N.Y. Public Health Law § 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

* NB Effective until January 1, 2027

* (iii) for purposes of a determination involving substance-related

and addictive 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-related and addictive

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-related and addictive 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

* NB Effective January 1, 2027

(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;

* NB Effective until January 1, 2027

* (D) for purposes of a determination involving substance-related and

addictive 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-related and addictive disorder courses of treatment;

* NB Effective January 1, 2027

(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;

* NB Effective until January 1, 2027

* (E) for purposes of a determination involving substance-related and

addictive disorder, specializes in behavioral health and has experience

in the delivery of substance-related and addictive 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;

* NB Effective January 1, 2027

(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.

* NB Effective until January 1, 2027

* (2-c) "Chronic health condition" means a condition that is expected

to last for at least one year and requires ongoing treatment to

effectively manage the condition or prevent an adverse health event.

* NB Effective January 1, 2027

* 2-d. "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.

* NB Effective January 1, 2027

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.