S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  180--A
 
                        2021-2022 Regular Sessions
 
                           I N  A S S E M B L Y
 
                                (PREFILED)
 
                              January 6, 2021
                                ___________
 
 Introduced by M. of A. GOTTFRIED, PAULIN, GUNTHER, L. ROSENTHAL, CAHILL,
   GALEF,  ENGLEBRIGHT,  ZEBROWSKI,  LUPARDO,  ABINANTI,  WEPRIN, SAYEGH,
   SALKA, SEAWRIGHT -- Multi-Sponsored by -- M. of  A.  CARROLL  --  read
   once  and referred to the Committee on Health -- reported and referred
   to the Committee on Ways and Means -- recommitted to the Committee  on
   Ways and Means in accordance with Assembly Rule 3, sec. 2 -- committee
   discharged, bill amended, ordered reprinted as amended and recommitted
   to said committee
 
 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.
   C.  "ANCILLARY  COSTS"  MEANS COSTS ASSOCIATED WITH PARTICIPATION IN A
 CLINICAL TRIAL, INCLUDING BUT NOT LIMITED TO COSTS FOR:
   (I) TRAVEL;
   (II) LODGING;

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

                                                            LBD00038-02-2
 A. 180--A                           2
 
   (III) PARKING AND TOLLS;
   (IV)  A  TRAVEL  COMPANION  TO  ASSIST  PATIENTS WHO ARE ELDERLY, VERY
 YOUNG, OR TOO ILL TO TRAVEL ALONE; AND
   (V) OTHER COSTS CONSIDERED APPROPRIATE JOINTLY BY THE DEPARTMENT,  THE
 SERVICE PROVIDING ORGANIZATION AND THE TRIAL SITE.
   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:
   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. A.   THE COMMISSIONER SHALL ESTABLISH AN APPLICATION
 PROCESS BY WHICH ELIGIBLE APPLICANTS MAY APPLY FOR A  GRANT  UNDER  THIS
 SECTION.  THE APPLICATION SHALL INCLUDE:
   (I) THE GEOGRAPHIC AREA IN WHICH THE SERVICES SHALL BE PROVIDED;
   (II) A DETAILED DESCRIPTION OF THE SERVICES TO BE PROVIDED;
   (III) APPLICANT'S EXPERIENCE WORKING WITH PATIENTS WITH LIFE-THREATEN-
 ING OR DISABLING CONDITIONS OR DISEASES;
   (IV) 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
   (V) ANY OTHER INFORMATION THAT THE  COMMISSIONER  DEEMS  RELEVANT  AND
 APPROPRIATE.
   B. ELIGIBLE APPLICANTS SHALL:
   (I)  HAVE  EXPERIENCE  AND  EXPERTISE WORKING WITH PATIENTS WITH LIFE-
 THREATENING OR DISABLING CONDITIONS OR DISEASES;
   (II) PROVIDE PATIENT OUTREACH, EDUCATION AND  HEALTH  CARE  NAVIGATION
 SERVICES;
   (III) COLLABORATE WITH PHYSICIANS, HEALTH CARE PROVIDERS, AND CLINICAL
 TRIAL SPONSORS TO NOTIFY A PROSPECTIVE SUBJECT ABOUT THE PROGRAM WHEN:
   (1) THE PROSPECTIVE SUBJECT CONSENTS TO A CLINICAL TRIAL; AND
   (2) FUNDING IS AVAILABLE TO PROVIDE THE PROGRAM FOR THE CLINICAL TRIAL
 IN WHICH THE PROSPECTIVE SUBJECT PARTICIPATES; AND
   (IV)  REIMBURSE  SUBJECTS  BASED  ON  FINANCIAL NEED TO SUBJECTS WHOSE
 INCOME IS AT OR BELOW SEVEN  HUNDRED  PERCENT  OF  THE  FEDERAL  POVERTY
 LEVEL, WHICH SHALL INCLUDE REIMBURSEMENT FOR REASONABLE ANCILLARY COSTS.
   4.  INSTITUTIONAL  REVIEW  BOARD REQUIREMENTS. A REIMBURSEMENT PROGRAM
 UNDER THIS SECTION SHALL:
   A. BE APPROVED BY THE INSTITUTIONAL REVIEW BOARD ASSOCIATED  WITH  THE
 CLINICAL TRIAL; AND
   B. COMPLY WITH APPLICABLE FEDERAL AND STATE LAWS.
 A. 180--A                           3
 
   5.  REIMBURSEMENT. REIMBURSEMENT TO A SUBJECT OF ANCILLARY COSTS UNDER
 THE PROGRAM:
   A.  DOES  NOT CONSTITUTE AN UNDUE INDUCEMENT TO PARTICIPATE IN A CLIN-
 ICAL TRIAL;
   B. IS NOT CONSIDERED COERCION OR THE EXERTION OF  UNDUE  INFLUENCE  TO
 PARTICIPATE IN A CLINICAL TRIAL; AND
   C.  IS  MEANT  TO  ACCOMPLISH  PARITY IN ACCESS TO CLINICAL TRIALS AND
 REMOVE BARRIERS TO PARTICIPATION  IN  CLINICAL  TRIALS  FOR  FINANCIALLY
 BURDENED SUBJECTS.
   6.  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.
   7. REGULATIONS.  THE COMMISSIONER SHALL  MAKE  REGULATIONS  REASONABLY
 NECESSARY TO IMPLEMENT THE PROVISIONS OF THIS SECTION.
   § 2. This act shall take effect immediately.