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.