Spinal Cord Stimulator Does It Work?

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Spinal Cord StimulatorDoes It Work?

• Steve Storick, M.D.
• Palmetto Health
• Pain Management and Rehabilitation Center
• October 15, 2012

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Disclaimer

• I do not receive any direct compensation from the
  makers of Spinal Cord Stimulators (Medtronic, St.
  Jude or Boston Scientific)
• I may have stock in all three companies through
  an investment banker

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Approved Uses

• Chronic Pain of the Trunk or Limbs
• Neuropathic Pain
• Radiculopathy
• Peripheral Neuropathy
• Failed Back Surgery Syndrome
• Arachnoiditis
• Phantom Limb / Stump Pain
• Complex Regional Pain Syndrome (RSD)

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Other Uses

• Peripheral Vascular Disease / Ischemic Limbs
• Angina Pectoris (not approved in US)

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Maybe / Maybe Not

• Knee Pain
• Shoulder Pain
• Groin / Testicular Pain
• Mechanical Back Pain
• Abdominal Pain
• Post Surgical Pain (Orthopedic)
• Primarily Back or Neck Pain
• Many abstracts, but not studies

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Due Diligence

• Extremity Pain
• Symptoms c/w neuropathic pain
• Test supporting diagnosis
• MRI, EMG, Myelogram/CT Scan
• Appropriate conservative treatments
• Surgical remedy?
• Psychological evaluation
• SCS Trial

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Back / Neck Pain

• When SCS does not work well
• Back or Neck Pain greater than extremity pain
• Short term relief during trial and maybe up to 6
  months with permanent device
• Peripheral Field Electrodes are experimental
• Very expensive TENS unit
• Placed under skin not epidural

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COMPLEX REGIONAL PAIN SYNDROME (CRPS)

• Old term is Reflex Sympathetic Dystrophy (RSD)
• Usually post traumatic
• Fracture most common injury
• Usually affects upper gt lower extremity
• Based on specific subjective and objective
  criteria (IASP)
• 2 0f 4 signs
• 3 of 4 symptoms

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CRPS (RSD)

• Patients knowledgeable of symptoms (Internet) but
  entire clinical picture not c/w CRPS
• Chronic pain maybe secondary to surgical trauma
• One Physician says so, everyone else does too
• No specific test
• Incidence 5.5-16.8 per 100,000

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Back to SCS Trials

• Should have appropriate Psychological Evaluation
  including testing
• Not just a mental status exam
• Clear understanding of purpose of SCS and goals
  (Reduce pain gt50-60 and Functional Improvement)
• Should last several days
• Complications should be unusual
• Rarely need repeating

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Manufacturer

• Three Companies (Boston Scientific, Medtronic,
  St. Jude)
• All three equal
• Few different bells and whistles
• No reason to repeat trial with different system
• No reason to replace functioning implanted
  system w/ different manufacturer

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CMS proposes 2013 changes

• Bundle cost of the lead into 63650 for office
• Suggest that L8680 not appropriate code for
  office setting
• Establish values for physician practice expense
  in the office setting

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Palmetto GBA Draft (DL32549)

• Patients must have undergone careful screening,
  evaluation and diagnosis by a multidisciplinary
  team prior to implantation
• Must not have active substance abuse issues
• Proper patient education about SCS
• Appropriate Psychological screening
• No major issues including severe depression
• May be a candidate if patient receives treatment

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Palmetto GBA Draft (DL32549)

• Can perform SCS trial in office if appropriately
  supplied and staffed. Must have like privileges
  in local hospital / ASC or board certified in
  Pain Management
• Preferable that trial physician also implant
  permanent
• Successful trial should be associated w/ at least
  50 reduction of target pain or analgesic
  medication and show some element of functional
  improvement

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Palmetto GBA Draft (DL32549)

• Physicians w/ low trial to permanent implant
  ratio (lt50) will be subject to post payment
  review
• May lead to overimplanting of permanent devices
• Reimburse for a maximum of 2 leads or 16 contacts
  for 1 trial per anatomic spinal region per
  patient per lifetime
• Repeat trial only w/ extenuating circumstances

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L8680

• CMS pays per contact to maximum of 16
• /- 428 x 16 6828
• Cost Free(?) to 1200 per electrode (8 contacts)
• Procedural codes CPT 63650 and 63650-59 are
  separate fees
• BCBS of SC pays invoice for L8680

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Decisions

• ASC or Hospital costs 6,000-12,000 or more for
  trial
• In office has led to over utilization
• Repeat trials w/ different device companies
• No proof one is better than other different
  whistles and bells
• Wrong reason (diagnosis) or patient

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Advantages/Disadvantages

• Less medication
• More control of pain
• Functional improvement
• Limited MRI use
• Potential interaction with Pacemakers/AICDs
• Electrocautery/Surgery

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Outcomes

• Over 60 studies of varying quality
• Lumbar fusions 1 or 2 level or even more?
• Back to work
• Private Insurance Patients
• When can I go back to work?
• WC Patients
• I cant work!

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• No, the SCS does not make patient worse
• Unless major complication such as infection
• or nerve damage with implantation

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THANK YOU