S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  901--A
 
                        2023-2024 Regular Sessions
 
                           I N  A S S E M B L Y
 
                             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:
 
   Section  1.  Subsection  (a)  of  section 4902 of the insurance law is
 amended by adding two new paragraphs 15 and 16 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 IS NOT SUPPORTED BY CURRENT EVIDENCE-BASED GUIDE-
 LINES FOR THE MEDICAL CONDITION BEING TREATED;
   (II) REQUIRE AN INSURED TO TRY AND FAIL ON MORE THAN TWO DRUGS  WITHIN
 ONE  THERAPEUTIC  CATEGORY  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;
   (IV)  BE  IMPOSED  ON  AN  INSURED  IF A THERAPEUTIC EQUIVALENT TO THE
 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.
                                                            LBD02501-04-4
              

 A. 901--A                           2
 
 TION THAT IT HAS COVERED THE DRUG FOR THE ENROLLEE WITHIN THE PAST THREE
 HUNDRED SIXTY-FIVE DAYS;
   (V)  REQUIRE  A  NEWLY  ENROLLED  INSURED TO REPEAT STEP THERAPY FOR A
 PRESCRIBED DRUG WHERE THAT INSURED ALREADY COMPLETED  STEP  THERAPY  FOR
 THAT  DRUG  UNDER  A  PRIOR  PLAN,  SO  LONG AS THE ENROLLEE OR PROVIDER
 SUBMITS INFORMATION DEMONSTRATING COMPLETION OF A STEP THERAPY  PROTOCOL
 OF THE PRIOR 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 PLAN FOR A SPECIFIC MEDICAL CONDITION
 AFTER THE INSURED'S 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 THERA-
 PEUTIC ALTERNATIVE 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 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,
 subsection  (c-3)  as added and subsection (g) as amended by chapter 512
 of the laws of 2016, are amended to read as follows:
   (c-3) Upon a determination that the step therapy  protocol  should  be
 overridden,  the  health 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  FIFTEEN  AND  SIXTEEN 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.  Section  4902 of the public health law is amended by adding two
 new subdivisions 5 and 6 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 IS  NOT  SUPPORTED  BY
 CURRENT EVIDENCE-BASED GUIDELINES FOR THE MEDICAL CONDITION BEING TREAT-
 ED;
   (B)  REQUIRE AN ENROLLEE TO TRY AND FAIL ON MORE THAN TWO DRUGS WITHIN
 ONE THERAPEUTIC CATEGORY BEFORE PROVIDING COVERAGE TO  THE  INSURED  FOR
 THE PRESCRIBED DRUG;
 A. 901--A                           3
 
   (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 PLAN  HAS  DOCUMENTA-
 TION 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 STEP THERAPY FOR A
 PRESCRIBED DRUG WHERE THAT ENROLLEE ALREADY COMPLETED STEP  THERAPY  FOR
 THAT DRUG UNDER A PRIOR PLAN, SO LONG AS THE ENROLLEE OR PROVIDER SUBMIT
 INFORMATION  DEMONSTRATING  COMPLETION OF A STEP THERAPY PROTOCOL OF THE
 PRIOR 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 PLAN  FOR  A  SPECIFIC  MEDICAL  CONDITION
 AFTER  THE ENROLLEE'S 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  STATING  THAT  A
 REQUIRED  DRUG HAS FAILED AS PRIMA FACIE EVIDENCE THAT THE REQUIRED DRUG
 HAS FAILED.
   § 4. Subdivisions 3-c and 7 of section 4903 of the public health  law,
 subdivision  3-c as added and subdivision 7 as amended by chapter 512 of
 the laws of 2016, are amended to read as follows:
   3-c. Upon a determination that the step  therapy  protocol  should  be
 overridden,  the  health 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 OVERRIDE
 DETERMINATION REQUEST SHALL BE HONORED UNTIL THE LESSER OF EITHER TREAT-
 MENT 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.
   7. 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 forty-
 nine hundred four of this title, provided, however, that failure to meet
 such time periods for a step therapy protocol as defined in  subdivision
 seven-f-three  of  section  forty-nine  hundred  of this title or a step
 therapy  protocol  override  determination  pursuant   to   subdivisions
 three-a,  three-b  and  three-c 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 SUBDIVISIONS FIVE AND SIX OF SECTION FORTY-NINE HUNDRED  TWO
 OF  THIS  TITLE  SHALL BE CONSIDERED A BASIS FOR GRANTING AN OVERRIDE OF
 THE STEP THERAPY PROTOCOL, ABSENT FRAUD.
   § 5. This act shall take effect on the one hundred twentieth day after
 it shall have become a law.