April 19, 2022
NASS and MPW Advocate for Medicare Advantage Coverage of Interspinous Spacer Devices
Medicare Advantage plans do not offer coverage for lumbar interspinous spacer devices (ISD) implantation without fusion for patients suffering from lumbar spinal stenosis (LSS). This lack of coverage persists even though a device is FDA-approved and the implantation is covered by Medicare. In Medicare Advantage coverage plans reviewed, ISD is reported to be “experimental or investigational,” despite the FDA’s acceptance of the technology, the American Medical Association creating a non-investigational billing code, and Medicare’s reimbursement policies.
The Multi-Specialty Pain Workgroup (MPW), of which NASS is a member, recently wrote to United Health Care advocating for Medicare Advantage coverage of ISD. The MPW has a strong record of working to eliminate fraudulent, unproven, and inappropriate procedures. At the same time, they are equally committed to assuring that appropriate, effective, and responsible treatments are preserved. The MPW societies, including NASS, support the use of ISD in the treatment of appropriately selected patients suffering from lumbar spinal stenosis. The societies strongly affirm that appropriate patient selection is essential. Stringent patient selection criteria limit the number of patients who can be offered ISD but assure that those receiving ISD have the greatest chance to benefit from the procedure with the least harm.
The efficacy of the only ISD currently available is supported by favorable 2-year outcomes in LSS patients in a prospective, multicenter, randomized, controlled investigational device noninferiority trial in comparison with a control ISD that had already achieved FDA approval. After FDA approval, a post-market registry was implemented at 86 sites across the US involving 316 physicians. Data on clinical outcomes of the novel ISD showed a mean VAS score of leg and back pain reduction resulting in overall improvement with 80% patient satisfaction in the first 12 months. Improvements in quality of life and decreased opioid use up to 60 months were reported as well among those receiving the ISD.
ISD has been demonstrated to be effective in the treatment of LSS symptoms in a carefully designed trial, and there is evidence it maintains effectiveness in extended follow-up. It improves pain, function, quality of life, and decreases exposure to opioid medications when applied according to indications. ISD has limited indications and specific contraindications, which support its utility and safety when followed. Clinical judgment of the physician and shared decision-making between physician and patient with a full discussion of risks and potential benefits must be undertaken. The MPW will continue to work with Medicare Advantage health plans to establish a reasonable coverage policy that will eliminate inappropriate utilization and ensure appropriate access to ISD for Medicare patients.