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Implantable Pain Pump — Arkansas PASSE

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Medical necessity and coverage criteria for implantation, trialing, revision, removal, and single-shot intrathecal injections of implantable pain pumps for malignant and non-malignant severe chronic intractable pain for CareSource Arkansas PASSE members.

Policy Summary

PayerCareSource

PolicyImplantable Pain Pump — Arkansas PASSE

Policy CodePolicy N/A

Change TypeAdministrative — no material changes

Effective DateMay 1, 2026

Last ReviewJan 28, 2026

Next Review DateN/A

Key ActionObtain prior authorization demonstrating that all clinical criteria are met before authorizing a trial, permanent implantation, revision, or removal.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥50%Pain reduction threshold

1-2 daysTrial duration

≥6 moConservative therapy

≥3 moMalignant life expectancy

Coverage Criteria for Implantable Intrathecal Pain Pumps

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Implantable Pain Pump — Arkansas PASSE

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Policy Summary

PayerCareSource

PolicyImplantable Pain Pump — Arkansas PASSE

Policy CodePolicy N/A

Change TypeAdministrative — no material changes

Effective DateMay 1, 2026

Last ReviewJan 28, 2026

Next Review DateN/A

Key ActionObtain prior authorization demonstrating that all clinical criteria are met before authorizing a trial, permanent implantation, revision, or removal.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥50%Pain reduction threshold

1-2 daysTrial duration

≥6 moConservative therapy

≥3 moMalignant life expectancy

Coverage Criteria for Implantable Intrathecal Pain Pumps

inv-01: General medical necessity

Covered when ALL of the following are met

General criteria: Attempts to ameliorate physical and behavioral abnormalities which may cause an exaggerated reaction to pain have failed; the medication must require administration through the intrathecal route and be FDA-approved for pain management; the infusion pump has been approved by the FDA for infusion of the particular drug to be administered; the type and dosage of the medication must reasonably be expected to alleviate or reduce the pain; implantation is performed by a physician in a facility with experience and expertise in this procedure; evaluation by an appropriate specialist (orthopedic surgeon, neurologist, neurosurgeon, oncologist, pain management physician, or other specialist familiar with the underlying disease) validates other treatments have failed to alleviate the pain.

inv-02: Preliminary trial for malignant pain

Covered when ALL of the following are met

Malignant trial criteria: Member has an estimated life expectancy of at least 3 months; member is unresponsive to less invasive medical therapy documented in the medical record, including oral or subcutaneous medications (including systemic opioids) that were ineffective or complicated by side effects; no evidence of tumor encroachment on the thecal sac or epidural metastatic lesions; no contraindications evident, including local infection, sepsis, or coagulopathy.trial 1-2 days

inv-03: Permanent pump for malignant pain

Covered when ALL of the preliminary trial criteria are met and the following

Malignant permanent placement: Patient met all preliminary malignant trial criteria and achieved at least a 50% reduction in pain documented in the medical record following the trial.≥50% pain reduction

inv-04: Preliminary trial for non-malignant pain

Covered when ALL of the following are met

Non-malignant trial criteria: Pain has persisted for at least 6 months; a 1- to 2-day observation stay is required for a preliminary trial of spinal opioid administration; pain pathology has been identified; no evidence of current drug and/or alcohol abuse (including documentation of at least one negative drug test within the last 3 months); psychological evaluation has been performed and confirms pain is not due to mental health causes; surgical intervention is not indicated; oral or subcutaneous medication (including systemic opioids) treatment was ineffective or complicated by side effects; failure of conservative therapy evidenced by documentation of at least 6 months of active conservative therapy within the past 12 months OR inability to complete active conservative therapy due to contraindication, increased pain, or intolerance, and documentation of at least 6 months of inactive conservative therapy within the past 12 months.trial 1-2 days; ≥6 months conservative therapy

Active and inactive conservative therapies defined per policy (e.g., PT, OT, supervised HEP, chiropractic; and rest, ice/heat, TENS, pharmacotherapy).

inv-05: Permanent pump for non-malignant pain

Covered when ALL of the non-malignant trial criteria are met and the following

Non-malignant permanent placement: Patient met all non-malignant preliminary trial criteria and achieved at least a 50% reduction in pain documented in the medical record following the trial.≥50% pain reduction

Intrathecal or epidural drug infusion of opioids, ziconotide, and/or clonidine is considered investigational for any indications that are not explicitly listed in this policy. Requests for these therapies for conditions outside the scope of the covered indications will be denied as investigational.

Implantable infusion pumps are not medically necessary for members with any of the following contraindications: active infection; insufficient body size to support the bulk and weight of the device; prior intolerance to implanted devices; spinal column anatomy that prevents intrathecal drug delivery or obstructs cerebrospinal fluid flow; known allergy or hypersensitivity to the selected drug; known or suspected allergy to a component of the implantable pain pump; or the presence of other implanted programmable devices that may interfere with pump function (for example, a cardiac pacemaker).

Key Clinical Thresholds and Trial Details

inv-08: Pain reduction threshold — ≥ 50% documented reduction in pain for permanent pump placement

Pain reduction threshold≥ 50% documented reduction in pain required in the medical record following trial for permanent pump placement (malignant and non-malignant).

Context — malignant painSection III: permanent placement for malignant origin requires meeting preliminary trial criteria and achieving ≥50% pain reduction documented in the medical record.

Context — non-malignant painSection V: permanent placement for non-malignant origin requires meeting non-malignant trial criteria and achieving ≥50% pain reduction documented in the medical record.

inv-09: Trial duration — 1-2 days observation stay

Trial durationPreliminary intrathecal trial requires a 1- to 2-day observation stay for spinal opioid drug administration.

Application — malignant painSection II lists trial duration as 1-2 days for malignant-origin preliminary trials.

Application — non-malignant painSection IV.B requires a 1- to 2-day observation stay for non-malignant preliminary trials.

inv-10: Conservative therapy duration for non-malignant pain — At least 6 months active and 6 months inactive within past 12 months

Required durationFor non-malignant pain, documentation of at least 6 months of active conservative therapy within the past 12 months AND at least 6 months of inactive conservative therapy within the past 12 months is required prior to trial/implantation.

Acceptable exceptionInability to complete active conservative therapy due to contraindication, increased pain, or intolerance may substitute for documented active therapy completion (must be documented).

DefinitionsActive conservative therapies include PT, OT, physician‑supervised HEP, and/or chiropractic care; inactive therapies include rest, ice/heat, medical devices, TENS, and/or pharmacotherapy.

inv-11: Malignant pain life expectancy — Estimated life expectancy of at least 3 months for trial eligibility

Minimum life expectancyMember must have an estimated life expectancy of at least 3 months to be eligible for a preliminary trial for malignant-origin pain.

Associated requirementsThe member must also be unresponsive to less invasive medical therapy and have no tumor encroachment on the thecal sac or epidural metastatic lesions and no contraindications (eg, local infection, sepsis, coagulopathy).

Policy locationSection II.A specifies the ≥3 months estimated life expectancy criterion for malignant pain trials.

Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit documentation that all clinical criteria in this policy are met before performing a trial or permanent implantation of an implantable pain pump (including single-shot intrathecal injections) or device revision/removal.

Applies to trial administration (1-2 day trial), permanent placement, single-shot intrathecal injections, and removal/revision procedures.
Member must meet the specific medical necessity criteria for malignant or non-malignant pain (see policy sections I–V).
For non-malignant pain, prior conservative therapy documentation (6 months active and 6 months inactive within the past 12 months, or documented inability to complete) must be included.
For malignant pain trial, include life expectancy estimate (≥3 months) and evidence of failure/unresponsiveness to less invasive therapy.

Step Therapy

Conservative / Step Therapy Requirement

Document and submit a complete conservative and stepwise treatment history. The medical record must clearly show failure of multiple less invasive therapies before considering trial or permanent implantation.

Active conservative therapy: at least 6 weeks of a supervised home exercise program (HEP), physical therapy, occupational therapy, or chiropractic care — include exercise prescription and post‑program follow-up or documented physical inability to complete.
Inactive conservative therapy: at least 6 months of passive measures (e.g., rest, heat/ice, TENS, pharmacotherapy) within the past 12 months.
Document dates, frequency, providers, specific modalities tried, responses, and reasons for discontinuation or intolerance.
For non-malignant pain, show failure of oral or subcutaneous medications (including systemic opioids) or complications/side effects from those therapies.

Documentation Required

Required Supporting Documentation

Include the following supporting documentation with the prior authorization request to allow adjudication:

Comprehensive history and physical documenting pain duration (≥6 months for non-malignant pain) and pain pathology.
Records of all conservative therapies (active and inactive) with dates, providers, modalities, treatment duration, and objective response.
HEP documentation: exercise prescription/plan and follow‑up note after completion, or documented reason the HEP could not be completed.
Medication history showing trials of oral/subcutaneous therapies and systemic opioids, including doses, duration, effectiveness, and adverse effects.
For malignant pain trials: life expectancy estimate (≥3 months) and imaging confirming no tumor encroachment on the thecal sac or epidural metastatic lesions where required.
Psychological evaluation for non-malignant pain confirming pain is not primarily due to mental health causes and assessment/optimization of psychiatric and psychosocial factors.
Drug testing: at least one negative drug test within the last 3 months when substance use is a concern.
Specialist evaluation (orthopedics, neurology/ neurosurgery, oncology, pain management, or other relevant specialist) documenting that other treatments have failed or are not indicated.
Documentation of 50% or greater pain reduction during trial period for progression to permanent implantation.
Any contraindications or reasons device is not appropriate (e.g., body habitus concerns, allergy history, prior device intolerance).

Denial Risk

Contraindications That Lead to Denial

Do not approve implantation when contraindications are present. Lack of clear documentation of contraindications or omission of required supporting records may result in denial.

Active infection or sepsis — recent or ongoing infections must be documented and treated prior to consideration.
Insufficient body size to support device bulk/weight or prior intolerance to implanted devices.
Spinal column anatomy preventing intrathecal delivery (eg, obstruction to CSF flow) or presence of other implanted programmable devices that could interfere (e.g., cardiac pacemaker) without adequate safety assessment.
Known allergy or hypersensitivity to the selected intrathecal drug or to any component of the pump.
Investigational/unproven indications: intrathecal/epidural infusion of opioids, ziconotide, and/or clonidine for indications outside those specified in this policy are not covered.

Key Definitions

inv-17: Chronic Pain — Pain persisting beyond normal healing time (> 3 months)

DefinitionChronic Pain: Pain that persists beyond normal healing time, lasting or recurring for more than 3 months.

Clinical implicationChronic pain designation is used to determine eligibility for preliminary trial and permanent implant criteria in policy sections II and IV–V.

ScopeApplies to both malignant and non-malignant severe chronic intractable pain considered by this policy.

inv-18: Conservative Therapy — Definition of active and inactive modalities

Definition — active modalitiesActive conservative therapies: actions that strengthen muscle groups and target spinal structures, including physical therapy, occupational therapy, physician‑supervised home exercise program (HEP), and/or chiropractic care.

Definition — inactive modalitiesInactive conservative therapies: passive measures such as rest, ice, heat, medical devices, TENS use, and/or pharmacotherapy (prescription or OTC e.g., NSAIDs, acetaminophen).

HEP specificsHEP is a 6‑week program requiring an exercise prescription and documented follow-up after completion or documented inability to complete due to a stated physical reason.

inv-19: Implantable Pain Pump — Device definition and delivery mechanisms

Device definitionImplantable Pain Pump: a medical device implanted under the skin that delivers medication intrathecally using a pump and catheter.

Delivery mechanismsMedication can be added to a refillable pump for continuous or variable rate (eg, bolus) intrathecal infusion.

Use caseUsed for intrathecal delivery of analgesic medications as part of management of severe chronic intractable pain per policy criteria.

inv-20: Refractory Pain — Definition including failure of multiple therapies and psychosocial evaluation

DefinitionRefractory Pain: failure of multiple treatment therapies to achieve adequate pain reduction and/or improvement in daily function AND psychiatric and psychosocial factors that could influence pain outcomes have been assessed and optimized.

Clinical prerequisitePolicy requires evaluation by an appropriate specialist and documented failure or intolerance of oral/subcutaneous/systemic therapies prior to trial/implantation.

Documentation requirementMedical record must document conservative therapy history, psychological evaluation for non‑malignant pain, and failure/intolerance of other therapies as part of determining refractory status.

Implantable Pain Pump — Arkansas PASSE

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Coverage Criteria for Implantable Intrathecal Pain Pumps

Implantable Pain Pump — Arkansas PASSE

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Coverage Criteria for Implantable Intrathecal Pain Pumps

Key Clinical Thresholds and Trial Details

Authorization, Documentation, and Provider Requirements

Conservative Treatment Documentation Requirements

Imaging and Assessment for Malignant Pain

Key Definitions

Background and Clinical Context

Services Not Covered

Policy Revision History