Prognostic Test for Uveal Melanoma is Proven, Medically Necessary
The DecisionDx-UM gene expression profile (GEP) test receives reimbursement from a number of commercial insurance companies. Appeals to the Administrative Law Judge level for Medicare have resulted in favorable decisions for full payment. The rationale for appropriate and prompt payment is based upon the conclusions that the test is proven, is not experimental, and is medically necessary and reasonable.
The following information is a compilation of feedback from insurers on the evidence they relied on to support decisions for reimbursement.
The DecisionDx-UM test has completed technical and clinical validation, is proven and is not experimental or investigational, and has been available for routine clinical use since 2009.
Appropriate Use: The DecisionDx-UM test has been proven for use in patients with uveal melanoma, consisting of choroidal, ciliary body, and iris melanomas.
General acceptance of the GEP test:
- The DecisionDx-UM test is recommended for clinical use due to its “clinically significant” impact on patient care in the guidelines of the American Joint Committee on Cancer (AJCC, ver 7, 2010), the only national body that issues treatment guidelines for uveal melanoma. It’s important to note that, by definition, experimental and investigational assays are not recommended for clinical use.
- The test has been incorporated into the routine clinical practice of over 100 of the estimated 110 ocular oncology practices in the U.S.
The GEP test has been proven, and found to be superior to all other predictive factors:
- Clinically validated in a series of clinical studies, including a prospective, five-year, multi-center, blinded to outcomes, NEI funded study of 494 patients. These studies have been published in numerous peer-reviewed journal articles (see Scientific References). These publications were used in the determination to incorporate the DecisionDx-UM test into the AJCC, January, 2010 guidelines;
- Technically proven through multiple platform, validation, concordance, reliability and specimen type studies, most of which have been published in peer reviewed journals;
- Technically validated using two specimen sources (fine-needle aspirate biopsy and formalin-fixed paraffin embedded) in a CAP accredited / CLIA certified laboratory;
- Shown to be clinically and statistically superior to all other clinical and pathologic factors and chromosome 3 (monosomy 3);
- Affidavits from leading ocular oncologists support the proven documentation, general acceptance, and medical reasonableness and necessity of the test.