FDA Approved Spinal Cord Stimulation Devices offer New Hope for Non-opioid Management of Chronic Pain

by | Published on Feb 2, 2018 | Healthcare News

Stimulation Devices
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The US Food and Drug Administration (FDA) recently approved two new spinal cord stimulation systems: the Senza II Spinal Cord Stimulation (SCS) System from medical device company Nevro Corporation and Spectra WaveWriter™ Spinal Cord Stimulator System from Boston Scientific. Both devices are designed to provide superior paresthesia-free pain relief for patients. Spinal cord stimulation (SCS) has been found to be an effective option to manage refractory chronic pain that fails to respond to conservative therapies. SCS is used clinical situations such as failed back surgery syndrome, complex regional pain syndrome, ischemic and coronary artery disease. Medicare and commercial payers have specific reimbursement rules for SCS and medical coding services are available to help pain management specialists get appropriately payment for implantation, removal and revision of electrical stimulators implanted in the spinal cord.

FDA approval for the new spinal cord stimulation systems is a welcome development in the light of the increasing focus on non-opioid pain management therapies. The Senza II Spinal Cord Stimulation (SCS) System delivers Nevro’s proprietary HF10 electrical pulse therapy to the spinal cord via small electrodes on leads placed near the treatment area. A battery-powered device implanted under the patient’s skin generates the therapy. According to Nevro, the HF10 therapy is the only SCS therapy indicated by the FDA to provide pain relief without paresthesia. In a comparative pivotal study, this new therapy was the first to demonstrate superiority to common SCS therapies for back and leg pain. The reduced size and optimized design of the updated Senza 2 system allows for greater patient comfort and placement options.

Boston Scientific’s Spectra WaveWriter™ Spinal Cord Stimulator System, the other new FDA-approved non-opioid treatment option, offers multiple therapies for people with chronic pain. According to the company’s press release, this is the “first and only system approved by the FDA to simultaneously provide paresthesia-based and sub-perception therapy”. It is designed to treat chronic and debilitating pain successfully by allowing physicians and patients to combine therapeutic options, customize therapy and capture real-time feedback.

SCS delivers low electrical pulses which vary in frequency, pulse width and amplitude to the nerves along the spinal column. This modifies nerve activity and minimizes the sensation of pain reaching the brain. The FDA first approved SCS in 1989 to treat chronic pain from nerve damage in the trunk, arms or legs. According to the International Neuromodulation Socienty (INS), the therapy now accounts for about 70% of all neuromodulation treatments.

With the increasing incidence and variety of chronic pain conditions, it can be expected that the use of SCS will continue to grow. In fact, a new study published by www.diabetesincontrol.com reported that this therapy is an effective option for painful diabetic peripheral neuropathy (PDPN). PDPN causes irreversible peripheral nerve damage resulting in severe pain that is difficult to manage. The debilitating pain can potentially affect quality of life. Though medications are available to help relieve pain, they often do not work. The study from the outpatient pain clinics of the Maastricht University Medical Center and the Radboud University Medical Center (UMC) found that:

  • Long-term SCS therapy was successful at improving chronic pain in patients with PDPN that had failed other pain therapies.
  • SCS therapy was still being used by 80% of patients at the end of the 5-year period.
  • Higher MDNS resulted in elevated treatment failure risk.

The INS cautions that as SCS does not work for all patients with all types of pain, physicians need to appropriately select patients who may benefit from the therapy. Generally, patients considered for SCS are those that have had chronic pain for more than a year.

Medicare’s National Coverage Determination (NCD) 160.7 allows for coverage of spinal cord stimulation when certain criteria are met. SCS is also reimbursed by some local Medicare Administrative Contractors (MACs) though they may require additional coverage criteria through their local policies (LCDs). Therefore, prior to treatment and billing, providers should verify payer coverage and payment policies. The CPT codes billed should reflect the services provided to each individual patient in the office (non-facility) or hospital/ASC (facility) setting. Further, modifiers need to be appended to CPT codes to indicate to a payer that a service or procedure has been altered by specific circumstances. Clinical documentation should reflect the use of any modifiers reported on claims, and providers should submit documentation to payers to justify any potential increases in payment. An experienced pain management medical billing company can provide valuable support to help providers report SCS therapy accurately and optimize reimbursement.

Natalie Tornese

Holding a CPC certification from the American Academy of Professional Coders (AAPC), Natalie is a seasoned professional actively managing medical billing, medical coding, verification, and authorization services at OSI.

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