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Lumbar Disc Disease: 10 Case Studies.

Cost of medical care, from drugs and band-aids to surgery and long-term care is a hotly debated topic in the medical and lay press. The authors undertook this small collection of case studies to access differing costs associated with a relatively new treatment for lumbar disc disease and the old “gold-standard”, surgery. In the genera of modern television, two differing views of the same problem were included. That of industry, which is represented by the HR director of the participating oil refinery, and that of medicine, was represented by the M.D. supervising the medical treatment of those patients not receiving surgery. The introduction is divided to represent these viewpoints.

This study was undertaken to explore creative suggestions in controlling benefits costs while maintaining an overall competitive health care package; reducing pain, suffering, and absenteeism in the company workforce; and reducing the associated costs of medical insurance and employee absences to the company. The “costs”

data for this paper was derived from a five (5) year study involving 10 employee

case files from a small petrochemical refinery and the experience gained in the

diverse worlds of medicine and business.

One of the biggest challenges facing employers today is how to strike a balance in

controlling benefits costs while maintaining an overall competitive health care

package for the workforce. It is no secret that benefits costs, particularly health

care costs, are escalating.

Double-digit increases are projected over the next several years according to a

percent average increase for 2003 and this comes after last year’s rate hike of 13.7

percent. This marks the highest increase since the early 1990s. “Unless there is a

fundamental change in the way health care is delivered, costs will double in the

next five years,” said Jack Bruner, national health care practice leader, Hewitt

Associates. “This is a major concern for senior management as it impacts the

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benefit costs for U.S. employers rose 14 percent in 2002, and are expected to

increase by 15 to 20 percent in 2003, according to a report released in August 2002

by the Philadelphia based Hay Group. “This is a very difficult time for companies

to cope with double-digit medical premium rate increases,” said Michael Carter,

vice president in Hay Group’s benefits practice. “In the current business

environment, most companies simply cannot afford to pass these costs along to

You do not have to be a benefits expert in light of the forgoing projections to

understand that any reduction in health care expense would be a positive move for

a company. You must, however, face the added challenge of controlling these

costs while providing a competitive package. Employers must be creative and

“think out-of-the-box.” Benefits will continue to be one of the top recruiting and

retention tools for a productive workforce. How employers manage the design,

cost and administration will distinguish them as an “employer of choice.”

Although the decision algorithm of the physician (efficacy and safety) is important

to industry as well, employers bear the cost and must consider the cost. The

American College of Occupational and Environmental Medicine reports, “Ninety

percent (90%) of adults in North America experience an acute episode of low-back

pain at least once in their lives.” Additionally, the COEM continues, “Costs

associated with compensable low-back injuries are estimated at $50 billion to $100

billion a year, with only one-third of that amount representing medical expenses.

The remaining two-thirds include non-medical costs for income replacement

indemnity, service benefits and medical legal expenses. (American College of

Occupational and Environmental Medicine, 1998).

The number one reason Americans miss work, after the common cold, is back

injuries. The ever-escalating costs of providing excellence in medical treatment

for our employees have far reaching effects. As our costs rise we must place

controls on our expenses to limit the rise in product price. We are forced to resort

to strategies that become progressively more draconian. We limit out health care

by selecting managed care and generic pharmaceuticals. We then outsource the

very management of our health care to an entity that is selected because it produces

a ‘lower utilization” of resources. We export production to other countries with

lower “costs”. This in turn necessitates that reduce our work force. We watch as

other industries work within this model and see industry giants in petrochemicals,

finance, and transportation in bankruptcies that would have been unimaginable

even ten years ago. We must be open to creative solutions.

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Physicians traditionally consider cost last when determining proper medical

treatment. Physicians are more concerned with risk-benefit ratios and

consideration of cost may place the patient at risk of receiving sub-optimal care.

Back injuries are the single largest medical expense for work related injuries. It is

time that we broaden our scope of vision and seek more effective and less

expensive methods of treatment. For those that have invested a lifetime of study to

a specific mode of treatment this change will be challenging both academically and

financially. This challenge is not new. General surgeons faced it and prospered

following the introduction of Cimetidine 25 years ago. Surgeries for “peptic ulcer

disease” accounted for a full 1/3 of surgeries performed and they disappeared

almost overnight.

First and foremost we must consider our patients. But we must consider them

within the totality of their life. Perhaps a little more of the Family Medicine

viewpoint and a little less of the lumbar spinal surgery specialist viewpoint is in

order. If we treat a person, but he no longer has a job to support his family have

we helped our patient? If we treat many such patients and as a result their industry

is shipped overseas or goes bankrupt because of uncontrollable costs, have we

helped our patient? I think not. We must always be the patient’s unrelenting

advocate in preventing and decreasing suffering, but we must open our horizons

and provide our expertise to industry so that the best care can also be affordable.

When in medical school, I first heard the parable about the toolbox. I will

paraphrase it here, as it is quite apropos. If the only tool in a physician’s toolbox is

a hammer, every problem looks like a nail. It is time to add other tools. VAD is

also in my toolbox. It cannot fix every problem nor is it safe in every

circumstance. I frequently call for a hammer, but in many cases where I

previously would use a hammer, it stays in the toolbox.

The Human Resource administrator is the person who must wear two hats for

industry. He is a patient advocate and an industry protector. Five years ago, a

novel agreement was reached through the efforts of the HR administrator of a

petrochemical refinery and with the refinery’s corporate Medical Director. This

limited study was undertaken to determine if a much less expensive mode of

treatment would be at least as effective as surgery and provide a measure of cost

control for the industry

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The agreement offers refinery employees, Vertebral Axial Decompression (VAD)

utilizing the Vax-D (the only scientifically validated methodology that produces

negative intradiscal pressure), as a self-selected alternative to back surgery. This

agreement was not planned as a research tool, but as an open-ended, non-blinded,

outcome based trial. The trial was justified by the success rate demonstrated in

previously published Vax-D studies. [3,4,5,6,7]

To qualify for Vax-D, the worker was required to meet four requirements.

1. Have sustained an acute traumatic or cumulative back injury for which

surgery had been recommended.

2. Have a symptom history for a minimum of 3 months.

3. Meet the inclusion criteria for Vax-D.

4. Not have any of the exclusion criteria for Vax-D.

Over the last 5 years, despite an excellent safety record at the refinery and strict

adherence to OSHA standards, there have been 10 cases meeting the above criteria

(three work related and seven non-work related). Of these employees, 5 elected to

have surgery and 5 elected VAD.

This presented a unique opportunity to access the “cost” of therapy. The company

is self insured, and provides excellent coverage for its employees. All medical

costs were paid by the company and were monitored by the HR administrator.

Additionally, non-medical costs such as medical leave pay, replacement worker

pay, permanent partial disability award, and, unfortunately, one case of permanent

total disability award could also be tracked and determined. A true cost to the

employer, the ultimate payee, was determined by including these “non-medical”

costs of care.

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The following tables describe the outcomes of the surgical group and the VAD

group.

_______________________________________________________________

3 re-operated a second time 1 retreated a second

1 operated a total of 5 times time

1 on long term permanent disability All working

1 is candidate for permanent partial

disability

________________________________________________________________

The re-operations were due to continued pain and/or pain at a different level.

The retreatment with Vax-D was due to a traumatic injury that occurred, while

building a retaining wall of railroad ties at a lake house 2 - years after the initial

Vax-D treatment.

This limited series suggests that Vertebral Axial Decompression (Vax-D) can

provide improved medical outcomes in patients with lumbar disc disease when

compared to surgery. These data further suggest that this is accomplished with

minimal risk.

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________________________________________________________________________

The four patients that returned

to work averaged 9 weeks TTD.

The one now on PTD

was on TTD for 52 weeks

prior to adjudication.

Average wage $ 22.50/hr. $22.50/hr.

Average overtime $ 33.75/hr N/A

wage

PTD/PPD total $ 726,142

Procedures total $263,434 $ 31, 135

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refinery’s Human Resource Administrator.

From a medical perspective, Vax-D has been rigorously demonstrated to be

successful despite its low cost and high safety record. However, as a medical

model, these case studies leave many questions for future research. How

equivalent were the injuries in both groups? Who well were the groups matched?

Is the “n” sufficient? How do pre and post-treatment imaging studies compare and

does that comparison actually matter? How long will the treatments last? [1,2] Are

employees, who work in a refinery representative of industry in general? Was the

failure rate for surgery representative? [1] Was the success rate of Vax-D

representative? [4] Does this refinery’s obvious concern for the employee’s

welfare represent industry as a whole?

Although a comparison of surgery and VAD efficacy demonstrates a statistical

relevance of the highest order that Vax-D was superior, p-values have not been

included in this report because the current model design was not adequate to

support such determinations. It does, however provide a basic model to access true

costs.

Clearly, more research is indicated.

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Assumptions:

Cost is determined by the amount of money that changed hands.

physical therapy, provider visits prior to and following the procedure, and the

medical procedure (surgery and/or Vax-D).

worker and replacement worker as well as paid indirect expenses including legal

and disability. This represents the actual dollars spent or “cash-cost to industry” of

a medical procedure. It does not include intangible, but real costs such as lost

productivity. It also does not attempt to measure the ability of the patient to work

and earn at the same level post treatment.

over a 5-year period. Many would argue that this rate of failure may be excessive,

although recent reviews of back procedures (laminectomy discectomy with fusion)

suggests that this may actually underestimate the failure rate. [1] However, in the

following calculations, we have assumed surgery to be the gold standard, and

100% successful.

published efficacy of 70%. Calculations will be made assuming the published 70%

success rate.

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We recognize that these assumptions over-estimate surgical success and underestimate

VAD success as Vax-D “failures” generally are improved sufficiently to

avoid surgery. [2]

procedures were undertaken, however, such is also the case in practice. Choice

and frequency of surgical procedure seems to be more closely related to the

number of available surgeons than any other criteria. [1]

at 4 years. Those patients (70%) who achieved initial success did not regress over

a 4-year period. [2]

other than the need for re-operation, are relatively rare. Death is extremely rare.

Although rare, these complications do occur. No serious safety problems, other

than 6 re-operations, were present in this study.

Personal experience and discussion with the authors of previous studies produced

no experience of medical injury related to the use of VAD when following Vax-D

protocols. At this time there are approximately 1500 Vax-D procedures done

daily. There has been only one reported significant, but not life-threatening injury

in the last 15 years. No safety problems were present in this study.

Utilizing the actual cost experience to the refinery and the above assumptions,

calculations of cost savings to industry were determined for 100 eligible patients

treated with Vax-D and assuming that the 30% that failed Vax-D would then

undergo surgery. These were then compared to an identical group of patients

being treated with conventional surgery alone.

The average, per patient, “cash-cost to industry” for the surgery treated injury was

$263,434. The average, per patient, “cash-cost to industry” for the Vax-D treated

injury was $7053.

100 patients treated with Vax-D would cost industry $705,300 dollars, using these

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surgery on these 30 patients is $7,125,450. “Cash-cost to industry” to treat 100

patients using Vax-D as a preferred treatment followed by surgery in Vax-D

failures would be $7,830,750. Actual cost could be substantially less with

additional savings of $237,515 for each of the 30 VAD failures that were

sufficiently improved to avoid surgery.

To treat the same patients with only surgery would have a “cash-cost to industry”

Author’s note: The term Vertebral Axial Decompression has been noted

interchangeably utilizing two acronyms Vax-D and VAD. Perhaps the generic

term VAD would be more accurate as Vax-D is a protected term of the company

that manufactures the equipment that I use. However, as there are several

manufacturers that produce equipment that can distract the lumbar spine in an axial

orientation there is only one that can demonstrate profound negative pressures

when doing so. That is the Vax-D. Without the negative pressures there is no

medical evidence for medical success.

It is not within the scope of this paper to delve into the physiology and physics of

why this is so. This information is available elsewhere. The scope of this paper is

limited to an appraisal of “costs” of surgery as compared to VAD only when the

VAD is accomplished with the Vax-D equipment.

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1. Dvorak J, Gauchat M H, Valach L. The Outcome of Surgery for Lumbar

Disc Herniation I. A 4-17 Years’ Follow-up with Emphasis on Somatic Aspects.

2. Boudreau D, et. al, Four Year Outcome of Vax-D.

3. Gustavo Ramos, M.D. and William Martin M.D., “Effects of Vertebral

Axial Decompression on Intradiscal Pressure”,

4. Earl E. Gose, M.D., William K. Naguszewski, M.D., and Robert K.

Naguszewski, M.D., “Vertebral Axial Decompression Therapy for Pain Associated

with Herniated or Degenerated Discs or Facet Syndrome: An Outcome Study”,

5. Frank Tilaro, M.D., “The Effects of Vertebral Axial Decompression On

Sensory Nerve Dysfunction”,

6. Eugene Sherry, M.D., F.R.A.C.S., Peter Kitchner, M.B., B.S.,

F.R.A.N.Z.C.R., and Russell Smart, M.B., ChB., “Prospective Randomized

Controlled Study of VAX-D and TENS for the Treatment of Chronic Low Back

7. William K. Naguszewski, M.D., Robert K. Naguszewski, M.D., and Earl

Gose, M.D., “Dermatomal Somatosensory Evoked Potential Demonstration of