Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1:  The patient is a 43-year-old female with low back and bilateral leg pain. She has had back pain for a number of years with leg pain beginning in 2005. She has been treated with medication, therapy injections and rhizotomy.X-rays performed in January 2006 showed moderate L4-5 disc space narrowing and modest L5-S1 narrowing.  There was L4-5 spur formation with no spondylosis. In February 2006 the patient was evaluated for low back and left leg pain to the foot. On examination sensation was grossly intact.  Reflexes were symmetrical and active.  The patient had a normal gait, more pain with extension and positive left straight leg raise.  Strength was 5/5.  The provider reported that an MRI showed degenerative disc disease and bulging at L3-4, L4-5 and L5-S1. A discogram in April 2006 revealed L2-3 was not painful. At L3-4 there was concordant pain of 8/10. L4-5 and L5-S1 injections produced 10/10 concordant pain.  A CT scan performed in April 2006 revealed L3-4 severe destruction of the annulus but the canal, facets and foramina were normal. At L4-5 there was severe annular destruction with a left paracentral protrusion narrowing the left neural foramina. Canal, facets and right foramen were normal. L5-S1 annular destruction was noted with normal facets, canal and foramina.  The patients provider reviewed the studies and recommended L3-4 and L4-5 disc replacement with an L5-S1 fusion. The Health Plan has denied authorization and coverage for the proposed surgery on the basis that it is considered investigational.Upon review of the relevant peer-reviewed literature, the proposed artificial disc replacement at two levels above a fused level is considered outside the standard of care and thus, is not recommended. There is no documentation on flexion or extension views of spondylolisthesis or motion segment instability. This patient has had chronic degenerative disc disease for over 10 years. The proposed surgery is not likely to result in an improved clinical outcome. There are no long-term studies addressing multi-level disc replacement. At this time there is inadequate evidence that the proposed surgical intervention is likely to be superior to standard of care modalities. As such, I have determined that the requested surgery is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.Physician 2:  The patient is a 43-year-old female with a history of low back and bilateral leg pain with some numbness and tingling. Conservative treatment has provided only temporary improvement.Lumbar x-rays dated January 2006 documented moderate L4-5 disc space narrowing and modest L5-S1 narrowing.  There was an L4-5 spur with no spondylosis. The patient was evaluated in February 2002 for ongoing pain. The physical examination revealed sensation was grossly intact. Reflexes were symmetrical and active.  Her gait was normal and she reported increased pain with extension.  Straight leg raise was positive on the left with intact lower extremity strength. An MRI reportedly showed degenerative disc disease and bulging at L3-4, L4-5 and L5-S1.  The patient had a discogram in April 2006. The results indicated that L2-3 was not painful. The L3-4 level produced concordant pain at 8/10 and the L4-5 and L5-S1 injection produced 10/10 concordant pain. The post CT scan showed L3-4 severe destruction of the annulus but the canal, facets and foramina were normal. At L4-5 there was severe annular destruction with a left paracentral protrusion narrowing the left neural foramina.  The report noted that the canal, facets and right foramen were normal. There was L5-S1 annular destruction with normal facets, canal and foramina. Based on these findings, the patients provider recommended L3-4 and L4-5 disc replacement with an L5-S1 fusion. The Health Plan has denied authorization for this procedure on the basis that it is considered investigational. While disc replacement surgery has shown promising results for single level surgery, those results have not been proven conclusively to be superior to the more standard methods of treatment. Results in the United States peer-reviewed literature still recommend that further study is needed. There are remaining questions regarding the magnitude and impact of debris from the prosthesis. Additionally, the optimal device to be used and the longevity of these devices have yet to be established. This is true of single level replacement. Even more questionable are the multiple level disc replacements with fusion above or below. There are no long-term studies in this arena and as such this approach remains unproven.For the reasons set forth above, I have determined that the requested surgery is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Phyician 3:  The patient is a 43-year-old woman with severe chronic back pain. She has attempted conservative treatment, which has failed. She has been advised that multi-level disc replacement and fusion would be appropriate. A second opinion was obtained; the conclusion concurred with the treating physicians recommendations. The Health Plan has denied coverage for the multi-level disc replacement and fusion indicating that the surgery remains investigational.The surgery proposed is quite extensive. However, as long as the patient is made aware of the risks and proposed goals as well as possible complications there is no contraindication to the procedure. She has failed all conservative measures and has pain that is affecting her functional ability. Given the absence of standard treatment alternatives that are likely to be effective, the proposed surgery is medically acceptable for this patient. Therefore, I have determined that the requested surgery is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.