S T A T E O F N E W Y O R K
________________________________________________________________________
3419--C
2015-2016 Regular Sessions
I N S E N A T E
February 9, 2015
___________
Introduced by Sens. YOUNG, AKSHAR, AVELLA, BRESLIN, CARLUCCI, GOLDEN,
KAMINSKY, LANZA, LARKIN, LATIMER, LAVALLE, MARCHIONE, PARKER, PERKINS,
RIVERA, SAVINO, SQUADRON, VALESKY -- read twice and ordered printed,
and when printed to be committed to the Committee on Insurance --
committee discharged, bill amended, ordered reprinted as amended and
recommitted to said committee -- recommitted to the Committee on
Insurance in accordance with Senate Rule 6, sec. 8 -- committee
discharged, bill amended, ordered reprinted as amended and recommitted
to said committee -- 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 expedited utilization review of prescription drugs
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. Paragraph 10 of subsection (b) of section 3217-a of the
insurance law, as added by chapter 705 of the laws of 1996, is amended
to read as follows:
(10) upon written request, provide specific written clinical review
criteria relating to a particular condition or disease INCLUDING CLIN-
ICAL REVIEW CRITERIA RELATING TO A STEP THERAPY PROTOCOL OVERRIDE DETER-
MINATION PURSUANT TO SUBSECTION (C-1), SUBSECTION (C-2) AND SUBSECTION
(C-3) OF SECTION FORTY-NINE HUNDRED THREE OF THIS CHAPTER, and, where
appropriate, other clinical information which the insurer might consider
in its utilization review and the insurer may include with the informa-
tion a description of how it will be used in the utilization review
process; provided, however, that to the extent such information is
proprietary to the insurer, the insured or prospective insured shall
only use the information for the purposes of assisting the enrollee or
prospective enrollee in evaluating the covered services provided by the
organization. SUCH CLINICAL REVIEW CRITERIA, AND OTHER CLINICAL INFORMA-
TION SHALL ALSO BE MADE AVAILABLE TO A HEALTH CARE PROFESSIONAL AS
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD03838-09-6
S. 3419--C 2
DEFINED IN SUBSECTION (F) OF SECTION FORTY-NINE HUNDRED OF THIS CHAPTER,
ON BEHALF OF AN INSURED AND UPON WRITTEN REQUEST;
S 2. Paragraph 10 of subsection (b) of section 4324 of the insurance
law, as added by chapter 705 of the laws of 1996, is amended to read as
follows:
(10) upon written request, provide specific written clinical review
criteria relating to a particular condition or disease INCLUDING CLIN-
ICAL REVIEW CRITERIA RELATING TO A STEP THERAPY PROTOCOL OVERRIDE DETER-
MINATION PURSUANT TO SUBSECTION (C-1), SUBSECTION (C-2) AND SUBSECTION
(C-3) OF SECTION FORTY-NINE HUNDRED THREE OF THIS CHAPTER, and, where
appropriate, other clinical information which the corporation might
consider in its utilization review and the corporation may include with
the information a description of how it will be used in the utilization
review process; provided, however, that to the extent such information
is proprietary to the corporation, the subscriber or prospective
subscriber shall only use the information for the purposes of assisting
the subscriber or prospective subscriber in evaluating the covered
services provided by the organization. SUCH CLINICAL REVIEW CRITERIA,
AND OTHER CLINICAL INFORMATION SHALL ALSO BE MADE AVAILABLE TO A HEALTH
CARE PROFESSIONAL AS DEFINED IN SUBSECTION (F) OF SECTION FORTY-NINE
HUNDRED OF THIS CHAPTER, ON BEHALF OF AN INSURED AND UPON WRITTEN
REQUEST;
S 3. Section 4900 of the insurance law is amended by adding two new
subsections (g-8) and (g-9) to read as follows:
(G-8) "STEP THERAPY PROTOCOL OVERRIDE DETERMINATION" MEANS A DETERMI-
NATION MADE BY A UTILIZATION REVIEW AGENT AS DEFINED IN SUBSECTION (I)
OF THIS SECTION TO OVERRIDE A STEP THERAPY PROTOCOL PURSUANT TO
SUBSECTIONS (C-1), (C-2) AND (C-3) OF SECTION FORTY-NINE HUNDRED THREE
OF THIS TITLE GRANTING COVERAGE FOR THE HEALTH CARE PROFESSIONAL'S
SELECTED PRESCRIPTION DRUG OR DRUGS. ANY STEP THERAPY OVERRIDE DETERMI-
NATION AS DEFINED BY THIS SUBSECTION SHALL BE ELIGIBLE FOR APPEAL BY AN
INSURED PURSUANT TO THIS ARTICLE.
(G-9) "STEP THERAPY PROTOCOL" MEANS A POLICY, PROTOCOL OR PROGRAM
ESTABLISHED BY A UTILIZATION REVIEW AGENT AS DEFINED IN SUBSECTION (I)
OF THIS SECTION THAT ESTABLISHES THE SPECIFIC SEQUENCE IN WHICH
PRESCRIPTION DRUGS FOR A SPECIFIED MEDICAL CONDITION ARE APPROVED FOR A
PARTICULAR INSURED. NOTHING IN THIS CHAPTER SHALL IMPAIR OR PREVENT AN
INSURED FROM HAVING THE RIGHT TO APPEAL PURSUANT TO THIS ARTICLE RELAT-
ING TO THE IMPOSITION OF A STEP THERAPY PROTOCOL.
S 4. Subsection (a) of section 4902 of the insurance law is amended by
adding two new paragraphs 10 and 11 to read as follows:
10. WHEN ESTABLISHING A STEP THERAPY PROTOCOL, A UTILIZATION REVIEW
AGENT SHALL UTILIZE RECOGNIZED EVIDENCE-BASED AND PEER REVIEWED CLINICAL
REVIEW CRITERIA THAT ALSO TAKES INTO ACCOUNT THE NEEDS OF ATYPICAL
PATIENT POPULATIONS AND DIAGNOSES WHEN ESTABLISHING THE CLINICAL REVIEW
CRITERIA.
11. WHEN CONDUCTING UTILIZATION REVIEW FOR A STEP THERAPY PROTOCOL
OVERRIDE DETERMINATION, A UTILIZATION REVIEW AGENT SHALL UTILIZE, IN
ADDITION TO ANY OTHER REQUIREMENTS OF THIS ARTICLE, RECOGNIZED
EVIDENCE-BASED AND PEER REVIEWED CLINICAL REVIEW CRITERIA THAT IS APPRO-
PRIATE FOR THE INSURED AND THE INSURED'S MEDICAL CONDITION.
S 5. Section 4903 of the insurance law is amended by adding three new
subsections (c-1), (c-2) and (c-3) to read as follows:
(C-1) A UTILIZATION REVIEW AGENT SHALL GRANT A STEP THERAPY PROTOCOL
OVERRIDE DETERMINATION WITHIN SEVENTY-TWO HOURS OF THE RECEIPT OF INFOR-
S. 3419--C 3
MATION THAT INCLUDES SUPPORTING RATIONALE AND DOCUMENTATION FROM A
HEALTH CARE PROFESSIONAL WHICH DEMONSTRATES THAT:
(1) THE REQUIRED PRESCRIPTION DRUG OR DRUGS IS CONTRAINDICATED OR WILL
LIKELY CAUSE AN ADVERSE REACTION BY OR PHYSICAL OR MENTAL HARM TO THE
INSURED;
(2) THE REQUIRED PRESCRIPTION DRUG OR DRUGS IS EXPECTED TO BE INEFFEC-
TIVE BASED ON THE KNOWN CLINICAL HISTORY AND CONDITIONS OF THE INSURED
AND THE INSURED'S PRESCRIPTION DRUG REGIMEN;
(3) THE INSURED HAS TRIED THE REQUIRED PRESCRIPTION DRUG OR DRUGS
WHILE UNDER THEIR CURRENT OR A PREVIOUS HEALTH INSURANCE OR HEALTH BENE-
FIT PLAN, OR ANOTHER PRESCRIPTION DRUG OR DRUGS IN THE SAME PHARMACOLOG-
IC CLASS OR WITH THE SAME MECHANISM OF ACTION AND SUCH PRESCRIPTION DRUG
OR DRUGS WAS DISCONTINUED DUE TO LACK OF EFFICACY OR EFFECTIVENESS,
DIMINISHED EFFECT, OR AN ADVERSE EVENT;
(4) THE INSURED IS STABLE ON A PRESCRIPTION DRUG OR DRUGS SELECTED BY
THEIR HEALTH CARE PROFESSIONAL FOR THE MEDICAL CONDITION UNDER CONSIDER-
ATION, PROVIDED THAT THIS SHALL NOT PREVENT A UTILIZATION REVIEW AGENT
FROM REQUIRING AN INSURED TO TRY AN AB-RATED GENERIC EQUIVALENT PRIOR TO
PROVIDING COVERAGE FOR THE EQUIVALENT BRAND NAME PRESCRIPTION DRUG OR
DRUGS; OR
(5) THE REQUIRED PRESCRIPTION DRUG OR DRUGS IS NOT IN THE BEST INTER-
EST OF THE INSURED BECAUSE IT WILL LIKELY CAUSE A SIGNIFICANT BARRIER TO
THE INSURED'S ADHERENCE TO OR COMPLIANCE WITH THE INSURED'S PLAN OF
CARE, WILL LIKELY WORSEN A COMORBID CONDITION OF THE INSURED, OR WILL
LIKELY DECREASE THE COVERED INDIVIDUAL'S ABILITY TO ACHIEVE OR MAINTAIN
REASONABLE FUNCTIONAL ABILITY IN PERFORMING DAILY ACTIVITIES.
(C-2) FOR AN INSURED WITH A MEDICAL CONDITION THAT PLACES THE HEALTH
OF THE INSURED IN SERIOUS JEOPARDY WITHOUT THE PRESCRIPTION DRUG OR
DRUGS PRESCRIBED BY THE INSURED'S HEALTH CARE PROFESSIONAL, THE STEP
THERAPY PROTOCOL OVERRIDE DETERMINATION SHALL BE GRANTED WITHIN TWENTY-
FOUR HOURS OF THE RECEIPT OF INFORMATION THAT INCLUDES SUPPORTING
RATIONALE AND DOCUMENTATION FROM A HEALTH CARE PROFESSIONAL DEMONSTRAT-
ING ONE OR MORE OF THE STANDARDS PROVIDED FOR IN SUBSECTION (C-1) OF
THIS SECTION.
(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.
S 6. Subsection (g) of section 4903 of the insurance law, as added by
chapter 586 of the laws of 1998, is amended to read as follows:
(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.
S 7. Paragraph (j) of subdivision 2 of section 4408 of the public
health law, as added by chapter 705 of the laws of 1996, is amended to
read as follows:
(j) upon written request, provide specific written clinical review
criteria relating to a particular condition or disease INCLUDING CLIN-
ICAL REVIEW CRITERIA RELATING TO A STEP THERAPY PROTOCOL OVERRIDE DETER-
MINATION PURSUANT TO SUBDIVISIONS THREE-A, THREE-B AND THREE-C OF
S. 3419--C 4
SECTION FORTY-NINE HUNDRED THREE OF THIS CHAPTER, and, where appropri-
ate, other clinical information which the organization might consider in
its utilization review and the organization may include with the infor-
mation a description of how it will be used in the utilization review
process; provided, however, that to the extent such information is
proprietary to the organization, the enrollee or prospective enrollee
shall only use the information for the purposes of assisting the enrol-
lee or prospective enrollee in evaluating the covered services provided
by the organization. SUCH CLINICAL REVIEW CRITERIA, AND OTHER CLINICAL
INFORMATION SHALL ALSO BE MADE AVAILABLE TO A HEALTH CARE PROFESSIONAL
AS DEFINED IN SUBDIVISION SIX OF SECTION FORTY-NINE HUNDRED OF THIS
CHAPTER, ON BEHALF OF AN ENROLLEE AND UPON WRITTEN REQUEST;
S 8. Section 4900 of the public health law is amended by adding two
new subdivisions 7-f-2 and 7-f-3 to read as follows:
7-F-2. "STEP THERAPY PROTOCOL OVERRIDE DETERMINATION" MEANS A DETERMI-
NATION MADE BY A UTILIZATION REVIEW AGENT AS DEFINED IN SUBDIVISION NINE
OF THIS SECTION TO OVERRIDE A STEP THERAPY PROTOCOL PURSUANT TO SUBDIVI-
SIONS THREE-A, THREE-B AND THREE-C OF SECTION FORTY-NINE HUNDRED THREE
OF THIS TITLE GRANTING COVERAGE FOR THE HEALTH CARE PROFESSIONAL'S
SELECTED PRESCRIPTION DRUG OR DRUGS. ANY STEP THERAPY PROTOCOL OVERRIDE
DETERMINATION AS DEFINED BY THIS SUBDIVISION SHALL BE ELIGIBLE FOR
APPEAL BY AN ENROLLEE PURSUANT TO THIS ARTICLE.
7-F-3. "STEP THERAPY PROTOCOL" MEANS A POLICY, PROTOCOL OR PROGRAM
ESTABLISHED BY A UTILIZATION REVIEW AGENT AS DEFINED IN SUBDIVISION NINE
OF THIS SECTION THAT ESTABLISHES THE SPECIFIC SEQUENCE IN WHICH
PRESCRIPTION DRUGS FOR A SPECIFIED MEDICAL CONDITION ARE APPROVED FOR A
PARTICULAR ENROLLEE. NOTHING IN THIS CHAPTER SHALL IMPAIR OR PREVENT AN
INSURED FROM HAVING THE RIGHT TO APPEAL PURSUANT TO THIS ARTICLE RELAT-
ING TO THE IMPOSITION OF A STEP THERAPY PROTOCOL.
S 9. Section 4902 of the public health law is amended by adding two
new subdivisions 3 and 4 to read as follows:
3. WHEN ESTABLISHING A STEP THERAPY PROTOCOL, A UTILIZATION REVIEW
AGENT SHALL UTILIZE RECOGNIZED EVIDENCE-BASED AND PEER REVIEWED CLINICAL
REVIEW CRITERIA THAT TAKES INTO ACCOUNT THE NEEDS OF ATYPICAL PATIENT
POPULATIONS AND DIAGNOSES AS WELL WHEN ESTABLISHING THE CLINICAL REVIEW
CRITERIA.
4. WHEN CONDUCTING UTILIZATION REVIEW FOR A STEP THERAPY PROTOCOL
OVERRIDE DETERMINATION, A UTILIZATION REVIEW AGENT SHALL UTILIZE, IN
ADDITION TO ANY OTHER REQUIREMENTS OF THIS ARTICLE, RECOGNIZED
EVIDENCE-BASED AND PEER REVIEWED CLINICAL REVIEW CRITERIA THAT IS APPRO-
PRIATE FOR THE ENROLLEE AND THE ENROLLEE'S MEDICAL CONDITION.
S 10. Section 4903 of the public health law is amended by adding three
new subdivisions 3-a, 3-b and 3-c to read as follows:
3-A. A UTILIZATION REVIEW AGENT SHALL GRANT A STEP THERAPY PROTOCOL
OVERRIDE DETERMINATION WITHIN SEVENTY-TWO HOURS OF THE RECEIPT OF INFOR-
MATION THAT INCLUDES SUPPORTING RATIONALE AND DOCUMENTATION FROM A
HEALTH CARE PROFESSIONAL WHICH DEMONSTRATES THAT:
(A) THE REQUIRED PRESCRIPTION DRUG OR DRUGS IS CONTRAINDICATED, WILL
LIKELY CAUSE AN ADVERSE REACTION BY OR PHYSICAL OR MENTAL HARM TO THE
ENROLLEE;
(B) THE REQUIRED PRESCRIPTION DRUG OR DRUGS IS EXPECTED TO BE INEFFEC-
TIVE BASED ON THE KNOWN CLINICAL HISTORY AND CONDITIONS OF THE ENROLLEE
AND THE ENROLLEE'S PRESCRIPTION DRUG REGIMEN;
(C) THE ENROLLEE HAS TRIED THE REQUIRED PRESCRIPTION DRUG OR DRUGS
WHILE UNDER THEIR CURRENT OR A PREVIOUS HEALTH INSURANCE OR HEALTH BENE-
FIT PLAN, OR ANOTHER PRESCRIPTION DRUG OR DRUGS IN THE SAME PHARMACOLOG-
S. 3419--C 5
IC CLASS OR WITH THE SAME MECHANISM OF ACTION AND SUCH PRESCRIPTION DRUG
OR DRUGS WAS DISCONTINUED DUE TO LACK OF EFFICACY OR EFFECTIVENESS,
DIMINISHED EFFECT, OR AN ADVERSE EVENT;
(D) THE ENROLLEE IS STABLE ON A PRESCRIPTION DRUG OR DRUGS SELECTED BY
THEIR HEALTH CARE PROFESSIONAL FOR THE MEDICAL CONDITION UNDER CONSIDER-
ATION, PROVIDED THAT THIS SHALL NOT PREVENT A UTILIZATION REVIEW AGENT
FROM REQUIRING AN INSURED TO TRY AN AB-RATED GENERIC EQUIVALENT PRIOR TO
PROVIDING COVERAGE FOR THE EQUIVALENT BRAND NAME PRESCRIPTION DRUG OR
DRUGS; OR
(E) THE REQUIRED PRESCRIPTION DRUG OR DRUGS IS NOT IN THE BEST INTER-
EST OF THE ENROLLEE BECAUSE IT WILL LIKELY CAUSE A SIGNIFICANT BARRIER
TO THE ENROLLEE'S ADHERENCE TO OR COMPLIANCE WITH THE ENROLLEE'S PLAN OF
CARE, WILL LIKELY WORSEN A COMORBID CONDITION OF THE ENROLLEE, OR WILL
LIKELY DECREASE THE COVERED ENROLLEE'S ABILITY TO ACHIEVE OR MAINTAIN
REASONABLE FUNCTIONAL ABILITY IN PERFORMING DAILY ACTIVITIES.
3-B. FOR AN ENROLLEE WITH A MEDICAL CONDITION THAT PLACES THE HEALTH
OF THE INSURED IN SERIOUS JEOPARDY WITHOUT THE PRESCRIPTION DRUG OR
DRUGS PRESCRIBED BY THE INSURED'S HEALTH CARE PROFESSIONAL, THE STEP
THERAPY PROTOCOL OVERRIDE DETERMINATION SHALL BE GRANTED WITHIN TWENTY-
FOUR HOURS OF THE RECEIPT OF INFORMATION THAT INCLUDES SUPPORTING
RATIONALE AND DOCUMENTATION FROM A HEALTH CARE PROFESSIONAL DEMONSTRAT-
ING ONE OR MORE OF THE STANDARDS PROVIDED FOR IN SUBDIVISION THREE-A OF
THIS SECTION.
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.
S 11. Subdivision 7 of section 4903 of the public health law, as added
by chapter 586 of the laws of 1998, is amended to read as follows:
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] 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 SUBDIVI-
SIONS THREE-A, THREE-B AND THREE-C OF THIS SECTION SHALL BE DEEMED TO BE
AN OVERRIDE OF THE STEP THERAPY PROTOCOL.
S 12. This act shall not be construed to prevent: a health care plan
or utilization review agent from requiring a patient to try an AB-rated
generic equivalent prior to providing coverage for the equivalent brand-
ed prescription drug; or a health care provider from prescribing a
prescription drug that is determined to be medically appropriate.
S 13. This act shall take effect on January 1, 2017, and shall apply
only to health insurance and health benefit plans delivered, issued for
delivery, or renewed after such date, provided further that effective
immediately the superintendent of financial services is authorized to
promulgate such rules and regulations and take any other measures as may
be necessary for the timely implementation of this act.
