Emerging Treatments for Neuropathy: What Medicare Patients Should Know

If you're living with diabetic neuropathy, you know the burning, tingling, and stabbing pain that can turn even simple tasks into challenges. For decades, treatment options meant choosing between medications with limited effectiveness or learning to live with constant discomfort. But between 2020 and 2024, the FDA approved eight new treatments specifically for painful diabetic neuropathy—and the majority aren't pills at all.

This shift toward device-based therapies reflects growing frustration with oral medications that help only about half of patients and cause side effects serious enough that 77% of people stop taking them within a year. The new device options show dramatically better results in clinical trials, with some achieving 90% response rates compared to traditional medications' 30-50% effectiveness.

For Medicare patients, understanding which treatments are covered and how to navigate the approval process has become essential. The coverage landscape changed significantly in 2023 when Medicare expanded access to spinal cord stimulation for diabetic neuropathy, but gaps remain—particularly for the newest non-invasive devices that patients must pay for entirely out-of-pocket.

Why This Matters for Medicare Patients

About 2.3 million Americans have diabetic neuropathy that doesn't respond to conventional treatments. Approximately 30% of people with diabetes develop neuropathy, and about half of those experience the kind of debilitating pain that interferes with sleep, mobility, and quality of life. For Medicare beneficiaries who've tried multiple medications without relief, these new treatment options represent real hope—but only if you can access them.

The approval pattern tells an important story. From 2020 through October 2025, the FDA approved eight treatments specifically for painful diabetic peripheral neuropathy—with zero approvals for general peripheral neuropathy from other causes. This narrow focus reflects both the massive patient population and the urgent need for alternatives to medications that so many people can't tolerate or don't find effective.

The One New Pharmaceutical Option: Qutenza

Qutenza is an 8% capsaicin patch that represents the only new drug option for diabetic neuropathy in the past five years. The FDA expanded its approval in July 2020 to include diabetic neuropathy of the feet, building on its original 2009 clearance for postherpetic neuralgia (the nerve pain that follows shingles).

How Qutenza Works

The patch delivers highly concentrated capsaicin—the compound that makes chili peppers hot—at 100 times the strength of over-the-counter creams. During a 30-minute in-office procedure, a healthcare professional applies the patch to your feet after using a topical anesthetic. The capsaicin binds to pain-sensing nerve fibers, initially causing intense activation but then creating a temporary shutdown of those pain receptors that can last up to three months.

This mechanism differs fundamentally from lower-dose capsaicin products you can buy at the drugstore. Those require continuous daily application and work primarily through counter-irritation—essentially distracting your nerves with mild burning. Qutenza actually reduces the density of nerve fibers temporarily, creating what researchers call a "pain holiday" while the nerves gradually regenerate over several months.

What the Research Shows

In clinical trials with 369 patients, Qutenza achieved 30% average pain reduction compared to 22% for placebo—a statistically significant but modest difference. About 41% of people using Qutenza experienced at least 30% pain relief, compared to 32% with placebo.

These numbers might seem underwhelming compared to the device trials we'll discuss later. But Qutenza offers specific advantages. The 52-week safety study found that 63% of patients preferred Qutenza to their previous therapy, and 73% wanted to continue treatments. Relief typically starts within one to three weeks and lasts the full three months in many patients. There are no drug interactions because capsaicin absorption remains negligible, and side effects stay local—mostly application-site burning, pain, and itching that resolve quickly.

Medicare Coverage for Qutenza

Medicare covers Qutenza exclusively under Part B when administered in clinical settings—never under Part D prescription plans. This unusual coverage pathway stems from FDA labeling that prohibits patient self-administration. The patch must be applied by a physician or healthcare professional in a well-ventilated treatment room, using specific safety equipment including nitrile gloves, protective eyewear, and blood pressure monitoring.

Traditional Medicare patients pay approximately $189 per patch (20% of the $946 Medicare-allowed amount) plus $40-80 for the administration procedure, totaling around $255-295 per treatment. With quarterly treatments, annual costs reach $1,020-1,180 for traditional Medicare beneficiaries without supplemental coverage.

Medicare Advantage plans typically charge fixed copays of $50-150 per treatment instead of percentage-based coinsurance, potentially offering significant savings. However, Medicare patients are explicitly excluded from manufacturer copay assistance programs, eliminating a cost-reduction option available to people with commercial insurance.

Up to four patches may be used per treatment session to cover painful areas, and treatments can be repeated every 90 days as warranted by pain return.

Spinal Cord Stimulation: The Game-Changer for Severe Cases

Five different spinal cord stimulation systems gained FDA approval for diabetic neuropathy between 2021 and 2023, representing the most significant advancement in treatment options. These devices work by delivering mild electrical impulses to the spinal cord that interrupt pain signals before they reach the brain.

The Evidence Is Compelling

The landmark SENZA-PDN trial enrolled 216 patients across 18 U.S. centers and demonstrated results that dramatically outperform traditional medications. After 24 months, 90% of patients using the Nevro Senza system achieved meaningful pain relief—defined as 50% or greater reduction in pain scores. Compare that to conventional medical management alone, where only 5% of patients achieved 50% pain relief.

Other studies show similar benefits. European trials found 59% treatment success with traditional spinal cord stimulation systems. Long-term data shows that 80% of patients continue using their devices at five years to manage pain, indicating sustained effectiveness rather than just a short-term placebo effect.

Beyond pain reduction, patients report improvements in sleep, mood, and function. The trial documented actual neurological restoration—not just symptom masking—with patients showing measurable improvements in nerve function tests.

How the Procedure Works

Spinal cord stimulation involves two stages. First, you undergo a trial period where temporary wires are placed through an epidural needle for five to seven days. This trial can be performed in an office or surgery center setting without major surgery. During the trial, you keep a daily pain diary documenting your pain levels and any functional improvements like better sleep or reduced medication use.

If the trial succeeds—meaning you achieve at least 50% pain reduction—you're eligible for permanent implantation. The permanent system includes a small battery-powered generator (about the size of a stopwatch) implanted under the skin, usually in the lower back or buttock area. Thin wires called leads run from the generator to your spinal cord. You control the device with a remote control, and depending on which system you get, you may need to recharge the battery periodically.

The entire process from initial consultation to permanent implant typically takes two to three months with proper documentation and authorization.

Five FDA-Approved Systems

Nevro Senza System has the strongest and most recent evidence specifically for diabetic neuropathy. The 216-patient U.S. trial demonstrated that 90% responder rate at 24 months we mentioned earlier. The high-frequency (10 kHz) stimulation is paresthesia-free, meaning patients don't feel uncomfortable tingling sensations. The system stimulates 10,000 times per second—much higher than nerves can track—at amplitudes where nerves don't feel any stimulation.

Medtronic, Abbott, and Boston Scientific systems also received FDA approval for diabetic neuropathy based on smaller European studies. These traditional systems offer decades of clinical experience and broader applications beyond diabetic neuropathy. Medtronic's Vanta offers an 11-year battery with no charging required. Abbott's system includes remote programming via cellular or Wi-Fi. Boston Scientific offers a portfolio of four different device options.

The key difference is that older systems use paresthesia-based stimulation—patients feel a tingling sensation where the stimulation occurs. Some people find this tolerable or even pleasant, while others find it bothersome. The newer high-frequency systems like Nevro's avoid this sensation entirely.

Medicare Coverage and Costs

Medicare expanded nationwide coverage for spinal cord stimulation in diabetic neuropathy in July 2023. This landmark policy change provided an additional 11 million Medicare beneficiaries across 12 states access to the treatment, making it now covered across the entire United States.

Traditional Medicare covers 80% of costs, leaving patients responsible for 20% coinsurance. The trial procedure costs approximately $14,345-25,730, and the permanent implant costs $30,000-35,000. That means patients pay roughly $2,869-5,146 for the trial plus permanent implant, plus 20% of all other Part B services throughout the year with no annual maximum.

Medicare Advantage plans typically charge fixed copays of $300-1,000 for the procedure depending on the specific plan, capped by the plan's annual maximum out-of-pocket limit (usually $900-11,000). However, these plans limit coverage to in-network providers and require mandatory prior authorization that can potentially cause delays or denials.

Traditional Medicare with a Medigap Plan G provides the most predictable costs—just $257 total annual out-of-pocket for all Part B services including spinal cord stimulation and Qutenza.

The Catch: High Denial Rates

Here's the frustrating reality: 72% of spinal cord stimulator requests are initially denied by Medicare. This high denial rate stems primarily from incomplete documentation rather than patients not actually meeting the criteria.

To qualify for coverage, you must demonstrate:

• Chronic intractable pain for at least three months (preferably 12+ months for diabetic neuropathy)
• Failed conservative management for at least six months, including specific medication trials with documented names, doses, durations, and reasons for discontinuation
• Physical therapy records showing 6-12 consecutive weeks of treatment
• Surgical consultation documenting either prior surgery or why you're not a surgical candidate
• Psychological evaluation by a qualified provider (psychologist, psychiatrist, or licensed clinical social worker) completed within 12 months
• Pain intensity scores of 5/10 or higher
• Diabetes control with HbA1c ≤10%
• Documentation of how pain impairs function, daily activities, sleep, and quality of life

Most denials happen because one or more of these documentation requirements is missing or incomplete. The good news: with proper documentation and a systematic appeal process, the vast majority of initially denied claims are eventually approved. The frustration is that patients may wait weeks or months longer for treatment they clearly need and qualify for.

The Non-Invasive Options You Can't Get Through Medicare

Two FDA-cleared non-invasive devices represent perhaps the most exciting developments in neuropathy treatment—and the most frustrating gap in Medicare coverage.

Neuralace Axon Therapy

Neuralace Medical's Axon Therapy received FDA clearance in January 2024 as the first-ever non-invasive magnetic peripheral nerve stimulation treatment for painful diabetic neuropathy. Each session lasts just 13.5 minutes and uses magnetic pulses to provide relief. The treatment is completely painless and requires no surgery, needles, or medication.

The technology represents what many experts call a "paradigm shift" in neuropathy treatment—offering a non-pharmaceutical, non-invasive option that could reduce dependence on medications and their associated side effects.

DyAnsys Nerve Stimulation

DyAnsys offers another non-invasive option using wearable electrical stimulation technology. Like Axon Therapy, it received FDA clearance based on clinical evidence of effectiveness for diabetic neuropathy pain.

The Coverage Gap

Despite FDA clearance confirming safety and effectiveness, traditional Medicare offers no coverage pathway for either device. Medicare Advantage plans may potentially cover these treatments, but coverage varies significantly by plan and most exclude them entirely.

This creates a paradox where the least invasive, safest treatments remain inaccessible to Medicare beneficiaries while surgical implants receive full coverage. Patients interested in these technologies face paying 100% out-of-pocket, with costs that remain undisclosed publicly but are likely substantial.

Veterans may have better luck—VA healthcare systems have adopted some of these technologies despite the lack of civilian Medicare coverage. Some private pain practices offer these treatments on a cash-pay basis.

The timeline for Medicare coverage remains uncertain—potentially two to five years from the current FDA clearances. Patients must choose between waiting for coverage development or pursuing currently covered options that carry higher invasiveness and cost but have established reimbursement.

Making Treatment Decisions: What to Consider

With multiple approved treatments offering different trade-offs in invasiveness, effectiveness, and cost, how do you decide which option makes sense for your situation?

When Qutenza Makes Sense

Consider Qutenza if you have localized pain in specific areas of your feet rather than pain throughout both legs. The patch works best for people with focal rather than diffuse pain. It's a good option if you want to avoid systemic medications or surgical procedures, can tolerate the application procedure (which some people find quite uncomfortable), and are willing to return to the clinic every three months for reapplication.

Qutenza makes particular sense if you're trying to reduce or eliminate oral pain medications, have medical conditions that make surgery riskier, or want a treatment with no drug interactions and minimal systemic side effects.

When Spinal Cord Stimulation Makes Sense

Consider spinal cord stimulation if your pain hasn't responded to multiple medication trials, you have pain throughout both feet and legs rather than just in specific spots, you're willing to undergo a surgical procedure and commit to the trial process, and you understand that the device will require ongoing maintenance and follow-up visits.

Spinal cord stimulation offers the strongest evidence for pain relief—particularly the newer high-frequency systems showing 90% response rates. It makes sense for people with severe, debilitating pain significantly impacting quality of life, those who haven't responded to conservative treatments for at least six months, and patients who are good surgical candidates without significant contraindications.

Comparing Your Options

Think about these factors when discussing options with your pain specialist:

Invasiveness: Qutenza requires no surgery but needs professional application. Spinal cord stimulation requires a trial procedure and permanent implantation. Non-invasive devices (if you can access them) require no procedures at all.

Effectiveness: Spinal cord stimulation shows the highest response rates (up to 90%), followed by Qutenza (around 40% achieving meaningful relief), with traditional medications at the bottom (30-50%).

Duration: Qutenza lasts up to three months between treatments. Spinal cord stimulation provides ongoing relief as long as the device functions. Traditional medications require daily use.

Reversibility: Qutenza is completely reversible—effects wear off in a few months. Spinal cord stimulators can be removed surgically if needed but leave small scars and require another procedure.

Medicare Coverage: Both Qutenza and spinal cord stimulation have established Medicare coverage, though with different cost-sharing structures. Non-invasive devices currently lack Medicare coverage entirely.

How a Solace Advocate Helps Navigate This System

The complexity of getting approved for these treatments—particularly spinal cord stimulators with their 72% initial denial rate—makes having an expert in your corner essential. A Solace advocate brings healthcare insider knowledge to transform this frustrating process into a manageable one.

Your advocate starts by reviewing your complete medical history to identify exactly what documentation you need to meet Medicare's coverage criteria. They know that most denials stem from incomplete records, not ineligible patients. They'll work with your doctors to ensure your medical records clearly demonstrate failed conservative treatments, document specific medication trials with proper detail, obtain the required psychological evaluation and surgical consultation, and compile evidence of functional impairment and pain intensity.

When your doctor submits the prior authorization request, your Solace advocate monitors the process proactively rather than waiting for a denial. If denial occurs—as it does for 72% of initial requests—they immediately begin the appeal process. They know the specific language Medicare Administrative Contractors require, understand the evidence standards for overturning denials, and have developed systematic approaches to identify denial reasons and craft targeted responses.

Your advocate also helps you understand and manage costs. They can explain the difference between traditional Medicare and Medicare Advantage coverage, help you evaluate whether a Medigap plan makes financial sense given your treatment needs, identify the most cost-effective path for your specific situation, and navigate quarterly Qutenza costs versus one-time spinal cord stimulator expenses.

Throughout the process, they communicate with your pain management physician, coordinate between multiple specialists if needed, schedule appointments efficiently, retrieve and organize records from various providers, and keep you informed of progress and next steps without requiring you to make dozens of phone calls.

Perhaps most importantly, they remove the burden of healthcare homework during a time when you're already dealing with chronic pain. You don't have to spend hours on the phone, track down missing documentation, learn Medicare coverage policy, or figure out appeal procedures. Your advocate handles all of that while you focus on getting through each day.

Frequently Asked Questions About Medicare Coverage of New Neuropathy Treatments

Can I get spinal cord stimulation if I've only tried one or two pain medications?

No. Medicare requires documented failure of conservative treatments for at least six months before approving spinal cord stimulation. This includes multiple medication trials, physical therapy for 6-12 weeks, and often other interventions like epidural steroid injections. The requirement exists to ensure the treatment is truly a late resort for chronic intractable pain that hasn't responded to less invasive options.

Will I still need pain medications after getting a spinal cord stimulator?

Many patients significantly reduce or eliminate pain medications after successful spinal cord stimulation, but individual results vary. In clinical trials, patients reported reduced medication use as one of the functional improvements alongside pain reduction. However, some people continue using lower doses of medication for breakthrough pain or use medications for other health conditions. Your pain management team will work with you to adjust medications based on your response to stimulation.

How long does Qutenza application take, and can I drive myself home afterward?

The complete Qutenza procedure takes about 90 minutes total—30 minutes of topical anesthetic pretreatment, 30 minutes with the patch in place, and immediate removal with specialized cleansing. You can drive yourself home afterward as the treatment is local and non-systemic. However, you may experience application site discomfort for several days and can use ice packs or over-the-counter analgesics for relief.

If my Medicare Advantage plan denies coverage for spinal cord stimulation, what are my options?

You have several options. First, file an appeal through your plan's grievance process—many denials are overturned on appeal with proper documentation. Second, consider whether traditional Medicare with a Medigap plan might provide better coverage for your needs during the next enrollment period. Third, pay out-of-pocket if financially feasible—though this is unrealistic for most people given the $30,000-35,000 cost. Fourth, work with a patient advocate who has experience navigating Medicare Advantage denials and knows effective strategies for achieving approval.

Are the non-invasive devices like Neuralace available anywhere for Medicare patients?

Currently, traditional Medicare provides no coverage pathway for non-invasive nerve stimulation devices, forcing patients to pay 100% out-of-pocket. Some Medicare Advantage plans may cover these treatments, but coverage varies significantly and remains the exception rather than the rule. Veterans may access these technologies through VA healthcare systems. Otherwise, you would need to find a private pain practice offering cash-pay treatment and be prepared for substantial out-of-pocket costs. Advocacy for Medicare coverage of FDA-cleared non-invasive devices continues, but approval timelines remain uncertain—likely two to five years from current clearances.

This article is for informational purposes only and should not be substituted for professional advice. Information is subject to change. Consult your healthcare provider or a qualified professional for guidance on medical issues, financial concerns, or healthcare benefits.

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