Spinal Cord StimulatorDoes It Work?

Steve Storick, M.D.Palmetto Health

Pain Management and Rehabilitation CenterOctober 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

THANK YOU