|By PR Newswire||
|December 10, 2013 11:24 AM EST||
- CMS determined that a programmatic need existed for new dedicated billing codes as the NovoTTF-100A System delivers a distinct cancer treatment modality and has achieved widespread adoption following pre-market approval from the Food and Drug Administration for the treatment of confirmed recurrent glioblastoma
NEW YORK, Dec. 10, 2013 /PRNewswire/ -- Novocure announced today that the Centers for Medicare and Medicaid Services (CMS) has established new therapy-specific Healthcare Common Procedure Coding System (HCPCS) codes (E0766 and A4555) to describe treatment with the NovoTTF-100A System. The new codes become effective January 1, 2014.
"The issuance of dedicated HCPCS codes for NovoTTF Therapy™ is an important event for recurrent glioblastoma patients," said Peter Melnyk, Novocure's Chief Commercial Officer. "Payers can now use these dedicated codes to automate coverage and payment decisions, which can benefit recurrent GBM patients who need rapid access to treatment due to the aggressive nature of the disease."
CMS also designated the product as a frequently serviced item, and as a result all necessary accessories are included in the E0766 code. The designation of a single HCPCS code, as opposed to separate codes for the device and monthly supplies, will enable a straightforward payment structure for payers, replacing the need to use separate codes for the device and standard monthly supplies. CMS issued a separate HCPCS code (A4555) to describe replacement supplies, if provided separately from the bundled accessories.
Additionally, CMS indicated that the local Durable Medical Equipment Medicare Administrative Contractors (DMACs) can provide patients with coverage for the product when reasonable and necessary. Novocure will continue to work with CMS and the DMACS to secure coverage for patients in compliance with program rules, as it has with the more than 90 private payers that have covered the product to date.
"Creating HCPCS codes for the NovoTTF-100A System is an important milestone for NovoTTF Therapy, an established standard of care treatment for patients with recurrent glioblastoma." said Asaf Danziger, Novocure's CEO. "Since receiving FDA approval for recurrent GBM, Novocure has certified 115 leading, US neuro-oncology centers to prescribe NovoTTF Therapy. Dedicated CMS HCPCS codes will streamline the process for these centers to provide NovoTTF Therapy to their patients in need."
About The NovoTTF-100A System
The NovoTTF-100A System is a wearable, non-invasive anti-mitotic device designed for continuous use throughout the day by the patient. The device has been shown in in vitro and in vivo studies to slow or reverse tumor growth by inhibiting mitosis, the process by which cells divide and replicate. The portable delivery system creates a low intensity, alternating electric field within the tumor that exerts physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death. The NovoTTF-100A System, a NovoTTF Therapy delivery system, has received FDA approval (PMA) in the United States (U.S.) and is a CE Marked device cleared for sale in the European Union, Switzerland, Australia and Israel.
The U.S. Food and Drug Administration (FDA) approved the NovoTTF-100A System for use as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM), following confirmed disease recurrence. The device is intended to be used as monotherapy as an alternative to standard medical therapy for recurrent GBM after surgical and radiation options have been exhausted. Patients should only use the NovoTTF-100A System under the supervision of a physician properly trained in use of the device.
Full prescribing information is available at NovoTTFTherapy.com or by calling toll free 1-855-281-9301. NovoTTF Therapy is experimental for the treatment of newly diagnosed glioblastoma. Limited by law to investigational use only.
Novocure Limited is a private Jersey Isle oncology company pioneering a novel therapy for solid tumors. Novocure Inc., Novocure's U .S. subsidiary, has operations in New York, NY and Portsmouth, NH. Novocure's research center is located in Haifa, Israel. For additional information about the company, please visit www.novocure.com.
About the Healthcare Common Procedure Coding System (HCPCS)
The HCPCS Level II Code Set is a standardized coding system that is used primarily to identify products, supplies, and services used in the outpatient setting. The Code Set was established and is annually updated by the Centers for Medicare and Medicaid Services, taking into account input from both public and private payors. The purpose of the Code Set is to ensure that claims submitted to Medicare and private payors are processed in an orderly and consistent manner.
Frank Leonard, Novocure