Bill Text: NY S02676 | 2025-2026 | General Assembly | Introduced

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Bill Title: Relates to health care plans for step therapy protocol; amends effective date to January 1, 2026.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Introduced) 2025-01-27 - ORDERED TO THIRD READING CAL.159 [S02676 Detail]

Download: New_York-2025-S02676-Introduced.html

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                STATE OF NEW YORK
        ________________________________________________________________________

                                          2676

                               2025-2026 Regular Sessions

                    IN SENATE

                                    January 22, 2025
                                       ___________

        Introduced  by  Sen.  BAILEY -- read twice and ordered printed, and when
          printed to be committed to the Committee on Rules

        AN ACT to amend the insurance law and the public health law, in relation
          to step therapy protocol; and to amend a chapter of the laws  of  2024
          amending  the  insurance  law  and  the public health law, relating to
          requiring a utilization review agent  to  follow  certain  rules  when
          establishing a step therapy protocol, as proposed in legislative bills
          numbers S. 1267-A and A. 901-A, in relation to the effectiveness ther-
          eof

          The  People of the State of New York, represented in Senate and Assem-
        bly, do enact as follows:

     1    Section 1. Paragraphs 15 and 16 of subsection (a) of section  4902  of
     2  the  insurance  law,  as added by a chapter of the laws of 2024 amending
     3  the insurance law and the public health law,  relating  to  requiring  a
     4  utilization  review  agent  to  follow certain rules when establishing a
     5  step therapy protocol, as  proposed  in  legislative  bills  numbers  S.
     6  1267-A and A. 901-A, are amended to read as follows:
     7    (15)  When  establishing a step therapy protocol, a utilization review
     8  agent shall ensure that the protocol cannot:
     9    (i) require a prescription drug that has  not  been  approved  by  the
    10  United  States  Food  and  Drug Administration for the medical condition
    11  being treated [and/or] or is not  supported  by  current  evidence-based
    12  guidelines for the medical condition being treated;
    13    (ii) require an insured to try and fail on more than two drugs [within
    14  one  therapeutic  category]  used to treat the same medical condition or
    15  disease before providing coverage to  the  insured  for  the  prescribed
    16  drug;
    17    (iii)  require the use of a step therapy-required drug for longer than
    18  thirty days or a duration of treatment supported  by  current  evidence-
    19  based  treatment  guidelines  appropriate  to the specific disease state
    20  being treated;

         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD02801-01-5
        S. 2676                             2

     1    (iv) be imposed on an insured  if  a  therapeutic  equivalent  to  the
     2  prescribed  drug  is  not  available,  or  if  the  health care plan has
     3  documentation that it has covered the drug for  the  [enrollee]  insured
     4  within the past three hundred sixty-five days;
     5    (v) require a newly enrolled insured to repeat a step therapy protocol
     6  for a prescribed drug where that insured already completed a step thera-
     7  py protocol for that drug under a prior health care plan, so long as the
     8  enrollee  or  provider submits information demonstrating completion of a
     9  step therapy protocol of the prior health  care  plan  within  the  past
    10  three hundred sixty-five days; and
    11    (vi) be imposed on an insured for a prescribed drug that was previous-
    12  ly  approved  for coverage by [a] the insured's current health care plan
    13  for a specific medical condition after the insured's current health care
    14  plan implements  a  formulary  change  or  utilization  management  that
    15  impacts the coverage criteria for the prescribed drug until the approved
    16  override   expires,   unless   a  specifically  identified  and  current
    17  evidence-based safety concern exists and a different therapeutic  alter-
    18  native drug exists.
    19    (16)  When  establishing a step therapy protocol, a utilization review
    20  agent shall ensure that the protocol accepts any written  or  electronic
    21  attestation  submitted  by  the  insured's  health care professional, as
    22  defined in section  four  thousand  nine  hundred  of  this  title,  who
    23  prescribed  the  drug  and  stating  that a required drug has failed, as
    24  [prima facie] evidence that the required drug has failed.
    25    § 2. Subsections (c-3) and (g) of section 4903 of the  insurance  law,
    26  as  amended  by a chapter of the laws of 2024 amending the insurance law
    27  and the public health law, relating to requiring  a  utilization  review
    28  agent to follow certain rules when establishing a step therapy protocol,
    29  as  proposed  in  legislative  bills numbers S. 1267-A and A. 901-A, are
    30  amended to read as follows:
    31    (c-3) Upon a determination that the step therapy  protocol  should  be
    32  overridden,  the health care plan shall authorize immediate coverage for
    33  the prescription drug prescribed by the insured's treating  health  care
    34  professional.  Any approval of a step therapy protocol override determi-
    35  nation request shall be honored until the  lesser  of  either  treatment
    36  duration  based on current evidence-based treatment guidelines or twelve
    37  months following the date of the approval of the request or  renewal  of
    38  the insured's coverage.
    39    (g)  Failure  by  the utilization review agent to make a determination
    40  within the time periods prescribed in this section shall be deemed to be
    41  an adverse determination subject to  appeal  pursuant  to  section  four
    42  thousand  nine hundred four of this title, provided, however, that fail-
    43  ure to meet such time periods for a step therapy protocol as defined  in
    44  subsection  (g-9)  of section forty-nine hundred of this title or a step
    45  therapy protocol override determination pursuant to  subsections  (c-1),
    46  (c-2) and (c-3) of this section shall be deemed to be an override of the
    47  step  therapy  protocol.  A utilization review agent's failure to comply
    48  with  any  of  the  step  therapy  protocol  requirements  required   in
    49  [subsections]  paragraphs  fifteen  and  sixteen  of  subsection  (a) of
    50  section four thousand nine hundred two of this title shall be considered
    51  a basis for granting an override of the step  therapy  protocol,  absent
    52  fraud.
    53    § 3. Subdivisions 5 and 6 of section 4902 of the public health law, as
    54  added  by  a  chapter of the laws of 2024 amending the insurance law and
    55  the public health law, relating to requiring a utilization review  agent
    56  to  follow  certain  rules when establishing a step therapy protocol, as
        S. 2676                             3

     1  proposed in legislative bills  numbers  S.  1267-A  and  A.  901-A,  are
     2  amended to read as follows:
     3    5.  When  establishing  a  step therapy protocol, a utilization review
     4  agent shall ensure that the protocol cannot:
     5    (a) require a prescription drug that has  not  been  approved  by  the
     6  United  States  Food  and  Drug  Administration [and/or] for the medical
     7  condition being treated or is not supported  by  current  evidence-based
     8  guidelines for the medical condition being treated;
     9    (b) require an enrollee to try and fail on more than two drugs [within
    10  one  therapeutic  category]  used to treat the same medical condition or
    11  disease before providing coverage to  the  [insured]  enrollee  for  the
    12  prescribed drug;
    13    (c)  require  the  use of a step therapy-required drug for longer than
    14  thirty days or a duration of treatment supported  by  current  evidence-
    15  based  treatment  guidelines  appropriate  to the specific disease state
    16  being treated;
    17    (d) be imposed on an enrollee  if  a  therapeutic  equivalent  to  the
    18  prescribed  drug  is  not  available;  or  if  the  health care plan has
    19  documentation that it has covered the drug for the enrollee  within  the
    20  past three hundred sixty-five days;
    21    (e)  require a newly enrolled enrollee to repeat a step therapy proto-
    22  col for a prescribed drug where that enrollee already completed  a  step
    23  therapy  protocol  for that drug under a prior health care plan, so long
    24  as the enrollee or provider [submit] submits  information  demonstrating
    25  completion  of  a  step  therapy  protocol of the prior health care plan
    26  within the past three hundred sixty-five days; and
    27    (f) be imposed on an enrollee for a prescribed drug that was previous-
    28  ly approved for coverage by [a] the enrollee's current health care  plan
    29  for  [a]  the enrollee's specific medical condition after the enrollee's
    30  current health care plan implements a formulary or  utilization  manage-
    31  ment  change  that impacts the coverage criteria for the prescribed drug
    32  until the approved override expires, unless  a  specifically  identified
    33  and  evidence-based  safety  concern  exists and a different therapeutic
    34  alternative drug exists.
    35    6. When establishing a step therapy  protocol,  a  utilization  review
    36  agent  shall  ensure that the protocol accepts any written or electronic
    37  attestation submitted by the enrollee's  health  care  professional,  as
    38  defined  in section forty-nine hundred of this title, who prescribed the
    39  drug and stating that a required  drug  has  failed,  as  [prima  facie]
    40  evidence that the required drug has failed.
    41    §  4.  Subdivision  3-c  of  section  4903 of the public health law as
    42  amended by a chapter of the laws of 2024 amending the insurance law  and
    43  the  public health law, relating to requiring a utilization review agent
    44  to follow certain rules when establishing a step  therapy  protocol,  as
    45  proposed in legislative bills numbers S. 1267-A and A. 901-A, is amended
    46  to read as follows:
    47    3-c.  Upon  a  determination  that the step therapy protocol should be
    48  overridden, the health care plan shall authorize immediate coverage  for
    49  the  prescription  drug  or  drugs prescribed by the enrollee's treating
    50  health care professional. Any approval of a step therapy protocol  over-
    51  ride  determination  request shall be honored until the lesser of either
    52  treatment duration based on current evidence-based treatment  guidelines
    53  or  twelve  months  following the date of the approval of the request or
    54  renewal of the enrollee's coverage.
    55    § 5. Section 5 of a chapter of the laws of 2024 amending the insurance
    56  law and the public health  law,  relating  to  requiring  a  utilization
        S. 2676                             4

     1  review  agent  to  follow certain rules when establishing a step therapy
     2  protocol, as proposed in legislative bills  numbers  S.  1267-A  and  A.
     3  901-A, is amended to read as follows:
     4    §  5.  This  act  shall  take effect [on the one hundred twentieth day
     5  after it shall have become a law] January 1, 2026 and shall apply to all
     6  policies issued, renewed, modified, altered or amended on or after  such
     7  date.
     8    §  6.  This  act shall take effect immediately; provided, however that
     9  the provisions of sections one, two, three and four of  this  act  shall
    10  take  effect on the same date and in the same manner as a chapter of the
    11  laws of 2024 amending the insurance  law  and  the  public  health  law,
    12  relating to requiring a utilization review agent to follow certain rules
    13  when  establishing  a  step therapy protocol, as proposed in legislative
    14  bills numbers S. 1267-A and A. 901-A, takes effect.