NY Pub Health L § 4900 (2021)
2021 New York Laws PBH - Public Health Article 49 - Utilization Review and External Appeal Title 1 - Certification of Agents and Utilization Review Process 4900 - Definitions.

§ 4900. Definitions. For purposes of this article:   1.  "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.   2. "Clinical peer reviewer" means:  (a) for purposes of title one of this article:  (i)  a  physician  who  possesses  a  current and valid non-restricted license to practice medicine; or  (ii) a health care professional other than a licensed physician who:  (A) 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  (B)  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  (iii) for purposes of a determination involving substance use disorder treatment:  (A) 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  (B)  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  (iv)  for purposes of a determination involving treatment for a mental health condition:  (A) 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  (B)  a  health  care  professional other than a licensed physician who specializes in behavioral health and has experience in the delivery of a 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  (b) for purposes of title two of this article:  (i) a physician who:  (A) possesses a current and valid non-restricted license  to  practice medicine;  (B) 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;  (C)  has  been practicing in such area of specialty for a period of at least five years; and  (D) is knowledgeable about the health care service or treatment  under appeal; or  (ii) a health care professional other than a licensed physician who:  (A)  where  applicable,  possesses  a current and valid non-restricted license, certificate or registration;  (B) 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;  (C)  has  been practicing in such area of specialty for a period of at least five years;  (D) is knowledgeable about the health care service or treatment  under appeal; and  (E)  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.  (c)   Nothing   herein   shall   be   construed    to    change    any statutorily-defined scope of practice.   2-a.  "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.   2-b. "Clinical trial" means a peer-reviewed study plan which has been  (a)  reviewed  and approved by a qualified institutional review board, and  (b) 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  subdivision,  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).   2-c.  "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.   3. "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 (a) 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;  (b)  serious  impairment to such person's bodily functions; (c) serious dysfunction of any bodily organ or part  of  such person;  (d)  serious  disfigurement  of such person; or (e) a condition described in clause (i), (ii) or (iii) of section 1867(e)(1)(A)  of  the Social Security Act.   4. "Enrollee" means a person subject to utilization review.   4-a. "Experimental and investigational treatment review plan" means:  (a)  a  description of the process for developing the written clinical review criteria used in rendering an  experimental  and  investigational treatment review determination; and  (b) 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.   4-b. "External appeal" means an appeal conducted by an external appeal agent in accordance with the provisions of  section  forty-nine  hundred fourteen of this article.   4-c.  "External  appeal  agent"  means  an  entity  certified  by  the commissioner pursuant to  section  forty-nine  hundred  eleven  of  this article.   4-d.  "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  forty-nine hundred four of this title.   4-e. "Health care plan" means any organization certified under article forty-four of this chapter.   5.  (a)  For purposes of this title and for appeals requested pursuant to paragraph (a) of subdivision two of section forty-nine hundred ten of title two of this article, "health care service" means:  (i) health care procedures, treatments or services  (A) provided by a facility licensed pursuant to article  twenty-eight, thirty-six,  forty-four  or  forty-seven  of this chapter or pursuant to article nineteen, twenty-three, thirty-one or thirty-two of  the  mental hygiene law; or  (B) provided by a health care professional; and  (ii)  the  provision of pharmaceutical products or services or durable medical equipment.  (b) For purposes of appeals requested pursuant  to  paragraph  (b)  of subdivision  two  of section forty-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 subdivision shall be construed to define what  are  covered  services  pursuant  to  a  subscriber  contract   or governmental health benefit program.   6.   "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.   7.  "Health  care  provider"  means  a  health  care professional or a facility  licensed  pursuant  to  articles   twenty-eight,   thirty-six, forty-four  or  forty-seven  of  this  chapter  or  a  facility licensed pursuant to article nineteen, twenty-three, thirty-one or thirty-two  of the mental hygiene law.   7-a.  "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.   7-b.  "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.   7-c. "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  (a)  an external  appeal agent to conduct an external appeal pursuant to section forty-nine hundred fourteen of title two  of  this  article,  or  (b)  a clinical peer reviewer for health services rendered to enrollees.   7-d.  "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.   7-e. "Medical and scientific evidence" means the following sources:  (a)  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;  (b) 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;  (c) peer-reviewed abstracts accepted for presentation at major medical association meetings;  (d)   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;  (e)  medical  journals recognized by the secretary of Health and Human Services, under section 1861 (t)(2) of the federal Social Security Act;  (f) the following standard reference compendia:  (i) the American Hospital Formulary Service - Drug Information;  (ii) the American Medical Association Drug Evaluation;  (iii) the American Dental Association  Accepted  Dental  Therapeutics; and  (iv) the United States Pharmacopeia - Drug Information;  (g)  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.   7-f.  "Out-of-network  denial"  means  a  denial  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  enrollee  shall  include  information  explaining  what  information the enrollee must submit  in  order  to  appeal  the  out-of-network  denial pursuant to subdivision one-a of section four thousand nine hundred four of  this  article.  An out-of-network denial under this subdivision does not constitute an adverse determination  as  defined  in  this  article. Notwithstanding   any   other   provision   of   this   subdivision,  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 enrollee.   7-f-1.  "Out-of-network  referral  denial" means a denial 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 enrollee,  and who  is  able  to provide the requested health service. The notice of an out-of-network referral denial provided to  an  enrollee  shall  include information  explaining  what  information  the  enrollee must submit in order  to  appeal  the  out-of-network  referral  denial   pursuant   to subdivision  one-b  of  section  four thousand nine hundred four of this article. An out-of-network referral denial under this  subdivision  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 subdivision seven-f of this section.   7-f-2.   "Step   therapy  protocol  override  determination"  means  a determination  made  by  a  utilization  review  agent  as  defined   in subdivision  nine  of  this  section to override a step therapy protocol pursuant  to  subdivisions  three-a,  three-b  and  three-c  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  protocol  override determination as defined by this subdivision shall be eligible for appeal by an enrollee pursuant to this article.   7-f-3. "Step therapy protocol" means a  policy,  protocol  or  program established by a utilization review agent as defined in subdivision nine of  this  section  that  establishes  the  specific  sequence  in  which prescription drugs for a specified medical condition are approved for  a particular  enrollee. 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.   7-g.  "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 enrollee'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  enrollee'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 enrollee  than  the  requested  health  service  or  procedure  and  the requested  health service or procedure is likely to benefit the enrollee in the treatment of the enrollee's rare disease and that such benefit to the enrollee 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  enrollee  or  enrollee's designee  shall also submit such approval as part of the external appeal application.   8. "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:  (a)  Denials  based  on  failure to obtain health care services from a designated  or  approved  health  care  provider  as  required  under  a subscriber's contract;  (b)  Where  any  determination  is  rendered  pursuant  to subdivision three-a of section twenty-eight hundred seven-c of this chapter;  (c) The  review  of  the  appropriateness  of  the  application  of  a particular  coding  to  a patient, including the assignment of diagnosis and procedure;  (d) 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  (e) Any determination of any coverage issues other than whether health care services are or were medically necessary.   9. "Utilization review agent" means any company, organization or other entity performing utilization review, except:  (a) an agency of the federal government;  (b)  an  agent acting on behalf of the federal government, but only to the  extent  that  the  agent  is  providing  services  to  the  federal government;  (c)  an  agent  acting on behalf of the state and local government for services provided pursuant to title XIX of the federal  social  security act;  (d)   a  hospital's  internal  quality  assurance  program  except  if associated with a health care financing mechanism; or  (e) any insurer subject to article thirty-two or  forty-three  of  the insurance  law  and  any independent utilization review agent performing utilization review under a contract with such insurer,  which  shall  be subject to article forty-nine of the insurance law.   10. "Utilization review plan" means:  (a)  a  description of the process for developing the written clinical review criteria;  (b) 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;  (c) a description of practice  guidelines  and  standards  used  by  a utilization  review  agent  in  carrying  out a determination of medical necessity;  (d) the procedures for scheduled review and evaluation of the  written clinical review criteria; and  (e)  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.