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.