Shown verbatim: the complete text as captured from the official source posted by the New York State Senate, fetched 2026-08-11. Nothing is edited or removed. Where this bill amends existing law, language marked for deletion in the official source appears here in brackets. The official bill page.
S T A T E O F N E W Y O R K
________________________________________________________________________
443
2025-2026 Regular Sessions
I N A S S E M B L Y
(PREFILED)
January 8, 2025
___________
Introduced by M. of A. McDONALD -- read once and referred to the Commit-
tee on Insurance
AN ACT to amend the insurance law and the public health law, in relation
to step therapy protocol; and to amend a chapter of the laws of 2024
amending the insurance law and the public health law, relating to
requiring a utilization review agent to follow certain rules when
establishing a step therapy protocol, as proposed in legislative bills
numbers S. 1267-A and A. 901-A, in relation to the effectiveness ther-
eof
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. Paragraphs 15 and 16 of subsection (a) of section 4902 of
the insurance law, as added by a chapter of the laws of 2024 amending
the insurance law and the public health law, relating to requiring a
utilization review agent to follow certain rules when establishing a
step therapy protocol, as proposed in legislative bills numbers S.
1267-A and A. 901-A, are amended 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] OR is not supported by current evidence-based
guidelines for the medical condition being treated;
(ii) require an insured to try and fail on more than two drugs [within
one therapeutic category] USED TO TREAT THE SAME MEDICAL CONDITION OR
DISEASE 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-
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD02801-01-5
A. 443 2
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 CARE plan has
documentation that it has covered the drug for the [enrollee] INSURED
within the past three hundred sixty-five days;
(v) require a newly enrolled insured to repeat A step therapy PROTOCOL
for a prescribed drug where that insured already completed A step thera-
py PROTOCOL for that drug under a prior HEALTH CARE plan, so long as the
enrollee or provider submits information demonstrating completion of a
step therapy protocol of the prior HEALTH CARE 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] THE INSURED'S CURRENT HEALTH CARE plan
for a specific medical condition after the insured's CURRENT HEALTH CARE
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 therapeutic alter-
native 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, WHO
PRESCRIBED THE DRUG AND 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,
as amended by a chapter of the laws of 2024 amending the insurance law
and the public health law, relating to requiring a utilization review
agent to follow certain rules when establishing a step therapy protocol,
as proposed in legislative bills numbers S. 1267-A and A. 901-A, are
amended to read as follows:
(c-3) Upon a determination that the step therapy protocol should be
overridden, the health CARE 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] PARAGRAPHS fifteen and sixteen of SUBSECTION (A) 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. Subdivisions 5 and 6 of section 4902 of the public health law, as
added by a chapter of the laws of 2024 amending the insurance law and
A. 443 3
the public health law, relating to requiring a utilization review agent
to follow certain rules when establishing a step therapy protocol, as
proposed in legislative bills numbers S. 1267-A and A. 901-A, are
amended 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] FOR THE MEDICAL
CONDITION BEING TREATED OR is not supported by current evidence-based
guidelines for the medical condition being treated;
(b) require an enrollee to try and fail on more than two drugs [within
one therapeutic category] USED TO TREAT THE SAME MEDICAL CONDITION OR
DISEASE before providing coverage to the [insured] ENROLLEE for the
prescribed drug;
(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 CARE plan has
documentation 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 A step therapy PROTO-
COL for a prescribed drug where that enrollee already completed A step
therapy PROTOCOL for that drug under a prior HEALTH CARE plan, so long
as the enrollee or provider [submit] SUBMITS information demonstrating
completion of a step therapy protocol of the prior HEALTH CARE 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] THE ENROLLEE'S CURRENT HEALTH CARE plan
for [a] THE ENROLLEE'S specific medical condition after the enrollee's
CURRENT HEALTH CARE 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, WHO PRESCRIBED THE
DRUG AND stating that a required drug has failed, as [prima facie]
evidence that the required drug has failed.
§ 4. Subdivision 3-c of section 4903 of the public health law as
amended by a chapter of the laws of 2024 amending the insurance law and
the public health law, relating to requiring a utilization review agent
to follow certain rules when establishing a step therapy protocol, as
proposed in legislative bills numbers S. 1267-A and A. 901-A, is amended
to read as follows:
3-c. Upon a determination that the step therapy protocol should be
overridden, the health CARE 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 over-
ride determination 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 enrollee's coverage.
A. 443 4
§ 5. Section 5 of a chapter of the laws of 2024 amending the insurance
law and the public health law, relating to requiring a utilization
review agent to follow certain rules when establishing a step therapy
protocol, as proposed in legislative bills numbers S. 1267-A and A.
901-A, is amended to read as follows:
§ 5. This act shall take effect [on the one hundred twentieth day
after it shall have become a law] JANUARY 1, 2026 AND SHALL APPLY TO ALL
POLICIES ISSUED, RENEWED, MODIFIED, ALTERED OR AMENDED ON OR AFTER SUCH
DATE.
§ 6. This act shall take effect immediately; provided, however that
the provisions of sections one, two, three and four of this act shall
take effect on the same date and in the same manner as a chapter of the
laws of 2024 amending the insurance law and the public health law,
relating to requiring a utilization review agent to follow certain rules
when establishing a step therapy protocol, as proposed in legislative
bills numbers S. 1267-A and A. 901-A, takes effect.Every fact on this page links to its source, starting with the official bill record.