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This entry was published on 2023-12-29
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SECTION 111-A
Notification of prescription drug price increases by manufacturers
Insurance (ISC) CHAPTER 28, ARTICLE 1
* § 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
forty-three of this chapter, a municipal cooperative health benefit plan
established pursuant to 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
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 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.

* NB Effective June 19, 2024