Bill Text: NY A00443 | 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 2-0)

Status: (Introduced) 2025-01-08 - referred to insurance [A00443 Detail]

Download: New_York-2025-A00443-Introduced.html

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                STATE OF NEW YORK
        ________________________________________________________________________

                                           443

                               2025-2026 Regular Sessions

                   IN ASSEMBLY

                                       (Prefiled)

                                     January 8, 2025
                                       ___________

        Introduced by M. of A. McDONALD -- read once and referred to the Commit-
          tee on Insurance

        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-

         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD02801-01-5
        A. 443                              2

     1  based treatment guidelines appropriate to  the  specific  disease  state
     2  being treated;
     3    (iv)  be  imposed  on  an  insured  if a therapeutic equivalent to the
     4  prescribed drug is not  available,  or  if  the  health  care  plan  has
     5  documentation  that  it  has covered the drug for the [enrollee] insured
     6  within the past three hundred sixty-five days;
     7    (v) require a newly enrolled insured to repeat a step therapy protocol
     8  for a prescribed drug where that insured already completed a step thera-
     9  py protocol for that drug under a prior health care plan, so long as the
    10  enrollee or provider submits information demonstrating completion  of  a
    11  step  therapy  protocol  of  the  prior health care plan within the past
    12  three hundred sixty-five days; and
    13    (vi) be imposed on an insured for a prescribed drug that was previous-
    14  ly approved for coverage by [a] the insured's current health  care  plan
    15  for a specific medical condition after the insured's current health care
    16  plan  implements  a  formulary  change  or  utilization  management that
    17  impacts the coverage criteria for the prescribed drug until the approved
    18  override  expires,  unless  a  specifically   identified   and   current
    19  evidence-based  safety concern exists and a different therapeutic alter-
    20  native drug exists.
    21    (16) 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  insured's  health  care  professional,  as
    24  defined  in  section  four  thousand  nine  hundred  of  this title, who
    25  prescribed the drug and stating that a  required  drug  has  failed,  as
    26  [prima facie] evidence that the required drug has failed.
    27    §  2.  Subsections (c-3) and (g) of section 4903 of the insurance law,
    28  as amended by a chapter of the laws of 2024 amending the  insurance  law
    29  and  the  public  health law, relating to requiring a utilization review
    30  agent to follow certain rules when establishing a step therapy protocol,
    31  as proposed in legislative bills numbers S. 1267-A  and  A.  901-A,  are
    32  amended to read as follows:
    33    (c-3)  Upon  a  determination that the step therapy protocol should be
    34  overridden, the health care plan shall authorize immediate coverage  for
    35  the  prescription  drug prescribed by the insured's treating health care
    36  professional. Any approval of a step therapy protocol override  determi-
    37  nation  request  shall  be  honored until the lesser of either treatment
    38  duration based on current evidence-based treatment guidelines or  twelve
    39  months  following  the date of the approval of the request or renewal of
    40  the insured's coverage.
    41    (g) Failure by the utilization review agent to  make  a  determination
    42  within the time periods prescribed in this section shall be deemed to be
    43  an  adverse  determination  subject  to  appeal pursuant to section four
    44  thousand nine hundred four of this title, provided, however, that  fail-
    45  ure  to meet such time periods for a step therapy protocol as defined in
    46  subsection (g-9) of section forty-nine hundred of this title or  a  step
    47  therapy  protocol  override determination pursuant to subsections (c-1),
    48  (c-2) and (c-3) of this section shall be deemed to be an override of the
    49  step therapy protocol. A utilization review agent's  failure  to  comply
    50  with   any  of  the  step  therapy  protocol  requirements  required  in
    51  [subsections] paragraphs  fifteen  and  sixteen  of  subsection  (a)  of
    52  section four thousand nine hundred two of this title shall be considered
    53  a  basis  for  granting an override of the step therapy protocol, absent
    54  fraud.
    55    § 3. Subdivisions 5 and 6 of section 4902 of the public health law, as
    56  added by a chapter of the laws of 2024 amending the  insurance  law  and
        A. 443                              3

     1  the  public health law, relating to requiring a utilization review agent
     2  to follow certain rules when establishing a step  therapy  protocol,  as
     3  proposed  in  legislative  bills  numbers  S.  1267-A  and A. 901-A, are
     4  amended to read as follows:
     5    5.  When  establishing  a  step therapy protocol, a utilization review
     6  agent shall ensure that the protocol cannot:
     7    (a) require a prescription drug that has  not  been  approved  by  the
     8  United  States  Food  and  Drug  Administration [and/or] for the medical
     9  condition being treated or is not supported  by  current  evidence-based
    10  guidelines for the medical condition being treated;
    11    (b) require an enrollee to try and fail on more than two drugs [within
    12  one  therapeutic  category]  used to treat the same medical condition or
    13  disease before providing coverage to  the  [insured]  enrollee  for  the
    14  prescribed drug;
    15    (c)  require  the  use of a step therapy-required drug for longer than
    16  thirty days or a duration of treatment supported  by  current  evidence-
    17  based  treatment  guidelines  appropriate  to the specific disease state
    18  being treated;
    19    (d) be imposed on an enrollee  if  a  therapeutic  equivalent  to  the
    20  prescribed  drug  is  not  available;  or  if  the  health care plan has
    21  documentation that it has covered the drug for the enrollee  within  the
    22  past three hundred sixty-five days;
    23    (e)  require a newly enrolled enrollee to repeat a step therapy proto-
    24  col for a prescribed drug where that enrollee already completed  a  step
    25  therapy  protocol  for that drug under a prior health care plan, so long
    26  as the enrollee or provider [submit] submits  information  demonstrating
    27  completion  of  a  step  therapy  protocol of the prior health care plan
    28  within the past three hundred sixty-five days; and
    29    (f) be imposed on an enrollee for a prescribed drug that was previous-
    30  ly approved for coverage by [a] the enrollee's current health care  plan
    31  for  [a]  the enrollee's specific medical condition after the enrollee's
    32  current health care plan implements a formulary or  utilization  manage-
    33  ment  change  that impacts the coverage criteria for the prescribed drug
    34  until the approved override expires, unless  a  specifically  identified
    35  and  evidence-based  safety  concern  exists and a different therapeutic
    36  alternative drug exists.
    37    6. When establishing a step therapy  protocol,  a  utilization  review
    38  agent  shall  ensure that the protocol accepts any written or electronic
    39  attestation submitted by the enrollee's  health  care  professional,  as
    40  defined  in section forty-nine hundred of this title, who prescribed the
    41  drug and stating that a required  drug  has  failed,  as  [prima  facie]
    42  evidence that the required drug has failed.
    43    §  4.  Subdivision  3-c  of  section  4903 of the public health law as
    44  amended by a chapter of the laws of 2024 amending the insurance law  and
    45  the  public health law, relating to requiring a utilization review agent
    46  to follow certain rules when establishing a step  therapy  protocol,  as
    47  proposed in legislative bills numbers S. 1267-A and A. 901-A, is amended
    48  to read as follows:
    49    3-c.  Upon  a  determination  that the step therapy protocol should be
    50  overridden, the health care plan shall authorize immediate coverage  for
    51  the  prescription  drug  or  drugs prescribed by the enrollee's treating
    52  health care professional. Any approval of a step therapy protocol  over-
    53  ride  determination  request shall be honored until the lesser of either
    54  treatment duration based on current evidence-based treatment  guidelines
    55  or  twelve  months  following the date of the approval of the request or
    56  renewal of the enrollee's coverage.
        A. 443                              4

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