Plus Therapeutics Inc. (NASDAQ: PSTV) announced that its subsidiary CNSide Diagnostics has enrolled in the Medicare program and received a Provider Transaction Access Number from the Centers for Medicare & Medicaid Services.

The enrollment establishes CNSide Diagnostics as a Medicare-enrolled clinical laboratory, enabling it to submit claims for its CNSide cerebrospinal fluid assay platform, including the tumor cell enumeration test. Claims will be reimbursed when determined reasonable and necessary by the Medicare Administrative Contractor with jurisdiction over the laboratory.

"Medicare enrollment represents a critical step in our commercialization strategy," said Russ Havranek, executive vice president of corporate and commercial strategy. "It enables access to approximately half of the U.S. Medicare population through Traditional Medicare, subject to coverage determinations, while establishing a clear pathway to expand into Medicare Advantage populations over time."

The company stated it currently has approximately 81 million commercial covered lives. The Medicare enrollment allows billing for testing provided to Medicare Fee-For-Service beneficiaries and positions CNSide Diagnostics to pursue coverage with Medicare Advantage plans.

CNSide Diagnostics plans to engage with Medicare Administrative Contractors to secure formal coverage determinations and establish payment rates for the new CPT code 0640U, effective for billing July 1, 2026. The company targets reaching 150 million covered lives by 2026.

The CNSide cerebrospinal fluid assay platform detects and characterizes tumor cells and circulating tumor DNA in cerebrospinal fluid for patients with leptomeningeal metastases, a complication of central nervous system cancers.

Plus Therapeutics, based in Houston, develops targeted radiotherapeutics for central nervous system cancers. The information was provided in a company press release.