Local Coverage Determination (LCD)

Spinal Cord Stimulators for Chronic Pain

L36204

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Contractor Information

LCD Information

Document Information

LCD ID
L36204
LCD Title
Spinal Cord Stimulators for Chronic Pain
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL36204
Original Effective Date
For services performed on or after 06/01/2016
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
04/14/2016
Notice Period End Date
05/31/2016
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

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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

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. In situations where the spinal cord stimulator has been working well but is in need of replacement for battery change, malfunction or end of stimulator life, a new trial is not needed to replace the stimulator.

Selection of patients for implantation of spinal cord stimulators 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. Patients being selected for a trial

  • Must not have active substance abuse issues.
  • Must undergo proper patient education, discussion, and disclosure including an extensive discussion of the risks and benefits of this therapy.
  • Must undergo appropriate psychological screening

Many experts recommend that the temporary neurostimulator be placed in an 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 1-2 week trial). Physician judgment and experience will also be taken into account.

Physicians with a low trial to permanent implant ratio (less than 50%) 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.

Noridian will reimburse for placement of a maximum of 2 leads or 16 “contacts,” and for 2 SCS trials per anatomic spinal region per patient per lifetime (with exceptions allowed for technical limitations for the initial trials or for use of different modalities of stimulation, including new technology). More than 2 SCS trials per anatomic spinal region per patient per lifetime is not considered reasonable and necessary.

If a trial fails, a repeat trial is not appropriate unless there are extenuating circumstances that lead to trial failure.

Summary of Evidence

NA

Analysis of Evidence (Rationale for Determination)

NA

General Information

Associated Information

This final LCD, effective 06/01/2016, combines JFA DL36202 into the JFB LCD so that both JFA and JFB contract numbers will have the same final MCD LCD number.

Sources of Information

1. Feler CA. Spinal Cord Stimulation: Parameter Selection and Equipment Choices. In: Deer TR, Editor. Neurostimulation for the Treatment of Chronic Pain. Interventional and Neuromodulatory Techniques for Pain Management Series. Philadelphia, PA: Elsevier Saunders; 2011: 1-7-65.

2. McIntyre PJ, Bedder MD. Complications of Spinal Cord Stimulation. In: Deer TR, Editor. Neurostimulation for the Treatment of Chronic Pain. Interventional and Neuromodulatory Techniques for Pain Management Series Philadelphia, PA: Elsevier Saunders; 2011:1-15-134.

3. North RB. Spinal Cord Stimulation as a Treatment of Failed Back Surgrey Syndrome. In: Deer TR, Editor. Neurostimulation for the Treatment of Chronic Pain. Interventional and Neuromodulatory Techniques for Pain Management Series. Philadelphia, PA: Elsevier Saunders; 2011: 1-8-72.

4. Rauck RL, Nagel S, North JL, Machado AG. Spinal Cord Stimulation: Implantation Techniques. In: Deer TR, Editor. Neurostimulation for the Treatment of Chronic Pain. Interventional and Neuromodulatory Techniques for Pain Management Series. Philadelphia, PA: Elsevier Saunders; 2011: 1-6-54.

5. Shah BJ, Hayek SM, Khalil AA. Medical Considerations in Spinal Cord Stimulation. In: Deer TR, Editor. Neurostimulation for the Treatment of Chronic Pain. Interventional and Neuromodulatory Techniques for Pain Management Series. Philadelphia, PA: Elsevier Saunders; 2011: 1-3-19.

6. Shahbazian MS, Richeimer SH. Implant Technologies for Severe Pain: Why, When and the Outcomes. Practical Pain Management. Oct 2011;11(8):73-9.

7. Wu C, Falowksi SM, Sharan A. Spinal Cord Stimulation: General Indications. In: Deer TR, Editor. Neurostimulation for the Treatment of Chronic Pain. Interventional and Neuromodulatory Techniques for Pain Management Series. Philadelphia, PA: Elsevier Saunders; 2011: 1-5-39.

Bibliography

NA

Revision History Information

Revision History DateRevision History NumberRevision History ExplanationReasons for Change
12/01/2019 R6

The LCD is revised to remove CPT/HCPCS codes in the Keyword Section of 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.

  • Other (The LCD is revised to remove CPT/HCPCS codes in the Keyword Section of the LCD.
    )
12/01/2019 R5

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

12/01/2019: 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.

  • Revisions Due To Code Removal
10/01/2019 R4

Per the annual update effective 10/01/2019, the ICD-10 code description Z45.42 - Encounter for adjustment and management of neuropacemaker (brain) (peripheral nerve) (spinal cord) was changed to Z45.42 - Encounter for adjustment and management of neurostimulator.

10/01/2019 - 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.

  • Revisions Due To ICD-10-CM Code Changes
10/01/2017 R3

DATE (08/21/2017): 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.

Effective DOS on or after 6/1/16, CPT® codes 63661, 63662, 63688, and 95970-95972 are removed from this LCD. These procedure codes may be used for services unrelated to this LCD and are not subject to the DX criteria in the LCD.

Effective DOS 10/01/2017, ICD-10-CM M48.06 was deleted. ICD-10-CM codes M48.061 and M48.062 replaced the deleted M48.06.

  • Revisions Due To ICD-10-CM Code Changes
  • Other (CPT┬« codes 63661, 63662, 63688, and 95970-95972 are used for conditions unrelated to this LCD and are not subject to the DX criteria in this LCD. These codes were deleted to decrease provider confusion.)
10/01/2016 R2 This LCD has been updated to clarify that a repeat trial is not needed when replacing the stimulator due to the need for battery change, malfunction or end of stimulator life. Also deleted HCPCS code L8680 from Group 2
  • Creation of Uniform LCDs Within a MAC Jurisdiction
  • Reconsideration Request
  • Other (clarified that a repeat trial is not needed when replacing the stimulator due to the need for battery change, malfunction or end of stimulator life.)
10/01/2016 R1 The LCD is revised to add new ICD-10 codes effective 10/1/2016: G57.73, T85.113A, T85.113D, T85.113S, T85.123A
T85.123D, T85.123S, T85.193A, T85.193D and T85.193S.

The following ICD-10 codes descriptors were changed effective 10/1/2016: T85.112A, T85.112D, T85.112S,
T85.122A, T85.122D, T85.122S, T85.192A, T85.192D and T85.192S.1
  • Revisions Due To ICD-10-CM Code Changes

Associated Documents

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

Keywords

  • spinal
  • cord
  • spinal cord
  • stimulator
  • SCS
  • therapy
  • neurostimulator
  • implant
  • trial

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