PRINTER'S NO. 1809
No. 1462 Session of 2007
INTRODUCED BY DeLUCA, BIANCUCCI, COHEN, COSTA, FABRIZIO,
FREEMAN, GEORGE, GIBBONS, GRUCELA, HERSHEY, HORNAMAN, JAMES,
JOSEPHS, KENNEY, KIRKLAND, KORTZ, KOTIK, MANN, McGEEHAN,
M. O'BRIEN, PARKER, PASHINSKI, PETRONE, SABATINA, SIPTROTH,
McILVAINE SMITH, TANGRETTI, WALKO, WANSACZ AND YOUNGBLOOD,
JUNE 5, 2007
REFERRED TO COMMITTEE ON INSURANCE, JUNE 5, 2007
AN ACT
1 Providing for insurance coverage for patient costs associated
2 with cancer clinical trials.
3 The General Assembly of the Commonwealth of Pennsylvania
4 hereby enacts as follows:
5 Section 1. Short title.
6 This act shall be known and may be cited as the Cancer
7 Clinical Trials Act.
8 Section 2. Definitions.
9 The following words and phrases when used in this act shall
10 have the meanings given to them in this section unless the
11 context clearly indicates otherwise:
12 "Carrier." An insurance company, health service corporation,
13 hospital service corporation, medical service corporation or
14 health maintenance organization authorized to issue health
15 benefits plans in this Commonwealth.
16 "Cooperative group." A formal network of facilities that
1 collaborates on research projects and that has an established
2 National Institutes of Health approved peer review program
3 operating within the group, including the National Cancer
4 Institute clinical cooperative group and the National Cancer
5 Institute community clinical oncology program.
6 "Health benefits plan." A hospital and medical expense
7 insurance policy or certificate; health, hospital or medical
8 service corporation contract or certificate; or health
9 maintenance organization subscriber contract or certificate
10 delivered or issued for delivery in this Commonwealth by any
11 carrier. The term excludes the following plans, policies or
12 contracts: accident only, credit, disability, long-term care,
13 coverage for Medicare services pursuant to a contract with the
14 Federal Government, Medicare supplement, dental only or vision
15 only, insurance issued as a supplement to liability insurance,
16 coverage arising out of a workers' compensation or similar law,
17 hospital confinement or other supplemental limited benefit
18 insurance coverage or automobile medical payment insurance.
19 "Institutional review board." Any board, committee or other
20 group that is both:
21 (1) Formally designated by an institution to approve the
22 initiation of and to conduct periodic review of biomedical
23 research involving human subjects and in which the primary
24 purpose of such review is to assure the protection of the
25 rights and welfare of the human subjects and not to review a
26 clinical trial for scientific merit.
27 (2) Approved by the National Institutes of Health office
28 for protection from research risks.
29 "Multiple project assurance contract." A contract between an
30 institution and the United States Department of Health and Human
20070H1462B1809 - 2 -
1 Services that defines the relationship of the institution to the
2 United States Department of Health and Human Services and that
3 sets out the responsibilities of the institution and the
4 procedures that will be used by the institution to protect human
5 subjects.
6 "Patient." The subscriber, insured or enrollee or the
7 covered dependent of the subscriber, insured or enrollee.
8 "Patient cost." Any fee or expense that is covered under the
9 policy, contract or certificate and that is for a service or
10 treatment that would be required if the patient were receiving
11 usual and customary care. The term does not include the cost:
12 (1) Of any drug or device provided in a Phase I cancer
13 clinical trial.
14 (2) Of any investigational drug or device.
15 (3) Of nonhealth services that might be required for a
16 person to receive treatment or intervention.
17 (4) Of managing the research of the clinical trial.
18 (5) That would not be covered under the patient's
19 contract.
20 (6) Of treatment or services provided outside this
21 Commonwealth.
22 Section 3. Coverage for clinical cancer trials.
23 (a) General rule.--A carrier is not obligated to pay any
24 costs, other than covered patient costs, that are directly
25 associated with a cancer clinical trial that is offered in this
26 Commonwealth and in which the subscriber, insured or enrollee
27 participates voluntarily. A cancer clinical trial is a course of
28 treatment in which all of the following apply:
29 (1) The treatment is part of a scientific study of a new
30 therapy or intervention that is being conducted at an
20070H1462B1809 - 3 -
1 institution in this Commonwealth, that is for the treatment,
2 palliation or prevention of cancer in humans and in which the
3 scientific study includes all of the following:
4 (i) Specific goals.
5 (ii) A rationale and background for the study.
6 (iii) Criteria for patient selection.
7 (iv) Specific directions for administering the
8 therapy and monitoring patients.
9 (v) A definition of quantitative measures for
10 determining treatment response.
11 (vi) Methods for documenting and treating adverse
12 reactions.
13 (2) The treatment is being provided as part of a study
14 being conducted in a Phase I, Phase II, Phase III or Phase IV
15 cancer clinical trial.
16 (3) The treatment is being provided as part of a study
17 being conducted in accordance with a clinical trial approved
18 by at least one of the following:
19 (i) One of the National Institutes of Health.
20 (ii) A National Institutes of Health cooperative
21 group or center.
22 (iii) The United States Food and Drug Administration
23 in the form of an investigational new drug application.
24 (iv) The United States Department of Defense.
25 (v) The United States Department of Veterans
26 Affairs.
27 (vi) A qualified research entity that meets the
28 criteria established by the National Institutes of Health
29 for grant eligibility.
30 (vii) A panel of qualified recognized experts in
20070H1462B1809 - 4 -
1 clinical research within academic health institutions in
2 this Commonwealth.
3 (4) The proposed treatment or study has been reviewed
4 and approved by an institutional review board of an
5 institution in this Commonwealth.
6 (5) The personnel providing the treatment or conducting
7 the study:
8 (i) Are providing the treatment or conducting the
9 study within their scope of practice, experience and
10 training and are capable of providing the treatment
11 because of their experience, training and volume of
12 patients treated to maintain expertise.
13 (ii) Agree to accept reimbursement as payment in
14 full from the carrier at the rates that are established
15 by the carrier and that are not more than the level of
16 reimbursement applicable to other similar services
17 provided by health care providers with the carrier's
18 provider network.
19 (6) There is no clearly superior, noninvestigational
20 treatment alternative.
21 (7) The available clinical or preclinical data provide a
22 reasonable expectation that the treatment will be at least as
23 efficacious as any noninvestigational alternative.
24 (b) Liability.--Pursuant to the patient informed consent
25 document, no party is liable for damages associated with the
26 treatment provided during any phase of a cancer clinical trial.
27 (c) Benefits.--Each health benefits plan delivered or issued
28 for delivery in this Commonwealth shall provide benefits under
29 the plan and those benefits shall not supplant any portion of
30 the clinical trial that is customarily paid for by government,
20070H1462B1809 - 5 -
1 biotechnical, pharmaceutical or medical device industry sources.
2 (d) Remedy.--This section does not create any private right
3 or cause of action for or on behalf of any patient against the
4 carrier. This section provides solely an administrative remedy
5 for any violation of this section or any related rule.
6 (e) Deductibles and other cost sharing.--Nothing in this
7 section prohibits the carrier from imposing deductibles,
8 coinsurance or other cost sharing measures in relation to
9 benefits provided pursuant to this section.
10 (f) Trade association participation.--A trade association
11 that represents a carrier may select a representative to
12 voluntarily serve on the institutional review board of an
13 institution in this Commonwealth that reviews and approves the
14 proposed treatment or study conducted during the cancer clinical
15 trial.
16 Section 4. Applicability.
17 This act applies to health benefit plans issued or renewed on
18 or after January 1, 2008.
19 Section 5. Effective date.
20 This act shall take effect immediately.
E30L40BIL/20070H1462B1809 - 6 -