THE GENERAL ASSEMBLY OF PENNSYLVANIA

SENATE BILL

INTRODUCED BY O'PAKE, COSTA, STOUT, LOGAN, KASUNIC, KITCHEN, GREENLEAF, RAFFERTY, WASHINGTON, FONTANA, WOZNIAK, TARTAGLIONE, STACK, LEACH AND BOSCOLA, FEBRUARY 19, 2009

REFERRED TO BANKING AND INSURANCE, FEBRUARY 19, 2009  

AN ACT

Providing for insurance coverage for routine patient care costs

when an insured, enrollee or subscriber participates in

approved cancer clinical trials; establishing the

Pennsylvania Cancer Clinical Trial Review Board to adjudicate

disputes involving third-party reimbursement for routine

patient care costs incurred in association with approved

cancer clinical trials; and providing for hearings and

appeals.

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.  Statement of purpose.

It is the policy of the General Assembly and the intent and

purpose of this act that the routine patient care expenses of

approved cancer clinical trials be paid or reimbursed by

insurers and other health care providers to promote the health

and welfare of the people of this Commonwealth. Sound health

care practices such as approved cancer clinical trials which

meet the requirements of this act should be available to all of

the residents of this Commonwealth notwithstanding the practices

and the discretion of insurers and other health care providers.

Scientists believe that higher participation in cancer clinical

trials will lead to faster development of therapies for those in

need. For decades well over 50% of pediatric cancer patients

were enrolled in clinical trials, and today, 75% of cancers in

children are curable. In 2000, about 600 cancer clinical trials

were in progress, but only 45,000 cancer patients were enrolled.

If more health care providers covered these trials, more people

would participate. Coverage for clinical trials would lead to

new therapies and treatments as well as help cancer patients in

this Commonwealth.

Section 3.  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:

"Approved cancer clinical trial."  A scientific study of a

new therapy for the treatment of cancer in human beings that

meets the requirements set forth in section 5 and consists of a

scientific plan of treatment that includes specified goals, a

rationale and background for the plan, criteria for patient

selection, specific directions for administering therapy and

monitoring patients, a definition of quantitative measures for

determining treatment response and methods for documenting and

treating adverse reactions.

"Board."  The Pennsylvania Cancer Clinical Trial Review Board

established in section 6.

"Institutional review board" or "IRB."  A board, committee or

other group formally designated by an institution and approved

by the National Institutes of Health, Office for Protection from

Research Risks to review, approve the initiation of and conduct

periodic review of biomedical research involving human subjects.

The primary purpose of such review is to assure the protection

of the rights and welfare of the human subjects. The term has

the same meaning as the phrase "institutional review committee"

as used in section 520(g) of the Federal Food, Drug, and

Cosmetic Act (52 Stat. 1040, 21 U.S.C. § 301 et seq.).

"Routine patient care costs."  Physician fees, laboratory

expenses and expenses associated with the hospitalization,

administering of treatment and evaluation of the patient during

the course of treatment which are consistent with usual and

customary patterns and standards of care incurred whenever an

enrollee, subscriber or insured receives medical care associated

with an approved cancer clinical trial, and which would be

covered if such items and services were provided other than in

connection with an approved cancer clinical trial.

"Therapeutic intent."  A treatment must be aimed at improving

patient outcome relative to either survival or quality of life.

Section 4.  Mandated coverage.

Notwithstanding any other provision of law, every health care

policy delivered, renewed, extended or modified in this

Commonwealth shall include coverage for routine patient care

costs incurred in approved clinical trials for cancer treatment

to the same degree as in treating any other sickness, injury,

disease or condition covered under the policy when the insured

has been referred for such treatment by two physicians who

specialize in oncology and the trials meet the requirements set

forth in section 5. Routine patient care costs for services

furnished without charge to any participant in the trial shall

not be subject to coverage under this section.

Section 5.  Criteria.

Routine patient care costs for approved cancer clinical

trials for cancer treatment shall be reimbursed when all of the

following requirements are met:

(1)  The treatment is provided with a therapeutic intent

and is being provided pursuant to an approved cancer clinical

trial that has been authorized or approved by one of the

following:

(i)  The National Institutes of Health.

(ii)  The United States Food and Drug Administration.

(iii)  The United States Department of Defense.

(iv)  The United States Department of Veterans

Affairs.

(2)  The proposed therapy has been reviewed and approved

by the applicable qualified institutional review board.

(3)  The available clinical or preclinical data indicate

that the treatment provided pursuant to the approved cancer

clinical trial will be at least as effective as the standard

therapy and is anticipated to constitute an improvement in

the therapeutic effectiveness for the treatment of the

disease in question.

Section 6.  Cancer Clinical Trial Review Board.

(a)  Establishment.--There is hereby established in the

Department of Health the Pennsylvania Cancer Clinical Trial

Review Board.

(b)  Membership.--The board shall consist of nine members

appointed by the Governor with the advice and consent of the

Senate, as follows:

(1)  One member shall be a physician licensed to practice

medicine and surgery in this Commonwealth who specializes in

oncology and is a member of a community medical oncology

practice and who is not on the staff of a comprehensive or

clinical cancer center designated by the National Cancer

Institute.

(2)  One member shall be a physician licensed to practice

medicine and surgery in this Commonwealth who specializes in

oncology and who is on the staff of a comprehensive or

clinical cancer center designated by the National Cancer

Institute.

(3)  One member shall be a medical ethicist recognized

for expertise in evaluating ethical implications of health

care practices and procedures.

(4)  One member shall be a medical economist recognized

for expertise in evaluating economic implications of health

care practices and procedures.

(5)  One member shall be a physician licensed to practice

medicine and surgery in this Commonwealth who is employed by

or who represents an insurer.

(6)  One member shall be a physician licensed to practice

medicine and surgery in this Commonwealth who is employed by

or represents a nonprofit health care service plan.

(7)  One member shall be a physician licensed to practice

medicine and surgery in this Commonwealth who is employed by

or who represents a health maintenance organization.

(8)  One member who is a resident of this Commonwealth

shall be a representative of Commonwealth residents with

health insurance who are consumers of oncology services.

(9)  One member shall be a representative of the

Pennsylvania Cancer Control, Prevention and Research Advisory

Board.

(c)  Chairman.--A chairman shall be selected by a majority

vote of the board members.

(d)  Meetings.--The board shall meet no less than four times

annually at the call of the chairman.

(e)  Terms.--Members shall be appointed for four-year terms.

Any vacancy occurring in the membership of the board shall be

filled by a qualified person appointed by the Governor for the

unexpired term of the member.

(f)  Hearings and appeals.--The board has the power and duty

to hold hearings and issue adjudications under 2 Pa.C.S. Ch. 5

Subch. A (relating to practice and procedure of Commonwealth

agencies) of disputes involving third-party reimbursement for

patient care costs incurred in association with cancer clinical

trials, subject to review and appeal in accordance with 2

Pa.C.S. Ch. 7 Subch. A (relating to judicial review of

Commonwealth agency action).

(g)  Compensation and staff.--Members of the board shall

receive no compensation for their services. Each member shall

receive reimbursement for actual traveling expenses and other

necessary expenses. Administrative staffing needs shall be

provided by the Department of Health. Any additional staffing

needs that the board has shall be provided by the institution

that provides or seeks to provide the therapeutic treatment that

is under review.

Section 7.  Construction of act.

Provisions of the Employee Retirement Income Security Act of

1974 (Public Law 93-406, 88 Stat. 829), referred to as ERISA,

currently prohibit the application of this act to certain types

of health care benefit plans and health care payers. It is the

intent of the General Assembly that this act be given the

broadest possible application and that its scope include

applications permitted by future legislative amendments and

judicial interpretations of ERISA.

Section 8.  Applicability.

This act shall apply to every group or individual policy,

contract or certificate issued under a policy or contract of

health, sickness or accident insurance delivered or issued for

delivery, renewed, extended or modified in this Commonwealth,

including, but not limited to, policies, contracts or

certificates issued by:

(1)  Any stock insurance company as defined in section

202(c)(4) and (11) of the act of May 17, 1921 (P.L.682, No.

284), known as The Insurance Company Law of 1921.

(2)  Any mutual insurance company as defined in section

202(d)(1) of The Insurance Company Law of 1921.

(3)  A health insurance policy or contract issued by a

nonprofit corporation subject to 40 Pa.C.S. Ch. 61 (relating

to hospital plan corporations) or 63 (relating to

professional health services plan corporations).

(4)  A health service plan operating under the act of

December 29, 1972 (P.L.1701, No.364), known as the Health

Maintenance Organization Act.

(5)  An employee welfare benefit plan as defined in

section 3 of the Employee Retirement Income Security Act of

1974 (Public Law 93-406, 88 Stat. 829).

(6)  Any fraternal benefit societies as defined in

Article XXIV of The Insurance Company Law of 1921.

(7)  Any voluntary nonprofit health services plan as

defined in the Health Maintenance Organization Act.

(8)  Any preferred provider organization as defined in

section 630 of The Insurance Company Law of 1921.

(9)  Any agreement by a self-insured employer or self-

insured multiple employer trust to provide health care

benefits to employees and their dependents.

(10)  Any person who sells or issues contracts or

certificates of insurance which meet the requirements of this

act.

Section 9.  Expiration.

This act shall expire June 30, 2012.

Section 10.  Effective date.

This act shall take effect in 180 days.