MolDX: Biomarker Testing for Risk Stratification in DCIS

Jurisdiction: J8 MAC Part B. States: Indiana, Michigan. Type: Active LCD

Biomarker tests (molecular or proteomic) that enable risk stratification of Ductal Carcinoma in situ (DCIS) patients into sufficiently low risk patients, who may safely forego the use of adjuvant radiation therapy (RT) or patients who should not forgo the use of RT or receive a higher intensity intervention are currently non-covered by this contractor. However, should evidence be further developed to meet reasonable and necessary standards, such a test may be considered for coverage when ALL the following criteria are met: The patient must: Have a diagnosis of DCIS and NOT have concurrent invasive breast carcinoma; Not be in consideration for mastectomy; Not have received RT for breast cancer in the same breast; Have a formulated treatment plan that includes: RT and consent to its use; AND Intent to forgo the use of RT, if determined to be placed in the “sufficiently low risk” category by the test; Not have been previously tested with the same or other similar test; Along with any sample used, be within the validated, intended use and population of the test; The test must: Have successfully completed a Technical Assessment (TA); AND Demonstrate significant improvement in accuracy of identification of sufficiently low-risk patients compared to existing risk stratification tools and methodologies, including non-biomarker clinical and laboratory findings or combinations of such findings (and including such findings within its internal algorithms), such as those found in nomograms and risk scoring systems, in appropriately designed and controlled studies published in peer-reviewed, published literature, OR Demonstrate equal or superior performance in risk stratification to any other biomarker test that has already met the criteria above; Definitions Sufficiently Low-Risk: For the purpose of this policy, this term is defined as a stratification group of patients wherein the absolute risk reduction of Ipsilateral Breast Tumor Recurrence (IBTR) from RT is estimated to be 5% or less when compared to Breast Conserving Surgery (BCS) alone regardless of individualized factors (extreme age, intolerance to RT, co-morbidities, etc.).