S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                    443
 
                        2025-2026 Regular Sessions
 
                           I N  A S S E M B L Y
 
                                (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:
 
   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-

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

 A. 443                              2
 
 based treatment guidelines appropriate to  the  specific  disease  state
 being treated;
   (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
 A. 443                              3
 
 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:
   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.
 A. 443                              4
 
   § 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
 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.