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Aspen™ Spinous Process Fixation System

ReimbuRsement Guide

Reimbursement Hotline: 855.438.5269 | Email: reimbursement@lanx.com Phone: 855.438.5269 Email: reimbursement@lanx.com

Lanx, Inc. provides this information to help you understand the reimbursement process. Nothing in these documents is intended to increase or maximize reimbursement by any payor. Laws, regulations and payor policies concerning reimbursement are complex and change frequently. This information was prepared on April 13, 2011. It is the provider’s sole responsibility to monitor any changes and to select appropriate codes for the procedures performed. Lanx, Inc. recommends that you consult with your payors, reimbursement specialist and legal counsel regarding coding, coverage and reimbursement matters. This reimbursement data is gathered from third party sources and does not constitute reimbursement or legal advice. Lanx, Inc. makes no representation or warranty regarding this information or its completeness, accuracy, timeliness or applicability with a particular patient. Lanx, Inc. specifically disclaims liability or responsibility for the results or consequences of any actions taken in reliance on information in this document.

Contents Aspen™ Spinous Process Fixation System Reimbursement Guide Section 1: Overview...............................................................................................................

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Section 2: Introduction – Understanding Aspen Spinous Process Fixation System.....................

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Background...........................................................................................................

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Section 3: Coverage................................................................................................................

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Benefits and Medical Necessity...............................................................................

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Sample Letter of Medical Necessity..........................................................................

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Patient Selection Criteria........................................................................................

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Preauthorization Process .......................................................................................

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Section 4: Physician Coding and Payment................................................................................ 10 ICD-9-CM Diagnosis Codes.................................................................................... 10 CPT Codes/Physician Services................................................................................. 11 Modifiers.............................................................................................................. 14 Section 5: Unlisted Procedure Code Billing............................................................................. 15 Section 6: Unlisted Procedure Code Submission Attachments/Templates.................................. 17 Unlisted Procedure Form........................................................................................ 17 Description of Unlisted Procedure Using the Aspen System....................................... 18 Sample Preauthorization Letter.............................................................................. 19 FDA Clearance Letter............................................................................................. 20 Section 7: Hospital Inpatient Coding and Payment................................................................... 23 Payment Methodologies.......................................................................................... 23 Diagnosis Related Groups (DRG’s).......................................................................... 23 Case Rates and Per Diems....................................................................................... 23 ICD-9-CM Diagnosis Codes.................................................................................... 24 ICD-9-CM Procedure Codes................................................................................... 24 Revenue Codes....................................................................................................... 25 Section 8: Outpatient Coding and Payment.............................................................................. 26 Section 9: Denials.................................................................................................................. 27 Sample Appeal Letter............................................................................................. 28 Sample Operative Report........................................................................................ 29 Section 10: Frequently Asked Questions.................................................................................. 30 Section 11: Bibliography........................................................................................................ 33 Hotline: 855.438.5269 | Email: reimbursement@lanx.com

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Section 1:   Overview In the last few decades, spine surgery has seen many advances. The rate at which medical technology continues to advance can be challenging, particularly when billing staff and payers begin evaluating claim authorization and/or reimbursement associated with established surgical procedures utilizing newer surgical tools. The information in this manual is provided for the benefit of Lanx, Inc. customers to help them better understand reimbursement guidelines for the Lanx® Aspen™ Spinous Process Fixation System. The information is intended to facilitate appropriate coverage and reimbursement for providers in various sites of service. Users of this manual should understand that these are guidelines and should not be construed as policies of Lanx, Inc. The suggested codes are to be used only to facilitate appropriate coding and should not be construed as recommended guidelines in the establishment of policy, physician services or procedures, physician practice or standards of care. Any descriptions of services contained in this manual are for the purpose of illustrating typical clinical services and not intended to represent practice guidelines or standards of care. Lanx, Inc. makes no representations or warranties with respect to the contents of this manual and disclaims any implied guarantee or warranty of fitness for any particular purpose. Lanx, Inc. will not be liable to any individual or entity for any losses or damages that may be incurred by the use of this manual. Furthermore, Lanx, Inc. specifically disclaims any liability or responsibility for the results or consequences of any actions taken in reliance on the statements, opinions, or suggestions in this manual. It is always the provider’s responsibility to determine coverage and submit appropriate codes and charges for services rendered. It is important to verify coverage for each patient as policies and guidelines can vary by payer and plan.

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seCtion 2: Understanding the asPen™ sPinoUs ProCess FiXation system

The Aspen™ Spinous Process Fixation System (also known as Aspen™) is a less invasive fixation device utilized during lumbar spinal fusion procedures. Like pedicle screws, rods, hooks or plates used to fixate the posterior spine, the Aspen device is a type of posterior fixation instrumentation intended to rigidly hold vertebrae together while spinal fusion occurs. The Aspen device consists of a pair of small, titanium plates connected by a central, hollow barrel. Small spikes on the plates grip the spinous processes for rigid fixation, intended to rigidly hold the vertebrae in place while spinal fusion occurs.

The Aspen System is: • Posterior spinal fixation • Adjunct to fusion for surgical treatment of degenerative disc disease, spondylolisthesis, tumor and trauma • Used to restrict, prevent, or inhibit spinal segmental mobility • Indicated for use as posterior, non-pedicle supplemental fixation as an adjunct to fusion

The Aspen System is NOT: • A procedure • A spacer or an interspinous process decompression device • A free floating decompressive/distraction device (e.g. X-Stop®) • A device to be used with a primary stenosis diagnosis • Used to preserve spinal mobility

Hotline: 855.438.5269 | Email: reimbursement@lanx.com

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Background The Aspen™ device’s surgical technique achieves the goals of minimally invasive spine surgery, as it spares tissue that routinely is disrupted to place pedicle screws, encourages fusion, and may allow for quicker postoperative recovery.1,2 In spinal fixation procedures utilizing pedicle screws much of the associated morbidity is secondary to the extensive soft-tissue dissection necessary to widely expose the spine for pedicle screw placement and arthrodesis.3 As a less invasive fixation method to treat patients suffering from various spinal disorders and conditions, the Aspen device is commercially available, having received regulatory clearance from the U.S. Food and Drug Administration (FDA) following a demonstration of substantial equivalence to a prior FDA-cleared device with a history of success. The Aspen Spinous Process Fixation device provides another option within the various methods surgeons currently use to instrument the posterior spine and, like unilateral and bilateral pedicle screws as well as facet screws, hooks and rods, supports several types of common fusion procedures to best meet the clinical needs of individual patients. The Lanx Spinal Fixation System was originally cleared by the FDA in May 2005 via 510(k) premarket notification K043484. Numerous additions of implant components and surgical instruments to the Lanx Spinal Fixation System have subsequently been cleared by the FDA through additional 510(k) premarket notifications. Lanx, Inc. first received marketing clearance from the FDA for the Aspen implant components in September 2000, when the Center for Devices & Radiological Health (CDRH) issued its Substantially Equivalent (SE) determination to the manufacturer (K071877). This SE decision rendered by FDA was based on comparison and functional equivalence of the Aspen device to the Medtronic Sofamor Danek CD Horizon™ Spinal Fixation System (Medtronic Spine, LLC, Memphis, TN), which has a long history of successful clinical use after nearly 15 years on the U.S. market, and the subject of more than 70 premarket notification clearances by the FDA. Included in the Medtronic Sofamor Danek CD Horizon™ Spinal System 510(k) (K032037) is the SPIRE™, a spinous process plate. This plate, like the Aspen device, is a posterior non-cervical supplemental fixation device intended for fixation and attachment to spinous processes to achieve supplemental fixation as an adjunct to fusion. Subsequent clearances for additional models or sizes within the Aspen family of implants were granted by the FDA in 2009, 2010, and 2011 (K083581, K090252, K100935 and K103091).

1R  egan JJ, et al. Laparoscopic Fusion of the Lumbar Spine: Minimally Invasive Spine Surgery: A Prospective Multicenter Study Evaluating Open and Laparoscopic Lumbar Fusion. Spine 1999; 24(4): 402-11. 2 Guiot BH, et al. A Minimally Invasive Technique for Decompression of the Lumbar Spine. Spine 2002; 27(4): 432-8. 3 Benzel, E, Watson J, et al. Spine Surgery: Techniques, Complication, Avoidance, and Management. Ch 95: Minimally Invasive Spinal Decompression and Stabilization Techniques I. Gulf Prof Publishing 2005; Ch 95: 1267.

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Section 3: Coverage Benefits Covered benefits under commercial health plans can vary by health plan and by the individual or group purchasing health plan coverage. It is important you verify the specific benefits by group and plan of the patient being considered for surgery.

Medical Necessity Medical necessity is routinely established prior to any service or procedure being considered for coverage or payment. Individual payers develop their own criteria for medical necessity. Payers should be consulted for their medical necessity guidelines.

A letter of medical necessity addressed to the Medical Director may be necessary, which includes: • Patient information—name, date of birth, policy number • Details of the patient’s medical history Current diagnosis(es) Duration and degree of illness or injury Summary of past treatment(s) (i.e. conservative care or other surgical interventions) Current status (why previous treatments failed) Reason for proposed treatment • Description of the patient’s current status and treatment plan Ability to work Activities of daily living • Proposed surgical procedure(s) and rationale for treatment • Proposed location of service and dates planned • Billing codes

Hotline: 855.438.5269 | Email: reimbursement@lanx.com

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Sample Preauthorization Request/Letter of Medical Necessity

RE: Preauthorization Request for Service Patient’s Name: Date of Birth: Subscriber/Policy #: Group #:

To Whom This May Concern:

This letter is to request approval for the surgery, hospitalization and post-surgical care needed for (Patient’s Name) who suffers from (L3-L4 degenerative disc disease and associated spondylolisthesis). (Patient’s Name) has suffered from back pain and radicular leg pain since (date), despite efforts to control (his/her) symptoms using physical therapy, medication and lifestyle changes. (Radicular pain resulting in significant functional impairment with associated spondylolisthesis) is a problem that impacts the patient’s lifestyle, job, family, and well being. (Patient’s Name) symptoms have steadily progressed and conservative treatment options have failed to alleviate the symptoms. Based on the patient’s presentation and physical findings, I am recommending a surgical decompression with posterior fusion and posterior fixation. My preference is to perform a posterior fusion with decompression at the (L3-L4) level and insertion of posterior spinal fixation instrumentation. For this patient I prefer a midline surgical approach which requires a small incision in the lower back. Decompression will be performed prior to the insertion of posterior spinal instrumentation. The instrumentation will be inserted and precisely fixated onto the posterior spinal segment, and permanently implanted, to achieve supplemental fusion. The procedure requires general anesthesia and postoperative monitoring. I prefer to perform this procedure at (Name of facility). Please advise me immediately if benefits are available for this procedure and/or if additional information is required. Because (Patient’s Name) is in considerable discomfort and (her/his) condition is impacting (his/her) quality of life, we appreciate your immediate attention to this request. Sincerely, Physician Name

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Patient Selection Criteria Appropriate patient selection is critical to coverage and payment for any procedure or service. It is recommended that each patient selected for the Aspen™ Spinous Process Fixation System adequately meet the following patient selection criteria. For patients with instability, neural compression and/or chronic, unremitting back pain resulting from degenerative disc disease, spondylolisthesis, trauma and/or tumor in the thoracic or lumbar spine, the Aspen device, like pedicle and facet screws, is used as supplemental fixation in patients requiring spinal arthrodesis.

Overview Utilizing the Aspen device offers surgeons and their patients an additional posterior fixation option to pedicle screw or facet screw fixation, when considering a posterior instrumented fusion. The Aspen device is designed to provide stabilization of spinal segments in the thoracic, lumbar and sacral spine to support fusion. Biomechanical testing has shown rigid immobilization comparable to pedicle screws and facet screws.4-6 The device is indicated for use in skeletally mature patients who require arthrodesis in the T1-S1 levels.

Arthrodesis utilizing the Aspen Spinous Process Fixation System may be an appropriate treatment option for patients who: • Are experiencing back pain due to degenerative disc disease • Are experiencing radicular pain resulting in significant functional impairment who fail conservative care and have evidence of stenosis associated with spondylolisthesis • Are experiencing severe or rapid progressive symptoms of motor loss, neurogenic claudication or cauda equine syndrome • Have instability or neural compression due to a fracture • Have a dislocation, tumor or infection which results in an unstable spine after debridement • Have progressive idiopathic scoliosis • Experience recurrent disc herniation • Have a documented pseudarthrosis 6 months after initial fusion with persistent back pain • Require fixation with the Aspen device at only one level • Do not have an active infection • Do not have an allergy to titanium • Are at least 18 years of age with skeletal maturity 4K  aibara T, et al. Biomechanics of a lumbar interspinous anchor with Transforaminal lumbar interbody fixation. World Neurosurg 2010; 73(5): 572-7. 5K  arahalios DG, et al. Biomechanics of a lumbar interspinous anchor with anterior lumbar interbody fusion. J Neurosurg Spine 2010; 12(4): 372-80. 6 Data on File.

Hotline: 855.438.5269 | Email: reimbursement@lanx.com

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Risks Along with the benefits of this technology, there are also potential risks. Risks associated with the Aspen™ device include, but are not limited to: • Early or late implant bending, breakage, failure, loosening or movement/migration • Bone and/or spinous process fracture • Allergic reaction to implant material Preoperative diagnostic evaluation followed by carefully executed surgical technique is required. Postoperative care, individualized to suit the particular injury/disease requirements, is essential for optimum outcome. The surgeon must be fully aware of the risks and complications inherent to this type of surgery. Only those individuals with specialized training and experience in spinal surgery should attempt use of the implants. Patient selection is extremely important. Refer to the Instruction for Use (IFU) for a more complete description of indications, contraindications, warnings, cautions and other information about the system.

Patient Assessment The Aspen device is indicated for use in skeletally mature patients requiring arthrodesis for degenerative disc disease, spondylolisthesis, trauma and/or tumor at the T1-S1 levels. The ideal patient for arthrodesis would have failed at least 3 months of conservative therapy including physical therapy, exercise, and/or analgesics and have documented confirmation of medical necessity for fusion. Lumbar fusion is often deemed medically necessary when there is associated spinal instability, spinal stenosis with associated spondylolisthesis, spondylolysis, chronic unremitting pain with function impairment, recurrent disc herniation, adjacent segment degeneration, and/or pseudarthrosis. As the Aspen device fixates the spinal segments by driving spikes into the cortical bone of the adjacent level spinous processes and laminar bone, the device is contraindicated when there is an incompetent or missing posterior arch.

Surgical Approach Lumbar fusion may be performed using various surgical techniques and instrumentation. Surgical approaches used to perform spinal fusion include anterior, posterior, and lateral. It is well accepted that anterior lumbar interbody fusion, posterior lumbar interbody fusion, transforaminal lumbar interbody fusion and posterolateral fusion are standard approaches to performing spinal fusion. When deviating from standard spinal fusion approaches, procedures may be viewed as experimental, investigational or unproven. The Aspen device is part of the Lanx Spinal Fixation System which offers the surgeon a variety of implant components from which to assemble a suitable construct according to each individual patient’s needs and requirements. Like pedicle screws, facet screws, hooks, and rods, the Aspen device is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. Standard approaches to performing spinal fusion are required when utilizing the Aspen device.

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Preauthorization Process Preauthorization is a process that allows physicians and other health care providers to determine, prior to treating the patient: • If the patient is a covered member • If the treatment is covered • If the site of service for the treatment is covered • The amount of co-payments/co-insurance, deductibles, and the patient’s maximum benefits Preauthorization clarifies benefits in advance, allowing the physician and patient to make informed decisions regarding treatment. We strongly recommend consulting the payer with respect to coverage policies and benefits specific to each patient’s coverage. Many commercial payers require that surgeries and procedures be preauthorized. Medicare is the exception, as Medicare does not preauthorize services. A preauthorization is not a guarantee of payment. Final determination will be subject to valid eligibility, applicable benefits and medical necessity at the time of rendered services. Many payers no longer require or perform preauthorization for outpatient procedures or services. Instead, services are reviewed for medical necessity and coverage conditions when the claim is received. Accordingly, prior to treatment, we strongly recommend your patient sign a Waiver of Financial Liability (Non-Medicare), in the event of a non-coverage or partial coverage decision. Once a patient has been identified, medical necessity established, selection criteria met and a Waiver of Financial Liability signed by the patient, a preauthorization request should be submitted to the patient’s insurance carrier. The following steps should assist in the preauthorization process: • A call should be placed to the payer to verify insurance benefits and to determine if preauthorization is required • Prepare letter of preauthorization request/medical necessity or certificate of medical necessity • Submit the letter and documentation to the Medical Director including: Copies of peer reviewed published studies supporting your treatment plan Aspen™ product information FDA clearance letter Copy of patient’s insurance card Physician notes regarding patient’s history and current medical condition Copies of previous surgical records Results of imaging and other diagnostic tests • If you have not received a response within 30 days, follow up with the health plan by phone • Records should be sent by fax or by standard or express mail, with return receipt requested • Document all contact with the insurer, including the name, department and contact phone number of the person with whom you communicated • Do not send protected health information through non-secure / non-encrypted e-mail Hotline: 855.438.5269 | Email: reimbursement@lanx.com

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Section 4: Physician Coding & Payment ICD-9-CM Diagnosis Codes Each claim must be submitted with the ICD-9-CM codes that reflect the highest level of specificity of the condition of the patient. The following list of diagnosis codes is not intended to be all inclusive, however these codes may be appropriate to support medical necessity for the procedures in which the Aspen™ Spinous Process Fixation System is used:

Degenerative Disc Disease 722.51

Degeneration of thoracic or thoracolumbar intervertebral disc

722.52

Degeneration of lumbar or lumbosacral intervertebral disc

722.6

Degeneration of intervertebral disc, site unspecified

722.70

Intervertebral disc disorder with myelopathy, unspecified region

722.72

Intervertebral disc disorder with myelopathy, thoracic region

722.73

Intervertebral disc disorder with myelopathy, lumbar region

Spondylolisthesis 721.2

Thoracic spondylolisthesis without myelopathy

721.3

Lumbosacral spondylolisthesis without myelopathy

721.4

Thoracic or lumbar spondylolisthesis with myelopathy

721.9

Spondylolisthesis of unspecified site 721.90 Without mention of myelopathy 721.91 With myelopathy

738.4

Acquired spondylolisthesis

738.5

Other acquired deformity of back or spine

756.12

Spondylolisthesis

Tumor 170.2

Malignant neoplasm of the vertebral column excluding sacrum and coccyx

Trauma

10

733.1

Pathologic fracture

733.10

Pathologic fracture, unspecified site

733.13

Pathologic fracture of vertebrae (collapse of vertebra NOS)

Current Procedural Terminology Codes (CPT® Codes) Physicians use Current Procedural Terminology (CPT®) codes to report all their services. These codes are accepted by most payers. Medicare, Medicaid, TriCare, some Workers Compensation programs and most indemnity insurers use a fee schedule to pay physicians for their professional services, assigning a flat payment amount to each CPT code. Under Medicare’s Resource Based Relative Value Scale (RBRVS) methodology for physician payment, each CPT code is assigned a point value, known as the relative value units or RVU, which is the sum of the physician work, practice expense and professional liability insurance multiplied by the geographic practice cost index (GPCI). Many other payers use Medicare’s RBRVS fee schedule or a variation of it. Industrial or work-related injury cases are usually reimbursed according to the official fee schedule for each state. Use of CPT codes is governed by various coding guidelines published by the American Medical Association (AMA) and have input from other sources such as physician specialty societies. In addition, the National Correct Coding Initiative (NCCI), a set of CPT coding edits created and maintained by the Centers for Medicare and Medicaid Services (CMS), has become a national standard. The following CPT codes may be appropriate to describe procedures associated with the implantation of the Aspen Spinous Process Fixation System, at a single level. The physician should report the CPT code(s) that best describe(s) the procedure(s) performed.

POSSIBLE PROCEDURE CODES CPT Code

Description

RVU

Medicare National Average Payment*

Spinal Instrumentation - reported separately and in addition to arthrodesis 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)

22841

Internal spinal fixation by wiring of spinous processes (list separately in addition to code for primary procedure)

*22899

Unlisted procedure, spine

22.91

$778.40

0

$0

*coverage and reimbursement consideration is made on the basis of individual claims.

* 2011 Medicare Physician Fee Schedule. No geographic adjustment.

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POSSIBLE PROCEDURE/SERVICE CODES CPT Code

Description

RVU

Medicare National Average Payment*

Arthrodesis 22610

Arthrodesis, posterior or posterolateral technique, single level; thoracic (with or without lateral transverse technique)

36.67

$1245.91

22612

Arthrodesis, posterior or posterolateral technique, single level; lumbar (with or without lateral transverse technique)

46.91

$1,593.83

22630

Arthrodesis, posterior interbody technique including laminectomy and/or discectomy to prepare interspace (other than for decompression), single interspace; lumbar

45.2

$1,535.73

Bone Graft, Allograft - report only once per operative session 20930

Allograft for spine surgery only; morselized (list separately in addition to code for primary procedure)

20931

Allograft for spine surgery only; structural (list separately in addition to code for primary procedure)

Bundled into payment for surgery 3.36

$114.16

Bone Graft, Autograft - report only once per operative session 20936

Autograft for spine surgery only; (including harvesting the graft); local (eg. ribs, spinous process, or laminar fragments)for surgery obtained from same incision (list separately in addition to code for primary procedure)

20937

Allograft for spine surgery only; (including harvesting the graft); morselized (through separate skin or fascial incision) (list separately in addition to code for primary procedure)

* 2011 Medicare Physician Fee Schedule. No geographic adjustment.

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Bundled into payment for surgery

5.03

$170.90

POSSIBLE PROCEDURE/SERVICE CODES CPT Code

Description

RVU

Medicare National Average Payment*

Laminotomy and Laminectomy 63003

Laminectomy with exploration and/ or decompression of spinal cord and/ or cauda equina, without facetectomy, foraminotomy or discectomy (eg, spinal stenosis), 1 or 2 vertebral segments; thoracic

36.37

$1,235.72

63005

Laminectomy with exploration and/ or decompression of spinal cord and/ or cauda equina, without facetectomy, foraminotomy or discectomy (eg, spinal stenosis), 1 or 2 vertebral segments; lumbar, except for spondylolisthesis

34.53

$1,273.21

63011

Laminectomy with exploration and/ decompression of spinal cord and/or cauda equina, without facetectomy, foraminotomy or discectomy (eg, spinal stenosis), 1 or 2 vertebral segments; sacral

31.8

$1,080.45

63012

Laminectomy with removal of abnormal facets and/or pars inter-articularis with decompression of cauda equina and nerve roots for spondylolisthesis, lumbar (Gill type procedure)

34.85

$1,184.08

63030

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

28.3

$961.53

* 2011 Medicare Physician Fee Schedule. No geographic adjustment.

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POSSIBLE PROCEDURE/SERVICE CODES CPT Code

Description

RVU

Medicare National Average Payment*

Laminotomy and Laminectomy continued 63046

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

35.5

$1,206.16

63047

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

32.23

$1,095.06

* 2011 Medicare Physician Fee Schedule. No geographic adjustment.

Modifiers The following modifiers are the most common to procedures utilizing the Aspen™ Spinous Process Fixation System procedure. This list is not all inclusive and is not intended to represent all applicable modifiers. Refer to your current CPTŽ and/or Healthcare Common Procedure Coding System (HCPCS) manual for a complete list of modifiers, descriptors and instruction.

Modifier

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Descriptor

Modifier

Descriptor

50

Bilateral Procedure

62

Two Surgeons

51

Multiple Procedures

66

Surgical Team

52

Reduced Services

99

Multiple Modifiers

59

Distinct Procedural Service

LT / RT

Left Side / Right Side

Section 5: Unlisted Procedure Code Billing Unlisted procedure codes are designated for reporting unlisted procedures. Unlisted codes do not have an assigned Relative Value Unit (RVU) for purposes of payment, so physicians need to request/ negotiate payment for this code. Coverage of unlisted codes is generally based on medical review of documentation submitted. It is important that the physician can identify the most similar existing code to the procedure performed. If CPT 22899 is used to report the Aspen™ Spinous Process Fixation System, it is recommended that the following guidelines be considered, and the sample unlisted billing model be referenced when preauthorizing an unlisted procedure and submitting an unlisted procedure claim. The following is a list of items that should be provided to the insurance carrier for both preauthorization and claim submission:

For Unlisted Code Preauthorization Include: • Nature and extent of the procedure performed • Patient’s medical history • Medical necessity for the procedure • Complexity of symptoms, final diagnosis, physical findings, concurrent problems, and follow up care • Detailed description of procedure and instrumentation (see page 18) • Preauthorization letter* (see sample, page 19) • Aspen IFU* • Aspen FDA clearance letter* • Aspen product information* • Clinical data bibliography* • Surgeon’s recommendation of crosswalk code(s) that compare in terms of time and complexity (* indicates an electronic copy is on the enclosed CD) For preauthorization denials, see page 27

Hotline: 855.438.5269 | Email: reimbursement@lanx.com

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For Unlisted Code Claim Submission Include: • Manual Claim Form (CMS-1500) • Unlisted procedure form • Operative report* (see sample, page 29) • Nature and extent of the procedure performed • Patient’s medical history • Medical necessity for the procedure • Total time, effort, and equipment needed and used • Complexity of symptoms, final diagnosis, physical findings, concurrent problems, and follow up care • Detailed description of procedure and instrumentation (see page 18) • Preauthorization letter* (see sample, page 19) • Aspen IFU* • Aspen FDA clearance letter* • Aspen product information* • Clinical data bibliography*

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Section 6: Unlisted Procedure Code Submission Attachments and Templates Aspen™ Spinous Process Fixation: Unlisted Procedure Form In accordance with American Medical Association Current Procedural Terminology (CPT®) reporting guidelines, please complete the following form to support the use of an unlisted procedure. This information will be used to determine appropriate payment and claim adjudication in conjunction with the member’s benefit plan.

Member name:__________________________________________________________________________________ Member ID #:___________________________ Member date of birth: ________________________________ Member address (Street, City, State, ZIP):______________________________________________________ ___________________________________________________________________________________________________ Date of service:__________________________________________________________________________________ Submitting provider name:_____________________________________________________________________ License or NPI#: ______________________________ Specialty type:__________________________________ Indicate the unlisted procedure or service code number:______________________________________ Indicate the specific CPT code that is most closely related to this service: ____________________ Describe the unlisted procedure and explain why the service does not meet the definition of the standard defined CPT code listed above. Please include an adequate definition or description of the nature, extent and need for the unlisted procedure and the time, effort and equipment necessary to provide the service. Additional items, which may be included, are complexity of symptoms, final diagnosis, pertinent physical findings, diagnostic/ therapeutic procedures, concurrent problems and follow up care. Description:____________________________________________________________________________________ __________________________________________________________________________________________________ __________________________________________________________________________________________________ __________________________________________________________________________________________________ Indicate perceived RVU value associated with this service:________________________ Indicate the name of the individual who may be contacted should there be questions regarding this form: Name:______________________________ Telephone: _________________________

(Attach this form to manual claim form)

Hotline: 855.438.5269 | Email: reimbursement@lanx.com

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Description of Spinous Process-Based Stabilization Procedure as an Adjunct to Fusion using CPT Code 22899 CPT Code 22899 Unlisted Procedure, Spine Sample description: Posterior, non pedicle supplemental fixation device for single level placement in the noncervical spine as an adjunct to fusion. The device is intended for use with bone graft material and is not intended for stand-alone use. The Aspen™ system is intended to be used to help provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system is intended for use with autograft or allograft. The Lanx Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and failed previous fusion. The Aspen device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease(defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Aspen device is intended for use with bone graft material, and is not intended for stand-alone use.

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Sample Preauthorization Letter Re: Patient’s Name: Date of Birth: Subscriber/Policy #: Group #:

To Whom It May Concern:

This letter serves to establish favorable coverage for the fusion procedure for the above referenced, patient who suffers from (L3-L4 degenerative disc disorder and associated spondylolisthesis). (Patient’s Name) has suffered from back and radicular leg pain since (enter start date of pain), despite efforts to control (his/her) symptoms using physical therapy, medication and lifestyle changes. (Patient ‘s Name)’s symptoms have significantly impacted the (his/her) lifestyle, job, family, and well being. (Patient’s Name)’s symptoms have progressed to the point that surgery is required. I am recommending a posterior spinal fusion in conjunction with surgical decompression and posterior fixation. My preference is to perform a standard posterior fusion with decompression with fusion utilizing spinous process fixation to help facilitate the fusion at the (L3-L4) level. For this patient I prefer a technique that ensures a small incision in the lower back. The decompression will be performed prior to the insertion of posterior spinal instrumentation. Bone will be placed over the posterior fusion bed and the Aspen device will be inserted and precisely fixated onto the posterior spinal segment, and permanently implanted. This instrumentation is intended to achieve supplemental fusion in patients who suffer from degenerative disc disease, spondylolisthesis, trauma and/ or tumor. The coding for the intended procedure is 22612 (posterior fusion, lumbar), 63030 (decompression), 22899 (unlisted procedure, spine) and 20930 (allograft for spine surgery). The procedure requires general anesthesia and postoperative monitoring. I prefer to perform this procedure at (Name of Hospital). Therefore I request that you authorize coverage for this procedure including posterior spinal fixation instrumentation billed under CPT 22899 – unlisted procedure, spine. Because (Patient’s Name) is in considerable discomfort and (her/his) condition is impacting (his/her) quality of life, we appreciate your immediate attention to this request. If you have any questions concerning this request please do not hesitate to contact me at (phone number). Sincerely, Physician Name

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Aspen Clearance Letter

Lanx, Inc. c/o Mr. Andrew Lamborne Vice President of Product Development 390 Interlocken Cresent, Suite 890 Broomfield, Colorado 80021 Re: K100935 Trade Device Name: Lanx Spinal Fixation System Regulation Number : 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWP Date: July 09, 2010 Received: July 12, 2o1o Dear Mr. Lamborne: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, lisitng of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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2 - Mr. Andrew Lamborne

Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center of Devices and Radiological Health’s (CDRH’s) Office of Compliance. Also, please note the regulation entitled, “Misbranding by reference to premarket notification” (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/ Safety/ReportaProblem/default.htm for the CDRH’s Office of Surveillance and Biometrics/ Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center of Devices and Radiological Health

Enclosure

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Indications for Use Statement 510(k)Number (if know):

Device Name: Indications for Use: The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The System is intended for use with autograft or allograft. The Lanx Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Lanx Spinous Process Fusion Plate (SPFP) is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Lanx SPFP is intended for use with bone graft material, not intended for stand-alone use. Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

22

Page

of

Section 7: Hospital Inpatient Coding and Payment Payment Methodologies Hospital payment for inpatient services/procedures is usually based on Diagnosis-Related Groups (DRGs), case rates, per diem rates or a line-item payment methodology. Medicare pays hospital inpatient procedures under the DRG system, while most other insurers usually pay the hospital on a contractual basis (i.e., case rate or per diem rate) that has been negotiated between the hospital and insurance carrier.

Diagnosis – Related Groups (DRGs) DRGs are a system of classification for inpatient hospital services based on principal diagnosis, secondary diagnosis, surgical procedures, patient age, and the presence of complication and/or comorbidities. The system of classification is used as a financing mechanism to reimburse hospitals and selected other providers for services rendered. The cost of the equipment, supplies, operating room, patient room, nursing care, and all other services the patient receives is covered in the DRG payment that the hospital receives. Each DRG is assigned a relative weight representative of the amount of resources required for the patient’s procedure/treatment. The relative weight is multiplied by the individual hospital’s base rate (adjusted depending on labor costs, non-labor costs, capital payments, type of hospital [e.g., teaching hospital or hospital that provides a disproportionate amount of care to the disadvantaged], etc.) to determine the payable amount.

Case Rates Using the case rate method, a payer pays the provider a fixed rate based on the diagnosis and/or presenting condition. For this rate, the provider covers all of the services the patient requires during an inpatient admission, observation stay, or specified outpatient procedure, if applicable. Case rates are typically established on the basis of major diagnostic categories and may be classified by a DRG, revenue center code, ICD-9 procedure code, or CPT code. The case rate may or may not include: 1) a specified number of days associated with the case rate; 2) outlier provisions if billed charges exceed a specific dollar amount; or 3) cost of instrumentation (implants). In this model, the provider is accepting some significant risk but has considerable flexibility in how it meets the patient’s needs. However, the provider must fully understand costs and volume potential when negotiating case rates. This type of financial arrangement is often used for high-cost or high volume procedures.

Per Diems In the per diem billing system, the hospital and insurance carrier agree to a “per day” payment amount that will reimburse the hospital for all the services, supplies, etc. provided to the patient. Payments are usually limited to predetermined lengths of stay.

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ICD-9-CM Diagnosis Codes (used by all providers to describe the diagnosis(es) that prompted treatment) Each claim must be submitted with the ICD-9-CM codes that reflect the highest level of specificity of the condition of the patient. The following diagnosis codes may be appropriate to support medical necessity for the Aspen™ Spinous Process Fixation System:

Degenerative Disc Disease 722.51

Degeneration of thoracic or thoracolumbar intervertebral disc

722.52

Degeneration of lumbar or lumbosacral intervertebral disc

722.6

Degeneration of intervertebral disc, site unspecified

722.70

Intervertebral disc disorder with myelopathy, unspecified region

722.72

Intervertebral disc disorder with myelopathy, thoracic region

722.73

Intervertebral disc disorder with myelopathy, lumbar region

Spondylolisthesis 721.2

Thoracic spondylolisthesis without myelopathy

721.3

Lumbosacral spondylolisthesis without myelopathy

721.4

Thoracic or lumbar spondylolisthesis with myelopathy

721.9

Spondylolisthesis of unspecified site 721.90 Without mention of myelopathy / 721.91 With myelopathy

738.4

Acquired spondylolisthesis

738.5

Other acquired deformity of back or spine

756.12

Spondylolisthesis

Tumor 170.2

Malignant neoplasm of the vertebral column excluding sacrum and coccyx

Trauma 733.1

Pathologic fracture

733.10

Pathologic fracture, unspecified site

733.13

Pathologic fracture of vertebrae (collapse of vertebra NOS)

CD-9-CM Procedure Codes (used by hospitals to describe inpatient procedures only)

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81.00

Spinal fusion, not otherwise specified

81.05

Dorsal and dorsolumbar fusion, posterior technique

81.06

Lumbar and lumbosacral fusion, anterior technique

81.08

Lumbar and lumbosacral fusion, posterior technique

81.62

Fusion or refusion of 2-3 vertebrae

Insertion of Interbody Spinal Fusion Device 84.51

Insertion of interbody spinal fusion device

Harvest of Bone for Graft 77.70-77.79 Excision of bone for graft

Laminotomy and Laminectomy 03.02

Reopening of laminectomy site

03.09

O  ther exploration and decompression of spinal canal; Includes: decompression laminectomy or laminotomy; expansile laminoplasty; exploration of spinal nerve root; foraminotomy Code also any synchronous insertion, replacement and revision of posterior spinal motion preservation device(s) if performed (84.80-84.85)

80.51

Excision of intervertebral disc (includes laminotomy and laminectomy)

Foraminotomy 03.09

Other exploration and decompression of spinal canal

Partial Facetectomy 77.89

Other partial ostectomy or other bone, except facial bones

Medicare FY2011 MS-DRG Payment (National Average Payment*) SPINAL FUSION 459

Spinal fusion except cervical with major complication/comorbidity

$33,600

460

Spinal fusion except cervical without major complication/comorbidity

$19,991

* MS-DRG 2011 national payment estimates are determined using the book DRG Expert, 2011 Edition

Revenue Codes

(used by facilities to describe specific accommodations, ancillary services, etc.) 0278

Medical/Surgical Supply - Other Implants

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Section 8: Hospital Outpatient and Ambulatory Surgery Center (ASC) Coding and Payment The Aspen™ Spinous Process Fixation System is part of an instrumented spinal fusion procedure. All instrumented spinal fusion procedures are on Medicare’s “Inpatient List” and thus are only covered when provided in an inpatient setting. Medicare does not cover instrumented spinal fusions in an outpatient setting. Please contact the respective payer regarding coverage and payment for this procedure by commercial insurance in the outpatient setting. It will be important to review contracts with payers to ensure they provide adequate payment for this procedure in an outpatient setting.

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Section 9: Denials Even with a comprehensive approach to preauthorization, you may occasionally receive denials from health plans. The following guidelines are based on industry-standard appeals processes. Most health plans have a three-level documented appeals process. If the health plan issues a denial to a preauthorization or a claim, it is advised that you inquire about the plan’s appeal process so you can initiate it.

Recommended Steps: • Request a copy of the denial in writing • Determine the reason for the denial (coding, technology, or medical necessity) • Reconsideration – Request a peer-to-peer review – surgeon to health plan Medical Director – focusing on benefits of treatment and its medical necessity • First Level Appeal – Include letter of appeal, medical necessity justification, successful outcomes, description of procedure, operative report and any peer reviewed literature to support your position • Second Level Appeal – Request a specialty matched external review from a Board Certified Physician (Neurosurgeon or Orthopaedic Spine Surgeon) with experience in posterior fixation instrumentation during spinal fusion following a decompression procedure. • Third Level Appeal – Request independent external review

The following are examples of an appeal letter and a hypothetical operative report which may be utilized in the appeal process: • Sample letter of appeal for a predetermination denial • Sample operative report

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Sample Appeal Letter

Re: Patient’s Name: Date of Birth: Subscriber/Policy #: Group #:

This is a follow up to my letter of (date of preauthorization request letter) regarding preauthorization of benefits for the above referenced patient. Your previous response indicates that benefits are not available because (reason for denial if related to instrumentation rather than procedure). I hope the following information clarifies the medical necessity of the technique I am recommending to resolve (Patient’s Name)’s chronic back and radicular leg pain. The spinal instrumentation I intend to implant is a posterior fixation device for the purpose of achieving posterior fusion (following a decompression procedure). The procedure is intended to treat (Patient Name)’s (enter diagnosis: degenerative disc disease, spondylolisthesis, tumor/or trauma). This spinous process fixation instrumentation provides supplemental posterior fixation and is a less invasive alternative to pedicle screws with decreased length of stay, blood loss and shorter recovery. The instrumentation is inserted through a minimal standard midline incision and compressed to the spinous processes. The spikes secure the device into the cortical bone and a central barrel acts to share compressive loads, stabilizing the spine and aiding in quicker patient recovery and return to normal activity. (Patient’s Name) is extremely eager to proceed and resolve (his/her) back pain symptoms which are chronic in nature and have failed to respond to conservative management. Of the options available for posterior fixation instrumentation, I feel that the Aspen Spinous Process Fixation device is the best option for my patient as it spares tissue that is otherwise disrupted to place pedicle screws, encouraging fusion, minimizing complications, and allowing for quicker post operative recovery and return to daily activities and work. Please review and reconsider the original request for predetermination for the spinal fusion procedure supplemented with spinous process instrumentation for fixation.

Sincerely, Physician Name

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Sample Operative Report (reference material only) Please Note: The following sample is for illustrative purposes only, and reflects one of several treatment options that may be available in this hypothetical case. Date of operation: . October 1, 2010 Date of birth: ....... November 25, 1940 Surgeon: .............. Dr. John Smith Diagnosis: ............ Severe Degenerative Disc Disease and Grade 1 Spondylolisthesis L4-L5 Procedure: ........... L4-L5 decompression and bilateral laminotomy, foraminotomy and fusion utilizing posterior non-pedicle spinal fixation. Anesthesia: .......... General Complications: ..... None Blood loss: ........... Minimal Indications: ......... Mrs. Jones, a 70 year old female with a medical history of diabetes mellitus, hypertension and coronary artery disease with previous cardiac stenting, presented with back pain and leg symptoms secondary to disc degeneration and spondylolisthesis. Her symptoms had been present for many years and significantly limited her daily activity. Extensive conservative therapy including epidural steroid injections and physical therapy failed to have any long term effect. MRI examination of the lumbar spine demonstrated degenerative changes at L4-L5 with severe degenerative disc disease and Grade 1 spondylolisthesis of L4 on L5. Surgical treatment is planned. Procedure: ........... After general endotracheal anesthesia was induced by Dr. Jones, the patient was placed into a standard prone position for lumbar surgery. The midline was marked and the L4-L5 level localized with an x-ray. A small midline incision over the spinous process of L4-L5 was made. Subcutaneous tissue and fascia were divided and the paraspinal muscles were reflected off of the spinous processes, laminar arches and facets of L4 and L5. A foraminotomy was performed taking the inferior aspect of the L4 lamina and medial facet, leaving the facet partially intact. A decompression was then performed exposing the L4-L5 nerve roots clearly to their respective foramens. The lamina and facets at L4-L5 were then decorticated bilaterally. The supraspinous ligament was preserved, and a 12 mm spinous process fixation device sized and filled with allograft and demineralized bone matrix was placed in the L4-L5 interspinous space providing stabilization of the L4-L5 spondylolisthesis. The fixation device was securely fixed to the L4-L5 spinous process. Additional bone graft material was placed over the lamina and packed into the facets. The wound was then copiously irrigated and closed in the standard layered fashion and was injected with marcaine with epinephrine (1:200,000) to help control postoperative pain. Sterile dressings were applied to the wound, and the patient was extubated and brought to the recovery room in satisfactory condition. Hotline: 855.438.5269 | Email: reimbursement@lanx.com

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Section 10: Frequently Asked Questions 1. W  hat is the appropriate CPT code for physicians to use to bill the Aspen™ device?* (see coding guidance on pages 10-14) There are three coding options available for reporting the Aspen system, which is a posterior, nonpedicle supplemental fixation device, intended for use at a single level in the non-cervical spine. The physician should report the CPT code that best describes the procedure performed.

POSSIBLE PROCEDURE CODES CPT Code 22840

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Description 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)

22841

Internal spinal fixation by wiring of spinous processes (list separately in addition to code for primary procedure)

22899

Unlisted procedure, spine (list separately in addition to code for primary procedure)

RVU

Medicare National Average Payment

22.91

$778.40

0

$0

*coverage and reimbursement consideration is made on basis of individual claims

2. W  hat is the difference between the Aspen™ Spinous Process Fixation System and the X-STOP®? While both devices are used at the spinous processes, and some patients may be candidates for either device (depending on clinical diagnosis), the two have different indications and are used in different ways. The Aspen Spinous Process Fixation System is a fixation device intended to support fusion of a spinal segment. The Aspen device is anchored to the bone, and is always used in conjunction with bone graft. The Aspen device is an alternative to pedicle screws or other types of fixation devices. The X-STOP® (Medtronic Spine, LLC, Memphis, TN) is not a fixation device, but a motion preserving decompression device. It is not part of a fusion procedure, and is not anchored to the patient’s bone.

Aspen

X-STOP®

Fixation Device

Decompression Device (motion preserving)

Anchored to Bone

Not Anchored to Bone

Always used in Conjunction with Bone Graft

Not part of a Fusion Procedure

Instrumentation: Not a Procedure or Therapy

Stenosis Therapy

3. D  oes Medicare pay for the implantation of the Aspen Process Fixation System in the outpatient setting? No. Spinal Fusion Instrumentation is considered by Medicare to be an “inpatient only” procedure and is not covered if performed in the outpatient setting. Private payer policies may vary, and it is recommended providers consult with each individual payer regarding coding, coverage and payment, in advance.

4. Is there a C Code for the Aspen Spinous Process Fixation System? No. C Codes are used by hospitals when billing Medicare for outpatient services. Insertion of spinal instrumentation is considered an inpatient only procedure by Medicare. Hotline: 855.438.5269 | Email: reimbursement@lanx.com

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5. I s CPT 22840 specific only to pedicle screws or may it be used to report Aspen™? No. CPT 22840 (Posterior Non-Segmental Instrumentation) describes the non-segmental instrumentation that may be used in a spinal fusion procedure. The descriptor provides examples (Harrington rod technique, pedicle fixation across one interspace, atlantoaxial transarticular screw fixation, sublaminar wiring at C1, facet screw fixation) but not an exhaustive list of instrumentation or devices.

6. I f I bill the Aspen system using the CPT 22899, the unlisted code, is there anything you can provide me to assist with the submission of the claim? Yes. Section 5 of this guide includes information about billing unlisted codes providing detailed recommendation for specific items to include in an unlisted claim submission. Included in this guide are: • Unlisted procedure form • Description of procedure and instrumentation • Sample Preauthorization Letter • Aspen IFU • Aspen FDA Clearance Letter • Aspen product information • Clinical data bibliography

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Section 11: Bibliography 1. Wilson PD, Straub LR. Spine fusion with internal plate fixation. NY State J Med. 1952 Dec 15;52(24):3003-4. 2. Cobey MC. The value of the Wilson plate in spinal fusion. Clin Orthop Relat Res. 1971 May;76:138-40. 3. Bostman O, Myllynen P, Riska EB. Posterior spinal fusion using internal fixation with the Daab plate. Acta Orthop Scand. 1984 Jun;55(3):310-4. 4. Karahalios DG, Kaibara T, Porter RW, Kakarla UK, Reyes PM, Baaj AA, Yaqoobi AS, Crawford NR.

Biomechanics of a lumbar interspinous anchor with anterior lumbar interbody fusion. J Neurosurg Spine. 2010 Apr; 12(4):372-80.* 5. Kaibara T, Karahalios DG, Porter RW, Kakarla UK, Reyes PM, Choi SK, Yaqoobi AS, Crawford NR.

Biomechanics of a lumbar interspinous anchor with transforaminal lumbar interbody fixation. World Neurosurg. 2010 May; 73(5):572-7.* 6. Wang JC, Spenciner D, Robinson JC. SPIRE spinous process stabilization plate: biomechanical

evolution of a novel technology. Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves. J Neurosurg Spine. 2006 Feb;4(2):160-4. 7. Hardenbrook M. Posterior fixation using an interspinous device for the treatment of degenerative spine disease. Orthopedicstoday. 2010 Sept;30(9).* 8. Aspen Spinous Process Fixation Instructions for Use (IFU)*

*Available upon request from Lanx

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With innovative solutions uniquely designed by surgeons for surgeons, Lanx specializes in devices and systems for all segments of spinal surgery. Integrating leading technology and state-of-the art engineering, our products have been created to meet the specific surgical needs of our customers and improve outcomes for their patients.

FOR ReimbuRsement suPPORt Hotline: 855.438.5269 email: reimbursement@lanx.com

2011   Lanx, inc. All rights reserved. Lanx, surgeon driven innovation, Aspen and other associated designs and logos are registrations or trademarks of Lanx, inc. X-stOP and Cd Horizon spire are a registered trademark of medtronic spine LLC. CPt is a registered trademark of the American medical Association. ©

Lanx, inc  || 310 interlocken Parkway, suite 120  broomfield, Colorado 80021 

P: 303.443.7500 ||  F: 303.443.7501 || www.lanx.com

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