Peripheral Nerve Stimulation and Peripheral Nerve Field Stimulation

*** This policy was implemented in the absence of National Coverage Determinations (NCD) or Local Coverage Determinations (LCD) coverage criteria. This policy applies to all Blue Medicare HMO, Blue Medicare PPO, Blue Medicare Rx members, and members of any third-party Medicare plans supported by Blue Cross NC through administrative or operational services. ***

Description of Procedure

Peripheral nerve stimulation (PNS) refers to the placement of a lead by a physician (via open surgical or percutaneous approach) near the known anatomical location of a peripheral nerve. The goal is to lessen pain for conditions known to be responsive to this form of therapy.

Peripheral Nerve Field Stimulation (PNFS) refers to the stimulation by a needle electrode inserted through the skin and is performed in a physician’s office, clinic, or hospital outpatient department.

In both PNS and PNFS, leads are connected to an external pulse generator if temporary or implanted when permanent, with the goal to lessen chronic pain.

The two most accepted uses are:

• Open exposure of a peripheral nerve and implantation of a PNS electrode (as in the treatment of the radial nerve, sciatic nerve, median nerve, etc);
• Percutaneous insertion of PNS in the vicinity of the stimulated nerve (i.e., occipital nerve for severe headaches)

Policy Statement

Coverage will be provided for a Peripheral Nerve Stimulator and Peripheral Nerve Field Stimulation when it is determined to be medically necessary, as outlined in the below guidelines and medical criteria.

Benefit Application

Please refer to the member’s individual Evidence of Coverage (EOC) for benefits.

Coverage decisions will be made in accordance with:

• The Centers for Medicare & Medicaid Services (CMS) National Coverage determinations (NCDs);
• General coverage guidelines included in Original Medicare manuals, unless superseded by operational policy letters or regulations; and
• Written coverage decisions of local Medicare carriers and intermediaries with jurisdiction for claims in the geographic area in which services are covered.

Benefit payments are subject to contractual obligations of the Plan. If there is a conflict between the general policy guidelines contained in the Medical Coverage Policy Manual and the terms of the member’s particular Evidence of Coverage (EOC), the EOC always governs the determination of benefits.

Indications for Coverage

1. PNS is covered only when performed by a physician or incident to a physician’s service and must meet ALL (a-g) of the following criteria:
   1. Documented chronic and severe pain for at least 3 months; AND
   2. Documented failure of less invasive treatment modalities as appropriate including but not limited to attempts to cure the underlying condition causing the pain, (i.e., examples are physical therapy, braces, or medications, such as Lyrica and Neurontin, have been tried and failed); AND
   3. Lack of surgical contraindications including infections and medical risks; AND
   4. Appropriate proper patient education, discussion and disclosure of risks and benefits; AND
   5. No active substance abuse issues; AND
   6. Formal psychological screening by a mental health professional; AND
   7. A successful stimulation trial with greater than or equal to 50% reduction in pain intensity before permanent implantation.

When Coverage Will Not Be Approved

1. When the criteria above have not been met.
2. Peer reviewed data has not found adequate evidence to indicate the use of the treatment of PNS for fibromyalgia, phantom limb pain, diffuse polyneuropathy, nociceptive pain in the trunk or lower back, or angina pectoris to result in improvements of health outcomes. Request for these diagnoses is not reasonable and necessary and will not be covered.
3. Current peer-reviewed data is insufficient to warrant the medical necessity of coverage for PNFS for any condition. Therefore, this service will not be covered for any condition.

Special Notes:

If pain is effectively controlled by percutaneous stimulation, implantation of electrodes is warranted.

The physician should be able to determine whether the member is likely to derive a significant therapeutic benefit from continuing use of an implanted nerve stimulator within a trial period of 1 month. In a few cases, this determination may take longer to make and the need for such services which are furnished beyond the first month must be documented.

The only reliable predictor of PNS effectiveness is atrial of stimulation with implanted PNS electrodes. If a trial fails, a repeat trial is usually not appropriate unless there are extenuating circumstances that led to the trial failure, technological advances, or an alternative neuromodulary technique that may lead to a more successful trial. Documentation is required to explain the unusual situations.

Examples of indications that may be covered are:

• PNS for occipital nerve for occipital neuralgia, post-surgical neuropathic pain, cervicogenic headaches and treatment of resistant migraine.
• PNS of the trigeminal nerves and branches for post-traumatic and postsurgical neuropathic pain in the face related to the trigeminal nerves.
• PNS of nerves in the upper and lower extremities of complex regional pain syndromes (type 1 and 2), pain due to peripheral nerve injury, post-surgical scar formation, nerve entrapment, painful mononeuropathy and painful amputation neuromas.
• PNS of intercostal and ilio-inguinal nerves for post-surgical and posttraumatic neuropathic pain involving these nerve distributions.

Billing/ Coding/physician Documentation Information

This policy may apply to the following codes. Inclusion of a code in the section does not guarantee reimbursement.

Applicable codes: 61885, 64553, 64555, 64561, 64569, 64570, 64575, 64581, 64585, 64590, 64595, 64596, 64597, 64598, 64999, 95970, 95971, 95972

The Plan may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

References:

1. Medicare National Coverage Determinations; 100-3, Chapter 1; Section 160.7.1; viewed online at NCD - Assessing Patient's Suitability for Electrical Nerve Stimulation Therapy (160.7.1) (cms.gov) on 12/26/2024.
2. 2. Medicare Local Coverage Determination; L34328 Peripheral Nerve and Peripheral Nerve Field Stimulation; viewed online at LCD - Peripheral Nerve Stimulation (L34328) (cms.gov) on01/17/2025. 3.
3. Medicare Local Coverage Article (A55530); Effective: 08/27/2018, Revised on 10/01/2024; viewed online Article -Billing and Coding: Peripheral Nerve Stimulation (A55530) on01/17/2025.

Policy Implementation/Update Information:

Revision Date: May 21, 2014. New policy developed for Medicare Covered service. Codes require Prior Approval by the Plan. October 29, 2015 removed LCD reference due to ICD-10 update only; there is no longer a local coverage determination.

Revision Date: September 21, 2016 Description section updated for consistency. Special Notes section updated to reflect new information added from updated LCD. Reference to new LCD added as agreed on per committee.

Revision Date: June 20, 2018; Annual Review. No CMS Updates. Minor Revisions Only.

Revision Date: June 17, 2020; Annual Review. Description Section: Removal of “Implantation of subcutaneous PNFS electrodes in the location of the applicable peripheral nerve field for severe axial or chest wall pain.” Deleted Codes: 95973,95974, 95975, 0282T, 0283T, 0284T, 0285T; Added 64590, 64595.

Revision Date: July 20, 2022; Annual Review. Minor Revisions only

Revision Date: October 18, 2023: Annual Review. No CMS Updates. Added new LCA reference. Verbiage added and deleted to reflect LCD/LCA.

Revision Date: November 20, 2023: Policy converted to a Summary of Coverage Criteria to align with the 2024 CMS Final Rule.

Revision Date: December 26, 2024; Annual Review, Converted to a Medical Policy based on CY 2024 CMS Final Rule and recommendation from Corporate Compliance. Added new codes per LCA reference. No other CMS updates noted

Revision Date: February 20, 2025: Converted from a Summary to a Policy based on CY 2024 CMS Final Rule. Minor grammatical revisions made. No guidance updates

Approval Dates:

Medical Coverage Policy Committee: February 20, 2025

PAG/UM Committee: February 18, 2025

Policy Owner: Name: Amy Russo, LPN

Medical Policy Coordinator