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.