(b) The health care insurer is required to provide coverage under this section only if the patient's treating physician determines that

1. (1) there is no clearly superior noninvestigational treatment alternative; and
2. (2) available clinical or preclinical data provide a reasonable expectation that the treatment provided in the clinical trial will be at least as efficacious as any noninvestigational alternative.

(c) The coverage to be provided under (a) of this section must include payment for the costs of

1. (1) prevention, diagnosis, treatment, and palliative care of cancer;
2. (2) medical care for an approved clinical trial related to cancer that would otherwise be covered under a health care insurance plan if the medical care were not in connection with an approved clinical trial related to cancer;
3. (3) items or services necessary to provide an investigational item or service;
4. (4) the diagnosis or treatment of complications;
5. (5) a drug or device approved by the United States Food and Drug Administration without regard to whether the United States Food and Drug Administration approved the drug or device for use in treating a patient's particular condition, but only to the extent that the drug or device is not paid for by the manufacturer, distributor, or provider of the drug or device;
6. (6) services necessary to administer a drug or device under evaluation in the clinical trial; and
7. (7) transportation for the patient that is primarily for and essential to the medical care.

(d) The coverage to be provided under (a) of this section may not include the cost of

1. (1) a drug or device that is associated with the clinical trial that has not been approved by the United States Food and Drug Administration;
2. (2) housing, companion expenses, or other nonclinical expenses associated with the clinical trial;
3. (3) an item or service provided solely to satisfy data collection and analysis and not used in the clinical management of the patient;
4. (4) an item or service excluded from coverage under the patient's health care insurance plan; and
5. (5) an item or service paid for or customarily paid for through grants or other funding.

(g) In this section, “approved clinical trial” means a scientific study using human subjects designed to test and improve prevention, diagnosis, treatment, or palliative care of cancer, or the safety and effectiveness of a drug, device, or procedure used in the prevention, diagnosis, treatment, or palliative care of a subject, if the study is approved by

1. (1) an institutional review board that complies with 45 C.F.R. Part 46; and

2. (2) one or more of the following:

   1. (A) the United States Department of Health and Human Services, National Institutes of Health, or its institutes or centers;
   2. (B) the United States Department of Health and Human Services, United States Food and Drug Administration;
   3. (C) the United States Department of Defense;
   4. (D) the United States Department of Veterans Affairs; or
   5. (E) a nongovernmental research entity abiding by current National Institutes of Health guidelines.