Medtronic, the global leader in healthcare technology, is pleased to share that Medicare has expanded coverage for spinal cord stimulation (SCS) therapy for patients with painful diabetic peripheral neuropathy (DPN).

Two of Medicare’s Administrative Contractors (MACs), First Coast Service Options and Novitas Solutions, will retire their local coverage determinations (LCD) for SCS with an anticipated effective date of July 13, 2023, and refer to the CMS National Coverage Determination (NCD) for SCS which places no restrictions on coverage for patients who meet medical necessity criteria. This decision will provide an additional 11 million Medicare beneficiaries in 12 states (Arkansas, Colorado, Delaware, Florida, Louisiana, Maryland, Mississippi, New Mexico, New Jersey, Oklahoma, Pennsylvania, and Texas), along with Washington D.C., with access to SCS coverage for treatment of painful DPN.

“This is impactful news for patients in these states with Medicare or Medicare Advantage insurance coverage,” said Dr. Michael Fishman, M.D., M.B.A., Anesthesiologist and Interventional Pain Medicine specialist in Lancaster, Pennsylvania. “Patients with DPN often suffer from debilitating pain for many years, and until recently, many were left with limited options once they exhausted conventional treatments. There is durable clinical evidence supporting the use of SCS therapy for DPN and I’m pleased to see that Medicare will now extend coverage to all beneficiaries nationwide, which represents 35 million people living with this painful condition.”

DPN is a debilitating and progressive neurological disorder that affects approximately 30% of people with diabetes, significantly impacting both quality of life and functional ability, including mood, social relationships, and sleep.¹ DPN occurs when high blood sugar (glucose) damages nerves in the body, most often in the legs and feet, which can lead to numbness and burning or stabbing pain. In some patients, the pain can become progressively worse and excruciating. Patients may be treated with medications, but they are often only partially effective and can result in serious side effects.

Independent studies show patients with DPN achieve significant pain relief when treated with SCS compared to conventional treatments alone.^2,3 In two randomized controlled trials, 70% of patients with DPN receiving SCS treatment experienced pain relief compared to 6% of patients receiving only conventional treatments. Those treated with SCS experienced a 53% average reduction in pain, compared to 0% among patients receiving only conventional treatments. Meta-analyses show a significant improvement in health-related quality of life in patients with DPN treated with SCS compared to those receiving only conventional treatments.⁴ A long-term analysis of patients treated in one of the studies using Medtronic SCS technology showed 80% of DPN patients treated with SCS continued to use their devices at five years to treat their pain.⁵

“We’re proud to have played a role in helping communicate the value of this therapy to encourage greater access for patients seeking relief from truly debilitating pain,” said Wendy Chan, vice president, Health Economics, Policy, and Reimbursement for Medtronic’s Neuromodulation, Neurovascular, and Pelvic Health Operating Units, which are part of the Neuroscience Portfolio at Medtronic. “Thanks to the local physicians and specialty societies who also advocated for SCS therapy to treat DPN, 11 million more Medicare beneficiaries will now have access to therapy.”

Medtronic estimates that up to 800,000 US patients suffer from moderate to severe DPN symptoms that are not resolved through conventional medical management approaches, like drugs.^6,7

Contacts:
Jeff Trauring
Public Relations
+1-763-505-0159

Ryan Weispfenning
Investor Relations
+1-763-505-4626

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit Medtronic.com, and follow @Medtronic on Twitter and LinkedIn.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

References

1. Sloan G, Alam, U, Selvarajah D, Tesfaye S. The Treatment of Painful Diabetic Neuropathy. Current Diabetes Reviews. July 2021
2. de Vos CC, Meier K, Zaalberg PB, et al. Spinal cord stimulation in patients with painful diabetic neuropathy: a multicentre randomized clinical trial. Pain. 2014 Nov;155(11):2426-31.
3. Slangen R, Schaper N, Faber C, et al. Spinal Cord Stimulation and Pain Relief in Painful Diabetic Peripheral Neuropathy: A Prospective Two-Center Randomized Controlled Trial. Diabetes Care. 2014;37:3016-3024.
4. Duarte RV, Nevitt S, Maden M, et al. Spinal cord stimulation for the management of painful diabetic neuropathy: a systematic review and meta-analysis of individual patient and aggregate data. Pain. March 2021.
5. Van Beek M, Geurts J, Slangen R, et al. Severity of Neuropathy Is Associated With Long-term Spinal Cord Stimulation Outcome in Painful Diabetic Peripheral Neuropathy: Five-Year Follow-up of a Prospective Two-Center Clinical Trial. Diabetes Care. 2018;41:32–38.
6. Centers for Disease Control and Prevention. National Diabetes Statistics Report website. https://www.cdc.gov/diabetes/data/statistics-report/index.html. Accessed [30-Jun-2023].
7. Veves A, Backonja M, Malik RA. Painful diabetic neuropathy: epidemiology, natural history, early diagnosis, and treatment options. Pain Med. 2008 Sep;9(6):660-74.