N.Y. ISC Law § 202 — New York Code / Act ISC / Article 2 / Section 202
Drug accountability board
Status: in_force

§ 202. Drug accountability board. (a) A nine member drug\naccountability board is hereby created in the department.\n  (b) The members of the board shall be appointed by the superintendent,\nprovided however that one member shall be appointed at the suggestion of\nthe temporary president of the senate and one member shall be appointed\nat the suggestion of the speaker of the assembly, and shall serve a\nthree-year term. Members may be reappointed upon the completion of other\nterms. In making appointments to the board the superintendent shall give\nconsideration to persons:\n  (1) licensed and actively engaged in the practice of medicine in the\nstate;\n  (2) licensed and actively practicing in pharmacy in the state;\n  (3) with expertise in drug utilization review who are health care\nprofessionals licensed under title eight of the education law and who\nare pharmacologists;\n  (4) that are consumers or consumer representatives of organizations\nwith a regional or statewide constituency and who have been involved in\nactivities related to health care consumer advocacy;\n  (5) who are health care economists;\n  (6) who are actuaries; and\n  (7) who are experts from the department of health.\n  (c) The superintendent shall designate a person from the department to\nserve as chairperson of the board.\n  (d) Members of the board and all its agents shall be deemed to be an\n"employee" for purposes of section seventeen of the public officers law.\n  (e) (1) The department shall have authority on all fiscal matters\nrelating to the board.\n  (2) The board may utilize or request assistance of any state agency or\nauthority subject to the approval of the superintendent.\n  (f) (1) Whenever the superintendent determines it would aid an\ninvestigation under section one hundred eleven of this chapter, the\nsuperintendent shall refer a drug to the board for a report thereon to\nbe prepared.\n  (2) If a drug is referred to the board under paragraph one of this\nsubsection the board shall determine:\n  (A) the drug's impact on the premium costs for commercial insurance in\nthis state, and the drug's affordability and value to the public;\n  (B) whether increases in the price of the drug over time were\nsignificant and unjustified;\n  (C) whether the drug may be priced disproportionately to its\ntherapeutic benefits; and\n  (D) any other question the superintendent may certify to the board in\naid of an investigation under section one hundred eleven of this\nchapter.\n  (3) In formulating its determinations, the board may consider:\n  (A) publicly available information relevant to the pricing of the\ndrug;\n  (B) information supplied by the department relevant to the pricing of\nthe drug;\n  (C) information relating to value-based pricing;\n  (D) the seriousness and prevalence of the disease or condition that is\ntreated by the drug;\n  (E) the extent of utilization of the drug;\n  (F) the effectiveness of the drug in treating the conditions for which\nit is prescribed, or in improving a patient's health, quality of life,\nor overall health outcomes;\n  (G) the likelihood that use of the drug will reduce the need for other\nmedical care, including hospitalization;\n  (H) the average wholesale price, wholesale acquisition cost, retail\nprice of the drug, and the cost of the drug to the Medicaid program\nminus rebates received by the state;\n  (I) in the case of generic drugs, the number of pharmaceutical\nmanufacturers that produce the drug;\n  (J) whether there are pharmaceutical equivalents to the drug;\n  (K) information supplied by the manufacturer, if any, explaining the\nrelationship between the pricing of the drug and the cost of development\nof the drug and/or the therapeutic benefit of the drug, or that is\notherwise pertinent to the manufacturer's pricing decision; any such\ninformation provided shall be considered confidential and shall not be\ndisclosed by the drug utilization review board in a form that identifies\na specific manufacturer or prices charged for drugs by such\nmanufacturer; and\n  (L) information from the department of health, including from the drug\nutilization review board.\n  (4) Following its review, the board shall report its findings to the\nsuperintendent. Such report shall include the determinations required by\nparagraph two of this subsection and any other information required by\nthe superintendent.\n  (g) Notwithstanding any law to the contrary, the papers and\ninformation considered by the board and any report thereof shall be\nconfidential and not subject to disclosure. The superintendent, in his\nor her sole discretion, may determine that the release of the board's\nreport would not harm an ongoing investigation and would be in the\npublic interest, and thereafter may release the report or any portion\nthereof to the public.\n  (h) The superintendent may call a public hearing on the determinations\nof the board, notice of such hearing shall be given to the manufacturer\nof the drug and shall be published on the website of the department for\nnot less than fifteen days before the hearing.\n