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Introduced by Senator Bloomer of Rutland County, Senator Campbell of Windsor County, Senator Chard of Windham County, Senator Lyons of Chittenden County and Senator Snelling of Chittenden County

Referred to Committee on


Subject: Insurance; health insurance; clinical trials

Statement of purpose: This bill proposes to require that health insurance plans cover routine patient care service in approved clinical trials for cancer or other life-threatening illnesses.


It is hereby enacted by the General Assembly of the State of Vermont:

Sec.1. 8 V.S.A. § 4088b is added to read:


(a) As used in this section:

(1) "Cooperative group" means a formal network of facilities that collaborate on research projects and have an established National Institutes of Health approved peer review program operating within the group.

(2) "Health insurance plan" means any health insurance policy or health benefit plan offered by a health insurer, as defined in 18 V.S.A. § 9402(7). "Health insurance plan" includes any health benefit plan offered or administered by the state, or any subdivision or instrumentality of the state.

(3) "Life-threatening illness" means a disease or condition in which the likelihood of death is high unless the course of the disease is interrupted.

(4) "Multiple project assurance contract" means a contract between an institution and the federal Department of Health and Human Services that defines the relationship of the institution to the federal Department of Health and Human Services, and sets out the responsibilities of the institution and the procedures that will be used by the institution to protect human subjects.

(5) "Routine patient care service" means any medically-necessary health care service that is incurred as a result of the treatment being provided for the purposes of the clinical trial. "Routine patient care service" does not mean:

(A) An investigational new drug that has not been approved for market for any indication by the federal Food and Drug Administration;

(B) A nonhealth care service that a patient may be required to receive as a result of the treatment being provided for the purposes of the clinical trial;

(C) Services that are clearly inconsistent with widely-accepted and established regional or national standards of care for a particular diagnosis, and performed specifically to meet the requirements of the clinical trial;

(D) Services associated with managing the research associated with the clinical trial; or

(E) Services that would not be covered under the insured’s health insurance plan, for noninvestigational treatments.

(b) Coverage for participation in a clinical trial shall be provided by a health insurance plan if:

(1) The treatment is being provided in a Phase I, II, III, or IV clinical trial, for cancer or other life-threatening illness, that is approved by:

(A) One of the National Institutes of Health;

(B) A National Institutes of Health-affiliated cooperative group;

(C) The Food and Drug Administration in the form of an investigational new drug exemption;

(D) The federal Department of Veterans Affairs or of Defense; or

(E) An institutional review board of an institution in this state that has a multiple project assurance contract approved by the Office of Protection from Research Risks of the National Institutes of Health;

(2) There is no clearly superior, noninvestigational treatment alternative;

(3) The facility and personnel providing the treatment are capable of doing so by virtue of their experience, training, and volume of patients treated to maintain their expertise; and

(4) The available clinical or preclinical data provide a reasonable expectation that the treatment will be at least as effective as the

noninvestigational alternative.

(c)(1) A health insurance plan subject to this section shall provide coverage for routine patient care costs incurred for drugs and devices used during the clinical trial, provided that those drugs or devices have been approved for sale by the federal Food and Drug Administration, whether or not the federal Food and Drug Administration has approved the drug or device for use in treating the particular condition, and to the extent those drugs or devices are not provided or paid by the sponsor of the clinical trial, or the manufacturer, distributor, or provider of that drug or device.

(2) The coverage required by this section shall include coverage for reasonable and medically-necessary services to administer the drug or use the device under evaluation in the clinical trial.

(d) For the purpose of this section, health care providers participating in a clinical trial shall obtain a patient’s informed consent for participation in a clinical trial, in a manner consistent with current legal and ethical standards. Such document shall be available to the health insurance plan upon request.

(e) Health insurance plans providing coverage under this section and the health care providers participating in such clinical trials shall develop a mutually-agreed-upon process to share appropriate aggregate clinical and financial data on the progress and outcomes of clinical trials subject to this section.


This section shall apply to all health insurance plans as such plans are offered, issued, or renewed in this state on or after October 1, 2001, but in no event later than October 1, 2002.