Skip to main content
Premium Trial:

Request an Annual Quote

Local Coverage Determinations Roundup: Castle Bio

NEW YORK – Medicare Administrative Contractor Wisconsin Physicians Service Insurance Corporation recently released a local coverage determination (LCD) to align its coverage terms 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.


WPSIC: Castle Biosciences' DecisionDx-Melanoma

The MAC aligned its coverage for melanoma risk stratification tests in patients with cutaneous melanoma. The local coverage determination, which applies to services performed on or after Nov. 26, follows Palmetto GBA's expanded LCD from October covering molecular diagnostic tests used to help in risk stratification of melanoma patients. The LCD is for risk stratification tests that meet the following guidelines in general, but specifically cites Castle Biosciences' DecisionDx-Melanoma test. 

The policy covers the tests when patients have a history of melanoma and either stage T1b and above or T1a with documented concern about adequacy of microstaging and do not have metastatic disease. Patients must also be undergoing workups or being evaluated for treatment and have a disease stage, grade, and Breslow thickness within the intended use of the test. They must have presumed risk greater than 5 percent for a positive sentinel lymph node biopsy based on clinical or histological information. 

In addition, the tests themselves must show clinical validity of the tested analytes, as well as utility beyond clinical, histological, and radiographical factors when stratifying patients into risk groups. Tests must also have appropriate analytical validity.

Earlier this year, Noridian and CGS Administrators aligned their coverage policies with Palmetto's expanded LCD.  


**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.  

The Scan

Drug Response Variants May Be Distinct in Somatic, Germline Samples

Based on variants from across 21 drug response genes, researchers in The Pharmacogenomics Journal suspect that tumor-only DNA sequences may miss drug response clues found in the germline.

Breast Cancer Risk Gene Candidates Found by Multi-Ancestry Low-Frequency Variant Analysis

Researchers narrowed in on new and known risk gene candidates with variant profiles for almost 83,500 individuals with breast cancer and 59,199 unaffected controls in Genome Medicine.

Health-Related Quality of Life Gets Boost After Microbiome-Based Treatment for Recurrent C. Diff

A secondary analysis of Phase 3 clinical trial data in JAMA Network Open suggests an investigational oral microbiome-based drug may lead to enhanced quality of life measures.

Study Follows Consequences of Early Confirmatory Trials for Accelerated Approval Indications

Time to traditional approval or withdrawal was shorter when confirmatory trials started prior to accelerated approval, though overall regulatory outcomes remained similar, a JAMA study finds.