Author
Kim Beladi, BSN, RN, LNCC, CNLCP
Kim Beladi, BSN, RN, LNCC, CNLCPConsultant

This blog discusses the criteria a person should satisfy before an SCS trial is medically necessary and appropriate. A spinal cord stimulator (SCS) is an implantable device designed to alleviate chronic pain by delivering mild electrical impulses to the spinal cord. SCSs have been in use for decades and have been shown to aid in treating pain for some patients when other forms of pain treatment were not effective. An SCS can sometimes decrease reliance on opioids or other pain medications.[1]

The lifetime cost of an SCS can be a large cost element in a life care plan. For example, assume the patient is a 40-year-old man living in Dallas, Texas, with a life expectancy of 42 years to age 82, who had a successful trial for a rechargeable SCS in 2024. The estimated lifetime usual, customary, and reasonable (UCR) cost for a permanent SCS is $923,911.66 to include the cost of the trial, initial permanent implantation, and replacements schedule.

Evidence of a successful trial of the SCS is necessary before the cost of a permanent SCS can be considered in the total cost of future care in the life care plan. There are generally accepted criteria for when a person is a candidate for an SCS trial. Before including the cost of a trial SCS in a life care plan, the life care planner should have evidence the person meets the criteria to be eligible for the trial.

Criteria for an Spinal Cord Stimulator Trial

An SCS trial should not be considered until conservative therapy has failed for six months or longer. Conservative therapy may include:

  • Cognitive behavioral therapy (CBT)
  • Psychotherapy
  • Pharmacotherapy (e.g., non-steroidal anti-inflammatory drugs)
  • Physical therapy

On July 26, 2024, the Official Disability Guidelines updated the criteria for determining when an SCS may be medically appropriate. All these conditions should be present:

  • Chronic pain due to chronic regional pain syndrome (CRPS) or failed back surgery
  • Failed back surgery syndrome with persistent leg pain determined to be related to nerve damage from pathology and/or surgery
  • Neuropathic pain of the extremities post spinal surgery
  • A favorable psychological evaluation performed by an independent behavioral health specialist that includes an assessment of motivation for recovery and return to work, psychological testing (at least one test with validity scales), including evaluation of personality style and coping ability
  • A favorable substance disorder screening[2]
  • Confirmation the individual can operate the stimulating device

These criteria would disqualify a person as a candidate for an SCS trial:

  • Coagulopathy, anticoagulant or antiplatelet therapy
  • Thrombocytopenia (platelets less than 75,000/mm)
  • Current or chronic infections
  • An implantable pacemaker or defibrillator
  • A high or low body mass index
  • Postural tachycardia syndrome (POTS)
  • Excessive use of alcohol, prescription medication, or recreational drugs
  • Any psychological and/or cognitive issues that would interfere with device management and treatment[3],[4]

The cost of an SCS trial should not be included in a life care plan unless the person meets the criteria for an SCS trial. The cost of a permanent SCS should not be included in the potential cost of future care unless the individual meets the criteria for a trial. This may be determined by consultation with a physician in a proper specialty or from review of medical records. The life care planner should specify any criteria a person does not meet in the life care plan. The cost of a permanent SCS should never be included in the cost of a life care plan if the person has not had a successful trial.

Spinal Cord Stimulator Technology and Lifetime Cost

The most common types of SCS are (1) battery-operated (non-rechargeable) implantable pulse generators (IPG) and (2) rechargeable pulse generators, [5],[6] A non-rechargeable SCS uses thin wires (electrodes) placed between the spinal cord and the vertebrae (epidural space), depending on the location of the pain generator. A battery is implanted under the skin, usually near the buttocks or abdomen, and must be replaced when the battery charge is depleted (usually around 5 years). A rechargeable SCS allows for recharging using an external charger to recharge the power source located under the skin and depending on the use of the SCS requires replacement every 7 to 10 years.[7],[8]

The pulse generator’s electric impulses can be adjusted for individual users to help improve pain relief. The patient is also given a device to program the SCS. Many units now have smartphone apps, eliminating the need for an extra device.

Replacement of the SCS depends on the type of SCS implanted and the usage of the SCS. Non-rechargeable SCS are replaced every 5 years. Rechargeable SCS requires battery replacement less frequently and depends on the amount of usage required by the individual. The rechargeable battery has a typical life expectancy of 10 years, although with heavy usage may require replacement every 7 years. The dual leads placed at the level to of the spine to control pain remain in place as long as the leads have not migrated and the individual continues to have successful pain management.

Many companies make SCS devices. Boston Scientific, Medtronic, Abbott, and Nervco are widely used brands. Each company has an educational website for clinicians and users to learn more about the device.

The total cost of a permanent SCS includes the initial cost of the device, lifetime maintenance of the device, and one-time physician services to permanently implant the device if the trial is successful, and on-going physician services to adjust the settings and maintain the SCS’s components. The table below shows the cost elements for our hypothetical patient.

Component Life Time Costs
SCS Trial Procedure $123,229.73
SCS Permanent Procedure $115,747.24
SCS Replacement $684,934.69
TOTAL Life Time Costs $923,911.66

Physician Specialties Involved in an Spinal Cord Stimulator Trial

An SCS may be used as part of a multidisciplinary treatment plan. Neurosurgeons, anesthesiologists and physiatrists, who specialize in pain management, are qualified to assess, evaluate, and prescribe an SCS. A pain management doctor is the proper specialist to consult about an SCS trial due to their knowledge of chronic pain management. A neurosurgeon may perform the surgical implantation of the device. For some patients, a neurologist may be involved in diagnosing the underlying pain condition, and a mental health professional may assess the patient’s psychological state. The implantation of the device for an SCS trial can be done in an ambulatory surgery center, a hospital, or a doctor’s office using a sterile technique.

If a person meets the positive and negative criteria for an SCS, a trial of the device can proceed. The trial determines whether the person can tolerate the device and how effective it is in reducing pain before permanent placement. The SCS trial determines proper lead placement and is done as an outpatient procedure under fluoroscopy, using local anesthesia. The leads are placed at the location of the pain generator, as determined by the treating provider. To be deemed successful, the three- to seven-day trial must provide ≥ 50% improvement in pain and function.

After a successful trial, the permanent SCS is installed. Permanent implantation typically requires general anesthesia and can be done in an ambulatory surgery center using fluoroscopy.[9] The temporary leads for the trial are replaced with permanent leads anchored with sutures to minimize movement. A generator is placed under the skin, generally near the buttocks or abdomen.

Downsides to Spinal Cord Stimulator Devices

A review of clinical literature found less than 70% of patients receiving trials had pain reduction of >50% when using a 10 kHz SCS. Clinical reviews also showed 54% to 87% of patients experienced pain relief with a 10 kHz SCS, with up to 60% of patients reducing their use of opioids.[10],[11] Some studies, however, show no decrease in opioid use after an SCS implant,[12],[13]particularly among patients who took more narcotics pre-implantation.[14]

From 2008 to 2017, a joint investigation found SCSs had the third-highest rate of injury reported (of over 4,000 medical devices) and had a 13% failure rate after permanent implantation, “which is disproportionately high when compared to other commonly implanted medical devices.” The complication rate for SCS implantation ranges from 5.3% to 40%, with the most frequent complication being lead migration (implanted leads dislodging and changing locations). Other complications include lead fractures, seromas, infections, dural punctures, and headaches.[15] Not all SCS devices are safe to be actively used during an MRI scan.[16]

These findings are further reasons an SCS should be considered “only as a last resort for treatment.”[17] Medicare echoes this warning, with one of its coverage criteria being that “the implantation of the stimulator” be “used as a late resort (if not a last resort) for patients with chronic intractable pain.”[18] Goudman et al. (2022) noted, “Patient selection [for SCS] in clinical practice remains challenging” due to the “lack of clear criteria for optimal patient selection.”[19] One reason for this could be, as Louis Gifford (1998) wrote, that pain is more than just “purely tissue-based.”[20]

Spinal Cord Stimulator in Life Care Plans

Life care planners should discuss the criteria with an SCS candidate’s treating or consulting physicians to determine whether the person meets the criteria for an SCS trial. The cost of an SCS trial should not be included in a life care plan unless the person meets the criteria for an SCS trial. The cost of a permanent SCS should not be included in the potential cost of future care unless the individual meets the criteria for a trial. This may be determined by consultation with a physician in a proper specialty or from review of medical records. The life care planner should specify any criteria a person does not meet in the life care plan. The cost of a permanent SCS should never be included in the cost of a life care plan if the person has not had a successful trial.

Many pain management physicians employ technicians or rely on an SCS manufacturer’s representatives to make SCS adjustments. Life care planners should verify with the provider doing the implantation whether these office visits are charged as routine office visits or are included in the cost of the implantation procedure.

The life care planner should also discuss the standard postoperative visits for SCS adjustments after permanent SCS implantation to determine the following:

  • Follow-up visits included in the global period after permanent implantation
  • Routine adjustments to the SCS after permanent implantation, to include duration and frequency
  • Lifelong expectations on follow-up care such as annual visits
  • Battery, lead, and device replacement schedule

Non-rechargeable devices need batteries replaced about every five years. Rechargeable systems should be replaced after ten to fifteen years. The replacement cycle may depend on individual use. A manufacturer’s warranty should also be considered in the cost of the life care plan. The life care planner should refer to the manufacturer’s website or call customer service for details on what the warranty covers.

[1] “Spinal Cord Stimulator,” Cleveland Clinic, https://my.clevelandclinic.org/health/treatments/24237-spinal-cord-stimulator-scs.

[2] Official Disability Guidelines, Psychological Testing, February 12, 2021.

[3] Spinal cord stimulation – Overview | Guy’s and St Thomas’ NHS Foundation Trust (guysandstthomas.nhs.uk) accessed August 20, 2024.

[4] Official Disability Guidelines, Spinal Cord Stimulator Conditionally Recommended, July 26, 2024.

[5] Eellan Sivanesan, “Spinal Cord Stimulator,” Johns Hopkins Medicine, https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/treating-pain-with-spinal-cord-stimulators, accessed July 16, 2024.

[6] “Treating Pain with Spinal Cord Stimulators,” University of Rochester Medical Center Health Encyclopedia, https://www.urmc.rochester.edu/encyclopedia/content?contenttypeid=134&contentid=126, accessed July 17, 2024.

[7] Eellan Sivanesan, “Spinal Cord Stimulator,” Johns Hopkins Medicine, https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/treating-pain-with-spinal-cord-stimulators,, accessed July 17, 2024.

[8] “Treating Pain with Spinal Cord Stimulators,” University of Rochester Medical Center Health Encyclopedia, https://www.urmc.rochester.edu/encyclopedia/content?contenttypeid=134&contentid=126, accessed July 17, 2024.

[9] A.M. Dydyk and P. Tadi, “Spinal Cord Stimulator Implant,” StatPearls, updated Jul 3, 2023, https://www.ncbi.nlm.nih.gov/books/NBK555994, accessed August 19, 2024.

[10] Adnan Al-Kaisy et al., “Opioid-Sparing Effects of 10 kHz Spinal Cord Stimulation: A Review of Clinical Evidence,” Feb. 2020, National Library of Medicine, Wiley Open Access Collection, https://pmc.ncbi.nlm.nih.gov/articles/PMC7065058, accessed August 20, 2024.

[11] S.M. Adil et al., “Impact of Spinal Cord Stimulation on Opioid Dose Reduction: A Nationwide Analysis,” Neurosurgery 88, no. 1 (Dec. 2020): 193-201, https://pubmed.ncbi.nlm.nih.gov/32866229, accessed August 20, 2024.

[12] S. Dhruva et al., “Long-Term Outcomes in Use of Opioids, Nonpharmacologic Pain Interventions, and Total Costs of Spinal Cord Stimulators Compared With Conventional Medical Therapy for Chronic Pain,” JAMA Neurology 80, no. 1 (Jan. 2023), https://pubmed.ncbi.nlm.nih.gov/36441532, accessed August 20, 2024.

[13] B.Y. Hwang et al., “Opioid Use and Spinal Cord Stimulation Therapy: The Long Game,” Journal of Clinical Neuroscience 84 (Feb. 2021): 50-52, https://pubmed.ncbi.nlm.nih.gov/33485599, accessed August 20, 2024.

[14] L. Labaran et al., “Opioids and Spinal Cord Stimulators: Pre- and Postoperative Opioid Use Patterns and Predictors of Prolonged Postoperative Opioid Use,” Neurospine 17, no. 1 (Mar. 2020): 246–253, https://pmc.ncbi.nlm.nih.gov/articles/PMC7136119, accessed August 20, 2024.

[15] A.M. Dydyk and P. Tadi, “Spinal Cord Stimulator Implant,” StatPearls, updated Jul 3, 2023, https://www.ncbi.nlm.nih.gov/books/NBK555994, accessed August 19, 2024.

[16] A.M. Dydyk and P. Tadi, “Spinal Cord Stimulator Implant,” StatPearls, updated Jul 3, 2023, https://www.ncbi.nlm.nih.gov/books/NBK555994, accessed August 19, 2024.

[17] “Investigation Shows High Failure Rate of Spinal Cord Stimulators,” Keller Thoma, https://www.kellerthoma.com/cases/2018/11/30/investigation-shows-high-failure-rate-of-spinal-cord-stimulators, accessed July 17, 2027.

[18] SCS_Procedure_Coding_and_Payment_Guide-Hospital_Outpatient.pdf (bostonscientific.com), accessed July 17, 2024.

[19] Lisa Goudman et al., “Patient Selection for Spinal Cord Stimulation in Treatment of Pain: Sequential Decision-Making Model – A Narrative Review,” Journal of Pain Research 15 (Apr. 2022): 1163–1171, DOI: 10.2147/JPR.S250455.

[20] Louis Gifford, “Pain, the Tissues, and the Nervous System: A Conceptual Model,” Physiotherapy 84, no. 1 (Jan. 1998): 27–36, DOI: 10.1016/S0031-9406(05)65900-7, accessed July 17, 2024.

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