UnitedHealthcare DRG/SCS Coverage Update

Coverage and Medical Necessity Criteria

Coverage linkage to NC Medicaid and InterQual

Coverage stance references external North Carolina Medicaid and InterQual criteria and specific statements about DRG:

DRG proven indications: Dorsal root ganglion (DRG) stimulation is proven and medically necessary for treating refractory complex regional pain conditions per the referenced North Carolina Medicaid Clinical Coverage Policy (1A-25) and InterQual procedures criteria.refer to referenced documents

Policy directs reader to NC Medicaid 1A-25 and InterQual for the detailed medical necessity criteria and indication list.

Replacement device coverage

Explicit policy statements in this document:

Replacement battery/generator: Coverage of a replacement battery/generator for a previously implanted electrical stimulator is appropriate when the individual's existing battery/generator is malfunctioning, cannot be repaired, and is no longer under warranty.device malfunction and warranty status documented

Include device history and malfunction documentation in the record.

Not medically necessary — unspecified other conditions

Limitations noted:

DRG unproven for other conditions: Dorsal root ganglion (DRG) stimulation is unproven and not medically necessary for treating all other conditions due to insufficient evidence of efficacy.condition not among referenced proven indications

Applies to indications not supported by NC Medicaid/InterQual or the evidence cited in this policy.

DRG stimulation effectiveness evidence

Evidence summary and outcomes from clinical trials and systematic reviews

ACCURATE trial primary composite endpoint: In the ACCURATE randomized trial (n=152) of patients with CRPS or causalgia, treatment success for permanent implants was defined as >=50% decrease in VAS from pre-implant baseline with no stimulation-related neurological deficits; at 3 months treatment success was 81.2% for DRG versus 55.7% for SCS, and device-related and serious adverse events were similar between groups.>=50% VAS reduction

Results assessed through 12 months; additional long-term randomized data are needed.

Dorsal root ganglion (DRG) stimulation is not medically necessary for conditions other than the FDA‑labeled or otherwise referenced proven indications because there is insufficient evidence of efficacy. This policy directs readers to the referenced North Carolina Medicaid and InterQual criteria for the detailed list of proven indications and medical necessity requirements, and limits coverage to those conditions supported by those referenced criteria.

FDA regulatory clearance or approval is provided for informational purposes only. FDA approval alone is not a basis for coverage; implantable spinal cord stimulation systems are regulated as Class III devices and may be approved via PMA or 510(k), but coverage determinations rely on the clinical coverage criteria and applicable benefit plan, state, or contractual rules rather than regulatory status.

Dorsal root ganglion stimulation is considered unproven and not medically necessary for all other conditions outside the specific indications referenced in the policy. Providers must rely on the cited NC Medicaid and InterQual criteria for which conditions are considered supported by evidence; procedures outside those supported indications are excluded due to insufficient evidence of clinical benefit.

Review of the referenced chunks did not identify additional explicit "not medically necessary" statements beyond those already summarized. The policy history notes changes to applicable codes and references but does not add separate NMN language in the cited revision notes.

Procedure and Device Codes

Procedure CPT codesCPT

63650	Percutaneous implantation of neurostimulator electrode array, epidural
63655	Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural
63685	Insertion or replacement of spinal neurostimulator pulse generator or receiver; requiring pocket creation and connection between electrode array and pulse generator or receiver
63688	Revision or removal of implanted spinal neurostimulator pulse generator or receiver, with detachable connection to electrode array

HCPCS device/supply codesHCPCS

L8679	Implantable neurostimulator, pulse generator; any type
L8680	Implantable neurostimulator electrode, each
L8682	Implantable neurostimulator radiofrequency receiver
L8685	Implantable neurostimulator pulse generator, single array, rechargeable, includes extension
L8686	Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension
L8687	Implantable neurostimulator pulse generator; dual array, rechargeable, includes extension
L8688	Implantable neurostimulator pulse generator; dual array, nonrechargeable, includes extension
L8695	External recharging system for battery (external) for use with implantable neurostimulator, replacement only

Applicable Codes with NC Medicaid noteHCPCS

L8695

Non-physician implantable neurostimulator lead — note: referenced as not on NC Medicaid Fee Schedule in this policy

inv-12: ACCURATE trial primary endpoint

ACCURATE trial primary composite endpointTreatment success defined as a composite: ≥50% decrease in VAS pain score from pre‑implant baseline AND no stimulation‑related neurological deficits (assessed at 3 months, with follow‑up through 12 months)

Study populationRandomized ACCURATE trial enrolled 152 subjects with CRPS or causalgia of the lower extremities

Assessment timelinePrimary composite end point assessed at 3 months; subjects followed through 12 months for outcomes and adverse events

inv-13: ACCURATE trial pain reduction threshold

Pain reduction threshold≥50% reduction in visual analog scale (VAS) pain score from pre‑implant baseline

Prior Authorization, Documentation, and Billing Notes

Prior Authorization

Prior Authorization Required (NC only)

Prior authorization is required for services under this policy in North Carolina. Refer to the state-specific prior authorization process and applicable code references when submitting requests.

State-specific prior authorization required (North Carolina).
Verify federal, state, or contractual benefit requirements prior to authorization.
Codes listed in this policy are for reference only; inclusion does not imply coverage or guarantee payment.

Billing Rule

Coding inclusion not a guarantee of coverage

Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by federal, state, or contractual requirements and applicable laws. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment.

Required Conservative Treatments Before Implant

See NC Medicaid 1A-25 and InterQual CP for required conservative treatments prior to SCS/DRG

Refer to external coverage criteria for required conservative treatments prior to consideration of SCS/DRG:

Follow NC Medicaid and InterQual conservative therapy requirements: Prior to approval of SCS or DRG therapy, providers must meet the conservative treatment prerequisites specified in the North Carolina Medicaid Clinical Coverage Policy (Physician 1A-25) and the InterQual Procedures: Spinal Cord Stimulator (SCS) Insertion criteria.see referenced policies

This policy defers to the referenced NC Medicaid and InterQual documents for specific therapy types, durations, and trial requirements.

Additional conservative treatment requirement

Additional conservative treatment requirement node:

Document conservative therapy per referenced criteria: When conservative therapies are required by the referenced NC Medicaid or InterQual criteria (e.g., medications, physical therapy, interventional procedures), documentation must demonstrate that indicated therapies were attempted and either failed or were contraindicated.

Replacement and Frequency Limits

inv-28: Replacement battery/generator (replacement allowed when device malfunctioning and not under warranty)

Replacement indicationReplacement of a previously implanted battery/generator is appropriate when the existing device is malfunctioning, cannot be repaired, and is no longer under warranty

Documentation requiredProvider should include device history and documentation of malfunction and warranty status when requesting replacement

ScopeApplies to replacement of previously implanted electrical stimulators referenced in this policy

inv-29: spinal cord or DRG stimulation (frequency limits reference)

Frequency limits referencePolicy lists spinal cord and DRG stimulation procedures under frequency limits section; specific numeric frequency limits are not specified in this document and providers should follow federal/state/contractual requirements

Imaging and Device Documentation

Note

FDA product pages and device coding are informational; no imaging mandate

FDA product pages and device coding are referenced for informational purposes only; the policy does not impose any specific imaging requirements.

FDA information is informational and not a basis for coverage decisions.
No imaging requirement is specified in the cited sections.

Note

No specific imaging requirements stated in policy

No specific imaging requirements are specified in the policy text provided; follow applicable state/contractual requirements or device manufacturer guidance as needed.

If imaging is required by a plan or device manufacturer, follow those instructions; this policy section does not set imaging criteria.

Clinical Background

Dorsal root ganglion (DRG) stimulation and spinal cord stimulation (SCS) are implantable neuromodulation therapies used to manage refractory chronic neuropathic pain. The policy references external clinical criteria (North Carolina Medicaid and InterQual) for detailed medical necessity requirements and provides FDA regulatory information for context; it emphasizes that regulatory status is informational and that coverage decisions must follow the clinical coverage criteria and applicable benefit rules.

Definitions and Regulatory Status

inv-23: FDA regulation — implantable spinal cord stimulation systems are Class III devices

FDA regulatory classImplantable spinal cord stimulation systems are regulated by the FDA as Class III devices

Regulatory contextFDA information is provided for informational purposes only; FDA approval alone is not a basis for coverage

Reference resourcesFDA product and approval webpages (PMA and 510(k)) cited for device‑level information (product codes e.g., LGW, GZB)

inv-24: Implantable spinal cord stimulation systems: Class III devices, approved through PMA or 510(k)

Approval pathwaysImplantable spinal cord stimulation systems are approved through the Premarket Approval (PMA) process or cleared via the 510(k) process

Device examples

Exclusions and Noncovered Services

DRG stimulation is not covered for conditions that are not supported by the evidence or not included among the proven indications referenced in the NC Medicaid and InterQual criteria. The policy explicitly states DRG is unproven and not medically necessary for treating all other conditions due to insufficient efficacy evidence.

Additionally, providers should note that listing a procedure or device in this policy does not guarantee coverage; state, federal, or contractual benefit plan rules govern final determinations.

The HCPCS code L8695 (external recharging system for implantable neurostimulator batteries) is noted in the policy as not appearing on the State of North Carolina Medicaid Fee Schedule and therefore may not be covered by North Carolina Medicaid. Providers should verify coverage and prior authorization requirements with the member’s specific plan and the NC Medicaid fee schedule.

OpenPayer

Implanted Electrical Stimulator for the Spinal Cord (for North Carolina Only)