Bill Text: NY S05646 | 2011-2012 | General Assembly | Amended


Bill Title: Requires medical assistance managed care providers to provide coverage for medically necessary prescription drugs and medical supplies.

Spectrum: Slight Partisan Bill (Democrat 2-1)

Status: (Engrossed - Dead) 2012-01-04 - REFERRED TO HEALTH [S05646 Detail]

Download: New_York-2011-S05646-Amended.html
                           S T A T E   O F   N E W   Y O R K
       ________________________________________________________________________
                                        5646--A
                              2011-2012 Regular Sessions
                                   I N  S E N A T E
                                     June 8, 2011
                                      ___________
       Introduced  by  Sens.  HANNON, PARKER -- read twice and ordered printed,
         and when printed to be committed to the Committee on Health -- commit-
         tee discharged, bill amended, ordered reprinted as amended and  recom-
         mitted to said committee
       AN  ACT  to  amend  the  social  services  law, in relation to requiring
         managed care providers to  provide  coverage  of  medically  necessary
         prescription drugs and medical supplies
         THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
       BLY, DO ENACT AS FOLLOWS:
    1    Section 1. Subdivision 1 of section 364-j of the social  services  law
    2  is amended by adding a new paragraph (z) to read as follows:
    3    (Z)  "PHARMACY  AND  THERAPEUTICS COMMITTEE". AN INDEPENDENT COMMITTEE
    4  USED BY A MANAGED CARE PROVIDER TO DEVELOP AND  MANAGE  A  FORMULARY  OR
    5  PREFERRED DRUG LIST THAT OPERATES PURSUANT TO THE REQUIREMENTS OF SUBDI-
    6  VISION TWENTY-FIVE OF THIS SECTION.
    7    S 2. Section 364-j of the social services law is amended by adding two
    8  new subdivisions 25 and 26 to read as follows:
    9    25.  NOTWITHSTANDING  ANY  OTHER  PROVISION  OF  LAW  TO THE CONTRARY,
   10  MANAGED CARE PROVIDERS  SHALL  COVER  MEDICALLY  NECESSARY  PRESCRIPTION
   11  DRUGS  AND  MEDICAL  SUPPLIES  IN ACCORDANCE WITH THE FOLLOWING REQUIRE-
   12  MENTS:
   13    (A) A MANAGED CARE PROVIDER MAY UTILIZE A FORMULARY OR PREFERRED  DRUG
   14  LIST  IN THE ADMINISTRATION OF THIS BENEFIT PROVIDED THAT SUCH FORMULARY
   15  SHALL HAVE BEEN REVIEWED AND APPROVED BY  A  PHARMACY  AND  THERAPEUTICS
   16  COMMITTEE  COMPRISED  OF  MEMBERS FROM VARIOUS CLINICAL SPECIALTIES THAT
   17  ADEQUATELY REPRESENT THE NEEDS OF ENROLLEES INCLUDING, AT A MINIMUM, THE
   18  FOLLOWING CATEGORIES OF MEMBERS:
   19    (I) NEW YORK STATE LICENSED, BOARD CERTIFIED PHYSICIAN  PRACTICING  IN
   20  THE COMMUNITY AND SERVING THE MEDICAID POPULATION;
   21    (II)  NEW  YORK  STATE LICENSED, BOARD CERTIFIED SPECIALTY PHYSICIANS,
   22  INCLUDING, AT A MINIMUM:
        EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                             [ ] is old law to be omitted.
                                                                  LBD11505-07-1
       S. 5646--A                          2
    1    (A) PHYSICIAN WHO IS BOARD CERTIFIED IN CARDIOLOGY, AND
    2    (B) PHYSICIAN WHO IS BOARD CERTIFIED IN PSYCHIATRY;
    3    (III)  NEW YORK STATE LICENSED PHARMACIST PRACTICING IN THE COMMUNITY;
    4  AND
    5    (IV) AT LEAST ON A CONSULTING BASIS, AN ADEQUATE NUMBER OF HIGH VOLUME
    6  SPECIALISTS, INCLUDING, BUT NOT LIMITED TO, AN HIV  SPECIALIST,  DEFINED
    7  AS A PHYSICIAN THAT HAS MET THE CRITERIA OF:
    8    (A)  THE HIV MEDICINE ASSOCIATION (HIVMA) DEFINITION OF AN HIV-EXPERI-
    9  ENCED PROVIDER, OR
   10    (B) HIV SPECIALIST STATUS ACCORDED BY  THE  AMERICAN  ACADEMY  OF  HIV
   11  MEDICINE (AAHIVM).
   12    (B)  THE  DEPARTMENT  OF HEALTH SHALL DEVELOP STANDARDS TO ENSURE THAT
   13  EACH MANAGED CARE PROVIDER'S PHARMACY AND THERAPEUTICS COMMITTEE MEMBERS
   14  COME FROM VARIOUS CLINICAL  SPECIALTIES  AND  ADEQUATELY  REPRESENT  THE
   15  NEEDS  OF  PLAN BENEFICIARIES. A MAJORITY OF MEMBERS SHALL BE PRACTICING
   16  PHYSICIANS OR PRACTICING PHARMACISTS LICENSED PURSUANT TO TITLE EIGHT OF
   17  THE EDUCATION LAW. SUCH  DEPARTMENT  SHALL  ALSO  DEVELOP  STANDARDS  TO
   18  ENSURE  A  TRANSPARENT  PROCESS  FOR  FORMULARY  DEVELOPMENT WHICH SHALL
   19  INCLUDE THE OPPORTUNITY FOR PUBLIC COMMENT PRIOR TO ANY CHANGES  TO  THE
   20  FORMULARY.    EACH  MANAGED CARE PROVIDER'S COMMITTEE SHALL MEET NO LESS
   21  FREQUENTLY THAN ON A QUARTERLY BASIS. MINUTES OF THE MEETINGS  SHALL  BE
   22  MADE  AVAILABLE TO THE PUBLIC WITHIN TEN BUSINESS DAYS AFTER THE MINUTES
   23  ARE APPROVED.
   24    (C) A MANAGED CARE  PROVIDER  THAT  ADOPTS  A  FORMULARY  SHALL  COVER
   25  PRESCRIPTION  DRUGS IN ALL CATEGORIES AND CLASSES FOR ALL DISEASE STATES
   26  AND PROVIDE A BROAD RANGE OF  THERAPEUTIC  OPTIONS  FOR  ALL  USP  MODEL
   27  GUIDELINES  FOR  FORMULARY  KEY  DRUG TYPES AND DESIGNATED DRUG CLASSES,
   28  INCLUDING ALL OR SUBSTANTIALLY ALL DRUGS IN THE ANTIDEPRESSANT, ATYPICAL
   29  ANTIPSYCHOTIC,  ANTINEOPLASTIC,  ANTICONVULSANT,  IMMUNOSUPPRESSANT  AND
   30  ANTI-RETROVIRAL  CLASSES.  A  MANAGED  CARE  PROVIDER SHALL ALSO COVER A
   31  PRESCRIPTION DRUG WHEN THE PHARMACY AND  THERAPEUTICS  COMMITTEE  DETER-
   32  MINES  A  DRUG  IS  SIGNIFICANTLY MORE CLINICALLY EFFECTIVE OR SAFE THAN
   33  OTHER DRUGS IN THE CLASS.
   34    (D) A MANAGED CARE PROVIDER SHALL PROVIDE COVERAGE FOR NOT LESS THAN A
   35  NINE MONTH SUPPLY OF NON-PREFERRED/NON-FORMULARY PRESCRIPTION DRUGS THAT
   36  WERE PRESCRIBED TO THE PARTICIPANT TO TREAT A CONDITION THAT IS  TREATED
   37  ON  AN  ONGOING BASIS, EITHER WITH CONTINUOUS MEDICATION OR A MEDICATION
   38  TAKEN AS NEEDED PRIOR TO PRESCRIPTION DRUGS BEING ADDED TO  THE  MANAGED
   39  CARE PROGRAM OR BEING REMOVED FROM THE FORMULARY.
   40    (E) THE PRIOR AUTHORIZATION SHALL BE PROCESSED, AND A RESPONSE SENT TO
   41  THE  REQUESTING PHARMACIST WITHIN TWO BUSINESS DAYS OF SUBMISSION. PRIOR
   42  TO THE COMPLETION OF THE PRIOR AUTHORIZATION PROCESS, A PLAN SHALL COVER
   43  A MINIMUM SEVENTY-TWO HOUR SUPPLY OF THE PRESCRIBED DRUG AND THE PHARMA-
   44  CIST SHALL BE REIMBURSED FOR DISPENSING A SEVENTY-TWO HOUR SUPPLY TO  AN
   45  ENROLLEE.
   46    (F) A MANAGED CARE PROVIDER SHALL ONLY IMPLEMENT REASONABLE AND GENER-
   47  ALLY  ACCEPTABLE FORMULARY AND UTILIZATION MANAGEMENT INCLUDING, BUT NOT
   48  LIMITED TO, PRIOR AUTHORIZATION, STEP THERAPY AND GENERIC SUBSTITUTIONS;
   49  PROVIDED SUCH TOOLS ARE REVIEWED AND APPROVED BY THE PHARMACY AND THERA-
   50  PEUTICS COMMITTEE BASED ON THE STRENGTH OF SCIENTIFIC  EVIDENCE,  STAND-
   51  ARDS OF PRACTICE AND NATIONALLY ACCEPTED TREATMENT GUIDELINES.
   52    (G)  PRIOR  TO  REMOVING  A COVERED DRUG FROM ITS FORMULARY, A MANAGED
   53  CARE PROVIDER MUST PROVIDE AT LEAST  SIXTY  DAYS  NOTICE  TO  ENROLLEES,
   54  AUTHORIZED  PRESCRIBERS, NETWORK PHARMACIES AND PHARMACISTS PRIOR TO THE
   55  DATE SUCH CHANGE BECOMES EFFECTIVE.
       S. 5646--A                          3
    1    (H) A MANAGED CARE PROVIDER SHALL REVIEW,  THROUGH  THE  PHARMACY  AND
    2  THERAPEUTICS COMMITTEE, ALL DRUGS THAT RECEIVE APPROVAL FROM THE FEDERAL
    3  FOOD  AND DRUG ADMINISTRATION WITHIN NINETY DAYS OF THEIR RELEASE IN THE
    4  MARKET, AND DECISIONS REGARDING INCLUSION IN ANY FORMULARY OR  PREFERRED
    5  DRUG  LIST SHALL BE MADE WITHIN ONE HUNDRED EIGHTY DAYS OF THEIR RELEASE
    6  IN THE MARKET.  PROVIDED, HOWEVER, THAT IN THE CASE OF THOSE DRUGS WHICH
    7  HAVE RECEIVED PRIORITY EXPEDITED REVIEW AND APPROVAL  OF  THE  FOOD  AND
    8  DRUG  ADMINISTRATION,  A  DECISION  FOR  INCLUSION  IN  THE FORMULARY OR
    9  PREFERRED DRUG LIST SHALL BE MADE WITHIN NINETY DAYS OF SUCH APPROVAL BY
   10  THE FOOD AND DRUG ADMINISTRATION.
   11    (I) A MANAGED CARE PROVIDER SHALL BE SUBJECT  TO  AND  SHALL  USE  THE
   12  GRIEVANCE  AND  APPEALS PROCESS, INCLUDING THE RIGHT TO EXTERNAL REVIEW,
   13  MANDATED BY ARTICLE FORTY-NINE OF THE PUBLIC HEALTH LAW AND TITLE 42  OF
   14  THE  CODE OF FEDERAL REGULATIONS, PART 438, UPON RECEIPT OF AN APPEAL OF
   15  A DENIAL OF A REQUESTED PRESCRIPTION DRUG, INCLUDING A DENIAL  BASED  ON
   16  STEP THERAPY OR FAIL FIRST PROTOCOLS.
   17    (J) ON OR BEFORE JANUARY FIRST, TWO THOUSAND TWELVE, THE DEPARTMENT OF
   18  HEALTH SHALL DEVELOP STANDARDIZED DRUG PRIOR AUTHORIZATION REQUEST FORMS
   19  TO  BE  UTILIZED  BY  HEALTHCARE PROVIDERS, AND ACCEPTED BY MANAGED CARE
   20  ORGANIZATIONS CONTRACTED BY THE STATE, THROUGH SECURE ELECTRONIC  TRANS-
   21  MISSIONS.  TO  THE EXTENT ELECTRONIC PRESCRIBING SYSTEMS ARE USED, ELEC-
   22  TRONIC PRIOR AUTHORIZATION CAPABILITIES SHALL BE INCORPORATED  INTO  THE
   23  PROGRAM.
   24    26.  THE  DEPARTMENT  OF  HEALTH  SHALL PREPARE A REPORT NO LATER THAN
   25  EIGHTEEN MONTHS AFTER THE IMPLEMENTATION OF  ANY  EXPANSION  OF  MANAGED
   26  CARE  TO  A  NEW  POPULATION  AND/OR  FOR  NEW BENEFITS OR SERVICES. THE
   27  DEPARTMENT SHALL POST A DRAFT REPORT  ON  ITS  WEBSITE  AND  PROVIDE  AN
   28  OPPORTUNITY  FOR  PUBLIC COMMENT. THE FINAL REPORT SHALL BE SUBMITTED TO
   29  THE GOVERNOR AND THE LEGISLATURE, ALONG WITH A DESCRIPTION OF THE  PROC-
   30  ESS PROVIDED FOR PUBLIC INPUT. THE REPORT SHALL INCLUDE AN ASSESSMENT OF
   31  THE FOLLOWING:
   32    (A) THE IMPACT OF MANAGED CARE ON PATIENT ACCESS TO CARE, INCLUDING AN
   33  EVALUATION  OF  ANY  BARRIERS TO USE OF SERVICES, INCLUDING PRESCRIPTION
   34  DRUGS, CREATED BY THE USE OF  MEDICAL  MANAGEMENT  OR  COST  CONTAINMENT
   35  TOOLS;
   36    (B)  THE  IMPACT  OF  THE  MANAGED  CARE  EXPANSION  ON UTILIZATION OF
   37  SERVICES, QUALITY OF CARE AND PATIENT OUTCOMES; AND
   38    (C) THE USE OF PRIOR AUTHORIZATION AND  OTHER  UTILIZATION  MANAGEMENT
   39  TOOLS,  INCLUDING  AN  ASSESSMENT  OF  WHETHER THESE TOOLS POSE AN UNDUE
   40  ADMINISTRATIVE BURDEN FOR PHYSICIANS AND/OR CREATE  BARRIERS  TO  NEEDED
   41  CARE.
   42    S  3.  This act shall take effect immediately; provided, however, that
   43  the amendments to section 364-j of  the  social  services  law  made  by
   44  sections  one  and  two  of this act shall not affect the repeal of such
   45  section and shall be deemed repealed therewith.
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