Long-term monitoring requirements for cell and gene therapy drugs
This policy governs long-term monitoring and follow-up data requirements for high-cost cell and gene therapy drugs administered to Harvard Pilgrim Health Care members; it affects providers who administer or follow patients after these therapies.
No material clinical or coverage changes in this revision.
Coverage Criteria
Long-term monitoring requirement
Covered when ALL of the following are met
Applies to high-cost cell and gene therapy drugs
No explicit exclusions are described in this policy document.
No conditions are listed as not medically necessary in this policy.
Provider Actions & Requirements
Long-term monitoring requirement
To ensure efficacy and durability of response, high-cost cell and gene therapies are subject to long-term monitoring. Providers must comply with long-term monitoring requirements, including responding to requests for follow-up clinical data and/or attestation of clinical outcome.
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