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S01267 Text:

 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                         1267--A
            Cal. No. 92
 
                               2023-2024 Regular Sessions
 
                    IN SENATE
 
                                    January 11, 2023
                                       ___________
 
        Introduced  by  Sens.  BRESLIN, ADDABBO, FERNANDEZ, MAY, SKOUFIS -- read
          twice and ordered printed, and when printed to  be  committed  to  the
          Committee on Insurance -- recommitted to the Committee on Insurance in
          accordance  with Senate Rule 6, sec. 8 -- reported favorably from said
          committee, ordered to first and second  report,  ordered  to  a  third
          reading,  passed  by  Senate  and delivered to the Assembly, recalled,
          vote reconsidered, restored to  third  reading,  amended  and  ordered
          reprinted, retaining its place in the order of third reading
 
        AN ACT to amend the insurance law and the public health law, in relation
          to  requiring  a utilization review agent to follow certain rules when
          establishing a step therapy protocol
 
          The People of the State of New York, represented in Senate and  Assem-
        bly, do enact as follows:
 
     1    Section  1.  Subsection  (a)  of  section 4902 of the insurance law is
     2  amended by adding two new paragraphs 15 and 16 to read as follows:
     3    (15) When establishing a step therapy protocol, a  utilization  review
     4  agent shall ensure that the protocol cannot:
     5    (i)  require  a  prescription  drug  that has not been approved by the
     6  United States Food and Drug Administration  for  the  medical  condition
     7  being  treated  and/or is not supported by current evidence-based guide-
     8  lines for the medical condition being treated;
     9    (ii) require an insured to try and fail on more than two drugs  within
    10  one  therapeutic  category  before providing coverage to the insured for
    11  the prescribed drug;
    12    (iii) require the use of a step therapy-required drug for longer  than
    13  thirty  days  or  a duration of treatment supported by current evidence-
    14  based treatment guidelines appropriate to  the  specific  disease  state
    15  being treated;
    16    (iv)  be  imposed  on  an  insured  if a therapeutic equivalent to the
    17  prescribed drug is not available, or if the health plan  has  documenta-
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD02501-05-4
        S. 1267--A                          2
 
     1  tion that it has covered the drug for the enrollee within the past three
     2  hundred sixty-five days;
     3    (v)  require  a  newly  enrolled  insured to repeat step therapy for a
     4  prescribed drug where that insured already completed  step  therapy  for
     5  that  drug  under  a  prior  plan,  so  long as the enrollee or provider
     6  submits information demonstrating completion of a step therapy  protocol
     7  of the prior plan within the past three hundred sixty-five days; and
     8    (vi) be imposed on an insured for a prescribed drug that was previous-
     9  ly  approved  for  coverage  by  a plan for a specific medical condition
    10  after the insured's plan implements a formulary  change  or  utilization
    11  management  that  impacts  the coverage criteria for the prescribed drug
    12  until the approved override expires, unless  a  specifically  identified
    13  and  current evidence-based safety concern exists and a different thera-
    14  peutic alternative drug exists.
    15    (16) When establishing a step therapy protocol, a  utilization  review
    16  agent  shall  ensure that the protocol accepts any written or electronic
    17  attestation submitted by  the  insured's  health  care  professional  as
    18  defined in section four thousand nine hundred of this title stating that
    19  a  required  drug  has  failed as prima facie evidence that the required
    20  drug has failed.
    21    § 2. Subsections (c-3) and (g) of section 4903 of the  insurance  law,
    22  subsection  (c-3)  as added and subsection (g) as amended by chapter 512
    23  of the laws of 2016, are amended to read as follows:
    24    (c-3) Upon a determination that the step therapy  protocol  should  be
    25  overridden,  the  health plan shall authorize immediate coverage for the
    26  prescription drug prescribed  by  the  insured's  treating  health  care
    27  professional.  Any approval of a step therapy protocol override determi-
    28  nation request shall be honored until the  lesser  of  either  treatment
    29  duration  based on current evidence-based treatment guidelines or twelve
    30  months following the date of the approval of the request or  renewal  of
    31  the insured's coverage.
    32    (g)  Failure  by  the utilization review agent to make a determination
    33  within the time periods prescribed in this section shall be deemed to be
    34  an adverse determination subject to  appeal  pursuant  to  section  four
    35  thousand  nine hundred four of this title, provided, however, that fail-
    36  ure to meet such time periods for a step therapy protocol as defined  in
    37  subsection  (g-9)  of section forty-nine hundred of this title or a step
    38  therapy protocol override determination pursuant to  subsections  (c-1),
    39  (c-2) and (c-3) of this section shall be deemed to be an override of the
    40  step  therapy  protocol.  A utilization review agent's failure to comply
    41  with  any  of  the  step  therapy  protocol  requirements  required   in
    42  subsections  fifteen  and  sixteen of section four thousand nine hundred
    43  two of this title shall be considered a basis for granting  an  override
    44  of the step therapy protocol, absent fraud.
    45    §  3.  Section  4902 of the public health law is amended by adding two
    46  new subdivisions 5 and 6 to read as follows:
    47    5. When establishing a step therapy  protocol,  a  utilization  review
    48  agent shall ensure that the protocol cannot:
    49    (a)  require  a  prescription  drug  that has not been approved by the
    50  United States Food and Drug Administration and/or is  not  supported  by
    51  current evidence-based guidelines for the medical condition being treat-
    52  ed;
    53    (b)  require an enrollee to try and fail on more than two drugs within
    54  one therapeutic category before providing coverage to  the  insured  for
    55  the prescribed drug;
        S. 1267--A                          3
 
     1    (c)  require  the  use of a step therapy-required drug for longer than
     2  thirty days or a duration of treatment supported  by  current  evidence-
     3  based  treatment  guidelines  appropriate  to the specific disease state
     4  being treated;
     5    (d)  be  imposed  on  an  enrollee  if a therapeutic equivalent to the
     6  prescribed drug is not available; or if the health plan  has  documenta-
     7  tion that it has covered the drug for the enrollee within the past three
     8  hundred sixty-five days;
     9    (e)  require  a  newly  enrolled enrollee to repeat step therapy for a
    10  prescribed drug where that enrollee already completed step  therapy  for
    11  that drug under a prior plan, so long as the enrollee or provider submit
    12  information  demonstrating  completion of a step therapy protocol of the
    13  prior plan  within the past three hundred sixty-five days; and
    14    (f) be imposed on an enrollee for a prescribed drug that was previous-
    15  ly approved for coverage by a plan  for  a  specific  medical  condition
    16  after  the enrollee's plan implements a formulary or utilization manage-
    17  ment change that impacts the coverage criteria for the  prescribed  drug
    18  until  the  approved  override expires, unless a specifically identified
    19  and evidence-based safety concern exists  and  a  different  therapeutic
    20  alternative drug exists.
    21    6.  When  establishing  a  step therapy protocol, a utilization review
    22  agent shall ensure that the protocol accepts any written  or  electronic
    23  attestation  submitted  by  the  enrollee's  health care professional as
    24  defined in section forty-nine hundred  of  this  title  stating  that  a
    25  required  drug has failed as prima facie evidence that the required drug
    26  has failed.
    27    § 4. Subdivisions 3-c and 7 of section 4903 of the public health  law,
    28  subdivision  3-c as added and subdivision 7 as amended by chapter 512 of
    29  the laws of 2016, are amended to read as follows:
    30    3-c. Upon a determination that the step  therapy  protocol  should  be
    31  overridden,  the  health plan shall authorize immediate coverage for the
    32  prescription drug or drugs prescribed by the enrollee's treating  health
    33  care  professional.  Any  approval  of  a step therapy protocol override
    34  determination request shall be honored until the lesser of either treat-
    35  ment duration based on current evidence-based  treatment  guidelines  or
    36  twelve  months  following  the  date  of  the approval of the request or
    37  renewal of the enrollee's coverage.
    38    7. Failure by the utilization review agent  to  make  a  determination
    39  within the time periods prescribed in this section shall be deemed to be
    40  an  adverse  determination  subject to appeal pursuant to section forty-
    41  nine hundred four of this title, provided, however, that failure to meet
    42  such time periods for a step therapy protocol as defined in  subdivision
    43  seven-f-three  of  section  forty-nine  hundred  of this title or a step
    44  therapy  protocol  override  determination  pursuant   to   subdivisions
    45  three-a,  three-b  and  three-c of this section shall be deemed to be an
    46  override of the step therapy protocol.   A  utilization  review  agent's
    47  failure  to  comply  with  any of the step therapy protocol requirements
    48  required in subdivisions five and six of section forty-nine hundred  two
    49  of  this  title  shall be considered a basis for granting an override of
    50  the step therapy protocol, absent fraud.
    51    § 5. This act shall take effect on the one hundred twentieth day after
    52  it shall have become a law.

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