SUPERSEDED Local Coverage Determination (LCD)

Peripheral Nerve Stimulation

L37360

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.
Superseded
To see the currently-in-effect version of this document, go to the section.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L37360
Original ICD-9 LCD ID
Not Applicable
LCD Title
Peripheral Nerve Stimulation
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL37360
Original Effective Date
For services performed on or after 08/27/2018
Revision Effective Date
For services performed on or after 12/01/2019
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
09/17/2018
Notice Period End Date
11/01/2018
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

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Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

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Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Title XVIII of the Social Security Act (SSA), §1862(a)(1)(A), states that no Medicare payment shall be made for items or services that “are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.”

CMS Manual System, Pub 100-03, Medicare National Coverage Determinations Manual, Chapter 1, §160.7, Electrical Nerve Stimulators.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Peripheral nerve stimulation (PNS) may be covered for relief of chronic intractable pain for patients 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 interdenominational treatments. As with spinal nerve stimulations (spinal cord stimulators (SCS) are dealt with in a companion policy), severe neuropathic pain is typically well suited for successful responses to PNS. There may be rare selected situations where both spinal cord stimulators and peripheral neurostimulators are used together.

PNS refers to the placement of a lead by a physician (via open surgical or percutaneous approach) near the known anatomic location of a peripheral nerve. Peripheral nerve field stimulation (PNFS) refers to use of a lead placed to stimulate the subcutaneous distal distribution of an area of pain (indirectly stimulating the peripheral nerve). In both PNS and PNFS leads are composed of multiple contacts (of varying number) connected to an external pulse generator when temporary and implanted when made permanent.

PNS, like deep brain stimulation and spinal cord stimulation modulates the nervous system with electrical stimulation to lessen chronic pain and other conditions. PNFS has an uncertain mechanism of action.

PNS has been tried for over 50 years and has been used in a wide variety of chronic pain syndromes, but the scientific literature is limited for many of the indications tried. The most accepted uses of PNS involves one of two methods:

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

As with a SCS and PNS, performance of an effective trial is a pre-requisite of final implantation. Many experts recommend that the temporary neurostimulator be placed in an Ambulatory Surgical Center (ASC) or outpatient hospital setting. However, the temporary neurostimulator trial can be done in an office setting if all the sterility, equipment, professional training and support personnel for the proper surgery and follow up of the patient are available. Permanent neurostimulators must be placed in an ASC or hospital. Physicians performing PNS trials in place of service office must have like privileges at an ASC or hospital, or the physician must be board certified or board eligible in Pain Medicine, Orthopedic Surgery, or Neurosurgery by an ABMS Board or the equivalent as determined by the state of practice. Other ABMS Specialty Boards or the equivalent in the state of practice may be included if such practice is included in the training program curriculum.

It is preferable that the physicians performing the PNS trials will also perform the permanent implant. If the physician implanting the trial PNS does not or cannot implant the permanent neurostimulator(s), the patient should be informed of this in writing and given the name of the referral surgeon who will implant the permanent neurostimulator(s).

Coverage of PNS trials requires that patients have all of the following:

  • Documented chronic and severe pain for at least 3 months,
  • Documented failure of less invasive treatment modalities and medications,
  • Lack of surgical contraindications including infections and medical risks,
  • Appropriate proper patient education, discussion and disclosure of risks and benefits,
  • No active substance abuse issues,
  • Formal psychological screening by a mental health professional, and
  • Successful stimulation trial with greater than or equal to 50% reduction in pain intensity before permanent implantation.

The only reliable predictor of PNS effectiveness is a trial 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 (equipment malfunction, early lead migration, etc.), technological advances, or an alternative neuromodulary technique that may lead to a more successful second trial. Documentation must explain these unusual situations. It is expected that accurate patient selection will lead to most patients going on to receive permanent implants. All trials which proceed to permanent implant must have adequate documentation in the chart to support that decision. A successful trial should be associated with at least a 50% reduction of target pain, or 50% reduction of analgesic medications, and show some element of functional improvement.

Physicians with a low trial to permanent implant ratio less than 50% will be subject to post payment review and may be asked to submit documentation as to the patient selection criteria, the imaging demonstrating proper lead placement, and the medical necessity of the trials. Failure to provide this documentation will be cause for post-payment denial and recoupment of reimbursement. It is understood that all patients may not have a favorable result of the trial implant; but careful selection should find the most appropriate patients.

Examples of peripheral stimulation indications with evidence of efficacy that may be covered are:

  • PNS of occipital nerves for occipital neuralgia, post-surgical neuropathic pain, cervicogenic headaches and treatment resistant migraines.
  • PNS of trigeminal nerves (and branches) for post-traumatic and post-surgical neuropathic pain in the face related to the trigeminal nerves.
  • PNS of nerves in 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 post-traumatic neuropathic pain involving these nerve distributions.


Current peer-reviewed data DOES NOT SUPPORT PNS for fibromyalgia, phantom limb pain, diffuse polyneuropathy, nociceptive pain in trunk or lower back, or angina pectoris. Claims for these indications will be denied as not reasonable and necessary. Current peer-reviewed data also is insufficient to warrant the medical necessity of coverage for PNFS for any condition. Therefore, this service will not be covered for any condition.

Summary of Evidence

NA

Analysis of Evidence (Rationale for Determination)

NA

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

Utilization Guidelines

Noridian expects no more than two services of 64555-(Percutaneous implantation of neurostimulator electrodes; peripheral nerve [excludes sacral nerve]) be billed per 365 days.

Trials will be limited to four leads with maximum of 16 contacts.

Sources of Information
  1. Al-Jehani H, Jacques L. Peripheral nerve stimulation for chronic neurogenic pain. Prog Neurol Surg. 2011;24:27-40. doi: 10.1159/000323017. Epub 2011 Mar 21.
  2. Cairns KD, McRoberts WP, Deer T. Peripheral nerve stimulation for the treatment of truncal pain. Prog Neurol Surg. 2011;24:58-69. doi: 10.1159/000323025. Epub 2011 Mar 21.
  3. Dafer RM. Neurostimulation in Headache Disorders. Neurol Clin. 2010; 28:835-41.
  4. Desai MJ, Jacob L, Leiphart J. Successful peripheral nerve field stimulation for thoracic radiculitis following Brown-Sequard syndrome. Neuromodulation. 2011 May-Jun;14(3):249-52; discussion 252. doi: 10.1111/j.1525-1403.2011.00356.x. Epub 2011 Apr 15.
  5. Ellens DJ, Levy RM. Peripheral neuromodulation for migraine headache. Prog Neurol Surg. 2011;24:109-17. doi:10.1159/000323890. Epub 2011 Mar 21.
  6. Hamm-Faber TE, Aukes HA, de Loos F, Gültuna I. Subcutaneous stimulation as an additional therapy to spinal cord stimulation for the treatment of lower limb pain and/or back pain: a feasibility study. Neuromodulation. 2012 Mar-Apr;15(2):108-16; discussion 116-7. doi: 10.1111/j.1525-1403.2011.00393.x. Epub 2011 Sep 21.
  7. Lepski G, Vahedi P, Tatagiba MS, Morgalla M. Combined spinal cord and peripheral nerve field stimulation for persistent post-herniorrhaphy pain. Neuromodulation. 2013 Jan;16(1):84-9. doi: 10.1111/j.1525-1403.2012.00463.x. Epub 2012 Jun 1.
  8. Reverberi C, Dario A, Barolat G. Spinal Cord Stimulation (SCS) in Conjunction With Peripheral Nerve Field Stimulation (PNfS) for the Treatment of Complex Pain in Failed Back Surgery Syndrome (FBSS). Neuromodulation. 2013 Jan;16(1):78-83. doi: 10.1111/j.1525-1403.2012.00497.x. Epub 2012 Sep 17.
  9. Occipital Nerve Stimulation. Blue Cross Blue Shield of Vermont. July, 2011.
Bibliography

NA

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
12/01/2019 R3

Removed the following information from the Utilization Guidelines in the Associated Information section as this is appropriately documented in the Revision History: 06/20/18 - At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy. LCD updated to add ICD-10-CM code M54.81.

As required by CR 10901, all billing and coding information has been moved to the companion article; this article is linked to the LCD.

12/01/19: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

 

  • Typographical Error
  • Revisions Due To Code Removal
01/01/2019 R2

The LCD revised to remove deleted CPT code 64550 from Group 1 effective 1/1/2019.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy. The draft LCD was issued prior to the implementation of the 21st Century Cures Act so the requirement of the Act does not apply to this policy.

 

  • Revisions Due To CPT/HCPCS Code Changes
11/02/2018 R1

08/23/2018 - At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy. The draft LCD was issued prior to the implementation of the 21st Century Cures Act so the requirement of the Act does not apply to this policy.

This LCD is being republished with a new Notice Period and Effective Date because the 45-day notice of the original Draft to Final LCD did not get published per CMS requirements.

  • Other (No Notice Period article posted with original Draft to Final LCD in error.)
N/A

Associated Documents

Attachments
N/A
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
01/29/2020 12/01/2019 - N/A Currently in Effect View
11/20/2019 12/01/2019 - N/A Superseded You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

  • Peripheral Nerve
  • Stimulation
  • Trial
  • 61885
  • 64550
  • 64553
  • 64555
  • 64561
  • 64569
  • 64570
  • 64575
  • 64581
  • 64585
  • 64590
  • 64595
  • 64999

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