                                 CODE OF VIRGINIA

EXPANDED ACCESS TO INVESTIGATIONAL DRUGS, BIOLOGICAL PRODUCTS, OR DEVICES; COST;
INSURANCE COVERAGE (§ 54.1-3442.3)

A. A manufacturer of an investigational drug, biological product, or device may
make such investigational drug, biological product, or device available to a
person who meets the criteria set forth in subsection A of &#xA7; 54.1-3442.2;
however, nothing in this article shall require a manufacturer of an
investigational drug, biological product, or device to make such investigational
drug, biological product, or device available to such person.

B. A manufacturer that makes an investigational drug, biological product, or
device available to a person who meets the criteria set forth in subsection A of
&#xA7; 54.1-3442.2 may provide the investigational drug, biological product, or
device to the person free of charge or may require the person to pay the costs
of, or the costs associated with, the manufacture of the investigational drug,
biological product, or device.

C. An insurer proposing to issue individual or group accident and sickness
insurance policies providing hospital, medical and surgical, or major medical
coverage on an expense-incurred basis, a corporation providing individual or
group accident and sickness subscription contracts, or a health maintenance
organization providing a health care plan for health care services may provide
coverage for costs related to treatment of a person&#8217;s terminal condition
with an investigational drug, biological product, or device; however, nothing in
this article shall require an insurer proposing to issue individual or group
accident and sickness insurance policies providing hospital, medical and
surgical, or major medical coverage on an expense-incurred basis, a corporation
providing individual or group accident and sickness subscription contracts, or a
health maintenance organization providing a health care plan for health care
services to provide coverage for costs related to treatment of a person&#8217;s
terminal condition with an investigational drug, biological product, or device.

HISTORY: 2015, cc. 655, 656.