H0126B2004A08945 VDL:JSL 06/22/18 #90 A08945
AMENDMENTS TO HOUSE BILL NO. 126
Sponsor: SENATOR DINNIMAN
Printer's No. 2004
Amend Bill, page 1, line 1, by striking out "Providing" and
inserting
Amending Title 35 (Health and Safety) of the Pennsylvania
Consolidated Statutes, providing for reimbursement of patient
expenses associated with participation in cancer clinical
trials and for duties of the Department of Health; imposing a
penalty; providing
Amend Bill, page 1, lines 6 through 15; pages 2 through 5,
lines 1 through 30; page 6, lines 1 through 6; by striking out
all of said lines on said pages and inserting
Section 1. Title 35 of the Pennsylvania Consolidated
Statutes is amended by adding chapters to read:
CHAPTER 54
CANCER TRIAL ACCESS FOR PENNSYLVANIA PATIENTS
Sec.
5401. Scope.
5402. Legislative findings and intent.
5403. Definitions.
5404. Improving access to cancer clinical trials.
ยง 5401. Scope.
This chapter relates to cancer trial access for Pennsylvania
patients.
ยง 5402. 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
diverse patient participation in cancer clinical trials.
(3) A low participation rate or a homogenous participant
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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
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
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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.
(11) While the United States Food and Drug
Administration recently confirmed to Congress and provided
guidance that, in fact, reimbursement of direct patient-
incurred expenses is not inducement, many organizations,
pharmaceutical companies, philanthropic individuals,
charitable organizations, government entities and others
still operate under the understanding that such reimbursement
could be, in fact, considered inducement.
(b) Intent.--It is the intent of the General Assembly to
enact legislation to define and establish a clear difference
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.
ยง 5403. Definitions.
The following words and phrases when used in this chapter
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.
"Department." The Department of Health of the Commonwealth.
"Inducement." Paying a person money, including a lump sum or
salary payment, to participate in a cancer clinical trial.
"IRB." An Institutional Review Board that is an
appropriately constituted group formally established in
accordance with applicable United States Food and Drug
Administration regulations or outside the United States by other
equivalent and applicable international regulations and
guidelines in order to review and monitor biomedical research
involving human subjects, and specifically having the authority
to approve or disapprove research or to require modifications in
research to secure approval.
"IEC." An Independent Ethics Review Committee that is an
appropriately constituted group formally established in
accordance with applicable United States Food and Drug
Administration regulations or outside the United States by other
equivalent and applicable international regulations and
guidelines in order to review and monitor biomedical research
involving human subjects, and specifically having the authority
to approve or disapprove research or to require modifications in
research to secure approval.
"Patient-subject." A person participating in a cancer
clinical trial.
"Third-party reimbursement entity." A third-party nonprofit
corporation or public charity that specializes in assisting
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cancer patients and increasing enrollment, retention and
minority participation in cancer clinical trials.
ยง 5404. 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.
(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) Expenses and registration.--The following apply:
(1) 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 a third-party reimbursement entity.
(2) A third-party reimbursement entity shall register
with a department-approved Pennsylvania college or university
with a school of public health. Registration must occur
within 30 days of the date the third-party reimbursement
entity first reimbursed a patient-subject, or the patient-
subject's family, friends or chaperones, for travel or
ancillary expenses related to a cancer clinical trial
conducted within this Commonwealth.
(3) Registration under paragraph (2) shall include:
(i) The name of the third-party reimbursement
entity.
(ii) The third-party reimbursement entity's legal
and tax status.
(iii) The third-party reimbursement entity's
employer or other similar identification number.
(iv) The names of the third-party reimbursement
entity's principal officers and directors.
(v) The names of donors of $5,000 or more to the
third-party reimbursement entity.
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(vi) Appropriate identifying information, as
determined by the department, regarding other sources of
funding from a source of $5,000 or more.
(vii) Other information as the department deems
necessary or appropriate.
(4) A third-party reimbursement entity registering under
paragraph (2) shall update the registration no less than once
annually utilizing forms and regulations developed by the
department.
(5) A third-party reimbursement entity that fails to
register as required by this subsection shall be subject to a
penalty of no more than $300 imposed by the department.
(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
informed consent process.
(3) The reimbursement process must conform to Federal
and State laws and guidance.
CHAPTER 55
EPINEPHRINE AUTO-INJECTOR ENTITIES
Sec.
5501. Scope.
5502. Definitions.
5503. Epinephrine auto-injectors for authorized entities.
ยง 5501. Scope.
This chapter relates to epinephrine auto-injector entities.
ยง 5502. Definitions.
The following words and phrases when used in this chapter
shall have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Administer." The direct application of an epinephrine auto-
injector to the body of an individual.
"Authorized entity." Any entity or organization, other than
a school entity or a nonpublic school under section 1414.2 of
the act of March 10, 1949 (P.L.30, No.14), known as the Public
School Code of 1949, which has an employee or agent who has
completed the required training and at which allergens capable
of causing anaphylaxis may be present, including, but not
limited to:
(1) recreation camps;
(2) colleges and universities;
(3) day-care facilities;
(4) youth sports leagues;
(5) amusement parks;
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(6) restaurants;
(7) places of employment; and
(8) sports arenas.
"Department." The Department of Health of the Commonwealth.
"Epinephrine auto-injector." A single-use device used for
the automatic injection of a premeasured dose of epinephrine
into the human body.
"Health care practitioner." An individual who is authorized
to practice some component of the healing arts by a license,
permit, certificate or registration issued by a Commonwealth
licensing agency or board .
ยง 5503. Epinephrine auto-injectors for authorized entities.
(a) Prescribing and dispensing.--Notwithstanding any
provision of law to the contrary, a health care practitioner
with prescriptive authority may prescribe epinephrine auto-
injectors in the name of an authorized entity for use in
accordance with this section. Pharmacists and health care
practitioners may dispense epinephrine auto-injectors pursuant
to a prescription issued in the name of an authorized entity.
(b) Supply.--
(1) An authorized entity may acquire and stock a supply
of epinephrine auto-injectors pursuant to a prescription
issued in accordance with this section. The epinephrine auto-
injectors shall be stored:
(i) in a location readily accessible in an
emergency; and
(ii) in accordance with:
(A) the epinephrine auto-injector's instructions
for use; and
(B) any additional requirements that may be
established by the department.
(2) An authorized entity shall designate employees or
agents who have completed the training required under
subsection (d) to be responsible for the storage,
maintenance, control and general oversight of epinephrine
auto-injectors acquired by the authorized entity.
(c) Use.--An employee or agent of an authorized entity or
other individual associated with the entity who has completed
the training required under subsection (d) may use epinephrine
auto-injectors prescribed under subsection (a) to do any of the
following:
(1) Provide an epinephrine auto-injector for immediate
administration to any individual, or the parent, guardian or
caregiver of the individual, who the employee, agent or other
individual associated with the entity believes, in good
faith, is experiencing anaphylaxis, regardless of whether the
individual has a prescription for an epinephrine auto-
injector or has previously been diagnosed with an allergy.
(2) Administer an epinephrine auto-injector to any
individual who the employee, agent or other individual
believes, in good faith, is experiencing anaphylaxis,
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regardless of whether the individual has a prescription for
an epinephrine auto-injector or has previously been diagnosed
with an allergy.
(d) Training.--
(1) An employee or agent of the authorized entity or
other individual associated with the entity shall complete an
anaphylaxis training program as required by the department.
The training shall be conducted by a nationally recognized
organization experienced in training laypersons in emergency
health treatment , a health care practitioner employed or
contracted by the authorized entity or an entity or
individual approved by the department. The department may
approve specific entities or individuals or may approve
classes of entities or individuals to conduct the training.
Training may be conducted online or in person and, at a
minimum, shall cover:
(i) how to recognize signs and symptoms of severe
allergic reactions, including anaphylaxis;
(ii) standards and procedures for the storage and
administration of an epinephrine auto-injector; and
(iii) emergency follow-up procedures.
(2) The entity or individual that conducts the training
shall issue a certificate, on a form developed or approved by
the department, to each individual who successfully completes
the anaphylaxis training program.
(e) Good Samaritan protections.--
(1) The following shall not be liable for any injuries
or related damages that result from any act or omission taken
under this section:
(i) An authorized entity that possesses and makes
available epinephrine auto-injectors and its employees,
agents and other individuals associated with the entity;
(ii) a health care practitioner that prescribes or
dispenses epinephrine auto-injectors to an authorized
entity;
(iii) a pharmacist or health care practitioner that
dispenses epinephrine auto-injectors to an authorized
entity; and
(iv) an individual or entity that conducts the
training described under subsection (d).
(2) The immunity provided under paragraph (1) shall not
apply to acts or omissions constituting intentional
misconduct or gross negligence.
(3) The administration of an epinephrine auto-injector
in accordance with this section shall not be considered the
practice of medicine or any other profession that otherwise
requires licensure.
(4) This subsection shall not eliminate, limit or reduce
any other immunity or defense that may be available under
law, including that provided under 42 Pa.C.S. ยง 8332
(relating to emergency response provider and bystander good
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Samaritan civil immunity).
(5) An entity located in this Commonwealth shall not be
liable for any injuries or related damages that result from
the provision or administration of an epinephrine auto-
injector outside of this Commonwealth if the entity:
(i) would not have been liable for the injuries or
related damages had the provision or administration
occurred within this Commonwealth; or
(ii) is not liable for the injuries or related
damages under the law of the state in which the provision
or administration occurred.
Section 2. This act shall take effect as follows:
(1) The addition of 35 Pa.C.S. Ch. 54 shall take effect
in six months.
(2) This section shall take effect immediately.
(3) The remainder of this act shall take effect in 60
days.
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