The DecisionDx-UM test receives reimbursement from a number of commercial insurance companies, and 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 DecisionDx-UM test is proven, is not experimental, and is medically necessary and reasonable. The following information is a compilation of feedback from these insurers that support their 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 test:
- The DecisionDx-UM test is recommended for clinical use as the results were determined to be "clinically significant" by the American Joint Committee on Cancer (AJCC, version 7, January, 2010). Note that the AJCC is the only national guideline association that reviews uveal melanoma.
- The DecisionDx-UM test has been incorporated into the routine clinical practice of over 55 of the estimated 70 ocular oncologists that manage the overwhelming majority of these patients.
Proven:
- Clinically validated in a series of clinical studies, including a prospective, 5-year, multi-center, blinded to outcomes, NEI funded study of 694 patients. These studies have been published in numerous peer-reviewed journal articles (see Resources / Publications tab for bibliography). 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 other clinical and pathologic factors and chromosome 3 (monosomy 3);
- Recommended for use due to its "clinically significant" impact on patient care in the guidelines of the American Joint Committee on Cancer (AJCC, ver 7, 2010). By definition, experimental and investigational assays are not recommended for clinical use. Note that the AJCC is the only national body that issues treatment guidelines for uveal melanoma; and
- Affidavits from leading ocular oncologists supporting the proven documentation, general acceptance, and medical reasonableness and necessity of the test.
The DecisionDx-UM test exceeds the requirements of medical necessity and reasonableness
Most commercial insurance carriers and Medicare are obligated to pay for services that meet appropriate standards of medical reasonableness and necessity.
It is generally accepted that medically necessary and reasonable services meet the elements listed in the rubric table below. As shown in the right hand column, the DecisionDx-UM test meets and exceeds these elements.
| Medically Necessary and Reasonable Rubric | |
|---|---|
| Element | Support for DecisionDx-UM Test |
| Appropriate for the symptoms and diagnosis or treatment of the patient's condition, illness, disease or injury | DecisionDx-UM test is ordered in patients diagnosed with uveal melanoma with no indication of metastatic disease for the purpose of identifying the patient's individual risk for metastasis, thereby enabling development of patient specific surveillance and treatment plans |
| Provided for the diagnosis or the direct care of the patient's condition, illness, disease or injury | DecisionDx-UM test is only ordered for patients diagnosed with uveal melanoma (melanoma of the choroid, ciliary body, or iris). The test is ordered because it has the potential to direct patient care; e.g. the intensity of the surveillance plan and decision for referral to a medical oncologist and evaluation for adjuvant treatment. |
| In accordance with current standards of good medical practice | The DecisionDx-UM test is recommended for use due to its "clinically significant" impact on patient care in the national guidelines issued by the American Joint Committee on Cancer (2010, version 7). The DecisionDx-UM test has been adopted for routine clinical use by the majority of ocular oncologists. By definition, the DecisionDx-UM test is the current standard of good medical practice. |
| Not primarily for the convenience of the patient or provider | The clinicians who order the DecisionDx-UM test cite medical necessity based on intent to use the results in the management of their patient. |
| The most appropriate supply or level of service that can be safely provided to the patient | The DecisionDx-UM test is a proprietary assay that is only available through Castle Biosciences. There is no alternative supply option. The DecisionDx-UM test has been compared to clinical and pathologic factors, including chromosome 3 (monosomy 3) and found to be clinically and statistically superior to all of these factors. |