tool that is appropriate to the age of the patient. When\nconducting such utilization review for treatment provided in this state,\na utilization review agent shall utilize an evidence-based and peer\nreviewed clinical tool designated by the office of alcoholism and\nsubstance abuse services that is consistent with the treatment service\nlevels within the office of alcoholism and substance abuse services\nsystem. All approved tools shall have inter rater reliability testing\ncompleted by December thirty-first, two thousand sixteen.\n 10. When establishing a step therapy protocol, a utilization review\nagent shall utilize recognized evidence-based and peer reviewed clinical\nreview criteria that also takes into account the needs of atypical\npatient populations and diagnoses when establishing the clinical review\ncriteria.\n 11. When conducting utilization review for a step therapy protocol\noverride determination, a utilization review agent shall utilize, in\naddition to any other requirements of this article, recognized\nevidence-based and peer reviewed clinical review criteria that is\nappropriate for the insured and the insured's medical condition.\n (12) When conducting utilization review for purposes of determining\nhealth care coverage for a mental health condition, a utilization review\nagent shall utilize evidence-based and peer reviewed clinical review\ncriteria that is appropriate to the age of the patient. The utilization\nreview agent shall use clinical review criteria deemed appropriate and\napproved for such use by the commissioner of the office of mental\nhealth, in consultation with the commissioner of health and the\nsuperintendent. Approved clinical review criteria shall have inter rater\nreliability testing completed by December thirty-first, two thousand\nnineteen.\n (13) Establishment of a requirement that emergency department and\ninpatient hospital services rendered by a general hospital certified\npursuant to article twenty-eight of the public health law to an insured\nto treat COVID-19 during a declared state disaster emergency related to\nCOVID-19 shall not be denied on retrospective review on the basis that\nsuch services were not medically necessary.\n (14) The superintendent, in consultation with the commissioner of\nhealth, may, as necessary, promulgate by regulation special\nconsiderations and processes for utilization review related to medically\nfragile children. Such regulations may include, at a minimum,\nconsiderations and processes related to:\n (i) medically necessary covered services to medically fragile\nchildren;\n (ii) determinations specific to the needs of medically fragile\nchildren;\n (iii) stabilization and discharge plans; and\n (iv) payment for the care of medically fragile children.\n (15) When establishing a step therapy protocol, a utilization review\nagent shall ensure that the protocol cannot:\n (i) require a prescription drug that has not been approved by the\nUnited States Food and Drug Administration for the medical condition\nbeing treated or is not supported by current evidence-based guidelines\nfor the medical condition being treated;\n (ii) require an insured to try and fail on more than two drugs used to\ntreat the same medical condition or disease before providing coverage to\nthe insured for the prescribed drug;\n (iii) require the use of a step therapy-required drug for longer than\nthirty days or a duration of treatment supported by current\nevidence-based treatment guidelines appropriate to the specific disease\nstate being treated;\n (iv) be imposed on an insured if a therapeutic equivalent to the\nprescribed drug is not available, or if the health care plan has\ndocumentation that it has covered the drug for the insured within the\npast three hundred sixty-five days;\n (v) require a newly enrolled insured to repeat a step therapy protocol\nfor a prescribed drug where that insured already completed a step\ntherapy protocol for that drug under a prior health care plan, so long\nas the enrollee or provider submits information demonstrating completion\nof a step therapy protocol of the prior health care plan within the past\nthree hundred sixty-five days; and\n (vi) be imposed on an insured for a prescribed drug that was\npreviously approved for coverage by the insured's current health care\nplan for a specific medical condition after the insured's current health\ncare plan implements a formulary change or utilization management that\nimpacts the coverage criteria for the prescribed drug until the approved\noverride expires, unless a specifically identified and current\nevidence-based safety concern exists and a different therapeutic\nalternative drug exists.\n (16) When establishing a step therapy protocol, a utilization review\nagent shall ensure that the protocol accepts any written or electronic\nattestation submitted by the insured's health care professional, as\ndefined in section four thousand nine hundred of this title, who\nprescribed the drug and stating that a required drug has failed, as\nevidence that the required drug has failed.\n (b) Each utilization review agent shall assure adherence to the\nrequirements stated in subsection (a) of this section by all\ncontractors, subcontractors, subvendors, agents and employees affiliated\nby contract or otherwise with such utilization review agent.\n