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.

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