Bill Text: NY A00901 | 2023-2024 | General Assembly | Amended
Bill Title: Requires a utilization review agent to follow certain rules when establishing a step therapy protocol; requires that the protocol accepts any attestation submitted by the insured's health care professional stating that a required drug has failed as prima facie evidence that the required drug has failed.
Spectrum: Moderate Partisan Bill (Democrat 26-6)
Status: (Introduced) 2024-06-03 - substituted by s1267a [A00901 Detail]
Download: New_York-2023-A00901-Amended.html
STATE OF NEW YORK ________________________________________________________________________ 901--A 2023-2024 Regular Sessions IN ASSEMBLY January 11, 2023 ___________ Introduced by M. of A. McDONALD, STECK, STIRPE, SANTABARBARA, THIELE, HEVESI, BURDICK, BEEPHAN, NORRIS, K. BROWN, COLTON, BENDETT, GUNTHER, PAULIN, SEAWRIGHT, LEVENBERG, LAVINE, LUNSFORD, ARDILA, COOK, REYES, MEEKS, SAYEGH, JACOBSON, SIMPSON, DAVILA, LUPARDO, SIMON, GALLAHAN, RAGA -- Multi-Sponsored by -- M. of A. EPSTEIN -- read once and referred to the Committee on Insurance -- recommitted to the Committee on Insurance in accordance with Assembly Rule 3, sec. 2 -- committee discharged, bill amended, ordered reprinted as amended and recommitted to said committee AN ACT to amend the insurance law and the public health law, in relation to requiring a utilization review agent to follow certain rules when establishing a step therapy protocol The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. Subsection (a) of section 4902 of the insurance law is 2 amended by adding two new paragraphs 15 and 16 to read as follows: 3 (15) When establishing a step therapy protocol, a utilization review 4 agent shall ensure that the protocol cannot: 5 (i) require a prescription drug that has not been approved by the 6 United States Food and Drug Administration for the medical condition 7 being treated and/or is not supported by current evidence-based guide- 8 lines for the medical condition being treated; 9 (ii) require an insured to try and fail on more than two drugs within 10 one therapeutic category before providing coverage to the insured for 11 the prescribed drug; 12 (iii) require the use of a step therapy-required drug for longer than 13 thirty days or a duration of treatment supported by current evidence- 14 based treatment guidelines appropriate to the specific disease state 15 being treated; 16 (iv) be imposed on an insured if a therapeutic equivalent to the 17 prescribed drug is not available, or if the health plan has documenta- EXPLANATION--Matter in italics (underscored) is new; matter in brackets [] is old law to be omitted. LBD02501-04-4A. 901--A 2 1 tion that it has covered the drug for the enrollee within the past three 2 hundred sixty-five days; 3 (v) require a newly enrolled insured to repeat step therapy for a 4 prescribed drug where that insured already completed step therapy for 5 that drug under a prior plan, so long as the enrollee or provider 6 submits information demonstrating completion of a step therapy protocol 7 of the prior plan within the past three hundred sixty-five days; and 8 (vi) be imposed on an insured for a prescribed drug that was previous- 9 ly approved for coverage by a plan for a specific medical condition 10 after the insured's plan implements a formulary change or utilization 11 management that impacts the coverage criteria for the prescribed drug 12 until the approved override expires, unless a specifically identified 13 and current evidence-based safety concern exists and a different thera- 14 peutic alternative drug exists. 15 (16) When establishing a step therapy protocol, a utilization review 16 agent shall ensure that the protocol accepts any written or electronic 17 attestation submitted by the insured's health care professional as 18 defined in section four thousand nine hundred of this title stating that 19 a required drug has failed as prima facie evidence that the required 20 drug has failed. 21 § 2. Subsections (c-3) and (g) of section 4903 of the insurance law, 22 subsection (c-3) as added and subsection (g) as amended by chapter 512 23 of the laws of 2016, are amended to read as follows: 24 (c-3) Upon a determination that the step therapy protocol should be 25 overridden, the health plan shall authorize immediate coverage for the 26 prescription drug prescribed by the insured's treating health care 27 professional. Any approval of a step therapy protocol override determi- 28 nation request shall be honored until the lesser of either treatment 29 duration based on current evidence-based treatment guidelines or twelve 30 months following the date of the approval of the request or renewal of 31 the insured's coverage. 32 (g) Failure by the utilization review agent to make a determination 33 within the time periods prescribed in this section shall be deemed to be 34 an adverse determination subject to appeal pursuant to section four 35 thousand nine hundred four of this title, provided, however, that fail- 36 ure to meet such time periods for a step therapy protocol as defined in 37 subsection (g-9) of section forty-nine hundred of this title or a step 38 therapy protocol override determination pursuant to subsections (c-1), 39 (c-2) and (c-3) of this section shall be deemed to be an override of the 40 step therapy protocol. A utilization review agent's failure to comply 41 with any of the step therapy protocol requirements required in 42 subsections fifteen and sixteen of section four thousand nine hundred 43 two of this title shall be considered a basis for granting an override 44 of the step therapy protocol, absent fraud. 45 § 3. Section 4902 of the public health law is amended by adding two 46 new subdivisions 5 and 6 to read as follows: 47 5. When establishing a step therapy protocol, a utilization review 48 agent shall ensure that the protocol cannot: 49 (a) require a prescription drug that has not been approved by the 50 United States Food and Drug Administration and/or is not supported by 51 current evidence-based guidelines for the medical condition being treat- 52 ed; 53 (b) require an enrollee to try and fail on more than two drugs within 54 one therapeutic category before providing coverage to the insured for 55 the prescribed drug;A. 901--A 3 1 (c) require the use of a step therapy-required drug for longer than 2 thirty days or a duration of treatment supported by current evidence- 3 based treatment guidelines appropriate to the specific disease state 4 being treated; 5 (d) be imposed on an enrollee if a therapeutic equivalent to the 6 prescribed drug is not available; or if the health plan has documenta- 7 tion that it has covered the drug for the enrollee within the past three 8 hundred sixty-five days; 9 (e) require a newly enrolled enrollee to repeat step therapy for a 10 prescribed drug where that enrollee already completed step therapy for 11 that drug under a prior plan, so long as the enrollee or provider submit 12 information demonstrating completion of a step therapy protocol of the 13 prior plan within the past three hundred sixty-five days; and 14 (f) be imposed on an enrollee for a prescribed drug that was previous- 15 ly approved for coverage by a plan for a specific medical condition 16 after the enrollee's plan implements a formulary or utilization manage- 17 ment change that impacts the coverage criteria for the prescribed drug 18 until the approved override expires, unless a specifically identified 19 and evidence-based safety concern exists and a different therapeutic 20 alternative drug exists. 21 6. 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 enrollee's health care professional as 24 defined in section forty-nine hundred of this title stating that a 25 required drug has failed as prima facie evidence that the required drug 26 has failed. 27 § 4. Subdivisions 3-c and 7 of section 4903 of the public health law, 28 subdivision 3-c as added and subdivision 7 as amended by chapter 512 of 29 the laws of 2016, are amended to read as follows: 30 3-c. Upon a determination that the step therapy protocol should be 31 overridden, the health plan shall authorize immediate coverage for the 32 prescription drug or drugs prescribed by the enrollee's treating health 33 care professional. Any approval of a step therapy protocol override 34 determination request shall be honored until the lesser of either treat- 35 ment duration based on current evidence-based treatment guidelines or 36 twelve months following the date of the approval of the request or 37 renewal of the enrollee's coverage. 38 7. Failure by the utilization review agent to make a determination 39 within the time periods prescribed in this section shall be deemed to be 40 an adverse determination subject to appeal pursuant to section forty- 41 nine hundred four of this title, provided, however, that failure to meet 42 such time periods for a step therapy protocol as defined in subdivision 43 seven-f-three of section forty-nine hundred of this title or a step 44 therapy protocol override determination pursuant to subdivisions 45 three-a, three-b and three-c of this section shall be deemed to be an 46 override of the step therapy protocol. A utilization review agent's 47 failure to comply with any of the step therapy protocol requirements 48 required in subdivisions five and six of section forty-nine hundred two 49 of this title shall be considered a basis for granting an override of 50 the step therapy protocol, absent fraud. 51 § 5. This act shall take effect on the one hundred twentieth day after 52 it shall have become a law.
