The New York State Senate

 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   8191
 
                             I N  S E N A T E
 
                             February 1, 2022
                                ___________
 
 Introduced  by  Sen. BRESLIN -- read twice and ordered printed, and when
   printed to be committed to the Committee on Insurance
 
 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 14 and 15 to read as follows:
   (14)  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;
   (II) REQUIRE AN INSURED TO TRY AND FAIL ON MORE THAN ONE  DRUG  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;
   (IV) BE IMPOSED ON AN INSURED IF THE INSURED HAS TAKEN THE  PRESCRIBED
 DRUG COVERED BY THE PLAN 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; 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 THAT IMPACTS  THE
 FORMULARY STATUS OF THE PRESCRIBED DRUG.
   (15)  WHEN  ESTABLISHING A STEP THERAPY PROTOCOL, A UTILIZATION REVIEW
 AGENT SHALL ENSURE THAT THE PROTOCOL ACCEPTS ANY  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.
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD14433-01-2
 S. 8191                             2

 
   §  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 LATER OF TWELVE MONTHS FOLLOW-
 ING THE DATE OF THE APPROVAL OR RENEWAL OF THE PLAN.
   (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  FOURTEEN  AND FIFTEEN OF SECTION FOUR THOUSAND NINE HUNDRED
 TWO OF THIS TITLE SHALL BE CONSIDERED A BASIS FOR GRANTING  AN  OVERRIDE
 OF THE STEP THERAPY PROTOCOL.
   §  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  FOR  THE  MEDICAL  CONDITION
 BEING TREATED;
   (B)  REQUIRE  AN ENROLLEE TO TRY AND FAIL ON MORE THAN ONE DRUG BEFORE
 PROVIDING COVERAGE TO THE INSURED FOR THE PRESCRIBED DRUG;
   (C) REQUIRE THE USE OF A STEP THERAPY-REQUIRED DRUG  FOR  LONGER  THAN
 THIRTY DAYS;
   (D) BE IMPOSED ON AN ENROLLEE IF THE ENROLLEE HAS TAKEN THE PRESCRIBED
 DRUG COVERED BY THE PLAN WITHIN THE PAST THREE HUNDRED SIXTY-FIVE DAYS;
   (F)  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; AND
   (G) 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 CHANGE THAT IMPACTS THE
 FORMULARY STATUS OF THE PRESCRIBED DRUG.
   6. WHEN ESTABLISHING A STEP THERAPY  PROTOCOL,  A  UTILIZATION  REVIEW
 AGENT  SHALL  ENSURE THAT THE PROTOCOL ACCEPTS ANY 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 LATER OF TWELVE  MONTHS
 FOLLOWING THE DATE OF THE APPROVAL OR RENEWAL OF THE PLAN.
 S. 8191                             3
 
   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.
   § 5. This act shall take effect immediately.