N.Y.
Insurance Law Section 111-A
Notification of prescription drug price increases by manufacturers
(a)
This section shall apply to a manufacturer of a prescription drug that is purchased or reimbursed in this state by any of the following:(1)
An insurance company authorized in this state to write accident and health insurance, a company organized pursuant to article 43 (Non-profit Medical and Dental Indemnity, or Health and Hospital Service Corporations)article forty-three of this chapter, a municipal cooperative health benefit plan established pursuant to article 47 (Municipal Cooperative Health Benefit Plans)article forty-seven of this chapter, an organization certified pursuant to article forty-four of the public health law, an institution of higher education certified pursuant to § 1124 (Institutions of higher education exempt)section one thousand one hundred twenty-four of this chapter, or the New York state health insurance plan established pursuant to article eleven of the civil service law; or(2)
A pharmacy benefit manager, including an entity that directly or through an intermediary, manages the prescription drug coverage provided by a health insurer under a contract or policy delivered or issued for delivery in this state or a health plan subject to Social Services Law § 364-J (Managed care programs)section three hundred sixty-four-j of the social services law, including the processing and payment of claims for prescription drugs, the performance of drug utilization review, the processing of drug prior authorization requests, the adjudication of appeals or grievances related to prescription drug coverage, contracting with network pharmacies, and controlling the cost of covered prescription drugs.(b)
(1) A manufacturer of a prescription drug with a wholesale acquisition cost of more than forty dollars for a course of therapy shall notify the superintendent, his or her deputy or other officer designated by the superintendent, if the increase in the wholesale acquisition cost of such prescription drug is more than sixteen percent, including the proposed increase and the cumulative increases that occurred within the previous twenty-four months prior to the planned effective date of the increase. For purposes of this section, a “course of therapy” is defined as either of the following:(i)
the recommended daily dosage units of a prescription drug pursuant to its prescribing label as approved by the federal Food and Drug Administration for thirty days; or(ii)
the recommended daily dosage units of a prescription drug pursuant to its prescribing label as approved by the federal Food and Drug Administration for a normal course of treatment that is less than thirty days.(2)
(i) The notice required by paragraph one of this subsection shall be provided in writing to the superintendent at least sixty days prior to the planned effective date of the increase and shall include the proposed increase and the cumulative increases that occurred within the previous twenty-four months.(ii)
The superintendent shall forthwith publish the notice required by paragraph one of this subsection on the department of financial services website within five days of its receipt.(3)
(i) The notice required by paragraph one of this subsection shall include the date of the increase, the current wholesale acquisition cost of the prescription drug, and the dollar amount of the future increase in the wholesale acquisition cost of the prescription drug.(ii)
The notice required by paragraph one of this subsection shall include a statement regarding whether a change or improvement in the drug necessitates the price increase. If so, the manufacturer shall describe the change or improvement.(4)
Information supplied by a manufacturer pursuant to this section that the manufacturer has reasonably designated as a trade secret shall be considered confidential and a trade secret, shall be exempt from public disclosure and copying under article six of the public officers law and shall not be disclosed directly or indirectly by the superintendent. Notwithstanding the foregoing sentence, the superintendent shall be permitted to disclose information in an aggregated format if such aggregate information cannot directly or indirectly be used to identify trade secret information related to a specific manufacturer or the manufacturer’s prescription drug, including but not limited to any information related to pricing for the manufacturer’s prescription drug that has been reasonably designated as a trade secret.(5)
In the event that a manufacturer of a prescription drug subject to this section does not report the information required in paragraph one of this subsection, the superintendent is authorized to impose any penalty or remedy authorized by this chapter, after notice and a hearing, against such manufacturer of up to five thousand dollars per day for every day after the reporting period described in this section that the required information is not reported.
Source:
Section 111-A — Notification of prescription drug price increases by manufacturers, https://www.nysenate.gov/legislation/laws/ISC/111-A (updated Jun. 21, 2024; accessed Oct. 26, 2024).
