PRINTER'S NO. 2863
No. 2135 Session of 2003
INTRODUCED BY SCRIMENTI, BEBKO-JONES, LEDERER, GRUCELA, WALKO,
TRAVAGLIO, GEORGE, JAMES, WASHINGTON, FABRIZIO, JOSEPHS,
KIRKLAND, MELIO, FREEMAN, YOUNGBLOOD, BELFANTI, CRUZ AND
HARHAI, OCTOBER 27, 2003
REFERRED TO COMMITTEE ON INSURANCE, OCTOBER 27, 2003
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 reimbursement for
12 clinical trial treatments.
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 635.2. Reimbursement for Clinical Trial Treatment.--
19 (a) All group or individual health or sickness or accident or
20 pharmaceutical insurance policies providing hospital or
21 medical/surgical or pharmaceutical coverage and all group or
22 individual subscribers contracts or certificates issued by any
1 entity subject to 40 Pa.C.S. Ch. 61 (relating to hospital plan
2 corporations) or 63 (relating to professional health services
3 plan corporations), this act, the act of December 29, 1972
4 (P.L.1701, No.364), known as the "Health Maintenance
5 Organization Act," or an employee welfare benefit plan as
6 defined in section 3 of the Employee Retirement Income Security
7 Act of 1974 (Public Law 93-406, 88 Stat. 829) providing hospital
8 or medical/surgical or pharmaceutical coverage shall also
9 provide coverage for patient cost to a member in a clinical
10 trial as a result of:
11 (1) treatment provided for a life-threatening condition; or
12 (2) prevention, early detection and treatment studies on
13 cancer.
14 (b) The coverage under subsection (a) is required if:
15 (1) The treatment is being provided in a Phase I, Phase II,
16 Phase III or Phase IV clinical trial for cancer or for any other
17 life-threatening condition.
18 (2) The treatment is being provided in a clinical trial
19 approved by:
20 (i) one of the National Institutes of Health;
21 (ii) an NIH cooperative group or an NIH center;
22 (iii) the FDA in the form of an investigational new drug
23 application;
24 (iv) the Department of Veterans Affairs; or
25 (v) an institutional review board of an institution in this
26 Commonwealth which has a multiple project assurance contract
27 approved by the Office of Human Research Protections under the
28 United States Department of Health and Human Services.
29 (3) The facility and personnel providing treatment are
30 capable of doing so by virtue of their experience, training and
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1 volume of patients treated to maintain expertise.
2 (4) There is no clearly superior, noninvestigational
3 treatment.
4 (5) The available clinical or preclinical data provide a
5 reasonable expectation that the treatment will be at least as
6 effective as the noninvestigational alternative.
7 (c) The coverage under subsection (a) shall include coverage
8 for patient cost incurred for drugs and devices that have been
9 approved for sale by the FDA whether or not the FDA has approved
10 the drug or device for use in treating that patient's particular
11 condition, to the extent that the drugs or devices are not paid
12 for by the manufacturer, distributor or provider of that drug or
13 device.
14 (d) An entity seeking coverage for treatment in a clinical
15 trial approved by an institutional review board under subsection
16 (b)(2)(v) shall post electronically and keep up-to-date a list
17 of the clinical trials meeting the requirements of subsections
18 (a) and (b). For each clinical trial, the list shall include:
19 (1) The phase for which the trial is approved.
20 (2) The entity approving the trial.
21 (3) Whether the trial is for treatment of cancer or another
22 life-threatening disease, specifying the specific disease.
23 (4) The estimated number of participants in the trial.
24 (e) As used in this section, the following words and phrases
25 shall have the meanings given to them in this subsection:
26 "Cooperative group." A formal network of facilities that
27 collaborate on research projects and have an established NIH-
28 approved Peer Review Program operating within the group. This
29 term includes:
30 (1) The National Cancer Institute Clinical Cooperative
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1 Group.
2 (2) The National Cancer Institute Community Clinical
3 Oncology Program.
4 (3) The AIDS Clinical Trials Group.
5 (4) The Community Programs for Clinical Research in AIDS.
6 "FDA." The United States Food and Drug Administration.
7 "Member." A policyholder, subscriber, insured, or
8 certificate holder or a covered dependent of a policy holder,
9 subscriber, insured, or certificate holder.
10 "Multiple project assurance contract." A contract between an
11 institution and the United States Department of Health and Human
12 Services that defines the relationship of the institution to the
13 United States Department of Health and Human Services and sets
14 out the responsibilities of the institution and the procedures
15 that will be used by the institution to protect human subjects.
16 "NIH." The National Institutes of Health.
17 "Patient cost." The cost of medically necessary health care
18 services that is incurred as a result of the treatment being
19 provided to the member for purposes of the clinical trial. This
20 term does not include:
21 (1) The cost of an investigational drug or device.
22 (2) The cost of nonhealth care services that a patient may
23 be required to receive as a result of the treatment being
24 provided for purposes of the clinical trial.
25 (3) Costs associated with managing the research associated
26 with the clinical trial.
27 (4) Costs that would not be covered under the patient's
28 policy, plan or contract for noninvestigational treatments.
29 Section 2. This act shall take effect in 60 days.
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