NY Ins L § 4900 (2021)
2021 New York Laws ISC - Insurance Article 49 - Utilization Review and External Appeal Title 1 - Registration of Agents and Review Process 4900 - Definitions.

§ 4900. Definitions. For purposes of this article:  (a)  "Adverse  determination"  means  a determination by a utilization review agent that an admission, extension of stay, or other health  care service, upon review based on the information provided, is not medically necessary.  (b) "Clinical peer reviewer" means:  (1) for purposes of title one of this article:  (A)  a  physician  who  possesses  a  current and valid non-restricted license to practice medicine; or  (B) a health care professional other than a licensed physician who:  (i) where applicable, possesses a  current  and  valid  non-restricted license,  certificate  or  registration  or,  where  no  provision for a license, certificate or registration  exists,  is  credentialed  by  the national accrediting body appropriate to the profession; and  (ii)  is  in  the same profession and same or similar specialty as the health care provider who typically  manages  the  medical  condition  or disease  or  provides the health care service or treatment under review; or  (C) for purposes of a determination involving substance  use  disorder treatment:  (i)  a  physician  who  possesses  a  current and valid non-restricted license to practice medicine and who specializes  in  behavioral  health and  has experience in the delivery of substance use disorder courses of treatment; or  (ii) a health care professional other than a  licensed  physician  who specializes  in  behavioral health and has experience in the delivery of substance use disorder  courses  of  treatment  and,  where  applicable, possesses  a  current  and  valid non-restricted license, certificate or registration or, where  no  provision  for  a  license,  certificate  or registration  exists,  is  credentialed by the national accrediting body appropriate to the profession; or  (D) for purposes of a determination involving treatment for  a  mental health condition:  (i)  a  physician  who  possesses  a  current and valid non-restricted license to practice medicine and who specializes  in  behavioral  health and  has  experience  in  the  delivery  of  mental  health  courses  of treatment; or  (ii) a health care professional other than a  licensed  physician  who specializes  in  behavioral health and has experience in the delivery of mental health courses of treatment and, where  applicable,  possesses  a current  and  valid non-restricted license, certificate, or registration or, where no  provision  for  a  license,  certificate  or  registration exists,  is credentialed by the national accrediting body appropriate to the profession; and  (2) for purposes of title two of this article:  (A) a physician who:  (i) possesses a current and valid non-restricted license  to  practice medicine;  (ii)  where  applicable,  is  board certified or board eligible in the same or similar specialty as the  health  care  provider  who  typically manages  the  medical  condition  or disease or provides the health care service or treatment under appeal;  (iii) has been practicing in such area of specialty for a period of at least five years; and  (iv) is knowledgeable about the health care service or treatment under appeal; or  (B) a health care professional other than a licensed physician who:  (i) where applicable, possesses a  current  and  valid  non-restricted license, certificate or registration;  (ii)  where  applicable,  is  credentialed by the national accrediting body appropriate to the profession in the same profession  and  same  or similar  specialty as the health care provider who typically manages the medical condition or disease or provides  the  health  care  service  or treatment under appeal;  (iii) has been practicing in such area of specialty for a period of at least five years;  (iv) is knowledgeable about the health care service or treatment under appeal; and  (v)  where  applicable  to  such  health  care professional's scope of practice, is clinically supported by a physician who possesses a current and valid non-restricted license to practice medicine.  (3)   Nothing   herein   shall   be   construed    to    change    any statutorily-defined scope of practice.  (b-1)  "Clinical  standards"  means those guidelines and standards set forth in the utilization review plan by  the  utilization  review  agent whose adverse determination is under appeal.  (b-2)  "Clinical  trial"  means  a  peer-reviewed study plan which has been:  (1) reviewed and approved by a qualified institutional  review  board, and  (2)  approved by one of the National Institutes of Health (NIH), or an NIH  cooperative  group  or  an  NIH  center,  or  the  Food  and   Drug Administration  in the form of an investigational new drug exemption, or the  federal   Department   of   Veteran   Affairs,   or   a   qualified nongovernmental  research  entity  as identified in guidelines issued by individual NIH Institutes for center support grants, or an institutional review board of a  facility  which  has  a  multiple  project  assurance approved by the Office of Protection from Research Risks of the National Institutes of Health.   As used in this subsection, the term "cooperative groups" means formal networks  of  facilities  that collaborate on research projects and have established NIH-approved peer review  programs  operating  within  their groups;  and  that  include, but are not limited to, the National Cancer Institute (NCI) Clinical Cooperative Groups, the NCI Community  Clinical Oncology Program (CCOP), the AIDS Clinical Trials Groups (ACTG), and the Community Programs for Clinical Research in AIDS (CPCRA).  (b-3)  "Disabling  condition  or disease" means a condition or disease which, according to the current diagnosis of  the  enrollee's  attending physician,  is  consistent  with  the  definition  of  "disabled person" pursuant to subdivision five of section two hundred eight of the  social services law.  (c)  "Emergency  condition"  means  a medical or behavioral condition, that  manifests  itself  by  acute  symptoms  of  sufficient   severity, including  severe  pain,  such  that  a prudent layperson, possessing an average knowledge of medicine and health, could  reasonably  expect  the absence  of  immediate  medical  attention  to result in (1) placing the health of the person afflicted with such condition in serious  jeopardy, or  in  the  case  of  a behavioral condition placing the health of such person or others in serious jeopardy; (2)  serious  impairment  to  such person's  bodily  functions; (3) serious dysfunction of any bodily organ or part of such person; (4) serious disfigurement of such person; or (5) a  condition  described  in  clause  (i),  (ii)  or  (iii)  of   section 1867(e)(1)(A) of the Social Security Act.  (d) "Insured" means a person subject to utilization review.  (d-1) "Experimental and investigational treatment review plan" means:  (1)  a  description of the process for developing the written clinical review criteria used in rendering an  experimental  and  investigational treatment review determination; and  (2) a description of the qualifications and experience of the clinical peers  who  developed  the  criteria,  who  are responsible for periodic evaluation of the criteria, and who  use  the  written  clinical  review criteria   in   the  process  of  reviewing  proposed  experimental  and investigational health services and procedures.  (d-2) "External appeal" means  an  appeal  conducted  by  an  external appeal agent, pursuant to section four thousand nine hundred fourteen of this article.  (d-3)  "External  appeal  agent"  means  an  entity  certified  by the superintendent pursuant to section four thousand nine hundred eleven  of this article.  (d-4)  "Final  adverse  determination"  means an adverse determination which has been upheld by a utilization review agent with  respect  to  a proposed  health  care  service  following  a  standard  appeal,  or  an expedited appeal where applicable, pursuant  to  section  four  thousand nine hundred four of this title.  (d-5)   "Health  care  plan"  means  an  insurer  subject  to  article thirty-two or forty-three of this chapter, or any organization  licensed under article forty-three of this chapter.  (e)  (1) For purposes of this title and for appeals requested pursuant to paragraph one of subsection (b) of section four thousand nine hundred ten of title two of this article, "health care service" means:  (A) health care procedures, treatments or services  (i) provided by a facility licensed pursuant to article  twenty-eight, thirty-six,  forty-four  or  forty-seven  of  the  public  health law or pursuant to article nineteen, twenty-three, thirty-one or thirty-two  of the mental hygiene law; or  (ii) provided by a health care professional; and  (B)  the  provision  of pharmaceutical products or services or durable medical equipment.  (2) For purposes of appeals requested pursuant  to  paragraph  two  of subsection (b) of section four thousand nine hundred ten of title two of this   article,  "health  care  services"  shall  mean  experimental  or investigational procedures, treatments or services, including:  (A) services provided within a clinical trial, and  (B) the provision of a pharmaceutical product pursuant to prescription by the enrollee's attending physician for a use other  than  those  uses for which such pharmaceutical product has been approved for marketing by the federal Food and Drug Administration; to the extent that coverage for such services are prohibited by law from being excluded under the plan.   Provided  that nothing in this subsection shall be construed to define what  are  covered  services  pursuant  to  a  subscriber  contract   or governmental health benefit program.  (f)  "Health  care  professional"  means  an  appropriately  licensed, registered or certified health care professional pursuant to title eight of the education law or a health care professional comparably  licensed, registered or certified by another state.  (g)  "Health  care  provider"  means  a  health care professional or a facility  licensed  pursuant  to   article   twenty-eight,   thirty-six, forty-four  or  forty-seven  of  the  public  health  law  or a facility licensed pursuant  to  article  nineteen,  twenty-three,  thirty-one  or thirty-two of the mental hygiene law.  (g-1)  "Life-threatening  condition  or  disease" means a condition or disease which, according to the  current  diagnosis  of  the  enrollee's  attending  physician,  has  a high probability of causing the enrollee's death.  (g-2)  "Material  familial  affiliation"  means  any relationship as a spouse, child, parent, sibling, spouse's parent, spouse's child, child's parent, child's spouse, or sibling's spouse.  (g-3) "Material financial affiliation" means any financial interest of more than five percent of total annual revenue or total annual income of an external appeal agent or officer, director,  or  management  employee thereof;  or  clinical  peer  reviewer  employed  or  engaged thereby to conduct any external appeal. The term "material  financial  affiliation" shall  not  include  revenue  received from a health care plan by (1) an external appeal agent to conduct an external appeal pursuant to  section four thousand nine hundred fourteen of title two of this article, or (2) a clinical peer reviewer for health services rendered to enrollees.  (g-4)  "Material professional affiliation" means any physician-patient relationship, any partnership or employment relationship, a  shareholder or  similar  ownership  interest  in  a professional corporation, or any independent contractor arrangement that constitutes a material financial affiliation  with  any  expert  or  any  officer  or  director  of   the independent organization.  (g-5) "Medical and scientific evidence" means the following sources:  (1)  peer-reviewed  scientific  studies  published in, or accepted for publication  by,  medical  journals  that  meet  nationally   recognized requirements  for  scientific  manuscripts and that submit most of their published articles for review  by  experts  who  are  not  part  of  the editorial staff;  (2) peer-reviewed medical literature, including literature relating to therapies  reviewed  and  approved  by  a qualified institutional review board, biomedical compendia and other medical literature that  meet  the criteria  of  the  National  Institute  of  Health's National Library of Medicine for indexing in Index Medicus, Excerpta  Medicus,  Medline  and MEDLARS database Health Services Technology Assessment Research;  (3) peer-reviewed abstracts accepted for presentation at major medical association meetings;  (4)   peer-reviewed  literature  shall  not  include  publications  or supplements to publications sponsored  to  a  significant  extent  by  a pharmaceutical manufacturing company or medical device manufacturer;  (5)  medical  journals recognized by the secretary of Health and Human Services, under section 1861 (t)(2) of the federal Social Security Act;  (6) the following standard reference compendia:  (A) the American Hospital Formulary Service - Drug Information;  (B) the National Comprehensive Cancer Network's  Drugs  and  Biologics Compendium;  (C) the American Dental Association Accepted Dental Therapeutics;  (D) Thomson Micromedex DrugDex;  (E)   Elsevier   Gold   Standard's  Clinical  Pharmacology;  or  other authoritative compendia as identified by the Federal Secretary of Health and Human Services or the  Centers  for  Medicare  &  Medicaid  Services (CMS);  or recommended by review article or editorial comment in a major peer reviewed professional journal;  (7) findings, studies, or research conducted by or under the  auspices of   federal  government  agencies  and  nationally  recognized  federal research institutes including the federal Agency for Health Care  Policy and  Research, National Institutes of Health, National Cancer Institute, National Academy of  Sciences,  Health  Care  Financing  Administration, Congressional  Office  of  Technology Assessment, and any national board recognized by the National Institutes  of  Health  for  the  purpose  of evaluating the medical value of health services.  (g-6)  "Out-of-network  denial"  means  a  denial under a managed care product as defined in subsection (c)  of  section  four  thousand  eight hundred  one  of  this  chapter  of  a  request for pre-authorization to receive a particular health service from an out-of-network  provider  on the  basis  that  such  out-of-network  health service is not materially different than the health service available in-network. The notice of an out-of-network denial provided to an insured shall  include  information explaining  what  information the insured must submit in order to appeal the out-of-network denial pursuant to subsection (a-1) of  section  four thousand  nine  hundred  four  of this article. An out-of-network denial under this subsection does not constitute an  adverse  determination  as defined  in  this  article.  Notwithstanding any other provision of this subsection, an out-of-network denial shall not be construed to include a denial for a referral to an out-of-network provider on the basis that  a health  care  provider is available in-network to provide the particular health service requested by the insured.  (g-6-a) "Out-of-network  referral  denial"  means  a  denial  under  a managed  care  product  as  defined  in  subsection  (c) of section four thousand eight  hundred  one  of  this  chapter  of  a  request  for  an authorization  or  referral  to  an out-of-network provider on the basis that the health care plan has a health care provider in  the  in-network benefits portion of its network with appropriate training and experience to  meet the particular health care needs of an insured, and who is able to provide the requested health service. The notice of an out-of-network referral  denial  provided  to  an  insured  shall  include  information explaining  what  information the insured must submit in order to appeal the out-of-network referral  denial  pursuant  to  subsection  (a-2)  of section   four   thousand   nine   hundred  four  of  this  article.  An out-of-network referral denial under this subsection does not constitute an adverse determination as defined in this article.  An  out-of-network referral  denial  shall  not  be  construed to include an out-of-network denial as defined in subsection (g-6) of this section.  (g-7) "Rare disease" means a  condition  or  disease  that  (1)(A)  is currently  or  has  been  subject  to  a  research study by the National Institutes of Health Rare Diseases Clinical  Research  Network;  or  (B) affects  fewer  than  two  hundred  thousand United States residents per year; and (2) for which there does not exist a standard  health  service or  procedure  covered  by  the health care plan that is more clinically beneficial than the requested health service or treatment. A  physician, other  than  the  insured's treating physician, shall certify in writing that the condition is a rare disease as defined in this subsection.  The certifying   physician   shall   be   a   licensed,  board-certified  or board-eligible  physician  who  specializes  in  the  area  of  practice appropriate to treat the insured's rare disease. The certification shall provide  either: (1) that the insured's rare disease is currently or has been subject to a research study by the National  Institutes  of  Health Rare  Diseases Clinical Research Network; or (2) that the insured's rare disease affects fewer than two hundred thousand United States  residents per  year.  The  certification  shall  rely  on  medical  and scientific evidence to support the requested health service or procedure,  if  such evidence  exists,  and  shall  include  a  statement  that, based on the physician's credible experience, there is no standard treatment that  is likely  to  be  more  clinically  beneficial  to  the  insured  than the requested health service or procedure and the requested  health  service or  procedure  is  likely to benefit the insured in the treatment of the insured's rare disease and that such benefit to  the  insured  outweighs the  risks of such health service or procedure. The certifying physician shall disclose any material financial or professional relationship  with  the provider of the requested health service or procedure as part of the application  for  external appeal of denial of a rare disease treatment. If the provision of the requested  health  service  or  procedure  at  a health  care facility requires prior approval of an institutional review board, an insured or insured's designee shall also submit such  approval as part of the external appeal application.  (g-8)   "Step   therapy   protocol  override  determination"  means  a determination  made  by  a  utilization  review  agent  as  defined   in subsection  (i)  of  this  section  to  override a step therapy protocol pursuant to subsections (c-1), (c-2) and  (c-3)  of  section  forty-nine hundred  three  of  this  title  granting  coverage  for the health care professional's selected prescription drug or  drugs.  Any  step  therapy override  determination  as defined by this subsection shall be eligible for appeal by an insured pursuant to this article.  (g-9) "Step therapy protocol" means  a  policy,  protocol  or  program established  by  a utilization review agent as defined in subsection (i) of  this  section  that  establishes  the  specific  sequence  in  which prescription  drugs for a specified medical condition are approved for a particular insured. Nothing in this chapter shall impair or  prevent  an insured  from  having  the  right  to  appeal  pursuant  to this article relating to the imposition of a step therapy protocol.  (h) "Utilization review" means the review to determine whether  health care  services  that  have  been  provided,  are  being  provided or are proposed to be provided to  a  patient,  whether  undertaken  prior  to, concurrent  with  or  subsequent  to  the  delivery of such services are medically necessary. For the  purposes  of  this  article  none  of  the following shall be considered utilization review:  (1)  Denials  based  on  failure to obtain health care services from a designated  or  approved  health  care  provider  as  required  under  a contract;  (2)  Where  any  determination  is  rendered  pursuant  to subdivision three-a of section twenty-eight hundred seven-c  of  the  public  health law;  (3)  The  review  of  the  appropriateness  of  the  application  of a particular coding to a patient, including the  assignment  of  diagnosis and procedure;  (4)  Any  issues relating to the determination of the amount or extent of payment other than determinations to deny payment based on an adverse determination; and  (5) Any determination of any coverage issues other than whether health care services are or were medically necessary.  (i) "Utilization review agent" means any insurer  subject  to  article thirty-two  or forty-three of this chapter and any municipal cooperative health benefit plan certified pursuant to article  forty-seven  of  this chapter  performing  utilization  review and any independent utilization review agent performing utilization  review  under  contract  with  such insurer or municipal cooperative health benefit plan.  (j)  "Utilization review plan" means: (1) a description of the process for developing the written clinical review criteria; (2)  a  description of  the  types  of  written  clinical  information  which the plan might consider in its clinical review, including but not limited to, a set  of specific written clinical review criteria; (3) a description of practice guidelines  and standards used by a utilization review agent in carrying out a  determination  of  medical  necessity;  (4)  the  procedures  for scheduled review and evaluation of the written clinical review criteria; and (5) a description of the qualifications and experience of the health care  professionals  who developed the criteria, who are responsible for periodic evaluation of the criteria and of the health care professionals  or others who use the written clinical review criteria in the process of utilization review.