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.

Relates to step therapy protocol

What's Happening

Why It Matters