Experimental or investigational Experimental or investigational means any treatment that is not recognized by the plan as conforming to standard medical care for the condition, disease, illness, or injury being treated. ”Treatment” in this setting may include any intervention, therapy, procedure, facility, equipment, drug usage, device, service, supply, intervention, biologic product or drug (prescription or nonprescription). Experimental and investigational treatments are not covered, even if the treatment is considered medically necessary. The plan will review scientific evidence from well-designed clinical studies found in peer-reviewed medical literature, if available, and information obtained from the treating provider regarding the treatment to determine if it is experimental or investigational. A treatment meeting any of the following criteria is considered experimental or investigational: • Approval of the treatment or one of its components by one or more government agencies (e.g., FDA) is required but has not been obtained at the time the treatment is requested or administered. • The improvement has not been shown to be attainable outside the laboratory or clinical research setting. • The scientific evidence does not permit conclusions concerning the effect of the treatment on health outcomes, which include the disease process, injury or illness, length of life, ability to function, and quality of life. • The scientific evidence does not show that the treatment is as beneficial as any established alternatives. • The treatment has not been demonstrated to improve net health outcomes. • The treatment has scientific evidence to support its use, but not for the specific indication for which it is being requested. • The treatment is a drug or device that is prescribed for other than its FDA-approved use(s) and is not recognized as “effective” for the use for which it is being prescribed. To be considered “effective” for other than its FDA-approved use, a prescription drug or device must be so recognized in one of the standard reference compendia or, if not, then in a majority of relevant peer-reviewed medical literature; or by the U.S. Secretary of Health and Human Services. • The treatment is considered to be experimental or investigational by U.S. standards. • The treatment is drug combination therapy, when the scientific literature only supports the drug’s use as monotherapy and not when utilized in combination with other drugs. • The treatment is drug monotherapy, when the scientific literature only supports the drug’s use when utilized in combination with other drugs. • The treatment is not provided by a provider that has demonstrated medical proficiency in the provision of the treatment. • The treatment is only available in the U.S. as part of a clinical trial or research program for the illness or condition being treated. ▪ Although the plan does not pay for items, drugs, devices, or services (including items, drugs, devices, or services provided in a clinical trial) for investigational use, the plan does not deny qualified individuals from participating in approved clinical trials. The terms “qualified individual” and “approved clinical trial” are defined in 42 U.S.C. §300gg-8. If a qualified individual is participating in an approved clinical trial, the plan will not deny, limit, or impose additional conditions on the coverage for routine patient costs for items and services furnished in connection with participation in the trial and will not discriminate against the individual on the basis of the individual’s participation in such trial. The plan will apply its standard terms and conditions for routine patient costs for items and services furnished in connection with participation in the trial. 174 2024 UMP Plus–PSHVN (PEBB) Certificate of Coverage