Local Coverage Determination (LCD)

Spinal Cord Stimulators for Chronic Pain

L37632

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Contractor Information

LCD Information

Document Information

LCD ID
L37632
LCD Title
Spinal Cord Stimulators for Chronic Pain
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 01/29/2018
Revision Effective Date
For services performed on or after 05/13/2021
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
12/14/2017
Notice Period End Date
01/28/2018
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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CMS National Coverage Policy

Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 2, §160.7 Electrical Nerve Stimulators

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Background

The implantation of spinal cord stimulators (SCS) may be covered as therapies for the relief of chronic intractable pain. SCS is best suited for neuropathic pain, but may have some limited value in other types of nociceptive severe, intractable pain. Therapy consists of a short trial with a percutaneous implantation of neurostimulator electrode(s) in the epidural space for assessing a patient’s suitability for ongoing treatment with a permanent surgically implanted nerve stimulator. Performance and documentation of an effective trial is a prerequisite for permanent nerve stimulation.

Selection of patients for implantation of SCS is critical to success of this therapy. SCS therapy should be considered as a late option after more conservative attempts, such as medications, physical therapy, psychological therapy or other modalities have been tried.

Patients must have undergone careful screening, evaluation and diagnosis by a multidisciplinary team prior to implantation. (Such screening must include psychological, as well as, physical evaluation). Documentation of the history and careful screening must be available in the patient chart if requested.

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 required for the proper surgery, and follow up of the patient are available. Permanent neurostimulators must be placed in an ASC or hospital. Physicians performing SCS trials in the office setting must have like privileges at a local hospital or ASC, or the providers must be subspecialty boarded in Pain Medicine by the American Board of Anesthesiology.

It is preferable that physicians performing the SCS trial will also perform the permanent implant. If the physician implanting the trial neurostimulator does not or cannot implant the permanent neurostimulator, the patient should be informed of this in writing and given the name of the referral surgeon, who will implant the permanent neurostimulator(s). It is expected that accurate patient selection will lead to most patients going on to receive permanent implants.

Only patients who experience a positive response to a trial should proceed to a permanent implantation. 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. (Patients with reflex sympathetic dystrophy may show lower levels of improvement, since it takes longer periods for improvement than the typical 1 to 2 week trial). Physician judgment and experience will also be taken into account. Physicians with a low trial to permanent implant ratio (less than 50%) may/can/will be subject to post-payment review and may be asked to submit documentation as to the patient selection criteria, the radiologic 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.

Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

General Information

Associated Information

Documentation Requirements

The patient's medical record must contain documentation that fully supports the medical necessity for services included within this Local Coverage Determination (LCD). This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

Documentation supporting medical necessity should be legible, maintained in the patient’s medical record, and made available to A/B MAC upon request.

The clinical record should include the elements leading to the diagnosis and the therapies tried before the decision to use SCS.

When the documentation does not meet the criteria for the service rendered, or the documentation does not establish the medical necessity for the services, such services will be denied as not reasonable and necessary.

Sources of Information

N/A

 

 

Bibliography

McIntyre PJ, Bedder MD. Complications of spinal cord stimulation. In: Deer TR, Ed. Neurostimulation for the Treatment of Chronic Pain: Interventional and Neuromodulatory Techniques for Pain Management Series. Vol 1. 1st ed. Philadelphia, PA: Elsevier Saunders;2011.

Rauck RL, Nagel S, North JL, Machado AG. Spinal cord stimulation: Implantation techniques. In: Deer TR, Ed. Neurostimulation for the Treatment of Chronic Pain: Interventional and Neuromodulatory Techniques for Pain Management Series. Vol 1. 1st ed. Philadelphia, PA: Elsevier Saunders;2011.

Shah BJ, Hayek SM, Khalil AA. Medical considerations in spinal cord stimulation. In: Deer TR, Ed. Neurostimulation for the Treatment of Chronic Pain: Interventional and Neuromodulatory Techniques for Pain Management Series. Vol 1. 1st ed. Philadelphia, PA: Elsevier Saunders;2011.

Shahbazian MS, Richeimer SH. Implant technologies for severe pain: Why, when, and the outcomes. Practical Pain Management.2011;11(8):73-79.

Wu C, Falowksi SM, Sharan A. Spinal cord stimulation: General indications. In: Deer TR, Ed. Neurostimulation for the Treatment of Chronic Pain: Interventional and Neuromodulatory Techniques for Pain Management Series. Vol 1. 1st ed. Philadelphia, PA: Elsevier Saunders;2011.

Revision History Information

Revision History DateRevision History NumberRevision History ExplanationReasons for Change
05/13/2021 R7

Under CMS National Coverage Policy added regulation CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 2, §160.7 Electrical Nerve Stimulators. Formatting, punctuation and typographical errors were corrected throughout the LCD.

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.

  • Public Education/Guidance
12/10/2020 R6

Under Bibliography changes were made to citations to reflect AMA citation guidelines. Formatting, punctuation and typographical errors were corrected throughout the LCD. Acronyms were inserted and defined where appropriate throughout the LCD.

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.

  • Provider Education/Guidance
10/24/2019 R5

This LCD is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs. There has been no change in coverage with this LCD revision. Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of this LCD and placed in the related Billing and Coding: Spinal Cord Stimulators for Chronic Pain A56876 article. Formatting, punctuation and typographical errors were corrected throughout the LCD.

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.

 

  • Provider Education/Guidance
08/22/2019 R4

All verbiage regarding billing and coding under the Coverage Indications, Limitations and/or Medical Necessity and Associated Information sections and all coding located in the Coding Information section has been moved into the related Billing and Coding: Spinal Cord Stimulators for Chronic Pain A56876 article and removed from the LCD. Under Bibliography changes were made to citations to reflect AMA citation guidelines. Formatting and punctuation were corrected throughout the LCD. 

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.

  • Provider Education/Guidance
01/01/2019 R3

Under CMS National Coverage Policy the verbiage, “NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860 (b) and 42 CFR 426 (Subpart D)). In addition, an administrative law judge may not review a NCD. See section 1869 (f)(1)(A)(l) of the Social Security Act” has been deleted. Under CPT/HCPCS Codes Group 1: Codes the code descriptions were revised for CPT codes 95970, 95971 and 95972. This revision is due to the Annual CPT/HCPCS Code Update.

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.

 

  • Provider Education/Guidance
  • Revisions Due To CPT/HCPCS Code Changes
02/26/2018 R2 The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.
  • Change in Affiliated Contract Numbers
01/29/2018 R1

The Jurisdiction "J" Part A Contracts for Alabama (10111), Georgia (10211) and Tennessee (10311) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 01/28/18. Effective 01/29/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part A contract numbers) have been completed in this revision.

 

  • Other

Associated Documents

Attachments
N/A
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
05/04/2021 05/13/2021 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

  • Spinal Cord
  • Chronic Pain

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