1Providing for insurance coverage for patient costs associated
2with cancer clinical trials.

3The General Assembly of the Commonwealth of Pennsylvania
4hereby enacts as follows:

5Section 1.  Short title.

6This act shall be known and may be cited as the Cancer
7Clinical Trials Act.

8Section 2.  Definitions.

9The following words and phrases when used in this act shall
10have the meanings given to them in this section unless the
11context clearly indicates otherwise:

12"Carrier."  An insurance company, health service corporation, 
13hospital service corporation, medical service corporation or 
14health maintenance organization authorized to issue health 
15benefits plans in this Commonwealth.

16"Cooperative group."  A formal network of facilities that 
17collaborates on research projects and that has an established 

1National Institutes of Health approved peer review program 
2operating within the group, including the National Cancer 
3Institute clinical cooperative group and the National Cancer 
4Institute community clinical oncology program.

5"Health benefits plan."  A hospital and medical expense 
6insurance policy or certificate; health, hospital or medical 
7service corporation contract or certificate; or health 
8maintenance organization subscriber contract or certificate 
9delivered or issued for delivery in this Commonwealth by any 
10carrier. The term excludes the following plans, policies or 
11contracts: specified disease, CHAMPUS supplement, accident only, 
12credit, disability, long-term care, coverage for Medicare 
13services pursuant to a contract with the Federal Government, 
14Medicare supplement, dental only or vision only, insurance 
15issued as a supplement to liability insurance, coverage arising 
16out of a workers' compensation or similar law, hospital 
17confinement or other supplemental limited benefit insurance 
18coverage or automobile medical payment insurance.

19"Institutional review board."  Any board, committee or other 
20group that is both:

21(1)  Formally designated by an institution to approve the
22initiation of and to conduct periodic review of biomedical
23research involving human subjects and in which the primary
24purpose of such review is to assure the protection of the
25rights and welfare of the human subjects and not to review a
26clinical trial for scientific merit.

27(2)  Approved by the National Institutes of Health office
28for protection from research risks.

29"Multiple project assurance contract."  A contract between an 
30institution and the United States Department of Health and Human 

1Services that defines the relationship of the institution to the 
2United States Department of Health and Human Services and that 
3sets out the responsibilities of the institution and the 
4procedures that will be used by the institution to protect human 
5subjects.

6"Patient."  The subscriber, insured or enrollee or the 
7covered dependent of the subscriber, insured or enrollee.

8"Routine care costs."  Physician fees, laboratory expenses
9and expenses associated with the hospitalization, administering
10of treatment and evaluation of the patient during the course of
11treatment which are consistent with usual and customary patterns
12and standards of care incurred whenever an enrollee, subscriber
13or insured receives medical care associated with an approved
14cancer clinical trial and which would be covered if such items
15and services were provided other than in connection with an
16approved cancer clinical trial.

17Section 3.  Coverage for clinical cancer trials.

18(a)  General rule.--A carrier is not obligated to pay any
19costs, other than routine care costs, that are directly
20associated with a cancer clinical trial that is offered in this
21Commonwealth and in which the subscriber, insured or enrollee
22participates voluntarily. A cancer clinical trial is a course of
23treatment in which all of the following apply:

24(1)  The treatment is part of a scientific study of a new
25therapy or intervention that is being conducted at an
26institution in this Commonwealth, that is for the treatment,
27palliation or prevention of cancer in humans and in which the
28scientific study includes all of the following:

29(i)  Specific goals.

30(ii)  A rationale and background for the study.

1(iii)  Criteria for patient selection.

2(iv)  Specific directions for administering the
3therapy and monitoring patients.

4(v)  A definition of quantitative measures for
5determining treatment response.

6(vi)  Methods for documenting and treating adverse
7reactions.

8(2)  The treatment is being provided as part of a study
9being conducted in a Phase I, Phase II, Phase III or Phase IV
10cancer clinical trial.

11(3)  The treatment is being provided as part of a study
12being conducted in accordance with a clinical trial approved
13by at least one of the following:

14(i)  One of the National Institutes of Health.

15(ii)  A National Institutes of Health cooperative
16group or center.

17(iii)  The United States Food and Drug Administration
18in the form of an investigational new drug application.

19(iv)  The United States Department of Defense.

20(v)  The United States Department of Veterans
21Affairs.

22(vi)  A qualified research entity that meets the
23criteria established by the National Institutes of Health
24for grant eligibility.

25(vii)  A panel of qualified recognized experts in
26clinical research within academic health institutions in
27this Commonwealth.

28(4)  The proposed treatment or study has been reviewed
29and approved by an institutional review board of an
30institution in this Commonwealth.

1(5)  The personnel providing the treatment or conducting
2the study:

3(i)  Are providing the treatment or conducting the
4study within their scope of practice, experience and
5training and are capable of providing the treatment
6because of their experience, training and volume of
7patients treated to maintain expertise.

8(ii)  Agree to accept reimbursement as payment in
9full from the carrier at the rates that are established
10by the carrier and that are not more than the level of
11reimbursement applicable to other similar services
12provided by health care providers with the carrier's
13provider network.

14(6)  There is no clearly superior, noninvestigational
15treatment alternative.

16(7)  The available clinical or preclinical data provide a
17reasonable expectation that the treatment will be at least as
18efficacious as any noninvestigational alternative.

19(b)  Liability.--Pursuant to the patient informed consent
20document, no party is liable for damages associated with the
21treatment provided during any phase of a cancer clinical trial.

22(c)  Benefits.--Each health benefits plan delivered or issued
23for delivery in this Commonwealth shall provide benefits under
24the plan, and those benefits shall not supplant any portion of
25the clinical trial that is customarily paid for by government,
26biotechnical, pharmaceutical or medical device industry sources.

27(d)  Remedy.--This section does not create any private right
28or cause of action for or on behalf of any patient against the
29carrier. This section provides solely an administrative remedy
30for any violation of this section or any related rule.

1(e)  Deductibles and other cost sharing.--Nothing in this
2section prohibits the carrier from imposing deductibles,
3coinsurance or other cost sharing measures in relation to
4benefits provided pursuant to this section.

5Section 4.  Applicability.

6This act applies to health benefit plans issued or renewed on
7or after January 1, 2014.

8Section 5.  Effective date.

9This act shall take effect immediately.