PRINTER'S NO. 660
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No.
576
Session of
2017
INTRODUCED BY DINNIMAN, FONTANA, SCHWANK, GREENLEAF AND WARD,
APRIL 6, 2017
REFERRED TO HEALTH AND HUMAN SERVICES, APRIL 6, 2017
AN ACT
Providing for the reimbursement of programs for patient expenses
associated with participation in cancer clinical trials.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Short title.
This act shall be known and may be cited as the Cancer Trial
Access for Pennsylvania Patients (TAPP) Act.
Section 2. Legislative findings and intent.
(a) Findings and declarations.--The General Assembly finds
and declares as follows:
(1) A Pennsylvanian will be diagnosed with cancer
approximately every four minutes, and a Pennsylvanian will
die of cancer every 10 minutes. African-American
Pennsylvanians in particular face higher rates of cancer
incidence and mortality compared to other races and
ethnicities.
(2) The ability to translate medical findings from
research to practice relies largely on having robust and
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diverse patient participation in cancer clinical trials.
(3) A low participation rate or a homogenous participant
group prevents segments of the population from benefiting
from advances achieved through clinical research, creates
uncertainties over the applicability of research findings and
has proven to develop lifesaving drugs that work for some
ethnic populations but not others.
(4) Conversely, some drug trials are canceled because
they do not show promise for the current homogenous study
population of patients but could be beneficial to other
ethnicities who are not receiving the trial drug because of
poor participation rates.
(5) Diverse patient participation in cancer clinical
trials depends, in part, on whether a participant can afford
ancillary medical and other costs, including transportation
for clinical visits required by trial participation, which
are not covered by standard of care, or lodging during the
course of his or her participation. A national study in 2015
found that patient households making less than $50,000
annually were almost 30% less likely to participate in
clinical trials.
(6) Another barrier to cancer clinical trial
participation is the cost of travel, lodging and other
expenses for a patient's travel companion, including a family
member, friend, health care provider or chaperones that
attend cancer clinical trial treatments to provide emotional,
physical and mental support to the trial participant. Some
trial participants are too old, too young or too ill to
simply travel on their own.
(7) Cancer clinical trials often only cover the actual
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cost of the drug being tested and very rarely the direct
costs of participation by a patient-subject. There are often
significant expenses associated with enrollment in a clinical
trial that are not covered by the clinical trial site or
sponsor. These include travel expenses to and from the
clinical sites whether by air, car, bus, train, taxi or
public transportation along with the travel costs of parking,
car rental, gas, tolls and lodging.
(8) This disparity threatens one of the most basic
ethical underpinnings of clinical research, the requirement
that the benefits of research be made available equitably
among all eligible individuals.
(9) According to the National Cancer Institute, Cancer
Clinical Trials Resource Guide, some of the barriers
preventing individuals, with cancer or at high risk of
developing cancer, from participating in clinical trials are
direct and indirect financial and personal costs, including
travel.
(10) Some corporations, individuals, public and private
foundations, health care providers and other stakeholders are
hesitant to contribute to or accept funds from programs that
are organized to alleviate financial burdens faced by
patients who wish to participate in clinical trials and their
caregivers due to concerns that the United States Food and
Drug Administration or other Federal regulators would view
the payments made from those funds as prohibited inducements
for patients to receive the health care services provided
during clinical trials.
(b) Intent.--It is the intent of the General Assembly to
enact legislation to define and establish a clear difference
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between what is considered "inducement" for a patient to
participate in a clinical trial and direct reimbursement of
patient-incurred expenses for participating in a cancer clinical
trial.
Section 3. Definitions.
The following words and phrases when used in this act shall
have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Cancer clinical trials." Research studies that test new
cancer treatments on people, including chemotherapies, stem cell
therapies and other new treatments.
"IEC." Independent Ethics Review Board.
"Inducement." Paying a person money, including a lump sum or
salary payment, to participate in a cancer clinical trial.
"IRB." Institutional Review Board.
"Patient-subject." A person participating in a cancer
clinical trial.
Section 4. Improving access to cancer clinical trials.
(a) Inducement.--All sponsors of cancer clinical trials
shall inform potential patient-subjects at the time of the
informed consent process of the following:
(1) Reimbursement for travel and ancillary costs is
available to all enrollees based on financial need.
(2) Coverage of the travel and other ancillary costs is
done to eliminate financial barriers to enrollment in order
to retain patient-subjects in the clinical trial.
(3) Family, friends or chaperones that attend the cancer
clinical trial treatments to support the patient-subject are
eligible for reimbursement of their travel and ancillary
expenses.
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(b) Reimbursement.--
(1) Reimbursement of travel, ancillary medical costs and
other direct patient-incurred expenses related to trial
participation shall not be considered an inducement to
participate in a cancer clinical trial.
(2) Reimbursement for travel and ancillary expenses
shall not be considered coercive or exerting undue influence
to participate in a trial, instead reimbursement shall be
considered a means to create parity in clinical trial access
and remove a barrier to participation for financially
burdened patient-subjects.
(c) Assistance in covering ancillary and travel expenses.--
Government, industry, public and private foundations,
corporations and individuals may offer financial support to
patient-subjects, or the family, friends or chaperones of
patient-subjects, to cover ancillary costs through their support
of third party nonprofit corporations and public charities that
specialize in assisting cancer patients and increasing
enrollment, retention and minority participation in cancer
clinical trials.
(d) Reimbursement programs.--Reimbursement programs must
comply with the following:
(1) Reimbursement programs that cover ancillary medical
and travel expenses must be reviewed and approved by the IRB
or IEC in conjunction with their review of the proposed
clinical trial. The IRB or IEC must consider whether the
reimbursed patient-subjects are recruited fairly, informed
adequately and paid appropriately.
(2) The nature of the ancillary support and general
guidelines on financial eligibility must be disclosed in the
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informed consent process.
(3) The reimbursement process must conform to Federal
and State laws and guidance.
Section 5. Effective date.
This act shall take effect in 90 days.
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