S T A T E O F N E W Y O R K
________________________________________________________________________
1805
2009-2010 Regular Sessions
I N A S S E M B L Y
January 12, 2009
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Introduced by M. of A. GOTTFRIED, PAULIN, TITONE, ROSENTHAL, JACOBS,
GUNTHER, FIELDS, MILLMAN, SPANO, JAFFEE, ZEBROWSKI, CAHILL, MAISEL,
SCHROEDER, ESPAILLAT, BRODSKY, GALEF, STIRPE, HOOPER, KELLNER, LUPAR-
DO, ENGLEBRIGHT, BROOK-KRASNY, KOON, SCHIMEL -- Multi-Sponsored by --
M. of A. ALFANO, BACALLES, BARCLAY, BING, BOYLAND, BRENNAN, BURLING,
CALHOUN, COLTON, DelMONTE, DINOWITZ, DUPREY, ERRIGO, GLICK, GORDON,
HEASTIE, LATIMER, McENENY, McKEVITT, J. MILLER, PHEFFER, PRETLOW,
QUINN, REILLY, SAYWARD, SCARBOROUGH, SCOZZAFAVA, SWEENEY, WEISENBERG
-- read once and referred to the Committee on Health
AN ACT to amend the public health law, in relation to establishing the
clinical trial access and education fund
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. The public health law is amended by adding a new section
2424 to read as follows:
S 2424. CLINICAL TRIAL ACCESS AND EDUCATION FUND. 1. DEFINITIONS. FOR
THE PURPOSES OF THIS SECTION, THE FOLLOWING TERMS SHALL HAVE THE FOLLOW-
ING MEANINGS:
A. "ELIGIBLE APPLICANT" MEANS (I) A MEDICAL SCHOOL THAT SPONSORS A
CLINICAL TRIAL, (II) A NOT-FOR-PROFIT ORGANIZATION WITH EXPERIENCE AND
EXPERTISE WORKING WITH PATIENTS WITH LIFE-THREATENING OR DISABLING
CONDITIONS OR DISEASES, (III) A HEALTH CARE PROVIDER ORGANIZATION, ASSO-
CIATION OR SOCIETY, (IV) A GENERAL HOSPITAL DEFINED IN ARTICLE
TWENTY-EIGHT OF THIS CHAPTER, (V) A COUNTY OR CITY HEALTH DEPARTMENT, OR
(VI) A MUNICIPALITY.
B. "CLINICAL TRIAL" SHALL HAVE THE SAME MEANING AS IN SUBDIVISION
TWO-B OF SECTION FORTY-NINE HUNDRED OF THIS CHAPTER.
2. ESTABLISHMENT OF FUND. THERE IS HEREBY ESTABLISHED WITHIN THE
DEPARTMENT A CLINICAL TRIAL ACCESS AND EDUCATION FUND. SUBJECT TO APPRO-
PRIATIONS, THE DEPARTMENT SHALL PROVIDE GRANTS TO ELIGIBLE APPLICANTS ON
A COMPETITIVE REQUEST FOR PROPOSAL BASIS TO PROVIDE ONE OR MORE OF THE
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
A LBD00367-01-9
A. 1805 2
FOLLOWING SERVICES TO PATIENTS WITH LIFE-THREATENING OR DISABLING CONDI-
TIONS OR DISEASES, AS SUCH TERMS ARE DEFINED IN SECTION FORTY-NINE
HUNDRED OF THIS CHAPTER, TO FACILITATE ACCESS TO OR EDUCATION ON CLIN-
ICAL TRIALS OF TREATMENTS FOR THE PATIENT'S CONDITION OR DISEASE:
A. TRANSPORTATION SERVICES AND LODGING TO PROVIDE PATIENTS WITH ACCESS
TO CLINICAL TRIALS OR OTHER RELATED TREATMENTS WHILE ENROLLED IN A CLIN-
ICAL TRIAL OR TO ACCESS TESTING AND OTHER SERVICES TO DETERMINE PATIENT
ELIGIBILITY FOR A CLINICAL TRIAL;
B. PATIENT OUTREACH AND EDUCATION SERVICES TO EDUCATE PATIENTS, THEIR
FAMILIES AND HEALTH CARE PROVIDERS ABOUT THE EXISTENCE OF AND HOW
PATIENTS MAY ENROLL IN CLINICAL TRIALS, UNDER SECTION TWO HUNDRED SEVEN
OF THIS CHAPTER; AND
C. PATIENT NAVIGATION SERVICES TO HELP PATIENTS TO DETERMINE IF THEY
ARE ELIGIBLE FOR CLINICAL TRIALS, TO HELP PATIENTS TO ENROLL IN CLINICAL
TRIALS AND TO ASSIST PATIENTS IN DEALING WITH INSURANCE OR OTHER ISSUES
WHICH SERVE AS BARRIERS TO PATIENT ENROLLMENT IN CLINICAL TRIALS.
3. APPLICATIONS. THE COMMISSIONER SHALL ESTABLISH AN APPLICATION PROC-
ESS BY WHICH ELIGIBLE APPLICANTS MAY APPLY FOR A GRANT UNDER THIS
SECTION. THE APPLICATION SHALL INCLUDE:
A. THE GEOGRAPHIC AREA IN WHICH THE SERVICES SHALL BE PROVIDED;
B. A DETAILED DESCRIPTION OF THE SERVICES TO BE PROVIDED;
C. APPLICANT'S EXPERIENCE WORKING WITH PATIENTS WITH LIFE-THREATENING
OR DISABLING CONDITIONS OR DISEASES;
D. APPLICANT'S ABILITY TO PROVIDE PATIENT OUTREACH OR CLINICAL TRIAL
EDUCATION AND NAVIGATION SERVICES, OR COORDINATE OR PROVIDE TRANSPORTA-
TION AND LODGING FOR PATIENTS; AND
E. ANY OTHER INFORMATION THAT THE COMMISSIONER DEEMS RELEVANT AND
APPROPRIATE.
THE COMMISSIONER SHALL GIVE PREFERENCE TO ELIGIBLE APPLICANTS WHO HAVE
EXPERIENCE AND EXPERTISE WORKING WITH PATIENTS WITH LIFE-THREATENING OR
DISABLING CONDITIONS OR DISEASES AND PROVIDING PATIENT OUTREACH, EDUCA-
TION AND HEALTH CARE NAVIGATION SERVICES.
4. REPORTS. GRANTEES SHALL FILE AN ANNUAL REPORT WITH THE COMMISSION-
ER, IN SUCH FORM AND WITH SUCH INFORMATION AND DATA AS THE COMMISSIONER
PRESCRIBES DETAILING THE EXPENDITURE OF GRANT FUNDS AND SUMMARIZING THE
EFFORTS UNDERTAKEN TO INCREASE PATIENT ACCESS TO CLINICAL TRIALS.
5. THE COMMISSIONER SHALL MAKE REGULATIONS REASONABLY NECESSARY TO
IMPLEMENT THE PROVISIONS OF THIS SECTION.
S 2. This act shall take effect immediately.