S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   2676
 
                        2025-2026 Regular Sessions
 
                             I N  S E N A T E
 
                             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:
 
   Section 1. Paragraphs 15 and 16 of subsection (a) of section  4902  of
 the  insurance  law,  as added by 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, are amended to read as follows:
   (15)  When  establishing a step therapy protocol, a utilization review
 agent shall ensure that the protocol cannot:
   (i) require a prescription drug that has  not  been  approved  by  the
 United  States  Food  and  Drug Administration for the medical condition
 being treated [and/or] OR is not  supported  by  current  evidence-based
 guidelines for the medical condition being treated;
   (ii) require an insured to try and fail on more than two drugs [within
 one  therapeutic  category]  USED TO TREAT THE SAME MEDICAL CONDITION OR
 DISEASE before providing coverage to  the  insured  for  the  prescribed
 drug;
   (iii)  require the use of a step therapy-required drug for longer than
 thirty days or a duration of treatment supported  by  current  evidence-
 based  treatment  guidelines  appropriate  to the specific disease state
 being treated;

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

 S. 2676                             2
 
   (iv) be imposed on an insured  if  a  therapeutic  equivalent  to  the
 prescribed  drug  is  not  available,  or  if  the  health CARE plan has
 documentation that it has covered the drug for  the  [enrollee]  INSURED
 within the past three hundred sixty-five days;
   (v) require a newly enrolled insured to repeat A step therapy PROTOCOL
 for a prescribed drug where that insured already completed A step thera-
 py PROTOCOL for that drug under a prior HEALTH CARE plan, so long as the
 enrollee  or  provider submits information demonstrating completion of a
 step therapy protocol of the prior HEALTH  CARE  plan  within  the  past
 three hundred sixty-five days; and
   (vi) be imposed on an insured for a prescribed drug that was previous-
 ly  approved  for coverage by [a] THE INSURED'S CURRENT HEALTH CARE plan
 for a specific medical condition after the insured's CURRENT HEALTH CARE
 plan implements  a  formulary  change  or  utilization  management  that
 impacts the coverage criteria for the prescribed drug until the approved
 override   expires,   unless   a  specifically  identified  and  current
 evidence-based safety concern exists and a different therapeutic  alter-
 native drug exists.
   (16)  When  establishing a step therapy protocol, a utilization review
 agent shall ensure that the protocol accepts any written  or  electronic
 attestation  submitted  by  the  insured's  health care professional, as
 defined in section  four  thousand  nine  hundred  of  this  title,  WHO
 PRESCRIBED  THE  DRUG  AND  stating  that a required drug has failed, as
 [prima facie] evidence that the required drug has failed.
   § 2. Subsections (c-3) and (g) of section 4903 of the  insurance  law,
 as  amended  by 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, are
 amended to read as follows:
   (c-3) Upon a determination that the step therapy  protocol  should  be
 overridden,  the health CARE plan shall authorize immediate coverage for
 the prescription drug prescribed by the insured's treating  health  care
 professional.  Any approval of a step therapy protocol override determi-
 nation request shall be honored until the  lesser  of  either  treatment
 duration  based on current evidence-based treatment guidelines or twelve
 months following the date of the approval of the request or  renewal  of
 the insured's coverage.
   (g)  Failure  by  the utilization review agent to make a determination
 within the time periods prescribed in this section shall be deemed to be
 an adverse determination subject to  appeal  pursuant  to  section  four
 thousand  nine hundred four of this title, provided, however, that fail-
 ure to meet such time periods for a step therapy protocol as defined  in
 subsection  (g-9)  of section forty-nine hundred of this title or a step
 therapy protocol override determination pursuant to  subsections  (c-1),
 (c-2) and (c-3) of this section shall be deemed to be an override of the
 step  therapy  protocol.  A utilization review agent's failure to comply
 with  any  of  the  step  therapy  protocol  requirements  required   in
 [subsections]  PARAGRAPHS  fifteen  and  sixteen  of  SUBSECTION  (A) OF
 section four thousand nine hundred two of this title shall be considered
 a basis for granting an override of the step  therapy  protocol,  absent
 fraud.
   § 3. Subdivisions 5 and 6 of section 4902 of the public health law, as
 added  by  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
 S. 2676                             3
 
 proposed in legislative bills  numbers  S.  1267-A  and  A.  901-A,  are
 amended to read as follows:
   5.  When  establishing  a  step therapy protocol, a utilization review
 agent shall ensure that the protocol cannot:
   (a) require a prescription drug that has  not  been  approved  by  the
 United  States  Food  and  Drug  Administration [and/or] FOR THE MEDICAL
 CONDITION BEING TREATED OR is not supported  by  current  evidence-based
 guidelines for the medical condition being treated;
   (b) require an enrollee to try and fail on more than two drugs [within
 one  therapeutic  category]  USED TO TREAT THE SAME MEDICAL CONDITION OR
 DISEASE before providing coverage to  the  [insured]  ENROLLEE  for  the
 prescribed drug;
   (c)  require  the  use of a step therapy-required drug for longer than
 thirty days or a duration of treatment supported  by  current  evidence-
 based  treatment  guidelines  appropriate  to the specific disease state
 being treated;
   (d) be imposed on an enrollee  if  a  therapeutic  equivalent  to  the
 prescribed  drug  is  not  available;  or  if  the  health CARE plan has
 documentation that it has covered the drug for the enrollee  within  the
 past three hundred sixty-five days;
   (e)  require a newly enrolled enrollee to repeat A step therapy PROTO-
 COL for a prescribed drug where that enrollee already completed  A  step
 therapy  PROTOCOL  for that drug under a prior HEALTH CARE plan, so long
 as the enrollee or provider [submit] SUBMITS  information  demonstrating
 completion  of  a  step  therapy  protocol of the prior HEALTH CARE plan
 within the past three hundred sixty-five days; and
   (f) be imposed on an enrollee for a prescribed drug that was previous-
 ly approved for coverage by [a] THE ENROLLEE'S CURRENT HEALTH CARE  plan
 for  [a]  THE ENROLLEE'S specific medical condition after the enrollee's
 CURRENT HEALTH CARE plan implements a formulary or  utilization  manage-
 ment  change  that impacts the coverage criteria for the prescribed drug
 until the approved override expires, unless  a  specifically  identified
 and  evidence-based  safety  concern  exists and a different therapeutic
 alternative drug exists.
   6. When establishing a step therapy  protocol,  a  utilization  review
 agent  shall  ensure that the protocol accepts any written or electronic
 attestation submitted by the enrollee's  health  care  professional,  as
 defined  in section forty-nine hundred of this title, WHO PRESCRIBED THE
 DRUG AND stating that a required  drug  has  failed,  as  [prima  facie]
 evidence that the required drug has failed.
   §  4.  Subdivision  3-c  of  section  4903 of the public health law as
 amended by 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, is amended
 to read as follows:
   3-c.  Upon  a  determination  that the step therapy protocol should be
 overridden, the health CARE plan shall authorize immediate coverage  for
 the  prescription  drug  or  drugs prescribed by the enrollee's treating
 health care professional. Any approval of a step therapy protocol  over-
 ride  determination  request shall be honored until the lesser of either
 treatment duration based on current evidence-based treatment  guidelines
 or  twelve  months  following the date of the approval of the request or
 renewal of the enrollee's coverage.
   § 5. Section 5 of a chapter of the laws of 2024 amending the insurance
 law and the public health  law,  relating  to  requiring  a  utilization
 S. 2676                             4

 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, is amended to read as follows:
   §  5.  This  act  shall  take effect [on the one hundred twentieth day
 after it shall have become a law] JANUARY 1, 2026 AND SHALL APPLY TO ALL
 POLICIES ISSUED, RENEWED, MODIFIED, ALTERED OR AMENDED ON OR AFTER  SUCH
 DATE.
   §  6.  This  act shall take effect immediately; provided, however that
 the provisions of sections one, two, three and four of  this  act  shall
 take  effect on the same date and in the same manner as 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, takes effect.