Implantable Intrathecal or Epidural Pain Pump (implantation and trialing)
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Medical necessity criteria for trialing and permanent implantation of implantable intrathecal or epidural opioid (and non-opioid adjunct) drug delivery systems for chronic malignant and nonmalignant pain for health plans affiliated with Centene Corporation (Arizona Complete Health).
Restructured and reformatted criteria sections and added explicit contraindications including known allergies to implant materials, active substance abuse, dementia/psychosis, active systemic infection, and active infection at implantation site.
Removed criterion requiring active participation in psychotherapeutic interventions from trial criteria (I.A.2.f).
Medical Necessity Criteria for Trial and Implantation
I. Trial of epidural or intrathecal administration (preliminary trial)
A preliminary trial is medically necessary when ALL of the following are met:
ALL of the following
Indication (one of)
1. Chronic intractable pain of malignant origin
- Inadequate response to, or intolerable side effects from, noninvasive methods of pain control such as systemic opioids
- Life expectancy > three months> 3 months
- No evidence of epidural metastatic lesion(s) or tumor encroachment of the thecal sac by imaging
2. Chronic intractable pain of nonmalignant origin
- Pathology for the pain has been identified
- Life expectancy is > three months> 3 months
- Failure or inability to tolerate other conservative treatment methods, including but not limited to, systemic pharmacotherapy, physical therapy, behavioral health treatment for pain, and appropriate nonsurgical treatment
- Compliance with previous attempts to treat the condition
- A psychological evaluation confirms a mental health condition is not a major contributor to chronic pain symptoms
- Further surgical intervention or other treatment is not indicated or likely to be effective
- Prior to the trial, systemic opioids have been weaned by at least 50%>= 50% reduction
- Opioid induced hyperalgesia has been ruled out as a possible cause of the chronic pain symptoms
Contraindications (none of the following)
- Known allergies to materials in the implant
- Active alcohol or drug abuse, including but not limited to opioid addiction and intravenous drug abuse
- Diagnosis of dementia or psychosis
- Active systemic infection
- Active infection at the site of implantation
II. Permanent implantation of epidural or intrathecal pump
Permanent implantation is medically necessary when ALL of the following are met:
ALL of the following
Indication (one of)
1. Chronic intractable pain of malignant origin
- The above criteria for the preliminary trial are met
- The trial provided ≥ 50% reduction in pain with minimal side effects>= 50% reduction
- Body size is sufficient to support the weight and bulk of the device
- No other implanted programmable devices for which the interaction between devices may inadvertently change the prescription
- No known allergy or hypersensitivity to the drug being used
2. Severe chronic pain of non-malignant origin
- The above criteria for the preliminary trial are met
- Preliminary trial provided ≥ 50% reduction in pain and increase in function with minimal side effects>= 50% reduction
- There is a plan in place to continue to wean systemic opioids
- No active coagulopathy
- Body size is sufficient to support the weight and bulk of the device
- No other implanted programmable devices for which the interaction between devices may inadvertently change the prescription
- No known allergy or hypersensitivity to the drug being used
- No evidence of increased intracranial pressure
- No spinal anomalies that may complicate the implantation and fixation of a catheter for drug delivery
- Continued active participation in any behavioral health or psychological treatment modalities
Contraindications (none of the following)
- Known allergies to materials in the implant
- Active alcohol or drug abuse, including but not limited to opioid addiction and intravenous drug abuse
- Diagnosis of dementia or psychosis
- Active systemic infection
- Active infection at the site of implantation
Note on malignant pain trial requirement exception
Exception/medical director review:
ALL of the following
- The trial requirement for a percutaneous intrathecal or epidural drug delivery system for pain of malignant origin may be reviewed by a medical director on a case-by-case basis for instances of advanced disease, when survival time is limited, or when the patient is considered high risk for procedures
Relevant Procedure and Supply Codes
| 62320 | Injection(s), interlaminar epidural or subarachnoid, cervical or thoracic; without imaging guidance |
| 62321 | Injection(s), interlaminar epidural or subarachnoid, cervical or thoracic; with imaging guidance |
| 62322 | Injection(s), interlaminar epidural or subarachnoid, lumbar or sacral (caudal); without imaging guidance |
| 62323 | Injection(s), interlaminar epidural or subarachnoid, lumbar or sacral (caudal); with imaging guidance |
| 62326 | Injection(s), including indwelling catheter placement... lumbar or sacral; without imaging guidance |
| 62327 | Injection(s), including indwelling catheter placement... with imaging guidance |
| 62350 | Implantation, revision or repositioning of tunneled intrathecal or epidural catheter; without laminectomy |
| 62351 | Implantation, revision or repositioning of tunneled intrathecal or epidural catheter; with laminectomy |
| 62355 | Removal of previously implanted intrathecal or epidural catheter |
| 62360 | Implantation or replacement of device for intrathecal or epidural drug infusion; subcutaneous reservoir |
| A4300 | Implantable access catheter, external access |
| A4301 | Implantable access total catheter, port/reservoir |
| E0782 | Infusion pump, implantable, nonprogrammable |
| E0783 | Infusion pump system, implantable, programmable |
| E0785 | Implantable intraspinal catheter used with implantable infusion pump, replacement |
| E0786 | Implantable programmable infusion pump, replacement |
| C1772 | Infusion pump, programmable (implantable) |
| C1755 | Catheter, intraspinal |
| J2274 | Injection, morphine sulfate, preservative free for epidural or intrathecal use, 10 mg |
| S0093 | Injection, morphine sulfate, 500 mg (loading dose for infusion pump) |
Prior Authorization, Documentation, and Denial Risks
Preliminary trial required prior to permanent implant
A documented preliminary epidural or intrathecal trial demonstrating >= 50% pain reduction (and for nonmalignant pain, increase in function) with minimal side effects is required before permanent implantation except when medical director review approves bypass in select advanced malignant disease cases.
Documentation of failed conservative therapy and psychosocial evaluation
Providers must document failure or intolerance of conservative treatments, evidence that pathology for the pain has been identified, compliance with prior treatments, psychological evaluation confirming a mental health condition is not a major contributor to symptoms, and that opioid-induced hyperalgesia has been ruled out.
Contraindications lead to non-coverage
Requests will be denied if the patient has any of the listed contraindications; these contraindications must be absent for coverage.
- Known allergies to materials in the implant
- Active alcohol or drug abuse (including opioid addiction and IV drug use)
- Diagnosis of dementia or psychosis
- Active systemic infection
- Active infection at the site of implantation
Body habitus and device interaction assessment
For permanent implantation document that body size is sufficient to support the weight and bulk of the device and that there are no other implanted programmable devices that could interact and alter therapy.
Plan for opioid weaning (nonmalignant pain)
For nonmalignant pain, document a plan in place to continue to wean systemic opioids after implantation.
Numeric and Clinical Thresholds
Clinical Background and Scope
Implantable intrathecal and epidural drug delivery systems consist of an implanted catheter and pump that deliver medication directly into the spinal fluid to provide targeted long-term analgesia for select patients with recalcitrant chronic pain. These systems are most commonly used for cancer-related (malignant) pain and are considered an invasive option after other conservative and surgical therapies have failed (see device description and implantation technique).
Use of intrathecal/epidural pumps for chronic nonmalignant pain is controversial and generally reserved as a last-resort option for patients who have exhausted less invasive treatments. The evidence base for long-term benefit in noncancer pain is limited and consists mainly of observational and retrospective studies; large randomized controlled trials demonstrating superiority over systemic therapy are lacking.
A preliminary percutaneous trial of epidural or intrathecal administration is required before permanent implantation in most cases. The trial is intended to demonstrate an adequate predefined improvement in pain—typically ≥ 50% pain reduction—without intolerable adverse effects; for nonmalignant pain the trial should also demonstrate an increase in function. For malignant pain, a medical director may waive the percutaneous trial requirement in selected cases of advanced disease, limited life expectancy, or high procedural risk.
Defined Terms
Policy Changes and Revision Notes
Annual review: Restructured and reformatted criteria sections; added explicit contraindications including known allergies to implant materials, active alcohol or drug abuse (including opioid addiction and IV drug use), dementia/psychosis, active systemic infection, and active infection at implantation site; background updated with no impact to criteria.
Annual review: Removed criterion I.A.2.f requiring active participation in psychotherapeutic interventions from trial criteria; minor grammatical edits to criteria I.A.2.h and II.A.2.i; background and references updated.
Annual review: References reviewed and updated; minor rewording and format changes with no clinical significance; ICD-10 table removed and title updated to 'Implantable Intrathecal or Epidural Pain Pump.'
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