2019 - 2020 LEGISLATURE
October 10, 2019 - Introduced by Senators Kooyenga, Darling, Carpenter,
Erpenbach, Jacque, L. Taylor, Smith, Olsen and Craig, cosponsored by
Representatives Kulp, Duchow, Rodriguez, Dittrich, Sinicki, Skowronski,
Tittl, Steffen, Spiros, Ott, Mursau, Knodl, Kerkman, Horlacher,
Felzkowski, Ballweg, Anderson, Allen and C. Taylor. Referred to
Committee on Health and Human Services.
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:
146.348 of the statutes is created to read:
2146.348 Reimbursement in cancer clinical trial programs. (1)
In this 3
(a) “Cancer clinical trial” means a research study that tests a new cancer 5
treatment regimen on patients, including chemotherapy and other new treatments.
(b) “Inducement” means paying a person money, including a lump sum or 7
salary payment, to participate in a cancer clinical trial.
(c) “Patient-subject” means a person participating in a cancer clinical trial.
All sponsors of cancer clinical trials shall provide potential patient-subjects 10
at the time of the informed consent process the following information:
(a) Whether reimbursement for travel and ancillary costs may be available to 12
(b) That coverage of the travel and ancillary costs is done to eliminate financial 14
barriers to enrollment in order to retain patient-subjects in the cancer clinical trial.
(c) Whether family members, friends, or chaperones who attend the cancer 16
clinical trial treatments to support the patient-subject may be eligible for 17
reimbursement of their travel and ancillary costs.
(a) Reimbursement of travel, ancillary costs, and other direct 19
patient-incurred expenses related to cancer clinical trial participation will not be 20
considered an undue inducement to participate in a cancer clinical trial.
(b) Reimbursement for travel and ancillary costs may not be considered 2
coercive or as exerting undue influence to participate in a cancer clinical trial, but 3
rather shall be considered a means to create parity in cancer clinical trial access and 4
remove a barrier to participation for financially burdened patient-subjects.
(c) Government, industry, public charities, private foundations and other 6
nonprofit organizations, associations, corporations and other business entities, 7
individuals, and any other legal or commercial entities may offer financial support 8
to patient-subjects, or the family, friends, or chaperones of patient-subjects, to cover 9
ancillary costs through their support of a reimbursement entity or program.
(a) Language informing patient-subjects that reimbursement entities or 11
programs that cover travel, ancillary costs, and other direct patient-incurred 12
expenses may be available must be submitted for review to the relevant federally 13
designated institutional review board in conjunction with the review of a proposed 14
cancer clinical trial and included in the informed consent form approved by the 15
institutional review board.
(b) A reimbursement entity or program must disclose the nature of the 17
ancillary support and general guidelines on financial eligibility to interested 18
patient-subjects and employ a reimbursement process that conforms to federal law 19
(1) Legislative intent statement.
It is the intent of the legislature to define and 22
establish a clear difference between what is considered undue inducement for a 23
patient to participate in a cancer clinical trial and direct reimbursement of 24
patient-incurred expenses for participating in a cancer clinical trial.
(2) Legislative findings.
The legislature finds all of the following:
(a) The ability to translate medical findings from research to practice relies 2
largely on having robust and diverse patient participation in cancer clinical trials.
A low participation rate or a homogenous participant group prevents 4
segments of the population from benefiting from advances achieved through clinical 5
research and creates uncertainties over the applicability of research findings.
(c) Diverse patient participation in cancer clinical trials depends, in part, on 7
whether a participant can afford ancillary medical and other costs, including 8
transportation for clinical visits required by cancer clinical trial participation, which 9
are not covered by standard of care, or lodging during the course of his or her 10
(d) Another barrier to cancer clinical trial participation is the costs of travel, 12
lodging, and other expenses for a patient-subject's travel companion, including a 13
family member, friend, health care provider, or chaperone who attends cancer 14
clinical trial treatments to provide emotional, physical, and mental support to the 15
patient-subject. Some patient-subjects are too old, too young, or too ill to simply 16
travel on their own.
(e) Cancer clinical trials often cover only the actual costs of the drug being 18
tested and very rarely the direct costs of participation by a patient-subject. There 19
are often significant expenses associated with enrollment in a cancer clinical trial 20
that are not covered by the cancer clinical trial site or sponsor. These include travel 21
expenses to and from the clinical sites whether by air, car, bus, train, taxi, or other 22
public transportation, along with the travel costs of parking, car rental, gas, tolls, 23
(f) According to the National Cancer Institute, Cancer Clinical Trials Resource 25
Guide, some of the barriers preventing individuals, with cancer or at high risk of
developing cancer, from participating in cancer clinical trials are direct and indirect 2
financial and personal costs, including travel.
(g) Some corporations, individuals, public and private foundations, health care 4
providers, and other stakeholders are hesitant to contribute to or accept funds from 5
programs that are organized to alleviate financial burdens faced by patients who 6
wish to participate in cancer clinical trials and their caregivers due to concerns that 7
the federal food and drug administration or other federal regulators would view the 8
payments made from those funds as prohibited inducements for patients to receive 9
the health care services provided during cancer clinical trials.
(h) While the federal food and drug administration recently confirmed to 11
Congress and provided guidance that, in fact, reimbursement of direct 12
patient-incurred expenses is not undue inducement, many organizations, 13
pharmaceutical companies, philanthropic individuals, charitable organizations, and 14
government entities still operate with the understanding that such reimbursement 15
could be, in fact, considered undue inducement.