Artificial Disc Replacement

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ARTIFICIAL DISC REPLACEMENT HS-046

Clinical Coverage Guideline page 1 Original Effective Date: 9/18/2008 - Revised: 9/18/2009, 9/24/2010, 9/1/2011, 9/6/2012, 9/5/2013, 9/4/2014, 9/17/2015

Easy Choice Health Plan, Inc.

Exactus Pharmacy Solutions, Inc.

Harmony Health Plan of Illinois, Inc.

Missouri Care, Incorporated

WellCare Health Insurance of Arizona, Inc., operating in Hawai‘i as ‘Ohana Health Plan, Inc.

WellCare of Kentucky, Inc.

WellCare Health Plans of Kentucky, Inc.

WellCare Health Plans of New Jersey, Inc.

WellCare of Connecticut, Inc.

WellCare of Florida, Inc., operating in Florida as Staywell

WellCare of Georgia, Inc.

WellCare of Louisiana, Inc.

WellCare of New York, Inc.

WellCare of South Carolina, Inc.

WellCare of Texas, Inc.

WellCare Prescription Insurance, Inc.

Windsor Health Plan, Inc.

Artificial Disc Replacement

Policy Number: HS-046 Original Effective Date: 9/18/2008

Revised Date(s): 9/18/2009; 9/24/2010;

9/1/2011; 9/6/2012; 9/5/2013; 9/4/2014;

9/17/2015

APPLICATION STATEMENT

The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any.

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ARTIFICIAL DISC REPLACEMENT HS-046

DISCLAIMER

The Clinical Coverage Guideline is intended to supplement certain standard WellCare benefit plans. The terms of a member’s particular Benefit Plan, Evidence of Coverage, Certificate of Coverage, etc., may differ significantly from this Coverage Position. For example, a member’s benefit plan may contain specific exclusions related to the topic addressed in this Clinical Coverage Guideline. When a conflict exists between the two documents, the Member’s Benefit Plan always supersedes the information contained in the Clinical Coverage Guideline. Additionally, Clinical Coverage Guidelines relate exclusively to the administration of health benefit plans and are NOT recommendations for treatment, nor should they be used as treatment guidelines. The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any. Note: Lines of business (LOB) are subject to change without notice; current LOBs can be found at www.wellcare.com – select the Provider tab, then

“Tools” and “Clinical Guidelines”.

BACKGROUND

Degenerative disc disease (DDD) of the lower back results from changes in the intervertebral discs in the lumbar region, and is characterized by chronic low back pain. An estimated 60% to 80% of adults in the United States have low back pain at some time in their lives with DDD being a major contributor. In most cases, low back pain can be relieved through rest and conservative therapy, but, for 5% to 10% of patients, it becomes chronic and disabling. It is a leading cause of physician visits, surgery, hospitalization, and disability. Chronic low back pain that is refractory to conservative therapies might require surgical therapy, mainly lumbar spinal fusion; over 200,000 of these surgeries are performed annually in the United States at a cost of more than $6 billion. An aging population and improvements in diagnosis, expanding surgical indications, and new instrumentation have led to a marked increase in the utilization of lumbar spinal fusion and an increase in hospital charges.^1,2

A new technique has been developed in which the diseased spinal disc is removed surgically and replaced with an artificial disc. Artificial discs for the cervical and lumbar sections of the spine are available. These devices are composed of two cobalt-chromium endplates that are attached to the vertebrae and a polyethylene disk that is inserted between the metal endplates. The goal of this procedure is to reduce or eliminate back pain while

maintaining spinal curvature, flexibility and load bearing. Discs are implanted through an anterior approach and are attached to vertebrae with screws, teeth, ridges, or fins. Several models have a rough or porous coating to

encourage bone in growth around the disc. Current models use metal alloys, ultra-high molecular weight polyethylene, and ceramics.^1,2

The artificial disc was developed in response to these concerns. Designed to maintain the function of the natural spine, the artificial disc is hypothesized to prevent degeneration of adjacent discs, which is presumably caused by the increased movement required of these discs when the fused area becomes immobilized. Currently there are two artificial lumbar discs approved by the Food and Drug Administration (FDA) for use in the United States, the

Charité® Artificial Disc (DePuy Spine Inc., a Johnson & Johnson Company) and ProDisc-L® Total Disc Replacement (Synthes Spine Inc.). Both discs are approved for use in adult patients with single-level DDD between L3 and S1.

Other discs, such as the Maverick™ Total Disc Replacement (Medtronic Sofamor Danek Inc.) and FlexiCore®

Lumber Intervertebral Disk Replacement (Stryker Spine), are not approved for use in the U.S.^1,2

The evidence from uncontrolled long-term studies suggests that potential degeneration of adjacent discs and facets and wear of the polyethylene part of the disc may occur and that, in some cases, revision surgery may be needed.

Long-term follow-up results from randomized controlled studies are not yet available, and it is therefore not known how the long-term safety of LTDR compares with spinal fusion. Furthermore, patient selection criteria still need to be refined. The evidence was further limited by the absence of appropriate control conditions and blind assessments in some studies.³

POSITION STATEMENT

Applicable To:

Medicaid – All Markets Medicare – All Markets

Artificial Disc Replacement in the lumbar and cervical spine is considered experimental and investigational.

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ARTIFICIAL DISC REPLACEMENT HS-046

CODING

Non-Covered CPT© Codes

22856 Cervical - Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation includes osteophytectomy for nerve root or spinal cord decompression and microdissection, single interspace

22857 Lumbar - Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare Interspace other than for decompression, each additional interspace

22861 Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, single interspace; cervical

22862 Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, single interspace; lumbar

22864 Removal of total disc arthroplasty (artificial disc), anterior approach, single interspace; cervical 22865 Removal of total disc arthroplasty (artificial disc), anterior approach, single interspace; lumbar Non-Covered CPT© Category II Codes

0092T+ Cervical - Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation includes osteophytectomy for nerve root or spinal cord decompression and microdissection, each additional interspace,

+ Add on code List separately in addition to code for primary procedure 22856

0095T+ Removal (artificial disc), anterior approach, each additional interspace, cervical + Add on code List separately in addition to code for primary procedure 22864

0098T+ Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, cervical

0163T+ Lumbar - Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare Interspace other than for decompression, each additional interspace

0164T+ Removal of total disc arthroplasty, (artificial disc), anterior approach, each additional interspace, lumbar + Add on code List separately in addition to code for primary procedure 22865

0165T+ Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, lumbar

+ Add on code List separately in addition to code for primary procedure 22862 HCPCS Level II © Codes – No applicable codes.

Non-Covered ICD-9-CM Procedure Codes

84.62 Insertion of total spinal disc prosthesis, cervical 84.65 Insertion of total spinal disc prosthesis, lumbosacral

84.66 Revision or replacement of artificial spinal disc prosthesis, cervical 84.68 Revision or replacement of artificial spinal disc prosthesis, lumbosacral Non-Covered DRAFT ICD-10-PCS Codes

Refer to the following ICD-10-PCS table(s) for specific PCS code assignment based on physician documentation.

NOTE: Per ICD-10-PCS Coding Guidelines, “ICD-10-PCS codes are composed of seven characters.

Each character is an axis of classification that specifies information about the procedure performed.

Within a defined code range, a character specifies the same type of information in that axis of classification.

One of 34 possible values can be assigned to each axis of classification in the seven-character code”.

0RR30JZ Replacement of cervical vertebral disc with synthetic substitute, open approach 0RR50JZ Replacement of cervicothoracic vertebral disc with synthetic substitute, open approach 0RW30JZ Revision of synthetic substitute from cervical vertebral disc, open approach

0RW50JZ Revision of synthetic substitute from cervicothorathic vertebral disc, open approach

0SR20JZ Med/Surgical Upper Joints, Replacement, Lumbar Vertebral Disc, Open, Synthetic Substitute 0SR40JZ Med/Surgical Upper Joints, Replacement, Lumbosacral Disc, Open, Synthetic Substitute

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ARTIFICIAL DISC REPLACEMENT HS-046

0RP30JZ Removal of Synthetic Substitute from Cervical Vertebral Disc, Open Approach 0RP50JZ Removal of Synthetic Substitute from Cervicothoracic Vertebral Disc, Open Approach 0RR30JZ Replacement of Cervical Vertebral Disc with Synthetic Substitute, Open Approach 0RR30JZ Replacement of Cervical Vertebral Disc with Synthetic Substitute, Open Approach 0RR50JZ Replacement of Cervicothoracic Vertebral Disc with Synthetic Substitute, Open Approach 0RR50JZ Replacement of Cervicothoracic Vertebral Disc with Synthetic Substitute, Open Approach 0RW30JZ Revision of Synthetic Substitute in Cervical Vertebral Disc, Open Approach

0RW33JZ Revision of Synthetic Substitute in Cervical Vertebral Disc, Percutaneous Approach

0RW34JZ Revision of Synthetic Substitute in Cervical Vertebral Disc, Percutaneous Endoscopic Approach 0RW50JZ Revision of Synthetic Substitute in Cervicothoracic Vertebral Disc, Open Approach

0RW53JZ Revision of Synthetic Substitute in Cervicothoracic Vertebral Disc, Percutaneous Approach 0RW54JZ Revision of Synthetic Substitute in Cervicothoracic Vertebral Disc, Percutaneous Endoscopic Approach 0SP20JZ Removal of Synthetic Substitute from Lumbar Vertebral Disc, Open Approach

0SP40JZ Removal of Synthetic Substitute from Lumbosacral Disc, Open Approach

0SR20JZ Replacement of Lumbar Vertebral Disc with Synthetic Substitute, Open Approach 0SR20JZ Replacement of Lumbar Vertebral Disc with Synthetic Substitute, Open Approach 0SR40JZ Replacement of Lumbosacral Disc with Synthetic Substitute, Open Approach 0SR40JZ Replacement of Lumbosacral Disc with Synthetic Substitute, Open Approach 0SW20JZ Revision of Synthetic Substitute in Lumbar Vertebral Disc, Open Approach

0SW23JZ Revision of Synthetic Substitute in Lumbar Vertebral Disc, Percutaneous Approach

0SW24JZ Revision of Synthetic Substitute in Lumbar Vertebral Disc, Percutaneous Endoscopic Approach 0SW40JZ Revision of Synthetic Substitute in Lumbosacral Disc, Open Approach

0SW43JZ Revision of Synthetic Substitute in Lumbosacral Disc, Percutaneous Approach

0SW44JZ Revision of Synthetic Substitute in Lumbosacral Disc, Percutaneous Endoscopic Approach Non-Covered ICD-9-CM Diagnosis Codes

722.4 Degeneration of cervical intervertebral disc

722.52 Degeneration of lumbar or lumbosacral intervertebral disc Non-Covered ICD-10-CM Diagnosis Codes

M50.30 - M50.33 Other cervical disc degeneration

M51.36 Other intervertebral disc degeneration, lumbar region M52.37 Other intervertebral disc degeneration, lumbosacral region

*Current Procedural Terminology (CPT®) 2015 American Medical Association: Chicago, IL.

REFERENCES

1. National coverage determination for lumbar artificial disc replacement (150.10). Centers for Medicare and Medicaid Services Web site.

http://www.cms.hhs.gov/mcd/search.asp. Published August 2007. Accessed August 17, 2015.

2. Artificial intervertebral disc arthroplasty for treatment of degenerative disc disease of the cervical spine. BlueCross BlueShield Technology Assessment Web site. http://www.bcbs.com/blueresources/tec/vols/26/26_05.pdf. Published February 2008 (updated 2011). Accessed August 17, 2015.

3. Artificial disc replacement for cervical degenerative disc disease. Hayes Directory Web site. http://www.hayesinc.com. Published December 24, 2012 (reviewed December 23, 2014). Accessed August 17, 2015.

MEDICAL POLICY COMMITTEE HISTORY AND REVISIONS

Date Action

9/17/2015  Approved by MPC. Coding updates only.

9/4/2014, 9/5/2013, 9/6/2012  Approved by MPC. No changes.

12/1/2011  New template design approved by MPC.

9/1/2011  Approved by MPC.