N.Y. Public Health Law § 4902: Utilization review program standards

§ 4902. Utilization review program standards. 1. Each utilization

review agent shall adhere to utilization review program standards

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

include:

(a) 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;

(b) 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 enrollees

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 commissioner and the

superintendent of financial services as required pursuant to subdivision

five of section forty-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;

(c) Utilization of written clinical review criteria developed pursuant

to a utilization review plan;

(d) 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 enrollee, an

enrollee's designee and/or an enrollee'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 enrollee;

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

of an adverse determination includes: (1) the reasons for the

determination including the clinical rationale, if any; (2) instructions

on how to initiate standard and expedited appeals pursuant to section

forty-nine hundred four and an external appeal pursuant to section

forty-nine hundred fourteen of this article; (3) notice of the

availability, upon request of the enrollee or the enrollee's designee,

of the clinical review criteria relied upon to make such determination;

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

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

decision on an appeal; and (5) 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 notice of an adverse

determination related to a step therapy protocol override determination

electronically pursuant to subdivision nine of section forty-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 five of subparagraph (i) of this paragraph by linking to

information posted on the website of the health care plan;

(f) 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

subdivision three of section forty-nine hundred three of this title or

an expedited appeal filed pursuant to subdivision two of section

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

seven day a week basis;

(g) 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;

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

an enrollee 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.

* (i) 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

* (i) 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

(j) 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 and the superintendent of

financial services. Approved clinical review criteria shall have inter

rater reliability testing completed by December thirty-first, two

thousand nineteen.

(k) Establishment of a requirement that emergency department and

inpatient hospital services rendered by a general hospital certified

pursuant to article twenty-eight of this chapter to an enrollee 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.

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

financial services, 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.

2. Each utilization review agent shall assure adherence to the

requirements stated in subdivision one of this section by all

contractors, subcontractors, subvendors, agents and employees affiliated

by contract or otherwise with such utilization review agent.

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

agent shall utilize recognized evidence-based and peer reviewed clinical

review criteria that takes into account the needs of atypical patient

populations and diagnoses as well when establishing the clinical review

criteria.

4. 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 enrollee and the enrollee's medical condition.

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

agent shall ensure that the protocol cannot:

(a) 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;

(b) require an enrollee to try and fail on more than two drugs used to

treat the same medical condition or disease before providing coverage to

the enrollee for the prescribed drug;

(c) 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;

(d) be imposed on an enrollee 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 enrollee within the

past three hundred sixty-five days;

(e) require a newly enrolled enrollee to repeat a step therapy

protocol for a prescribed drug where that enrollee 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

(f) be imposed on an enrollee for a prescribed drug that was

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

plan for the enrollee's specific medical condition after the enrollee's

current health care plan implements a formulary or utilization

management change that impacts the coverage criteria for the prescribed

drug until the approved override expires, unless a specifically

identified and evidence-based safety concern exists and a different

therapeutic alternative drug exists.

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

agent shall ensure that the protocol accepts any written or electronic

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

defined in section forty-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.