Coding for Spinal Augmentation

1. Coding for Spinal Augmentation Presented by Tammy Cox, CPC and Lori Dafoe, CPC

2. Diagrams for Vertebrae of the Spine Can be found at: http://www.cedars-sinai.edu/Patients/Programs-and-Services/Spine-Center/Anatomy-of-the-Spine/Vertebrae-of-the-Spine.aspx

3. Spine Coding References • Current Procedural Terminology (CPT 2012) • CPT Assistant • North American Spine Society (NASS) – Common Coding Scenarios for Comprehensive Spine Care • American Academy of Orthopaedic Surgeons (AAOS) – Coding Companion • American Academy of Professional Coders (AAPC) Coding Forums • Noridian, Medicare Administrative Contractor for Washington

4. Another Round of Kyphoplasty Settlements Yields More Than $12 Million in Payments to Resolve False Claims Act Allegations • On February 7, 2012, the Department of Justice (“DOJ”) announced settlements totaling more than $12 million to resolve allegations that fourteen hospitals had violated the False Claims Act by overcharging Medicare for kyphoplasty procedures on patients. • The fourteen hospitals (located in New York, Mississippi, North Carolina, Washington, Indiana, Missouri, and Florida) overcharged Medicare for kyphoplasty procedures by performing them as inpatient procedures when they could have been performed safely as less costly outpatient procedures. • These are not the first settlements between hospitals and the DOJ involving kyphoplasty billing. This latest round brings the number of settlements to more than 40 hospitals nationwide, totaling over $39 million, and they expect more to come.

5. Kyphoplasty Settlements, continued. • These settlements with the hospitals follow on the heels of the federal government’s 2008 settlement with the manufacturer, which paid $75 million to resolve allegations that it defrauded the Medicare program by counseling hospitals to perform the kyphoplasty procedures on an inpatient basis even though many of the cases could have safely been done on an outpatient basis. • All of the kyphoplasty settlements stem from a qui tam (whistleblower) lawsuit brought under the False Claims Act, which permits private citizens to bring lawsuits on behalf of the United States. The lawsuit underlying these settlements was filed in 2008 in New York by two former employees of the manufacturer; one was a former reimbursement manager and the other was a former regional sales manager. They will share in approximately $2.1 million from the settlements.

6. Absolute Contraindications • Symptomatic foraminal stenosis or other spinal degenerative disease, or facet arthropathy, or other significant coexistent spinal or bony pain generators require treatment before an intervention. Following adequate address of all other pain generators, residual disabling pain localized to the compression fracture may allow payment for vertebroplasty or vertebral augmentation procedures. • Bone fragment retropulsion. • Absence of a confirmed fracture. The medical record must support that the fracture has been present no more than 4 months; • Symptoms that cannot be related to a fracture; • Neither Percutaneous Vertebroplasty nor Percutaneous vertebral augmentation will be separately paid when combined with any open spine procedure; • Unstable fracture or requirement for stabilization procedure in same or adjacent spinal region; • Radicular symptoms without evidence of adequate pain management and address of the underlying pathology; • Asymptomatic vertebral compression fracture;

7. Absolute Contraindications, Cont. • Active osteomyelitis whether fungal, bacterial or mycobacterial, or any other active infection, including urinary tract infection (UTI); • Presence of painful metastases to areas other than the spine, spinal cord compression, primary bone and osteoblastic tumors, solitary plasmacytomas; • Uncorrected coagulation disorders; • Known allergy to any of the materials used in these procedures; • Presence of any other condition described as a contraindication in the FDA labeling. • The medical record does not indicate appropriate attempts at conservative medical management, including (either singly or in combination), bed rest, bracing, and local or systemic analgesics (e.g., narcotic and/or non-narcotic drugs) has been tried and failed, except as noted above. • The service does not follow the guidelines of NAS; and/or • Prophylactic treatment for osteoporosis of the spine or for chronic back pain of long-standing duration, even if associated with old compression fractures. Prophylactic procedures will be denied.

8. Payer Limitations • Percutaneous vertebral augmentation is NOT indicated for treatment of lesions of the sacrum or coccyx.NAS will not allow payment for any such treatment until and unless either becomes listed as a covered indication in FDA labeling AND literature supports and describes appropriate criteria for such use. The CPT Category III codes, 0200T and 0201T, are non-covered. • These procedures are not to be considered prophylactic for osteoporosis of the spine or for chronic back pain of long-standing duration, even if associated with old compression fractures.

9. Medicare Part B Policy: Noridian- MAC F • Indications & Limitations – “Medical record review has demonstrated widespread, fundamental errors in patient selection, technical performance of procedures, pre and post procedural assessment of patients and the common absence of follow-up of any kind – which initiated our coverage review and resulted in this LCD. Among our clinical concerns are the failure to attempt appropriate conservative management for a reasonable – or any – period of time; failure to inform patients of alternative treatments and potential complications of the injection procedures; treatment of an inappropriate number of levels; treatment during an active infection; treatment in the face of other unaddressed pain generators both spinal in in other body areas; treatment when other procedures are indicated or performed; failure to adequately follow patients for a reasonable period of time; and, a disturbing incidence of complications. These concerns resulted in an extensive literature review, consequent proposal to non-cover any vertebral augmentation procedure and ultimately, resulted in this policy.”

10. Guidelines • Several days prior to Vertebroplasty, radiography and/or computed tomography (CT) or MRI, consistent with the physician’s judgment and absent contraindications may be performed to assess the extent of vertebral collapse, the location and extent of the lytic or degenerative process, the visibility and degree of involvement of the pedicles, the present of cortical destruction or fracture and the presence of epidural or foraminalstenosis caused by tumor extension or bone fragment retropulsion. • NAS requires that the medical record documentation support that the procedure is conducted in accordance with the clinical and procedural criteria established in the literature produced in recent years. • The most important clinical information – information that must be unequivocally documented in the medical record – is that one or more vertebral compression fractures are present and that the patient’s pain is predominantly, if not solely, related to the demonstrated fracture(s). The fracture can be acceptably confirmed by plain film x-ray or by MRI depending on the clinical circumstances. In situations where the patient’s history does not clearly document the age of the compression fracture, MRI may be useful if vertebral augmentation is considered.

11. More Guidelines, continued • For Both PercutaneousVertebroplasty and Percutaneous Vertebral Augmentation: Oneindication – painful compression fracture, regardless of etiology, described below. • Clearly demonstrated vertebral compression fracture, with severe pain, refractory to conservative treatment and referable specifically to that site – non-specific documentation of “lower back pain” or similar language will not support payment. • So long as the LCD-specified vertebral compression fracture is documented and so long as there is literature support for Vertebroplasty or Vertebral Augmentation for compression fractures caused by that condition, NAS will consider treatment eligible for payment if all LCD requirements are met. • Assuming all of the below criteria are fulfilled, the only circumstance in which these procedures will be considered by NAS to be medically reasonable and necessary occurs when there is a painful compression fracture (e.g., pain level > 7 on VAS 1-10) which is refractory to non-invasive pain intervention(s) applied for reasonable time periods and only when interference with basic activities of daily life (ADLs) is present and documented, and then only after a documented comprehensive pain evaluation and examination. • This comprehensive pain assessment and consequent pain management treatment plan must address all pain generators affecting the patient’s painful state and physical function. The plan must begin with the least invasive approach that addresses all or most of the pain generators. (For example, a patient with multiple painful bony metastases and a compression fracture may be served best with an implantable pump for analgesia. On the other hand, a surgical stabilization procedure may be more appropriate in a patient with multiple compression fractures in the thoracic spine).

12. Diagnoses • Two codes are required to describe the medical necessity of the procedure: one for the compression fracture and one to indicate pain. These are the only covered ICD-9-CM codes that support medical necessity:

14. Coding for Percutaneous Vertebral Augmentation Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device, one vertebral body, unilateral or bilateral cannulation (eg, kyphoplasty) • CPT 22523; thoracic • CPT 22524; lumbar • CPT 22525; each additional thoracic or lumbar vertebral body (List separately in addition to code for primary procedure) • No code for cervical (not clinically indicated for Medicare) – CPT 22899 – Unlisted procedure, spine

15. Assistant Surgeon – 80,82, AS • Statutory payment restriction for assistants at surgery applies to this procedure. Assistant at surgery may not be paid.

16. Coding for Radiological Supervision and Interpretation Radiological supervision and interpretation, percutaneousvertebroplasty, vertebral augmentation, or sacral augmentation (sacroplasty), including cavity creation, per vertebral body or sacrum • CPT 72291; under flouroscopic guidance • CPT 72292; under CT guidance Don’t forget modifier -26 to denote the professional component of this service!

17. Noridian Part B Documentation Findings • Failure to Submit Documentation • Insufficient Documentation • Diagnosis Codes • Medical Necessity of the Service • Signatures

18. Appeals Cautions • Resubmitting Claims • Phone Appeals • Medical Necessity Denials https://www.noridianmedicare.com/partb/appeals/

19. Documentation Requirements for Vertebroplasty and KyphoplastyReference: Local Coverage Determination (LCD) for Vertebroplasty, Vertral Augmentation; Percutaneous (L23888)The following documentation is required in order for this service to be covered by Medicare: Pre-Operatively • Clearly documented vertebral compression fracture to specific location • Record should reflect that the patient’s pain is predominantly, if not solely, related to the demonstrated fractures. • Fracture is confirmed by plain film x-ray or by MRI pre-operatively. • Comprehensive pain evaluation with documentation of severe pain (e.g., pain level >7 on VAS 1-10) • Documentation of interference with basic activities of daily life • Pain management treatment plan • Must address all pain generators affecting the patient’s painful state and physical function. • Plan must begin with least invasive approach that addresses all or most of the pain generators. • Documentation must specifically indicate the attempts at conservative treatment.

20. Documentation Requirements for Vertebroplasty and Kyphoplasty, cont.Pre-Operative requirements, continued. • Complete assessment of the patient • Clear documentation that the patient is neurologically intact relative to the vertebral levels of proposed treatment. • Any patient currently significantly symptomatic from other spinal pathologies requires treatment prior to the performance of any vertebroplasty or vertebral augmentation • Payment is not allowed immediately following acute compression fractures or diagnosis of them. • Prolonged delay is not always in the best interest of the patient. In those instances Medicare would require the provider to clearly document the rationale for this decision.

21. Documentation Requirements for Vertebroplasty and Kyphoplasty, cont. Procedural Requirements Procedural: • Procedure must be performed utilizing CT or fluoroscopic guidance during the procedure with retained images of final trocar placement as well as the vertebral body at the end of the procedure. • Coverage limited to a maximum of three (3) vertebral levels on any date of service and only within the range of T5-L5 (L4-L5, not L5-S1).

22. Documentation Requirements for Vertebroplasty and Kyphoplasty, cont. Post-Operative Requirements Post-Operative • Follow-up assessments required at one week, one month, and three months. • Telephone follow-up is acceptable with appropriate documentation. Note: This document has been created solely as a tool to assist in the documentation requirements. It should not be used to replace the Local Coverage Determination of Vertebroplasty or Vertebral Augmentation Procedures.

23. Coding Practice!

24. Operative Report – Practice Coding Operative Report CPT & ICD- 9 Codes • The path for the Kyphon tamp was created with (a) hand reamer advised and (b) the kyphoncuret. The balloon tamps were utilized bilaterally at the T12 and L2 levels to create a vacuum/void for the cement within the targeted vertebrae. Cement was allowed to cure to perfect viscosity and then advanced under direct fluoroscopic visualization on AP and lateral views into the confines of the vertebral body of T12 and L1. • 22523: PVA, thoracic (T12) • 22525: PVA, additional vertebral body (L2) • 77291-26 : Fluoro guidance • 733.13: Pathologic fracture of vertebrae • 724.1: Pain in thoracic spine • 724.2: Pain in lumbar spine

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