Experimental and Investigational Technologies
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Governs how OrthoNet/Optum determines whether a healthcare technology (service, procedure, device, supply, or drug) is considered experimental or investigational and therefore denied; applies to utilization review across in- and out-of-network providers when no other policy exists.
No material clinical or coverage changes in this revision.
Coverage Criteria for Investigational / Experimental Technologies
Investigational / Experimental Determination
Technologies are classified as investigational/experimental when any of the following conditions are met:
Determination is based on transparent, evidence‑informed processes including methods to identify evidence, critical appraisal, and contextual judgment; findings are translated consistent with member benefit documents.
This policy does not apply to healthcare technologies employed within clinical trials.
A technology (service, procedure, device, supply, or drug) that is deemed investigational or experimental will be denied based upon the applicable exclusions recorded in the member's benefit coverage document or medical policy; or as not medically necessary in accordance with the criteria established by Optum.
Provider Actions, Authorization, and Denial Basis
Prior authorization applicability
Applies to Utilization Review determinations for all in- and out-of-network programs and all provider types when no other policy, criteria, or coverage statement is available; prior authorization requirements follow applicable Utilization Review processes.
- Scope covers all in- and out-of-network programs and all provider types where Utilization Review determinations are rendered.
- This policy is applicable only when there is no other policy, criteria, or coverage statement available.
Step therapy not addressed
Step therapy sequencing is not addressed by this policy; the document focuses on classification of technologies as investigational or experimental rather than specifying step therapy requirements.
Evidence-informed documentation required
Determinations that a technology is investigational or experimental are based on transparent, evidence-informed processes that describe methods to identify evidence, include critical appraisal of research, and incorporate considered judgments and contextual factors; findings are translated into terminology consistent with member benefit documents.
- Document methods used to identify and select evidence and the critical appraisal approach.
- Record considered judgments and contextual factors that informed the determination.
- Ensure translation of findings aligns with the member's benefit coverage language.
Denial basis for investigational technologies
Technologies deemed investigational or experimental will be denied either based on applicable exclusions in the member's benefit coverage document or as not medically necessary in accordance with Optum/OrthoNet criteria.
- Cite the specific member benefit exclusion when applicable.
- When denying as not medically necessary, reference the Optum criteria used to assess investigational status.
Background
Experimental or investigational technologies are those that are not of proven benefit for a particular diagnosis or treatment, are not generally recognized by the healthcare community as effective or appropriate, and have uncertainty about associated risks; they are generally provided in research or controlled environments. Determinations consider regulatory status, the strength and quality of peer-reviewed evidence, whether the technology improves net health outcomes, comparative benefit and safety versus established alternatives, and whether expected improvements are achievable in routine clinical practice. Evidence review follows transparent, evidence-informed methods (including identification and critical appraisal of studies) and aligns decisions with applicable member benefit documents.
Definitions
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