Bill Text: NY A09397 | 2011-2012 | General Assembly | Introduced

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Bill Title: Regulates step therapy and first fail health insurance policies and contracts.

Spectrum: Slight Partisan Bill (Democrat 20-7)

Status: (Introduced - Dead) 2012-02-24 - referred to insurance [A09397 Detail]

Download: New_York-2011-A09397-Introduced.html

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                           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:
    1    Section 1. The insurance law is amended by adding a new article 33  to
    2  read as follows:
    3                                 ARTICLE 33
    4                       REGULATION OF STEP THERAPY AND
    5                             FIRST FAIL POLICIES
    6  SECTION 3301. DEFINITIONS.
    7          3302. PRESCRIPTION DRUG RESTRICTION OVERRIDES.
    8    S 3301. DEFINITIONS. AS USED IN THIS ARTICLE:
    9    (A)  "INSURER"  SHALL MEAN ANY PERSON OR ENTITY WHO OFFERS A POLICY OF
   10  ACCIDENT AND/OR HEALTH INSURANCE PURSUANT TO SECTION THREE THOUSAND  TWO
   11  HUNDRED SIXTEEN, THREE THOUSAND TWO HUNDRED TWENTY-ONE, OR FOUR THOUSAND
   12  THREE  HUNDRED THREE OF THIS CHAPTER OR ARTICLE FORTY-FOUR OF THE PUBLIC
   13  HEALTH LAW, INCLUDING MANAGED CARE PROVIDERS AS DEFINED IN SECTION THREE
   14  HUNDRED SIXTY-FOUR-J OF THE SOCIAL SERVICES LAW;
   15    (B) "PHARMACY BENEFIT MANAGEMENT" OR  "PBM"  SHALL  MEAN  THE  SERVICE
   16  PROVIDED  TO  AN  INSURER, DIRECTLY OR THROUGH ANOTHER ENTITY; INCLUDING
   17  THE PROCUREMENT  OF  PRESCRIPTION  DRUGS  TO  BE  DISPENSED  TO  COVERED
   18  PERSONS,  OR THE ADMINISTRATION OR MANAGEMENT OF PRESCRIPTION DRUG BENE-
   19  FITS INCLUDING, BUT NOT LIMITED TO, ANY OF THE FOLLOWING:
   20    (1) A MAIL ORDER PHARMACY;
   21    (2) CLAIMS PROCESSING, RETAIL NETWORK MANAGEMENT AND PAYMENT OF CLAIMS
   22  TO PHARMACIES FOR DISPENSING PRESCRIPTION DRUGS;
   23    (3) CLINICAL OR OTHER FORMULARY, OR PREFERRED DRUG LIST DEVELOPMENT OR
   24  MANAGEMENT;
   25    (4) NEGOTIATION  OR  ADMINISTRATION  OF  REBATES,  DISCOUNTS,  PAYMENT
   26  DIFFERENTIALS  OR  OTHER  INCENTIVES  FOR  THE  INCLUSION  OF PARTICULAR
   27  PRESCRIPTION DRUGS IN A PARTICULAR CATEGORY OR TO PROMOTE  THE  PURCHASE
   28  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
    1    (5)  PATIENT  COMPLIANCE, THERAPEUTIC INTERVENTION AND GENERIC SUBSTI-
    2  TUTION PROGRAMS; AND
    3    (6) DISEASE MANAGEMENT.
    4    S  3302. PRESCRIPTION DRUG RESTRICTION OVERRIDES. (A) WHEN MEDICATIONS
    5  FOR THE TREATMENT OF ANY MEDICAL CONDITION ARE RESTRICTED FOR USE BY  AN
    6  INSURER  OR  PBM  BY A STEP THERAPY OR FAIL FIRST PROTOCOL, A PRESCRIBER
    7  SHALL HAVE ACCESS TO A CLEAR AND CONVENIENT  PROCESS  TO  OVERRIDE  SUCH
    8  RESTRICTIONS  FROM  THE  INSURER  AND  MAY  EXPEDITIOUSLY  OVERRIDE SUCH
    9  RESTRICTION IF:
   10    (1) SUCH PRESCRIBER, IN HIS OR  HER  PROFESSIONAL  JUDGMENT,  BELIEVES
   11  THAT THE PREFERRED TREATMENT BY THE INSURER OR THE PBM HAS BEEN INEFFEC-
   12  TIVE  IN THE TREATMENT OF THE COVERED PERSON'S DISEASE OR MEDICAL CONDI-
   13  TION; OR
   14    (2) BASED ON  SOUND  CLINICAL  EVIDENCE  AND  MEDICAL  AND  SCIENTIFIC
   15  EVIDENCE:
   16    (A)  SUCH  PRESCRIBER,  IN  HIS OR HER PROFESSIONAL JUDGMENT, BELIEVES
   17  THAT THE PREFERRED TREATMENT IS EXPECTED TO BE INEFFECTIVE BASED ON  THE
   18  KNOWN  RELEVANT PHYSICAL OR MENTAL CHARACTERISTICS OF THE COVERED PERSON
   19  AND KNOWN CHARACTERISTICS OF THE DRUG REGIMEN, AND IS LIKELY TO BE INEF-
   20  FECTIVE OR ADVERSELY AFFECT THE DRUG'S EFFECTIVENESS OR PATIENT  COMPLI-
   21  ANCE; OR
   22    (B)  SUCH  PRESCRIBER,  IN  HIS OR HER PROFESSIONAL JUDGMENT, BELIEVES
   23  THAT THE PREFERRED TREATMENT HAS CAUSED OR IS LIKELY TO CAUSE AN ADVERSE
   24  REACTION OR OTHER HARM TO THE COVERED PERSON.
   25    (B) THE DURATION OF ANY STEP THERAPY OR FAIL FIRST PROTOCOL SHALL  NOT
   26  BE LONGER THAN EITHER (1) THE PERIOD DEEMED NECESSARY BY THE PRESCRIBING
   27  PHYSICIAN OR HEALTH CARE PROFESSIONAL TO DETERMINE THE TREATMENT'S CLIN-
   28  ICAL EFFECTIVENESS, OR (2) A PERIOD OF THIRTY DAYS.
   29    (C) FOR MEDICATIONS WITH NO GENERIC EQUIVALENT AND FOR WHICH THE PRES-
   30  CRIBER  IN  HIS  OR  HER  CLINICAL JUDGMENT BELIEVES THAT NO APPROPRIATE
   31  THERAPEUTIC ALTERNATIVE IS AVAILABLE, AN INSURER OR  PBM  SHALL  PROVIDE
   32  ACCESS TO UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA) LABELED MEDI-
   33  CATIONS  WITHOUT  RESTRICTION TO TREAT SUCH MEDICAL CONDITIONS FOR WHICH
   34  AN FDA LABELED MEDICATION IS AVAILABLE.
   35    (D) NOTHING IN THIS SECTION SHALL REQUIRE COVERAGE FOR  AN  ADDITIONAL
   36  CONDITION NOT ALREADY COVERED BY THE POLICY OR CONTRACT, OR WHICH IS NOT
   37  OTHERWISE COVERED BY LAW.
   38    S 2. This act shall take effect on the one hundred twentieth day after
   39  it shall have become a law.