Print Spinal Cord Stimulation

Spinal Cord Stimulation

 

DESCRIPTION

This policy addresses the use of electrical stimulation of the dorsal columns by implantation of electrodes in the epidural space as a treatment of chronic pain. The neurophysiology of pain relief after spinal cord injury is uncertain, but may be related to either activation of an inhibitory system or blockage of facilitory circuits. Spinal cord stimulation devices consist of implantable electrodes and receiver/transducer and a programmable transmitter that may be worn externally or may be fully implanted.

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 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 the other, a radiofrequency receiver is implanted, and the power source is worn externally with an antenna over the receiver. Totally implantable systems are most commonly used.

Spinal cord stimulation has been used in a wide variety of chronic refractory pain conditions, including pain associated with cancer, failed back pain syndromes, arachnoiditis, and complex regional pain syndrome (i.e., chronic reflex sympathetic dystrophy). There has also been interest in spinal cord stimulation as a treatment of critical limb ischemia, primarily in patients who are poor candidates for revascularization, and in patients with refractory chest pain. The neurophysiology of pain relief after spinal cord stimulation is uncertain, but may be related to either activation of an inhibitory system or blockage of facilitative circuits.

The patient’s pain distribution pattern dictates at what level in the spinal cord the stimulation lead is placed. The pain pattern may influence the type of device used; for example, a lead with 8 electrodes may be selected for those with complex pain patterns or bilateral pain. Implantation of the spinal cord stimulator is typically a 2-step process. Initially, the electrode is temporarily implanted in the epidural space, allowing a trial period of stimulation. Once treatment effectiveness is confirmed (defined as at least 50% reduction in pain), the electrodes and radio-receiver/transducer are permanently implanted. Successful spinal cord stimulation may require extensive programming of the neurostimulators to identify the optimal electrode combinations and stimulation channels. Computer-controlled programs are often used to assist the physician in studying the millions of programming options when complex systems are used.

A number of total implanted spinal cord stimulators have received U.S. Food and Drug Administration (FDA) premarket approval (PMA). The Cordis programmable neurostimulator from Cordis, Corp. was approved in 1981 and the Itrel(R) manufactured by Medtronic was approved in 1984. In April 2004, Advanced Bionics received PMA for its Precision spinal cord stimulator as an aid in management of chronic, intractable trunk and limb pain. All are fully implanted devices.

Spinal Cord Stimulation (SCS) for the Treatment of Intractable Angina Pectoris is addressed in a separate policy.

Deep Brain Stimulation of the thalamus as a treatment of tremor is addressed in a separate policy.

 

POLICY

Spinal cord stimulation may be considered medically necessary for the treatment of severe and chronic pain of the trunk or limbs that is refractory to all other pain therapies, when performed according to policy guidelines.

Spinal cord stimulation is considered investigational in all other situations including but not limited to treatment of critical limb ischemia as a technique to forestall amputation, treatment for refractory angina pectoris and treatment of cancer-related pain.

 

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity. 

 

POLICY GUIDELINES

Patient selection focuses on determining whether or not the patient is refractory to other types of treatment. The following considerations may apply.

  • The treatment is used only as a last resort; other treatment modalities (pharmacological, surgical, psychological, or physical, if applicable) have been tried and failed or are judged to be unsuitable or contraindicated;
  • Pain is neuropathic in nature; i.e., resulting from actual damage to the peripheral nerves. Common indications include, but are not limited to, failed back syndrome, complex regional pain syndrome (i.e., reflex sympathetic dystrophy), arachnoiditis, radiculopathies, phantom limb/stump pain, peripheral neuropathy. Spinal cord stimulation is generally not effective in treating nociceptive pain (resulting from irritation, not damage to the nerves) and central deafferentation pain (related to central nervous system damage from a stroke or spinal cord injury).
  • No serious untreated drug habituation exists;
  • Demonstration of at least 50% pain relief with a temporarily implanted electrode precedes permanent implantation;
  • All the facilities, equipment, and professional and support personnel required for the proper diagnosis, treatment, and follow-up of the patient are available.

Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

 

POLICY HISTORY

6/1993: Approved by Medical Policy Advisory Committee (MPAC)

3/2001: Policy reviewed; Hyperlinks inserted under Policy, Managed Care Requirements deleted, Sources updated

2/15/2002: Investigational definition added

3/6/2002: Individual consideration requirement deleted

5/7/2002: Type of Service and Place of Service deleted

2/21/2005: CPT  63685  , 95970  , 95971  , 95972  , 95973  description revised, CPT 63690-63691 deleted 1999, ICD-9 procedure codes 02.93, 03.93 description revised, HCPCS E0751 deleted 2001, HCPCS E0753 deleted 2002

10/26/2005: Code Reference section updated; CPT-4: 63660 added; ICD-9 Procedure: 02.93 deleted; 03.94, 86.94, 86.95, 86.96 added; HCPCS: E0752, E0754 added

11/15/2005:  ICD9 procedure codes 86.97, 86.98 added

3/14/2006:  Coding updated.  HCPCS 2005 & 2006 revisions added to policy

4/1/2008: Policy reviewed, no changes

12/31/2008: Code reference section updated per 2009 CPT/HCPCS revisions

1/8/2009: Policy reviewed, no changes

12/16/2009: Coding Section revised for 2010 CPT4 and HCPCS revisions

04/27/2010:  Policy description re-written extensively to provide information on various conditions spinal cord stimulation is used for, FDA status of devices, and techniques for device placement. Policy statement updated to add “and as a treatment for refractory angina pectoris” to the investigational statement. Patient selection criteria added to the policy guidelines. FEP verbiage added to the Policy Exceptions section.  Deleted outdated references in the Sources section.

04/18/2011: Policy description and statement unchanged. Removed deleted CPT code 63660 from the Code Reference section.

03/02/2012: Policy reviewed; no changes.

04/04/2013: Policy reviewed; no changes to policy statement.  Added ICD-9 procedure code 86.05 to the Code Reference section.

04/22/2014: Policy statement updated to add "in all other situations including but not limited to" and "cancer-related pain" to the investigational policy statement.

 

SOURCE(S)

Blue Cross & Blue Shield Association policy # 7.01.25

 

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

Code Number

Description

CPT-4

63650

Percutaneous implantation of neurostimulator electrode array; epidural

63655

Laminectomy for implantation of neurostimulator electrode 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

95970

Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude and 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 (ie, cranial nerve, peripheral nerve, autonomic nerve, neuromuscular) neurostimulator pulse generator/transmitter, without reprogramming

95971

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

95972

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

95973

Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex spinal cord, or peripheral (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, each additional 30 minutes after first hour (List separately in addition to code for primary procedure)

ICD-9 Procedure

03.93

Implantation or replacement of spinal neurostimulator lead(s)

03.94

Removal of spinal neurostimulator lead(s)

86.05

Incision with removal of foreign body or device from skin and subcutaneous tissue (Added 04-04-2013)

86.09

Other incision of skin and subcutaneous tissue

86.94

Insertion or replacement of single array neurostimulator pulse generator

86.95

Insertion or replacement of dual array neurostimulator pulse generator

86.96

Insertion or replacement of other neurostimulator pulse generator

86.97

Insertion or replacement of single array rechargeable neurostimulator pulse generator

86.98

Insertion or replacement of dual array rechargeable neurostimulator pulse generator

ICD-9 Diagnosis

 

See "Pain" in ICD-9 Diagnosis Guide

HCPCS

E0752

Implantable neurostimulator electrode, each

E0754

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

E0756

Implantable neurostimulator pulse generator

E0757

Implantable neurostimulation radiofrequency receiver

E0758

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

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

 

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