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

                                  2688

                       2013-2014 Regular Sessions

                          I N  A S S E M B L Y

                            January 17, 2013
                               ___________

Introduced  by  M.  of A. GOTTFRIED, PAULIN, JACOBS, GUNTHER, ROSENTHAL,
  CAHILL, GALEF, ENGLEBRIGHT, MILLMAN, JAFFEE, ZEBROWSKI, MAISEL,  HOOP-
  ER,  LUPARDO, SCHIMEL, TITONE, CASTRO, KELLNER, BROOK-KRASNY, ABINANTI
  -- 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
HUNDRED  OF  THIS CHAPTER, TO FACILITATE ACCESS TO OR EDUCATION ON CLIN-
ICAL TRIALS OF TREATMENTS FOR THE PATIENT'S CONDITION OR DISEASE:

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD01585-01-3

              

A. 2688                             2

  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.