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

                                   807

                       2011-2012 Regular Sessions

                          I N  A S S E M B L Y

                               (PREFILED)

                             January 5, 2011
                               ___________

Introduced  by  M.  of A. GOTTFRIED, PAULIN, JACOBS, GUNTHER, ROSENTHAL,
  CAHILL, GALEF, N. RIVERA, ENGLEBRIGHT, MILLMAN, SPANO, JAFFEE, ZEBROW-
  SKI,  MAISEL,  HOOPER,  LUPARDO,  SCHIMEL,  TITONE,  CASTRO,  KELLNER,
  BROOK-KRASNY,  SCHROEDER -- 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
FOLLOWING SERVICES TO PATIENTS WITH LIFE-THREATENING OR DISABLING CONDI-
TIONS OR DISEASES, AS SUCH  TERMS  ARE  DEFINED  IN  SECTION  FORTY-NINE

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD02358-01-1
              

A. 807                              2

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.