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
                               ___________

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.