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H.372
Introduced by Representatives Pugh of South Burlington, Dunne of Hartland
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and Kitzmiller of Montpelier
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Referred to Committee on
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Date:
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Subject: Insurance; health insurance; clinical trials
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Statement of purpose: This bill proposes to require health insurance plans to
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provide coverage for the patient cost to a member of a clinical trial of
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treatment for cancer or other life-threatening condition.
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AN ACT RELATING TO HEALTH INSURANCE COVERAGE OF THE
PATIENT COST TO A MEMBER OF A CLINICAL TRIAL
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It is hereby enacted by the General Assembly of the State of Vermont:
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Sec. 1. 8 V.S.A. § 4099f is added to read:
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§ 4099f. HEALTH INSURANCE AND CLINICAL TRIALS
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(a) A health insurance plan shall provide coverage for the patient cost to a
member in a clinical trial as a result of:
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(1) treatment provided for a life-threatening condition; or
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(2) prevention, early detection, and treatment studies on cancer.
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(b) The coverage under subsection (a) of this section shall be required if:
(1)(A) the treatment is being provided or the studies are being conducted
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in a Phase I, Phase II, Phase III, or Phase IV clinical trial for cancer; or
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(B) the treatment is being provided in a Phase II, Phase III, or Phase
IV clinical trial for any other life-threatening condition;
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(2) the treatment is being provided in a clinical trial approved by:
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(A) one of the National Institutes of Health;
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(B) an NIH cooperative group or an NIH center;
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(C) the FDA in the form of an investigational new drug application;
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(D) the federal Department of Veterans’ Affairs; or
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(E) an institutional review board of an institution in the state that has
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a multiple project assurance contract approved by the Office of Protection from
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Research Risks of the NIH;
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(3) the facility and personnel providing the treatment are capable of
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doing so by virtue of their experience, training, and volume of patients treated
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to maintain expertise;
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(4) there is no clearly superior, noninvestigational treatment alternative;
and
(5) the available clinical or preclinical data provide a reasonable
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expectation that the treatment will be at least as effective at the
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noninvestigational alternative.
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(c) The coverage under this section may be provided on a case-by-case
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basis if the treatment is being provided in a Phase I clinical trial for any life-
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threatening condition other than cancer.
(d) Coverage required by this section shall include coverage for patient cost
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incurred for drugs and devices that have been approved for sale by the FDA,
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whether or not the FDA has approved the drug or device for use in treating the
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patient’s particular condition, to the extent that the drugs or devices are not
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paid for by the manufacturer, distributor, or provider of that drug or device.
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(e)(1) An entity seeking coverage for treatment in a clinical trial approved
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by an institutional review board under subsection (b)(2)(E) of this section shall
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post electronically and keep up-to-date a list of the clinical trials meeting the
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requirements of subsections (a) and (b) of this section.
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(2) The list shall include, for each clinical trial:
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(A) the phase for which the trial is approved;
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(B) the entity approving the trial;
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(C) whether the trial is for treatment of cancer or another life-
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threatening disease and, if not cancer, the particular disease; and
(D) the estimated number of participants in the trial.
(f) As used in this section:
(1) “Cooperative group” means a formal network of facilities that
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collaborate on research projects and have an established NIH-approved Peer
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Review Program operating within the group. The term includes:
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(A) National Cancer Institute Clinical Cooperative Group;
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(B) National Cancer Institute Community Clinical Oncology
Program;
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(C) AIDS Clinical Trials Group; and
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(D) Community Programs for Clinical Research in AIDS.
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(2) “FDA” means the federal Food and Drug Administration.
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(3) “Health insurance plan” means any individual or group health
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benefit plan offered by a health insurer, as defined by section 9402(7) of Title
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18. The term does not include any health benefit paid for under the Social
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Security Act.
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(4) “Member” means a policyholder, subscriber, insured, or certificate
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holder of a health insurance plan, or a covered dependent of a policyholder,
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subscriber, insured, or certificate holder.
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(5) “Multiple project assurance contract” means a contract between an
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institution and the federal Department of Health and Human Services that
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defines the relationship of the institution to the federal Department of Health
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and Human Services and sets out the responsibilities of the institution and the
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procedures that will be used by the institution to protect human subjects.
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(6) “NIH” means the National Institutes of Health.
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(7) “Patient cost” means the cost of a medically-necessary health care
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service that is incurred as a result of the treatment being provided to the
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member for purposes of the clinical trial. The term does not include:
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(A) the cost of an investigational drug or device. The term does
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include drugs and devices that have been approved for sale by the United
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States Food and Drug Administration and used in the qualified clinical trial,
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whether or not the Food and Drug Administration has approved the drug or
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device for use in treating the patient’s particular condition, to the extent that
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the drug or device is not paid for by the manufacturer, distributor, or provider
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of the drug or device;
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(B) the cost of nonhealth care services that a patient may be required
to receive as a result of the treatment being provided for purposes of the
clinical trial;
(C) costs associated with managing the research associated with the
clinical trial; or
(D) costs that would not be covered under the patient’s policy, plan,
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or contract for noninvestigational treatments.
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Sec. 2. WORKGROUP ON INSURANCE COVERAGE FOR PATIENT
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COSTS IN CLINICAL TRIALS
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(a) The commissioner of banking, insurance, securities, and health care
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administration shall establish a workgroup on insurance coverage for patient
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costs in clinical trials to assess the costs and benefits of insurance coverage for
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patient care costs incurred in clinical trials.
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(b) The workgroup shall:
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(1) develop a methodology for assessing the economic and clinical
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impact of the health insurance coverage required by this act for patient care
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costs in clinical trials;
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(2) request and collect from health care providers and payers pertinent
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aggregate clinical and financial data on patient treatment to assess differences
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in patient care costs and clinical outcomes between patients treated in clinical
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trials and patients treated outside clinical trials; and
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(3) review any other issue the workgroup considers appropriate to assess
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and on which to make recommendations pertaining to coverage for patient care
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costs in clinical trials.
(c) The workgroup shall report on its findings and recommendations to the
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committees on health and welfare of the house and the senate on or before
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January 1, 2001.