(b) This section applies to: 

(1) insurers and nonprofit health service plans that provide hospital,
medical, surgical, or pharmaceutical benefits to individuals or groups on an
expense-incurred basis under a health insurance policy or contract issued or
delivered in the State; and

(2) health maintenance organizations that provide hospital, medical,
surgical, or pharmaceutical benefits to individuals or groups under contracts that are
issued or delivered in the State.

(c) This section does not apply to a policy, plan, or contract paid for under Title
XVIII or Title XIX of the Social Security Act.

(d) A policy, plan, or contract subject to this section shall provide coverage for
patient cost to a member in a clinical trial, as a result of:

(1) treatment provided for a life-threatening condition; or

(2) prevention, early detection, and treatment studies on cancer.

(e) The coverage under subsection (d) of this section shall be required if:

(1) (i) the treatment is being provided or the studies are being
conducted in a Phase I, Phase II, Phase III, or Phase IV clinical trial for cancer; or

(ii) the treatment is being provided in a PHASE I, Phase II, Phase
III, or Phase IV clinical trial for any other life-threatening condition;

(2) the treatment is being provided in a clinical trial approved by:
(i) one of the National Institutes of Health;

(ii) an NIH cooperative group or an NIH center;

(iii) the FDA in the form of an investigational new drug application;

(iv) the federal Department of Veterans Affairs; or

(v) an institutional review board of an institution in the state
which has a multiple project assurance contract approved by the Office of Protection
from Research Risks of the National Institutions of Health;

(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 expertise;

(4) there is no clearly superior, noninvestigational treatment alternative;

and

(5) the available clinical or preclinical data provide a reasonable
expectation that the treatment will be at least as effective as the noninvestigational
alternative.