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Reimbursement Overview Supporting Adjunctive Use of the coflex-f Implant During Lumbar Fusion Procedures


Academic year: 2021

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Reimbursement Overview

Supporting Adjunctive Use of the coflex-F® Implant

During Lumbar Fusion Procedures

Coding Recommendations Overview

Implant Description & Device Type Differentiation

U.S. Payor Concerns & Pre-Authorization Recommendations



Paradigm Spine is committed to providing the most appropriate and accurate coding recommendations to

users of the coflex-F® implant. We recognize the significant responsibility you have as healthcare professionals

to accurately code and bill third-party insurers for the procedures you perform. Recent changes to the coverage

and coding landscape for lumbar spinal fusion, including those supported by use of instrumentation such as the

coflex-F® implant, have prompted updated review of the issues. To validate its 2012 physician and facility coding

recommendations, Paradigm Spine has consulted with an external professional coding staff. A listing of possible

coding solutions and applicable codes we have found appropriate for both physicians and facilities* has been

provided within this document.

For physician billing, the use of CPT code 22840 is an established code for non-segmental instrumentation and

has an RVU assignment for reimbursement by Medicare and many commercial insurance carriers. Use of this

permanent CPT code for description of the implantation of the coflex-F® device is most appropriate over other

codes which do not describe this implant’s mechanism of action in the posterior spine. Therefore, use of CPT

code 22840 is appropriate at this time, in terms of current coding convention and definitions issued by

authoritative bodies.

Also, it may be appropriate to use CPT code 22851 to describe other instrumentation codes, when a separate

procedure involving application of an intervertebral biomechanical device, such as a synthetic cage, is

documented in the operative note.

Coding solutions for relevant hospital outpatient scenarios are provided for specific procedures associated with

the coflex-F® implant; however, most procedures applicable to the coflex-F® surgical procedure are designated

as “inpatient only” by Medicare, and are not available in ASC or hospital outpatient settings of care. Commercial

carriers may vary in their policies regarding these procedures, and reimbursement may be available in the

outpatient and ASC settings under individual policies.

For Coding and Reimbursement Support, call 1-888-796-8411 or email


* While recommendations are offered within this document, each coding solution must reflect the actual documented procedures performed, and may not necessarily include all of the coding options presented within this document. While it is common to utilize multiple procedure codes in association with a coflex-F® implantation, be aware that all procedures must be supported by specific documentation. Reimbursement for the correct codes may also be subject to multiple procedure reductions.



CPT Codes


CPT Description


National Average

2012 RVUs



National Average

2012 Payment


22558 Arthrodesis, anterior interbody technique, including minimal discectomy to prepare interspace (other than for decompression); lumbar

45.48 $1,548.03 +22585 Arthrodesis, anterior interbody technique, including minimal discectomy to

prepare interspace (other than for decompression); each additional interspace (List separately in addition to code for primary procedure)

10.01 $340.72

22612 Arthrodesis, posterior or posterolateral technique, single level; lumbar (with lateral transverse technique, when performed)

47.14 $1,604.53 22630 Arthrodesis, posterior interbody technique, including laminectomy and/or

discectomy to prepare interspace (other than for decompression), single inter-space; lumbar

45.62 $1,552.80

22633 Arthrodesis, combined posterior or posterolateral technique with posterior interbody technique including laminectomy and/or discectomy sufficient to prepare interspace (other than for decompression), single interspace and seg-ment; lumbar

54.79 $1,864.92

+22614 Arthrodesis, posterior or posterolateral technique, single level; each additional vertebral segment (List separately in addition to code for primary procedure)

11.65 $396.54

+22632 Arthrodesis, posterior interbody technique, including laminectomy and/or discectomy to prepare interspace (other than for decompression), single inter-space; each additional interspace (List separately in addition to code for primary procedure)

9.51 $323.70

+22634 Arthrodesis, combined posterior or posterolateral technique with posterior interbody technique including laminectomy and/or discectomy sufficient to prepare interspace (other than for decompression), single interspace and seg-ment; each additional interspace and segment (List separately in addition to code for primary procedure)

14.78 $503.08


+22840 Posterior non-segmental instrumentation (eg, Harrington rod technique, pedicle fixation across 1 interspace, atlantoaxial transarticular screw fixation, sublaminar wiring at C1, facet screw fixation) (List separately in addition to code for primary procedure)

22.70 $772.65

+22851 Application of intervertebral biomechanical device(s) (eg, synthetic cage(s), methylmethacrylate) to vertebral defect or interspace (List separately in addi-tion to code for primary procedure

12.16 $413.90


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

28.63 $974.50


+20930 Allograft, morselized, or placement of osteopromotive material, for spine surgery only (List separately in addition to code for primary procedure)

0 0

+20936 Autograft for spine surgery only (includes harvesting the graft); local (eg, ribs, spinous process, or laminar fragments) obtained from same incision (List sepa-rately in addition to code for primary procedure)

0 0

+20937 Autograft for spine surgery only (includes harvesting the graft); morselized (through separate skin or fascial incision) (List separately in addition to code for primary procedure)

4.98 $169.51

1CPT codes proceeded by “+” are add-on codes and are not subject to multiple procedure reductions per CPT guidelines.

2RVUs (Relative Value Units) are multiplied by the conversion factor (CF) CY2012= 34.0376, provided yearly by CMS to determine physician payment values. For Coding and Reimbursement Support, call 1-888-796-8411 or email reimbursement@mcra.com






ICD-9-CM Description

77.79 Excision of other bone for graft, except facial bones 78.09 Bone graft of other bone, except facial bones

81.07 Lumbar and lumbosacral fusion of the posterior column, posterior technique 81.08 Lumbar and lumbosacral fusion of the anterior column, posterior technique 84.51 Insertion of interbody spinal fusion device

84.59 Insertion of other spinal devices 80.51 Excision of intervertebral disc


MS-DRG Description

2012 Medicare National Average Payment


459 Spinal Fusion Except Cervical with MCC $36,557.49 460 Spinal Fusion Except Cervical without MCC $21,725.01


CPT Code APC APC Description Status Indicator 2012 Medicare Payment Rate3 Fusion

22558 C4

22612 0208 Laminotomies and laminectomies T5 $3,560.20

22614 0208 Laminotomies and laminectomies T $3,560.20

22630 C

22633 C


22840 C

22851 0050 Level II Musculoskeletal Procedures Except Hand and Foot

T $2,271.75 Decompression

63030 0208 Laminotomies and laminectomies T $3,560.20

63035 0208 Laminotomies and laminectomies T $3,560.20


20930 C

20936 C

20937 C



1 CPT 2012 Professional Edition, 2011, American Medical Association 2 Medicare RVUs 2012, www.cms.gov 2011

3 2012 Medicare HOPPS, November 2011, www.cms.gov 4 C=Inpatient only procedure

5 T=subject to multiple procedure reduction.

6 2012 ICD-9-CM for Hospitals-Volumes 1,2&3, 2011 Ingenix

7 2012 MS-DRG relative weight multiplied by 2012 CF per IPPS Final Rule CMS-1518, as calculated by MCRA, payment rates will vary by facility.



There are four common elements to account for in coding adjunctive fusion procedures, when clinically indicated:

Coding Element


1) Fusion approach / technique type

(e.g., open posterior / anterior) 22612Fusion, use appropriate approach and technique code for each level.

2) Instrumentation type

(e.g., posterior instrument) 22840Instrumentation, per level.

3) Decompression performed

(e.g., laminotomy, laminectomy, facet resection) 63030Decompression, if performed, use appropriate code for procedure.

4) Autograft or allograft used 20937

Graft, use appropriate code for type used.

Insurers will not always ask what brand (e.g., “coflex-F®”) or type of instrumentation (“pedicle screws” or “interspinous process plate”) will be used in a spine procedure. In communicating with the insurer, the review nurse will typically only require the billing code for posterior instrumentation (CPT 22840).

If asked how the procedure will be coded, it might be helpful to indicate that instrumentation will be used in accordance with its clearance from the FDA as an adjunct to fusion. We will code for bone graft (allograft or autograft). The pre-authorization nurse does not need to know specific terms. Some “translation” or “instability” observed may be enough to relay to the insurer for purposes of pre-authorization.

Proper documentation is key to assuring the procedure will be paid. Make notes concise – the notes should be written in a way that accurately reflect and describe the procedure’s elements (1-4, above), and which will support the payor’s fusion policies. Review the lumbar fusion policies of your top 1-3 payors for reference on what needs to be included in the notes. Use simple terminology in the notes - similar to the terms used for pre-authorization. Avoid specific product classifications and types (e.g., “pedicle screws” or “plates”), brand names, or other details that are not necessary for insurers to see (unless they ask).

Physicians and coders should collaborate throughout the process - this ensures the codes used for pre-authorization will be reflected in the

documentation used to support claims sent to payors (as best as possible).

Pre-authorization obtained with coding for the four procedural elements: • Approach / Technique

• Instrumentation • Decompression • Autograft / Allograft

Coders / billers and the physicians are involved early in the process, so they understand the proper notes to be dictated, and the codes which were used to secure authorization.

Procedure is performed and operative notes are generated that are accurate to describe the four procedural coding elements; and are no more specific than necessary for the payor



Payors commonly confuse the coflex-F® implant with other cleared or approved products. In October 2010, Paradigm Spine received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for its coflex-F® implant (K093438) to act as an adjunct to fusion. This is different from certain interspinous technologies, like the X-STOP® spacer. The X-STOP® implant is a non-fusion, “extension blocker” therapeutic mechanism that provides relief of different symptoms stemming from nerve impingement in and around the spinal canal. As such, there is a significant distinction to be made between traditional thoracolumbar arthrodesis using the coflex-F® implant for rigid fixation, versus non-fusion spinal therapies using interspinous process devices (e.g., X-STOP®).

While both devices are placed between the spinous processes, the two devices have different indications and accomplish their desired outcome in different ways. The coflex-F® implant is a fixation device intended to support anterior fusion of a spine segment in cases of DDD. The coflex-F® implant is an alternative to pedicle screws or other fixation devices. The X-STOP® implant is not a fixation device, but rather an interspinous extension blocker for patients with a different diagnosis, and different symptoms. In addition, the X-STOP® is not part of a fusion procedure, nor is it anchored to the patient’s bone like the coflex-F® implant.


The coflex-F® Interlaminar Stabilization System FDA Marketing Clearance Letter:


The coflex-F® implant is used in spinal fusion. It takes the role of pedicle screws, in addition to bone graft or substitutes used. In this regard, it is similar to these adjunct-to-fusion products:

• Posterior Stabilization Systems (e.g. DSS, Dynesys)

• Spinous Process Fixation Devices (e.g. Aspen, CD Horizon Spire)

COMMON MISCONCEPTION: The coflex-F® implant is NOT like any other types of non-fusion posterior spine devices:

X-STOP® Interspinous Process Decompression System (FDA-approved)




• Medicare (CMS) considers this procedure reasonable and necessary. There have been no national (or local) coverage decisions on this topic of adjunctive fusion devices.

• Adjunct-to-fusion instrumentation, like the coflex-F® instrumentation, is covered by Aetna, Cigna

-Aetna Policy: Back Pain-Invasive Procedures


-Cigna Policy: Lumbar Fusion for Spinal Instability & Degenerative Disc Conditions

www.cigna.com/customer_care/healthcare_professional/coverage_positions/medical/mm_0303_ coveragepositioncriteria_lumbar_fusion_degenerative_conditions.pdf


Regence BCBS has a non-coverage policy for the Aspen device.


During pre-authorization for the coflex-F® system, your provision of CPT coding and explanation will ensure it is not treated like Aspen. Additionally, appeals and reconsiderations will allow for further explanation and differentiation, if necessary.

Other BCBS plans, like BCBS NC, will not cover X-STOP® but will cover fusion procedures

• No X-STOP® coverage...


...BUT spine fusion for the coflex-F® system indications are covered



As an alternative to pedicle screws and rods, the surgeon may suggest the coflex-F® implant. The coflex-F® implant is a minimally invasive lumbar fusion device that can be inserted through a small skin incision in the back. The implant is intended to stabilize the spine in conjunction with an interbody cage. The coflex-F® implant is sized to fit between the lamina and is attached to the spinous processes by rivets (see picture below). This interlaminar stabilization allows the body to heal and the spine to fuse in the intended segment. The implant is made of titanium and is available in a variety of sizes to fit precisely to the anatomy.

Due to its unique “U” design, the coflex-F® implant can be placed between the two laminae, which are the strongest bones of the posterior spine. At the same time, the implant covers a large surface area which allows for optimal load distribution and stable fixation. The coflex-F® device can help relieve symptoms by limiting how far back the patient can arch and decreases the abnormal motion at the painful spinal segment. This device helps improve the ability to surgically decompress the nerves and relieve the back and leg pain the patient is experiencing.





When is surgery necessary?

Surgery is considered when non-surgical therapy fails to adequately control the symptoms of pain, weakness or nerve dysfunction and if symptoms become disabling. Generally, the need for surgery is a quality of life decision, not a life or death decision. The surgeon will work with the patient to customize a treatment plan.

How does a fusion improve pain?

It is believed that pain originates in levels of the spine where the bones are slipped or the discs or joints are damaged. This may be due to irritated nerve endings around the disc, bone, or joints, or it may be due to actual entrapment of the spinal nerves in that region. By eliminating motion across the damaged level, pain can be improved. The fusion is designed to eliminate motion in that fused segment of the spine, thereby decreasing back pain created by motion.

Will a fusion prevent the patient from bending?

Ninety-five percent of all bending, in terms of being able to touch your toes, involves your hip joints, not your spine. Thus, patients undergoing a lumbar fusion typically have no loss of ability to touch their toes. If more than two levels of the spine are fused, there is some permanent loss of motion, but again, more than 95% of all the flexion occurs at the hip joints, not the spine. Stretching the muscles around the pelvis and hips cannot be over-emphasized.

Why coflex-F® over pedicle screws?

Pedicle screws often require a more extensive dissection. The coflex-F® implant is intended to be less invasive compared to traditional pedicle screw fixation. It provides significant segmental stability and posterior fixation. The implant design allows for a tissue-sparing insertion with a smaller skin incision, reduced blood loss and reduced muscle trauma. The neural structures are protected and complications encountered with conventional pedicle screw systems can be avoided. Due to the less invasive surgical technique, the operating time can be reduced, leading to a faster rehabilitation after surgery.




1. Bono CM, Lee CK. Critical analysis of trends in the treatment of degenerative disc disease over the past 20 years, Spine, 2004;29:455-463.

2. Urban JP, Roberts S. Degeneration of the intervertebral disc. Arthritis Res Ther 2003;5:120-30. By the third decade of life, the nucleus pulposus becomes replaced with fibrocartilage, and the distinction between the nucleus and the annulus becomes blurred. The proteoglycan, water, and noncollagenous protein concentrations decrease, while the collagen concentration increases. The increase in collagen concentration is more pronounced in the nucleus and in the posterior quadrants of the disc. It is more pronounced with age and as one proceeds more caudally in the lumbar spine.

3. AANS guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Chapter 10: fusion following decompression in patients with stenosis without spondylolisthesis. J Neurosurg: Spine 2005; 2: 686-91

4. Weinstein JN, et al. Surgical versus Nonsurgical Therapy for Lumbar Spinal Stenosis. NEJM 2008; 358-8; 794-810.

5. Delawi D, Dhert WJA, Castelein Rm, etal. The incidence of donor site pain after bone graft harvesting from the posterior iliac crest may be overestimated. A study on spine fracture patients, Spine, 2007;32:1865-1868.

6. Freebody, RB et al. Anterior Transperitoneal Lumbar Fusion, JBJS Vol 53-B, No 4, p 617 (1971) 7. Hanley EN, David SM. Lumbar arthrodesis for treatment of back pain. JBJS. 1999;81:716-730. 8. Ulrich PF. Anterior Lumbar Interbody Fusion (ALIF) Surgery. Spine-Health. 2004.

9. Chung, SK et al. Comparative study of laparoscopic L5-S1 fusion versus open mini-ALIF, with a minimum 2-year follow-up, Eur Spine J, Vol 12, p 613 (2003)

10. Fairbank JC, Pynsent PB, The Oswestry Disability Index. Spine 2000; 25(22):2940-2952

11. Bradford, DS. One-Staged anterior and posterior hemivertebral resection and arthrodesis for congenital scoliosis. 12. Enker P, Steffee AD. Interbody fusion and instrumentation. Clin Orthop. 1994;300:90-101.

13. McKenna, PJ et al. A prospective, randomized controlled trial of femoral ring allograft versus a titanium cage in circumferential lumbar spinal fusion with minimum 2-year clinical results. Eur Spine J, Vol 14, p 727 (2005)

For a more detailed analysis of the above noted references from peer-reviewed clinical literature on this topic, please contact Paradigm Spine.

For more information on Paradigm Spine, LLC or its portfolio of products, please visit www.paradigmspine.com or call 212-367-7274. For questions pertaining to reimbursement, please call 1-888-796-8411.



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