Coverage Policies

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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 01/01/2007 Title: Intervertebral Disc Prostheses
Revision Date: 07/01/2020 Document: BI182:00
CPT Code(s): 0092T; 0095T; 0163T-0165T; 0375T; 0609T, 0610T, 0611T, 0612T, 22100, 22101, 22102, 22110, 2212-22114, 22206-22207, 22210, 22212-22214, 22220, 22222-22224, 22310, 22315, 22318, 22319, 22325, 22326-22327, 22532-22533, 22551, 22552, 22554, 22556, 22590, 22595, 22600, 22610, 22612, 22630, 22633, 22634, 22802, 22804, 22808, 22810, 22853, 22854, 22856, 22857-22858; 22859, 22861, 22862, 22864, 22865; 63001, 63003, 63005, 63011, 63012, 63015, 63016, 63017, 63020-63030, 63040, 63042, 63045, 63046, 63047, 63050, 63051, 63055-63056, 63064, 63075, 63077, 63081, 63085, 63087, 63090, 63101-63102, 63170, 63172, 63173, 63180, 63182, 63185, 63190, 63250, 63251, 63252, 63265, 63266, 63267, 63268, 63270, 63281, 63282, 63283, 63285, 63286, 63287-63290, 63300, 63301, 63302, 63303, 63304, 63305, 63306-63307
Public Statement

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    The artificial intervertebral disc requires pre-authorization.

2)    The artificial intervertebral disc is designed to replace a spinal disc that has been damaged from degenerative disc disease. Examples of these devices are:

a)    INMOTION artificial disc

b)    ProDisc-L Total Disc Replacement

c)    Activ-L

d)    ProDisc-C Total Disc Replacement

e)    Mobi-C Cervical Disc Prosthesis

f)     BRYAN Disc

g)    PCM Cervical Disc

h)    Prestige Cervical Disc System

i)     SECURE-C

3)    Magnetic resonance spectroscopy for determination and localization of discogenic back pain is considered experimental and is not covered.


Medical Statement

1)    The  FDA-approved prosthetic intervertebral discs (e.g., the INMOTION artificial disc, the ProDisc-L Total Disc  Replacement and Activ-L) require prior authorization and are considered medically necessary for lumbar spinal arthroplasty meeting all of the following criteria:

a)    Skeletally mature persons; AND

b)    With degenerative disc disease at one level from L3 to S1 confirmed radiologically; AND

c)    Are symptomatic with radicular pain; AND

d)    Who have failed at least six months of conservative management including 2 or more of the following:

i)     NSAIDS, analgesics, steroids

ii)    Physical therapy

iii)   Epidural steroid injection/selective nerve root block

To optimize clinical outcomes for this major elective procedure, it is also required:
- Patient is a non-smoker, OR
- Patient is a documented smoker and has abstained for at least 6 weeks prior to surgery as evidenced by lab results documenting nicotine-free status (cotinine level)

a)    Requests for insertion of intervertebral disc placement CPT 22853, 22854, 22859) require at least one of the following spinal surgery (parent) codes listed below (Also, each of the following spinal surgical procedures (parent codes) performed with or without the intervertebral disc insertion require pre- authorization):

2)    22100, 22101, 22102, 22110, 22112, 22114, 22206, 22207, 22210, 22212,22214, 22220, 22222, 22224, 22310, 22315, 22318, 22319, 22325, 22326,22327, 22532, 22533, 22548, 22551, 22552, 22554, 22556, 22558, 22590, 22595, 22600, 22610,22612, 22630, 22633, 22634, 22800, 22802, 22804, 22808, 22810,22812, 22856, 22857, 22861, 22862, 22864, 22865, 63001, 63003, 63005, 63011, 63012, 63015, 63016, 63017, 63020,63030, 63040, 63042, 63045, 63046,63047, 63050, 63051, 63055, 63056, 63064, 63075, 63077, 63081, 63085, 63087, 63090, 63101, 63102, 63170, 63172, 63173, , 63185, 63190, 63250, 63251, 63252, 63265, 63266, 63267, 63268, 63270, 63281, 63282, 63283, 63285, 63287, 63290 and 63300, 63301, 63302, 63303, 63304, 63305, 63306,63307.The  FDA-approved prosthetic intervertebral discs (e.g., ProDisc-C Total Disc Replacement, BRYAN Disc, PCM Cervical Disc, Prestige Cervical Disc System, SECURE-C, and Mobi-C Cervical Disc Prosthesis) require prior authorization and are considered medically necessary for cervical spinal arthroplasty meeting all of the following criteria:

a)    Skeletally mature persons; AND

b)    With degenerative disc disease at one level from C3 to T1 confirmed radiologically; AND

c)    Are symptomatic (e.g., radicular neck and/or arm pain and or functional/neurological deficit); AND

d)    Who have failed at least six months of conservative management including 2 or more of the following:

i)     NSAIDS, analgesics, steroids

ii)    Physical therapy

iii)   Epidural steroid injection/selective nerve root block

To optimize clinical outcomes for this major elective procedure, it is also required:
- Patient is a non-smoker, OR
- Patient is a documented smoker and has abstained for at least 6 weeks prior to surgery as evidenced by lab results documenting nicotine-free status ((cotinine level)

Codes Used In This BI:

0092T  Total Disc Arthroplasty, cervical; ea addt’l interspace (code deleted 1/1/15)

0095T  Rmvl of Total Disc Arthroplasty, cervical; ea addt’l interspace

0098T  Rvsn incl replacement of Total Disc Arthroplasty, cervical; ea addt’l interspace

0375T   Total disc arthroplasty, cervical; three or more levels Deleted code eff 01/01/2020

0163T   Total disc arthroplasty, lumbar; ea addt’l interspace

0164T   Rmvl of Total Disc Arthroplasty, lumbar; ea addt’l interspace

0165T   Rvsn of Total Disc Arthroplasty, lumbar; ea addt’l interspace

0609T  Magnetic resonance spectroscopy, determination and localization of discogenic pain (cervical, thoracic, or lumbar); acquisition of single voxel data, per disc, on biomarkers (ie, lactic acid, carbohydrate, alanine, laal, propionic acid, proteoglycan, and collagen) in at least 3 discs (new code 7/1/2020): E/I

0610T Magnetic resonance spectroscopy, determination and localization of discogenic pain (cervical, thoracic, or lumbar); transmission of biomarker data for software analysis (new code 7/1/2020): E/I

0611T Magnetic resonance spectroscopy, determination and localization of discogenic pain (cervical, thoracic, or lumbar); postprocessing for algorithmic analysis of biomarker data for determination of relative chemical differences between discs (new code 7/1/2020): E/I

0612T Magnetic resonance spectroscopy, determination and localization of discogenic pain (cervical, thoracic, or lumbar); interpretation and report (new code 7/1/2020): E/I

22100 Part excision of posterior vertebral component (eg, spinous process, lamina or facet) for intrinsic bony lesion, single vertebral segment; cervical

22101 Part excision of posterior vertebral component (eg, spinous process, lamina or facet) for intrinsic bony lesion, single vertebral segment; thoracic

22102 Part excision of posterior vertebral component (eg, spinous process, lamina or facet) for intrinsic bony lesion, single vertebral segment; lumbar

22110 Part excision of vertebral body, for intrinsic bony lesion, w/o decompression of spinal cord or nerve root(s), single vertebral segment; cervical

22112 Part excision of vertebral body, for intrinsic bony lesion, w/o decompression of spinal cord or nerve root(s), single vertebral segment; thoracic

22114 Part excision of vertebral body, for intrinsic bony lesion, w/o decompression of spinal cord or nerve root(s), single vertebral segment; lumbar

22206 osteotomy of spine, post or posterolateral approach, 3 columns, 1 vertebral segment (eg, pedicle/vertebral body subtraction); thoracic

22207 osteotomy of spine, post or posterolateral approach, 3 columns, 1 vertebral segment (eg, pedicle/vertebral body subtraction); lumbar

22210 osteotomy of spine, post or posterolateral approach, 1 vertebral segment; cervical

22212 osteotomy of spine, post or posterolateral approach, 1 vertebral segment; thoracic

22214 osteotomy of spine, post or posterolateral approach, 1 vertebral segment; lumbar

22220 osteotomy of spine, incl discectomy, ant approach, single vertebral segment; cervical

22222 osteotomy of spine, incl discectomy, ant approach, single vertebral segment; thoracic

22224 osteotomy of spine, incl discectomy, ant approach, single vertebral segment; lumbar

22310 closed tx of vertebral body fx(s), w/o manipulation, requiring and incl casting or bracing

22315 closed tx of vertebral fx(s), and/or dislocation(s) requiring casting or bracing, w/and incl casting and/or bracing by manipulation or traction

22318 open tx and/or reduction of odontoid fx(s) and/or dislocation(s) incl as odontoideum, ant approach, incl placement of internal fixation; w/o grafting

22319 open tx and/or reduction of odontoid fx(s) and/or dislocation(s) incl as odontoideum, ant approach, incl placement of internal fixation; w/grafting

22325 open tx and/or reduction of vertebral fx(s) and/or dislocation(s), post approach, 1 fractured vertebra or dislocated segment; lumbar

22326 open tx and/or reduction of vertebral fx(s) and/or dislocation(s), post approach, 1 fractured vertebra or dislocated segment; cervical

22327 open tx and/or reduction of vertebral fx(s) and/or dislocation(s), post approach, 1 fractured vertebra or dislocated segment; thoracic

22532 Arthrodesis, lateral extracavitary tech, incl minimal discectomy to prepare interspace (other than for decompression); thoracic

22532 Arthrodesis, lateral extracavitary tech, incl minimal discectomy to prepare interspace (other than for decompression); lumbar

22551 Arthrodesis, ant interbody, incl disc space preparation, discectomy, osteophytectomy and decompression of spinal cord and/or nerve roots; cervical below C2

22552 Arthrodesis, ant interbody, incl disc space preparation, discectomy, osteophytectomy and decompression of spinal cord and/or nerve roots; cervical below C2 each add’l interspace

22554 Arthrodesis, ant interbody tech, incl minimal discectomy to prepare interspace (other than for decompression); cervical below C2

22556 Arthrodesis, ant interbody tech, incl minimal discectomy to prepare interspace (other than for decompression); thoracic

22558 Arthrodesis, ant interbody tech, incl minimal discectomy to prepare interspace (other than for decompression); lumbar

22590 Arthrodesis, post tech, craniocervical

22595 Arthrodesis, post tech, atlas-axix

22600 Arthrodesis, post or posterolateral tech, single level; cervical below C2 segment

22610 Arthrodesis, post or posterolateral tech, single level; thoracic (w/lateral transverse tech, when performed)

22612 Arthrodesis, post or posterolateral tech, single level; lumbar (w/lateral transverse tech, when performed)

22630 Arthrodesis, post interbody tech, incl laminectomy and/or discectomy to prepare interspace (other than decompress), single interspace; lumbar

22633 Arthrodesis, combined post or posterolateral tech w/post interbody tech incl laminectomy and/or discectomy sufficient to prepare interspace (other than for decompression), single interspace and segment; lumbar

22800 Arthrodesis, post, for spinal deformity, w/or w/o cast; up to 6 vertebral segments

22802 Arthrodesis, post, for spinal deformity, w/or w/o cast; 7-12 vertebral segments

22804 Arthrodesis, post, for spinal deformity, w/or w/o cast; 13 or more vertebral segments

22808 Arthrodesis, ant, for spinal deformity, w/or w/o cast; 2-3 vertebral segments

22810 Arthrodesis, ant, for spinal deformity, w/or w/o cast; 4-7 vertebral segments

22812 Arthrodesis, ant, for spinal deformity, w/or w/o cast; 8 or more vertebral segments

22856   Total Disc Arthroplasty, cervical

22857   Total Disc Arthroplasty, lumbar; single interspace

22858   Total Disc Arthroplasty, cervical; second level

22861   Rvsn of Total Disc Arthroplasty, cervical; single interspace

22862   Rvsn of Total Disc Arthroplasty, lumbar; single interspace

22864   Rmvl of Total Disc Arthroplasty, cervical

22865   Rmvl of Total Disc Arthroplasty, lumbar; single interspace

63001 Laminectomy w/exploration and/or decompression of spinal cord and/or cauda equine, w/o facetectomy, foraminotomy or discectomy (eg, spinal stenosis), 1 or 2 vertebral segments; cervical

63003 Laminectomy w/exploration and/or decompression of spinal cord and/or cauda equine, w/o facetectomy, foraminotomy or discectomy (eg, spinal stenosis), 1 or 2 vertebral segments; thoracic

63005 Laminectomy w/exploration and/or decompression of spinal cord and/or cauda equine, w/o facetectomy, foraminotomy or discectomy (eg, spinal stenosis), 1 or 2 vertebral segments; lumbar, except for spondylolisthesis

63011 Laminectomy w/exploration and/or decompression of spinal cord and/or cauda equine, w/o facetectomy, foraminotomy or discectomy (eg, spinal stenosis), 1 or 2 vertebral segments; sacral

63012 Laminectomy w/rmvl of abn facets and/or pars inter-articularis w/decompression of cauda equine and nerve roots for spondylolisthesis, lumbar (Gill type proc)

63015 Laminectomy w/exploration and/or decompression of spinal cord and/or cauda equine, w/o facetectomy, foraminotomy or discectomy (eg, spinal stenosis) more than 2 vertebral segments; cervical

63016 Laminectomy w/exploration and/or decompression of spinal cord and/or cauda equine, w/o facetectomy, foraminotomy or discectomy (eg, spinal stenosis) more than 2 vertebral segments; thoracic

63017 Laminectomy w/exploration and/or decompression of spinal cord and/or cauda equine, w/o facetectomy, foraminotomy or discectomy (eg, spinal stenosis) more than 2 vertebral segments; lumbar

63020 Laminotomy (hemilaminectomy), w/decompression of nerve root(s), incl partial facetectomy, foraminotomy and/or exc of herniated intervertebral disc; 1 interspace, cervical

63030 Laminotomy (hemilaminectomy), w/decompression of nerve root(s), incl partial facetectomy, foraminotomy and/or exc of herniated intervertebral disc; 1 interspace, lumbar

63040 Laminotomy (hemilaminectomy), w/decompression of nerve root(s), incl partial facetectomy, foraminotomy and/or exc of herniated intervertebral disc, reexploration, single interspace; cervical

63042 Laminotomy (hemilaminectomy), w/decompression of nerve root(s), incl partial facetectomy, foraminotomy and/or exc of herniated intervertebral disc, reexploration, single interspace; lumbar

63045 Laminectomy, facetectomy and foraminotomy (unilateral or bilateral w/decompression of spinal cord, cauda equine and/or nerve root(s), (eg, spinal or lateral recess stenosis), single vertebral segment; cervical

63046 Laminectomy, facetectomy and foraminotomy (unilateral or bilateral w/decompression of spinal cord, cauda equine and/or nerve root(s), (eg, spinal or lateral recess stenosis), single vertebral segment; thoracic

63047 Laminectomy, facetectomy and foraminotomy (unilateral or bilateral w/decompression of spinal cord, cauda equine and/or nerve root(s), (eg, spinal or lateral recess stenosis), single vertebral segment; lumbar

63050 Laminoplasty, cervical, w/decompression of the spinal cord, 2 or more vertebral segments;

63051 Laminoplasty, cervical, w/decompression of the spinal cord, 2 or more vertebral segments; w/reconstruction of the post bony elements (incl the app of bridging bone graft and non-segmental fixation devices [eg, wire, suture, mini-plates], when performed)

63055 Transpedicular approach w/decompression of spinal cord, equine and/or nerve root(s) (eg, herniated intervertebral disc), single segment; thoracic

63056 Transpedicular approach w/decompression of spinal cord, equine and/or nerve root(s) (eg, herniated intervertebral disc), single segment; lumbar (incl transfacet, or lateral extraforaminal approach) (eg, far lateral herniated intervertebral disc)

63064 Costovertebral approach w/decompression of spinal cord or nerve root(s) (eg, herniated intervertebral disc), thoracic; single segment

63075 Discectomy, ant, w/decompression of spinal cord and/or nerve root(s), incl ostephytectomy; cervical, single interspace

63077 Discectomy, ant, w/decompression of spinal cord and/or nerve root(s), incl ostephytectomy; thoracic, single interspace

63081 Vertebral corpectomy (vertebral body resection), part or complete, ant approach w/decompression of spinal cord and/or nerve root(s); cervical, single segment

63085 Vertebral corpectomy (vertebral body resection), part or complete, transthoracic approach w/decompression of spinal cord and/or nerve root(s); thoracic, single segment

63087 Vertebral corpectomy (vertebral body resection), part or complete, thoracolumbar approach w/decompression of spinal cord, cauda equine or nerve root(s), lower thoracic or lumbar; single segmnt

63090 Vertebral corpectomy (vertebral body resection), part or complete, transperitoneal or retroperitoneal approach w/decompression of spinal cord, cauda equine or nerve root(s), lower thoracic, lumbar, or sacral; single segment

63101 Vertebral corpectomy (vertebral body resection), part or complete, lateral extracavitary approach w/decompression of spinal cord and/or nerve root(s) (eg, for tumor or retropulsed bone fragments); thoracic, single segment

63102 Vertebral corpectomy (vertebral body resection), part or complete, lateral extracavitary approach w/decompression of spinal cord and/or nerve root(s) (eg, for tumor or retropulsed bone fragments); lumbar, single segment

63170 Laminectomy w/myelotomy (eg, Bischof or DREZ type), cervical, thoracic, or thoracolumbar

63172 Laminectomy w/drainage of intramedullary cyst/syrinx; to subarachnoid space

63173 Laminectomy w/drainage of intramedullary cyst/syrinx; to peritoneal or pleural space

63180 Laminectomy and sect of dentate ligaments, with or w/o dural graft, cervical; 1 or 2 segments (code deleted eff 01-01-2021)

63182 Laminectomy and sect of dentate ligaments, with or w/o dural graft, cervical; more than 2 segments (code deleted eff 01-01-2021)

63185 Laminectomy w/rhizotomy; 1 or 2 segments

63190 Laminectomy w/rhizotomy; more than 2 segments

63191 Laminectomy w/sect of spinal accessory nerve

63194 Laminectomy w/cordotomy, w/sect of 2 spinothalamic tract, 1 stage; cervical

63195 Laminectomy w/cordotomy, w/sect of 2 spinothalamic tract, 1 stage; thoracic

63196 Laminectomy w/cordotomy, w/sect of both spinothalamic tracts, 1 stage; cervical

63197 Laminectomy w/cordotomy, w/sect of both spinothalamic tracts, 1 stage; thoracic

63198 Laminectomy w/cordotomy, w/sect of both spinothalamic tracts, 2 stages w/in 14 days; cervical

63199 Laminectomy w/cordotomy, w/sect of both spinothalamic tracts, 2 stages w/in 14 days; thoracic

63200 Laminectomy, w/release of tethered spinal cord, lumbar

63250 Laminectomy for exc or occlusion of anteriovenous malformation of spinal cord; cervical

63251 Laminectomy for exc or occlusion of anteriovenous malformation of spinal cord; thoracic

63252 Laminectomy for exc or occlusion of anteriovenous malformation of spinal cord; thoracolumbar

63265 Laminectomy for exc or evacuation of intraspinal lesion other than neoplasm, extradural; cervical

63266 Laminectomy for exc or evacuation of intraspinal lesion other than neoplasm, extradural; thoracic

63267 Laminectomy for exc or evacuation of intraspinal lesion other than neoplasm, extradural; lumbar

63268 Laminectomy for exc or evacuation of intraspinal lesion other than neoplasm, extradural; sacral

63270 Laminectomy for exc of intraspinal lesion other than neoplasm, intradural; cervical

63271 Laminectomy for exc of intraspinal lesion other than neoplasm, intradural; thoracic

63272 Laminectomy for exc of intraspinal lesion other than neoplasm, intradural; lumbar

63273 Laminectomy for exc of intraspinal lesion other than neoplasm, intradural; sacral

63275 Laminectomy for biopsy/exc of intraspinal neoplasm, extradural, cervical

63276 Laminectomy for biopsy/exc of intraspinal neoplasm, extradural, thoracic

63277 Laminectomy for biopsy/exc of intraspinal neoplasm, extradural, lumbar

63278 Laminectomy for biopsy/exc of intraspinal neoplasm, extradural, sacral

63280 Laminectomy for biopsy/exc of intraspinal neoplasm, intradural, extramedullary, cervical

63281 Laminectomy for biopsy/exc of intraspinal neoplasm, intradural, extramedullary, thoracic

63282 Laminectomy for biopsy/exc of intraspinal neoplasm, intradural, extramedullary, lumbar

63283 Laminectomy for biopsy/exc of intraspinal neoplasm, intradural, sacral

63285 Laminectomy for biopsy/exc of intraspinal neoplasm, intradural, intramedullary, cervical

63286 Laminectomy for biopsy/exc of intraspinal neoplasm, intradural, intramedullary, thoracic

63287 Laminectomy for biopsy/exc of intraspinal neoplasm, intradural, intramedullary, thoracolumbar

63290 Laminectomy for biopsy/exc of intraspinal neoplasm, combined extradural-intradural lesion, any level

63300 Vertebral corpectomy (vertebral body resection), part or complete, for exc of intraspinal lesion, single segment, extradural, cervical

63301 Vertebral corpectomy (vertebral body resection), part or complete, for exc of intraspinal lesion, single segment, extradural, thoracic by transthoracic approach

63302 Vertebral corpectomy (vertebral body resection), part or complete, for exc of intraspinal lesion, single segment, extradural, thoracic by thoracolumbar approach

63303 Vertebral corpectomy (vertebral body resection), part or complete, for exc of intraspinal lesion, single segment, extradural, lumbar or sacral by transperitoneal or retroperitoneal approach

63304 Vertebral corpectomy (vertebral body resection), part or complete, for exc of intraspinal lesion, single segment, intradural, cervical

63305 Vertebral corpectomy (vertebral body resection), part or complete, for exc of intraspinal lesion, single segment, intradural, thoracic by transthoracic approach

63306 Vertebral corpectomy (vertebral body resection), part or complete, for exc of intraspinal lesion, single segment, intradural, thoracic by thoracolumbar approach

63307 Vertebral corpectomy (vertebral body resection), part or complete, for exc of intraspinal lesion, single segment, intradural, lumbar or sacral by transperitoneal or retroperitoneal approach

Limits

1)    Prosthetic intervertebral disc replacement is considered experimental and investigational for all other indications.

2)    Lumbar partial disc prosthetics (e.g., Nubac, DASCOR Disc Arthroplasty System) are considered experimental and investigational because of insufficient evidence of their effectiveness. The use of hybrid fusion with artificial disc replacement is considered experimental and investigational for the management of back pain, spinal disorders, and all other indications.

3)    Intervetebral disc prostheses are not covered with presence of any of the following contraindications:

a)    Fused level adjacent to the level to be treated or planned fusion at an adjacent level with the disc replacement procedure,

b)    Evidence of cervical instability on dynamic flexion-extension radiographs, sagittal plane transition of > 3.5 mm, or sagittal-plane angulation > 20o at a single level,

c)    Diagnosis of osteoporosis, osteopenia or osteomalacia,

d)    Spinal metastatses,

e)    Severe facet joint disease at the involved level,

f)     Active infection,

g)    Known allergy or sensitivity to implant materials (chromium, cobalt, molybdenum, polyethelyne, stainless steel, titanium or a titanium alloy),

h)    Chronic steroid use,

i)     Pregnancy,

j)     Morbid obesity.

4)    Magnetic resonance spectroscopy for determination and localization of discogenic back pain (0609T – 0612T) is considered experimental and is not covered.


Background

1)    The major potential advantage of a prosthetic intervertebral disc over current therapies for degenerated disks (such as spinal fusion or discectomy) is that the prosthetic intervertebral disk is intended to restore or preserve the natural biomechanics of the intervertebral segment and to reduce further degeneration of adjacent levels.

2)    The United States Food and Drug Administration (FDA) have approved the INMOTIONe Artificial Disc for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at one level from L4-S1. The indications for the INMOTION define DDD as disco genic back pain with degeneration of the disc that is confirmed by patient history and radiographic studies. According to the FDA-approved labeling, these DDD patients should have no more than 3 mm of spondylolisthesis at the involved level. The FDA approved labeling states that patients receiving the INMOTION Artificial Disc should have failed at least six months of conservative treatment prior to implantation of the INMOTION Artificial Disc.

3)    On August 14, 2006, the FDA approved the ProDisc-L Total Disc Replacement (Synthes Spine, Inc., West Chester, PA) for spinal arthroplasty in patients who meet all of the following criteria:

a)    Patients are skeletally mature; AND

b)    Patients have DDD at one level in the lumbar spine (from L3 to S1); AND

c)    Patients have no more than Grade 1 spondylolisthesis at the involved level; AND

d)    Patients have had no relief from pain after at least 6 months of non-surgical treatment.

4)    In June, 2015, the FDA approved Activ-L for spinal arthroplasty in patients who meet all of the following criteria:

a)    Patients are skeletally mature; AND

b)    Patients have DDD at one level in the lumbar spine (from L4 to S1); AND

c)    Patients have no more than Grade 1 spondylolisthesis at the involved level; AND

d)    Patients have had no relief from pain after at least 6 months of non-surgical treatment.

5)    On August 13, 2013, FDA approved Mobi-C Cervical disc Prosthesis for two contiguous levels total disc replacements from C3-C7 levels. However, the Hayes review of this technology on December 11, 2015 still rates this as only a “C” for bi-level total disc replacement (low-quality evidence suggesting this is comparable to standard treatment for efficacy and safety)—compared with a “B” rating for single-level total cervical disc replacement (moderate-quality evidence suggesting that the efficacy of TDR is at least comparable to standard treatment, and low-quality evidence that the benefits may outweigh the harms).  All other FDA-approved cervical disc prostheses (ProDisc-C Total Disc Replacement, BRYAN Disc, PCM Cervical Disc, Prestige Cervical Disc System and SECURE-C) are only approved for single level spinal arthroplasty.


Reference

1)    Buttner-Janz K, Schellnack K, Zippel H. An alternative treatment strategy for lumbar disc damage using the SB Charite Modular Disc Prosthesis. Z Orthop. 1987; 125:1-6.

2)    Benini A. Indications for single-segment intervertebral prosthesis implantation. Revista Di Neuroradiologia. 1999; 12(Suppl):171-173.

3)    Lemaire JP, Skalli W, Lavaste F, et al. Intervertebral disc prosthesis. Results and prospects for the year 2000. Clin Orthop. 1997; 337:64-76.

4)    National Institute for Clinical Excellence (NICE). Interventional procedures consultation document - prosthetic intervertebral disc replacement. London, UK: NICE; October 2003. Available at: http://www.nice.org.uk/page.aspx?o=87530

5)    Zigler JE, Burd TA, Vialle EN, and et al. Lumbar spine arthroplasty: Early results using the ProDisc II: A prospective randomized trial of arthroplasty versus fusion. J Spinal Disord Tech. 2003; 16(4):352-361.

6)    Van Ooij A, Oner FC, Verbout AJ. Complications of artificial disc replacement: A report of 27 patients with the SB Charite disc. J Spinal Disord Tech. 2003; 16(4):369-383.

7)    Geisler FH, Blumenthal SL, Guyer Rd, and et al. Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: Results of a multicenter, prospective, randomized investigational device exemption study of Charite intervertebral disc. J Neurosurg (Spine 2). 2004; 1:143-154.

8)    Ontario Health Technology Advisory Committee (OHTAC). Bone morphogenetic proteins (BMP) and artificial disc use in spinal surgery for degenerative disc disease (DDD). OHTAC Recommendation. Toronto, ON: Ontario Ministry of Health and Long-Term Care; March 24, 2004.

9)    Wang G. Artificial disc replacement. Health Technology Assessment. Olympia, WA: Washington State Department of Labor and Industries, Office of the Medical Director; November 1, 2004. Available at http://www.lni.wa.gov/ClaimsIns/Files/OMD/ArtificialDiscReplacement20041101.pdf

10) National Institute for Clinical Excellence (NICE). Prosthetic intervertebral disc replacement. Interventional Procedure Guidance 100. London, UK: NICE; November 2004. Available at: http://www.nice.org.uk/page.aspx?o=56892

11) Tropiano P, Huang RC, Girardi FP, et al. Lumbar total disc replacement. Seven to eleven-year follow-up. Bone Joint Surg Am. 2005; 87(3):490-496.

12) Ohio Bureau of Workers` Compensation (BWC). Position paper on artificial lumbar disc. Medical Position Papers. Columbus, OH: Ohio BWC; February 2005.

13) Blumenthal S, McAfee PC, Guyer RD, et al. A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: Part I: Evaluation of clinical outcomes. Spine. 2005; 30(14):1565-1575; discussion E387-391.

14) Acosta FL Jr, Ames CP. Cervical disc arthroplasty: General introduction. Neurosurg Clin N Am. 2005; 16(4):603-607, VI.

15) Pracyk JB, Traynelis VC. Treatment of the painful motion segment: Cervical arthroplasty. Spine. 2005; 30(16 Suppl):S23-S32.

16) Phillips FM, Garfin SR. Cervical disc replacement. Spine. 2005; 30(17 Suppl):S27-S33.

17) Schroven I, Dorofey D. Intervertebral prosthesis versus anterior lumbar interbody fusion: One-year results of a prospective non-randomized study. Acta Orthop Belg. 2006; 72(1):83-86.

18) Tropiano P, Huang RC, Girardi FP, et al. Lumbar total disc replacement. Surgical technique. J Bone Joint Surg Am. 2006; 88 Suppl 1 Pt 1:50-64.

19) Bertagnoli R, Yue JJ, Fenk-Mayer A, et al. Treatment of symptomatic adjacent-segment degeneration after lumbar fusion with total disc arthroplasty by using the prodisc prosthesis: A prospective study with 2-year minimum follow up. J Neurosurg Spine. 2006a; 4(2):91-97.

20) Bertagnoli R, Yue JJ, Nanieva R, et al. Lumbar total disc arthroplasty in patients older than 60 years of age: A prospective study of the ProDisc prosthesis with 2-year minimum follow-up period. J Neurosurg Spine. 2006b; 4(2):85-90.

21) Bertagnoli R, Yue JJ, Kershaw T, et al. Lumbar total disc arthroplasty utilizing the ProDisc prosthesis in smokers versus nonsmokers: A prospective study with 2-year minimum follow-up. Spine. 2006c; 31(9):992-997.

22) No authors listed. New Device Approval. The Prodisc-L Total Disc Replacement - P050010. United States Food and Drug Administration, August 14, 2006. Available at: http://www.fda.gov/cdrh/mda/docs/p050010.html

23) Ontario Ministry of Health and Long-Term Care, Medical Advisory Secretariat. Artificial discs for lumbar and cervical degenerative disc disease - update. Health Technology Policy Assessment. Toronto, ON: Ontario Ministry of Health and Long-Term Care; April 2006.

Addendum:

Effective 09/01/2018: Clarified that CPT 22853, 22854 and 22859 (Insertion of intervertebral disc placement) also require prior authorization.

 

Effective 9/13/2018: Specified additional FDA-approved intervertebral prostheses, contraindications added and non-smoking requirement to optimize clinical outcomes.

 

Effective 03/01/2019: Specified intervertebral disc placement requires spinal surgery (parent procedure) codes.

 

Effective 12/01/2019: Added codes to the search box as well as the description of codes and deleted code ranges listing each code separately and deleted pathology codes 88264 and 88265, they should have been 22864 and 22865, which were added to search box as well as claims and medical statement.

Effective 01/01/2020: Code update – 0375T deleted eff 01/01/2020

Effective 07/01/2020: New E/I codes added (0609T – 0612T).

Effective 01-01-2021: Deleted codes 63180 and 63182.


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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