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Spinal Cord Stimulator Does It Work?. Steve Storick, M.D. Palmetto Health Pain Management and Rehabilitation Center October 15, 2012. Disclaimer. I do not receive any direct compensation from the makers of Spinal Cord Stimulators (Medtronic, St. Jude or Boston Scientific)
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Spinal Cord StimulatorDoes It Work? Steve Storick, M.D. Palmetto Health Pain Management and Rehabilitation Center October 15, 2012
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
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)
Other Uses • Peripheral Vascular Disease / Ischemic Limbs • Angina Pectoris (not approved in US)
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
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
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
COMPLEX REGIONAL PAIN SYNDROME (CRPS) • Old term is Reflex Sympathetic Dystrophy (RSD) • Usually post traumatic • Fracture most common injury • Usually affects upper > lower extremity • Based on specific subjective and objective criteria (IASP) • 2 0f 4 signs • 3 of 4 symptoms
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
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 >50-60% and Functional Improvement) • Should last several days • Complications should be unusual • Rarely need repeating
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
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
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
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
Palmetto GBA Draft (DL32549) • Physicians w/ low trial to permanent implant ratio (<50%) 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
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
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
Advantages/Disadvantages • Less medication • More control of pain • Functional improvement • Limited MRI use • Potential interaction with Pacemakers/AICDs • Electrocautery/Surgery
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!
No, the SCS does not make patient worse • Unless major complication such as infection or nerve damage with implantation