PRINTER'S NO. 135
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
167
Session of
2021
INTRODUCED BY DeLUCA, BOBACK, HILL-EVANS, CIRESI, LONGIETTI,
KINSEY, SAMUELSON, FREEMAN, IRVIN, DEASY, WEBSTER, SCHWEYER
AND ROZZI, JANUARY 14, 2021
REFERRED TO COMMITTEE ON INSURANCE, JANUARY 14, 2021
AN ACT
Providing for insurance coverage for patient costs associated
with 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
Clinical Trials Act.
Section 2. 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:
"Carrier." An insurance company, health service corporation,
hospital service corporation, medical service corporation or
health maintenance organization authorized to issue health
benefits plans in this Commonwealth.
"Cooperative group." A formal network of facilities that
collaborate on research projects and that has an established
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National Institutes of Health approved peer review program
operating within the group, including the National Cancer
Institute clinical cooperative group and the National Cancer
Institute community clinical oncology program.
"Health benefits plan." As follows:
(1) Any of the following, which is delivered or issued
for delivery in this Commonwealth by a carrier:
(i) A hospital and medical expense insurance policy
or certificate.
(ii) A health, hospital or medical service
corporation contract or certificate.
(iii) A health maintenance organization subscriber
contract or certificate.
(2) The term does not include any of the following
plans, policies or contracts:
(i) Specified disease.
(ii) CHAMPUS supplement.
(iii) Accident only.
(iv) Credit.
(v) Disability.
(vi) Long-term care.
(vii) Coverage for Medicare services pursuant to a
contract with the Federal Government.
(viii) Medicare supplement.
(ix) Dental only.
(x) Vision only.
(xi) Insurance issued as a supplement to liability
insurance.
(xii) Coverage arising out of a workers'
compensation or similar law.
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(xiii) Hospital confinement or other supplemental
limited benefit insurance coverage.
(xiv) Automobile medical payment insurance.
"Institution." A hospital or organization that is involved
in administering clinical trials.
"Institutional review board." A board, committee or other
group that is:
(1) formally designated by an institution to approve the
initiation of and to conduct periodic review of biomedical
research involving human subjects and in which the primary
purpose of the review is to assure the protection of the
rights and welfare of the human subjects and not to review a
clinical trial for scientific merit; and
(2) approved by the National Institutes of Health Office
for Protection from Research Risks.
"Multiple project assurance contract." A contract between an
institution and the United States Department of Health and Human
Services that defines the relationship of the institution to the
United States Department of Health and Human Services and that
sets out the responsibilities of the institution and the
procedures that will be used by the institution to protect human
subjects.
"Patient." The subscriber, insured or enrollee or the
covered dependent of the subscriber, insured or enrollee.
"Routine care costs." Physician fees, laboratory expenses
and expenses associated with the hospitalization, administering
of treatment and evaluation of the patient during the course of
treatment that:
(1) are consistent with usual and customary patterns and
standards of care incurred whenever an enrollee, subscriber
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or insured receives medical care associated with an approved
cancer clinical trial; and
(2) would be covered if the items and services were
provided other than in connection with an approved cancer
clinical trial.
Section 3. Coverage for clinical cancer trials.
(a) General rule.--A carrier is not obligated to pay any
costs, other than routine care costs, that are directly
associated with a cancer clinical trial that is offered in this
Commonwealth and in which the subscriber, insured or enrollee
participates voluntarily. A cancer clinical trial is a course of
treatment in which all of the following apply:
(1) The treatment is part of a scientific study of a new
therapy or intervention that is being conducted at an
institution in this Commonwealth, that is for the treatment,
palliation or prevention of cancer in humans and in which the
scientific study includes all of the following:
(i) Specific goals.
(ii) A rationale and background for the study.
(iii) Criteria for patient selection.
(iv) Specific directions for administering the
therapy and monitoring patients.
(v) A definition of quantitative measures for
determining treatment response.
(vi) Methods for documenting and treating adverse
reactions.
(2) The treatment is being provided as part of a study
being conducted in a Phase I, Phase II, Phase III or Phase IV
cancer clinical trial.
(3) The treatment is being provided as part of a study
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being conducted in accordance with a clinical trial approved
by at least one of the following:
(i) One of the National Institutes of Health.
(ii) A National Institutes of Health cooperative
group or center.
(iii) The United States Food and Drug Administration
in the form of an investigational new drug application.
(iv) The United States Department of Defense.
(v) The United States Department of Veterans
Affairs.
(vi) A qualified research entity that meets the
criteria established by the National Institutes of Health
for grant eligibility.
(vii) A panel of qualified recognized experts in
clinical research within academic health institutions in
this Commonwealth.
(4) The proposed treatment or study has been reviewed
and approved by an institutional review board of an
institution in this Commonwealth.
(5) The personnel providing the treatment or conducting
the study:
(i) Are providing the treatment or conducting the
study within their scope of practice, experience and
training and are capable of providing the treatment
because of their experience, training and volume of
patients treated to maintain expertise.
(ii) Agree to accept reimbursement as payment in
full from the carrier at the rates that are established
by the carrier and that are not more than the level of
reimbursement applicable to other similar services
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provided by health care providers with the carrier's
provider network.
(6) There is no clearly superior, noninvestigational
treatment alternative.
(7) The available clinical or preclinical data provide a
reasonable expectation that the treatment will be at least as
efficacious as any noninvestigational alternative.
(b) Liability.--Pursuant to the patient informed consent
document, no party is liable for damages associated with the
treatment provided during any phase of a cancer clinical trial.
(c) Benefits.--Each health benefits plan delivered or issued
for delivery in this Commonwealth shall provide benefits under
the plan, and those benefits may not supplant any portion of the
clinical trial that is customarily paid for by government,
biotechnical, pharmaceutical or medical device industry sources.
(d) Remedy.--This section does not create any private right
or cause of action for or on behalf of any patient against the
carrier. This section provides solely an administrative remedy
for any violation of this section or any related rule.
(e) Deductibles and other cost sharing.--Nothing in this
section prohibits the carrier from imposing deductibles,
coinsurance or other cost-sharing measures in relation to
benefits provided under this section.
Section 4. Applicability.
This act applies to health benefits plans issued or renewed
on or after January 1, 2022.
Section 5. Effective date.
This act shall take effect immediately.
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