1. (1) "Qualifying clinical trial" means a clinical trial in any clinical phase of development that is approved, conducted, or supported, which may include funding through in-kind contributions, by one or more of the following governing bodies.

   1. (a) The National Institutes of Health.
   2. (b) The Centers for Disease Control and Prevention.
   3. (c) The Agency for Healthcare Research and Quality.
   4. (d) The Centers for Medicare and Medicaid Services.
   5. (e) A cooperative group or center of any of the entities described in Subsections (1)(a) through (d), the Department of Defense, or the Department of Veterans Affairs.
   6. (f) A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants.

   7. (g) The Department of Veterans Affairs, the Department of Defense, or the Department of Energy if the conditions of the clinical trial have been reviewed and approved through a system of peer review determined:

      1. (i) to be comparable to the system of peer review of studies and investigations used by the National Institutes of Health; and
      2. (ii) assures unbiased review of the highest scientific standards by qualified individuals with no interest in the outcome of the review.
2. (2) "Serious or life-threatening disease or condition means a disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted.

In addition to the definitions in Section R414-1-2, the following definitions apply to this rule.

KEY: Medicaid

Date of Last Change: January 22, 2024

Notice of Continuation: August 12, 2024

Authorizing, and Implemented or Interpreted Law: 26B-1-213; 26B-3-108