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Defines medical necessity criteria, prior authorization requirements, and CPT coding for multigene expression assays (Breast Cancer Index, Oncotype DX Breast, Prosigna, MammaPrint, EndoPredict, Oncotype DX Breast DCIS Score, BluePrint) to determine prognosis and inform adjuvant therapy decisions in breast cancer.
New code 81522 (EndoPredict) effective 1/1/2020 noted in coding section.
This policy addresses multigene mRNA expression assays used to predict distant recurrence risk and endocrine responsiveness in breast cancer, specifically: Breast Cancer Index (BCI), Oncotype DX Breast, Prosigna, MammaPrint, EndoPredict, Oncotype DX Breast DCIS Score, and BluePrint. Coverage stance is mixed: several tests are covered when specified medical criteria are met for BlueCHiP for Medicare and for Commercial Products (with recommendations/limits), while some tests or uses are not covered or are considered not medically necessary in certain product lines.
Breast Cancer Index (CPT 81518) - Medically Necessary Criteria
BCI may be considered medically necessary when ALL of the following are met:
ALL of the following
Oncotype DX Breast (CPT 81519) - Medically Necessary Criteria
Oncotype DX Breast may be considered medically necessary for patients with ANY of the following:
ANY of the following
Prosigna (CPT 81520) - Medically Necessary Criteria
Prosigna may be considered medically necessary when ANY of the following member descriptions apply:
ANY of the following
MammaPrint (CPT 81521) - Medically Necessary Criteria
MammaPrint may be considered medically necessary when ALL of the following are met:
ALL of the following
MammaPrint - High clinical risk definition
High clinical risk is defined by ANY of the following grade/size combinations:
ANY of the following
EndoPredict (CPT 81522) - Medically Necessary Criteria
EndoPredict may be considered medically necessary when ALL of the following are met:
ALL of the following
Oncotype DX Breast DCIS Score (0045U) - Medically Necessary Criteria
Oncotype DX DCIS assay may be considered medically necessary when ALL of the following are met:
ALL of the following
BluePrint - Coverage Determination
BluePrint is considered NOT COVERED when used for prognosis because evidence is insufficient:
Use of multiple tests
Commercial Products - restriction
Operational coding note: CPT 81522 (EndoPredict) is listed as a new code effective 1/1/2020. Use of the unlisted molecular pathology code 81479 is required when no specific CPT exists and 81479 requires prior authorization for BlueCHiP for Medicare and Commercial Products. The Oncotype DX Breast DCIS Score (0045U) is covered for BlueCHiP for Medicare when criteria are met but is not medically necessary for Commercial Products.
Prior Authorization Required (BlueCHiP for Medicare)
Prior authorization is required for BlueCHiP for Medicare for the tests listed below. Providers must obtain authorization prior to performing the service.
Prior Authorization Recommended (Commercial Products)
Prior authorization is recommended for Commercial Products for the tests listed below. Participating providers may obtain authorization via the online authorization tool; medical criteria are available in that tool.
Ordering Physician Authorization and Documentation
The ordering physician is responsible for obtaining prior authorization and must be the only party involved in the authorization, appeal, or other administrative processes related to prior authorization/medical necessity. Laboratories and third parties are prohibited from obtaining authorization on behalf of the ordering physician. If a laboratory provides a service that has not been authorized, the service will be denied and financial liability may fall to the laboratory.
Use of Unlisted CPT Code (81479)
When there is no specific CPT code available for a genetic test described in this policy, use the Unlisted CPT code 81479. All Unlisted genetic testing CPT codes require prior authorization to determine the specific service rendered and coverage/medical necessity.
Multiple Tests for Same Clinical Decision — Denial Risk
For Commercial Products, performing more than one of the referenced genomic tests to determine the necessity of adjuvant therapy for the same clinical decision is considered not medically necessary and may be denied.
Multigene expression assays evaluate messenger RNA expression profiles from formalin-fixed paraffin-embedded (FFPE) breast tumor tissue to estimate distant recurrence risk and endocrine responsiveness. They are intended to be used as adjuncts to conventional clinicopathologic factors (eg, staging, grading, receptor status) to inform adjuvant therapy decisions. These assays are typically performed once per patient lifetime on the primary tumor specimen prior to adjuvant treatment.
Policy basis: coverage determinations are informed by multiple Centers for Medicare & Medicaid Services Local Coverage Determinations (MolDX LCDs), peer-reviewed clinical studies, and professional guidelines (eg, NCCN, ASCO). Cited guidelines and studies are used to support the clinical contexts in which these assays may inform management decisions for adjuvant chemotherapy, DCIS treatment choices, or extended endocrine therapy.
| LCD name | LCD number/type |
|---|---|
| MolDX: Breast Cancer Index (BCI) Gene Expression Test | L37822 (LCD) |
| MolDX: Oncotype DX® Breast Cancer for DCIS | L36941 (LCD) |
New CPT code 81522 (EndoPredict) became effective 1/1/2020 (Oncology (breast), mRNA, gene expression profiling by real-time RT-PCR of 12 genes).
Policy last updated (policy last updated date).
Policy effective date established.
Provider update published (June 2020).
Prior authorization requirements and coding guidance reiterated for listed assays and use of unlisted code 81479 when no specific CPT exists.