2023 New York Laws › ISC - Insurance › Article 2 - Organization of the Department of Financial Services › 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.