Introducing HFX for PDN. Finally, a nonpharmacologic approved to treat painful diabetic neuropathy.
86% of patients have substantial, durable pain relief1
77% average pain relief at 12-months1
92% of patients were satisfied with their treatment2
What an endocrinologist has to say about HFX for PDN
Finally, there’s a treatment option for PDN patients refractory to conventional medical management (CMM).
SCS is a well-established approach to managing chronic pain
The HFX Solution uses 10 kHz Therapy to activate inhibitory neurons in the dorsal horn, calming abnormal pain signals to the brain.
68% of patients demonstrated neurologic improvements1
Such as motor strength, reflexes, or sensory function.
Proven safe and effective for patients with diabetes1
At 12 months, 8 of 152 patients receiving 10 kHz therapy (5.2%) experienced infections.
Frequently asked questions about patient access
Is SCS covered under Medicare?
- SCS is covered under the Medicare Part B benefit
- Spinal cord stimulation is broadly covered by a National Coverage Decision for “chronic tractable pain of the trunk and limbs” with more specific local coverage determinations for some Medicare Administrative Contractors (MACs)
- SCS trial and implant procedures do not require prior authorization except when done in the Hospital Outpatient setting
How is SCS covered under a commercial health plan?
- SCS is covered under the medical benefit of the health plan
- Spinal cord stimulation is broadly covered by all major commercial health plans with specific coverage language and indications varying by plan type
- Prior authorization of the SCS trial and implant procedure is typically required for all commercial health plans
How is individual patient coverage determined?
- An HFX implanting physician will be able to determine appropriateness of the HFX Solution for their PDN patients
- Due to medical necessity requirements, a detailed clinical history of tried and failed conservative therapies will be needed to facilitate access during the prior authorization process
- Individual out of pocket amounts will be determined during benefit investigations and will be based upon individual plan details, deductible limits, and out of pocket maximum amounts