NY State Senate Bill S3419C

Archive: Last Bill Status - Signed by Governor

Introduced
In Committee
On Floor Calendar
- Passed Senate
- Passed Assembly
Delivered to Governor
Signed by Governor

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Actions

view actions (20)

	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Dec 31, 2016	signed chap.512 approval memo.30
Dec 20, 2016	delivered to governor
Jun 16, 2016	returned to senate passed assembly
Jun 14, 2016	ordered to third reading rules cal.266 substituted for a2834d referred to insurance delivered to assembly passed senate ordered to third reading cal.1675 committee discharged and committed to rules
Jun 07, 2016	print number 3419c
Jun 07, 2016	amend (t) and recommit to insurance
Mar 16, 2016	print number 3419b
Mar 16, 2016	amend and recommit to insurance
Jan 06, 2016	referred to insurance
May 06, 2015	print number 3419a
May 06, 2015	amend (t) and recommit to insurance
Feb 09, 2015	referred to insurance

Votes

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Original

C (Active)

Original

C (Active)

Co-Sponsors

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S3419 - Details

See Assembly Version of this Bill:: A2834
Law Section:: Insurance Law
Laws Affected:: Amd §§3217-a, 4324, 4900, 4902 & 4903, Ins L; amd §§4408, 4900, 4902 & 4903, Pub Health L
Versions Introduced in Other Legislative Sessions:: 2011-2012: S6464
2013-2014: S2711

S3419 - Summary

Relates to expedited utilization review of prescription drugs.

S3419 - Sponsor Memo

BILL NUMBER:S3419

TITLE  OF BILL:  An act to amend the insurance law, in relation to the
regulation of step therapy and first fail policies

PURPOSE: This bill would amend the insurance law by adding Article  33
which  would regulate fail first accident/or health insurance policies
that require a patient to exhaust the  least  expensive  drug  options
before insurers will cover more expensive treatment options.

SUMMARY  OF  PROVISIONS:    This bill would amend the insurance law by
adding a new Article 33 which would ensure prescribers  have  a  clear
and  convenient  process  to  override  step  therapy  under  specific
conditions when medically in the best interest of the patient.

This bill does not  prohibit  step  therapy,  but  rather  establishes
guidelines to ensure providers have an expeditious process to override
step  therapy  in  select  instances where based on sound clinical and
medical evidence and professional medical judgment  providers  believe
it  is  medically  in  the best interest of the patient not to require
failure on an alternative and chemically different therapeutic agent.

In cases where step therapy is required, the bill would limit the time
period a patient could be subjected to step-therapy  (or  required  to
fail on a treatment) to the period deemed necessary by the prescribing
physician to determine the treatment's clinical effectiveness or for a

period no longer than thirty days.

The   amendments   provided   in  this  bill  do  not  impact  generic
substitution authorized by  the  New  York  State  Medicaid  Mandatory
Generic Drug Program.

JUSTIFICATION:    Step  Therapy  or  fail first policies is a practice
which requires the least expensive drug in any class to be  proscribed
to  a  patient  first,  even  if  the  required therapy is a different
therapeutic agent that the patient's physician believes  is  medically
in  the best interest of the patient. If the treatment is ineffective,
insurers will then cover the more expensive treatment options.

There are currently no time limits  or  restrictions  placed  on  fail
first   policies.  Patients,  including  those  with  serious  medical
conditions, can be required to fail for an indefinite period  of  time
before  the  agent  preferred by the physician can be prescribed. This
practice has the potential to result in serious negative  consequences
for  consumers  and the public health system. By limiting the array of
medication options,  both  physicians  and  consumers  are  forced  to
compromise  their treatment decisions in a way that is dangerous, time
consuming and more expensive.

Under fail first, a consumer will often have to fail on  one  or  more
medications  before they are allowed access to the medication that his
or her physician would have tried as an initial treatment. It is  poor
clinical  care  to delay the start of effective treatment and expose a
person to unnecessary risk. In this way, fail  first  denies  patients
the  drugs  they  need  when  they  need  them, and effectively allows
insurers to practice medicine without a license. There are significant
administrative costs' associated with these types of policies and most


importantly, consumers can relapse and require more expensive  medical
interventions such as hospitalization.

The  internal and external appeals process provisions in the insurance
law, Title II (sections 4900-08  and  4910-17),  do  not  provide  the
necessary  protections for patients and physicians regarding access to
treatments restricted by fail first protocols. Title  II  outlines  an
appeal process for an "adverse determination"; however a fail first or
step   therapy   requirement   does   not   qualify   as  an  "adverse
determination"  under  the  definition.  The  existing  appeal   right
addresses  a  determination  later  in the process than a step therapy
override  would.  For  example,  the  step  therapy  override  process
addresses   whether   a  patient  should  be  required  to  try  other
medications before the  desired  treatment  is  covered,  rather  than
whether  the  desired  treatment  is medically necessary and should be
covered at all. The proposed legislation would  expedite  the  process
and allow for an override at an earlier point in the treatment process
than a final adverse determination.

When medically in the best interest of the patient, prescribers need a
clear  process to override the step therapy or fail first requirement.
In cases where step therapy or fail  first  policies  continue  to  be
applied,  the time period a patient could be subjected to step-therapy
(or required to fail on a treatment) should be limited to  the  period
deemed  necessary  by  the  prescribing  physician  to  determine  the
treatment's clinical effectiveness or  a  period  of  no  longer  than
thirty days.

The  following states have recently enacted legislation to prohibit or
limit fail first and step therapy practices when medically in the best
interest   of   the   patient:   Arkansas,   Connecticut,   Louisiana,
Mississippi,  Texas,  Utah, California, and Massachusetts. Patients in
New York currently subject to step therapy and  fail  first  practices
require similar protections.

LEGISLATIVE  HISTORY:  2013/2014: S. 2711A Referred to Insurance 2012:
S.6464/A.9397 Referred to Insurance

FISCAL IMPLICATIONS:  Undetermined at this time.

EFFECTIVE DATE: This act shall take effect 120th day.

S3419 - Bill Text download pdf

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

                                  3419

                       2015-2016 Regular Sessions

                            I N  S E N A T E

                            February 9, 2015
                               ___________

Introduced  by  Sens.  YOUNG, BRESLIN, GOLDEN, LANZA, MARCHIONE, PARKER,
  VALESKY -- read twice and ordered printed,  and  when  printed  to  be
  committed 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;
  (3) CLINICAL OR OTHER FORMULARY, OR PREFERRED DRUG LIST DEVELOPMENT OR
MANAGEMENT;

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

S. 3419                             2

  (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.

Co-Sponsors

view additional co-sponsors

S3419A - Details

See Assembly Version of this Bill:: A2834
Law Section:: Insurance Law
Laws Affected:: Amd §§3217-a, 4324, 4900, 4902 & 4903, Ins L; amd §§4408, 4900, 4902 & 4903, Pub Health L
Versions Introduced in Other Legislative Sessions:: 2011-2012: S6464
2013-2014: S2711

S3419A - Summary

Relates to expedited utilization review of prescription drugs.

S3419A - Sponsor Memo

BILL NUMBER:S3419A

TITLE OF BILL:  An act to amend the insurance law, in relation to the
regulation of step therapy policies

PURPOSE:

This bill would amend the insurance law by adding Article 33 which
would regulate fail first accident/or health insurance policies that
require a patient to exhaust the least expensive drug options before
insurers will cover more expensive treatment options.

SUMMARY OF PROVISIONS:

Section 1 provides legislative findings

Section 2 creates a new Article 33 within the insurance law.

Section 3301 defines key terms.

Section 3302 allows for clinical review criteria to establish a step
therapy protocol based on clinical practice guidelines that meet
specific standards as provided. The guidelines mandate an independent
and transparent process intended to protect the best interests of
patients.

Section 3303 establishes that patients and prescribing doctors shall
have a clear and convenient process to request a step therapy
exception determination (henceforth "override determination"), and the
guidelines by which an insurer or health plan may satisfy that
requirement. Section 3303 further establishes rules for expediting an
override determination. This section also provides rules and
guidelines upon an override determination being granted, to prevent
the misconstruing of this bill's intent by those providing such
determinations, including the retention and annual submission of
specific records to the superintendent of financial services.

Section 3304 establishes that direct providers of health insurance or
health benefit plans shall ensure availability and affordability of
prescription drugs when step therapy protocols require clinical
prerequisites.

Section 3305 allows the superintendent of financial services to
develop rules necessary to enforce the provisions within this bill.

Section 3 establishes the effective date

JUSTIFICATION:

Step Therapy or fail first policies is a practice which requires the
least expensive drug in any class to be proscribed to a patient first,
even if the required therapy is a different therapeutic agent that the
patient's physician believes is medically in the best interest of the
patient. If the treatment is ineffective, insurers will then cover the
more expensive treatment options.


There are currently no time limits or restrictions placed on fail
first policies. Patients, including those with serious medical
conditions, can be required to fail for an indefinite period of time
before the agent preferred by the physician can be prescribed. This
practice has the potential to result in serious negative consequences
for consumers and the public health system. By limiting the array of
medication options, both physicians and consumers are forced to
compromise their treatment decisions in a way that is dangerous, time
consuming and more expensive.

Under fail first, a consumer will often have to fail on one or more
medications before they are allowed access to the medication that his
or her physician would have tried as an initial treatment. It is poor
clinical care to delay the start of effective treatment and expose a
person to unnecessary risk. In this way, fail first denies patients
the drugs they need when they need them, and effectively allows
insurers to practice medicine without a license. There are significant
administrative costs' associated with these types of policies and most
importantly, consumers can relapse and require more expensive medical
interventions such as hospitalization.

The internal and external appeals process provisions in the insurance
law, Title II (sections 4900-08 and 4910-17), do not provide the
necessary protections for patients and physicians regarding access to
treatments restricted by fail first protocols. Title II outlines an
appeal process for an "adverse determination"; however a fail first or
step therapy requirement does not qualify as an "adverse
determination" under the definition. The existing appeal right
addresses a determination later in the process than a step therapy
override would. For example, the step therapy override process
addresses whether a patient should be required to try other
medications before the desired treatment is covered, rather than
whether the desired treatment is medically necessary and should be
covered at all. The proposed legislation would expedite the process
and allow for an override at an earlier point in the treatment process
than a final adverse determination.

When medically in the best interest of the patient, prescribers need a
clear process to override the step therapy or fail first requirement.
In cases where step therapy or fail first policies continue to be
applied, the time period a patient could be subjected to step-therapy
(or required to fail on a treatment) should be limited to the period
deemed necessary by the prescribing physician to determine the
treatment's clinical effectiveness or a period of no longer than
thirty days.

The following states have recently enacted legislation to prohibit or
limit fail first and step therapy practices when medically in the best
interest of the patient: Arkansas, Connecticut, Louisiana,
Mississippi, Texas, Utah, California, and Massachusetts. Patients in
New York currently subject to step therapy and fail first practices
require similar protections.

LEGISLATIVE HISTORY:

2013/2014: S. 2711A Referred to Insurance
2012: S.6464/A.9397 Referred to Insurance


FISCAL IMPLICATIONS:

Undetermined at this time.

EFFECTIVE DATE:

This act shall take effect January 1, 2016.

S3419A - Bill Text download pdf

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

                                 3419--A

                       2015-2016 Regular Sessions

                            I N  S E N A T E

                            February 9, 2015
                               ___________

Introduced  by  Sens.  YOUNG,  AVELLA,  BRESLIN,  GOLDEN, LANZA, LARKIN,
  MARCHIONE, PARKER,  PERKINS,  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

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.
  (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.

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD03838-03-5

S. 3419--A                          2

  (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;
  (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.

S. 3419--A                          3

  (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:
  (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. 3419--A                          4

  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.

Co-Sponsors

view additional co-sponsors

S3419B - Details

See Assembly Version of this Bill:: A2834
Law Section:: Insurance Law
Laws Affected:: Amd §§3217-a, 4324, 4900, 4902 & 4903, Ins L; amd §§4408, 4900, 4902 & 4903, Pub Health L
Versions Introduced in Other Legislative Sessions:: 2011-2012: S6464
2013-2014: S2711

S3419B - Summary

Relates to expedited utilization review of prescription drugs.

S3419B - Sponsor Memo

 BILL NUMBER:  S3419B

 TITLE OF BILL :

An act to amend the insurance law, in relation to the regulation of
step therapy policies

 PURPOSE :

This bill would amend the insurance law by adding Article 33 which
would regulate fail first accident/or health insurance policies that
require a patient to exhaust the least expensive drug options before
insurers will cover more expensive treatment options.

 SUMMARY OF PROVISIONS :

Section 1 provides legislative findings

Section 2 creates a new Article 33 within the insurance law.

Section 3301 defines key terms.

Section 3302 allows for clinical review criteria to establish a step
therapy protocol based on clinical practice guidelines that meet
specific standards as provided. The guidelines mandate an independent
and transparent process intended to protect the best interests of

patients.

Section 3303 establishes that patients and prescribing doctors shall
have a clear and convenient process to request a step therapy
exception determination (henceforth "override determination"), and the
guidelines by which an insurer or health plan may satisfy that
requirement. Section 3303 further establishes rules for expediting an
override determination. This section also provides rules and
guidelines upon an override determination being granted, to prevent
the misconstruing of this bill's intent by those providing such
determinations, including the retention and annual submission of
specific records to the superintendent of financial services.

Section 3304 establishes that direct providers of health insurance or
health benefit plans shall ensure availability and affordability of
prescription drugs when step therapy protocols require clinical
prerequisites.

Section 3305 allows the superintendent of financial services to
develop rules necessary to enforce the provisions within this bill.

Section 3 establishes the effective date

 JUSTIFICATION :

Step Therapy or fail first policies is a practice which requires the
least expensive drug in any class to be proscribed to a patient first,
even if the required therapy is a different therapeutic agent that the
patient's physician believes is medically in the best interest of the
patient. If the treatment is ineffective, insurers will then cover the
more expensive treatment options.

There are currently no time limits or restrictions placed on fail
first policies. Patients, including those with serious medical
conditions, can be required to fail for an indefinite period of time
before the agent preferred by the physician can be prescribed. This
practice has the potential to result in serious negative consequences
for consumers and the public health system. By limiting the array of
medication options, both physicians and consumers are forced to

compromise their treatment decisions in a way that is dangerous, time
consuming and more expensive.

Under fail first, a consumer will often have to fail on one or more
medications before they are allowed access to the medication that his
or her physician would have tried as an initial treatment. It is poor
clinical care to delay the start of effective treatment and expose a
person to unnecessary risk. In this way, fail first denies patients
the drugs they need when they need them, and effectively allows
insurers to practice medicine without a license. There are significant
administrative costs' associated with these types of policies and most
importantly, consumers can relapse and require more expensive medical
interventions such as hospitalization.

The internal and external appeals process provisions in the insurance
law, Title II (sections 4900-08 and 4910-17), do not provide the
necessary protections for patients and physicians regarding access to
treatments restricted by fail first protocols. Title II outlines an
appeal process for an "adverse determination"; however a fail first or
step therapy requirement does not qualify as an "adverse
determination" under the definition. The existing appeal right
addresses a determination later in the process than a step therapy
override would. For example, the step therapy override process
addresses whether a patient should be required to try other
medications before the desired treatment is covered, rather than
whether the desired treatment is medically necessary and should be
covered at all. The proposed legislation would expedite the process
and allow for an override at an earlier point in the treatment process
than a final adverse determination.

When medically in the best interest of the patient, prescribers need a
clear process to override the step therapy or fail first requirement.
In cases where step therapy or fail first policies continue to be
applied, the time period a patient could be subjected to step-therapy
(or required to fail on a treatment) should be limited to the period
deemed necessary by the prescribing physician to determine the
treatment's clinical effectiveness or a period of no longer than
thirty days.

The following states have recently enacted legislation to prohibit or
limit fail first and step therapy practices when medically in the best
interest of the patient: Arkansas, Connecticut, Louisiana,
Mississippi, Texas, Utah, California, and Massachusetts. Patients in
New York currently subject to step therapy and fail first practices
require similar protections.

 LEGISLATIVE HISTORY :

2015: S.3419-A Referred to Insurance
2013/2014: S. 2711A Referred to Insurance
2012: S.6464/A.9397 Referred to Insurance

 FISCAL IMPLICATIONS :

Undetermined at this time.

 EFFECTIVE DATE :
This act shall take effect January 1, 2017.

S3419B - Bill Text download pdf

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

                                 3419--B

                       2015-2016 Regular Sessions

                            I N  S E N A T E

                            February 9, 2015
                               ___________

Introduced  by  Sens.  YOUNG,  AVELLA, BRESLIN, CARLUCCI, GOLDEN, LANZA,
  LARKIN, 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  commit-
  tee  --  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

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.
                                                           LBD03838-04-6

S. 3419--B                          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;
  (B) EXPLAINS THE RELATIONSHIP BETWEEN TREATMENT OPTIONS AND OUTCOMES;

S. 3419--B                          3

  (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:
  (1) THE TOTAL NUMBER OF REQUESTS RECEIVED;

S. 3419--B                          4

  (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.

Co-Sponsors

view additional co-sponsors

S3419C (ACTIVE) - Details

See Assembly Version of this Bill:: A2834
Law Section:: Insurance Law
Laws Affected:: Amd §§3217-a, 4324, 4900, 4902 & 4903, Ins L; amd §§4408, 4900, 4902 & 4903, Pub Health L
Versions Introduced in Other Legislative Sessions:: 2011-2012: S6464
2013-2014: S2711

S3419C (ACTIVE) - Summary

Relates to expedited utilization review of prescription drugs.

S3419C (ACTIVE) - Sponsor Memo

 BILL NUMBER:  S3419C

 TITLE OF BILL :

An act to amend the insurance law and the public health law, in
relation to expedited utilization review of prescription drugs

 PURPOSE OR GENERAL IDEA OF BILL :

The purpose of this bill is to regulate insurance companies, health
maintenance organizations (HMOs), and utilization review agents who
impose step therapy protocols on patients and to provide for an
expedited appeals process for patients and their health care
professionals to override such protocols.

 SUMMARY OF SPECIFIC PROVISIONS :

Sections 1 and 2 amend Section 3217-a (b)(10) and Section 4324 (b)
(10) of the Insurance Law to require health insurance companies to
provide patients and health care professionals with specific written
information on their clinical review criteria relating to a decision
made to utilize a step therapy protocol for a particular patient.

Section 3 amends Section 4900 of the Insurance Law to define key terms
such as "Step therapy protocol override determination" and "Step
therapy protocol." Step therapy protocol means a policy, protocol or

program that establishes the specific sequence in which prescription
drugs for a specified medical condition are approved for a particular
patient. Step therapy protocol override determination means a
determination made by a utilization review agent to override a step
therapy protocol.

Section 4 amends Section 4902 (a) of the Insurance Law by adding a two
new subdivisions (10) and (11). Subdivision 10 requires a utilization
review agent to utilize evidenced-based and peer reviewed clinical
review criteria that is appropriate for a patient's medical condition
when establishing a step therapy protocol. Subdivision 11 requires a
utilization review agent to utilize evidence-based and peer reviewed
clinical review criteria that is appropriate to a particular patient
and such patient's medical condition when making a determination about
whether to override a step therapy protocol.

Section 5 adds three new subsections (c-a), (c-b) and (c-c) to the
Insurance Law to provide an expedited process for patients and health
care providers to override a step therapy protocol. A determination
must be made within 24 hours of the receipt of all information from
the patient and/or health care provider in emergency cases. This
section establishes standards for an override determination. Upon a
determination that the step therapy protocol should be overridden, the
health plan must authorize immediate coverage for the prescription
drug prescribed by the patient's treating health care provider.

Section 6 amends Section 4902 (a) of the Insurance Law to provide that
if an insurance company or utilization review agent fails to respond
within the required timeframes, the appeal shall be deemed granted in
favor of the patient.

Sections 7, 8, 9, 10 and 11 make identical amendments as those
described above to the Public Health Law to regulate step therapy or
fail first protocols imposed by HMOs.

An amendment is made to the Unconsolidated Laws to provide that the
bill shall not be construed to prevent: a health care plan,
utilization review agent, or pharmacy benefit manager from requiring a
patient to try an AB-rated generic equivalent prior to providing
coverage for the equivalent branded prescription drug; or a health
care provider from prescribing a prescription drug that is determined
to be medically appropriate.

Section 11 provides for an effective date of January 1, 2017
applicable to health insurance and health benefit plans delivered,
issued for delivery, or renewed after such date.

 JUSTIFICATION :

The Legislature makes the following findings:

(1) Health insurance plans are increasingly making use of step therapy
or "fail first" 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.

(2) Step therapy protocols, where they are based on well-developed
scientific standards and administered in a flexible manner that takes
into account the individual needs of patients, can play an important
role in controlling health care costs.

(3) In some cases, requiring a patient to follow a step therapy
protocol may have adverse and even dangerous consequences for the
patient who may either not realize a benefit from taking a
prescription drug or may suffer harm from taking an inappropriate
drug.

(4) Without uniform policies in the State for step therapy protocols,
all patients may not receive the equivalent or most appropriate
treatment.

(5) It is imperative that step therapy protocols in the State preserve
the health care provider's right to make treatment decisions in the
best interests of the patient.

(6) Therefore, it is a matter of public interest to require health
insurance companies and utilization review organizations to base step
therapy protocols on appropriate clinical practice guidelines or
published peer review data 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
requesting an excep- tion to a step therapy protocol when the
patients' physician deems appropriate.

The following states have enacted strong laws to prohibit or limit
step therapy or fail first practices: Connecticut, Kentucky,
Louisiana, Maryland, Mississippi, Indiana and Washington. Patients in
New York currently subject to step therapy or fail first practices
require similar protections.

 PRIOR LEGISLATIVE HISTORY :

2015: S.3419-A Referred to Insurance
2013/2014: S. 2711A Referred to Insurance
2012: S.6464/A.9397 Referred to Insurance

 FISCAL IMPLICATIONS :

Undetermined at this time.

 EFFECTIVE DATE :
The act would take effect on January 1, 2017 and apply to health
insurance and health benefit plans delivered, issued for delivery, or
renewed after such date.

S3419C (ACTIVE) - Bill Text download pdf

                    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.

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The New York State Senate

senate Bill S3419C

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Jun 14, 2016 - Rules committee Vote

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senate Bill S3419C

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Sponsored By

Archive: Last Bill Status - Signed by Governor

Your Voice

Actions

Votes

Jun 14, 2016 - floor Vote

Floor Vote: Jun 14, 2016

Jun 14, 2016 - Rules committee Vote

Rules Committee Vote: Jun 14, 2016

Bill Amendments

Co-Sponsors

S3419 - Details

S3419 - Summary

S3419 - Sponsor Memo

S3419 - Bill Text download pdf

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S3419A - Details

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S3419C (ACTIVE) - Details

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