§ 4900 — Definitions

§ 4900. Definitions. For purposes of this article:\n (a) "Adverse determination" means a determination by a utilization\nreview agent that an admission, extension of stay, or other health care\nservice, upon review based on the information provided, is not medically\nnecessary.\n (b) "Clinical peer reviewer" means:\n (1) for purposes of section four thousand nine hundred three of this\narticle:\n (A) a physician who possesses a current and valid non-restricted\nlicense to practice medicine; or\n (B) a health care professional other than a licensed physician who:\n (i) where applicable, possesses a current and valid non-restricted\nlicense, certificate or registration or, where no provision for a\nlicense, certificate or registration exists, is credentialed by the\nnational accrediting body appropriate to the profession; and\n (ii) is in the same profession and same or similar specialty as the\nhealth care provider who typically manages the medical condition or\ndisease or provides the health care service or treatment under review;\nor\n (C) for purposes of a determination involving substance use disorder\ntreatment:\n (i) a physician who possesses a current and valid non-restricted\nlicense to practice medicine and who specializes in behavioral health\nand has experience in the delivery of substance use disorder courses of\ntreatment; or\n (ii) a health care professional other than a licensed physician who\nspecializes in behavioral health and has experience in the delivery of\nsubstance use disorder courses of treatment and, where applicable,\npossesses a current and valid non-restricted license, certificate or\nregistration or, where no provision for a license, certificate or\nregistration exists, is credentialed by the national accrediting body\nappropriate to the profession; or\n (D) for purposes of a determination involving treatment for a mental\nhealth condition:\n (i) a physician who possesses a current and valid non-restricted\nlicense to practice medicine and who specializes in behavioral health\nand has experience in the delivery of mental health courses of\ntreatment; or\n (ii) a health care professional other than a licensed physician who\nspecializes in behavioral health and has experience in the delivery of\nmental health courses of treatment and, where applicable, possesses a\ncurrent and valid non-restricted license, certificate, or registration\nor, where no provision for a license, certificate or registration\nexists, is credentialed by the national accrediting body appropriate to\nthe profession; and\n (2) for purposes of section four thousand nine hundred four and title\ntwo of this article:\n (A) a physician who:\n (i) possesses a current and valid non-restricted license to practice\nmedicine;\n (ii) where applicable, is board certified or board eligible in the\nsame or similar specialty as the health care provider who typically\nmanages the medical condition or disease or provides the health care\nservice or treatment under appeal;\n (iii) for purposes of title two of this article, has been practicing\nin such area of specialty for a period of at least five years;\n (iv) for purposes of a determination involving substance use disorder\ntreatment, possesses a current and valid non-restricted license to\npractice medicine and who specializes in behavioral health and has\nexperience in the delivery of substance use disorder courses of\ntreatment;\n (v) for purposes of a determination involving treatment for a mental\nhealth condition, possesses a current and valid non-restricted license\nto practice medicine and who specializes in behavioral health and has\nexperience in the delivery of mental health courses of treatment; and\n (vi) is knowledgeable about the health care service or treatment under\nappeal; or\n (B) a health care professional other than a licensed physician who:\n (i) where applicable, possesses a current and valid non-restricted\nlicense, certificate or registration;\n (ii) where applicable, is credentialed by the national accrediting\nbody appropriate to the profession in the same profession and same or\nsimilar specialty as the health care provider who typically manages the\nmedical condition or disease or provides the health care service or\ntreatment under appeal;\n (iii) for purposes of title two of this article, has been practicing\nin such area of specialty for a period of at least five years;\n (iv) for purposes of a determination involving substance use disorder\ntreatment, specializes in behavioral health and has experience in the\ndelivery of substance use disorder courses of treatment and, where\napplicable, possesses a current and valid non-restricted license,\ncertificate or registration or, where no provision for a license,\ncertificate or registration exists, is credentialed by the national\naccrediting body appropriate to the profession;\n (v) for purposes of a determination involving treatment for a mental\nhealth condition, specializes in behavioral health and has experience in\nthe delivery of mental health courses of treatment and, where\napplicable, possesses a current and valid non-restricted license,\ncertificate, or registration or, where no provision for a license,\ncertificate or registration exists, is credentialed by the national\naccrediting body appropriate to the profession;\n (vi) is knowledgeable about the health care service or treatment under\nappeal; and\n (vii) where applicable to such health care professional's scope of\npractice, is clinically supported by a physician who possesses a current\nand valid non-restricted license to practice medicine.\n (3) Nothing in this subsection shall be construed to change any\nstatutorily-defined scope of practice.\n (b-1) "Clinical standards" means those guidelines and standards set\nforth in the utilization review plan by the utilization review agent\nwhose adverse determination is under appeal or, in the case of medically\nfragile children those guidelines and standards as required by section\nthree thousand two hundred seventeen-j and four thousand three hundred\nsix-i of this chapter.\n (b-2) "Clinical trial" means a peer-reviewed study plan which has\nbeen:\n (1) reviewed and approved by a qualified institutional review board,\nand\n (2) approved by one of the National Institutes of Health (NIH), or an\nNIH cooperative group or an NIH center, or the Food and Drug\nAdministration in the form of an investigational new drug exemption, or\nthe federal Department of Veteran Affairs, or a qualified\nnongovernmental research entity as identified in guidelines issued by\nindividual NIH Institutes for center support grants, or an institutional\nreview board of a facility which has a multiple project assurance\napproved by the Office of Protection from Research Risks of the National\nInstitutes of Health.\n As used in this subsection, the term "cooperative groups" means formal\nnetworks of facilities that collaborate on research projects and have\nestablished NIH-approved peer review programs operating within their\ngroups; and that include, but are not limited to, the National Cancer\nInstitute (NCI) Clinical Cooperative Groups, the NCI Community Clinical\nOncology Program (CCOP), the AIDS Clinical Trials Groups (ACTG), and the\nCommunity Programs for Clinical Research in AIDS (CPCRA).\n (b-3) "Disabling condition or disease" means a condition or disease\nwhich, according to the current diagnosis of the enrollee's attending\nphysician, is consistent with the definition of "disabled person"\npursuant to subdivision five of section two hundred eight of the social\nservices law.\n (c) "Emergency condition" means a medical or behavioral condition,\nthat manifests itself by acute symptoms of sufficient severity,\nincluding severe pain, such that a prudent layperson, possessing an\naverage knowledge of medicine and health, could reasonably expect the\nabsence of immediate medical attention to result in (1) placing the\nhealth of the person afflicted with such condition in serious jeopardy,\nor in the case of a behavioral condition placing the health of such\nperson or others in serious jeopardy; (2) serious impairment to such\nperson's bodily functions; (3) serious dysfunction of any bodily organ\nor part of such person; (4) serious disfigurement of such person; or (5)\na condition described in clause (i), (ii) or (iii) of section\n1867(e)(1)(A) of the Social Security Act.\n (d) "Insured" means a person subject to utilization review.\n (d-1) "Experimental and investigational treatment review plan" means:\n (1) a description of the process for developing the written clinical\nreview criteria used in rendering an experimental and investigational\ntreatment review determination; and\n (2) a description of the qualifications and experience of the clinical\npeers who developed the criteria, who are responsible for periodic\nevaluation of the criteria, and who use the written clinical review\ncriteria in the process of reviewing proposed experimental and\ninvestigational health services and procedures.\n (d-2) "External appeal" means an appeal conducted by an external\nappeal agent, pursuant to section four thousand nine hundred fourteen of\nthis article.\n (d-3) "External appeal agent" means an entity certified by the\nsuperintendent pursuant to section four thousand nine hundred eleven of\nthis article.\n (d-4) "Final adverse determination" means an adverse determination\nwhich has been upheld by a utilization review agent with respect to a\nproposed health care service following a standard appeal, or an\nexpedited appeal where applicable, pursuant to section four thousand\nnine hundred four of this title.\n (d-5) "Health care plan" means an insurer subject to article\nthirty-two or forty-three of this chapter, or any organization licensed\nunder article forty-three of this chapter.\n (e) (1) For purposes of this title and for appeals requested pursuant\nto paragraph one of subsection (b) of section four thousand nine hundred\nten of title two of this article, "health care service" means:\n (A) health care procedures, treatments or services\n (i) provided by a facility licensed pursuant to article twenty-eight,\nthirty-six, forty-four or forty-seven of the public health law or\npursuant to article nineteen, twenty-three, thirty-one or thirty-two of\nthe mental hygiene law; or\n (ii) provided by a health care professional; and\n (B) the provision of pharmaceutical products or services or durable\nmedical equipment.\n (2) For purposes of appeals requested pursuant to paragraph two of\nsubsection (b) of section four thousand nine hundred ten of title two of\nthis article, "health care services" shall mean experimental or\ninvestigational procedures, treatments or services, including:\n (A) services provided within a clinical trial, and\n (B) the provision of a pharmaceutical product pursuant to prescription\nby the enrollee's attending physician for a use other than those uses\nfor which such pharmaceutical product has been approved for marketing by\nthe federal Food and Drug Administration;\nto the extent that coverage for such services are prohibited by law from\nbeing excluded under the plan.\n Provided that nothing in this subsection shall be construed to define\nwhat are covered services pursuant to a subscriber contract or\ngovernmental health benefit program.\n (f) "Health care professional" means an appropriately licensed,\nregistered or certified health care professional pursuant to title eight\nof the education law or a health care professional comparably licensed,\nregistered or certified by another state.\n (g) "Health care provider" means a health care professional or a\nfacility licensed pursuant to article twenty-eight, thirty-six,\nforty-four or forty-seven of the public health law or a facility\nlicensed pursuant to article nineteen, twenty-three, thirty-one or\nthirty-two of the mental hygiene law.\n (g-1) "Life-threatening condition or disease" means a condition or\ndisease which, according to the current diagnosis of the enrollee's\nattending physician, has a high probability of causing the enrollee's\ndeath.\n (g-2) "Material familial affiliation" means any relationship as a\nspouse, child, parent, sibling, spouse's parent, spouse's child, child's\nparent, child's spouse, or sibling's spouse.\n (g-3) "Material financial affiliation" means any financial interest of\nmore than five percent of total annual revenue or total annual income of\nan external appeal agent or officer, director, or management employee\nthereof; or clinical peer reviewer employed or engaged thereby to\nconduct any external appeal. The term "material financial affiliation"\nshall not include revenue received from a health care plan by (1) an\nexternal appeal agent to conduct an external appeal pursuant to section\nfour thousand nine hundred fourteen of title two of this article, or (2)\na clinical peer reviewer for health services rendered to enrollees.\n (g-4) "Material professional affiliation" means any physician-patient\nrelationship, any partnership or employment relationship, a shareholder\nor similar ownership interest in a professional corporation, or any\nindependent contractor arrangement that constitutes a material financial\naffiliation with any expert or any officer or director of the\nindependent organization.\n (g-5) "Medical and scientific evidence" means the following sources:\n (1) peer-reviewed scientific studies published in, or accepted for\npublication by, medical journals that meet nationally recognized\nrequirements for scientific manuscripts and that submit most of their\npublished articles for review by experts who are not part of the\neditorial staff;\n (2) peer-reviewed medical literature, including literature relating to\ntherapies reviewed and approved by a qualified institutional review\nboard, biomedical compendia and other medical literature that meet the\ncriteria of the National Institute of Health's National Library of\nMedicine for indexing in Index Medicus, Excerpta Medicus, Medline and\nMEDLARS database Health Services Technology Assessment Research;\n (3) peer-reviewed abstracts accepted for presentation at major medical\nassociation meetings;\n (4) peer-reviewed literature shall not include publications or\nsupplements to publications sponsored to a significant extent by a\npharmaceutical manufacturing company or medical device manufacturer;\n (5) medical journals recognized by the secretary of Health and Human\nServices, under section 1861 (t)(2) of the federal Social Security Act;\n (6) the following standard reference compendia:\n (A) the American Hospital Formulary Service - Drug Information;\n (B) the National Comprehensive Cancer Network's Drugs and Biologics\nCompendium;\n (C) the American Dental Association Accepted Dental Therapeutics;\n (D) Thomson Micromedex DrugDex;\n (E) Elsevier Gold Standard's Clinical Pharmacology; or other\nauthoritative compendia as identified by the Federal Secretary of Health\nand Human Services or the Centers for Medicare & Medicaid Services\n(CMS); or recommended by review article or editorial comment in a major\npeer reviewed professional journal;\n (7) findings, studies, or research conducted by or under the auspices\nof federal government agencies and nationally recognized federal\nresearch institutes including the federal Agency for Health Care Policy\nand Research, National Institutes of Health, National Cancer Institute,\nNational Academy of Sciences, Health Care Financing Administration,\nCongressional Office of Technology Assessment, and any national board\nrecognized by the National Institutes of Health for the purpose of\nevaluating the medical value of health services.\n (g-6) "Out-of-network denial" means a denial under a managed care\nproduct as defined in subsection (c) of section four thousand eight\nhundred one of this chapter of a request for pre-authorization to\nreceive a particular health service from an out-of-network provider on\nthe basis that such out-of-network health service is not materially\ndifferent than the health service available in-network. The notice of an\nout-of-network denial provided to an insured shall include information\nexplaining what information the insured must submit in order to appeal\nthe out-of-network denial pursuant to subsection (a-1) of section four\nthousand nine hundred four of this article. An out-of-network denial\nunder this subsection does not constitute an adverse determination as\ndefined in this article. Notwithstanding any other provision of this\nsubsection, an out-of-network denial shall not be construed to include a\ndenial for a referral to an out-of-network provider on the basis that a\nhealth care provider is available in-network to provide the particular\nhealth service requested by the insured.\n (g-6-a) "Out-of-network referral denial" means a denial under a\nmanaged care product as defined in subsection (c) of section four\nthousand eight hundred one of this chapter of a request for an\nauthorization or referral to an out-of-network provider on the basis\nthat the health care plan has a health care provider in the in-network\nbenefits portion of its network with appropriate training and experience\nto meet the particular health care needs of an insured, and who is able\nto provide the requested health service. The notice of an out-of-network\nreferral denial provided to an insured shall include information\nexplaining what information the insured must submit in order to appeal\nthe out-of-network referral denial pursuant to subsection (a-2) of\nsection four thousand nine hundred four of this article. An\nout-of-network referral denial under this subsection does not constitute\nan adverse determination as defined in this article. An out-of-network\nreferral denial shall not be construed to include an out-of-network\ndenial as defined in subsection (g-6) of this section.\n (g-7) "Rare disease" means a condition or disease that (1)(A) is\ncurrently or has been subject to a research study by the National\nInstitutes of Health Rare Diseases Clinical Research Network; or (B)\naffects fewer than two hundred thousand United States residents per\nyear; and (2) for which there does not exist a standard health service\nor procedure covered by the health care plan that is more clinically\nbeneficial than the requested health service or treatment. A physician,\nother than the insured's treating physician, shall certify in writing\nthat the condition is a rare disease as defined in this subsection. The\ncertifying physician shall be a licensed, board-certified or\nboard-eligible physician who specializes in the area of practice\nappropriate to treat the insured's rare disease. The certification shall\nprovide either: (1) that the insured's rare disease is currently or has\nbeen subject to a research study by the National Institutes of Health\nRare Diseases Clinical Research Network; or (2) that the insured's rare\ndisease affects fewer than two hundred thousand United States residents\nper year. The certification shall rely on medical and scientific\nevidence to support the requested health service or procedure, if such\nevidence exists, and shall include a statement that, based on the\nphysician's credible experience, there is no standard treatment that is\nlikely to be more clinically beneficial to the insured than the\nrequested health service or procedure and the requested health service\nor procedure is likely to benefit the insured in the treatment of the\ninsured's rare disease and that such benefit to the insured outweighs\nthe risks of such health service or procedure. The certifying physician\nshall disclose any material financial or professional relationship with\nthe provider of the requested health service or procedure as part of the\napplication for external appeal of denial of a rare disease treatment.\nIf the provision of the requested health service or procedure at a\nhealth care facility requires prior approval of an institutional review\nboard, an insured or insured's designee shall also submit such approval\nas part of the external appeal application.\n (g-8) "Step therapy protocol override determination" means a\ndetermination made by a utilization review agent as defined in\nsubsection (i) of this section to override a step therapy protocol\npursuant to subsections (c-1), (c-2) and (c-3) of section forty-nine\nhundred three of this title granting coverage for the health care\nprofessional's selected prescription drug or drugs. Any step therapy\noverride determination as defined by this subsection shall be eligible\nfor appeal by an insured pursuant to this article.\n (g-9) "Step therapy protocol" means a policy, protocol or program\nestablished by a utilization review agent as defined in subsection (i)\nof this section that establishes the specific sequence in which\nprescription drugs for a specified medical condition are approved for a\nparticular insured. Nothing in this chapter shall impair or prevent an\ninsured from having the right to appeal pursuant to this article\nrelating to the imposition of a step therapy protocol.\n (h) "Utilization review" means the review to determine whether health\ncare services that have been provided, are being provided or are\nproposed to be provided to a patient, whether undertaken prior to,\nconcurrent with or subsequent to the delivery of such services are\nmedically necessary. For the purposes of this article none of the\nfollowing shall be considered utilization review:\n (1) Denials based on failure to obtain health care services from a\ndesignated or approved health care provider as required under a\ncontract;\n (2) Where any determination is rendered pursuant to subdivision\nthree-a of section twenty-eight hundred seven-c of the public health\nlaw;\n (3) The review of the appropriateness of the application of a\nparticular coding to a patient, including the assignment of diagnosis\nand procedure;\n (4) Any issues relating to the determination of the amount or extent\nof payment other than determinations to deny payment based on an adverse\ndetermination; and\n (5) Any determination of any coverage issues other than whether health\ncare services are or were medically necessary.\n (i) "Utilization review agent" means any insurer subject to article\nthirty-two or forty-three of this chapter and any municipal cooperative\nhealth benefit plan certified pursuant to article forty-seven of this\nchapter performing utilization review and any independent utilization\nreview agent performing utilization review under contract with such\ninsurer or municipal cooperative health benefit plan.\n (j) "Utilization review plan" means: (1) a description of the process\nfor developing the written clinical review criteria; (2) a description\nof the types of written clinical information which the plan might\nconsider in its clinical review, including a set of specific written\nclinical review criteria; (3) a description of practice guidelines and\nstandards used by a utilization review agent in carrying out a\ndetermination of medical necessity, which, in the case of medically\nfragile children, shall incorporate the standards required by sections\nthree thousand two hundred seventeen-j and four thousand three hundred\nsix-i of this chapter; (4) the procedures for scheduled review and\nevaluation of the written clinical review criteria; and (5) a\ndescription of the qualifications and experience of the health care\nprofessionals who developed the criteria, who are responsible for\nperiodic evaluation of the criteria and of the health care professionals\nor others who use the written clinical review criteria in the process of\nutilization review.\n