Bill Text: NY A00180 | 2021-2022 | General Assembly | Amended

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Bill Title: 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.

Spectrum: Strong Partisan Bill (Democrat 16-1)

Status: (Introduced - Dead) 2022-04-29 - print number 180a [A00180 Detail]

Download: New_York-2021-A00180-Amended.html

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                STATE OF NEW YORK
        ________________________________________________________________________

                                         180--A

                               2021-2022 Regular Sessions

                   IN ASSEMBLY

                                       (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:

     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;

         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD00038-02-2
        A. 180--A                           2

     1    (iii) parking and tolls;
     2    (iv)  a  travel  companion  to  assist  patients who are elderly, very
     3  young, or too ill to travel alone; and
     4    (v) other costs considered appropriate jointly by the department,  the
     5  service providing organization and the trial site.
     6    2.  Establishment  of  fund.  There  is  hereby established within the
     7  department a clinical trial access and education fund. Subject to appro-
     8  priations, the department shall provide grants to eligible applicants on
     9  a competitive request for proposal basis to provide one or more  of  the
    10  following services to patients with life-threatening or disabling condi-
    11  tions  or  diseases,  as  such  terms  are defined in section forty-nine
    12  hundred of this chapter, to facilitate access to or education  on  clin-
    13  ical trials of treatments for the patient's condition or disease:
    14    a. transportation services and lodging to provide patients with access
    15  to clinical trials or other related treatments while enrolled in a clin-
    16  ical  trial or to access testing and other services to determine patient
    17  eligibility for a clinical trial;
    18    b. patient outreach and education services to educate patients,  their
    19  families  and  health  care  providers  about  the  existence of and how
    20  patients may enroll in clinical trials, under section two hundred  seven
    21  of this chapter; and
    22    c.  patient  navigation services to help patients to determine if they
    23  are eligible for clinical trials, to help patients to enroll in clinical
    24  trials and to assist patients in dealing with insurance or other  issues
    25  which serve as barriers to patient enrollment in clinical trials.
    26    3.  Applications. a.   The commissioner shall establish an application
    27  process by which eligible applicants may apply for a  grant  under  this
    28  section.  The application shall include:
    29    (i) the geographic area in which the services shall be provided;
    30    (ii) a detailed description of the services to be provided;
    31    (iii) applicant's experience working with patients with life-threaten-
    32  ing or disabling conditions or diseases;
    33    (iv) applicant's ability to provide patient outreach or clinical trial
    34  education  and navigation services, or coordinate or provide transporta-
    35  tion and lodging for patients; and
    36    (v) any other information that the  commissioner  deems  relevant  and
    37  appropriate.
    38    b. Eligible applicants shall:
    39    (i)  have  experience  and  expertise working with patients with life-
    40  threatening or disabling conditions or diseases;
    41    (ii) provide patient outreach, education and  health  care  navigation
    42  services;
    43    (iii) collaborate with physicians, health care providers, and clinical
    44  trial sponsors to notify a prospective subject about the program when:
    45    (1) the prospective subject consents to a clinical trial; and
    46    (2) funding is available to provide the program for the clinical trial
    47  in which the prospective subject participates; and
    48    (iv)  reimburse  subjects  based  on  financial need to subjects whose
    49  income is at or below seven  hundred  percent  of  the  federal  poverty
    50  level, which shall include reimbursement for reasonable ancillary costs.
    51    4.  Institutional  review  board requirements. A reimbursement program
    52  under this section shall:
    53    a. be approved by the institutional review board associated  with  the
    54  clinical trial; and
    55    b. comply with applicable federal and state laws.
        A. 180--A                           3

     1    5.  Reimbursement. Reimbursement to a subject of ancillary costs under
     2  the program:
     3    a.  does  not constitute an undue inducement to participate in a clin-
     4  ical trial;
     5    b. is not considered coercion or the exertion of  undue  influence  to
     6  participate in a clinical trial; and
     7    c.  is  meant  to  accomplish  parity in access to clinical trials and
     8  remove barriers to participation  in  clinical  trials  for  financially
     9  burdened subjects.
    10    6.  Reports. Grantees shall file an annual report with the commission-
    11  er, in such form and with such information and data as the  commissioner
    12  prescribes  detailing the expenditure of grant funds and summarizing the
    13  efforts undertaken to increase patient access to clinical trials.
    14    7. Regulations.  The commissioner shall  make  regulations  reasonably
    15  necessary to implement the provisions of this section.
    16    § 2. This act shall take effect immediately.