Approval of External Recharging System Replacement for Spinal Cord Stimulator
The replacement of the external recharging system (precision charging system) for this patient's spinal cord stimulator should be approved as medically necessary, and the device may be obtained from a medical equipment provider. 1
Medical Necessity Justification
Generator/charging system replacement is medically necessary when the existing device requires more frequent charging and the patient has demonstrated positive pain relief response from the existing system. 1 This patient meets these criteria with:
- Established long-term efficacy: Previously implanted spinal cord stimulator system providing pain control for CRPS and back pain 1
- Clinical deterioration: Current presentation with back spasms and multiple falls suggests inadequate pain control, likely related to charging system failure 1
- Appropriate diagnosis: CRPS of the left foot with chronic neuropathic pain and radicular symptoms (back pain/lumbar disc disease) are established indications for spinal cord stimulation 2, 3
Device Specifications and Standard of Care
The precision charging system requested represents standard equipment rather than an upgrade beyond medical necessity. 1 Key considerations include:
- Rechargeable systems are standard of care: They reduce replacement surgeries, overall costs, and therapy-related morbidity compared to non-rechargeable systems 4
- Charging frequency impacts outcomes: Patients typically recharge 5.2 times per month for 2.3 hours each session, with 23.3% of recharging attempts being problematic 4
- Battery optimization is critical: Proper charging systems can extend battery life 2.2-fold (29.6 months improvement on average), significantly delaying surgical replacement 5
Safety and Quality of Life Considerations
The patient's history of multiple falls creates urgent medical necessity for optimal device function. 1 Falls in patients with chronic pain and spinal cord stimulators represent significant morbidity risk:
- Infection risk with device complications: Device extrusion and other complications can occur, particularly with mechanical stress 6
- Functional decline prevention: Pain relief facilitates participation in functional therapies to normalize use and improve motion, strength, and dexterity 2
- Fall prevention: Adequate pain control through properly functioning neuromodulation reduces fall risk in this vulnerable population 7
Procurement Source
The external recharging system may appropriately be obtained from a medical equipment provider rather than requiring hospital-based procurement. 1 This is standard practice for external components of implanted neuromodulation systems, as these are durable medical equipment items that interface with but are not surgically implanted components.
Clinical Caveats
Monitor for charging system complications: Great variability exists in length, frequency, and ease of recharging, with these factors determining patient satisfaction and compliance 4. If the patient experiences ongoing difficulties with the new charging system (>23% failed charging attempts), reassessment may be needed 4.
Ensure voltage compliance matching: The new charging system's voltage compliance must match the existing electrode impedance to maintain therapeutic efficacy 1. This technical requirement should be verified by the medical equipment provider before dispensing.