PRINTER'S NO. 703
No. 647 Session of 2001
INTRODUCED BY DeLUCA, BEBKO-JONES, BELARDI, BELFANTI, BISHOP,
CAPPABIANCA, M. COHEN, CORRIGAN, COSTA, CURRY, FRANKEL,
FREEMAN, GEORGE, HARHAI, HENNESSEY, JAMES, JOSEPHS, LAUGHLIN,
MANDERINO, MICHLOVIC, OLIVER, ORIE, PISTELLA, READSHAW,
SCRIMENTI, SOLOBAY, STABACK, STEELMAN, STURLA, SURRA, TIGUE,
TRAVAGLIO, TRELLO, TRICH, VEON, WALKO, C. WILLIAMS,
WOJNAROSKI, YEWCIC AND YOUNGBLOOD, FEBRUARY 12, 2001
REFERRED TO COMMITTEE ON INSURANCE, FEBRUARY 12, 2001
AN ACT
1 Amending the act of May 17, 1921 (P.L.682, No.284), entitled "An
2 act relating to insurance; amending, revising, and
3 consolidating the law providing for the incorporation of
4 insurance companies, and the regulation, supervision, and
5 protection of home and foreign insurance companies, Lloyds
6 associations, reciprocal and inter-insurance exchanges, and
7 fire insurance rating bureaus, and the regulation and
8 supervision of insurance carried by such companies,
9 associations, and exchanges, including insurance carried by
10 the State Workmen's Insurance Fund; providing penalties; and
11 repealing existing laws," providing for health insurance
12 coverage for cancer clinical trials costs.
13 The General Assembly of the Commonwealth of Pennsylvania
14 hereby enacts as follows:
15 Section 1. The act of May 17, 1921 (P.L.682, No.284), known
16 as The Insurance Company Law of 1921, is amended by adding a
17 section to read:
18 Section 631.1. Reimbursement for Clinical Trials.--(a) Any
19 other provision of law notwithstanding, any individual or group
20 health, sickness and accident insurance policy, group health
1 insurance plans/policies, and all other forms of
2 managed/capitated care plans/policies or subscriber contract or
3 certificate issued by any entity subject to 40 Pa.C.S. Ch. 61
4 (relating to hospital plan corporations) or 63 (relating to
5 professional health services plan corporations) or the act of
6 December 29, 1972 (P.L.1701, No.364), known as the "Health
7 Maintenance Organization Act," the act of December 14, 1992
8 (P.L.835, No.134), known as the "Fraternal Benefit Societies
9 Code," or this act providing hospital or medical/surgical
10 coverage shall provide coverage for patient costs incurred
11 during participation in clinical trials for treatment studies on
12 cancer, including ovarian cancer trials, under any such policy,
13 contract or plan delivered, issued for delivery, or renewed in
14 this Commonwealth on and after July 1, 1999. The benefits
15 specified in this section may be provided through a combination
16 of policies, contracts, certificates or riders, including major
17 medical contracts.
18 (b) The reimbursement for patient costs incurred during
19 participation in clinical trials for treatment studies on cancer
20 shall be determined in the same manner as reimbursement is
21 determined for other medical and surgical procedures. Such
22 coverage shall have durational limits, dollar limits,
23 deductibles, copayments and coinsurance factors that are no less
24 favorable than for physical illness generally.
25 (c) Coverage for patient costs incurred during clinical
26 trials for treatment studies on cancer shall be provided if the
27 treatment is being conducted in a Phase II, Phase III or Phase
28 IV clinical trial. Such treatment may, however, be provided on a
29 case-by-case basis if the treatment is being provided in a Phase
30 I clinical trial.
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1 (d) The treatment described in subsection (c) shall be
2 provided by a clinical trial approved by one of the following:
3 (1) The National Cancer Institute.
4 (2) An NCI cooperative group or an NCI center.
5 (3) The FDA in the form of an investigational new drug
6 application.
7 (4) The United States Department of Veterans Affairs.
8 (5) An institutional review board of an institution in this
9 Commonwealth that has a multiple project assurance contract
10 approved by the Office of Protection from Research Risks of the
11 NCI.
12 (e) The facility and personnel providing the treatment shall
13 be capable of doing so by virtue of their experience, training
14 and expertise.
15 (f) Coverage under this section shall apply only if:
16 (1) There is no clearly superior, noninvestigational
17 treatment alternative.
18 (2) The available clinical or preclinical data provide a
19 reasonable expectation that the treatment will be at least as
20 effective as the noninvestigational alternative.
21 (3) The member and the physician or health care provider who
22 provides services to the member under the insurance policy,
23 subscriber contract or health care plan conclude that the
24 member's participation in the clinical trial would be
25 appropriate, pursuant to procedures established by the insurer,
26 corporation or health maintenance organization and as disclosed
27 in the policy and evidence of coverage.
28 (g) This section shall not apply to short-term travel,
29 accident-only, limited or specified disease policies or
30 contracts designed for issuance to persons eligible for coverage
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1 under Title XVIII of the Social Security Act (49 Stat. 620, 42
2 U.S.C. § 301 et seq.), known as Medicare, or any other similar
3 coverage under State or governmental plans or to short-term
4 nonrenewable policies of not more than six months' duration.
5 (h) Definitions.--As used in this section, the following
6 words and phrases shall have the meanings given to them in this
7 subsection:
8 (1) "Cooperative group" means a formal network of facilities
9 that collaborate on research projects and have an established
10 NIH-approved peer review program operating within the group. The
11 term includes:
12 (i) The National Cancer Institute Clinical Cooperative
13 Group.
14 (ii) The National Cancer Institute Community Clinical
15 Oncology Program.
16 (2) "FDA" means the United States Food and Drug
17 Administration.
18 (3) "Member" means a policyholder, subscriber, insured or
19 certificate holder or a covered dependent of a policyholder,
20 subscriber, insured or certificate holder.
21 (4) "Multiple project assurance contract" means a contract
22 between an institution and the Department of Health and Human
23 Services (DHHS) (20 U.S.C. § 3508) that defines the relationship
24 of the institution to the Department of Health and Human
25 Services and sets out the responsibilities of the institution
26 and the procedures that will be used by the institution to
27 protect human subjects.
28 (5) "NCI" means the National Cancer Institute.
29 (6) "NIH" means the National Institutes of Health.
30 (7) "Patient cost" means the cost of a medically necessary
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1 health care service that is incurred as a result of the
2 treatment being provided to the member for purposes of a
3 clinical trial. The term does not include:
4 (i) The cost of nonhealth care services that a patient may
5 be required to receive as a result of the treatment being
6 provided for purposes of a clinical trial.
7 (ii) Costs associated with managing the research associated
8 with the clinical trial.
9 (iii) The cost of the investigational drug or device.
10 Section 2. This act shall take effect immediately.
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