Experimental and Investigational Services coverage
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Defines Alliance Health's principles for determining coverage of experimental or investigational services for Medicaid beneficiaries, including qualified clinical trial routine costs and EPSDT provisions for beneficiaries under 21.
Clarified EPSDT, policy hierarchy, devices/IDE, and UM requirements.
Included language related to member rights and appeals.
Coverage Criteria
Clinical Coverage Criteria (all required)
Alliance will cover services when ALL of the following are met:
Qualified clinical trial requires IRB approval, active protocol, documentation of therapeutic intent, beneficiary enrollment and informed consent, completed Medicaid attestation, and documentation separating routine care from investigational costs.
Services will be excluded from coverage when they are provided solely for the purpose of research data collection. Coverage is also denied when the investigational item itself is billed to Medicaid, when a non‑FDA‑approved item is continued for use after completion of a trial, and for ancillary costs such as travel, lodging, or meals.
This policy does not determine coverage of routine patient costs that are otherwise covered under the State Plan. Routine costs associated with participation in qualifying clinical trials are addressed separately under Clinical Coverage Policy 1A-39 and by applicable NCDHHS guidance; providers should refer to those authorities for coverage of routine trial-related services.
Purely experimental services limited to pre‑clinical testing (for example, laboratory or animal studies that occur prior to human use) are non‑covered. Such services remain outside coverage because they have not advanced to human studies and lack the regulatory and clinical evidence required for consideration.
Provider Actions, Notices, and Appeals
Prior authorization always required
Prior authorization is required for all requests under this policy; providers must obtain prior authorization before services are rendered.
Appeals through Alliance grievance process
Members retain all applicable Medicaid due process rights for adverse benefit determinations and may appeal through the Alliance grievance and appeal process consistent with NC Medicaid Tailored Plan requirements and applicable law.
- Alliance will provide written notice of adverse benefit determinations including reason and instructions for filing an appeal and requesting a State Fair Hearing when applicable.
No equally effective, less costly alternative required
Coverage is allowed only when no equally effective, less costly alternative exists; the absence of such alternatives is part of the medical necessity assessment for investigational services.
Use required prior auth and documentation templates
Providers must follow all prior authorization and documentation requirements and submit requests using Alliance's required templates for Clinical Specialist and Medical Director review.
Submit protocol, IRB approval, consent, attestations, and separation of costs
Providers must submit documentation supporting medical necessity, including the study protocol, IRB approval, informed consent, completed Medicaid attestations, and clear separation of routine care versus investigational costs; use Alliance-specific templates for Clinical Specialist and Medical Director review.
Written notice must state reason and appeal instructions
Alliance will provide members with written notice of any adverse benefit determination that explains the reason for the determination and includes instructions for filing an appeal and requesting a State Fair Hearing when applicable.
Services excluded when solely for research or billed investigational items
Services will not be covered when they are solely for research data collection; when the investigational item itself is billed to Medicaid; for continued use of non‑FDA‑approved items after trial completion; or for travel, lodging, or meals.
Adverse benefit determinations trigger appeal rights
Denials, reductions, suspensions, or terminations of requested services constitute adverse benefit determinations that trigger members' Medicaid due process appeal rights; Alliance will provide required notices and appeal information.
Definitions
Background and Scope
This policy governs how Alliance Health determines coverage for services considered investigational or experimental for Medicaid beneficiaries and aligns with NCDHHS policy and state regulations. It sets the framework for evaluating investigational items, clarifies exclusions, and references EPSDT and related policy guidance for beneficiaries under 21; routine clinical trial costs are addressed under the referenced State Plan policy.
Revision History
Updated policy to clarify EPSDT applicability, policy hierarchy, device/IDE requirements, and utilization management requirements; added member rights and appeals language.
Policy reviewed (no substantive change noted in revision log).
Original policy approval recorded in the revision log.
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