S T A T E O F N E W Y O R K
________________________________________________________________________
8237--C
2011-2012 Regular Sessions
I N A S S E M B L Y
June 8, 2011
___________
Introduced by M. of A. P. RIVERA, CASTRO, CYMBROWITZ, CRESPO, SCARBOR-
OUGH, N. RIVERA, JAFFEE, GIBSON, MOYA, HIKIND, ARROYO, J. RIVERA,
RODRIGUEZ, LINARES, STEVENSON, RAMOS, ROSENTHAL, ABINANTI, PERRY,
MILLMAN, GUNTHER, BURLING, HOOPER, WEISENBERG, SCHIMEL -- Multi-Spon-
sored by -- M. of A. COOK, GLICK, HEASTIE, V. LOPEZ, McDONOUGH, SWEE-
NEY, TITONE -- read once and referred to the Committee on Health --
committee discharged, bill amended, ordered reprinted as amended and
recommitted to said committee -- again reported from said committee
with amendments, ordered reprinted as amended and recommitted to said
committee -- recommitted to the Committee on Health in accordance with
Assembly Rule 3, sec. 2 -- committee discharged, bill amended, ordered
reprinted as amended and recommitted 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:
Section 1. Subdivision 1 of section 364-j of the social services law
is amended by adding a new paragraph (z) to read as follows:
(Z) "PHARMACY AND THERAPEUTICS COMMITTEE". AN INDEPENDENT COMMITTEE
USED BY A MANAGED CARE PROVIDER TO DEVELOP AND MANAGE A FORMULARY OR
PREFERRED DRUG LIST THAT OPERATES PURSUANT TO THE REQUIREMENTS OF SUBDI-
VISION TWENTY-SIX OF THIS SECTION.
S 2. Section 364-j of the social services law is amended by adding two
new subdivisions 26 and 27 to read as follows:
26. NOTWITHSTANDING ANY OTHER PROVISION OF LAW TO THE CONTRARY,
MANAGED CARE PROVIDERS SHALL COVER MEDICALLY NECESSARY PRESCRIPTION
DRUGS AND MEDICAL SUPPLIES IN ACCORDANCE WITH THE FOLLOWING REQUIRE-
MENTS:
(A) A MANAGED CARE PROVIDER MAY UTILIZE A FORMULARY OR PREFERRED DRUG
LIST IN THE ADMINISTRATION OF THIS BENEFIT PROVIDED THAT SUCH FORMULARY
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD11505-11-2
A. 8237--C 2
SHALL HAVE BEEN REVIEWED AND APPROVED BY AN INDEPENDENT PHARMACY AND
THERAPEUTICS COMMITTEE COMPRISED OF MEMBERS FROM VARIOUS CLINICAL
SPECIALTIES THAT ADEQUATELY REPRESENT THE NEEDS OF ENROLLEES INCLUDING,
AT A MINIMUM, THE FOLLOWING CATEGORIES OF MEMBERS:
(I) NEW YORK STATE LICENSED, BOARD CERTIFIED PHYSICIAN PRACTICING IN
THE COMMUNITY AND SERVING THE MEDICAID POPULATION;
(II) NEW YORK STATE LICENSED, BOARD CERTIFIED SPECIALTY PHYSICIANS,
INCLUDING, AT A MINIMUM:
(A) PHYSICIAN WHO IS BOARD CERTIFIED IN CARDIOLOGY, AND
(B) PHYSICIAN WHO IS BOARD CERTIFIED IN PSYCHIATRY;
(III) NEW YORK STATE LICENSED PHARMACIST PRACTICING IN THE COMMUNITY;
AND
(IV) AT LEAST ON A CONSULTING BASIS, AN ADEQUATE NUMBER OF HIGH VOLUME
SPECIALISTS, INCLUDING, BUT NOT LIMITED TO, AN HIV SPECIALIST, DEFINED
AS A PHYSICIAN THAT HAS MET THE CRITERIA OF:
(A) THE HIV MEDICINE ASSOCIATION (HIVMA) DEFINITION OF AN HIV-EXPERI-
ENCED PROVIDER, OR
(B) HIV SPECIALIST STATUS ACCORDED BY THE AMERICAN ACADEMY OF HIV
MEDICINE (AAHIVM).
(B) THE DEPARTMENT OF HEALTH SHALL DEVELOP STANDARDS TO ENSURE THAT
EACH MANAGED CARE PROVIDER'S PHARMACY AND THERAPEUTICS COMMITTEE MEMBERS
COME FROM VARIOUS CLINICAL SPECIALTIES AND ADEQUATELY REPRESENT THE
NEEDS OF PLAN BENEFICIARIES. A MAJORITY OF MEMBERS SHALL BE PRACTICING
PHYSICIANS OR PRACTICING PHARMACISTS LICENSED PURSUANT TO TITLE EIGHT OF
THE EDUCATION LAW. SUCH DEPARTMENT SHALL ALSO DEVELOP STANDARDS TO
ENSURE A TRANSPARENT PROCESS FOR FORMULARY DEVELOPMENT WHICH SHALL
INCLUDE THE OPPORTUNITY FOR PUBLIC COMMENT PRIOR TO ANY CHANGES TO THE
FORMULARY. EACH MANAGED CARE PROVIDER'S COMMITTEE SHALL MEET NO LESS
FREQUENTLY THAN ON A QUARTERLY BASIS AND SHALL MEET THE FOLLOWING
REQUIREMENTS:
(I) MINUTES OF THE MEETINGS SHALL BE MADE AVAILABLE TO THE PUBLIC AND
ON THE APPROPRIATE STATE INTERNET WEBSITE WITHIN TEN BUSINESS DAYS AFTER
SUCH MINUTES ARE APPROVED;
(II) NOT LESS THAN THIRTY DAYS PRIOR TO A MEETING THE PHARMACY AND
THERAPEUTICS COMMITTEE SHALL POST TO THE APPROPRIATE STATE INTERNET
WEBSITE (A) THE MEETING AGENDA, (B) A LIST OF THE DRUG CLASSES TO BE
CONSIDERED AT THE MEETING, AND (C) BACKGROUND MATERIALS AND SUPPORTING
DOCUMENTATION PROVIDED TO THE MEMBERS OF SUCH COMMITTEE WITH RESPECT TO
DRUGS AND DRUG CLASSES THAT ARE BEFORE THE COMMITTEE FOR REVIEW; AND
(III) THE PHARMACY AND THERAPEUTICS COMMITTEE SHALL PROVIDE APPROPRI-
ATE OPPORTUNITY FOR PUBLIC TESTIMONY AT EACH REGULARLY SCHEDULED COMMIT-
TEE MEETING. PRIOR TO DELIBERATING ON ANY RECOMMENDATIONS REGARDING A
DRUG OR A CLASS OF DRUGS, THE COMMITTEE SHALL ACCEPT TESTIMONY, IN WRIT-
ING OR IN PERSON, THAT IS OFFERED BY A MANUFACTURER OF SUCH DRUGS OR
ANOTHER INTERESTED PARTY.
(C) A MANAGED CARE PROVIDER THAT ADOPTS A FORMULARY SHALL COVER
PRESCRIPTION DRUGS IN ALL CATEGORIES AND CLASSES FOR ALL DISEASE STATES
AND PROVIDE A BROAD RANGE OF THERAPEUTIC OPTIONS FOR ALL USP MODEL
GUIDELINES FOR FORMULARY KEY DRUG TYPES AND DESIGNATED DRUG CLASSES,
INCLUDING ALL OR SUBSTANTIALLY ALL DRUGS IN THE ANTIDEPRESSANT, ATYPICAL
ANTIPSYCHOTIC, ANTINEOPLASTIC, ANTICONVULSANT, IMMUNOSUPPRESSANT AND
ANTI-RETROVIRAL CLASSES. A MANAGED CARE PROVIDER SHALL ALSO COVER A
PRESCRIPTION DRUG WHEN THE PHARMACY AND THERAPEUTICS COMMITTEE DETER-
MINES A DRUG IS SIGNIFICANTLY MORE CLINICALLY EFFECTIVE OR SAFE THAN
OTHER DRUGS IN THE CLASS.
A. 8237--C 3
(D) A MANAGED CARE PROVIDER SHALL PROVIDE COVERAGE FOR
NON-PREFERRED/NON-FORMULARY PRESCRIPTION DRUGS THAT WERE PRESCRIBED TO
THE PARTICIPANT TO TREAT A CONDITION THAT IS TREATED ON AN ONGOING
BASIS, EITHER WITH CONTINUOUS MEDICATION OR A MEDICATION TAKEN AS NEEDED
PRIOR TO PRESCRIPTION DRUGS BEING ADDED TO THE MANAGED CARE PROGRAM OR
BEING REMOVED FROM THE FORMULARY.
(E) THE PRIOR AUTHORIZATION SHALL BE PROCESSED, AND A RESPONSE SENT TO
THE REQUESTING PHARMACIST WITHIN TWO BUSINESS DAYS OF SUBMISSION. PRIOR
TO THE COMPLETION OF THE PRIOR AUTHORIZATION PROCESS, A PLAN SHALL COVER
A MINIMUM SEVENTY-TWO HOUR SUPPLY OF THE PRESCRIBED DRUG AND THE PHARMA-
CIST SHALL BE REIMBURSED FOR DISPENSING A SEVENTY-TWO HOUR SUPPLY TO AN
ENROLLEE.
(F) A MANAGED CARE PROVIDER SHALL ONLY IMPLEMENT REASONABLE AND GENER-
ALLY ACCEPTABLE FORMULARY AND UTILIZATION MANAGEMENT INCLUDING, BUT NOT
LIMITED TO, PRIOR AUTHORIZATION, STEP THERAPY AND GENERIC SUBSTITUTIONS;
PROVIDED SUCH TOOLS ARE REVIEWED AND APPROVED BY THE PHARMACY AND THERA-
PEUTICS COMMITTEE BASED ON THE STRENGTH OF SCIENTIFIC EVIDENCE, STAND-
ARDS OF PRACTICE AND NATIONALLY ACCEPTED TREATMENT GUIDELINES.
(G) PRIOR TO REMOVING A COVERED DRUG FROM ITS FORMULARY, A MANAGED
CARE PROVIDER MUST PROVIDE AT LEAST SIXTY DAYS NOTICE TO ENROLLEES,
AUTHORIZED PRESCRIBERS, NETWORK PHARMACIES AND PHARMACISTS PRIOR TO THE
DATE SUCH CHANGE BECOMES EFFECTIVE.
(H) A MANAGED CARE PROVIDER SHALL REVIEW, THROUGH THE PHARMACY AND
THERAPEUTICS COMMITTEE, ALL DRUGS THAT RECEIVE APPROVAL FROM THE FEDERAL
FOOD AND DRUG ADMINISTRATION WITHIN NINETY DAYS OF THEIR RELEASE IN THE
MARKET, AND DECISIONS REGARDING INCLUSION IN ANY FORMULARY OR PREFERRED
DRUG LIST SHALL BE MADE WITHIN ONE HUNDRED EIGHTY DAYS OF THEIR RELEASE
IN THE MARKET. PROVIDED, HOWEVER, THAT IN THE CASE OF THOSE DRUGS WHICH
HAVE RECEIVED PRIORITY EXPEDITED REVIEW AND APPROVAL OF THE FOOD AND
DRUG ADMINISTRATION, A DECISION FOR INCLUSION IN THE FORMULARY OR
PREFERRED DRUG LIST SHALL BE MADE WITHIN NINETY DAYS OF SUCH APPROVAL BY
THE FOOD AND DRUG ADMINISTRATION.
(I) A MANAGED CARE PROVIDER SHALL BE SUBJECT TO AND SHALL USE THE
GRIEVANCE AND APPEALS PROCESS, INCLUDING THE RIGHT TO EXTERNAL REVIEW,
MANDATED BY ARTICLE FORTY-NINE OF THE PUBLIC HEALTH LAW AND TITLE 42 OF
THE CODE OF FEDERAL REGULATIONS, PART 438, UPON RECEIPT OF AN APPEAL OF
A DENIAL OF A REQUESTED PRESCRIPTION DRUG, INCLUDING A DENIAL BASED ON
STEP THERAPY OR FAIL FIRST PROTOCOLS.
(J) ON OR BEFORE APRIL FIRST, TWO THOUSAND THIRTEEN, THE DEPARTMENT OF
HEALTH SHALL DEVELOP STANDARDIZED DRUG PRIOR AUTHORIZATION REQUEST FORMS
TO BE UTILIZED BY HEALTHCARE PROVIDERS, AND ACCEPTED BY MANAGED CARE
ORGANIZATIONS CONTRACTED BY THE STATE. TO THE EXTENT ELECTRONIC
PRESCRIBING SYSTEMS ARE USED, ELECTRONIC PRIOR AUTHORIZATION CAPABILI-
TIES SHALL BE INCORPORATED INTO THE PROGRAM.
27. THE DEPARTMENT OF HEALTH SHALL PREPARE A REPORT NO LATER THAN
EIGHTEEN MONTHS AFTER THE IMPLEMENTATION OF ANY EXPANSION OF MANAGED
CARE TO A NEW POPULATION AND/OR FOR NEW BENEFITS OR SERVICES. THE
DEPARTMENT SHALL POST A DRAFT REPORT ON ITS WEBSITE AND PROVIDE AN
OPPORTUNITY FOR PUBLIC COMMENT. THE FINAL REPORT SHALL BE SUBMITTED TO
THE GOVERNOR AND THE LEGISLATURE, ALONG WITH A DESCRIPTION OF THE PROC-
ESS PROVIDED FOR PUBLIC INPUT. THE REPORT SHALL INCLUDE AN ASSESSMENT OF
THE FOLLOWING:
(A) THE IMPACT OF MANAGED CARE ON PATIENT ACCESS TO CARE, INCLUDING AN
EVALUATION OF ANY BARRIERS TO USE OF SERVICES, INCLUDING PRESCRIPTION
DRUGS, CREATED BY THE USE OF MEDICAL MANAGEMENT OR COST CONTAINMENT
TOOLS;
A. 8237--C 4
(B) THE IMPACT OF THE MANAGED CARE EXPANSION ON UTILIZATION OF
SERVICES, QUALITY OF CARE AND PATIENT OUTCOMES; AND
(C) THE USE OF PRIOR AUTHORIZATION AND OTHER UTILIZATION MANAGEMENT
TOOLS, INCLUDING AN ASSESSMENT OF WHETHER THESE TOOLS POSE AN UNDUE
ADMINISTRATIVE BURDEN FOR PHYSICIANS AND/OR CREATE BARRIERS TO NEEDED
CARE.
S 3. This act shall take effect immediately; provided, however, that
the amendments to section 364-j of the social services law made by
sections one and two of this act shall not affect the repeal of such
section and shall be deemed repealed therewith.