Clinical Policy: Experimental Technologies
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Guidelines for evaluating coverage of medical and behavioral health technologies considered experimental or investigational when no other policy or coverage statement exists; applies to providers requesting coverage determinations under QualChoice health plans.
No material clinical or coverage changes in this revision.
Coverage Criteria for Experimental or Investigational Technologies
Definition of Experimental/Investigational (I.A) and Medical Necessity Evaluation (I.B)
A requested technology is considered experimental/investigational when ANY of the following apply, and medical necessity will be evaluated when ALL of the listed elements are considered:
From criteria I.A.1-2
Criteria I.B.1 through I.B.10
It is the policy of QualChoice that coverage determinations for any technology (drug, procedure, device, service, or supply) that is or may be considered experimental or investigational must be decided on a case-by-case basis by a physician or an ad hoc committee and in accordance with the member's Benefit Plan Contract and applicable law. A requested technology will be considered experimental or investigational if any of the policy triggers apply (for example, it is the subject of active/credible evaluation such as clinical trials, or recent peer‑reviewed studies are inconclusive about safety and effectiveness). When a technology is being considered, medical necessity will be evaluated using the policy’s listed elements (including regulatory approval status, available peer‑reviewed evidence, benefit‑risk assessment, exhaustion of established alternatives, impact on patient management, and informed consent).
Technologies that lack sufficient peer‑reviewed evidence, do not have necessary regulatory approval when applicable, or for which the benefits do not clearly outweigh the harms may be determined to be experimental or investigational and therefore not covered under this policy. Further, this policy does not obligate the Health Plans to provide coverage for experimental or investigational technologies that are not included in the member/enrollee’s benefit plan; the Plan may refuse coverage on that basis even if a request is made.
Provider Requirements and Prior Authorization
Case-by-case prior authorization required
All coverage determinations for technologies considered experimental or investigational must be made on a case-by-case basis by a physician or ad hoc committee and in accordance with the member's benefit plan contract and applicable state and federal requirements.
- Decisions must follow the Benefit Plan Contract provisions and applicable law.
Exhaust established treatments first
Before approval, the provider must document that other established treatment alternatives have been exhausted and failed, or that no established treatment exists for the condition.
- This exhaustion of alternatives is one of the medical necessity considerations evaluated on a case-by-case basis.
Provide peer-reviewed evidence and documentation
Submit peer-reviewed evidence demonstrating safety and effectiveness, including at least two well-designed, well-conducted studies, plus documentation of regulatory approval when applicable and evidence that benefits outweigh risks; include informed consent and any prior treatment attempts.
- At least two peer-reviewed studies supporting effect and net health impact are required.
- Studies must be well-designed and well-conducted and demonstrate the effect on the condition.
- Provide documentation of FDA or other governmental regulatory approval when applicable.
- Document informed consent and prior treatment attempts or lack of alternatives.
Coverage may be refused if not in benefit plan
The Plan may refuse coverage of an experimental or investigational technology if coverage is not required under the member/enrollee's benefit plan.
- Approval in one case does not guarantee coverage for other cases.
- Ensure services furnished align with the Benefit Plan Contract; the Plan reserves the right to deny when not obligated to cover.
Background and Purpose
This policy provides criteria to guide evaluation of whether a technology is experimental or investigational and to determine medical necessity where applicable. It applies to technologies including drugs, biological products, devices, procedures, services, and supplies. When the medical necessity criteria are met, the policy directs that the technology be furnished, when possible, by a participating or in‑state provider. However, approval under this policy for a particular case does not create an obligation to cover the same technology in other cases, and the Plan retains the right to deny coverage when the Benefit Plan Contract does not require it.
Key Definitions
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