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        PRIOR PRINTER'S NO. 1809                      PRINTER'S NO. 4336

THE GENERAL ASSEMBLY OF PENNSYLVANIA


HOUSE BILL

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
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     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
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     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.
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