Artificial intervertebral disc replacement – lumbar
These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan will be used to determine your coverage.
Prior authorization is required for Artificial Intervertebral Disc Replacement – Lumbar, single level.
Artificial Intervertebral Disc Replacement – Lumbar, single level is generally covered subject to the indications listed below and per your plan documents.
Indications that are covered
Surgical implantation of an FDA-approved lumbar artificial intervertebral disc in a skeletally mature member is eligible for coverage when all of the following criteria are met:
- Documentation indicates chronic, unremitting discogenic low back pain and functional impairment due to single-level degenerative disc disease (DDD).
- Single-level disc degeneration has been confirmed on complex imaging studies (i.e. computerized tomography [CT] scan, magnetic resonance imaging [MRI]).
- Imaging studies confirm either 3 millimeters or less of spondylolisthesis at the involved level or Grade 1 spondylolisthesis.
- The implant will be inserted at an FDA-approved lumbar/sacral level specific to the implant being used (See explanation below).
- Documentation indicates that the member has failed (failed is defined as unremitting low back pain and significant functional impairment refractory to conservative treatments) ≥ 6 months of structured, physician supervised conservative medical treatment which includes ALL of the following components:
- exercise, including core stabilization exercises
- non-steroidal and/or steroidal medication (unless contraindicated)
- physical therapy.
NOTE: Conservative therapy must include physical therapy (PT) and may include activity modification, weight loss, and drug therapy. Documentation must correspond to the current episode of pain (within 6 months).
Formal physical therapy, at least four visits over a six week course, including active muscle conditioning is required, OR there must be an explicit statement in the clinical documents that explains why such physical therapy is contraindicated. The requirement for physical therapy will not be met if there is a failure to complete prescribed physical therapy for non-clinical reasons. Documentation of formal physical therapy would be the therapist’s notes. If a patient is unable to complete physical therapy (PT) due to progressively, worsening pain and disability, the case will be reviewed on an individual basis by an internal physician reviewer. Documentation in the physical therapist’s notes demonstrating this must be submitted.
Indications that are not covered
Artificial Intervertebral Disc Replacement – Lumbar, single level is not covered for any additional indication, including, but not limited to the following because each is considered investigational:
- The planned procedure includes the combined use of an artificial disc prosthesis and spinal fusion (i.e., hybrid surgery).
- The planned procedure includes simultaneous multilevel implantation.
- The member has osteopenia or osteoporosis (T-score < -1.0).
- The member has a history of previous fusion surgery at any lumbar vertebral level.
- There is evidence on imaging studies of ANY of the following:
- degenerative spondylolisthesis of Grade 2 or greater at the involved level
- multilevel degenerative disc disease
- nerve root compression or spinal stenosis
- pars interarticularis defect with either spondylolysis or isthmic spondylolisthesis
- severe facet joint arthrosis
- spinal fracture
- The requested device is a non FDA–approved lumbar artificial intervertebral disc
Examples of devices that have been approved by the U.S. Food and Drug Administration (FDA) for single level lumbar disc replacement include:
- The ProDisc-L Lumbar : approved for use at levels L3-S1
- The activL Artificial Disc: approved for use at levels L4-S1
- The InMotion Lumbar Artificial Disc System is a more recent modification of the former Charité device with a change in name under the same pre-market approval. It is approved for use at levels L4-S1, but is not currently marketed in the United States.
Arthroplasty is the surgical repair of a joint.
Artificial intervertebral disc replacement, also known as spinal arthroplasty, is a procedure which replaces a degenerated spinal disc with a prosthetic disc. Lumbar artificial intervertebral disc replacement is intended as an alternative to fusion surgery and is carried out by anterior (frontal) approach. It is intended to maintain motion at the operative level once the damaged disc has been removed and to maintain the normal biomechanics of the adjacent vertebrae.
Degenerative Disc Disease is a general term for the condition in which a damaged vertebral disc causes chronic pain; low back and/or leg pain when the damaged disc is in the lumbar spine.
Spondylolisthesis refers to forward slippage of one vertebrae over the vertebrae below it. Grade 1 means that 25% of the vertebral body has slipped forward.
If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.
The services associated with these codes require prior authorization:
Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression), single interspace, lumbar
The services associated with these codes are considered investigational and are not covered:
Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression), each additional interspace, lumbar (List separately in addition to code for primary procedure)
Removal of total disc arthroplasty, (artificial disc), anterior approach, each additional interspace, lumbar (List separately in addition to code for primary procedure)
Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, lumbar (List separately in addition to code for primary procedure)
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This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.
- Chou, R. & Huffman, L.H. Guideline for the Evaluation and Management of Low Back Pain- Evidence Review. American Pain Society. Glenview, IL. Retrieved from http://americanpainsociety.org/uploads/education/guidelines/evaluation-management-lowback-pain.pdf
- Hayes, Inc. Hayes Medical Technology Directory Report. Lumbar Total Disc Replacement for Degenerative Disc Disease. Lansdale, PA: Hayes, Inc.; August, 2015. Reviewed August, 2016.
- Guyer, R.D., McAfee, P.C., Banco R.J., Bitan, F.D., Cappuccino, A., Geisler, F. H.…Blumenthal, S.L. (2009) Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the Charite artificial disc versus lumbar fusion: Five year follow-up. The Spine Journal, 9(5), May 2009, 374-386.
- Guyer, R. D., Pettine, K., Roh, J.S., Dimming, T.A., Coric, D., McAfee, P.C. & Ohnmeiss, D.D. (2016) Five-Year Follow-Up of a Perspective, Randomized Trial Comparing Two LumbarTotal Disc Replacements. Spine, 41(1), January 2016, 3-8.
- Park, C.K., Ryu K.S., Lee, H.J. (2012) Clinical outcome of lumbar total disc replacement using ProDisc-L in degenerative disc disease: minimum 5-year follow-up results at a single institute. Spine, 37(8)15 April 2012, 672-677. .
- Thavaneswaran, P.& Vandepeer, M. (2014) Lumbar artificial intervertebral disc replacement: a systematic review. ANZ Journal Surgery, 84 (2014), 121-127. .
- United States Food and Drug Administration. (2004) Recently Approved Devices-Charite Artificial Disc- P040006. Retrieved from http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm
- United States Food and Drug Administration. (2006) Recently Approved Devices-PRODISC-L Total Disc Replacement- P050010. Retrieved from http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm
- United States Food and Drug Administration (2015) Recently approved Devices- activL Artificial Disc- P120024, Retrieved from https://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/recently-approveddevices/ucm455656.htm
- Zigler, J. and Garcia, R. (2007) International Society for the Advancement of Spine Surgery Policy Statement-Lumbar Artificial Disc, Retrieved fromhttps://www.isass.org/public-policy/isass-policy-statement-lumbar-artificial-disc/.