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Date Printed: June 27, 2016: 06:00 PM

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This medical policy (medical coverage guideline) is Copyright 2016, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2016 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-61000-03

Original Effective Date: 09/15/02

Reviewed: 08/25/11

Revised: 05/11/14

Subject: Percutaneous Electrical Nerve Stimulation (PENS)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
Other References Updates

DESCRIPTION:

Percutaneous electrical nerve stimulation (PENS) is similar in concept to TENS but differs in that needles are inserted either around or immediately adjacent to the nerves serving the painful area and then stimulated. PENS is generally reserved for patients who fail to get pain relief from TENS. PENS is also distinguished from acupuncture with electrical stimulation. In electrical acupuncture, needles are also inserted just below the skin, but the placement of needles is based on specific theories regarding energy flow throughout the human body. In PENS, the location of stimulation is determined by proximity to the pain rather than the theories of energy flow that guide placement of stimulation for acupuncture.

Percutaneous neuromodulation therapy (PNT) is a variant of PENS in which fine filament electrodes are temporarily placed at specific anatomic landmarks in the deep tissues near the area of the spine that is causing pain (with or without radiating lower extremity pain). Treatment regimens consist of 30-minute sessions, once or twice a week for 8 to 10 sessions.

Percutaneous Neuromodulation Therapy™ (Vertis Neurosciences) received approval to market by the U.S. Food and Drug Administration (FDA) through the 510(k) process in 2002. The labeled indication reads as follows:

“Percutaneous neuromodulation therapy (PNT) is indicated for the symptomatic relief and management of chronic or intractable pain and/or as an adjunctive treatment in the management of post-surgical pain and post-trauma pain.”

The Deepwave Percutaneous Neuromodulation Pain Therapy System (Biowave) received 510(k) approval in 2006, listing the Vertis Neuromodulation system and a Biowave TENS unit as predicate devices. The Deepwave system includes a sterile single-use percutaneous electrode array that contains 1,014 microneedles in a 1.5-inch diameter area. The needles are 736 microns (0.736 millimeters) in length; the patch is reported to feel like sandpaper or Velcro.

POSITION STATEMENT:

Percutaneous electrical nerve stimulation/percutaneous neuromodulation meets the definition of medical necessity when ALL of the following criteria are met:

NOTE: This diagnostic procedure, which involves stimulation of peripheral nerves by a needle electrode inserted through the skin, is performed only in a physician’s office, clinic, or hospital outpatient department. Therefore it is covered only when performed by a physician or incident to physician or incident to physician’s service. If pain is effectively controlled by percutaneous stimulation, implantation of electrodes is warranted.

BILLING/CODING INFORMATION:

There are no specific CPT codes for PENS or PNT. Unlisted CPT code 64999 may be used to report percutaneous electrical nerve stimulation (PENS) and percutaneous neuromodulation therapy (PNT). CPT codes for percutaneous implantation of neurostimulator electrodes (i.e., 64553–64565) are not appropriate since PENS and PNT use percutaneously inserted needles and wires rather than percutaneously implanted electrodes. The stimulation devices used in PENS and PNT are not implanted, so CPT code 64590 is also not appropriate.

LOINC Codes:

The following information may be required documentation to support medical necessity: physician history and physical, physician progress notes, treatment plan, radiology report(s) and diagnostic studies.

Documentation Table

LOINC Codes

LOINC
Time Frame
Modifier Code

LOINC Time Frame Modifier Codes Narrative

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

Attending physician visit note

18733-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Treatment plan

18776-5

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Radiology report

18726-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

Diagnostic studies (non-lab)

27899-4

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Treatment of Motor Function Disorders with Electric Nerve Stimulation (160.2) and Assessing Patient's Suitability for Electrical Nerve Stimulation Therapy (160.7.1), located at cms.gov.

The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Noncovered Services (L29288) located at fcso.com.

DEFINITIONS:

TENS (transcutaneous electric nerve stimulation): a small battery powered electronic device used for the treatment of pain. An electrode attaches to the skin near the painful area and sends a signal to the brain that competes with “pain signals” from the painful area, resulting in less perception of pain by the brain. These devices do not treat the cause of the pain, but decreases the brain’s sensation of the pain.

PENS (percutaneous electric nerve stimulation): similar to TENS except that instead of electrodes attached to the skin, a needle is inserted into the site of pain.

PNT (percutaneous neuromodulation therapy): a variant of PENS in which up to 10 fine filament electrodes are temporarily placed at specific anatomical landmarks in the back.

RELATED GUIDELINES:

Transcutaneous Electric Nerve Stimulation (TENS) 02-61000-04
Diaphragmatic-Phrenic Nerve Stimulation (i.e., Electrophrenic Pacemaker), 02-61000-33

OTHER:

Indexing terms:

Implantation of neurostimulator electrodes
Percutaneous electric nerve stimulator
Percutaneous implantation of neurostimulator electrodes
PENS

REFERENCES:

  1. American Society of Anesthesiologists, Practice Guidelines for Chronic Pain Management, 1997.
  2. Blue Cross and Blue Shield Association Medical Policy – Percutaneous Electric Nerve Stimulation (PENS) 7.01.29, (01/08/09).
  3. Blue Cross and Blue Shield Association TEC Assessments, (1988, 1996).
  4. Centers for Medicare and Medicaid Services (CMS) Manual System, Pub. 100-3, Medicare National Coverage, Chapter 1, Part 2, Section 160.2 Treatment of Motor Function Disorders with Electric Nerve Stimulation. 04/01/03.
  5. Centers for Medicare and Medicaid Services (CMS) Manual System, Pub. 100-3, Medicare National Coverage, Chapter 1, Part 2, Section 160.7.1 Assessing Patient’s Suitability for Electrical Nerve Stimulation Therapy. Accessed 07/22/11.
  6. Chou R, Qaseem A et al. Diagnosis and Treatment of Low Back Pain: A Joint Clinical Practice Guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007;147:478-491.
  7. ECRI TARGET database. Percutaneous neuromodulation therapy (PNT) for low-back pain. Target report 877. April 2005.
  8. Hayes, Inc. Hayes Medical Technology Directory. Electrical Stimulation of the Occipital Nerve for the Treatment of Occipital Neuralgia and Cervicogenic Headache. Lansdale, PA: Hayes, Inc., 12/13/06.
  9. National Guideline Clearing House. Guideline Summary NGC-8519. Pain (chronic). Work Loss Data Institute; 2008. Last updated 2011.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 08/25/11.

GUIDELINE UPDATE INFORMATION:

09/15/02

Medical Coverage Guideline Reformatted.

09/15/04

Scheduled review and revision to guideline; consisting of updated references and changed non-covered statement to investigational for electrical stimulation used for motor function disorders.

01/01/05

Annual HCPCS update; consisting of the revision of 64590.

01/01/07

HCPCS coding update consisting of the revision of 64590 and 64595.

07/15/07

Scheduled review, coverage and limitations maintained, Description, Billing/Coding Information, and Reimbursement Information section updated with CPT codes, guideline reformatted, and references updated.

09/15/09

Scheduled review; no change in position statement.

05/15/11

Revision; formatting changes.

09/15/11

Scheduled review; no change in position statement. Updated description section, billing/coding section and references, formatting changes.

05/11/14

Revision: Program Exceptions section updated.

Date Printed: June 27, 2016: 06:00 PM