2023 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 section four thousand nine hundred three 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 section four thousand nine hundred four and 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)  for purposes of title two of this article, has been practicing in
such area of specialty for a period of at least five years;
(D) for purposes of a determination involving substance  use  disorder
treatment,  possesses  a  current  and  valid  non-restricted license to

practice  medicine  and  specializes  in  behavioral  health   and   has
experience  in  the  delivery  of  substance  use  disorder  courses  of
treatment;
(E)  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
(F) 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) for purposes of title two of this article, 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;
(E) for purposes of a determination involving substance use  disorder,
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;
(F) 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; and
(G)  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 in this subdivision  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 or, in the case of medically
fragile  children, those guidelines and standards as required by section
forty-four hundred six-i of this chapter.
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, which  in  the  case  of  medically  fragile  children  shall
incorporate  the  standards required by section forty-four hundred six-i
of this chapter;
(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.