PRINTER'S NO. 533
No. 515 Session of 2001
INTRODUCED BY SCHWARTZ, WAGNER, MUSTO, COSTA, TILGHMAN, BODACK,
TARTAGLIONE, LAVALLE AND MELLOW, FEBRUARY 15, 2001
REFERRED TO BANKING AND INSURANCE, FEBRUARY 15, 2001
AN ACT
1 Providing for insurance coverage for routine patient care costs
2 when an insured, enrollee or subscriber participates in
3 approved cancer clinical trials; establishing the
4 Pennsylvania Cancer Clinical Trial Review Board to adjudicate
5 disputes involving third-party reimbursement for routine
6 patient care costs incurred in association with approved
7 cancer clinical trials; and providing for hearings and
8 appeals.
9 The General Assembly of the Commonwealth of Pennsylvania
10 hereby enacts as follows:
11 Section 1. Short title.
12 This act shall be known and may be cited as the Cancer
13 Clinical Trials Act.
14 Section 2. Statement of purpose.
15 It is the policy of the General Assembly and the intent and
16 purpose of this act that the routine patient care expenses of
17 approved cancer clinical trials be paid or reimbursed by
18 insurers and other health care providers to promote the health
19 and welfare of the people of this Commonwealth. Sound health
20 care practices such as approved cancer clinical trials which
1 meet the requirements of this act should be available to all of
2 the residents of this Commonwealth notwithstanding the practices
3 and the discretion of insurers and other health care providers.
4 Scientists believe that higher participation in cancer clinical
5 trials will lead to faster development of therapies for those in
6 need. For decades well over 50% of pediatric cancer patients
7 were enrolled in clinical trials, and today, 75% of cancers in
8 children are curable. About 600 cancer clinical trials are in
9 progress, but only 45,000 cancer patients are enrolled. If more
10 health care providers covered these trials, more people would
11 participate. Coverage for clinical trials would lead to new
12 therapies and treatments as well as help cancer patients in this
13 Commonwealth.
14 Section 3. Definitions.
15 The following words and phrases when used in this act shall
16 have the meanings given to them in this section unless the
17 context clearly indicates otherwise:
18 "Approved cancer clinical trial." A scientific study of a
19 new therapy for the treatment of cancer in human beings that
20 meets the requirements set forth in section 5. An "approved
21 cancer clinical trial" consists of a scientific plan of
22 treatment that includes specified goals, a rationale and
23 background for the plan, criteria for patient selection,
24 specific directions for administering therapy and monitoring
25 patients, a definition of quantitative measures for determining
26 treatment response and methods for documenting and treating
27 adverse reactions.
28 "Board." The Pennsylvania Cancer Clinical Trial Review Board
29 established in section 6.
30 "Institutional review board" or "IRB." A board, committee or
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1 other group formally designated by an institution and approved
2 by the National Institutes of Health Office for Protection from
3 Research Risks to review, approve the initiation of and conduct
4 periodic review of biomedical research involving human subjects.
5 The primary purpose of such review is to assure the protection
6 of the rights and welfare of the human subjects. The term has
7 the same meaning as the phrase "Institutional Review Committee"
8 as used in section 520(g) of the Federal Food, Drug, and
9 Cosmetic Act (52 Stat. 1040, 21 U.S.C. § 301 et seq.).
10 "Routine patient care costs." Physician fees, laboratory
11 expenses and expenses associated with the hospitalization,
12 administering of treatment and evaluation of the patient during
13 the course of treatment which are consistent with usual and
14 customary patterns and standards of care incurred whenever an
15 enrollee, subscriber or insured receives medical care associated
16 with an approved cancer clinical trial, and which would be
17 covered if such items and services were provided other than in
18 connection with an approved cancer clinical trial.
19 "Therapeutic intent." A treatment must be aimed at improving
20 patient outcome relative to either survival or quality of life.
21 Section 4. Mandated coverage.
22 Any other provision of law to the contrary notwithstanding,
23 any health, sickness or accident policy, contract or certificate
24 which is delivered, issued for delivery, renewed, extended or
25 modified in this Commonwealth shall provide that benefits
26 applicable under the policy include coverage for routine patient
27 care costs incurred in association with approved cancer clinical
28 trials for the treatment of cancer in the same manner any other
29 sickness, injury, disease or condition is covered under the
30 policy, contract or certificate if the insured, enrollee or
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1 subscriber upon informed consent has been referred for such
2 treatment by two physicians who specialize in oncology and such
3 approved cancer clinical trials meet the requirements set forth
4 in section 5. Routine patient care costs for services furnished
5 by the sponsor of an approved cancer clinical trial without any
6 charge to any participant in the approved cancer clinical trial
7 shall not be subject to coverage under this section.
8 Section 5. Criteria.
9 Routine patient care costs for approved cancer clinical
10 trials for cancer treatment shall be reimbursed when all of the
11 following requirements are met:
12 (1) The treatment is provided with a therapeutic intent
13 and is being provided pursuant to an approved cancer clinical
14 trial that has been authorized or approved by one of the
15 following:
16 (i) The National Institutes of Health.
17 (ii) The United States Food and Drug Administration.
18 (iii) The United States Department of Defense.
19 (iv) The United States Department of Veterans
20 Affairs.
21 (2) The proposed therapy has been reviewed and approved
22 by the applicable qualified institutional review board.
23 (3) The available clinical or preclinical data indicate
24 that the treatment provided pursuant to the approved cancer
25 clinical trial will be at least as effective as the standard
26 therapy and is anticipated to constitute an improvement in
27 the therapeutic effectiveness for the treatment of the
28 disease in question.
29 Section 6. Cancer Clinical Trial Review Board.
30 (a) Establishment.--There is hereby established in the
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1 Department of Health the Pennsylvania Cancer Clinical Trial
2 Review Board.
3 (b) Membership.--The board shall consist of nine members
4 appointed by the Governor with the advice and consent of the
5 Senate, as follows:
6 (1) One member shall be a physician licensed to practice
7 medicine and surgery in this Commonwealth who specializes in
8 oncology and is a member of a community medical oncology
9 practice and who is not on the staff of a comprehensive or
10 clinical cancer center designated by the National Cancer
11 Institute.
12 (2) One member shall be a physician licensed to practice
13 medicine and surgery in this Commonwealth who specializes in
14 oncology and who is on the staff of a comprehensive or
15 clinical cancer center designated by the National Cancer
16 Institute.
17 (3) One member shall be a medical ethicist recognized
18 for his or her expertise in evaluating ethical implications
19 of health care practices and procedures.
20 (4) One member shall be a medical economist recognized
21 for his or her expertise in evaluating economic implications
22 of health care practices and procedures.
23 (5) One member shall be a physician licensed to practice
24 medicine and surgery in this Commonwealth who is employed by
25 or who represents an insurer.
26 (6) One member shall be a physician licensed to practice
27 medicine and surgery in this Commonwealth who is employed by
28 or represents a nonprofit health care service plan.
29 (7) One member shall be a physician licensed to practice
30 medicine and surgery in this Commonwealth who is employed by
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1 or who represents a health maintenance organization.
2 (8) One member who is a resident of this Commonwealth
3 shall be a representative of Commonwealth residents with
4 health insurance who are consumers of oncology services.
5 (9) One member shall be a representative of the
6 Pennsylvania Cancer Control, Prevention and Research Advisory
7 Board.
8 (c) Chairman.--A chairman will be selected by a majority
9 vote of the board members.
10 (d) Meetings.--The board shall meet no less than four times
11 annually at the call of the chairman.
12 (e) Terms.--Members shall be appointed for four-year terms.
13 Any vacancy occurring in the membership of the board shall be
14 filled by a qualified person appointed by the Governor for the
15 unexpired term of the member.
16 (f) Hearings and appeals.--The board has the power and duty
17 to hold hearings and issue adjudications under 2 Pa.C.S. Ch. 5
18 Subch. A (relating to practice and procedure of Commonwealth
19 agencies) of disputes involving third-party reimbursement for
20 patient care costs incurred in association with cancer clinical
21 trials, subject to review and appeal in accordance with 2
22 Pa.C.S. Ch. 7, Subch. A (relating to judicial review of
23 Commonwealth agency action).
24 (g) Compensation and staff.--Members of the board shall
25 receive no compensation for their services. Each member shall
26 receive reimbursement for actual traveling expenses and other
27 necessary expenses. Administrative staffing needs will be
28 provided by the Department of Health. Any additional staffing
29 needs that the board has shall be provided by the institution
30 that provides or seeks to provide the therapeutic treatment that
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1 is under review.
2 Section 7. Construction of act.
3 Provisions of the Employee Retirement Income Security Act of
4 1974 (Public Law 93-406, 88 Stat. 829), referred to as ERISA,
5 currently prohibit the application of this act to certain types
6 of health care benefit plans and health care payers. It is the
7 intent of the General Assembly that this act be given the
8 broadest possible application and that its scope include
9 applications permitted by future legislative amendments and
10 judicial interpretations of ERISA.
11 Section 8. Applicability.
12 This act shall apply to every group or individual policy,
13 contract or certificate issued under a policy or contract of
14 health, sickness or accident insurance delivered or issued for
15 delivery, renewed, extended or modified in this Commonwealth,
16 including, but not limited to, policies, contracts or
17 certificates issued by:
18 (1) Any stock insurance company as defined in section
19 202(c)(4) and (11) of the act of May 17, 1921 (P.L.682,
20 No.284), known as The Insurance Company Law of 1921.
21 (2) Any mutual insurance company as defined in section
22 202(d)(1) of The Insurance Company Law of 1921.
23 (3) A health insurance policy or contract issued by a
24 nonprofit corporation subject to 40 Pa.C.S. Chs. 61 (relating
25 to hospital plan corporations) or 63 (relating to
26 professional health services plan corporations).
27 (4) A health service plan operating under the act of
28 December 29, 1972 (P.L.1701, No.364), known as the Health
29 Maintenance Organization Act.
30 (5) An employee welfare benefit plan as defined in
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1 section 3 of the Employee Retirement Income Security Act of
2 1974 (Public Law 93-406, 88 Stat. 829).
3 (6) Any fraternal benefit societies as defined in the
4 act of December 14, 1992 (P.L.835, No.134), known as the
5 Fraternal Benefit Societies Code.
6 (7) Any voluntary nonprofit health services plan as
7 defined in the Health Maintenance Organization Act.
8 (8) Any preferred provider organization as defined in
9 section 630 of The Insurance Company Law of 1921.
10 (9) Any agreement by a self-insured employer or self-
11 insured multiple employer trust to provide health care
12 benefits to employees and their dependents.
13 (10) Any person who sells or issues contracts or
14 certificates of insurance which meet the requirements of this
15 act.
16 Section 9. Expiration.
17 This act shall expire June 30, 2008.
18 Section 10. Effective date.
19 This act shall take effect in 180 days.
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