SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF
MARYLAND, That the Laws of Maryland read as follows:

Article - Insurance

15-827.

(a) (1) In this section the following words have the meanings indicated.

(2) (i) "Cooperative group" means a formal network of facilities that
collaborate on research projects and have an established NIH-approved Peer Review
Program operating within the group.

(ii) "Cooperative group" includes:

1. the National Cancer Institute Clinical Cooperative Group;

2. the National Cancer Institute Community Clinical

Oncology Program;

3. the AIDS Clinical Trials Group; and

4. the Community Programs for Clinical Research in AIDS.

(3) "FDA" means the federal Food and Drug Administration.

(4) "Member" means a policyholder, subscriber, insured, or certificate
holder or a covered dependent of a policyholder, subscriber, insured, or certificate
holder.

(5) "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.

(6) "NIH" means the National Institutes of Health.

(7) (i) "Patient cost" means the cost of a medically necessary health
care service that is incurred as a result of the treatment being provided to the
member for purposes of the clinical trial.

(ii) "Patient cost" does not include:

1. the cost of an investigational drug or device;

2. 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;

3. costs associated with managing the research associated
with the clinical trial; or

4. costs that would not be covered under the patient's policy,
plan, or contract for noninvestigational treatments.