S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                  2834

                       2015-2016 Regular Sessions

                          I N  A S S E M B L Y

                            January 20, 2015
                               ___________

Introduced  by  M. of A. TITONE, GOTTFRIED, RODRIGUEZ, ROBERTS, GUNTHER,
  ZEBROWSKI, QUART, PEOPLES-STOKES, MONTESANO, CUSICK, BRINDISI,  TEDIS-
  CO,  WEPRIN,  ROSENTHAL, SKOUFIS, ROZIC, JOHNS, JAFFEE, STIRPE, STECK,
  OTIS -- Multi-Sponsored by -- M.  of A. CRESPO, DUPREY,  FAHY,  GALEF,
  HEVESI,  KOLB,  LUPARDO, McLAUGHLIN, PERRY, RIVERA, SCHIMEL, SEPULVEDA
  -- read once and referred to the Committee on Insurance

AN ACT to amend the insurance law, in relation to the regulation of step
  therapy and first fail policies

  THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section  1. The insurance law is amended by adding a new article 33 to
read as follows:
                               ARTICLE 33
                     REGULATION OF STEP THERAPY AND
                           FIRST FAIL POLICIES
SECTION 3301. DEFINITIONS.
        3302. PRESCRIPTION DRUG RESTRICTION OVERRIDES.
  S 3301. DEFINITIONS. AS USED IN THIS ARTICLE:
  (A) "INSURER" SHALL MEAN ANY PERSON OR ENTITY WHO OFFERS A  POLICY  OF
ACCIDENT  AND/OR HEALTH INSURANCE PURSUANT TO SECTION THREE THOUSAND TWO
HUNDRED SIXTEEN, THREE THOUSAND TWO HUNDRED TWENTY-ONE, OR FOUR THOUSAND
THREE HUNDRED THREE OF THIS CHAPTER OR ARTICLE FORTY-FOUR OF THE  PUBLIC
HEALTH LAW.
  (B)  "PHARMACY  BENEFIT  MANAGEMENT"  OR  "PBM" SHALL MEAN THE SERVICE
PROVIDED TO AN INSURER, DIRECTLY OR THROUGH  ANOTHER  ENTITY;  INCLUDING
THE  PROCUREMENT  OF  PRESCRIPTION  DRUGS  TO  BE  DISPENSED  TO COVERED
PERSONS, OR THE ADMINISTRATION OR MANAGEMENT OF PRESCRIPTION DRUG  BENE-
FITS INCLUDING, BUT NOT LIMITED TO, ANY OF THE FOLLOWING:
  (1) A MAIL ORDER PHARMACY;
  (2) CLAIMS PROCESSING, RETAIL NETWORK MANAGEMENT AND PAYMENT OF CLAIMS
TO PHARMACIES FOR DISPENSING PRESCRIPTION DRUGS;

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD03838-01-5
              

A. 2834                             2

  (3) CLINICAL OR OTHER FORMULARY, OR PREFERRED DRUG LIST DEVELOPMENT OR
MANAGEMENT;
  (4)  NEGOTIATION  OR  ADMINISTRATION  OF  REBATES,  DISCOUNTS, PAYMENT
DIFFERENTIALS OR  OTHER  INCENTIVES  FOR  THE  INCLUSION  OF  PARTICULAR
PRESCRIPTION  DRUGS  IN A PARTICULAR CATEGORY OR TO PROMOTE THE PURCHASE
OF PARTICULAR PRESCRIPTION DRUGS;
  (5) PATIENT COMPLIANCE, THERAPEUTIC INTERVENTION AND  GENERIC  SUBSTI-
TUTION PROGRAMS; AND
  (6) DISEASE MANAGEMENT.
  S  3302. PRESCRIPTION DRUG RESTRICTION OVERRIDES. (A) WHEN MEDICATIONS
FOR THE TREATMENT OF ANY MEDICAL CONDITION ARE RESTRICTED FOR USE BY  AN
INSURER  OR  PBM  BY A STEP THERAPY OR FAIL FIRST PROTOCOL, A PRESCRIBER
SHALL HAVE ACCESS TO A CLEAR AND CONVENIENT PROCESS AT NO CHARGE TO SUCH
PRESCRIBER AND/OR PATIENT TO OVERRIDE SUCH RESTRICTIONS FROM THE INSURER
AND MAY EXPEDITIOUSLY OVERRIDE SUCH RESTRICTION IF:
  (1) SUCH PRESCRIBER, IN HIS OR  HER  PROFESSIONAL  JUDGMENT,  BELIEVES
THAT THE PREFERRED TREATMENT BY THE INSURER OR THE PBM HAS BEEN INEFFEC-
TIVE  IN THE TREATMENT OF THE COVERED PERSON'S DISEASE OR MEDICAL CONDI-
TION; OR
  (2) BASED ON  SOUND  CLINICAL  EVIDENCE  AND  MEDICAL  AND  SCIENTIFIC
EVIDENCE:
  (A)  SUCH  PRESCRIBER,  IN  HIS OR HER PROFESSIONAL JUDGMENT, BELIEVES
THAT THE PREFERRED TREATMENT IS EXPECTED TO BE INEFFECTIVE BASED ON  THE
KNOWN  RELEVANT PHYSICAL OR MENTAL CHARACTERISTICS OF THE COVERED PERSON
AND KNOWN CHARACTERISTICS OF THE DRUG REGIMEN, AND IS LIKELY TO BE INEF-
FECTIVE OR ADVERSELY AFFECT THE DRUG'S EFFECTIVENESS OR PATIENT  COMPLI-
ANCE; OR
  (B)  SUCH  PRESCRIBER,  IN  HIS OR HER PROFESSIONAL JUDGMENT, BELIEVES
THAT THE PREFERRED TREATMENT HAS CAUSED OR IS LIKELY TO CAUSE AN ADVERSE
REACTION OR OTHER HARM TO THE COVERED PERSON.
  (B) THE DURATION OF ANY STEP THERAPY OR FAIL FIRST PROTOCOL SHALL  NOT
BE LONGER THAN EITHER (1) THE PERIOD DEEMED NECESSARY BY THE PRESCRIBING
PHYSICIAN OR HEALTH CARE PROFESSIONAL TO DETERMINE THE TREATMENT'S CLIN-
ICAL EFFECTIVENESS, OR (2) A PERIOD OF THIRTY DAYS.
  (C)  NOTHING  IN THIS SECTION SHALL REQUIRE COVERAGE FOR AN ADDITIONAL
CONDITION NOT ALREADY COVERED BY THE POLICY OR CONTRACT, OR WHICH IS NOT
OTHERWISE COVERED BY LAW.
  S 2. This act shall take effect on the one hundred twentieth day after
it shall have become a law.

                            
                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                 2834--A

                       2015-2016 Regular Sessions

                          I N  A S S E M B L Y

                            January 20, 2015
                               ___________

Introduced  by  M. of A. TITONE, GOTTFRIED, RODRIGUEZ, ROBERTS, GUNTHER,
  ZEBROWSKI, QUART, PEOPLES-STOKES, MONTESANO, CUSICK, BRINDISI,  TEDIS-
  CO,  WEPRIN,  ROSENTHAL, SKOUFIS, ROZIC, JOHNS, JAFFEE, STIRPE, STECK,
  OTIS, ABINANTI, CLARK, BARRETT -- Multi-Sponsored by -- M. of A. CRES-
  PO, DUPREY, FAHY, GALEF, HEVESI,  KOLB,  LUPARDO,  McLAUGHLIN,  PERRY,
  RIVERA,  SCHIMEL, SEPULVEDA -- read once and referred to the Committee
  on Insurance -- committee discharged, bill amended, ordered  reprinted
  as amended and recommitted to said committee

AN ACT to amend the insurance law, in relation to the regulation of step
  therapy policies

  THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section 1. Legislative findings.  The  legislature  hereby  finds  and
declares that:
  (a) Health insurance plans are increasingly making use of step therapy
protocols  under  which  patients  are  required  to  try  one  or  more
prescription drugs before coverage is provided for a  drug  selected  by
the patient's health care provider.
  (b)  The  legislature  further finds that such step therapy protocols,
where they are based on well-developed scientific standards and adminis-
tered in a flexible manner that takes into account the individual  needs
of  patients,  can  play  an  important  role in controlling health care
costs.
  (c) The legislature further finds that, in  some  cases,  requiring  a
patient  to  follow  a  step  therapy protocol may have adverse and even
dangerous consequences for the patient who may  not  realize  a  benefit
from  taking a prescription drug or may suffer harm from taking an inap-
propriate drug.
  (d) The legislature further finds that, without  uniform  policies  in
the  state for step therapy protocols, patients may not receive the best
and most appropriate treatment.

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD03838-02-5
              

A. 2834--A                          2

  (e) The legislature further finds that  it  is  imperative  that  step
therapy protocols in the state preserve the health care provider's right
to make treatment decisions in the best interest of the patient.
  (f) Therefore, the legislature declares it a matter of public interest
that it require health insurers to base step therapy protocols on appro-
priate  clinical  practice  guidelines  developed by independent experts
with knowledge of the condition or conditions under consideration;  that
patients  be  exempt  from  step therapy protocols when inappropriate or
otherwise not in the best interest of the patients;  and  that  patients
have  access to a fair, transparent and independent process for request-
ing an exception to a step therapy protocol when appropriate.
  S 2. The insurance law is amended by adding a new article 33  to  read
as follows:
                               ARTICLE 33
                   REGULATION OF STEP THERAPY POLICIES

SECTION 3301. DEFINITIONS.
        3302. CLINICAL REVIEW CRITERIA.
        3303. EXCEPTIONS PROCESS TRANSPARENCY.
        3304. COST-SHARING.
        3305. REGULATIONS.
  S 3301. DEFINITIONS. AS USED IN THIS ARTICLE:
  (A)  "CLINICAL PRACTICE GUIDELINES" SHALL MEAN A SYSTEMATICALLY DEVEL-
OPED STATEMENT TO ASSIST HEALTH  CARE  PROVIDER  AND  PATIENT  DECISIONS
ABOUT  APPROPRIATE  HEALTHCARE  FOR  SPECIFIC CLINICAL CIRCUMSTANCES AND
CONDITIONS.
  (B) "CLINICAL REVIEW CRITERIA" SHALL MEAN THE WRITTEN SCREENING PROCE-
DURES, DECISION ABSTRACTS, CLINICAL PROTOCOLS  AND  PRACTICE  GUIDELINES
USED  BY  AN INSURER, HEALTH PLAN, OR UTILIZATION REVIEW ORGANIZATION TO
DETERMINE  THE  MEDICAL  NECESSITY  AND  APPROPRIATENESS  OF  HEALTHCARE
SERVICES.
  (C)  "STEP  THERAPY  PROTOCOL"  SHALL  MEAN A PROTOCOL OR PROGRAM THAT
ESTABLISHES THE SPECIFIC SEQUENCE IN  WHICH  PRESCRIPTION  DRUGS  FOR  A
SPECIFIED  MEDICAL  CONDITION AND MEDICALLY APPROPRIATE FOR A PARTICULAR
PATIENT ARE COVERED BY AN INSURER OR HEALTH PLAN.
  (D) "STEP THERAPY OVERRIDE DETERMINATION" SHALL MEAN  A  DETERMINATION
AS TO WHETHER A STEP THERAPY PROTOCOL SHOULD APPLY IN A PARTICULAR SITU-
ATION,  OR  WHETHER  THE  STEP  THERAPY PROTOCOL SHOULD BE OVERRIDDEN IN
FAVOR OF IMMEDIATE COVERAGE  OF  THE  HEALTH  CARE  PROVIDER'S  SELECTED
PRESCRIPTION  DRUG.  THIS  DETERMINATION  IS  BASED  ON  A REVIEW OF THE
PATIENT'S OR PRESCRIBER'S REQUEST FOR AN OVERRIDE, ALONG WITH SUPPORTING
RATIONALE AND DOCUMENTATION.
  (E) "UTILIZATION  REVIEW  ORGANIZATION"  SHALL  MEAN  AN  ENTITY  THAT
CONDUCTS  UTILIZATION  REVIEW,  OTHER  THAN  AN  INSURER  OR HEALTH PLAN
PERFORMING UTILIZATION REVIEW FOR ITS OWN HEALTH BENEFIT PLANS.
  S 3302. CLINICAL REVIEW CRITERIA. (A) CLINICAL REVIEW CRITERIA USED TO
ESTABLISH A STEP THERAPY PROTOCOL SHALL BE BASED  ON  CLINICAL  PRACTICE
GUIDELINES THAT:
  (1)  RECOMMEND  THAT  THE  PRESCRIPTION DRUGS BE TAKEN IN THE SPECIFIC
SEQUENCE REQUIRED BY THE STEP THERAPY PROTOCOL.
  (2) ARE DEVELOPED AND ENDORSED BY  AN  INDEPENDENT,  MULTIDISCIPLINARY
PANEL OF EXPERTS NOT AFFILIATED WITH AN INSURER, HEALTH PLAN OR UTILIZA-
TION REVIEW ORGANIZATION.
  (3) ARE BASED ON HIGH QUALITY STUDIES, RESEARCH, AND MEDICAL PRACTICE.
  (4) ARE CREATED BY AN EXPLICIT AND TRANSPARENT PROCESS THAT:
  (A) MINIMIZES BIASES AND CONFLICTS OF INTEREST;

A. 2834--A                          3

  (B) EXPLAINS THE RELATIONSHIP BETWEEN TREATMENT OPTIONS AND OUTCOMES;
  (C) RATES THE QUALITY OF THE EVIDENCE SUPPORTING RECOMMENDATIONS; AND
  (D) CONSIDERS RELEVANT PATIENT SUBGROUPS AND PREFERENCES.
  (5)  ARE  CONTINUALLY  UPDATED  THROUGH  A  REVIEW OF NEW EVIDENCE AND
RESEARCH.
  (B) AN INSURER, HEALTH PLAN, OR UTILIZATION REVIEW ORGANIZATION  SHALL
CERTIFY ANNUALLY IN RATE FILING DOCUMENTS SUBMITTED TO THE DEPARTMENT OF
FINANCIAL SERVICES THAT THE CLINICAL REVIEW CRITERIA USED IN STEP THERA-
PY  PROGRAMS FOR PHARMACEUTICALS MEET THE REQUIREMENTS SET FORTH IN THIS
ACT.
  (C) PROPOSED CLINICAL REVIEW CRITERIA WILL BE SUBMITTED TO THE DEPART-
MENT OF FINANCIAL SERVICES FOR  REVIEW  AND  MUST  RECEIVE  APPROVAL  OR
ACCREDITATION PRIOR TO IMPLEMENTATION.
  S  3303.  EXCEPTIONS  PROCESS  TRANSPARENCY.  (A)  WHEN  COVERAGE OF A
PRESCRIPTION  DRUG  FOR  THE  TREATMENT  OF  ANY  MEDICAL  CONDITION  IS
RESTRICTED  FOR  USE  BY  AN INSURER, HEALTH PLAN, OR UTILIZATION REVIEW
ORGANIZATION THROUGH THE USE OF A STEP THERAPY PROTOCOL, THE PATIENT AND
PRESCRIBING PRACTITIONER SHALL HAVE ACCESS TO  A  CLEAR  AND  CONVENIENT
PROCESS  TO  REQUEST A STEP THERAPY EXCEPTION DETERMINATION. AN INSURER,
HEALTH PLAN, OR UTILIZATION REVIEW ORGANIZATION  MAY  USE  ITS  EXISTING
MEDICAL  EXCEPTIONS  PROCESS  TO  SATISFY  THIS REQUIREMENT. THE PROCESS
SHALL BE MADE EASILY ACCESSIBLE ON  THE  INSURER'S,  HEALTH  PLAN'S,  OR
UTILIZATION REVIEW ORGANIZATION'S WEBSITE.
  (B)  A  STEP  THERAPY  OVERRIDE  DETERMINATION  REQUEST SHALL BE EXPE-
DITIOUSLY GRANTED IF:
  (1) THE REQUIRED PRESCRIPTION DRUG IS CONTRAINDICATED OR  WILL  LIKELY
CAUSE AN ADVERSE REACTION BY OR PHYSICAL OR MENTAL HARM TO THE PATIENT.
  (2) THE REQUIRED PRESCRIPTION DRUG IS EXPECTED TO BE INEFFECTIVE BASED
ON  THE KNOWN RELEVANT PHYSICAL OR MENTAL CHARACTERISTICS OF THE PATIENT
AND THE KNOWN CHARACTERISTICS OF THE PRESCRIPTION DRUG REGIMEN.
  (3) THE PATIENT HAS TRIED THE REQUIRED PRESCRIPTION DRUG  WHILE  UNDER
THEIR  CURRENT OR A PREVIOUS HEALTH INSURANCE OR HEALTH BENEFIT PLAN, OR
ANOTHER PRESCRIPTION DRUG IN THE SAME PHARMACOLOGIC CLASS  OR  WITH  THE
SAME MECHANISM OF ACTION AND SUCH PRESCRIPTION DRUG WAS DISCONTINUED DUE
TO A LACK OF EFFICACY OR EFFECTIVENESS, DIMINISHED EFFECT, OR AN ADVERSE
EVENT.
  (4)  THE REQUIRED PRESCRIPTION DRUG IS NOT IN THE BEST INTEREST OF THE
PATIENT, BASED ON MEDICAL APPROPRIATENESS.
  (5) THE PATIENT IS STABLE ON A PRESCRIPTION  DRUG  SELECTED  BY  THEIR
HEALTH CARE PROVIDER FOR THE MEDICAL CONDITION UNDER CONSIDERATION.
  (C)  UPON  THE  GRANTING OF A STEP THERAPY OVERRIDE DETERMINATION, THE
INSURER, HEALTH PLAN, OR UTILIZATION REVIEW ORGANIZATION SHALL AUTHORIZE
COVERAGE FOR THE PRESCRIPTION DRUG PRESCRIBED BY THE PATIENT'S  TREATING
HEALTHCARE  PROVIDER,  PROVIDED  SUCH  PRESCRIPTION  DRUG  IS  A COVERED
PRESCRIPTION DRUG UNDER SUCH POLICY OR CONTRACT.
  (D) THIS SECTION SHALL NOT BE CONSTRUED TO PREVENT:
  (1) AN INSURER, HEALTH PLAN, OR UTILIZATION REVIEW  ORGANIZATION  FROM
REQUIRING  A  PATIENT  TO  TRY  AN  AB-RATED GENERIC EQUIVALENT PRIOR TO
PROVIDING COVERAGE FOR THE EQUIVALENT BRANDED PRESCRIPTION DRUG.
  (2) A HEALTH CARE PROVIDER FROM PRESCRIBING A PRESCRIPTION  DRUG  THAT
IS DETERMINED TO BE MEDICALLY APPROPRIATE.
  (E)  EACH  HEALTH INSURER SHALL MAINTAIN WRITTEN OR ELECTRONIC RECORDS
AND DATA SUFFICIENT TO DEMONSTRATE COMPLIANCE WITH THE  REQUIREMENTS  OF
THIS  SECTION  AND  ON  AN  ANNUAL BASIS SUBMIT TO THE SUPERINTENDENT OF
FINANCIAL SERVICES THE FOLLOWING INFORMATION WITH  RESPECT  TO  REQUESTS
MADE UNDER THIS SECTION:

A. 2834--A                          4

  (1) THE TOTAL NUMBER OF REQUESTS RECEIVED;
  (2) THE NUMBER OF REQUESTS APPROVED AND DENIED; AND
  (3) ANY OTHER INFORMATION THE SUPERINTENDENT MAY REQUEST.
  S 3304. COST-SHARING. (A) NOTWITHSTANDING ANY OTHER PROVISION OF STATE
OR FEDERAL LAW, AN ENTITY LICENSED IN THIS STATE TO SELL A HEALTH INSUR-
ANCE  OR  HEALTH  BENEFITS PLAN DIRECTLY TO A CONSUMER SHALL ENSURE THAT
WHERE STEP THERAPY PROTOCOLS ARE USED TO IMPOSE  CLINICAL  PREREQUISITES
FOR COVERAGE OF PRESCRIPTION DRUGS, SUCH DRUGS SHALL BE AVAILABLE TO THE
CONSUMER AT THE PREFERRED COST-SHARING LEVEL FOR THE ITEM ONCE THE CLIN-
ICAL PREREQUISITES HAVE BEEN SATISFIED.
  (B) THIS SECTION SHALL NOT BE CONSTRUED TO PREVENT INSURERS FROM USING
TIERED COPAYMENT STRUCTURES.
  S  3305.  REGULATIONS.  NOTWITHSTANDING  ANY  LAW TO THE CONTRARY, THE
SUPERINTENDENT OF FINANCIAL SERVICES SHALL  PROMULGATE  ANY  REGULATIONS
NECESSARY TO IMPLEMENT THIS ACT.
  S  3.  This  act  shall take effect on January 1, 2016 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.

                            
                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                 2834--B

                       2015-2016 Regular Sessions

                          I N  A S S E M B L Y

                            January 20, 2015
                               ___________

Introduced by M. of A. TITONE, GOTTFRIED, RODRIGUEZ, GUNTHER, ZEBROWSKI,
  QUART,  PEOPLES-STOKES,  MONTESANO, CUSICK, BRINDISI, TEDISCO, WEPRIN,
  ROSENTHAL, SKOUFIS, ROZIC, JOHNS, JAFFEE, STIRPE, STECK, OTIS, ABINAN-
  TI, CLARK, BARRETT, THIELE, PICHARDO, KEARNS, SANTABARBARA  --  Multi-
  Sponsored by -- M. of A. CERETTO, CRESPO, DUPREY, FAHY, GALEF, HEVESI,
  KOLB,  LUPARDO,  McLAUGHLIN, PERRY, RIVERA, SCHIMEL, SEPULVEDA -- read
  once  and  referred  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 Assembly Rule 3, sec. 2 -- committee discharged,  bill
  amended,  ordered reprinted as amended and recommitted to said commit-
  tee

AN ACT to amend the insurance law, in relation to the regulation of step
  therapy policies

  THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section  1.  Legislative  findings.  The  legislature hereby finds and
declares that:
  (a) Health insurance plans are increasingly making use of step therapy
protocols  under  which  patients  are  required  to  try  one  or  more
prescription  drugs  before  coverage is provided for a drug selected by
the patient's health care provider.
  (b) The legislature further finds that such  step  therapy  protocols,
where they are based on well-developed scientific standards and adminis-
tered  in a flexible manner that takes into account the individual needs
of patients, can play an  important  role  in  controlling  health  care
costs.
  (c)  The  legislature  further  finds that, in some cases, requiring a
patient to follow a step therapy protocol  may  have  adverse  and  even
dangerous  consequences  for  the  patient who may not realize a benefit

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD03838-05-6

              

A. 2834--B                          2

from taking a prescription drug or may suffer harm from taking an  inap-
propriate drug.
  (d)  The  legislature  further finds that, without uniform policies in
the state for step therapy protocols, patients may not receive the  best
and most appropriate treatment.
  (e)  The  legislature  further  finds  that it is imperative that step
therapy protocols in the state preserve the health care provider's right
to make treatment decisions in the best interest of the patient.
  (f) Therefore, the legislature declares it a matter of public interest
that it require health insurers to base step therapy protocols on appro-
priate clinical practice guidelines  developed  by  independent  experts
with  knowledge of the condition or conditions under consideration; that
patients be exempt from step therapy  protocols  when  inappropriate  or
otherwise  not  in  the best interest of the patients; and that patients
have access to a fair, transparent and independent process for  request-
ing an exception to a step therapy protocol when appropriate.
  S  2.  The insurance law is amended by adding a new article 33 to read
as follows:
                               ARTICLE 33
                   REGULATION OF STEP THERAPY POLICIES
SECTION 3301. DEFINITIONS.
        3302. CLINICAL REVIEW CRITERIA.
        3303. EXCEPTIONS PROCESS TRANSPARENCY.
        3304. COST-SHARING.
        3305. REGULATIONS.
  S 3301. DEFINITIONS. AS USED IN THIS ARTICLE:
  (A) "CLINICAL PRACTICE GUIDELINES" SHALL MEAN A SYSTEMATICALLY  DEVEL-
OPED  STATEMENT  TO  ASSIST  HEALTH  CARE PROVIDER AND PATIENT DECISIONS
ABOUT APPROPRIATE HEALTHCARE FOR  SPECIFIC  CLINICAL  CIRCUMSTANCES  AND
CONDITIONS.
  (B) "CLINICAL REVIEW CRITERIA" SHALL MEAN THE WRITTEN SCREENING PROCE-
DURES,  DECISION  ABSTRACTS,  CLINICAL PROTOCOLS AND PRACTICE GUIDELINES
USED BY AN INSURER, HEALTH PLAN, OR UTILIZATION REVIEW  ORGANIZATION  TO
DETERMINE  THE  MEDICAL  NECESSITY  AND  APPROPRIATENESS  OF  HEALTHCARE
SERVICES.
  (C) "STEP THERAPY PROTOCOL" SHALL MEAN  A  PROTOCOL  OR  PROGRAM  THAT
ESTABLISHES  THE  SPECIFIC  SEQUENCE  IN  WHICH PRESCRIPTION DRUGS FOR A
SPECIFIED MEDICAL CONDITION AND MEDICALLY APPROPRIATE FOR  A  PARTICULAR
PATIENT ARE COVERED BY AN INSURER OR HEALTH PLAN.
  (D)  "STEP  THERAPY OVERRIDE DETERMINATION" SHALL MEAN A DETERMINATION
AS TO WHETHER A STEP THERAPY PROTOCOL SHOULD APPLY IN A PARTICULAR SITU-
ATION, OR WHETHER THE STEP THERAPY  PROTOCOL  SHOULD  BE  OVERRIDDEN  IN
FAVOR  OF  IMMEDIATE  COVERAGE  OF  THE  HEALTH CARE PROVIDER'S SELECTED
PRESCRIPTION DRUG. THIS DETERMINATION  IS  BASED  ON  A  REVIEW  OF  THE
PATIENT'S OR PRESCRIBER'S REQUEST FOR AN OVERRIDE, ALONG WITH SUPPORTING
RATIONALE AND DOCUMENTATION.
  (E)  "UTILIZATION  REVIEW  ORGANIZATION"  SHALL  MEAN  AN  ENTITY THAT
CONDUCTS UTILIZATION REVIEW,  OTHER  THAN  AN  INSURER  OR  HEALTH  PLAN
PERFORMING UTILIZATION REVIEW FOR ITS OWN HEALTH BENEFIT PLANS.
  S 3302. CLINICAL REVIEW CRITERIA. (A) CLINICAL REVIEW CRITERIA USED TO
ESTABLISH  A  STEP  THERAPY PROTOCOL SHALL BE BASED ON CLINICAL PRACTICE
GUIDELINES THAT:
  (1) RECOMMEND THAT THE PRESCRIPTION DRUGS BE  TAKEN  IN  THE  SPECIFIC
SEQUENCE REQUIRED BY THE STEP THERAPY PROTOCOL.

A. 2834--B                          3

  (2)  ARE  DEVELOPED  AND ENDORSED BY AN INDEPENDENT, MULTIDISCIPLINARY
PANEL OF EXPERTS NOT AFFILIATED WITH AN INSURER, HEALTH PLAN OR UTILIZA-
TION REVIEW ORGANIZATION.
  (3) ARE BASED ON HIGH QUALITY STUDIES, RESEARCH, AND MEDICAL PRACTICE.
  (4) ARE CREATED BY AN EXPLICIT AND TRANSPARENT PROCESS THAT:
  (A) MINIMIZES BIASES AND CONFLICTS OF INTEREST;
  (B) EXPLAINS THE RELATIONSHIP BETWEEN TREATMENT OPTIONS AND OUTCOMES;
  (C) RATES THE QUALITY OF THE EVIDENCE SUPPORTING RECOMMENDATIONS; AND
  (D) CONSIDERS RELEVANT PATIENT SUBGROUPS AND PREFERENCES.
  (5)  ARE  CONTINUALLY  UPDATED  THROUGH  A  REVIEW OF NEW EVIDENCE AND
RESEARCH.
  (B) AN INSURER, HEALTH PLAN, OR UTILIZATION REVIEW ORGANIZATION  SHALL
CERTIFY ANNUALLY IN RATE FILING DOCUMENTS SUBMITTED TO THE DEPARTMENT OF
FINANCIAL SERVICES THAT THE CLINICAL REVIEW CRITERIA USED IN STEP THERA-
PY  PROGRAMS FOR PHARMACEUTICALS MEET THE REQUIREMENTS SET FORTH IN THIS
ACT.
  (C) PROPOSED CLINICAL REVIEW CRITERIA WILL BE SUBMITTED TO THE DEPART-
MENT OF FINANCIAL SERVICES FOR  REVIEW  AND  MUST  RECEIVE  APPROVAL  OR
ACCREDITATION PRIOR TO IMPLEMENTATION.
  S  3303.  EXCEPTIONS  PROCESS  TRANSPARENCY.  (A)  WHEN  COVERAGE OF A
PRESCRIPTION  DRUG  FOR  THE  TREATMENT  OF  ANY  MEDICAL  CONDITION  IS
RESTRICTED  FOR  USE  BY  AN INSURER, HEALTH PLAN, OR UTILIZATION REVIEW
ORGANIZATION THROUGH THE USE OF A STEP THERAPY PROTOCOL, THE PATIENT AND
PRESCRIBING PRACTITIONER SHALL HAVE ACCESS TO  A  CLEAR  AND  CONVENIENT
PROCESS  TO  REQUEST A STEP THERAPY EXCEPTION DETERMINATION. AN INSURER,
HEALTH PLAN, OR UTILIZATION REVIEW ORGANIZATION  MAY  USE  ITS  EXISTING
MEDICAL  EXCEPTIONS  PROCESS  TO  SATISFY  THIS REQUIREMENT. THE PROCESS
SHALL BE MADE EASILY ACCESSIBLE ON  THE  INSURER'S,  HEALTH  PLAN'S,  OR
UTILIZATION REVIEW ORGANIZATION'S WEBSITE.
  (B)  A  STEP  THERAPY  OVERRIDE  DETERMINATION  REQUEST SHALL BE EXPE-
DITIOUSLY GRANTED IF:
  (1) THE REQUIRED PRESCRIPTION DRUG IS CONTRAINDICATED OR  WILL  LIKELY
CAUSE AN ADVERSE REACTION BY OR PHYSICAL OR MENTAL HARM TO THE PATIENT.
  (2) THE REQUIRED PRESCRIPTION DRUG IS EXPECTED TO BE INEFFECTIVE BASED
ON  THE KNOWN RELEVANT PHYSICAL OR MENTAL CHARACTERISTICS OF THE PATIENT
AND THE KNOWN CHARACTERISTICS OF THE PRESCRIPTION DRUG REGIMEN.
  (3) THE PATIENT HAS TRIED THE REQUIRED PRESCRIPTION DRUG  WHILE  UNDER
THEIR  CURRENT OR A PREVIOUS HEALTH INSURANCE OR HEALTH BENEFIT PLAN, OR
ANOTHER PRESCRIPTION DRUG IN THE SAME PHARMACOLOGIC CLASS  OR  WITH  THE
SAME MECHANISM OF ACTION AND SUCH PRESCRIPTION DRUG WAS DISCONTINUED DUE
TO A LACK OF EFFICACY OR EFFECTIVENESS, DIMINISHED EFFECT, OR AN ADVERSE
EVENT.
  (4)  THE REQUIRED PRESCRIPTION DRUG IS NOT IN THE BEST INTEREST OF THE
PATIENT, BASED ON MEDICAL APPROPRIATENESS.
  (5) THE PATIENT IS STABLE ON A PRESCRIPTION  DRUG  SELECTED  BY  THEIR
HEALTH CARE PROVIDER FOR THE MEDICAL CONDITION UNDER CONSIDERATION.
  (C)  UPON  THE  GRANTING OF A STEP THERAPY OVERRIDE DETERMINATION, THE
INSURER, HEALTH PLAN, OR UTILIZATION REVIEW ORGANIZATION SHALL AUTHORIZE
COVERAGE FOR THE PRESCRIPTION DRUG PRESCRIBED BY THE PATIENT'S  TREATING
HEALTHCARE  PROVIDER,  PROVIDED  SUCH  PRESCRIPTION  DRUG  IS  A COVERED
PRESCRIPTION DRUG UNDER SUCH POLICY OR CONTRACT.
  (D) THIS SECTION SHALL NOT BE CONSTRUED TO PREVENT:
  (1) AN INSURER, HEALTH PLAN, OR UTILIZATION REVIEW  ORGANIZATION  FROM
REQUIRING  A  PATIENT  TO  TRY  AN  AB-RATED GENERIC EQUIVALENT PRIOR TO
PROVIDING COVERAGE FOR THE EQUIVALENT BRANDED PRESCRIPTION DRUG.

A. 2834--B                          4

  (2) A HEALTH CARE PROVIDER FROM PRESCRIBING A PRESCRIPTION  DRUG  THAT
IS DETERMINED TO BE MEDICALLY APPROPRIATE.
  (E)  EACH  HEALTH INSURER SHALL MAINTAIN WRITTEN OR ELECTRONIC RECORDS
AND DATA SUFFICIENT TO DEMONSTRATE COMPLIANCE WITH THE  REQUIREMENTS  OF
THIS  SECTION  AND  ON  AN  ANNUAL BASIS SUBMIT TO THE SUPERINTENDENT OF
FINANCIAL SERVICES THE FOLLOWING INFORMATION WITH  RESPECT  TO  REQUESTS
MADE UNDER THIS SECTION:
  (1) THE TOTAL NUMBER OF REQUESTS RECEIVED;
  (2) THE NUMBER OF REQUESTS APPROVED AND DENIED; AND
  (3) ANY OTHER INFORMATION THE SUPERINTENDENT MAY REQUEST.
  S 3304. COST-SHARING. (A) NOTWITHSTANDING ANY OTHER PROVISION OF STATE
OR FEDERAL LAW, AN ENTITY LICENSED IN THIS STATE TO SELL A HEALTH INSUR-
ANCE  OR  HEALTH  BENEFITS PLAN DIRECTLY TO A CONSUMER SHALL ENSURE THAT
WHERE STEP THERAPY PROTOCOLS ARE USED TO IMPOSE  CLINICAL  PREREQUISITES
FOR COVERAGE OF PRESCRIPTION DRUGS, SUCH DRUGS SHALL BE AVAILABLE TO THE
CONSUMER AT THE PREFERRED COST-SHARING LEVEL FOR THE ITEM ONCE THE CLIN-
ICAL PREREQUISITES HAVE BEEN SATISFIED.
  (B) THIS SECTION SHALL NOT BE CONSTRUED TO PREVENT INSURERS FROM USING
TIERED COPAYMENT STRUCTURES.
  S  3305.  REGULATIONS.  NOTWITHSTANDING  ANY  LAW TO THE CONTRARY, THE
SUPERINTENDENT OF FINANCIAL SERVICES SHALL  PROMULGATE  ANY  REGULATIONS
NECESSARY TO IMPLEMENT THIS ACT.
  S  3.  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.

                            
                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                 2834--C

                       2015-2016 Regular Sessions

                          I N  A S S E M B L Y

                            January 20, 2015
                               ___________

Introduced by M. of A. TITONE, GOTTFRIED, RODRIGUEZ, GUNTHER, ZEBROWSKI,
  QUART,  PEOPLES-STOKES,  MONTESANO, CUSICK, BRINDISI, TEDISCO, WEPRIN,
  ROSENTHAL, SKOUFIS, ROZIC, JOHNS, JAFFEE, STIRPE, STECK, OTIS, ABINAN-
  TI, BARRETT, THIELE, PICHARDO, KEARNS, SANTABARBARA,  COLTON,  CROUCH,
  HUNTER,  PAULIN, COOK, CYMBROWITZ, JOYNER, GOLDFEDER, LAVINE, CASTORI-
  NA, DILAN,  McDONALD,  MOYA,  BRAUNSTEIN,  SEAWRIGHT,  RAIA,  WOERNER,
  MAGNARELLI  -- Multi-Sponsored by -- M. of A. BUCHWALD, CERETTO, CRES-
  PO, DUPREY, ENGLEBRIGHT, FAHY, FRIEND, GALEF,  HEVESI,  KOLB,  LENTOL,
  LUPARDO,  LUPINACCI,  McLAUGHLIN,  MURRAY, PERRY, RA, RIVERA, SCHIMEL,
  SEPULVEDA, TENNEY -- read once and referred to the Committee on Insur-
  ance -- committee  discharged,  bill  amended,  ordered  reprinted  as
  amended  and  recommitted  to  said  committee  --  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 -- again reported  from  said  committee
  with  amendments, 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 follow:
  (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-

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD03838-07-6
              

A. 2834--C                          2

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
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.  NOTHING  IN THIS SUBSECTION SHALL
IMPAIR OR PREVENT AN INSURED FROM SEEKING ANY APPEALS 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.
  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 MEDICAL AND SCIENTIFIC EVIDENCE REQUIRED  BY  THIS

A. 2834--C                          3

ARTICLE,  RECOGNIZED  EVIDENCE-BASED  AND  PEER REVIEWED CLINICAL REVIEW
CRITERIA THAT IS APPROPRIATE 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-
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; 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:

A. 2834--C                          4

  (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
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. NOTHING IN THIS SUBDIVI-
SION SHALL IMPAIR OR PREVENT AN ENROLLEE FROM SEEKING ANY APPEALS PURSU-
ANT 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.
  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 MEDICAL AND SCIENTIFIC EVIDENCE REQUIRED BY THIS
ARTICLE, RECOGNIZED EVIDENCE-BASED AND  PEER  REVIEWED  CLINICAL  REVIEW
CRITERIA THAT IS APPROPRIATE 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;

A. 2834--C                          5

  (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-
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; 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.