Eculizumab / Complement inhibitor coverage (diagnosis codes & CMS guidance)
This appendix lists covered ICD-10 diagnosis codes relevant to complement inhibitor therapy and provides CMS/Medicare guidance and MAC jurisdiction information that may affect coverage determinations for outpatient (Part B) drugs. It affects providers submitting claims for these therapies to Viva Health.
No material clinical or coverage changes in this revision.
Coverage Criteria & Medicare Guidance
Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-02), Chapter 15, §50 Drugs and Biologicals. Where NCDs, LCDs, or LCAs exist for a drug or indication, providers must follow those policies for coverage and billing.
Use the CMS Medicare Coverage Database to search for applicable NCDs, LCDs, and LCAs: https://www.cms.gov/medicare-coveragedatabase/search.aspx. Local Coverage Articles may clarify benefit eligibility or claims payment for drugs that may otherwise be self-administered.
When a Medicare-specific coverage determination applies, the provider must document in the medical record which NCD/LCD/LCA was used to support medical necessity and include any required elements specified by that determination (diagnosis codes, clinical findings, prior authorization numbers, dates of service, supporting labs/imaging, etc.). Failure to include required documentation may lead to denial.
If step therapy or other utilization management is specified by a CMS determination or contractual payer guidance for a Part B drug, the provider must follow the step-therapy sequence or submit a step-therapy exception request consistent with CMS and payer procedures. Consult the payer or CMS guidance for how to document trials of prior therapies and the process for requesting exceptions.
Medicare NCD/LCD compliance
Follow all applicable Medicare NCDs, LCDs, and LCAs for Part B drugs. Noncompliance may result in claim denial or recoupment. Document the specific NCD/LCD/LCA used to support medical necessity and include required supporting elements. If step therapy is required by CMS or payer guidance, either complete the required prior therapy steps or submit a documented exception per CMS/payer process.
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