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Date Printed: August 21, 2017: 07:33 PM

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This medical policy (medical coverage guideline) is Copyright 2017, 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 2017 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.

Original Effective Date: 09/15/02

Reviewed: 05/25/17

Revised: 06/15/17

Subject: Spinal Cord Stimulation

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:

Spinal cord stimulation delivers low voltage electrical stimulation to the dorsal columns of the spinal cord to block the sensation of pain. Spinal cord stimulation devices have a radiofrequency receiver that is surgically implanted and a power source (battery) that is either implanted or worn externally. Spinal cord stimulation devices consist of several components:

1. The lead that delivers the electrical stimulation to the spinal cord;

2. An extension wire that conducts the electrical stimulation from the power source to the lead, AND

3. A power source that generates the electrical stimulation.

The lead may incorporate from 4 to 8 electrodes, with 8 electrodes more commonly used for complex pain patterns, such as bilateral pain or pain extending from the limbs to the trunk. There are two basic types of power source. In one type the power source (battery) can be surgically implanted. In another a radio-frequency receiver is implanted, and the power source is worn externally with an antenna over the receiver. Totally implantable systems are most commonly used.

Traditional spinal cord stimulation devices use electrical stimulation with a frequency on the order of 100 to 1000 Hz. Some devices allow adjustment of the frequency settings. In 2015, a device using a higher frequency of electrical stimulation (10,000 Hz) than predicate devices was approved by the U.S. Food and Drug Administration (FDA). The high-frequency stimulation is proposed to be associated with fewer paresthesias, which are a recognized effect of SCS. In addition, in 2016, FDA approved a clinician programmer “app” that allows a spinal cord stimulation device to provide stimulation in “bursts” rather than at a constant rate. Burst stimulation is proposed to provide pain relief with fewer paresthesias. The burst stimulation device works in conjunction with standard SCS devices. With the newly approved app, stimulation is provided in five 500-Hz burst spikes at a rate of 40 Hz, with a pulse width of 1 ms.

Another variation on spinal cord stimulation is the wireless injectable stimulator. These miniaturized neurostimulators are transforaminally placed at the dorsal root ganglion (DRG) and are used to treat pain. DRG are located between spinal nerves and the spinal cord on the posterior root and are believed to play an important role in neuropathic pain perception. Two systems have received approval or clearance from FDA.

POSITION STATEMENT:

 

Certificate of Medical Necessity

Submit a completed Certificate of Medical Necessity (CMN) along with your request to expedite the medical review process.

1. Click the link Spinal Cord Stimulation - Certificate of Medical Necessity (MS Word) to open the form.

2. Complete all fields on the form thoroughly.

3. Print and submit a copy of the form with your request.

Note: Florida Blue regularly updates CMNs. Ensure you are using the most current copy of a CMN before submitting to Florida Blue. For a complete list of available CMNs, visit the Certificates of Medical Necessity page.

Temporarily implanted standard or high-frequency spinal cord stimulator meets the definition of medical necessity for the treatment of severe and chronic, intractable neuropathic pain of the trunk or limbs when ALL of the following criteria are met:

Permanent implanted standard or high-frequency spinal cord stimulator meets the definition of medical necessity for the treatment of severe and chronic, intractable neuropathic pain of the trunk or limbs when ALL of the following criteria are met:

Spinal cord stimulation is experimental or investigational for all other indications including, but not limited to, treatment of critical limb ischemia to forestall amputation, treatment of refractory angina pectoris, heart failure, and cancer-related pain. There is insufficient evidence to conclude that spinal cord stimulation improves net health outcomes.

Wireless injectable dorsal root ganglion neurostimulation is considered experimental or investigational for the treatment of severe and chronic pain of the trunk or limbs. The evidence is insufficient to determine the effects of the technology on health outcomes.

BILLING/CODING INFORMATION

CPT Coding:

63650

Percutaneous implantation of neurostimulator electrode array, epidural

63655

Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural

63661

Removal of spinal neurostimulator electrode percutaneous array(s), including fluoroscopy, when performed

63662

Removal of spinal neurostimulator electrode plate/paddle(s) placed via laminotomy or laminectomy, including fluoroscopy, when performed

63663

Revision including replacement, when performed, of spinal neurostimulator electrode percutaneous array(s), including fluoroscopy, when performed

63664

Revision including replacement, when performed, of spinal neurostimulator electrode plate/paddle(s) placed via laminotomy or laminectomy, including fluoroscopy, when performed

63685

Insertion or replacement of spinal neurostimulator pulse generator or receiver, direct or inductive coupling

63688

Revision or removal of implanted spinal neurostimulator pulse generator or receiver

95970

Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple or complex brain, spinal cord, or peripheral (i.e. cranial nerve, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, without reprogramming

95971

Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple spinal cord, or peripheral (i.e. peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming

95972

Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex spinal cord, or peripheral (ie, peripheral nerve, sacral nerve, neuromuscular) (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming

HCPCS Coding:

L8679

Implantable neurostimulator pulse generator, any type

L8680

Implantable neurostimulator electrode, each

L8681

Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only

L8682

Implantable neurostimulator radiofrequency receiver

L8683

Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver

L8685

Implantable neurostimulator pulse generator, single array, rechargeable, includes extension

L8686

Implantable neurostimulator pulse generator, single array, non-rechargeable, includes extension

L8687

Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension

L8688

Implantable neurostimulator pulse generator, dual array, non-rechargeable, includes extension

L8689

External recharging system for implanted neurostimulator, replacement only battery (internal) for use with implantable neurostimulator, replacement only

L8695

External recharging system for battery (external) for use with implantable neurostimulator, replacement only

ICD-10 Diagnosis Codes That Support Medical Necessity:

G56.40

Causalgia of unspecified upper limb

G56.41

Causalgia of right upper limb

G56.42

Causalgia of left upper limb

G56.43

Causalgia of bilateral upper limbs

G57.70

Causalgia of unspecified lower limb

G57.71

Causalgia of right lower limb

G57.72

Causalgia of left lower limb

G57.73

Causalgia of bilateral lower limbs

G89.0 – G89.4

Pain, not elsewhere classified

G90.50 – G90.59

Complex regional pain syndrome l (CRPS l)

M25.50 – M25.579

Pain in joint

M54.10 – M54.18

Radiculopathy

M54.30 – M54.32

Sciatica

M54.40 – M54.42

Lumbago with sciatica

M54.5

Low back pain

M54.6

Pain in thoracic spine

M54.81 – M54.9

Dorsalgia

M79.1

Myalgia

M79.60 – M79.676

Pain in limb, hand, foot, fingers and toes

REIMBURSEMENT INFORMATION:

Reimbursement for the revision or removal of spinal neurostimulator pulse generator or receiver is made only if the implantation procedure was initially allowed.

The following information is required documentation to support medical necessity: physician history and physical, physician progress notes including demonstration of pain relief with temporary stimulator, documentation of other treatment modalities (pharmacological, surgical, therapy), treatment plan including narrative, radiology study reports, and physician operative report.

LOINC Codes:

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 progress note

18741-9

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

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.

Physician operative report

28573-4

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

Treatment plan, plan of treatment

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

Physical therapy initial assessment

18735-1

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

Physical therapy progress note

11508-9

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

Current, discharge, or administered medications

34483-8

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

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following National Coverage Determinations (NCDs) were reviewed on the last guideline reviewed date: Electrical Nerve Stimulators (160.7) located at cms.gov.

DEFINITIONS:

Intractable: not easily relieved or cured

Refractory: resistant to treatment or cure

RELATED GUIDELINES:

Deep Brain Stimulation and Responsive Neurostimulation, 02-61000-24

OTHER:

None

REFERENCES:

  1. Blue Cross Blue Shield Association. Medical Policy Reference Manual. 7.01.25 Spinal Cord Stimulation; 04/17.
  2. Boswell MV, Trescot AM, Datta S, Schultz DM, Hansen HC, Abdi S, Sehgal N, Shah RV, Singh V, Benyamin RM, Patel VB, Buenaventura RM, Colson JD, Cordner HJ, Epter RS, Jasper JF, Dunbar EE, Atluri SL, Bowman RC, Deer TR, Swicegood JR, Staats PS, Smith HS, Burton AW, Kloth DS, Giordano J, Manchikanti L; American Society of Interventional Pain Physicians. Interventional Techniques: Evidence-based Practice Guidelines in the Management of Chronic Spinal Pain. Pain Physician. 2007 Jan; 10(1): 7-111.
  3. Centers for Medicare and Medicaid Services (CMS), National Coverage Determination (NCD) for Electrical Nerve Stimulators (160.7), accessed at cms.gov.
  4. ClinicalTrials.gov, Clinical Study Protocol Dorsal Root Ganglion Stimulation for the Management of Painful Intractable Small Fibre Neuropathy, sponsored by Dr med. Paolo Maino Viceprimario Anestesiologia, accessed 04/24/17.
  5. ClinicalTrials.gov, Multi-center, Prospective, Randomized, Controlled Clinical Trial of Wireless High Frequency Spinal Cord Stimulation to Demonstrate Non-Inferiority in the Treatment of Chronic Pain as Compared to Traditional Stimulation, sponsored by Stimwave Technologies, accessed 05/23/16.
  6. ClinicalTrials.gov, The Pain Suppressive Effect of Low Frequency Spinal Cord Stimulation Versus High Frequency Spinal Cord Stimulation, sponsored by Jennifer Breel, accessed 05/23/16.
  7. ClinicalTrials.gov, Rospective, Open Label, Pilot Study of Patient OutcoMes Following Successful TriAl of High Frequency SpInal CorD Stimulation at 10kHz (HF10™) Leading to Permanent Implant Compared to Trial Failure and Standard CarE for the TreatmeNt of Persistent Low BACK Pain of Neuropathic Origin, sponsored by The leeds Teaching Hospital NHS Trust, accessed 05/23/16.
  8. ClinicalTrial.gov, Spinal Cord Stimulation for Heart Failure (SCS HEART), sponsored by St. Jude Medical, accessed 01/21/14.
  9. ClinicalTrials.gov, Spinal Cord Stimulation in Refractory Angina, sponsored by Catholic University of the Sacred Heart, accessed 01/21/14.
  10. ClinicalTrials.gov, STructural And FunCTional Brain Alterations by HIgh FrequenCy Spinal Cord Stimulation: a Combined Voxel-based Morphometry and Resting State Functional Connectivity Study, sponsored by Universitair Ziekenhuis Brussel, accessed 05/23/16.
  11. Cruccu G, Garcia-Larrea L, Hansson P, et al. EAN guidelines on central neurostimulation therapy in chronic pain conditions. Eur J Neurol. Oct 2016;23(10):1489-1499.
  12. Deer TR, Levy RM, Kramer J, et al. Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial. Pain. Dec 23 2016.
  13. Dworkin RH, O'Connor AB, Kent J et al. Interventional management of neuropathic pain: NeuPSIG recommendations. Pain 2013; 154(11):2249-61.
  14. ECRI. Custom Hotline Response. Rechargeable Spinal Cord Stimulation Systems for Chronic Pain Control. Plymouth Meeting, PA: ECRI. Updated 03/20/08.
  15. Hainline B. Chronic pain: physiological, diagnostic, and management considerations. Psychiatr Clin North Am. 2005 Sep; 28(3): 713-35.
  16. Kim JK, Hong SH, Lee JK, High-Level Cervical Spinal Cord Stimulation Used to Treat Intractable Pain Arising From Transverse Myelitis Caused by Schistosomiasis, J Korean Neurosurg Soc, 2010 February; 47(2): 151-154.
  17. Kumar K, Taylor R, et al, The Effects of Spinal Cord Stimulation in Neuropathic Pain are Sustained, Neurosurgery, October 2008, Vol 63, issue 4, p762-770.
  18. Mailis-Gagnon A, Furlan AD, Sandoval JA, Taylor R. Spinal cord stimulation for chronic pain. Cochrane Database of Systematic Reviews 2004, Issue 3. Art. No.: CD003783. DOI: 10. 1002/14651858. CD003783.pub2.
  19. Mailis A, Taenzer P. Evidence-based guideline for neuropathic pain interventional treatments: spinal cord stimulation, intravenous infusions, epidural injections and nerve blocks. Pain Res Manag 2012; 17(3):150-8.
  20. Manca A, Kumar K, Taylor RS, et al, Quality of Life, Resources Consumption and Costs of Spinal Cord Stimulation Versus Conventional Medical Management in Neuropathic Pain Patients with Failed Back Surgery Syndrome, Eur J Pain, November 2008.
  21. Manchikanti L, Abdi S, Atluri S et al. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician 2013; 16(2 Suppl):S49-283.
  22. National Guideline Clearinghouse (NGC), Guideline Summary: 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease. Accessed at guideline.gov 01/20/15..
  23. National Institute for Health and Clinical Excellence (NICE), Spinal Cord Stimulation for Chronic Pain of Neuropathic or Ischaemic Origin, October 2008.
  24. North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005 Jan; 56(1): 98-106; discussion 106-7.
  25. Ontario Ministry of Health and Long Term Care, Medical Advisory Secretariat. Spinal cord stimulation for the management of neuropathic pain. Health Technology Literature Review. Toronto, ON: Ontario Ministry of Health and Long Term Care; March 2005.
  26. Pedrini L, Magnoni F. Spinal cord stimulation for lower limb ischemic pain treatment. Interact Cardiovasc Thorac Surg. 2007 Aug; 6(4):495-500. Epub 2007 Apr 6. Review.
  27. Practice guidelines for chronic pain management. A report by the American Society of Anesthesiologists Task Force on Pain Management, Chronic Pain Section. Anesthesiology. 1997 Apr; 86(4): 995-1004.
  28. Simpson EL, Duenas A, Holmes MW, et al, Spinal Cord Stimulation for Chronic Pain of Neuropathic or Ischaemic Origin: Systematic Review and Economic Evaluation, Health Technology Assessment, March 2009.
  29. Thevathasan W, Mazzone P, et al, Spinal Cord Stimulation Failed to Relieve Akinesia or Restore Locomotion in Parkinson Disease, Neurology, April 20, 2010.
  30. Ubbink DT, Vermeulen H. Spinal cord stimulation for non-reconstructable chronic critical leg ischaemia. Cochrane Database of Systematic Reviews 2005, Issue 3. Art. No.: CD004001. DOI: 10.1002/14651858.CD004001.pub2.
  31. Yakovlev AE, Tamimi MA, et al, Spinal Cord Stimulation as Alternative Treatment for Chronic Post-Herniorrhaphy Pain, Neuromodulation, Epub 24 Feb 2010.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 05/25/17.

GUIDELINE UPDATE INFORMATION:

09/15/02

Medical Coverage Guideline Reformatted.

01/01/04

Annual HCPCS coding update.

10/15/04

Review and revision to guideline; consisting of updated references, removed information about intracranial neurostimulation and moved information to Deep Brain Stimulation MCG, added information to description section, added additional information to When Services are Covered section, and changed name from Central Nervous Stimulators to Spinal Cord Stimulation.

01/01/05

Annual HCPCS coding update: consisting of the revision of 63685 and the addition of 95970, 95971, 95972 and 95973.

10/15/05

Review and revision of guideline; consisting of updated references.

01/01/06

Annual HCPCS coding update: consisting of the deletion of E0752, E0756, E0757, E0758 and the addition of L8680, L8681, L8682, L8683, L8685, L8687, L8688, and L8689.

10/15/06

Review and revision of guideline consisting of updated references.

01/01/07

Annual HCPCS coding update: consisting of the revision of L8689 and the addition of L8695.

07/15/07

Annual review, current coverage maintained, guideline reformatted, references updated.

10/15/08

Review and revision of guideline consisting of updated references.

01/01/09

Annual HCPCS coding update: revised descriptor for codes L8681, L8689, and L8695.

09/15/09

Annual review: maintained position statements, description section, and references updated.

01/01/10

Annual HCPCS coding update: added codes 63661 – 63664; deleted code 63660.

07/15/10

Annual review: position statements maintained and references updated.

10/15/10

Revision: formatting changes.

10/01/11

Revision: formatting changes.

01/01/12

Annual HCPCS update. Revised descriptor for codes 95970-95973.

01/01/14

Annual HCPCS update. Added code L8679. Program Exceptions section updated.

03/15/14

Review; updated position statement, Program Exceptions, and references; formatting changes.

01/01/15

Annual HCPCS/CPT update. Revised code 95972.

03/15/15

Annual review; investigational position statement and references updated; formatting changes.

01/01/16

Annual HCPCS/CPT update; code 95972 revised, code 95973 deleted.

07/15/16

Revision; description, position statement section and references updated; formatting changes.

10/01/16

ICD-10 coding update; codes G56.43 & G57.73 added. Revision; formatting changes.

01/01/17

Annual CPT/HCPCS update. Revised 95972.

06/15/17

Revision; High-frequency spinal cord stimulation added to position statements; investigational statement for wireless injectable dorsal root ganglion neurostimulation added; description section and references updated.

Date Printed: August 21, 2017: 07:33 PM