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

                                  9397

                          I N  A S S E M B L Y

                            February 24, 2012
                               ___________

Introduced by M. of A. TITONE -- 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;
  (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;

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

                                                           LBD06098-04-2

A. 9397                             2

  (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.