Premera Bluecross Implantable PNS Coverage Update

Coverage Determinations

Investigational (Not Covered) — Implantable PNS

Covered when ALL of the following are met

Investigational stance: A trial or permanent placement of an implantable peripheral nerve stimulator for the management of chronic pain or other conditions is investigational for all indications.

Policy states investigational — not covered as medically necessary

Coverage after conservative therapy per Medicare LCD

Medicare/LCD context and general coverage considerations

Medicare/local coverage conditions: Peripheral nerve stimulation (PNS) may be covered for relief of chronic intractable pain for individuals with conditions known to be responsive to this form of therapy, and only after attempts to cure the underlying conditions and appropriate attempts at medication management; physical therapy, psychological therapy, and other less invasive treatments.

From Noridian LCD summary

Use of ReActiv8 per NICE

NICE guidance for ReActiv8

NICE special arrangements: Evidence on the efficacy and safety of neurostimulation of lumbar muscles for refractory non-specific chronic low back pain is limited in quantity and quality; the procedure should only be used with special arrangements for clinical governance, consent, and audit or research, and further suitably powered randomized controlled trials with appropriate duration and long-term outcomes are needed.

From NICE September 2022 guidance on ReActiv8

Investigational Determinations

Investigational device determination: ReActiv8 implantable neurostimulation system was added to the policy history and its use considered investigational.

Device-specific investigational stance recorded in policy history; see history entries

The policy position for implantable peripheral nerve stimulation (PNS) is investigational for all indications. Specifically, "A trial or permanent placement of an implantable peripheral nerve stimulator for the management of chronic pain or other conditions is investigational for all indications," and such procedures are not considered medically necessary under this policy.

Several FDA-cleared PNS systems include labeling that explicitly states they are not intended to treat pain in the craniofacial region. Examples in the regulatory summaries include the SPRINT Peripheral Nerve Stimulation System and other cleared systems whose indications or labeling note that the device is not intended for craniofacial pain.

This medical policy is a coverage guideline and does not apply to Medicare Advantage. Member benefit contracts differ; providers and members should confirm Medicare Advantage plan coverage separately.

Trial or permanent placement of an implantable peripheral nerve stimulator — whether a short-term trial or a permanent implant — is considered investigational for management of chronic pain or other conditions and therefore not covered as medically necessary under this policy.

The policy originated as a new policy effective November 1, 2019. The initial statement in 2019 listed implantable peripheral nerve stimulation for the treatment of chronic pain of peripheral nerve origin as investigational, establishing the historical basis for the current investigational stance.

Previously, implantable peripheral nerve stimulation for chronic pain of peripheral nerve origin was listed as investigational in the policy history. Later entries document that ReActiv8 was added to the policy history and its use was also considered investigational when it was included.

Procedure, CPT and HCPCS Codes

Procedure CPT CodesCPT

08161	Open insertion or replacement of integrated neurostimulation system for bladder dysfunction including electrode(s) array or leadless), and pulse generator or receiver; including analysis, programming, and imaging guidance, when performed, posterior tibial nerve; subcutaneous.
0817T	Open insertion or replacement of integrated neurostimulation system for bladder dysfunction including electrode(s) array or leadless), and pulse generator or receiver, including analysis, programming and imaging guidance; when performed, posterior tibial nerve; subfascial.
0818T	Revision or removal of integrated neurostimulation system for bladder dysfunction, including analysis, programming; and imaging; when performed, posterior tibial nerve; subcutaneous.
0819T	Revision or removal of integrated neurostimulation system for bladder dysfunction, including analysis, programming, and imaging; when performed, posterior tibial nerve; subfascial.
64555	Percutaneous implantation of neurostimulator electrode array; peripheral nerve (excludes sacral nerve).
64575	Open implantation of neurostimulator electrode array; peripheral nerve (excludes sacral nerve).
64585	Revision or removal of peripheral neurostimulator electrode array.
64590	Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver; direct or inductive coupling.
64595	Revision or removal of peripheral or gastric neurostimulator pulse generator or receiver.

Additional CPT/UnlistedCPT

64596	Insertion or replacement of percutaneous electrode array, peripheral nerve; with integrated neurostimulator, including imaging guidance; when performed; initial electrode array.
64597	Insertion or replacement of percutaneous electrode array, integrated neurostimulator; including imaging guidance; when performed; each additional electrode array (List separately in addition to code for primary procedure).
64999	Unlisted procedure; nervous (if used for Reactiv8).

HCPCS / Device CodesHCPCS

A4438	Adhesive clip applied to the skin to secure external electrical nerve stimulator controller; each.
C1767	Generator, neurostimulator (implantable), nonrechargeable.
C1778	Lead, neurostimulator (implantable).
C1787	Patient programmer; neurostimulator.
C1816	Receiver and/or transmitter; neurostimulator (implantable).
C1883	Adapter/extension, pacing lead or neurostimulator lead (implantable).
C1897	Lead, neurostimulator test kit (implantable).
L8679	Generator; any type pulse.
L8680	Implantable neurostimulator electrode, each.
L8681	Patient programmer (external) for use with implantable programmable neurostimulator pulse generator; replacement only.

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1/2

Coding additions and referencesmixed

C1767	HCPCS code added (document reference)
C1778	HCPCS code added (document reference)
C1787	HCPCS code added (document reference)
A4438	HCPCS code added (document reference)
C1816	HCPCS code added (document reference)
C1883	HCPCS code added (document reference)
C1897	HCPCS code added (document reference)
0816T	CPT code added (document reference)
0817T	CPT code added (document reference)
0818T	CPT code added (document reference)

1–10 of 14

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Coding updates (HCPCS)HCPCS

C1767	HCPC code added
C1778	HCPC code added

Coding updates (ReActiv8)mixed

C1787	HCPCS code added
64999	CPT code added for ReActiv8 (listed)

CPT code additionsCPT

0816T	CPT code added
0817T	CPT code added
0818T	CPT code added
0819T	CPT code added
64596	CPT code added
64597	CPT code added

HCPCS additions (2024)HCPCS

A4438	HCPCS code added
C1816	HCPCS code added
C1883	HCPCS code added
C1897	HCPCS code added

inv-19: Trial duration for temporary electrode

Trial duration for temporary electrodeTemporary electrode trial period usually less than or equal to 5 days

Trial connectionElectrode is connected to an external device during the trial

Success threshold for permanent implantationTypically ≥50% pain reduction during the trial to consider permanent implantation

inv-20: eCoin recommended treatment frequency (initial)

Initial recommended frequency

Billing, Authorization and Documentation Guidance

Documentation Required

Coding and documentation

Billing and coding: submit the applicable CPT/HCPCS procedure and device codes for implantable peripheral nerve stimulation. Include operative notes describing the procedure (trial vs permanent), anatomical target (e.g., tibial nerve), laterality, approach (percutaneous vs open/subcutaneous/subfascial), device model and implantable device details (generator, leads, rechargeable vs nonrechargeable), and imaging guidance when performed.

Include operative report and device model/serial when available
Document whether procedure is trial or permanent and duration of trial (if applicable)

Billing Rule

Billing codes for implantable PNS

Billing codes for implantable PNS are listed below. Use the listed CPT and HCPCS codes when billing; unlisted codes (e.g., 64999) may be required for novel devices and should be accompanied by full operative/device documentation. Prior authorization may be required per member benefits.

Required Prior Therapies

Document prior behavioral and pharmacologic therapy or prior response to PTNS for tibial nerve implant indications.

Document prior therapies for tibial nerve implant indications: Document prior behavioral and pharmacologic therapy or demonstrate prior clinical response to percutaneous tibial nerve stimulation (PTNS) before considering implantation of an implantable tibial nerve stimulation system for non-neurogenic urinary dysfunction (e.g., overactive bladder).

Expectation derived from pivotal eCoin evidence and FDA context; documentation of prior therapies may be required

Required before coverage considered (per Medicare LCD summary)

Required before coverage considered (per Medicare LCD summary): Attempts to cure underlying conditions and appropriate attempts at medication management, physical therapy, psychological therapy, and other less invasive treatments must be documented before peripheral nerve stimulation is considered.

Medicare/Noridian LCD summary guidance

Treatment Frequency and Trial Durations

inv-45: SPRINT Peripheral Nerve Stimulation System trial indication (per device labeling)

SPRINT trial indication (per labeling)Indicated for up to 60 days in the back and/or extremities

Cleared date and manufacturerSPRINT Peripheral Nerve Stimulation System, cleared July 2018 (510(k) K181422)

Labeling exclusionSystem not intended to treat pain in the craniofacial region

inv-46: (blank) frequency limits item

No explicit frequency limits listedThis section does not specify additional frequency limits for PNS beyond device labeling

Refer to device labelingFrequency and treatment schedule should follow individual device labeling or manufacturer instructions

Imaging and Diagnostic Guidance

Documentation Required

Demonstrate multifidus dysfunction (prone test or MRI) before ReActiv8 implant

For ReActiv8 implantation, demonstrate multifidus muscle dysfunction by physical exam (prone instability test) or MRI prior to implantation as described in the device section.

Document prone instability test findings or MRI evidence of multifidus muscle atrophy/weakness in the chart

Prior Authorization

Obtain positive ultrasound-guided diagnostic block before PNS for mononeuropathies

For PNS targeting mononeuropathies, document a positive diagnostic ultrasound-guided nerve block of the targeted nerve prior to offering PNS as recommended by ASPN guidance.

Include procedure note and results of the ultrasound-guided diagnostic nerve block

Documentation Required

Definitions and Device Background

inv-36: Definition of PNS — components and placement

Definition of PNSA percutaneous or implantable system of leads, electrodes, and a pulse transmitter that delivers electrical impulses directly to peripheral nerves

ComponentsLeads, electrodes, and a pulse transmitter/generator (can be externalized during trial or implanted permanently)

PlacementLeads are placed using ultrasound guidance and may be placed temporarily (trial) or permanently in an outpatient procedure

inv-37: Differentiation from other therapies (SCS, TENS/PENS/PNT/PSFS)

Differentiation from SCSSpinal cord stimulation delivers impulses to the spine, whereas PNS targets specific peripheral nerves directly

Differentiation from TENS/PENS/PNT/PSFS

Clinical and Technical Background

Peripheral nerve stimulation (PNS) refers to an implantable system of leads/electrodes and a pulse generator that delivers electrical impulses directly to peripheral nerves to modulate pain signals. The policy’s clinical context notes that PNS may be performed as a temporary trial followed by permanent implantation if trial response is adequate, but the coverage stance in this policy classifies implantable PNS as investigational for all indications.

Services Not Covered

Summary: Implantable peripheral nerve stimulation is designated investigational and not covered for all indications. The policy cites an investigational procedure determination: a trial or permanent placement of an implantable peripheral nerve stimulator for chronic pain or other conditions is investigational. Device regulatory summaries note multiple cleared systems with specific indications and labeling (including statements that some systems are not intended for craniofacial pain). Policy history documents the original 2019 investigational position and subsequent updates (including addition of ReActiv8 content and coding updates). Providers should verify member benefits and Medicare Advantage applicability separately, as the policy does not apply to Medicare Advantage plans.

OpenPayer

Implantable Peripheral Nerve Stimulation (PNS)

Coverage Determinations

Procedure, CPT and HCPCS Codes

Billing, Authorization and Documentation Guidance

Required Prior Therapies

Treatment Frequency and Trial Durations

Imaging and Diagnostic Guidance

Definitions and Device Background

Clinical and Technical Background

Services Not Covered