N.Y. Insurance Law § 4902: Utilization review program standards

§ 4902. Utilization review program standards. (a) Each utilization

review agent shall adhere to utilization review program standards

consistent with the provisions of this title which shall, at a minimum,

include:

(1) Appointment of a medical director, who is a licensed physician;

provided, however, that the utilization review agent may appoint a

clinical director when the utilization review performed is for a

discrete category of health care service and provided further that the

clinical director is a licensed health care professional who typically

manages the category of service. Responsibilities of the medical

director, or, where appropriate, the clinical director, shall include,

but not be limited to, the supervision and oversight of the utilization

review process;

(2) Development of written policies and procedures that govern all

aspects of the utilization review process and a requirement that a

utilization review agent shall maintain and make available to insureds

and health care providers a written description of such procedures

including procedures to appeal an adverse determination together with a

description, jointly promulgated by the superintendent and the

commissioner of health as required pursuant to subsection (e) of section

four thousand nine hundred fourteen of this article, of the external

appeal process established pursuant to title two of this article and the

time frames for such appeals;

(3) Utilization of written clinical review criteria developed pursuant

to a utilization review plan;

(4) Establishment of a process for rendering utilization review

determinations which shall, at a minimum, include: written procedures to

assure that utilization reviews and determinations are conducted within

the timeframes established herein; procedures to notify an insured, an

insured's designee and/or an insured's health care provider of adverse

determinations; and procedures for appeal of adverse determinations

including the establishment of an expedited appeals process for denials

of continued inpatient care or where there is imminent or serious threat

to the health of the insured;

(5) (i) Establishment of a written procedure to assure that the notice

of an adverse determination includes:

(A) the reasons for the determination including the clinical

rationale, if any;

(B) instructions on how to initiate standard and expedited appeals

pursuant to section four thousand nine hundred four of this article and

an external appeal pursuant to section four thousand nine hundred

fourteen of this article; (C) notice of the availability, upon request

of the insured or the insured's designee, of the clinical review

criteria relied upon to make such determination;

(D) what, if any, additional necessary information must be provided

to, or obtained by, the utilization review agent in order to render a

decision on appeal; and

(E) for an adverse determination related to a step therapy protocol

override determination, information that includes the clinical review

criteria relied upon to make such determination and any applicable

alternative prescription drugs subject to the step therapy protocol of

the utilization review agent.

(ii) A utilization review agent may provide a notice of an adverse

determination related to a step therapy protocol override determination

electronically pursuant to subsection (i) of section four thousand nine

hundred three of this title, including by electronic mail or through the

health care plan's member portal and provider portal. An electronic

notice of such an adverse determination may meet the requirements of

clause (E) of subparagraph (i) of this paragraph by linking to

information posted on the website of the health care plan;

(6) Establishment of a requirement that appropriate personnel of the

utilization review agent are reasonably accessible by toll-free

telephone:

(i) not less than forty hours per week during normal business hours to

discuss patient care and allow response to telephone requests, and to

ensure that such utilization review agent has a telephone system capable

of accepting, recording or providing instruction to incoming telephone

calls during other than normal business hours and to ensure response to

accepted or recorded messages not less than one business day after the

date on which the call was received; or

(ii) notwithstanding the provisions of subparagraph (i) of this

paragraph, not less than forty hours per week during normal business

hours, to discuss patient care and allow response to telephone requests,

and to ensure that, in the case of a request submitted pursuant to

subsection (a) of section four thousand nine hundred three of this title

or an expedited appeal filed pursuant to subsection (b) of section four

thousand nine hundred four of this title, on a twenty-four hour a day,

seven day a week basis;

(7) Establishment of appropriate policies and procedures to ensure

that all applicable state and federal laws to protect the

confidentiality of individual medical records are followed;

(8) Establishment of a requirement that emergency services rendered to

an insured shall not be subject to prior authorization nor shall

reimbursement for such services be denied on retrospective review;

provided, however, that such services are medically necessary to

stabilize or treat an emergency condition.

* (9) When conducting utilization review for purposes of determining

health care coverage for substance use disorder treatment, a utilization

review agent shall utilize an evidence-based and peer reviewed clinical

review tool that is appropriate to the age of the patient. When

conducting such utilization review for treatment provided in this state,

a utilization review agent shall utilize an evidence-based and peer

reviewed clinical tool designated by the office of alcoholism and

substance abuse services that is consistent with the treatment service

levels within the office of alcoholism and substance abuse services

system. All approved tools shall have inter rater reliability testing

completed by December thirty-first, two thousand sixteen.

* NB Effective until January 1, 2027

* (9) When conducting utilization review for purposes of determining

health care coverage for substance-related and addictive disorder

treatment, a utilization review agent shall utilize an evidence-based

and peer reviewed clinical review tool that is appropriate to the age of

the patient. When conducting such utilization review for treatment

provided in this state, a utilization review agent shall utilize an

evidence-based and peer reviewed clinical tool designated by the office

of addiction services and supports that is consistent with the treatment

service levels within the office of addiction services and supports

system. All approved tools shall have inter rater reliability testing

completed by December thirty-first, two thousand sixteen.

* NB Effective January 1, 2027

10. When establishing a step therapy protocol, a utilization review

agent shall utilize recognized evidence-based and peer reviewed clinical

review criteria that also takes into account the needs of atypical

patient populations and diagnoses when establishing the clinical review

criteria.

11. When conducting utilization review for a step therapy protocol

override determination, a utilization review agent shall utilize, in

addition to any other requirements of this article, recognized

evidence-based and peer reviewed clinical review criteria that is

appropriate for the insured and the insured's medical condition.

(12) When conducting utilization review for purposes of determining

health care coverage for a mental health condition, a utilization review

agent shall utilize evidence-based and peer reviewed clinical review

criteria that is appropriate to the age of the patient. The utilization

review agent shall use clinical review criteria deemed appropriate and

approved for such use by the commissioner of the office of mental

health, in consultation with the commissioner of health and the

superintendent. Approved clinical review criteria shall have inter rater

reliability testing completed by December thirty-first, two thousand

nineteen.

(13) Establishment of a requirement that emergency department and

inpatient hospital services rendered by a general hospital certified

pursuant to article twenty-eight of the public health law to an insured

to treat COVID-19 during a declared state disaster emergency related to

COVID-19 shall not be denied on retrospective review on the basis that

such services were not medically necessary.

(14) The superintendent, in consultation with the commissioner of

health, may, as necessary, promulgate by regulation special

considerations and processes for utilization review related to medically

fragile children. Such regulations may include, at a minimum,

considerations and processes related to:

(i) medically necessary covered services to medically fragile

children;

(ii) determinations specific to the needs of medically fragile

children;

(iii) stabilization and discharge plans; and

(iv) payment for the care of medically fragile children.

(15) When establishing a step therapy protocol, a utilization review

agent shall ensure that the protocol cannot:

(i) require a prescription drug that has not been approved by the

United States Food and Drug Administration for the medical condition

being treated or is not supported by current evidence-based guidelines

for the medical condition being treated;

(ii) require an insured to try and fail on more than two drugs used to

treat the same medical condition or disease before providing coverage to

the insured for the prescribed drug;

(iii) require the use of a step therapy-required drug for longer than

thirty days or a duration of treatment supported by current

evidence-based treatment guidelines appropriate to the specific disease

state being treated;

(iv) be imposed on an insured if a therapeutic equivalent to the

prescribed drug is not available, or if the health care plan has

documentation that it has covered the drug for the insured within the

past three hundred sixty-five days;

(v) require a newly enrolled insured to repeat a step therapy protocol

for a prescribed drug where that insured already completed a step

therapy protocol for that drug under a prior health care plan, so long

as the enrollee or provider submits information demonstrating completion

of a step therapy protocol of the prior health care plan within the past

three hundred sixty-five days; and

(vi) be imposed on an insured for a prescribed drug that was

previously approved for coverage by the insured's current health care

plan for a specific medical condition after the insured's current health

care plan implements a formulary change or utilization management that

impacts the coverage criteria for the prescribed drug until the approved

override expires, unless a specifically identified and current

evidence-based safety concern exists and a different therapeutic

alternative drug exists.

(16) When establishing a step therapy protocol, a utilization review

agent shall ensure that the protocol accepts any written or electronic

attestation submitted by the insured's health care professional, as

defined in section four thousand nine hundred of this title, who

prescribed the drug and stating that a required drug has failed, as

evidence that the required drug has failed.

(b) Each utilization review agent shall assure adherence to the

requirements stated in subsection (a) of this section by all

contractors, subcontractors, subvendors, agents and employees affiliated

by contract or otherwise with such utilization review agent.