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Local Coverage Determinations Roundup: Natera, DermTech

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 of for each of the LCDs. Each listing starts with the Medicare contractor that made the decision.

Final LCDs:

Wisconsin Physicians Service Insurance Corporation: DermTech's Pigmented Lesion Assay**

WPSIC issued a final LCD that aligns with Palmetto's earlier coverage determination for this test. The contractors will cover the non-invasive RNA gene expression test to rule out primary cutaneous melanoma and to help decide if patients with melanocytic skin lesions that display one or more clinical characteristics of melanoma should be biopsied. CGS Administrators also recently aligned its coverage with Palmetto. The LCD takes effect April 12.

Wisconsin Physicians Service Insurance Corporation: Natera's Prospera Kidney Transplant Test

WPSIC issued a final LCD that aligns with Palmetto's previous LCD for Natera's Prospera donor-derived cell-free DNA test to supplement evaluation and management of kidney transplant patients. The Medicare contractor will only cover the test when the patient has a renal allograft and the physician has assessed a need to further evaluate the patient for the probability of active renal allograft rejection. The LCD will go into effect on April 12.

CGS Administrators: Decipher Biosciences' Decipher Prostate Biopsy Test**

CGS Administrators issued a final LCD that aligns with Palmetto's earlier coverage determination for Decipher's test. Men with prostate cancer will be covered for the test when several criteria are met, including a needle biopsy with localized adenocarcinoma of prostate with no clinical evidence of metastasis or lymph node involvement; FFPE prostate biopsy specimen with at least 0.5 millimeters of cancer length and favorable or unfavorable intermediate risk disease as defined in the most recent available NCCN guideline; patient life expectancy of at least 10 years; candidacy for definitive therapy; no pelvic radiation or androgen deprivation therapy before the biopsy; and monitoring for disease progression. The LCD takes effect April 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.