Is a spinal cord stimulator (SCS) implant medically indicated for a 50-year-old female with complex regional pain syndrome (CRPS), significant pulmonary history, and 60% relief during a previous SCS trial?

Medical Necessity Determination: SCS Implant NOT Approved

The permanent spinal cord stimulator implant is NOT medically indicated at this time due to failure to meet multiple critical criteria, specifically: absence of psychological clearance, lack of recent formal physical therapy (within past year), and missing baseline functional assessment (Oswestry Disability Index).

Critical Missing Requirements

Psychological Evaluation - NOT MET

• Psychological clearance is an absolute requirement before SCS implantation for CRPS. 1
• The American Society of Anesthesiologists explicitly mandates favorable psychological evaluation and absence of untreated psychiatric comorbidity before proceeding with SCS trial or permanent implantation. 1
• This patient has no documentation of psychological clearance, motivation assessment, or capability to follow medical recommendations. 1
• Multidisciplinary team screening including psychological evaluation is required prior to implantation for CRPS patients. 2

Physical Therapy - PARTIALLY MET (Insufficient)

• Formal in-person physical therapy with a licensed physical therapist for a minimum of 6 weeks within the past year is required. 1
• This patient completed PT from [DATE] to [DATE], which is more than one year ago and therefore does not meet the temporal requirement. 1
• The documentation notes she has "not been in PT in the past year" and it is "unknown if she could tolerate due to shortness of breath."
• Recent PT documentation must include dates of service, specific interventions, patient response, and therapist assessment. 1

Functional Assessment - NOT MET

• Baseline validated outcome measures including Oswestry Disability Index (ODI) scores are required. 1
• The case explicitly states "without an Oswestry score," which is a mandatory baseline functional assessment tool. 1
• The member must have functional disability assessed using validated instruments with documented scores. 2

Positive Factors Present (But Insufficient Alone)

Trial Success

• The patient achieved 60% pain relief during SCS trial, which exceeds the 50% threshold typically required for permanent implantation. 2, 3
• A successful trial with at least 50% improvement is a key requirement that this patient has met. 2

Conservative Treatment Failure

• The patient has tried multiple medications including [MEDICATIONS] without benefit. 4, 3
• She has undergone injections in the right shoulder without benefit.
• She is at least 6 months post-operative from any spinal surgery (if applicable). 2

Diagnosis Appropriateness

• CRPS Type I is an established indication for SCS when other criteria are met. 4, 3, 5
• SCS demonstrates high-level evidence (1B+) for improving pain relief, pain scores, and quality of life in CRPS patients. 3

Special Considerations for This Patient

Pulmonary Complications

• This patient has significant pulmonary disease requiring 2-3L oxygen at baseline and 4L with activities.
• She cannot tolerate prone positioning, which creates substantial surgical risk for SCS implantation.
• Hardware-related complications occur in 10-29% of cases, including infection (10-29% risk) and wound dehiscence (14% risk). 1
• Given her compromised pulmonary status and inability to position prone, the surgical risk is markedly elevated beyond typical SCS candidates.

Infection Risk

• Wound complications followed by infection occur in 14% of cases under normal circumstances. 1
• This patient's oxygen dependence and pulmonary compromise significantly increase infection risk.
• Lead migration occurs in 9% of cases, which may require revision surgery she may not tolerate. 1

Required Actions Before Approval Can Be Considered

1. Psychological Clearance (Mandatory)

• Formal psychological evaluation must be completed documenting:
  • Absence of untreated psychiatric comorbidities 1
  • Absence of substance use disorders 1
  • Patient motivation and capability to operate the device 2, 1
  • Ability to follow medical recommendations 1

2. Recent Physical Therapy (Mandatory)

• Complete formal in-person PT for minimum 6 weeks within the past year with documentation including: 1
  • Specific dates of service
  • Interventions performed
  • Patient response to treatment
  • Therapist assessment
• Given her shortness of breath concerns, PT should specifically address whether she can tolerate exercises and document any limitations.

3. Functional Assessment (Mandatory)

• Obtain baseline Oswestry Disability Index (ODI) score before proceeding. 1
• Visual Analog Scale (VAS) pain scores should also be formally documented. 1

4. Risk-Benefit Analysis

• Given her high pulmonary risk and inability to position prone, a multidisciplinary vascular/surgical team should formally assess whether she can safely undergo the implantation procedure. 6
• Pulmonary clearance alone is insufficient; the surgical team must confirm they can safely perform the procedure given positioning limitations.

Clinical Rationale

While SCS has demonstrated excellent efficacy for CRPS (72% good to very good results in recent series 4, and 1B+ evidence for pain relief and quality of life improvement 3), the procedural safeguards exist to protect patients from unnecessary harm and optimize outcomes.

The 60% trial relief is encouraging, but the missing psychological clearance, outdated PT, and absent functional assessment represent fundamental gaps in the evidence-based treatment algorithm that cannot be bypassed. 1 These requirements are not arbitrary—they predict long-term success and identify patients at risk for poor outcomes or complications.

The combination of missing mandatory criteria plus elevated surgical risk from pulmonary disease creates an unacceptable risk-benefit ratio at this time.

Determination

DENIED pending completion of:

1. Psychological evaluation with formal clearance 1
2. Formal PT (minimum 6 weeks) within past year with complete documentation 1
3. Baseline ODI score 1
4. Surgical team confirmation that procedure can be safely performed given positioning limitations

Once these requirements are met and documented, the case may be resubmitted for reconsideration.