Streamlining Medicare Enhertu Prior Authorization Workflows

Enhertu: A Critical Oncology Therapy Under Medicare Coverage

Enhertu (trastuzumab deruxtecan) is an antibody-drug conjugate indicated for various HER2-positive cancers, including metastatic breast cancer, non-small cell lung cancer, and gastric cancer. As an intravenously administered medication, Enhertu often falls under the medical benefit (Medicare Part B) when administered in an outpatient setting. For Medicare beneficiaries, securing timely prior authorization is essential to ensure continuity of care and prevent treatment delays.

Medicare Prior Authorization Pathways for Enhertu

The prior authorization process for Enhertu under Medicare varies significantly between Original Medicare (Fee-for-Service) and Medicare Advantage (MA) plans. While Original Medicare has a limited scope for prior authorization, specific programs may apply. Medicare Advantage plans, operated by private insurers, typically have broader PA requirements mirroring commercial plans, often utilizing their own medical policies and formularies. For pharmacy benefit (Part D) coverage, Enhertu's administration method usually places it under Part B, though specific scenarios or formulations may involve Part D plans and their associated Pharmacy Benefit Managers (PBMs).

Key Considerations for Enhertu Prior Authorization Under Medicare

• **Original Medicare (Part A/B)**: Where PA is required, submissions route through the responsible Medicare Administrative Contractor (MAC) for the provider's jurisdiction, such as Noridian, NGS, WPS, Palmetto, FCSO, or Novitas.
• **Medicare Advantage (MA) Plans**: These plans operate with their own prior authorization criteria, often requiring detailed clinical documentation to establish medical necessity per plan-specific guidelines.
• **National and Local Coverage Determinations (NCDs/LCDs)**: Coverage for Enhertu under Original Medicare is guided by CMS-published National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) published by the responsible MAC.
• **Part D Pharmacy Benefit**: Although Enhertu is typically a Part B drug, understanding Part D formulary and step-therapy protocols is critical for other oncology drugs or potential future Enhertu formulations.

Klivira's Role in Automating Medicare Enhertu Prior Authorization

Klivira's platform is engineered to navigate the intricate landscape of Medicare prior authorization for high-volume specialty drugs like Enhertu. For Original Medicare, Klivira identifies the correct MAC jurisdiction and routes submissions through the appropriate channels, incorporating NCD/LCD-aware policy logic. For Medicare Advantage plans, our system integrates with payer portals and leverages ePA standards like X12 278 and Da Vinci PAS to streamline submissions, ensuring that all necessary clinical documentation is accurately submitted per plan-specific requirements. This automation minimizes manual effort, reduces submission errors, and accelerates approval times.

Common Denial Reasons and Appeal Pathways

Denials for Enhertu prior authorizations under Medicare often stem from insufficient clinical documentation, failure to meet NCD/LCD criteria, or incorrect submission pathways. Klivira helps mitigate these issues by ensuring comprehensive data capture and adherence to payer-specific rules. When denials occur, Klivira supports the appeal process by organizing clinical evidence and tracking submission statuses, facilitating timely resubmissions and appeals in line with Medicare's established review processes.