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A00663 Text:



 
                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.
                                                                   LBD05130-05-2

        A. 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.
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