Plus Therapeutics Secures Medicare Enrollment, Unlocks Billing for CNSide Assay to 35M Patients
Plus Therapeutics’ subsidiary CNSide Diagnostics enrolled in the Medicare program and received a PTAN, enabling billing for its CNSide® CSF Assay tumor cell enumeration test. This milestone opens access to 35 million Medicare Advantage beneficiaries and triggers CPT 0640U pricing July 1, 2026, alongside 81 million commercial lives.
1. Medicare Enrollment Approval and PTAN
CNSide Diagnostics, Plus Therapeutics’ wholly owned laboratory subsidiary, achieved Medicare enrollment and received its Provider Transaction Access Number (PTAN), officially qualifying the CNSide® CSF Assay tumor cell enumeration test for Traditional Medicare billing subject to local coverage determinations.
2. Expanded Patient Access
Enrollment enables billing for Fee-For-Service Medicare beneficiaries and positions the assay for reimbursement to approximately 35 million Medicare Advantage policyholders, complementing the company’s existing 81 million commercial covered lives to enhance patient access and revenue potential.
3. Reimbursement and Pricing Pathway
The company will engage Medicare Administrative Contractors (MACs) to secure local coverage determinations, pursue Clinical Laboratory Fee Schedule (CLFS) pricing, and establish a payment rate for the new CPT code 0640U, effective July 1, 2026, via crosswalk or gap-fill methodology.
4. Commercial Strategy and Future Steps
Plus Therapeutics plans to expand national and regional payer contracts, generate real-world utility data, and optimize billing processes to reach over 150 million covered lives by year-end 2026 and accelerate adoption within academic and community oncology networks.