Currentsierra health and lifePolicy 2026T0626M

Implanted Spinal Drug Delivery Systems

Clinical coverage policy for implantation, trialing, and replacement of implanted intrathecal or epidural drug delivery systems for pain and spasticity in adults; applies to UnitedHealthcare commercial and individual exchange plans.

Policy Summary

Payersierra health and life

PolicyImplanted Spinal Drug Delivery Systems

Policy CodePolicy 2026T0626M

Change TypeNo material changes

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain and document a neuraxial screening trial (commonly ≥50% pain reduction) and at least 6 months of prior conservative therapy before considering implantation; secure prior authorization per member plan rules.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>50%trial response

6 moconservative therapy

>18min age

62320-62362CPT refs

Coverage Criteria

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Chronic non-malignant pain: Chronic intractable pain of non-malignant origin (e.g., failed back surgery syndrome, complex regional pain syndrome, neuropathic pain)

from policy

Age requirement: Age > 18 years

policy excludes <18

Known etiology: Etiology of pain is known and clearly documented

No further indicated surgery: Further treatment or surgical intervention for underlying condition is not indicated or is refused

Conservative therapy: Documentation of treatment failure due to intolerable side-effects or inadequate analgesia after a minimum 6-month trial of conservative methods (e.g., pharmacologic, physical therapy, behavioral health)>= 6 months

Must be documented prior to trial

Psychosocial assessment: Documentation of absence of underlying, untreated psychological or psychosocial issues that will interfere with successful pain treatment

inv-02: Implantation (chronic non-malignant pain)

Epidural or intrathecal catheter pump placement (implantation) for non-malignant pain is proven and medically necessary when ALL of the following are met:

Successful trial completion: Completion of a drug infusion trial that met the trial infusion criteria above

trial must meet criteria documented prior to implantation

Magnitude of response: Documentation of a > 50% reduction in pain during the trial>50%

implantation indicated only after successful trial

inv-03: Cancer-related pain and severe spasticity

Epidural or intrathecal drug infusion trial or catheter pump placement for cancer-related pain or severe spasticity:

Cancer-related pain or severe spasticity: Epidural or intrathecal trial or catheter pump placement is proven and medically necessary in certain circumstances; refer to InterQual CP: Procedures, Epidural or Intrathecal Catheter Placement for specific clinical criteria

policy references InterQual criteria

inv-04: Device replacement

Replacement of device

Replacement criteria: Replacement of the device is medically necessary when the individual has met all criteria for initial placement and the existing device is non-functional and either cannot be repaired or is no longer under warranty

from policy

Within the provided excerpt there are no explicit coverage exclusions listed for implanted epidural or intrathecal drug delivery systems beyond the age limitation noted elsewhere. Applicability and any plan-specific exclusions should be verified against the member’s benefit document and other UnitedHealthcare policies.

Coding

Applicable CPT Codes (reference)CPT

62320	Injection(s), of diagnostic or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, cervical or thoracic; without imaging guidance.
62321	Injection(s), of diagnostic or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, cervical or thoracic; with imaging guidance (i.e., fluoroscopy or CT).
62322	Injection(s), of diagnostic or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); without imaging guidance.
62323	Injection(s), of diagnostic or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); with imaging guidance (i.e., fluoroscopy or CT).
62324	Injection(s), including indwelling catheter placement, continuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, interlaminar epidural or subarachnoid, cervical or thoracic; without imaging guidance.
62325	Injection(s), including indwelling catheter placement, continuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, interlaminar epidural or subarachnoid, cervical or thoracic; with imaging guidance (i.e., fluoroscopy or CT).
62326	Injection(s), including indwelling catheter placement, continuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); without imaging guidance.
62327	Injection(s), including indwelling catheter placement, continuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); with imaging guidance (i.e., fluoroscopy or CT).
62350	Implantation, revision or repositioning of tunneled intrathecal or epidural catheter, for long-term medication administration via an external pump or implantable reservoir/infusion pump; without laminectomy.
62351	Implantation, revision or repositioning of tunneled intrathecal or epidural catheter, for long-term medication administration via an external pump or implantable reservoir/infusion pump; with laminectomy.

1–10 of 13

1/2

FDA Device Product Codemixed

LKK	FDA product code for implanted programmable infusion pump

inv-10: Trial response — Key threshold: > 50% reduction in pain during trial

Trial response threshold> 50% reduction in pain during trial

ContextRequired documentation of a successful drug infusion trial precedes implantation for chronic non-malignant pain

Applicable populationAdults with chronic intractable non-malignant pain (Age > 18 years)

inv-11: Screening trial success threshold — Commonly ≥ 50% pain reduction

Common success thresholdSuccessful screening trial most often defined as ≥ 50% pain reduction from baseline with no adverse effects

Role of trialScreening trial used to evaluate clinical response to an epidural or intrathecal opioid prior to pump implantation

Evidence noteMost studies required a screening trial and used the ≥50% threshold when selecting patients for implantation

Provider Actions and Administrative Requirements

Billing Rule

Applicable codes and PA note

The following procedure and diagnosis codes are provided for reference only and may not be all-inclusive. Inclusion of a code does not imply coverage or guarantee payment. Verify member-specific benefits and obtain prior authorization when required by the payer/member plan.

Codes are informational only — check member-specific benefit plan for coverage.
Listing of a code is not a guarantee of reimbursement.

Prior Authorization

Prior authorization and benefit verification

Prior authorization and benefit verification should be obtained per payer and member plan rules before scheduling implantation or trials. FDA approval or device marketing status is informational and does not by itself establish coverage.

Obtain prior authorization when required by the member's plan.
Confirm benefit coverage and any precertification requirements prior to service.

Documentation Required

Medical records

Medical records and supporting documentation may be requested to determine whether the member meets clinical criteria for coverage. Lack of adequate documentation may result in denial of the request.

Include relevant clinic notes, medication trials, diagnostic testing, and prior authorization information when submitting requests.
Failure to provide documentation demonstrating criteria have been met may lead to denial.

Denial Risk

Screening trial requirement

A neuraxial screening trial is typically required prior to permanent pump implantation. A successful trial is generally defined in the evidence base as a clinically significant pain reduction (commonly ≥50% from baseline) without unacceptable adverse effects. Absence of a successful screening trial may lead to denial.

Document screening trial method (epidural or intrathecal), duration, and measured pain reduction.
Document absence of significant adverse effects during trial.

Step Therapy

Conservative therapy requirement

Before considering implantation, document a minimum of 6 months of conservative therapy failure. Conservative measures should include, where appropriate, pharmacologic management, physical therapy, and behavioral health interventions. Evidence of intolerable side effects or insufficient analgesia from conservative care must be included.

Document start and end dates of conservative treatments and responses.
Include rationale for why further surgical or alternative interventions are not indicated or were refused.

Documentation Required

Required clinical documentation

Required clinical documentation to support medical necessity includes but is not limited to: indication for device, etiology of pain, prior conservative therapies and their durations/results, results of the neuraxial screening trial (including quantitative pain reduction), and documentation that further treatment or surgery is not indicated or was refused. Also document absence of untreated psychological or psychosocial issues that would interfere with successful treatment.

Indication and diagnosis with relevant imaging or diagnostic support.
Detailed record of conservative therapy trials (types, durations, outcomes).
Screening trial documentation showing percent pain reduction and absence of adverse effects.
Statement that further treatment or surgery is not indicated or was refused.
Assessment of psychological/psychosocial factors and any behavioral health treatment provided.

Step Therapy

Screening trial / conservative steps

Typical screening trial and conservative-step workflow: (1) Ensure at least 6 months of documented conservative management with inadequate pain relief or intolerable side effects; (2) Perform a neuraxial screening trial (epidural or intrathecal) and document objective pain reduction and tolerability; (3) If trial demonstrates clinically significant improvement (commonly ≥50% reduction) without adverse effects, obtain prior authorization for permanent pump implantation with complete documentation; (4) Submit medical records to support the request — lack of documentation at any step may result in denial.

Step 1: Document ≥6 months of conservative therapy and outcomes.
Step 2: Conduct and document neuraxial screening trial with quantified pain reduction.
Step 3: If trial successful, document >50% pain reduction and no adverse effects prior to implantation.
Step 4: Obtain prior authorization and submit complete medical records for review.

Definitions

inv-21: Implanted drug delivery system (IDDS) — Definition

DefinitionDevice composed of a catheter and a constant-flow or programmable pump that delivers drug directly into the intrathecal (IT) space for long-term administration

IndicationsUsed to treat pain or spasticity when trial infusion demonstrates adequate response

Preimplantation stepImplantation generally follows a successful IT or epidural trial infusion

inv-22: Trial infusion — Definition and purpose

DefinitionAn epidural or intrathecal trial infusion performed prior to pump implantation to determine whether a patient exhibits an adequate analgesic or spasticity response

PurposeAssess analgesic response and tolerance before permanent implanted device placement

RequirementTrial infusion meeting trial criteria (including conservative therapy documentation) is required prior to implantation for non-malignant pain

inv-23: Implanted drug delivery system / pump — FDA product code LKK

Device classificationImplanted programmable infusion pump — FDA product code LKK

Regulatory noteRegulated as Class III medical devices; FDA approval is informational and not a basis for coverage

ReferenceMore than 500 device approvals listed under product code LKK in the FDA PMA database

inv-24: Screening trial — Success definition

Common definition of successSuccessful screening trial most often defined as ≥50% reduction in pain from baseline with no adverse effects

Clinical implicationPatients with a successful screening trial are typically selected for implantation

Study practiceMost studies required a screening trial prior to pump implantation

Conservative Treatment Requirements

inv-25: Must be documented prior to trial for chronic non-malignant pain

Minimum duration of prior conservative therapy that must be documented before performing a trial infusion for chronic non-malignant pain:

Minimum conservative therapy duration: Documentation of failure due to intolerable side-effects or inadequate analgesia after conservative therapies (pharmacologic, physical therapy, behavioral health)>= 6 months

Must be documented prior to trial for chronic non-malignant pain

inv-26: Neuraxial screening trial demonstrating clinically significant response (commonly ≥50%) prior to implantation

Neuraxial screening trial demonstrating clinically significant response (commonly ≥50%) prior to implantation:

Screening trial required: A neuraxial screening trial must be performed prior to permanent pump implantation; most studies define a successful trial as a clinically significant pain reduction of ≥ 50% from baseline with no adverse effects>= 50%

Document magnitude of pain reduction and any adverse effects in the medical record

Frequency and Replacement

inv-27: Pump implantation/replacement — Frequency and replacement criteria

Practice intervalsDevice replacements and pump exchanges typically occur over multi-year intervals (examples: second pump ~10 years after first; subsequent intervals vary)

Policy frequency limitsNo explicit payer frequency limits for pump replacement or exchange specified in this policy excerpt

Replacement criteriaReplacement is medically necessary when initial placement criteria were met and the existing device is non-functional, unrepairable, or out of warranty

Imaging Requirements

Billing Rule

Use fluoroscopy or CT when code specifies imaging guidance

For CPT codes that specify 'with imaging guidance' (for example 62321, 62323, 62325, 62327), perform the procedure with fluoroscopy or CT as the imaging guidance modality.

When billing these CPT codes, ensure documentation that fluoroscopy or CT was used for imaging guidance.
Codes without the 'with imaging guidance' descriptor indicate procedures performed without fluoroscopy/CT.

Note

Imaging specifics for targeted regional analgesia not specified here

The policy notes epidural or intrathecal routes may be considered for broader areas of pain; specific imaging requirements for targeted regional analgesia are not provided in this excerpt.

For settings requiring longer-term intrathecal/epidural analgesics, implanted pump systems are typically used to reduce catheter migration and infection risk.
Consult full policy or specialty guidance for imaging details not included here.

Background

Implanted intrathecal/epidural drug delivery systems (IDDS) consist of a catheter and a constant-flow or programmable pump that deliver medication directly into the cerebrospinal fluid for long-term administration. Implantation typically follows a successful epidural or intrathecal trial infusion to evaluate analgesic or antispasticity response. FDA-approved intrathecal agents cited in the evidence base include opioid analgesics and ziconotide for pain and baclofen for spasticity, and clinical studies report reductions in pain intensity and decreases in systemic opioid use in selected adult cancer and noncancer populations.