§ 4900 — Definitions

§ 4900. Definitions. For purposes of this article:\n 1. "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 2. "Clinical peer reviewer" means:\n (a) for purposes of section four thousand nine hundred three of this\narticle:\n (i) a physician who possesses a current and valid non-restricted\nlicense to practice medicine; or\n (ii) a health care professional other than a licensed physician who:\n (A) 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 (B) 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 (iii) for purposes of a determination involving substance use disorder\ntreatment:\n (A) 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 (B) 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 (iv) for purposes of a determination involving treatment for a mental\nhealth condition:\n (A) 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 (B) a health care professional other than a licensed physician who\nspecializes in behavioral health and has experience in the delivery of a\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 (b) for purposes of section four thousand nine hundred four and title\ntwo of this article:\n (i) a physician who:\n (A) possesses a current and valid non-restricted license to practice\nmedicine;\n (B) where applicable, is board certified or board eligible in the same\nor similar specialty as the health care provider who typically manages\nthe medical condition or disease or provides the health care service or\ntreatment under appeal;\n (C) for purposes of title two of this article, has been practicing in\nsuch area of specialty for a period of at least five years;\n (D) for purposes of a determination involving substance use disorder\ntreatment, possesses a current and valid non-restricted license to\npractice medicine and specializes in behavioral health and has\nexperience in the delivery of substance use disorder courses of\ntreatment;\n (E) 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 (F) is knowledgeable about the health care service or treatment under\nappeal; or\n (ii) a health care professional other than a licensed physician who:\n (A) where applicable, possesses a current and valid non-restricted\nlicense, certificate or registration;\n (B) where applicable, is credentialed by the national accrediting body\nappropriate to the profession in the same profession and same or similar\nspecialty as the health care provider who typically manages the medical\ncondition or disease or provides the health care service or treatment\nunder appeal;\n (C) for purposes of title two of this article, has been practicing in\nsuch area of specialty for a period of at least five years;\n (D) is knowledgeable about the health care service or treatment under\nappeal;\n (E) for purposes of a determination involving substance use disorder,\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;\n (F) 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; and\n (G) 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 (c) Nothing in this subdivision shall be construed to change any\nstatutorily-defined scope of practice.\n 2-a. "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\nforty-four hundred six-i of this chapter.\n 2-b. "Clinical trial" means a peer-reviewed study plan which has been\n (a) reviewed and approved by a qualified institutional review board,\nand\n (b) 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 subdivision, the term "cooperative groups" means\nformal networks of facilities that collaborate on research projects and\nhave established NIH-approved peer review programs operating within\ntheir groups; and that include, but are not limited to, the National\nCancer Institute (NCI) Clinical Cooperative Groups, the NCI Community\nClinical Oncology Program (CCOP), the AIDS Clinical Trials Groups\n(ACTG), and the Community Programs for Clinical Research in AIDS\n(CPCRA).\n 2-c. "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 3. "Emergency condition" means a medical or behavioral condition, that\nmanifests itself by acute symptoms of sufficient severity, including\nsevere pain, such that a prudent layperson, possessing an average\nknowledge of medicine and health, could reasonably expect the absence of\nimmediate medical attention to result in (a) placing the health of the\nperson afflicted with such condition in serious jeopardy, or in the case\nof a behavioral condition, placing the health of such person or others\nin serious jeopardy; (b) serious impairment to such person's bodily\nfunctions; (c) serious dysfunction of any bodily organ or part of such\nperson; (d) serious disfigurement of such person; or (e) a condition\ndescribed in clause (i), (ii) or (iii) of section 1867(e)(1)(A) of the\nSocial Security Act.\n 4. "Enrollee" means a person subject to utilization review.\n 4-a. "Experimental and investigational treatment review plan" means:\n (a) a description of the process for developing the written clinical\nreview criteria used in rendering an experimental and investigational\ntreatment review determination; and\n (b) 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 4-b. "External appeal" means an appeal conducted by an external appeal\nagent in accordance with the provisions of section forty-nine hundred\nfourteen of this article.\n 4-c. "External appeal agent" means an entity certified by the\ncommissioner pursuant to section forty-nine hundred eleven of this\narticle.\n 4-d. "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 forty-nine\nhundred four of this title.\n 4-e. "Health care plan" means any organization certified under article\nforty-four of this chapter.\n 5. (a) For purposes of this title and for appeals requested pursuant\nto paragraph (a) of subdivision two of section forty-nine hundred ten of\ntitle two of this article, "health care service" means:\n (i) health care procedures, treatments or services\n (A) provided by a facility licensed pursuant to article twenty-eight,\nthirty-six, forty-four or forty-seven of this chapter or pursuant to\narticle nineteen, twenty-three, thirty-one or thirty-two of the mental\nhygiene law; or\n (B) provided by a health care professional; and\n (ii) the provision of pharmaceutical products or services or durable\nmedical equipment.\n (b) For purposes of appeals requested pursuant to paragraph (b) of\nsubdivision two of section forty-nine hundred ten of title two of this\narticle, "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 subdivision shall be construed to define\nwhat are covered services pursuant to a subscriber contract or\ngovernmental health benefit program.\n 6. "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 7. "Health care provider" means a health care professional or a\nfacility licensed pursuant to articles twenty-eight, thirty-six,\nforty-four or forty-seven of this chapter or a facility licensed\npursuant to article nineteen, twenty-three, thirty-one or thirty-two of\nthe mental hygiene law.\n 7-a. "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 7-b. "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 7-c. "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 (a) an\nexternal appeal agent to conduct an external appeal pursuant to section\nforty-nine hundred fourteen of title two of this article, or (b) a\nclinical peer reviewer for health services rendered to enrollees.\n 7-d. "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 7-e. "Medical and scientific evidence" means the following sources:\n (a) 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 (b) 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 (c) peer-reviewed abstracts accepted for presentation at major medical\nassociation meetings;\n (d) 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 (e) medical journals recognized by the secretary of Health and Human\nServices, under section 1861 (t)(2) of the federal Social Security Act;\n (f) the following standard reference compendia:\n (i) the American Hospital Formulary Service - Drug Information;\n (ii) the American Medical Association Drug Evaluation;\n (iii) the American Dental Association Accepted Dental Therapeutics;\nand\n (iv) the United States Pharmacopeia - Drug Information;\n (g) 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 7-f. "Out-of-network denial" means a denial of a request for\npre-authorization to receive a particular health service from an\nout-of-network provider on the basis that such out-of-network health\nservice is not materially different than the health service available\nin-network. The notice of an out-of-network denial provided to an\nenrollee shall include information explaining what information the\nenrollee must submit in order to appeal the out-of-network denial\npursuant to subdivision one-a of section four thousand nine hundred four\nof this article. An out-of-network denial under this subdivision does\nnot constitute an adverse determination as defined in this article.\nNotwithstanding any other provision of this subdivision, an\nout-of-network denial shall not be construed to include a denial for a\nreferral to an out-of-network provider on the basis that a health care\nprovider is available in-network to provide the particular health\nservice requested by the enrollee.\n 7-f-1. "Out-of-network referral denial" means a denial of a request\nfor an authorization or referral to an out-of-network provider on the\nbasis that the health care plan has a health care provider in the\nin-network benefits portion of its network with appropriate training and\nexperience to meet the particular health care needs of an enrollee, and\nwho is able to provide the requested health service. The notice of an\nout-of-network referral denial provided to an enrollee shall include\ninformation explaining what information the enrollee must submit in\norder to appeal the out-of-network referral denial pursuant to\nsubdivision one-b of section four thousand nine hundred four of this\narticle. An out-of-network referral denial under this subdivision does\nnot constitute an adverse determination as defined in this article. An\nout-of-network referral denial shall not be construed to include an\nout-of-network denial as defined in subdivision seven-f of this section.\n 7-f-2. "Step therapy protocol override determination" means a\ndetermination made by a utilization review agent as defined in\nsubdivision nine of this section to override a step therapy protocol\npursuant to subdivisions three-a, three-b and three-c of section\nforty-nine hundred three of this title granting coverage for the health\ncare professional's selected prescription drug or drugs. Any step\ntherapy protocol override determination as defined by this subdivision\nshall be eligible for appeal by an enrollee pursuant to this article.\n 7-f-3. "Step therapy protocol" means a policy, protocol or program\nestablished by a utilization review agent as defined in subdivision nine\nof this section that establishes the specific sequence in which\nprescription drugs for a specified medical condition are approved for a\nparticular enrollee. 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 7-g. "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 enrollee'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 enrollee's rare disease. The certification\nshall provide either: (1) that the insured's rare disease is currently\nor has been subject to a research study by the National Institutes of\nHealth Rare Diseases Clinical Research Network; or (2) that the\ninsured's rare disease affects fewer than two hundred thousand United\nStates residents per year. The certification shall rely on medical and\nscientific evidence to support the requested health service or\nprocedure, if such evidence exists, and shall include a statement that,\nbased on the physician's credible experience, there is no standard\ntreatment that is likely to be more clinically beneficial to the\nenrollee than the requested health service or procedure and the\nrequested health service or procedure is likely to benefit the enrollee\nin the treatment of the enrollee's rare disease and that such benefit to\nthe enrollee outweighs the risks of such health service or procedure.\nThe certifying physician shall disclose any material financial or\nprofessional relationship with the provider of the requested health\nservice or procedure as part of the application for external appeal of\ndenial of a rare disease treatment. If the provision of the requested\nhealth service or procedure at a health care facility requires prior\napproval of an institutional review board, an enrollee or enrollee's\ndesignee shall also submit such approval as part of the external appeal\napplication.\n 8. "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 (a) Denials based on failure to obtain health care services from a\ndesignated or approved health care provider as required under a\nsubscriber's contract;\n (b) Where any determination is rendered pursuant to subdivision\nthree-a of section twenty-eight hundred seven-c of this chapter;\n (c) The review of the appropriateness of the application of a\nparticular coding to a patient, including the assignment of diagnosis\nand procedure;\n (d) 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 (e) Any determination of any coverage issues other than whether health\ncare services are or were medically necessary.\n 9. "Utilization review agent" means any company, organization or other\nentity performing utilization review, except:\n (a) an agency of the federal government;\n (b) an agent acting on behalf of the federal government, but only to\nthe extent that the agent is providing services to the federal\ngovernment;\n (c) an agent acting on behalf of the state and local government for\nservices provided pursuant to title XIX of the federal social security\nact;\n (d) a hospital's internal quality assurance program except if\nassociated with a health care financing mechanism; or\n (e) any insurer subject to article thirty-two or forty-three of the\ninsurance law and any independent utilization review agent performing\nutilization review under a contract with such insurer, which shall be\nsubject to article forty-nine of the insurance law.\n 10. "Utilization review plan" means:\n (a) a description of the process for developing the written clinical\nreview criteria;\n (b) a description of the types of written clinical information which\nthe plan might consider in its clinical review, including but not\nlimited to, a set of specific written clinical review criteria;\n (c) a description of practice guidelines and standards used by a\nutilization review agent in carrying out a determination of medical\nnecessity, which in the case of medically fragile children shall\nincorporate the standards required by section forty-four hundred six-i\nof this chapter;\n (d) the procedures for scheduled review and evaluation of the written\nclinical review criteria; and\n (e) a description of the qualifications and experience of the health\ncare professionals 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