Md. Code Regs. 10.67.06.26-1 - Clinical Trial Items and Services - Coverage for Routine Costs
A. Subject to
the conditions specified in §§B-F of this regulation, an MCO shall
provide coverage for cost to an enrollee in an approved clinical trial for:
(1) Treatment provided for life-threatening
conditions; or
(2) Prevention,
early detection, and treatment studies on cancer.
B. Clinical trials are deemed to be
automatically approved if:
(1) The treatment
is:
(a) Being provided or the studies are
being conducted in a Phase I, Phase II, Phase III, or Phase IV clinical trials
for cancer; or
(b) Being provided
in 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:
(a) Approved by:
(i) The National Institutes of Health
(NIH);
(ii) An NIH cooperative
group or an NIH center;
(iii) The
Centers for Disease Control and Prevention;
(iv) The Agency for Healthcare Research and
Quality;
(v) The Centers for
Medicare and Medicaid Services (CMS);
(vi) The Department of Defense;
(vii) The Department of Veterans Affairs;
or
(viii) An institutional review
board of an institution in the State that has a multiple project assurance
contract approved by the Office of Protection from Research Risks of the NIH;
or
(b) Conducted:
(i) At National Cancer Institute
Centers;
(ii) Under Investigational
New Drug application (IND) reviewed by the Food and Drug Administration (FDA);
or
(iii) As a clinical trial with
deemed status through an exemption from having an IND under
21 CFR §
312.2(b)(1);
(3) The facility and the
personnel providing the treatment are capable of doing so by virtue of the
facility and the personnel's experience, training, and volume of patients
treated to maintain expertise;
(4)
There is no clearly superior, non-investigational 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 non-investigational alternative.
C. Enrollee cost includes the following:
(1) The cost of all medically necessary items
and services that are otherwise available to Medicaid beneficiaries such as
hospital services, physician services, or diagnostic tests; and
(2) The cost of medically necessary items or
services required solely for the provision of the following:
(a) Investigational item or service such as
administration of a noncovered chemotherapeutic agent;
(b) The clinically appropriate monitoring of
the effects of the item or service; or
(c) The prevention, diagnosis, and treatment
of complications.
D. Enrollee cost does not include the
following:
(1) The cost of the investigational
item or service itself;
(2) The
cost of items and services provided solely to satisfy data collection and
analysis needs and that are not used in the direct clinical management of the
enrollee;
(3) The cost of items and
services customarily provided by the research sponsors free of charge for any
enrollee in the trial; and
(4) The
cost of non-health care services that an enrollee may be required to receive as
a result of the treatment being provided for purposes of the clinical
trial.
E. If the enrollee
has insurance or other coverage, or if any other person is obligated, either
legally or contractually, to pay for, or to reimburse the enrollee for,
services covered by this regulation, the provider shall seek payment from that
source first.
F. The MCO shall
authorize the request for participation in an approved clinical trial within 72
hours of the request.
Notes
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