The DecisionDx-GBM 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 DecisionDx-GBM test is also the subject of a Noridian Administrative Services Billing Instruction Bulletin "to avoid denial of service not medically necessary" for Medicare claims. The rationale for appropriate and prompt payment is based upon the conclusions that the DecisionDx-GBM 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-GBM test has completed technical and clinical validation, is proven and is not experimental or investigational and has been available for routine clinical use since 2008
Appropriate Use: The DecisionDx-GBM test has been proven for use in patients diagnosed with glioblastoma multiforme (GBM). Note that GBM has several acronyms such as WHO grade IV astrocytic tumor and malignant anaplastic astrocytoma.
General acceptance of test:
- The DecisionDx-GBM test has been adopted for routine clinical use in leading cancer centers which were not involved in the development or validation of the test.
- The DecisionDx-GBM test has been incorporated as a stratification factor in an FDA level registration double-blind, placebo-controlled, multi-center study evaluating the addition of bevacizumab to first line radiation plus temozolomide (protocol IDs: RTOG-0825 / NCT00884741). Expected enrollment is 942 subjects. After reviewing the prognostic significance of the DecisionDx-GBM test data in patients treated with first line radiation plus temozolomide, the sponsors and the steering committee decided to include the DecisionDx-GBM test (noted as the molecular profile) as a key entry and stratification factor. This review and decision was made prior to the study initiation in April, 2009.
The DecisionDx-GBM test has been available for routine clinical use since 2008. The assay underwent development and validation during the last decade. Specifically the DecisionDx-GBM test has been proven:
- Developed using four independent data sets from Massachusetts General Hospital (MGH), UCLA, UCSF, and M. D. Anderson Cancer Center;
- Clinically validated and proven in three independent studies, including (studies were combined in a single peer-review publication):
- M. D. Anderson Cancer Center study #1: Prospective study using archival specimens from consecutively resected patients at M. D. Anderson Cancer Center;
- M. D. Anderson Cancer Center study #2: : Prospective study using archival specimens from consecutively resected patients at M. D. Anderson Cancer Center;
- The Cancer Genome Atlas Project (National Cancer Institute's TCGA initiative),
- Clinically validated in a recent series of 220 newly diagnosed, consecutively resected patients at The University of Texas M. D. Anderson Cancer Center (presented at ASCO, June 2010);
- Technically proven through validation, concordance and reliability studies, some of which have been published;
- Technically validated using formalin-fixed paraffin embedded samples in a CAP accredited / CLIA certified laboratory;
- Adopted as standard of care in leading cancer centers which were not involved in the development or validation of the assay;
- Incorporated as a stratification factor in an FDA registration study evaluating the addition of bevacizumab to first line RT+TMZ (protocol IDs: RTOG-0825 / NCT00884741); and
- Analyzed in an FDA registration study evaluation dose dense radiation plus temozolomide (high dose TMZ) vs standard dose radiation plus temozolomide (n=725).
The DecisionDx-GBM 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-GBM test meets and exceeds these elements.
| Medically Necessary and Reasonable Rubric | |
|---|---|
| Element | Support for DecisionDx-GBM Test |
| Appropriate for the symptoms and diagnosis or treatment of the patient's condition, illness, disease or injury | DecisionDx-GBM test is ordered for patients diagnosed with glioblastoma. |
| Provided for the diagnosis or the direct care of the patient's condition, illness, disease or injury | The DecisionDx-GBM test is ordered for patients diagnosed with glioblastoma. The assay was ordered because it has the potential to direct patient care; e.g. first line treatment planning, differentiating between pseudo and early progression, decision to maintain temozolomide beyond initial six cycles. |
| In accordance with current standards of good medical practice | The DecisionDx-GBM test has been adopted for routine clinical use in leading cancer centers which were not involved in the development or validation of the assay. |
| Not primarily for the convenience of the patient or provider | The clinicians who order the DecisionDx-GBM test cite medical necessity based on intent to use the results in the management of the patient. |
| The most appropriate supply or level of service that can be safely provided to the patient | The DecisionDx-GBM test is a proprietary test that is only available through Castle Biosciences, there are no alternative supply options; The DecisionDx-GBM test has been compared to histology alone and other clinicopathologic factors and proven to be more robust than and statistically independent of these factors. |