N.Y. Insurance Law § 202: Drug accountability board

§ 202. Drug accountability board. (a) A nine member drug

accountability board is hereby created in the department.

(b) The members of the board shall be appointed by the superintendent,

provided however that one member shall be appointed at the suggestion of

the temporary president of the senate and one member shall be appointed

at the suggestion of the speaker of the assembly, and shall serve a

three-year term. Members may be reappointed upon the completion of other

terms. In making appointments to the board the superintendent shall give

consideration to persons:

(1) licensed and actively engaged in the practice of medicine in the

state;

(2) licensed and actively practicing in pharmacy in the state;

(3) with expertise in drug utilization review who are health care

professionals licensed under title eight of the education law and who

are pharmacologists;

(4) 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;

(5) who are health care economists;

(6) who are actuaries; and

(7) who are experts from the department of health.

(c) The superintendent shall designate a person from the department to

serve as chairperson of the board.

(d) Members of the board and all its agents shall be deemed to be an

"employee" for purposes of section seventeen of the public officers law.

(e) (1) The department shall have authority on all fiscal matters

relating to the board.

(2) The board may utilize or request assistance of any state agency or

authority subject to the approval of the superintendent.

(f) (1) Whenever the superintendent determines it would aid an

investigation under section one hundred eleven of this chapter, the

superintendent shall refer a drug to the board for a report thereon to

be prepared.

(2) If a drug is referred to the board under paragraph one of this

subsection the board shall determine:

(A) the drug's impact on the premium costs for commercial insurance in

this state, and the drug's affordability and value to the public;

(B) whether increases in the price of the drug over time were

significant and unjustified;

(C) whether the drug may be priced disproportionately to its

therapeutic benefits; and

(D) any other question the superintendent may certify to the board in

aid of an investigation under section one hundred eleven of this

chapter.

(3) In formulating its determinations, the board may consider:

(A) publicly available information relevant to the pricing of the

drug;

(B) information supplied by the department relevant to the pricing of

the drug;

(C) information relating to value-based pricing;

(D) the seriousness and prevalence of the disease or condition that is

treated by the drug;

(E) the extent of utilization of the drug;

(F) the effectiveness of the drug in treating the conditions for which

it is prescribed, or in improving a patient's health, quality of life,

or overall health outcomes;

(G) the likelihood that use of the drug will reduce the need for other

medical care, including hospitalization;

(H) the average wholesale price, wholesale acquisition cost, retail

price of the drug, and the cost of the drug to the Medicaid program

minus rebates received by the state;

(I) in the case of generic drugs, the number of pharmaceutical

manufacturers that produce the drug;

(J) whether there are pharmaceutical equivalents to the drug;

(K) information supplied by the manufacturer, if any, explaining the

relationship between the pricing of the drug and the cost of development

of the drug and/or the therapeutic benefit of the drug, or that is

otherwise pertinent to the manufacturer's pricing decision; any such

information provided shall be considered confidential and shall not be

disclosed by the drug utilization review board in a form that identifies

a specific manufacturer or prices charged for drugs by such

manufacturer; and

(L) information from the department of health, including from the drug

utilization review board.

(4) Following its review, the board shall report its findings to the

superintendent. Such report shall include the determinations required by

paragraph two of this subsection and any other information required by

the superintendent.

(g) Notwithstanding any law to the contrary, the papers and

information considered by the board and any report thereof shall be

confidential and not subject to disclosure. The superintendent, in his

or her sole discretion, may determine that the release of the board's

report would not harm an ongoing investigation and would be in the

public interest, and thereafter may release the report or any portion

thereof to the public.

(h) The superintendent may call a public hearing on the determinations

of the board, notice of such hearing shall be given to the manufacturer

of the drug and shall be published on the website of the department for

not less than fifteen days before the hearing.