THE GENERAL ASSEMBLY OF PENNSYLVANIA

HOUSE BILL

INTRODUCED BY DeLUCA, HORNAMAN, BARRAR, BELFANTI, BRENNAN, BUXTON, CALTAGIRONE, CREIGHTON, DONATUCCI, EVERETT, FABRIZIO, FRANKEL, GEORGE, GERGELY, GIBBONS, GOODMAN, GRELL, HARKINS, KORTZ, KOTIK, LEVDANSKY, MAHONEY, McCALL, McGEEHAN, McILVAINE SMITH, MELIO, MUNDY, D. O'BRIEN, M. O'BRIEN, READSHAW, REICHLEY, SABATINA, SAYLOR, SCAVELLO, SIPTROTH, SONNEY, STABACK, STERN, VULAKOVICH, WALKO, WHITE AND WANSACZ, JANUARY 28, 2009

REFERRED TO COMMITTEE ON INSURANCE, JANUARY 28, 2009  

AN ACT

Providing for insurance coverage for patient costs associated

with cancer clinical trials.

The General Assembly of the Commonwealth of Pennsylvania

hereby enacts as follows:

Section 1.  Short title.

This act shall be known and may be cited as the Cancer

Clinical Trials Act.

Section 2.  Definitions.

The following words and phrases when used in this act shall

have the meanings given to them in this section unless the

context clearly indicates otherwise:

"Carrier."  An insurance company, health service corporation,

hospital service corporation, medical service corporation or

health maintenance organization authorized to issue health

benefits plans in this Commonwealth.

"Cooperative group."  A formal network of facilities that

collaborates on research projects and that has an established

National Institutes of Health approved peer review program

operating within the group, including the National Cancer

Institute clinical cooperative group and the National Cancer

Institute community clinical oncology program.

"Health benefits plan."  A hospital and medical expense

insurance policy or certificate; health, hospital or medical

service corporation contract or certificate; or health

maintenance organization subscriber contract or certificate

delivered or issued for delivery in this Commonwealth by any

carrier. The term excludes the following plans, policies or

contracts:  specified disease, CHAMPUS supplement, accident

only, credit, disability, long-term care, coverage for Medicare

services pursuant to a contract with the Federal Government,

Medicare supplement, dental only or vision only, insurance

issued as a supplement to liability insurance, coverage arising

out of a workers' compensation or similar law, hospital

confinement or other supplemental limited benefit insurance

coverage or automobile medical payment insurance.

"Institutional review board."  Any board, committee or other

group that is both:

(1)  Formally designated by an institution to approve the

initiation of and to conduct periodic review of biomedical

research involving human subjects and in which the primary

purpose of such review is to assure the protection of the

rights and welfare of the human subjects and not to review a

clinical trial for scientific merit.

(2)  Approved by the National Institutes of Health office

for protection from research risks.

"Multiple project assurance contract."  A contract between an

institution and the United States Department of Health and Human

Services that defines the relationship of the institution to the

United States Department of Health and Human Services and that

sets out the responsibilities of the institution and the

procedures that will be used by the institution to protect human

subjects.

"Patient."  The subscriber, insured or enrollee or the

covered dependent of the subscriber, insured or enrollee.

"Patient cost."  Any fee or expense that is covered under the

policy, contract or certificate and that is for a service or

treatment that would be required if the patient were receiving

usual and customary care. The term does not include the cost:

(1)  Of any drug or device provided in a Phase I cancer

clinical trial.

(2)  Of any investigational drug or device.

(3)  Of nonhealth services that might be required for a

person to receive treatment or intervention.

(4)  Of managing the research of the clinical trial.

(5)  That would not be covered under the patient's

contract.

(6)  Of treatment or services provided outside this

Commonwealth.

Section 3.  Coverage for clinical cancer trials.

(a)  General rule.--A carrier is not obligated to pay any

costs, other than covered patient costs, that are directly

associated with a cancer clinical trial that is offered in this

Commonwealth and in which the subscriber, insured or enrollee

participates voluntarily. A cancer clinical trial is a course of

treatment in which all of the following apply:

(1)  The treatment is part of a scientific study of a new

therapy or intervention that is being conducted at an

institution in this Commonwealth, that is for the treatment,

palliation or prevention of cancer in humans and in which the

scientific study includes all of the following:

(i)  Specific goals.

(ii)  A rationale and background for the study.

(iii)  Criteria for patient selection.

(iv)  Specific directions for administering the

therapy and monitoring patients.

(v)  A definition of quantitative measures for

determining treatment response.

(vi)  Methods for documenting and treating adverse

reactions.

(2)  The treatment is being provided as part of a study

being conducted in a Phase I, Phase II, Phase III or Phase IV

cancer clinical trial.

(3)  The treatment is being provided as part of a study

being conducted in accordance with a clinical trial approved

by at least one of the following:

(i)  One of the National Institutes of Health.

(ii)  A National Institutes of Health cooperative

group or center.

(iii)  The United States Food and Drug Administration

in the form of an investigational new drug application.

(iv)  The United States Department of Defense.

(v)  The United States Department of Veterans

Affairs.

(vi)  A qualified research entity that meets the

criteria established by the National Institutes of Health

for grant eligibility.

(vii)  A panel of qualified recognized experts in

clinical research within academic health institutions in

this Commonwealth.

(4)  The proposed treatment or study has been reviewed

and approved by an institutional review board of an

institution in this Commonwealth.

(5)  The personnel providing the treatment or conducting

the study:

(i)  Are providing the treatment or conducting the

study within their scope of practice, experience and

training and are capable of providing the treatment

because of their experience, training and volume of

patients treated to maintain expertise.

(ii)  Agree to accept reimbursement as payment in

full from the carrier at the rates that are established

by the carrier and that are not more than the level of

reimbursement applicable to other similar services

provided by health care providers with the carrier's

provider network.

(6)  There is no clearly superior, noninvestigational

treatment alternative.

(7)  The available clinical or preclinical data provide a

reasonable expectation that the treatment will be at least as

efficacious as any noninvestigational alternative.

(b)  Liability.--Pursuant to the patient informed consent

document, no party is liable for damages associated with the

treatment provided during any phase of a cancer clinical trial.

(c)  Benefits.--Each health benefits plan delivered or issued

for delivery in this Commonwealth shall provide benefits under

the plan, and those benefits shall not supplant any portion of

the clinical trial that is customarily paid for by government,

biotechnical, pharmaceutical or medical device industry sources.

(d)  Remedy.--This section does not create any private right

or cause of action for or on behalf of any patient against the

carrier. This section provides solely an administrative remedy

for any violation of this section or any related rule.

(e)  Deductibles and other cost sharing.--Nothing in this

section prohibits the carrier from imposing deductibles,

coinsurance or other cost sharing measures in relation to

benefits provided pursuant to this section.

(f)  Trade association participation.--A trade association

that represents a carrier may select a representative to

voluntarily serve on the institutional review board of an

institution in this Commonwealth that reviews and approves the

proposed treatment or study conducted during the cancer clinical

trial.

Section 4.  Applicability.

This act applies to health benefit plans issued or renewed on

or after January 1, 2010.

Section 5.  Effective date.

This act shall take effect immediately.