§ 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.