Permanent HCPCS code granted following U.S. FDA approval of LUMISIGHT™ (pegulicianine) and Lumicell™ Direct Visualization System (DVS), together referred to as LumiSystem™, with commercial availability in Q4 2024
NEWTON, Mass.—Lumicell, Inc., a privately held company focused on developing innovative fluorescence-guided imaging technologies for cancerous tissue detection during surgery, today announced LUMISIGHT™ (pegulicianine) was granted a permanent Healthcare Common Procedure Coding System (HCPCS) code for Hospital Outpatient Prospective Payment System (OPPS) by the Centers for Medicare & Medicaid Services (CMS).
Effective on Jan. 1, 2025, this new code, A9615 Injection, pegulicianine, 1 mg, will enable streamlined billing and reimbursement for healthcare providers and patients. Transitional pass-through (TPT) payments will continue and will be associated with this permanent HCPCS code, A9615, instead of the temporary C-code, C9171, that was granted in September 2024.
HCPCS codes are established by CMS to facilitate accurate Medicare claims processing. The assignment of HCPCS code A9615 marks a major milestone for Lumicell as it seeks to improve patient access to its new and innovative technology while supporting healthcare providers by simplifying the claims submission process.
“We’re pleased that CMS has recognized the significance of LUMISIGHT with the issuance of this permanent HCPCS code,” said Howard Hechler, Chief Executive Officer at Lumicell. “This code will help patients with breast cancer and surgeons gain access to our technology that’s been clinically proven to find cancer that otherwise would have been missed during a lumpectomy procedure.”
LUMISIGHT is approved for use in combination with Lumicell™ Direct Visualization System (DVS) to detect cancerous tissue within the breast cavity as an adjunct during the lumpectomy procedure. LumiSystem is the combination of these two FDA-approved products.
Healthcare providers are encouraged to contact 1-833-4LUMDVS for any questions about LUMISIGHT or Lumicell DVS.
About Lumicell Inc.
Lumicell is a privately held company focused on enabling a more complete resection of cancer by advancing the development and commercialization of its innovative fluorescence guided surgery technology. The company’s lead products are LUMISIGHT™ (pegulicianine) and Lumicell™ DVS which are approved for use in combination to illuminate cancerous tissue within the breast cavity during the initial lumpectomy procedure, as an adjunct to the Standard of Care. Lumicell’s proprietary, pan-oncologic optical imaging agent, LUMISIGHT, is also being explored for further development across a wide variety of solid tumor indications. For more information, please visit www.Lumicell.com and follow the company on Facebook, X, and LinkedIn.
Indications for Use
LUMISIGHT, an optical imaging agent, and Lumicell DVS, a fluorescence imaging device, are indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery.
Important Safety Information
What is LUMISIGHT (pegulicianine) and Lumicell DVS?
- LUMISIGHT (pegulicianine), an optical imaging agent, and Lumicell DVS, a fluorescence imaging device, are used in adults with breast cancer to help detect any remaining cancerous tissue at the surgical site following removal of the primary specimen during a lumpectomy procedure.
What is the most important information I should know about LUMISIGHT?
- Hypersensitivity Reactions: LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred in 4/726 (0.6%) of patients in clinical studies. Tell your doctor if you have any history of hypersensitivity reactions to pegulicianine or to contrast media or products containing polyethylene glycol (PEG). Your healthcare provider should have emergency resuscitation drugs, equipment, and trained personnel available during use of LUMISIGHT. Healthcare providers should monitor all patients for hypersensitivity reactions and if one is suspected, immediately discontinue the injection and initiate appropriate therapy.
What are the most common side effects of LUMISIGHT?
- The most common side effects (≥1%) include hypersensitivity and an abnormal color in urine.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. Please see full Prescribing Information, including Boxed Warning.
What additional important information should I know about LUMISIGHT and Lumicell DVS?
- Adjunctive Use: Lumicell DVS is for use as part of the lumpectomy procedure and is not a replacement for the standard of care procedures and pathology. Your healthcare provider must be trained on proper use of the Lumicell DVS, and breast conserving surgery prior to performing any procedures.
- Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue.
- Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid use of dyes before imaging the lumpectomy cavity in patients who have received LUMISIGHT.
- Tissue Perforation or Damage: During the procedure, your healthcare provider should avoid excessive pressure or torque with the Lumicell DVS handheld probe while inside the cavity as it can cause tissue perforation or damage.
- Infection Risk: To avoid infection risk, the reusable Lumicell DVS handheld probe and cables should be properly and completely disinfected and reprocessed after each use by your healthcare provider. Your healthcare provider should also ensure proper use of the Lumicell DVS sterile, single-use probe cover.
- Eye Discomfort: Your healthcare provider should avoid direct eye exposure to the Lumicell DVS handheld light probe as it may cause pain.
Please see the LUMISIGHT Prescribing Information, including Boxed Warning, and Lumicell DVS Instructions for Use. For complete product information, visit www.LumiSystem.com.
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