Sec. 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 5 working days of the request.