LRB-3432/1
SWB:skw
2019 - 2020 LEGISLATURE
October 14, 2019 - Introduced by Representatives Kulp, Duchow, Rodriguez,
Dittrich, Sinicki, Skowronski, Tittl, Steffen, Spiros, Ott, Mursau, Knodl,
Kerkman, Horlacher, Felzkowski, Ballweg, Anderson, Allen and C.
Taylor
, cosponsored by Senators Kooyenga, Darling, Carpenter,
Erpenbach, Jacque, L. Taylor, Smith, Olsen and Craig. Referred to
Committee on Health.
AB542,1,2 1An Act to create 146.348 of the statutes; relating to: allowing reimbursement
2of certain expenses for patients participating in cancer clinical trials.
Analysis by the Legislative Reference Bureau
This bill provides that reimbursement of certain patient-incurred expenses
related to participation in a cancer clinical trial will not be considered undue
inducement to participate in a cancer clinical trial. Under the bill, reimbursement
of travel, ancillary costs, and other direct patient-incurred expenses related to
cancer clinical trial participation will not be considered an undue inducement to
participate in a cancer clinical trial, and reimbursement for travel and ancillary costs
may not be considered coercive or as exerting undue influence to participate in a
cancer clinical trial, but rather as a means to create parity in cancer clinical trial
access and remove a barrier to participation. The bill requires all sponsors of cancer
clinical trials to provide, during the informed consent process, potential participants
with information relating to the possible availability of reimbursement for certain
expenses. Under the bill, language informing patient-subjects that reimbursement
entities or programs that cover travel, ancillary costs, and other direct
patient-incurred expenses may be available must be submitted for review to the
relevant federally designated institutional review board in conjunction with the
review of a proposed cancer clinical trial and included in the informed consent form
approved by the institutional review board. The reimbursement entity or program
must also disclose the nature of the ancillary support and general guidelines on

financial eligibility to interested patient-subjects and employ a reimbursement
process that conforms to federal law and guidance.
The people of the state of Wisconsin, represented in senate and assembly, do
enact as follows:
AB542,1 1Section 1. 146.348 of the statutes is created to read:
AB542,2,3 2146.348 Reimbursement in cancer clinical trial programs. (1) In this
3section:
AB542,2,54 (a) “Cancer clinical trial” means a research study that tests a new cancer
5treatment regimen on patients, including chemotherapy and other new treatments.
AB542,2,76 (b) “Inducement” means paying a person money, including a lump sum or
7salary payment, to participate in a cancer clinical trial.
AB542,2,88 (c) “Patient-subject” means a person participating in a cancer clinical trial.
AB542,2,10 9(2) All sponsors of cancer clinical trials shall provide potential patient-subjects
10at the time of the informed consent process the following information:
AB542,2,1211 (a) Whether reimbursement for travel and ancillary costs may be available to
12patient-subjects.
AB542,2,1413 (b) That coverage of the travel and ancillary costs is done to eliminate financial
14barriers to enrollment in order to retain patient-subjects in the cancer clinical trial.
AB542,2,1715 (c) Whether family members, friends, or chaperones who attend the cancer
16clinical trial treatments to support the patient-subject may be eligible for
17reimbursement of their travel and ancillary costs.
AB542,2,20 18(3) (a) Reimbursement of travel, ancillary costs, and other direct
19patient-incurred expenses related to cancer clinical trial participation will not be
20considered an undue inducement to participate in a cancer clinical trial.
AB542,3,4
1(b) Reimbursement for travel and ancillary costs may not be considered
2coercive or as exerting undue influence to participate in a cancer clinical trial, but
3rather shall be considered a means to create parity in cancer clinical trial access and
4remove a barrier to participation for financially burdened patient-subjects.
AB542,3,95 (c) Government, industry, public charities, private foundations and other
6nonprofit organizations, associations, corporations and other business entities,
7individuals, and any other legal or commercial entities may offer financial support
8to patient-subjects, or the family, friends, or chaperones of patient-subjects, to cover
9ancillary costs through their support of a reimbursement entity or program.
AB542,3,15 10(4) (a) Language informing patient-subjects that reimbursement entities or
11programs that cover travel, ancillary costs, and other direct patient-incurred
12expenses may be available must be submitted for review to the relevant federally
13designated institutional review board in conjunction with the review of a proposed
14cancer clinical trial and included in the informed consent form approved by the
15institutional review board.
AB542,3,1916 (b) A reimbursement entity or program must disclose the nature of the
17ancillary support and general guidelines on financial eligibility to interested
18patient-subjects and employ a reimbursement process that conforms to federal law
19and guidance.
AB542,2 20Section 2. Nonstatutory provisions.
AB542,3,2421 (1) Legislative intent statement. It is the intent of the legislature to define and
22establish a clear difference between what is considered undue inducement for a
23patient to participate in a cancer clinical trial and direct reimbursement of
24patient-incurred expenses for participating in a cancer clinical trial.
AB542,3,2525 (2) Legislative findings. The legislature finds all of the following:
AB542,4,2
1(a) The ability to translate medical findings from research to practice relies
2largely on having robust and diverse patient participation in cancer clinical trials.
AB542,4,53 (b) A low participation rate or a homogenous participant group prevents
4segments of the population from benefiting from advances achieved through clinical
5research and creates uncertainties over the applicability of research findings.
AB542,4,106 (c) Diverse patient participation in cancer clinical trials depends, in part, on
7whether a participant can afford ancillary medical and other costs, including
8transportation for clinical visits required by cancer clinical trial participation, which
9are not covered by standard of care, or lodging during the course of his or her
10participation.
AB542,4,1611 (d) Another barrier to cancer clinical trial participation is the costs of travel,
12lodging, and other expenses for a patient-subject's travel companion, including a
13family member, friend, health care provider, or chaperone who attends cancer
14clinical trial treatments to provide emotional, physical, and mental support to the
15patient-subject. Some patient-subjects are too old, too young, or too ill to simply
16travel on their own.
AB542,4,2317 (e) Cancer clinical trials often cover only the actual costs of the drug being
18tested and very rarely the direct costs of participation by a patient-subject. There
19are often significant expenses associated with enrollment in a cancer clinical trial
20that are not covered by the cancer clinical trial site or sponsor. These include travel
21expenses to and from the clinical sites whether by air, car, bus, train, taxi, or other
22public transportation, along with the travel costs of parking, car rental, gas, tolls,
23and lodging.
AB542,5,224 (f) According to the National Cancer Institute, Cancer Clinical Trials Resource
25Guide, some of the barriers preventing individuals, with cancer or at high risk of

1developing cancer, from participating in cancer clinical trials are direct and indirect
2financial and personal costs, including travel.
AB542,5,93 (g) Some corporations, individuals, public and private foundations, health care
4providers, and other stakeholders are hesitant to contribute to or accept funds from
5programs that are organized to alleviate financial burdens faced by patients who
6wish to participate in cancer clinical trials and their caregivers due to concerns that
7the federal food and drug administration or other federal regulators would view the
8payments made from those funds as prohibited inducements for patients to receive
9the health care services provided during cancer clinical trials.
AB542,5,1510 (h) While the federal food and drug administration recently confirmed to
11Congress and provided guidance that, in fact, reimbursement of direct
12patient-incurred expenses is not undue inducement, many organizations,
13pharmaceutical companies, philanthropic individuals, charitable organizations, and
14government entities still operate with the understanding that such reimbursement
15could be, in fact, considered undue inducement.
AB542,5,1616 (End)
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