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Bill No.: Summary Actions Committee&nbspVotes Floor&nbspVotes Memo Text LFIN Chamber&nbspVideo/Transcript S05401 Summary: BILL NO S05401 &nbsp SAME AS No Same As &nbsp SPONSOR RIVERA &nbsp COSPNSR SEPULVEDA &nbsp MLTSPNSR &nbsp Add §2424, Pub Health L &nbsp Establishes the clinical trial access and education fund to provide grants to eligible applicants to provide certain services for patients with life-threatening or disabling conditions or diseases.

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STATE OF NEW YORK ________________________________________________________________________

5401

2025-2026 Regular Sessions

IN SENATE

February 21, 2025 ___________

Introduced by Sens. RIVERA, SEPULVEDA -- read twice and ordered printed, and when printed to be committed 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:

1 Section 1. The public health law is amended by adding a new section 2 2424 to read as follows: 3 § 2424. Clinical trial access and education fund. 1. Definitions. For 4 the purposes of this section, the following terms shall have the follow- 5 ing meanings: 6 a. "Eligible applicant" means (i) a medical school that sponsors a 7 clinical trial, (ii) a not-for-profit organization with experience and 8 expertise working with patients with life-threatening or disabling 9 conditions or diseases, (iii) a health care provider organization, asso- 10 ciation or society, (iv) a general hospital defined in article twenty- 11 eight of this chapter, (v) a county or city health department, or (vi) a 12 municipality. 13 b. "Clinical trial" shall have the same meaning as in subdivision 14 two-b of section forty-nine hundred of this chapter. 15 c. "Ancillary costs" means costs associated with participation in a 16 clinical trial, including but not limited to costs for: 17 (i) travel; 18 (ii) lodging; 19 (iii) parking and tolls; 20 (iv) a travel companion to assist patients who are elderly, very 21 young, or too ill to travel alone; and 22 (v) other costs considered appropriate jointly by the department, the 23 service providing organization and the trial site. 24 2. Establishment of fund. There is hereby established within the 25 department a clinical trial access and education fund. Subject to appro-

EXPLANATION--Matter in italics (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD08024-01-5

S. 5401 2

1 priations, the department shall provide grants to eligible applicants on 2 a competitive request for proposal basis to provide one or more of the 3 following services to patients with life-threatening or disabling condi- 4 tions or diseases, as such terms are defined in section forty-nine 5 hundred of this chapter, to facilitate access to or education on clin- 6 ical trials of treatments for the patient's condition or disease: 7 a. transportation services and lodging to provide patients with access 8 to clinical trials or other related treatments while enrolled in a clin- 9 ical trial or to access testing and other services to determine patient 10 eligibility for a clinical trial; 11 b. patient outreach and education services to educate patients, their 12 families and health care providers about the existence of and how 13 patients may enroll in clinical trials, under section two hundred seven 14 of this chapter; and 15 c. patient navigation services to help patients to determine if they 16 are eligible for clinical trials, to help patients to enroll in clinical 17 trials and to assist patients in dealing with insurance or other issues 18 which serve as barriers to patient enrollment in clinical trials. 19 3. Applications. a. The commissioner shall establish an application 20 process by which eligible applicants may apply for a grant under this 21 section. The application shall include: 22 (i) the geographic area in which the services shall be provided; 23 (ii) a detailed description of the services to be provided; 24 (iii) applicant's experience working with patients with life-threaten- 25 ing or disabling conditions or diseases; 26 (iv) applicant's ability to provide patient outreach or clinical trial 27 education and navigation services, or coordinate or provide transporta- 28 tion and lodging for patients; and 29 (v) any other information that the commissioner deems relevant and 30 appropriate. 31 b. Eligible applicants shall: 32 (i) have experience and expertise working with patients with life- 33 threatening or disabling conditions or diseases; 34 (ii) provide patient outreach, education and health care navigation 35 services; 36 (iii) collaborate with physicians, health care providers, and clinical 37 trial sponsors to notify a prospective subject about the program when: 38 (1) the prospective subject consents to a clinical trial; and 39 (2) funding is available to provide the program for the clinical trial 40 in which the prospective subject participates; and 41 (iv) reimburse subjects based on financial need to subjects whose 42 income is at or below seven hundred percent of the federal poverty 43 level, which shall include reimbursement for reasonable ancillary costs. 44 4. Institutional review board requirements. A reimbursement program 45 under this section shall: 46 a. be approved by the institutional review board associated with the 47 clinical trial; and 48 b. comply with applicable federal and state laws. 49 5. Reimbursement. Reimbursement to a subject of ancillary costs under 50 the program: 51 a. does not constitute an undue inducement to participate in a clin- 52 ical trial; 53 b. is not considered coercion or the exertion of undue influence to 54 participate in a clinical trial; and

S. 5401 3

1 c. is meant to accomplish parity in access to clinical trials and 2 remove barriers to participation in clinical trials for financially 3 burdened subjects. 4 6. Reports. Grantees shall file an annual report with the commission- 5 er, in such form and with such information and data as the commissioner 6 prescribes detailing the expenditure of grant funds and summarizing the 7 efforts undertaken to increase patient access to clinical trials. 8 7. Regulations. The commissioner shall make regulations reasonably 9 necessary to implement the provisions of this section. 10 § 2. This act shall take effect immediately.

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