Premera Bluecross PNS Coverage Update

Coverage determination and investigational stance

inv-01: Investigational / Not covered criteria

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 for all indications; therefore not covered as medically necessary.

inv-02: General coverage prerequisites / context

Coverage context and prerequisites drawn from referenced guidance and regulatory indications:

Coverage prerequisites per Medicare LCD: Peripheral nerve stimulation (PNS) may be covered for relief of chronic intractable pain only after attempts to cure the underlying condition and appropriate attempts at medication management, physical therapy, psychological therapy, and other less invasive treatments.

Derived from Medicare National Coverage/LCD summary in policy; regulatory device indications (e.g., ReActiv8, eCoin, Moventis/Neuspera) specify prior conservative treatment or trial requirements for their approved indications.

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. As investigational therapy, implantable PNS procedures (trial or permanent) are not considered medically necessary under this policy and claims for these indications are subject to denial.

Device labeling and cleared indications for multiple implantable PNS systems explicitly exclude the craniofacial region. Examples in the regulatory summaries include the SPRINT PNS System and several manufacturer kit and system clearances that state the system is not intended to treat pain in the craniofacial region, and similar exclusions appear in Moventis, Neuspera, Nalu, and StimRouter device indications.

Historical descriptions in prior policy entries have consistently described implantable peripheral nerve stimulation as investigational for the treatment of chronic pain of peripheral nerve origin. The original policy entry (effective November 1, 2019) and subsequent annual reviews maintained the investigational designation through later history entries.

The current policy classifies all implantable peripheral nerve stimulator placements for management of chronic pain or other conditions as investigational. This broad investigational classification applies to both temporary (trial) lead placements and permanent device implantation across indications.

Policy history entries document the investigational status over time, including initial policy creation (08/01/19) stating implantable PNS for chronic pain of peripheral nerve origin was investigational, and subsequent reviews and updates that preserved the investigational policy position while adding device- and coding-related updates.

A historical note in the policy history indicates that content for the ReActiv8 implantable neurostimulation system was added (06/01/22) and that its use was considered investigational at the time of that update.

Procedure and supply codes

Primary 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 and HCPCS codesmixed

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) system.
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).

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Policy-related CPT/HCPCS codesmixed

A4438	HCPCS code added in July 2024 (document notes addition).
C1816	HCPCS code added in July 2024 (document notes addition).
C1883	HCPCS code added in July 2024 (document notes addition).
C1897	HCPCS code added in July 2024 (document notes addition).
C1787	HCPCS code added previously for ReActiv8 (document notes addition).
C1767	HCPCS code added in July 2021 (document notes addition).
C1778	HCPCS code added in July 2021 (document notes addition).
0816T	CPT code added in 01/01/24 update (document notes addition).
0817T	CPT code added in 01/01/24 update (document notes addition).
0818T	CPT code added in 01/01/24 update (document notes addition).

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Coding updates and additions referenced in historymixed

C1767	HCPCS code added (description as listed in policy coding updates).
C1778	HCPCS code added (description as listed in policy coding updates).
C1787	HCPCS code added (ReActiv8 related).
A4438	HCPCS code added July 2024.
C1816	HCPCS code added July 2024.
C1883	HCPCS code added July 2024.
C1897	HCPCS code added July 2024.
0816T	CPT code added (Jan 1, 2024).
0817T	CPT code added (Jan 1, 2024).
0818T	CPT code added (Jan 1, 2024).

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Temporary trial duration

Typical temporary trial durationUsually less than 5 days (temporary electrode trial period)

Trial connection methodTemporary electrode connected to an external device during the brief trial

Progression criterion notedIf trial successful, a permanent lead and generator may be implanted or wireless external transmitter used

Trial success threshold

Trial success thresholdApproximately ≥50% reduction in pain during the trial

Documentation requirement

Authorization, documentation, and billing guidance

Prior Authorization

Prior Authorization and Benefit Verification

Prior authorization may be required for peripheral nerve stimulation (PNS) devices and related procedures. Verify prior authorization requirements with Premera before scheduling. Coverage is subject to member benefit plan limits and the member benefit booklet or customer service should be consulted to confirm plan-specific exclusions or requirements.

Verify member benefits and prior authorization requirements with Premera for PNS device placement and related CPT/HCPCS codes prior to service
Coverage is subject to individual member benefit plan limits; contact member services or review the benefit booklet for plan-specific restrictions

Billing Rule

Coding and Prior Authorization Note

Coding changes over time may affect prior authorization and claims processing. Ensure use of current CPT/HCPCS codes when requesting authorization and submitting claims. Historical coding updates (see Policy history) include addition/updates of CPT codes 0816T–0819T, 64596, 64597 and various HCPCS codes (e.g., C1767, C1778, C1787, A4438, C1816, C1883, C1897). If using unlisted or new codes (for example CPT 64999 or other temporary codes), include detailed operative and implant descriptions with authorization and claim submissions.

Required prior therapies and documentation

inv-33: Failure of behavioral and pharmacologic therapy or prior response to PTNS may be relevant for tibial nerve implants

Document prior attempts at conservative therapies when relevant to tibial nerve implant consideration:

Tibial nerve implant precedent: For subcutaneous tibial nerve implant (eCoin), document that the individual had failed behavioral and pharmacologic therapy or had a prior successful trial of percutaneous tibial nerve stimulation (PTNS) before implantation.

Based on pivotal study population and FDA indication described in the evidence summary; failure of behavioral and pharmacologic therapy or prior response to PTNS may be relevant to coverage determinations.

inv-34: Document prior attempts at conservative therapies

Documentation requirements for conservative management prior to considering PNS:

Conservative therapy documentation: Document prior attempts to cure underlying conditions and trials of medication management, physical therapy, psychological therapy, and other less invasive treatments before peripheral nerve stimulation is considered.

Trial duration and frequency constraints

SPRINT peripheral nerve stimulation system (trial duration up to 60 days)

SPRINT system trial durationSPRINT PNS system indicated for trial use up to 60 days

Indications summaryFor symptomatic relief of chronic intractable pain, post-surgical and post-traumatic acute pain, and post-traumatic/post-operative pain

Label limitationNot intended to treat craniofacial pain

Frequency limits

Frequency limits in policy excerptNo explicit frequency limits provided in this policy excerpt

Device-specific limits may existSome devices (e.g., SPRINT) have device labeling specifying trial durations rather than general frequency limits

Diagnostic imaging and procedural guidance

Documentation Required

Document multifidus dysfunction (prone instability test or MRI) for ReActiv8

For ReActiv8 implantation, demonstrate multifidus muscle dysfunction prior to implantation on physical exam (prone instability test) or on MRI and document these findings in the record.

Record prone instability test results or include MRI images/reports demonstrating multifidus atrophy/weakness when submitting authorization or clinical documentation.

Documentation Required

Document positive diagnostic ultrasound‑guided nerve block for upper‑extremity mononeuropathies

For PNS to treat mononeuropathies of the upper extremity, ASPN best-practice guidance recommends offering PNS following a positive diagnostic ultrasound-guided nerve block of the targeted nerve; document the diagnostic block result.

Include documentation of a positive diagnostic ultrasound-guided nerve block of the targeted nerve when considering PNS for mononeuropathies.
Reference ASPN guidance in clinical rationale when submitting authorization requests.

Key terms and device descriptions

Peripheral Nerve Stimulation (PNS) — system description

DefinitionA percutaneous or implantable system of leads/electrodes and a pulse transmitter that delivers electrical impulses directly to peripheral nerves to modulate pain signals

PlacementLeads are placed using ultrasound guidance and can be used for temporary (trial) or permanent implantation in an outpatient procedure

Two-step processTypically performed as a temporary electrode trial followed by permanent implantation if successful

ReActiv8 — restorative neurostimulation system definition

ReActiv8 definitionAn implantable restorative neurostimulation system that stimulates nerves activating the lumbar multifidus muscles to treat chronic low back pain

Pre-implantation requirement

Clinical and policy background

Peripheral nerve stimulation (PNS) systems deliver electrical impulses to peripheral nerves via implanted leads or electrodes and a pulse transmitter. Systems may be used in a brief temporary trial (typically using temporary leads) or as permanent implants with an implanted pulse generator. Trial periods reported in the literature and device labeling are often brief (commonly <5 days for typical temporary trials), with trial success commonly defined as approximately ≥50% pain reduction during the trial period.

Explicit not-covered statements

NOT COVERED: Placement of an implantable peripheral nerve stimulator, whether as a temporary trial or permanent implant, for the management of chronic pain or other conditions is considered investigational under this policy and therefore not covered. Device labeling for several cleared systems specifically excludes treatment of craniofacial pain; providers should note these device-specific exclusions when considering indications and when submitting requests for authorization.

Policy history and coding changes

2019-08-01policy_creation

New policy approved July 9, 2019; effective November 1, 2019; implantable PNS for chronic pain of peripheral nerve origin designated investigational.

2020-10-01annual_review

Annual review completed September 1, 2020; references added; policy statement unchanged.

2021-04-01annual_review

Annual review completed March 2, 2021; references added; policy statement unchanged.

OpenPayer

Implantable Peripheral Nerve Stimulation (PNS) — Coverage and Medical Necessity