N.Y. Social Services Law § 369-bb: Drug utilization review board

§ 369-bb. Drug utilization review board. 1. A twenty-three-member

drug utilization review board is hereby created in the department. The

board is responsible for the establishment and implementation of medical

standards and criteria for the retrospective and prospective DUR

program.

2. The members of the DUR board shall be appointed by the commissioner

and shall serve a three-year term. Members may be reappointed upon the

completion of other terms. The membership shall be comprised of the

following:

(a) Six persons licensed and actively engaged in the practice of

medicine in the state, with expertise in the areas of mental health,

HIV/AIDS, geriatrics, pediatrics or internal medicine and who may be

selected based on input from professional associations and/or advocacy

groups in New York state.

(b) Six persons licensed and actively practicing in pharmacy in the

state who may be selected based on input from professional associations

and/or advocacy groups in New York state.

(c) Two persons with expertise in drug utilization review who are

health care professionals licensed under Title VIII of the education law

at least one of whom is a pharmacologist.

(d) Three persons that are consumers or consumer representatives of

organizations with a regional or statewide constituency and who have

been involved in activities related to health care consumer advocacy,

including issues affecting Medicaid or EPIC recipients.

(e) One person licensed and actively practicing as a nurse

practitioner or midwife.

(f) Two persons who are health care economists.

(g) One person who is an actuary.

(h) One person representing the department of financial services.

(i) The commissioner shall designate a person from the department to

serve as chairperson of the board.

3. The appointed members to the board, or its agents shall have no

sanctions against them by medicare or medicaid.

4. The appointments to this board shall be made so that the length of

the terms are staggered. In making the appointments, the commissioner

shall consider geographic balance in the representation on the board.

5. (a) The functions, powers and duties of the former pharmacy and

therapeutics committee as established in article two-A of the public

health law shall now be considered a function of the drug utilization

review board, including but not limited to:

(i) conducting an executive session for the purpose of receiving and

evaluating drug pricing information related to supplemental rebates, or

receiving and evaluating trade secrets, or other information which, if

disclosed, would cause substantial injury to the competitive position of

the manufacturer; and

(ii) evaluating and providing recommendations to the commissioner of

health on other issues relating to pharmacy services under Medicaid or

EPIC, including, but not limited to: therapeutic comparisons; enhanced

use of generic drug products; enhanced targeting of physician

prescribing patterns; and

(iii) collaborating with managed care organizations to address drug

utilization concerns and to implement consistent management strategies

across the fee-for-service and managed care pharmacy benefits.

(b) Any business or other matter undertaken or commenced by the

pharmacy and therapeutics committee pertaining to or connected with the

functions, powers, obligations and duties are hereby transferred and

assigned to the drug utilization review board and pending on the

effective date of this subdivision, may be conducted and completed by

the drug utilization review board in the same manner and under the same

terms and conditions and with the same effect as if conducted and

completed by the pharmacy and therapeutics committee. All books, papers,

and property of the pharmacy and therapeutics committee shall continue

to be maintained by the drug utilization review board.

(c) All rules, regulations, acts, orders, determinations, and

decisions of the pharmacy and therapeutics committee pertaining to the

functions and powers herein transferred and assigned, in force at the

time of such transfer and assumption, shall continue in full force and

effect as rules, regulations, acts, orders, determinations and decisions

of the drug utilization review board until duly modified or abrogated by

the commissioner of health.

6. Members of the DUR utilization review board and all its employees

and agents shall be deemed to be an "employee" for purposes of section

seventeen of the public officers law.

7. The department shall provide administrative support to the DUR

board.

8. The duties of the DUR board are as follows:

(a) The development and application of the predetermined criteria and

standards to be used in retrospective and prospective DUR that ensure

that such criteria and standards are based on the compendia and that

they are developed with professional input in a consensus fashion with

provisions for timely revisions and assessments as necessary. Further,

that the DUR standards shall reflect the appropriate practices of

physicians in order to monitor:

(i) Therapeutic appropriateness;

(ii) Overutilization or underutilization;

(iii) Therapeutic duplication;

(iv) Drug-disease contraindications;

(v) Drug-drug interactions;

(vi) Incorrect drug dosage or duration of drug treatment; and

(vii) Clinical abuse/misuse.

(b) The development, selection, application, and assessment of

interventions or remedial strategies for physicians, pharmacists, and

recipients that are educational and not punitive in nature to improve

the quality of care including:

(i) Information disseminated to physicians and pharmacists to ensure

that physicians and pharmacists are aware of the board's duties and

powers;

(ii) Written, oral, or electronic reminders of patient-specific or

drug-specific information that are designed to ensure recipient,

physician, and pharmacist confidentiality, and suggested changes in the

prescribing or dispensing practices designed to improve the quality of

care;

(iii) Use of face-to-face discussions between experts in drug therapy

and the prescriber or pharmacist who has been targeted for educational

intervention;

(iv) Intensified reviews or monitoring of selected prescribers or

pharmacists;

(v) The creation of an educational program using data provided through

DUR to provide for active and ongoing educational outreach programs to

improve prescribing and dispensing practices as provided in this

subdivision. (This may be done directly or through contract with other

entities);

(vi) The timely evaluation of interventions to determine if the

interventions have improved the quality of care; and

(vii) The review of case profiles prior to the conducting of an

intervention.

(c) The publication of an annual report which shall be subject to the

department's comment prior to its issuance to the federal department of

health and human services by December first of each year. The annual

report also shall be submitted to the governor and the legislature

before December first of each year. The report shall include the

following information:

(i) A description of the activities of the board, including the nature

and scope of the prospective and retrospective drug use review programs;

(ii) A summary of the interventions used;

(iii) An assessment of the impact of these educational interventions

in quality of care;

(iv) An estimate of the cost savings generated as a result of such

program; and

(v) Recommendations for program improvement.

(d) The development of a working agreement for the DUR board with

related boards or agencies, including, but not limited to: the board of

pharmacy, the board of medicine, the SURS staff, and staff of the

department of health and the office of mental health, in order to

clarify the areas of responsibility for each where such areas may

overlap.

(e) The establishment of a process where physicians or pharmacists

will have the opportunity to submit responses to the DUR educational

letters.

(f) The publication and dissemination of educational information to

physicians and pharmacists on the DUR board and the DUR program to

include information on:

(i) Identifying and reducing the frequency of patterns of fraud,

abuse, gross overuse, or inappropriate or medically unnecessary care

among physicians, pharmacists, and recipients;

(ii) Potential or actual severe/adverse reactions to drugs;

(iii) Therapeutic appropriateness;

(iv) Overutilization or underutilization;

(v) Appropriate use of generics;

(vi) Therapeutic duplication;

(vii) Drug-disease contraindications;

(viii) Drug-drug interactions;

(ix) Incorrect drug dosage/duration of drug treatments;

(x) Drug allergy interactions; and

(xi) Clinical abuse/misuse.

(g) The evaluation of specific drugs submitted to the board for review

pursuant to section two hundred eighty of the public health law, and the

formulation of recommended target supplemental rebates, in accordance

with the standards established in such section.

(h) The adoption and implementation of procedures designed to ensure

the confidentiality of any information collected, stored, retrieved,

assessed or analyzed by the DUR board, staff to the board, or

contractors to the DUR program, that identifies individual physicians,

pharmacists, or recipients. The board may have access to identifying

information for purposes of carrying out intervention activities, but

such identifying information may not be released to anyone other than a

member of the DUR board or the department and its agents.

(i) The improper release of identifying information in violation of

this article may subject that person to criminal or civil penalties.

(j) The board may release cumulative non-identifying information for

purposes of legitimate research.

9. The relationship of the DUR board to the department is as follows:

(a) The department shall monitor the DUR board's compliance to federal

and state statute and regulation.

(b) The DUR board shall serve at the discretion of the commissioner.

(c) The department shall have authority on all fiscal matters relating

to the DUR program.

(d) The department shall have authority on all administrative matters

relating to the administration of the medical assistance program within

the DUR program.

(e) The DUR board shall have responsibility for all medical matters

relating to the DUR program.

(f) The DUR board may utilize medical consultants and review

committees as necessary, subject to department approval.