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SECTION 4900
Definitions
Public Health (PBH) CHAPTER 45, ARTICLE 49, TITLE 1
§ 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.