Biomarker Testing — Coverage Criteria
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Defines coverage and payment conditions for biomarker testing for beneficiaries of the Executive Office of Health and Human Services, specifying clinical documentation and prior authorization requirements that affect ordering providers and laboratories.
No material clinical or coverage changes in this revision.
Coverage Criteria
Covered indications
Covered when ALL of the following are met:
One of these is required for coverage
Clinical rationale options listed in policy
Requests for biomarker testing that is the subject of a clinical trial or experimental protocol are excluded from coverage and will be denied.
When Biomarker Testing Is Covered
Biomarker testing to inform treatment or monitoring strategy, confirm or rule out diagnosis, determine correct treatment plan, or manage complications related to clinical trial participation, when supported by medical/scientific evidence.
Covered when the following clinical purposes are supported by medical or scientific evidence and appropriate documentation is provided:
Policy-listed clinical reasons for testing
Required for coverage
Submit with PA when applicable
Provider Actions and Documentation Requirements
Prior authorization required — submit PA form and supporting documents
For tests that require prior authorization, submit a completed Rhode Island Medicaid Prior Authorization form, a Certificate of Medical Necessity for Biomarker Testing, and supporting clinical information with the request.
Include recent face-to-face visit or Tumor Board/consult note
Ensure either a face-to-face visit with the ordering healthcare professional within 30 days of the request or documentation that testing was recommended by a Tumor Board or consulting specialist is included with the request.
Required documentation for coverage — visit or Tumor Board recommendation
Required documentation must include either a face-to-face visit with the ordering healthcare professional within 30 days of submitting the request, or documentation that testing has been recommended by a Tumor Board or consulting specialist.
Prior authorization documentation — forms and clinical information
Requests for tests requiring Prior Authorization must include a completed Rhode Island Medicaid Prior Authorization form, a Certificate of Medical Necessity for Biomarker Testing, and supporting clinical information.
Denial risk — clinical trial or experimental protocol
Requests for Biomarker testing that is the subject of a clinical trial or experimental protocol will be denied.
Ordering Requirements
Ordering requirement — recent face-to-face visit or Tumor Board/consult
A face-to-face visit with the ordering healthcare professional within 30 days of the request, or documentation of a recommendation by a Tumor Board or consulting specialist, is required to meet ordering requirements for coverage.
Not Covered
Biomarker testing performed as part of a clinical trial or experimental protocol is not covered and will be denied.
Definitions
Background
Biomarker testing provides results intended to inform treatment formulation or monitoring strategies and to influence clinical decision-making and patient outcomes. Coverage is limited to situations where the test result will be used to guide care—such as to confirm or rule out a diagnosis, to determine the correct treatment plan, or to prevent, diagnose, monitor, or treat complications related to clinical trial participation—and when the efficacy of the test is supported by medical and scientific evidence. Documentation supporting the clinical need must include either a face-to-face visit with the ordering healthcare professional within 30 days of the request or documentation that the test was recommended by a Tumor Board or consulting specialist.
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