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

                                  5214

                       2013-2014 Regular Sessions

                          I N  A S S E M B L Y

                            February 21, 2013
                               ___________

Introduced  by  M. of A. TITONE -- Multi-Sponsored by -- M. of A. BARRON
  -- 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, INCLUDING MANAGED CARE PROVIDERS AS DEFINED IN SECTION THREE
HUNDRED SIXTY-FOUR-J OF THE SOCIAL SERVICES 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.
                                                           LBD05355-01-3

              

A. 5214                             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 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) FOR MEDICATIONS WITH NO GENERIC EQUIVALENT AND FOR WHICH THE PRES-
CRIBER IN HIS OR HER CLINICAL  JUDGMENT  BELIEVES  THAT  NO  APPROPRIATE
THERAPEUTIC  ALTERNATIVE  IS  AVAILABLE, AN INSURER OR PBM SHALL PROVIDE
ACCESS TO UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA) LABELED MEDI-
CATIONS WITHOUT RESTRICTION TO TREAT SUCH MEDICAL CONDITIONS  FOR  WHICH
AN FDA LABELED MEDICATION IS AVAILABLE.
  (D)  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.