PRIOR PRINTER'S NO. 1809 PRINTER'S NO. 4336
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, YOUNGBLOOD, MAHONEY, M. SMITH, SOLOBAY, MELIO, BRENNAN AND WOJNAROSKI, JUNE 5, 2007
AS REPORTED FROM COMMITTEE ON INSURANCE, HOUSE OF REPRESENTATIVES, AS AMENDED, SEPTEMBER 17, 2008
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.
1 "Cooperative group." A formal network of facilities that 2 collaborates on research projects and that has an established 3 National Institutes of Health approved peer review program 4 operating within the group, including the National Cancer 5 Institute clinical cooperative group and the National Cancer 6 Institute community clinical oncology program. 7 "Health benefits plan." A hospital and medical expense 8 insurance policy or certificate; health, hospital or medical 9 service corporation contract or certificate; or health 10 maintenance organization subscriber contract or certificate 11 delivered or issued for delivery in this Commonwealth by any 12 carrier. The term excludes the following plans, policies or 13 contracts: accident only, credit, disability, long-term care, 14 coverage for Medicare services pursuant to a contract with the 15 Federal Government, Medicare supplement, dental only or vision 16 only, insurance issued as a supplement to liability insurance, 17 coverage arising out of a workers' compensation or similar law, 18 hospital confinement or other supplemental limited benefit 19 insurance coverage or automobile medical payment insurance. 20 "Institutional review board." Any board, committee or other 21 group that is both: 22 (1) Formally designated by an institution to approve the 23 initiation of and to conduct periodic review of biomedical 24 research involving human subjects and in which the primary 25 purpose of such review is to assure the protection of the 26 rights and welfare of the human subjects and not to review a 27 clinical trial for scientific merit. 28 (2) Approved by the National Institutes of Health office 29 for protection from research risks. 30 "Multiple project assurance contract." A contract between an 20070H1462B4336 - 2 -
1 institution and the United States Department of Health and Human 2 Services that defines the relationship of the institution to the 3 United States Department of Health and Human Services and that 4 sets out the responsibilities of the institution and the 5 procedures that will be used by the institution to protect human 6 subjects. 7 "Patient." The subscriber, insured or enrollee or the 8 covered dependent of the subscriber, insured or enrollee. 9 "Patient cost." Any fee or expense that is covered under the <-- 10 policy, contract or certificate and that is for a service or 11 treatment that would be required if the patient were receiving 12 usual and customary care. The term does not include the cost: 13 (1) Of any drug or device provided in a Phase I cancer 14 clinical trial. 15 (2) Of any investigational drug or device. 16 (3) Of nonhealth services that might be required for a 17 person to receive treatment or intervention. 18 (4) Of managing the research of the clinical trial. 19 (5) That would not be covered under the patient's 20 contract. 21 (6) Of treatment or services provided outside this 22 Commonwealth. 23 "ROUTINE CARE COSTS." PHYSICIAN FEES, LABORATORY EXPENSES <-- 24 AND EXPENSES ASSOCIATED WITH THE HOSPITALIZATION, ADMINISTERING 25 OF TREATMENT AND EVALUATION OF THE PATIENT DURING THE COURSE OF 26 TREATMENT WHICH ARE CONSISTENT WITH USUAL AND CUSTOMARY PATTERNS 27 AND STANDARDS OF CARE INCURRED WHENEVER AN ENROLLEE, SUBSCRIBER 28 OR INSURED RECEIVES MEDICAL CARE ASSOCIATED WITH AN APPROVED 29 CANCER CLINICAL TRIAL, AND WHICH WOULD BE COVERED IF SUCH ITEMS 30 AND SERVICES WERE PROVIDED OTHER THAN IN CONNECTION WITH AN 20070H1462B4336 - 3 -
1 APPROVED CANCER CLINICAL TRIAL.
2 Section 3. Coverage for clinical cancer trials.
3 (a) General rule.--A carrier is not obligated to pay any
4 costs, other than covered patient ROUTINE CARE costs, that are <--
5 directly associated with a cancer clinical trial that is offered
6 in this Commonwealth and in which the subscriber, insured or
7 enrollee participates voluntarily. A cancer clinical trial is a
8 course of treatment in which all of the following apply:
9 (1) The treatment is part of a scientific study of a new
10 therapy or intervention that is being conducted at an
11 institution in this Commonwealth, that is for the treatment,
12 palliation or prevention of cancer in humans and in which the
13 scientific study includes all of the following:
14 (i) Specific goals.
15 (ii) A rationale and background for the study.
16 (iii) Criteria for patient selection.
17 (iv) Specific directions for administering the
18 therapy and monitoring patients.
19 (v) A definition of quantitative measures for
20 determining treatment response.
21 (vi) Methods for documenting and treating adverse
22 reactions.
23 (2) The treatment is being provided as part of a study
24 being conducted in a Phase I, Phase II, Phase III or Phase IV
25 cancer clinical trial.
26 (3) The treatment is being provided as part of a study
27 being conducted in accordance with a clinical trial approved
28 by at least one of the following:
29 (i) One of the National Institutes of Health.
30 (ii) A National Institutes of Health cooperative
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1 group or center. 2 (iii) The United States Food and Drug Administration 3 in the form of an investigational new drug application. 4 (iv) The United States Department of Defense. 5 (v) The United States Department of Veterans 6 Affairs. 7 (vi) A qualified research entity that meets the 8 criteria established by the National Institutes of Health 9 for grant eligibility. 10 (vii) A panel of qualified recognized experts in 11 clinical research within academic health institutions in 12 this Commonwealth. 13 (4) The proposed treatment or study has been reviewed 14 and approved by an institutional review board of an 15 institution in this Commonwealth. 16 (5) The personnel providing the treatment or conducting 17 the study: 18 (i) Are providing the treatment or conducting the 19 study within their scope of practice, experience and 20 training and are capable of providing the treatment 21 because of their experience, training and volume of 22 patients treated to maintain expertise. 23 (ii) Agree to accept reimbursement as payment in 24 full from the carrier at the rates that are established 25 by the carrier and that are not more than the level of 26 reimbursement applicable to other similar services 27 provided by health care providers with the carrier's 28 provider network. 29 (6) There is no clearly superior, noninvestigational 30 treatment alternative. 20070H1462B4336 - 5 -
1 (7) The available clinical or preclinical data provide a 2 reasonable expectation that the treatment will be at least as 3 efficacious as any noninvestigational alternative. 4 (b) Liability.--Pursuant to the patient informed consent 5 document, no party is liable for damages associated with the 6 treatment provided during any phase of a cancer clinical trial. 7 (c) Benefits.--Each health benefits plan delivered or issued 8 for delivery in this Commonwealth shall provide benefits under 9 the plan and those benefits shall not supplant any portion of 10 the clinical trial that is customarily paid for by government, 11 biotechnical, pharmaceutical or medical device industry sources. 12 (d) Remedy.--This section does not create any private right 13 or cause of action for or on behalf of any patient against the 14 carrier. This section provides solely an administrative remedy 15 for any violation of this section or any related rule. 16 (e) Deductibles and other cost sharing.--Nothing in this 17 section prohibits the carrier from imposing deductibles, 18 coinsurance or other cost sharing measures in relation to 19 benefits provided pursuant to this section. 20 (f) Trade association participation.--A trade association <-- 21 that represents a carrier may select a representative to 22 voluntarily serve on the institutional review board of an 23 institution in this Commonwealth that reviews and approves the 24 proposed treatment or study conducted during the cancer clinical 25 trial. 26 Section 4. Applicability. 27 This act applies to health benefit plans issued or renewed on 28 or after January 1, 2008 2009. <-- 29 Section 5. Effective date. 30 This act shall take effect immediately. E30L40BIL/20070H1462B4336 - 6 -