S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   2538
 
                        2017-2018 Regular Sessions
 
                           I N  A S S E M B L Y
 
                             January 20, 2017
                                ___________
 
 Introduced  by  M.  of A. GOTTFRIED, PAULIN, GUNTHER, ROSENTHAL, CAHILL,
   GALEF,  ENGLEBRIGHT,  JAFFEE,  ZEBROWSKI,  HOOPER,  LUPARDO,   TITONE,
   ABINANTI,  PERRY,  WEPRIN,  KEARNS, McDONALD, SEPULVEDA -- Multi-Spon-
   sored by -- M.  of A. CARROLL -- read once and referred to the Commit-
   tee 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:
   § 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.
              

                                                            LBD02083-01-7

 A. 2538                             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.
   § 2. This act shall take effect immediately.