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Local Coverage Determinations Roundup: Razor Genomics, Guardant Health

NEW YORK – Medicare Administrative Contractors released draft local coverage determinations (LCDs) for a number of molecular diagnostics this week.

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:

CGS Administrators, Wisconsin Physicians Service Insurance Corporation: Single-gene, multi-gene pharmacogenomics tests**

CGS Administrators and Wisconsin Physicians Service Insurance Corporation issued final LCDs aligning their coverage policies with Palmetto's previously announced limited coverage for single-gene and multi-gene pharmacogenomic panels. Under the policies, PGx testing is considered reasonable and necessary once a treating physician has narrowed a patient's treatment possibilities to specific medications, or if the physician is already using medications with clinically actionable gene-drug interactions as defined by the US Food and Drug Administration or the Clinical Pharmacogenetic Implementation Consortium. PGx testing must be used to help the physician's decision-making process for administering or dosing the drug. Combinatorial tests aren't covered under the policy, but some multi-gene components of certain combinatorial tests may be covered. The CGS LCD takes effect Aug. 3, and the WPSIC LCD takes effect July 26.   

CGS Administrators: Predictive classifiers for NSCLC**

The contractor issued a final LCD aligning with Palmetto's earlier decision to cover molecular diagnostic laboratory tests as predictive classifiers for non-small cell lung cancer, looking specifically at Razor Genomics' 14-Gene Lung Cancer Assay. The tests are covered for patients with NSCLC with tumors less than 5 centimeters and no positive lymph nodes. Patients must be able to tolerate chemotherapy and must be considered for adjuvant platinum-containing chemotherapy, and the test must be ordered by a physician to help in the decision of recommending adjuvant chemotherapy. The LCD goes into effect July 27.

CGS Administrators: Plasma-Based Genomic Profiling in Solid Tumors**

CGS issued a limited coverage policy for next-generation sequencing tests performed on solid tumor cell-free DNA in plasma, aligning with Palmetto's final coverage decision released in December.

The LCD specifically notes the Guardant360 liquid biopsy test, although it applies to other tests as well. The Guardant360 test is only covered for patients with recurrent, relapsed, refractory, metastatic, or advanced solid tumors that didn't originate from the central nervous system. Patients can't have been previously tested with Guardant360 for the same primary cancer and they must have decided to seek further cancer treatment. Patients who have decided to seek further treatment must be candidates for treatment with a drug approved by the FDA or with a National Comprehensive Cancer Network 1 or NCCN 2A recommendation for the cancer, and those indications must require the presence or absence of a genetic biomarker gauged by Guardant's test. The coverage determination goes into effect July 27.

Other liquid biopsies will be covered for the same indications if they have similar performance in their intended use applications to Guardant360.

**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.