1 Clinical Policy Title: Interspinous dynamic stabilization devices Clinical Policy Number: CCP.1213 Effective Date: April 1, 2016 Initial Review Date: November 18, 2015 Most Recent Review Date: January 8, 2019 Next Review Date: January 2020 Related policies: CCP.1003 Spine pain — epidural steroid injections CCP.1030 Spine pain — facet joint injections CCP.1063 Spinal surgeries CCP.1072 Spine pain — trigger point injections CCP.1101 Hierarchy of chronic pain management ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas’ clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by AmeriHealth Caritas when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas’ clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas’ clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas’ clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas considers the use of the coflex® Interlaminar Stabilization® device (Paradigm Spine LLC, New York, NY) to be clinically proven and, therefore, medically necessary when all of the following criteria are met (Guyer, 2016; Li, 2017; Musacchio, 2016; Schmidt, 2018; Schmier, 2014): Diagnosis of at least moderate lumbar spinal stenosis between L1 and L5 of one or two contiguous vertebrae, confirmed by radiography, with or without spondylolisthesis, which requires surgical decompression. Absence of gross angular or translatory instability of the spine at index or adjacent levels confirmed by radiology. Member must experience relief in flexion from their symptoms of leg, buttock, or groin pain, with or without back pain, and must have undergone a regimen of at least six months of unsuccessful Policy contains: Interspinous or interlaminar spacer. Neurogenic intermittent claudication. Spinal decompression. Lumbar spinal stenosis.
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Interspinous dynamic stabilization devices · (Donnally, 2018; Guyer, 2016; Jackson, 2016): More than two vertebral levels requiring surgical decompression. Conditions resulting in
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ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas’ clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by AmeriHealth Caritas when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas’ clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas’ clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas’ clinical policies are not guarantees of payment.
Coverage policy
AmeriHealth Caritas considers the use of the coflex® Interlaminar Stabilization® device (Paradigm Spine LLC,
New York, NY) to be clinically proven and, therefore, medically necessary when all of the following criteria
are met (Guyer, 2016; Li, 2017; Musacchio, 2016; Schmidt, 2018; Schmier, 2014):
Diagnosis of at least moderate lumbar spinal stenosis between L1 and L5 of one or two contiguous
vertebrae, confirmed by radiography, with or without spondylolisthesis, which requires surgical
decompression.
Absence of gross angular or translatory instability of the spine at index or adjacent levels confirmed
by radiology.
Member must experience relief in flexion from their symptoms of leg, buttock, or groin pain, with
or without back pain, and must have undergone a regimen of at least six months of unsuccessful
Policy contains:
Interspinous or interlaminar spacer.
Neurogenic intermittent
claudication.
Spinal decompression.
Lumbar spinal stenosis.
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non-operative treatment consisting of non-steroidal anti-inflammatory drugs and at least one of
the following: rest, restriction of activities of daily living, physical therapy, or steroid injections.
Member is skeletally mature.
AmeriHealth Caritas considers the use of all other interspinous dynamic stabilization devices to be
investigational and, therefore, not medically necessary. Medical necessity of requests for this device,
therefore, will be considered on a case-by-case basis.
Limitations:
All other uses of interspinous dynamic stabilization devices are not medically necessary.
Stabilization with the coflex device is not medically necessary for members with the following conditions
(Donnally, 2018; Guyer, 2016; Jackson, 2016):
More than two vertebral levels requiring surgical decompression.
Conditions resulting in gross instability of the lumbar spine, including:
o Prior surgical procedure that resulted in gross translatory instability of the lumbar spine.
o Prior fusion, implantation of a total disc replacement, or complete laminectomy at index
level.
o Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or
past trauma, tumor, or infection.
o Severe facet hypertrophy requiring extensive bone removal that would cause gross
instability.
o Radiographic confirmation of gross angular or translatory instability of the spine at index or
adjacent levels with sagittal plane translation > 4.0 mm as spondylolisthesis or retrolithesis.
o Osteopenia and osteoporosis.
o Degenerative lumbar scoliosis (Cobb angle > 25° lumbar segmental).
Isthmic spondylolisthesis or spondylolysis (pars fracture).
Back or leg pain of unknown etiology.
Axial back pain only, with no leg, buttock, or groin pain.
Obesity defined as a body mass index ≥ 35.
Active or chronic infection at a systemic or localized level, including infection with human
immunodeficiency virus. Clinicians should exercise caution in referring patients who are prone to
infection for elective spinal stabilization surgery.
History of Paget disease, osteomalacia, or any other metabolic bone disease (excluding osteopenia,
which is addressed above).
Rheumatoid arthritis or other autoimmune disease requiring chronic steroid use.
Active malignancy: a member with a history of any invasive malignancy (except nonmelanoma skin
cancer), unless they have been treated with curative intent and there has been no clinical signs or
symptoms of the malignancy for at least five years. Patients with a primary bony tumor are
excluded as well.
Known allergy to titanium alloys or magnetic resonance contrast agents.
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Cauda equina syndrome defined as neural compression causing neurogenic bowel or bladder
dysfunction.
Active tobacco use. Members who use tobacco should cease tobacco use for at least four weeks
before surgery and at least six months after surgery.
Uncertain commitment to rehabilitation. Members must express commitment to adhere to
recommendations for post-surgery limitations, activity, and exercise.
For Medicare members only:
AmeriHealth Caritas considers the use of interspinous dynamic stabilization devices to be clinically proven
and, therefore, medically necessary when using the X STOP® Interspinous Process Decompression System
(Medtronic Sofamor Danek Inc., Memphis, Tennessee) for persons who meet all of the following criteria
(Medicare coverage article A52693; Local Coverage Decisions L34006 and L35094):
Age 50 or older and suffering from intermittent neurogenic claudication secondary to a confirmed
diagnosis of lumbar spinal stenosis.
Experiencing moderately impaired physical function and relief in flexion from their symptoms of
leg, buttock, or groin pain, with or without back pain.
Have undergone at least six months of non-operative treatment.
The X STOP is not medically necessary for persons with any of the following conditions:
Allergy to titanium or titanium alloy.
Spinal anatomy or disease that would prevent implant of the device or cause the device to be
unstable in situ, such as significant instability of the lumbar spine (e.g., isthmic spondylolisthesis or
degenerative spondylolisthesis greater than grade 1.0 [on a scale of 1 to 4]); an ankylosed segment
at the affected levels, or acute fracture of the spinous process or pars interarticularis.
Significant scoliosis (Cobb angle greater than 25 degrees).
Cauda equina syndrome defined as neural compression causing neurogenic bowel or bladder
dysfunction.
Diagnosis of severe osteoporosis, defined as bone mineral density (from dual-energy X-ray
absorptiometry scan or some comparable study) in the spine or hip that is more than 2.5 standard
deviations below the mean of adult normals in the presence of one or more fragility fractures.
Active systemic infection or infection localized at the site of implantation.
Body mass index > 40 kg/m².
Alternative covered services:
Conservative nonsurgical treatments for lumbar spinal stenosis, including nonsteroidal anti-
L35094 Services That Are Not Reasonable and Necessary.
Commonly submitted codes
Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not
an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill
accordingly.
CPT Code Description Comment
22867 Insertion of interlaminar/interspinous process stabilization/distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; single level
22868
Insertion of interlaminar/Interspinous process stabilization/distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; second level (List separately in addition to code for primary procedure)
22869 Insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; single level
22870
Insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; second level (List separately in addition to code for primary procedure)
ICD-10 Code Description Comments
G95.89 Disease of the spinal cord, other specified
M48.061 Spinal stenosis, lumbar region without neurogenic claudication
M43.06 Spondylolisthesis, lumbar region
HCPCS
Level II Code Description Comments
C1821 Interspinous process distraction device (implantable)