Centers for Medicare & Medicaid Services

Technology Assessments
Spinal Fusion for the Treatment of Low Back Pain Secondary to Lumbar Degenerative Disc Disease

Issue
The incidence of low back pain at some time in a person's lifetime in the U.S. population is reported to be as high as 90%. There are numerous causes of low back pain and men and women are equally afflicted. The degenerative changes that occur in the intervertebral disc in the spine are thought to be part of the normal process of aging and do not always lead to low back pain. Low back pain secondary to lumbar degenerative disc disease (DDD) can usually be successfully treated conservatively. However, when conservative treatment is not successful, surgical intervention becomes an option to relieve the pain associated with DDD.

Since DDD is associated with the aging process, this is an affliction that is well represented in the Medicare population. CMS has a significant interest in discussing the evidence for surgical interventions for lumbar degenerative disc disease, with a specific focus on spinal fusion for low back pain associated with lumbar DDD in the Medicare population.

The Medicare Coverage Advisory Committee (MCAC) will hear presentations and discuss evidence relative to indications for spinal fusion, clinical outcomes (including adverse events) and the persistence of outcomes over time, outcome measurement tools, and outcomes related to different surgical spinal fusion procedures, as well as, the generalizability of this evidence to the Medicare population.

Technology Assessment
Download Technology Assessment [PDF, 897KB/98 páginas].
http://www.cms.hhs.gov/determinationprocess/downloads/id41ta.pdf

Questions
RE: Technology Assessment for Medicare Coverage Advisory Committee on Spinal Fusion for the Treatment of Low Back Pain Secondary to Lumbar Degenerative Disc Disease – November 30, 2006

Key questions to be addressed by technology assessment:

In patients 65 years of age or older with degenerative disc disease (DDD) and/or degenerative joint disease of the facets (DJD) of the lumbar spine, what is the evidence regarding indications and outcomes, including adverse events (overall net health benefit), of lumbar spinal fusion as compared to non-surgical conservative treatments/management or other surgical strategies?

The background section of the report will include a description of the processes of DDD and DJD of the spine, non-surgical conservative therapies and their timing with respect to surgical intervention involving lumbar spinal fusion (i.e. various rehabilitation strategies, cognitive intervention, injections/manipulations, medications [particularly narcotic use], etc) in comparison to non-fusion surgical strategies (such as laminectomy, lumbar disc arthroplasty, dynamic stabilization devices, etc). The background section will also include the description of various diagnostic technologies and techniques used in decision making about surgery and its effectiveness.

The report will describe the clinical and radiographic outcomes measures reported in the studies. It will also summarize the evidence on complications, harms, and adverse events associated with lumbar spinal fusion that have been reported or expected and whether conditions prevalent in the older Medicare population increase the risk for these events. Information on the following parameters and any relationship of these parameters to outcomes will be reported:


Patient selection criteria for studies of lumbar spinal fusion (i.e. age, gender, diagnostic techniques used, co-morbidities, etc).

Internal and external validity of the studies (includes inclusion and exclusion criteria of the studies).

Length of follow up.

Concurrent treatment strategies and disease management programs.

Place of delivery for alternative interventions (home, inpatient, outpatient).

Different surgical techniques of lumbar spinal fusion and alternatives (with or without instrumentation ).
a. Posterolateral fusion surgery (PLF)

b. Posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF)

c. Anterior lumbar interbody fusion (ALIF)

d. Anterior/posterior combined lumbar fusion

e. Lumbar disc arthroplasty and dynamic stabilization techniques


Components used for lumbar spinal fusion.
a. Bone graft from the iliac crest (autograft)

b. Bone allograft

c. Bone morphogenetic proteins (BMP)

d. Collagen sponges

e. Demineralized bone matrix

f. Platelet derived growth factors

g. Other


Patient characteristics (i.e. gender, comorbidity, medication [particularly narcotic use], etc) and disease characteristics (i.e. disease severity), age of patients and generalizability to Medicare population.

Short term outcomes (quality of life (QOL), SF-36, ODI, pain, narcotic use, other reported outcomes) and risks (ie, mortality, infections, morbidity).

Persistence of benefits/harms over time—long term results (including incidence of adjacent segment disease, pain, narcotic use, QOL, other outcomes as reported). Note that radiographic evidence of fusion is an often reported outcome which will be recorded, but will not, if the only outcome measure, meet the inclusion criteria.

Rate of repeat procedures or interventions.

Appendices [PDF, 531KB]
http://www.cms.hhs.gov/DeterminationProcess/downloads/id41TA1.pdf?origin=globalsearch&page=/mcd/viewtechassess.asp&tid=41&where=index

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Centers for Medicare & Medicaid Services