Menarini Silicon Biosystems (MSB), Inc. is announcing that the AMA has issued Current Procedural Terminology (CPT^®) Proprietary Laboratory Analyses (PLA) codes for two of its CELLSEARCH advanced liquid biopsy tests which received preliminary pricing determination by the US Centers for Medicare and Medicaid Services (CMS). Issuing of these codes represents a decisive step towards gaining broad access to Medicare/Medicaid reimbursement. This opens the door to affordable, less burdensome, minimally invasive liquid biopsy tests to improve the monitoring, and management of patients with challenging hematological and solid tumor types.

As part of the annual pricing process for CPT codes in the Medicare Clinical Laboratory Fee Schedule (CLFS), CMS recently issued a preliminary determination to price both CPT PLA codes on a 'gapfill' basis. Gapfilling occurs when no comparable, existing test is available and thereby recognizes the added value of MSB's two assays. This gapfill process enables Medicare contractors to recommend CLFS pricing for each new CPT code in a vote to CMS the following year based on actual cost data provided by the testing laboratory/manufacturer instead of previously established payment rates. Final CLFS pricing for the CPT PLA codes would thus go into effect in January 2024. Further details on the CLFS pricing process are available on the CMS website¹.

The new CPT PLA codes include:

• CELLSEARCH Circulating Multiple Myeloma Cell (CMMC) assay – 0337U
• CELLSEARCH HER2 Circulating Tumor Cell (CTC-HER2) assay – 0338U

Both of these assays are laboratory developed tests (LDTs) regulated under Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations provided out of Menarini Silicon Biosystems' clinical lab in Huntingdon Valley, PA.

The CELLSEARCH CMMC assay is intended for clinical use in patients with plasma cell disorders such as multiple myeloma (MM), the second most common blood cancer, as well as precursor conditions including monoclonal gammopathy of unknown significance (MGUS) and smoldering multiple myeloma (SMM). By capturing and enumerating CMMCs from peripheral blood, this assay has the potential to reduce invasive, often painful, and costly bone marrow (BM) biopsies to monitor MM disease progression and status in real-time.

The CELLSEARCH HER2 Circulating Tumor Cell (CTC-HER2) assay is intended to reduce the need for impractical or contraindicated tissue biopsy in patients with EpCAM (Epithelial Cell Adhesion Molecule)-expressing tumors that often overexpress the human epidermal growth factor receptor (HER) 2 biomarker. The HER family of receptors plays a central role in the pathogenesis of several human cancers and the introduction of HER2 directed therapies has the potential to dramatically influence the outcome of patients with HER2 positive breast and gastric/gastroesophageal cancers, making accurate testing for HER2 all the more critical.

According to Fabio Piazzalunga, President and CEO of Menarini Silicon Biosystems (MSB) Inc, "we are excited to be a step closer to making these tests more affordable and accessible for an increasing number of cancer patients who otherwise would not have the opportunity to benefit from the crucial clinical information and convenience of a minimally invasive liquid biopsy test. We are working hard to bring these innovative solutions to both healthcare providers and patients, knowing the considerable impact they can have on improving patient outcomes." 

CELLSEARCH CMMC and CELLSEARCH CTC-HER2 test results are available within 3 working days and allow treating physicians to timely access information for precision care.