January 8th, 2019 – Minneapolis, MN
Relievant Medsystems, a privately-held medical device company developing minimally-invasive solutions for chronic low back pain (CLBP), today announced that the Centers for Medicare & Medicaid Services (CMS) has established Healthcare Common Procedure Coding System (HCPCS) codes C9752 and C9753 for the Intracept Procedure effective January 1, 2019. The new codes have been assigned to Ambulatory Payment Classification (APC) 5115 with a 2019 hospital outpatient payment rate of approximately $10,700 on a nationally unadjusted basis. Additionally, the new codes are eligible for payment in the Ambulatory Surgery Center (ASC) setting.
“The issuance of reimbursement codes for the Intracept Procedure and assignment to an existing APC is a major early reimbursement milestone,” said Kevin Hykes, President and Chief Executive Officer of Relievant. “We are pleased to take this significant step forward in facilitating access to this important new procedure for the millions of CLBP patients who have failed conservative therapy and who are not surgical candidates.”
Relievant began commercializing the Intracept Procedure, a minimally-invasive and clinically-proven treatment for CLBP, in the United States in 2018. The Company has a dedicated team to assist patients and physicians in obtaining prior authorization approvals in advance of treatment with the Intracept Procedure. Relievant’s SMART trial, a landmark sham-controlled double-blind randomized clinical trial, serves as the foundation for case-by-case coverage decisions by commercial payers. More information regarding reimbursement for the Intracept Procedure can be found at www.relievant.com/reimbursement.
About Chronic Low Back Pain (CLBP)
Chronic low back pain is a widespread and often severely debilitating condition that is estimated to affect nearly 30 million people in the US, costing nearly $150 billion each year in medical treatment and lost productivity. Patients suffering from CLBP typically initiate treatment with conservative therapies such as activity modification, medications, bracing, physical therapy, manipulation and steroid injections. Existing therapies fail to provide adequate pain relief for approximately 80 percent of CLBP patients. Until recently the intervertebral discs have been thought to be the primary source of pain, also referred to as discogenic pain, in patients with CLBP. Research published over the past decade has concluded that the vertebral body endplates are a significant source of pain in patients with CLBP, and this pain is now referred to as vertebrogenic pain. Of the 30 million people in the US that suffer from CLBP, over five million have vertebrogenic pain and have not responded to conservative therapies, and may not be candidates for surgery.
About the Intracept Procedure
Relievant’s Intracept Procedure is a new, clinically proven treatment option for the relief of chronic vertebrogenic back pain. The FDA marketing clearance was supported by ground-breaking anatomic and clinical research which concluded that the vertebral body endplates are a significant source of chronic low back pain, and that the pain is transmitted by the basivertebral nerve (BVN). The procedure uses a transpedicular, minimally-invasive approach to reach the BVN near the center of the vertebral body and uses radiofrequency energy to ablate the nerve; once ablated, these nerves no longer transmit pain signals. Spine surgeons and interventional pain specialists perform the Intracept Procedure under image guidance in the outpatient setting, with the entire procedure taking 60-90 minutes. Treated patients report nearly immediate relief of their back pain.
About Relievant Medsystems
Founded in 2006 and with headquarters in Minneapolis, MN, Relievant Medsystems is a privately held medical device company developing new solutions to improve the quality of life for millions of patients suffering from chronic vertebrogenic back pain.
FDA has cleared Relievant’s Intracept System for the following Indications for Use: The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least 6 months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.
As with any surgical procedure, there are risks and considerations associated with the Intracept Procedure. Please visit www.relievant.com for a discussion of the risks, contraindications, warnings, precautions and a summary of the pivotal clinical trial data on the device.