2023 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 section four thousand nine hundred three 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 section four thousand nine hundred four and 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) for purposes of title two of this article, has  been  practicing
in such area of specialty for a period of at least five years;
(iv)  for purposes of a determination involving substance use disorder
treatment, 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;
(v)  for  purposes of a determination involving treatment for a mental
health condition, 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; and
(vi) 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)  for  purposes of title two of this article, has been practicing
in such area of specialty for a period of at least five years;
(iv) for purposes of a determination involving substance use  disorder
treatment,  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;
(v) for purposes of a determination involving treatment for  a  mental
health condition, 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;
(vi) is knowledgeable about the health care service or treatment under
appeal; and
(vii)  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 in this  subsection  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 or, in the case of medically
fragile  children  those guidelines and standards as required by section
three thousand two hundred seventeen-j and four thousand  three  hundred
six-i of this chapter.
(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 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,  which,  in the case of medically
fragile children, shall incorporate the standards required  by  sections
three  thousand  two hundred seventeen-j and four thousand three hundred
six-i of this chapter; (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.