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Local Coverage Determinations Roundup: CareDx, Castle Bio, Decipher Biosciences

NEW YORK – Medicare Administrative Contractor Noridian recently released a number of final local coverage determinations (LCDs) to align its coverage terms for a variety of tests with Palmetto’s MolDx program.

Below is a list and brief description for each of the LCDs. Each listing starts with the Medicare contractor that made the decision.

Final LCDs: 

Noridian: CareDx's AlloSure Kidney, Heart

Noridian aligned its local coverage terms with Palmetto's final LCD covering AlloSure Kidney to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection, as well as to inform clinical decision-making about the need for renal biopsy in these patients at least 2 weeks after their transplant. Noridian will also cover AlloSure Heart when used in conjunction with the CareDx's AlloMap test to assess probability of allograft rejection in heart transplant recipients with clinical suspicion of rejection and to inform clinical decision-making about the need for a heart biopsy in these patients at least 55 days after the transplant.

The LCD combines coverage for AlloSure Heart and AlloSure Kidney in one document, as AlloSure Kidney was previously covered. The non-invasive blood tests measure transplant injury via donor-derived, cell-free DNA. Other tests with similar indicated uses and similar performance to AlloSure may also be covered under the LCD, although Noridian did not specify any other tests. The LCD goes into effect Dec. 6.

Noridian: Castle Biosciences' DecisionDx-Melanoma

The MAC aligned its coverage terms with Palmetto's recently announced expanded coverage determination for the DecisionDx-Melanoma test for patients with cutaneous melanoma. The LCD is a general policy for molecular diagnostic tests used to assist in risk stratification of melanoma patients that cites DecisionDx-Melanoma specifically in the evidence review. The tests are covered when the patient has a personal history of melanoma with either stage T1b or stage T1a with documented concern about the adequacy of microstaging.

Patients must also be undergoing workup or being evaluated for treatment, not have metastatic disease, have presumed risk greater than 5 percent for a positive sentinel lymph node biopsy, and have disease stage, grade, and Breslow thickness within the intended use of the test. Noridian's LCD goes into effect Dec. 6.

Noridian: Decipher Biosciences' Decipher Prostate

Noridian aligned its coverage with Palmetto's expanded coverage decision for genomic derived tests that assess risk in localized prostate cancer, specifically focusing on the Decipher Prostate Cancer Classifier Assay in the evidence review. The test is used to identify men with prostate cancer and a life expectancy of at least 10 years who are good candidates for active surveillance according to National Comprehensive Cancer Network guidelines.

The test is covered for men with prostate cancer if they are a candidate for and are considering: conservative management but would be eligible for definitive therapy; radiation therapy but would be eligible for an additional brachytherapy boost; radiation therapy but would be eligible for the addition of short-term androgen deprivation therapy; radiation therapy with short-term ADT but eligible for long-term ADT; radiation with standard ADT but would be eligible for therapy intensification using next-generation androgen signaling inhibitors or chemotherapy; observation post-prostatectomy but eligible for the addition of post-op adjuvant radiotherapy; or salvage radiotherapy post-prostatectomy but eligible for the addition of ADT.

Patients can't have received pelvic radiation or ADT before the biopsy or prostate resection specimen. The LCD goes into effect Dec. 6.

**Palmetto administers the MolDX program, in which three other Medicare Administrative Contractors (MACs) participate, including Noridian, CGS, and Wisconsin Physicians Service Insurance Corporation. Each MAC issues its own draft and final policy to align with Palmetto’s coverage terms for a specific test.  

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