STATE OF NEW YORK ________________________________________________________________________ 663--B 2021-2022 Regular Sessions IN ASSEMBLY (Prefiled) January 6, 2021 ___________ Introduced by M. of A. D. ROSENTHAL, DICKENS, COLTON, WILLIAMS, SEAWRIGHT, COOK, O'DONNELL, SIMON, ABINANTI, JACOBSON, GRIFFIN -- Multi-Sponsored by -- M. of A. GALEF, SALKA -- read once and referred to the Committee on Health -- recommitted to the Committee on Health in accordance with Assembly Rule 3, sec. 2 -- committee discharged, bill amended, ordered reprinted as amended and recommitted to said committee -- again reported from said committee with amendments, ordered reprinted as amended and recommitted to said committee AN ACT to amend the insurance law, in relation to requiring certain manufacturers of prescription drugs to notify the superintendant of any proposed increase of the wholesale acquisition cost of such prescription drugs The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. The insurance law is amended by adding a new section 111-a 2 to read as follows: 3 § 111-a. Notification of prescription drug price increases by manufac- 4 turers. (a) This section shall apply to a manufacturer of a prescription 5 drug that is purchased or reimbursed in this state by any of the follow- 6 ing: 7 (1) An insurance company authorized in this state to write accident 8 and health insurance, a company organized pursuant to article forty- 9 three of this chapter, a municipal cooperative health benefit plan 10 established pursuant to article forty-seven of this chapter, an organ- 11 ization certified pursuant to article forty-four of the public health 12 law, an institution of higher education certified pursuant to section 13 one thousand one hundred twenty-four of this chapter, or the New York 14 state health insurance plan established pursuant to article eleven of 15 the civil service law; or 16 (2) A pharmacy benefit manager, including an entity that directly or 17 through an intermediary, manages the prescription drug coverage provided 18 by a health insurer under a contract or policy delivered or issued for 19 delivery in this state or a health plan subject to section three hundred EXPLANATION--Matter in italics (underscored) is new; matter in brackets [] is old law to be omitted. LBD05130-05-2A. 663--B 2 1 sixty-four-j of the social services law, including the processing and 2 payment of claims for prescription drugs, the performance of drug utili- 3 zation review, the processing of drug prior authorization requests, the 4 adjudication of appeals or grievances related to prescription drug 5 coverage, contracting with network pharmacies, and controlling the cost 6 of covered prescription drugs. 7 (b) (1) A manufacturer of a prescription drug with a wholesale acqui- 8 sition cost of more than forty dollars for a course of therapy shall 9 notify the superintendent, his or her deputy or other officer designated 10 by the superintendent, if the increase in the wholesale acquisition cost 11 of such prescription drug is more than ten percent, including the 12 proposed increase and the cumulative increases that occurred within the 13 previous twenty-four months. For purposes of this section, a "course of 14 therapy" is defined as either of the following: 15 (i) the recommended daily dosage units of a prescription drug pursuant 16 to its prescribing label as approved by the federal Food and Drug Admin- 17 istration for thirty days; or 18 (ii) the recommended daily dosage units of a prescription drug pursu- 19 ant to its prescribing label as approved by the federal Food and Drug 20 Administration for a normal course of treatment that is less than thirty 21 days. 22 (2) (i) The notice required by paragraph (1) of this subsection shall 23 be provided in writing to the superintendent at least sixty days prior 24 to the planned effective date of the increase and shall include the 25 proposed increase and the cumulative increases that occurred within the 26 previous twenty-four months. 27 (ii) The superintendent shall forthwith publish the notice required by 28 paragraph (a) of this subdivision on the department of financial 29 services website within five days of its receipt. 30 (3) (i) The notice required by paragraph (1) of this subsection shall 31 include the date of the increase, the current wholesale acquisition cost 32 of the prescription drug, and the dollar amount of the future increase 33 in the wholesale acquisition cost of the prescription drug. 34 (ii) The notice required by paragraph (1) of this subsection shall 35 include a statement regarding whether a change or improvement in the 36 drug necessitates the price increase. If so, the manufacturer shall 37 describe the change or improvement. 38 (4) Information supplied by a manufacturer pursuant to this section 39 that the manufacturer has designated as a trade secret shall be consid- 40 ered confidential and a trade secret and shall not be disclosed directly 41 or indirectly by the superintendent. Notwithstanding the foregoing 42 sentence, the superintendent shall be permitted to disclose information 43 in an aggregated format if such aggregate information cannot directly or 44 indirectly be used to identify trade secret information related to a 45 specific manufacturer or the manufacturer's prescription drug, including 46 but not limited to any information related to pricing for the manufac- 47 turer's prescription drug that has been designated as a trade secret. 48 (5) In the event that a manufacturer of a prescription drug subject to 49 this section does not report the information required in paragraph (1) 50 of this subsection, the superintendent is authorized to impose any 51 penalty or remedy authorized by this chapter, after notice and a hear- 52 ing, against such manufacturer of up to five thousand dollars per day 53 for every day after the reporting period described in this section that 54 the required information is not reported. 55 § 2. This act shall take effect immediately.