(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
(4) there is no clearly superior, noninvestigational treatment alternative;
(5) the available clinical or preclinical data provide a reasonable
expectation that the treatment will be at least as effective as the noninvestigational
[(f) The coverage under subsection (d) of this section may be provided on a case
by case basis if the treatment is being provided in a Phase I clinical trial for any
life-threatening condition other than cancer.]
[(g)] (F) In conjunction with the provisions of subsection (d) of this section, a
policy, plan, or contract shall provide coverage for patient cost incurred for drugs and
devices that have been approved for sale by the FDA whether or not the FDA has
approved the drug or device for use in treating the patient's particular condition, to
the extent that the drugs or devices are not paid for by the manufacturer, distributor,
or provider of that drug or device.
[(h)] (G) (1) An entity seeking coverage for treatment in a clinical trial
approved by an institutional review board under subsection (e)(2)(v) of this section
shall post electronically and keep up-to-date a list of the clinical trials meeting the
requirements of subsections (d) and (e) of this section.
(2) The list shall include, for each clinical trial:
(i) the phase for which the trial is approved;
(ii) the entity approving the trial;
(iii) whether the trial is for treatment of cancer or another
life-threatening disease and, if not cancer, the particular disease; and
(iv) the estimated number of participants in the trial.
[(i)] (H) This section may not be construed to affect compliance with § 15-804
of this subtitle regarding coverage for off-label use of drugs.
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall apply to all
new policies, contracts, or health benefit plans issued or delivered in the State on or
after July 1, 1999, and to the renewal of all policies, contracts, or health benefit plans
in effect before that date, except that any policy, contract, or health benefit plan in
effect before July 1, 1999, shall comply with the provisions of this Act no later than
January 1, 2000.