VAX-D Therapy Seminar Handout

May 4, 2000

This document was distributed in 1999 as a 2-page handout at a presentation to an insurance group given by VAT’-TECH medical director Frank Tilaro, M.D. The FDA’s 510K clearance to market the device does not permit the manufacturer to represent that VAX-D therapy affects disc metabolism or is “approved for lumbar disc herniations, degeneration, by effecting lumbar decompression,” as stated below.

COMPARISON VAX-D vs TRACTION
VAX-D TRACTION
Function Function
  1. Negative intradiscal pressure.
  2. Mechanical effect — capitalizes on the thixotrophic properties of the nucleus pulposis.
  3. Diffusion gradient — effect on biochemical and biophysiological aspect of disc metabolism.
  1. Intradiscal pressure may/may not be Reduced, not negative.
  2. Cannot capitalize on the thixotrophic properties of the nucleus pulposis.
  3. Diffusion gradient not effected may actually be decreased.
Use  Use
  1. Treatment last 30-45 minutes.
  2. Treatment requires 1:1 monitor by a trained, certified staff member under direct supervision of medical doctor.
  3. Treatment is a medical procedure that needs to be adjusted and controlled throughout the session.
  4. Cost of purchase $125,000
  5. Treat only discogenic pain syndromes.
  6. Patient selection: Only unresponsive lumbar discogenic pain syndromes. Must have tried at least 6 weeks of previous conservative care and not be progressing.
  1. Treatments may last minutes to 15 minutes.
  2. Treatment may/may not require any supervision.
  3. Receives only patient subject response as monitor and requires little to no adjusting during session.
  4. Cost to purchase: 0 – $7,000.
  5. Typically contraindicated for lumbar discogenic pain syndromes also used for lumbar strain/sprain.
  6. Patient selection: first tier treatment rendered on day one of the condition.
Studies  Studies
  1. FDA approved for lumbar disc herniations, degeneration, by effecting lumbar decompression
  2. Published study proving it effects negative pressure in lumbar discs in live patients. (1)
  3. Outcomes study: 70% success on unresponsive lumbar discogenic pain syndromes in over 700 patients’ trial. Average length of condition prior to treatment nearly 3 years. 90% had some improvement. (2)
  4. Objective neurologic improvement obtained using VAX-D. (3)
  5. Four published studies in peer reviewed journals 1,2,3,4.
  1. Not FDA approved to treat herniations, degeneration by decompressing the lumbar discs.
  2. No published study proving negative pressure in lumbar discs in live patients. Some studies indicate traction increases disc pressure.
  3. Studies not on long term disc sufferers. Studies available show equivocal results.
  4. Does not effect lumbar decompression.
  • Dozens of lower Courts as well as all appellate court decision have upheld that VAX-D is different than traction.
  • Medical Technology Group (5) National utilization and review company that reviews new technologies and reports findings to subscribing insurance companies. After an extensive study, they published a four part review of their findings.
  • VAX-D is different than traction and should have a separate identifiable code and separate relative value.
  • BLUE CROSS/ BLUE SHIELD OF MINNESOTA
    Has offered VAX-D providers a contract with a different relative value and procedure code than traction.
  • Relative Value for Physicians (RVP) (6) the most widely used proprietary relative value system. The only independent relative value source established other than medicare. Utilized by approximately 50% or insurance companies/HMO’s to determine reimbursability. Has established a preliminary code, separate from traction, in January of 1999.
    • Has established a relative value of 28 compared to traction which is, 6 after extensive review of the technology.
    • Based criteria on
      1. Time it takes.
      2. Skill involved.
      3. Risks to patient.
      4. Risks to provider
      5. Severity of illness.
  • Written opinions of two local Medical Doctors whom we utilized for case studies.
  • No previous U & R has been performed locally, regionally or nationally by ally independent entity that continues to describe as traction after review of all data.

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This article was posted on May 4, 2000.