BALLOON KYPHOPLASTY PROCEDURE REIMBURSEMENT GUIDE EFFECTIVE JANUARY 2018

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REIMBURSEMENT GUIDE EFFECTIVE JANUARY 2018 Medtronic provides this information for your convenience only. It does not constitute legal advice or a recommendation regarding clinical practice. Information provided is gathered from third-party sources and is subject to change without notice due to frequently changing laws, rules and regulations. Medtronic makes no guarantee that the use of this information will prevent differences of opinion or disputes with Medicare or other payers as to the correct form of billing or the amount that will be paid to providers of service. Please contact your Medicare contractor, other payers, reimbursement specialists and/or legal counsel for interpretation of coding, coverage and payment policies. This document provides assistance for FDA approved or cleared indications. Where reimbursement is sought for use of a product that may be inconsistent with, or not expressly specified in, the FDA cleared or approved labeling (eg, instructions for use, operator s manual or package insert), consult with your billing advisors or payers on handling such billing issues. Some payers may have policies that make it inappropriate to submit claims for such items or related service. The following information is calculated per the footnotes included and does not take into effect Medicare payment reductions resulting from sequestration associated with the Budget Control Act of 2011. Sequestration reductions went into effect on April 1, 2013. ICD-10-CM 1 Diagnosis Codes Medicare contractors have established Local Coverage Determinations (LCDs) which list medical indications for coverage and ICD-10-CM diagnosis codes that support medical necessity for Kyphon Balloon Kyphoplasty procedures. LCDs are available on the CMS website at https://www.cms.gov/medicare-coveragedatabase/overview-and-quick-search.aspx?clickon=search& Other payers also have medical policies which list ICD-10-CM diagnosis codes that support medical necessity. While balloon kyphoplasty is typically covered in the thoracic and lumbar spine for listed diagnosis codes, sacroplasty is typically not covered at this time regardless of the diagnosis. Please ensure you review your local commercial and Medicare coverage policies or contact the payer directly to determine if sacroplasty is covered. Diagnosis codes are used by both physicians and hospitals to document the indication for the procedure. Vertebroplasty is performed for pathological fractures of the vertebrae, including the sacral vertebrae, as well as the sacral ala. The codes shown below are commonly assigned for these diagnoses. 7th character A is used as long as the patient is receiving active treatment for the fracture. 2 Pathological fractures may be due to underlying conditions such as: osteoporosis; cancer, including metastatic lesions, multiple myeloma, and lymphoma; and benign lesions including hemangioma and giant cell tumor. Osteoporosis is included in the M80.- pathological facture codes above and is not coded separately. Otherwise, the underlying condition is coded separately. The codes shown below are examples commonly assigned for these underlying conditions. Sequencing of the codes for pathological fracture and the underlying condition depends on the focus of the encounter. When the encounter is specifically for vertebroplasty, the pathological fracture is ordinarily sequenced first. 6 Pathological Fracture Underlying Condition M80.08XA M80.88XA Age-related osteoporosis with current pathological fracture, vertebra(e) Other osteoporosis with current pathological fracture, vertebra(e) C41.2 Malignant neoplasm of vertebral column C41.4 Malignant neoplasm of pelvic bones, sacrum and coccyx C79.51 Secondary malignant neoplasm of bone M84.58XA Pathological fracture in neoplastic disease, other specified site 3 M84.650A Pathological fracture in other disease, pelvis 4 C83.39 Diffuse large B-cell lymphoma, extranodal and solid organ sites 7 C85.99 Non-Hodgkin lymphoma, unspecified, extranodal and solid organ sites 7 C90.00 Multiple myeloma not having achieved remission M84.68XA Pathological fracture in other disease, other site 5 D18.09 Hemangioma of other sites D48.0 Neoplasm of uncertain behavior of bone and articular cartilage 8 1. Centers for Disease Control and Prevention, National Center for Health Statistics. International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM). http://www.cdc.gov/nchs/ icd/icd10cm.htm. Updated October 1, 2017. Accessed November 21, 2017. 2. ICD-10-CM Official Guidelines for Coding and Reporting FY 2017, I.C.13.c. 3. In code M84.58XA, other specified site includes vertebrae and the sacral ala. 4. In code M84.650A, pelvis includes the sacral ala. 5. In code M84.68XA, other site includes vertebrae. 6. ICD-10-CM Official Guidelines for Coding and Reporting FY 2017, I.C.2.L.6. 7. Other codes are available for additional types of lymphoma causing pathological fracture. 8. Code D48.0 is assigned for giant cell tumor of bone.

PHYSICIAN CODING AND PAYMENT JANUARY 1, 2018 - DECEMBER 31, 2018 Physicians use CPT 1 codes for all services. Under Medicare s Resource-Based Relative Value Scale (RBRVS) methodology for physician payment, each CPT code is assigned a point value, the relative value unit (RVU), which is then converted to a flat payment amount. The listed CPT codes are appropriate for vertebral augmentation procedures: CPT 22513 Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; thoracic MEDICARE RVU 2 PHYSICIAN OFFICE FACILITY MEDICARE NATIONAL AVERAGE 3 PHYSICIAN OFFICE FACILITY 203.56 15.04 $7,826 $537 Check 22514 - lumbar 202.60 14.00 $7,792 $500 Check +22515 - each additional thoracic or lumbar vertebral body 122.65 6.49 $4,721 $230 Check 0200T Percutaneous sacral augmentation (sacroplasty), unilateral injection(s), including the use of a balloon or mechanical device, when used, 1 or more needles, includes imaging guidance and bone biopsy, when performed 4 _ Contractor _ Contractor priced 5 priced 5 Check 0201T Percutaneous sacral augmentation (sacroplasty), bilateral injections, including the use of a balloon or mechanical device, when used, 2 or more needles, includes imaging guidance and bone biopsy, when performed 4 _ Contractor _ Contractor priced 5 priced 5 Check 1. CPT copyright 2017 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. 2. Centers for Medicare & Medicaid Services. Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2018 Final Rule; 82 Fed. Reg. 52976-53371. https:// www.gpo.gov/fdsys/pkg/fr-2017-11-15/pdf/2017-23953.pdf Published November 15, 2017. Accessed November 21, 2017. The total RVU as shown here is the sum of three components: physician work RVU, practice expense RVU, and malpractice RVU. The total RVU as shown here is the sum of three components: physician work RVU, practice expense RVU, and malpractice RVU. RVUs and payment are different in the non-facility (office) setting versus the facility setting. For non-facility settings, payment is higher to the physician to account for the additional direct and indirect costs incurred by the practice when rendering the service in that setting. Non-facility expenses may include the cost of the physician s practice overhead, including rent, staff salaries and benefits, medical equipment, and supplies. In the facility, these direct and indirect costs are absorbed by the facility and thus are reflected in the payment to the facility (e.g., hospital, ASC). 3. Medicare national average payment is determined by multiplying the sum of the three RVUs by the conversion factor. The conversion factor for CY 2018 is $35.9996 per 82 Fed. Reg. 53344. https://www. gpo.gov/fdsys/pkg/fr-2017-11-15/pdf/2017-23953.. Published November 15, 2017. Accessed November 21, 2017. See also the January 2018 release of the PFS Relative Value File RVU18A at http:/ www.cms.gov/medicare/medicare-fee-for-service-payment/physicianfeesched/pfs-relative-value-files.html. Released November 15, 2017. Accessed November 21, 2017. Final payment to the physician is adjusted by the Geographic Practice Cost Indices (GPCI). Also note that any applicable coinsurance, deductible, and other amounts that are patient obligations are included in the payment amount shown. 4. Codes 0200T and 0201T are used for kyphoplasty of the sacrum (sacroplasty). Code 0200T is defined as unilateral and represents kyphoplasty of either the right or left side of the sacrum, regardless of the number of sacral levels. Code 0201T is defined as bilateral and represents kyphoplasty of both the right and left side of the sacrum, regardless of the number of sacral levels. 5. For Medicare, this is a contractor-priced code. Contractors establish the RVUs and the payment amount, usually on an individual basis after review of the procedure report.

HOSPITAL OUTPATIENT CODING AND PAYMENT JANUARY 1, 2018 - DECEMBER 31, 2018 Hospitals use CPT codes for outpatient services. Under Medicare s APC methodology for hospital outpatient payment, each CPT code is assigned to one of approximately 710 ambulatory payment classes. Each APC has a relative weight that is then converted to a flat payment amount. Multiple APCs can sometimes be assigned for each encounter, depending on the number of procedures coded and whether any of the procedure codes map to a Comprehensive APC. For 2018, there are 62 APCs which are designated as Comprehensive APCs (C-APCs). Each CPT procedure code assigned to one of these C-APCs is considered a primary service, and all other procedures and services coded on the bill are considered adjunctive to delivery of the primary service. This results in a single APC payment and a single beneficiary copayment for the entire outpatient encounter, based solely on the primary service. Separate payment is not made for any of the other adjunctive services. Instead, the payment level for the C-APC is calculated to include the costs of the other adjunctive services, which are packaged into the payment for the primary service. When more than one primary service is coded for the same outpatient encounter, the codes are ranked according to a fixed hierarchy. The C-APC is then assigned according to the highest ranked code. In some special circumstances, the combination of two primary services leads to a complexity adjustment in which the entire encounter is re-mapped to another higher-level APC. C-APCs are identified by status indicator J1. CPT 1 APC 2 STATUS INDICATOR 3 2018 MEDICARE PAYMENT 4 22513 Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device, (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; thoracic 5114, Level 4 22514 - lumbar 5114, Level 4 22513 Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device, (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; thoracic +22515 - each additional thoracic or lumbar vertebral body 5115, Level 5 J1 $10,123 CHECK 22514 Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; lumbar +22515 - each additional thoracic or lumbar vertebral body 0200T 0201T Percutaneous sacral augmentation (sacroplasty), unilateral injection(s), including the use of a balloon or mechanical device, when used, 1 or more needles, includes imaging guidance and bone biopsy, when performed 5 Percutaneous sacral augmentation (sacroplasty), bilateral injections, including the use of a balloon or mechanical device, when used, 2 or more needles, includes imaging guidance and bone biopsy, when performed 5 5115, Level 5 5114, Level 4 msculoskeletal 5114, Level 4 msculoskeletal J1 $10,123 CHECK 1. CPT copyright 2017 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. 2. Centers for Medicare & Medicaid Services. Medicare Program: Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment Systems..82 Fed. Reg. 52356-52637. https:// www.gpo.gov/fdsys/pkg/fr-2017-11-13/pdf/2017-23932.pdf. Published November 13, 2017. Accessed November 21, 2017. Centers for Medicare & Medicaid Services. Medicare Program: Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment Systems...Final Rule. 82 FR 61184..https://www.gpo.gov/fdsys/pkg/FR-2017-12-27/pdf/2017-27949.pdf. Published December 27, 2017. Accessed January 5, 2018. 3. Status Indicator (SI) shows how a code is handled for payment purposes: J1 = paid under comprehensive APC, single payment based on primary service without separate payment for other adjunctive services 4. Medicare national average payment is determined by multiplying the APC weight by the conversion factor. The conversion factor for 2018 is $78.636. The conversion factor of $78.636 assumes that hospitals meet reporting requirements of the Hospital Outpatient Quality Reporting Program. Centers for Medicare & Medicaid Services. Medicare Program: Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment Systems...82 Fed. Reg. 52398. https://www.gpo.gov/fdsys/pkg/fr-2017-11-13/pdf/2017-23932.pdf Published November 13, 2017. Accessed November 21, 2017. Centers for Medicare & Medicaid Services. Medicare Program: Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment Systems...Final Rule. 82 FR 61184..https://www.gpo.gov/fdsys/pkg/FR-2017-12-27/pdf/2017-27949.pdf. Published December 27, 2017. Accessed January 5, 2018. Payment is adjusted by the wage index for each hospital s specific geographic locality, so payment will vary from the national average Medicare payment levels displayed. Also note that any applicable coinsurance, deductible, and other amounts that are patient obligations are included in the national average payment amount shown. 5. Codes 0200T and 0201T are used for kyphoplasty of the sacrum (sacroplasty). Code 0200T is defined as unilateral and represents kyphoplasty of either the right or left side of the sacrum, regardless of the number of sacral levels. Code 0201T is defined as bilateral and represents kyphoplasty of both the right and left side of the sacrum, regardless of the number of sacral levels.

HOSPITAL INPATIENT CODING AND PAYMENT OCTOBER 1, 2017 - SEPTEMBER 30, 2018 Under Medicare s MS-DRG 1 methodology for hospital inpatient payment, each inpatient stay is assigned to one of about 755 diagnosis-related groups, based on the ICD-10-CM codes assigned to the diagnoses and ICD-10-PCS codes assigned to the procedures. Each MS-DRG has a relative weight that is then converted to a flat payment amount. Only one MS-DRG is assigned for each inpatient stay, regardless of the number of procedures performed. Other payers may also use DRGs or a variation on them, but many payers pay the hospital on a contractual basis (i.e., case rate or per diem rate) that has been negotiated between the hospital and the payer. ICD-10-PCS 2 Procedure Codes Kyphoplasty Kyphoplasty requires two codes in ICD-10-PCS and the codes must be used together to capture the entire procedure. The root operation for the first code is S-Reposition which represents restoration of height and spinal alignment. The root operation for the second code is U-Supplement which represents the cement injection. Root operation is shown by the third character in each code. Kyphoplasty uses the percutaneous approach, shown by the fifth character 3-Percutaneous. The cement injected is designated J-Synthetic Substitute as shown by the sixth character. Other code characters differentiate the anatomic site. The following ICD-10-PCS code combinations are assigned for kyphoplasty procedures. ICD-10-PCS Code Code Description 0PS43ZZ 0PU43JZ 0QS03ZZ 0QU03JZ 0QS13ZZ 0QU13JZ Reposition thoracic vertebra, percutaneous approach Supplement thoracic vertebra with synthetic substitute, percutaneous approach Reposition lumbar vertebra, percutaneous approach Supplement lumbar vertebra with synthetic substitute, percutaneous approach Reposition sacrum, percutaneous approach Supplement sacrum with synthetic substitute, percutaneous approach Vertebral Biopsy Vertebral biopsy is sometimes performed together with kyphoplasty and is coded separately in ICD-10-PCS. 3 The root operation for biopsy is B-Excision, shown by the third character in each code. Like kyphoplasty, biopsy uses the percutaneous approach shown by the fifth character 3-Percutaneous. Biopsy is considered a diagnostic step as shown by the seventh character X-Diagnostic. Other code characters differentiate the anatomic site. ICD-10-PCS Code 0PB43ZX 0QB03ZX 0QB13ZX Code Description Excision of thoracic vertebra, percutaneous approach, diagnostic Excision of lumbar vertebra, percutaneous approach, diagnostic Excision of sacrum, percutaneous approach, diagnostic

HOSPITAL INPATIENT CODING AND PAYMENT continued Diagnosis-Related Groups (DRGs) Kyphoplasty When kyphoplasty procedures are performed, without any additional procedures during the same inpatient admission, the following DRGs are typically assigned. MS-DRG 1 RELATIVE WEIGHT FY18 MEDICARE PAYMENT 4 515 Other System and Connective Tissue O.R. Procedure W MCC 2.9195 $17,594 CHECK 516 Other System and Connective Tissue O.R. Procedure W CC 1.882 $11,342 CHECK 517 Other System and Connective Tissue O.R. Procedure WO CC/ MCC 1.43608 $8,655 CHECK Kyphoplasty with Vertebral Biopsy When a vertebral biopsy is performed with the kyphoplasty, the biopsy procedure code takes precedence and the following DRGs are typically assigned. MS-DRG 1 RELATIVE WEIGHT FY18 MEDICARE PAYMENT 4 477 Biopsies of System and Connective Tissue W MCC 3.2332 $19,485 CHECK 478 Biopsies of System and Connective Tissue W CC 2.2386 $13,491 CHECK 479 Biopsies of System and Connective Tissue WO CC/MCC 1.7667 $10,647 CHECK 1. Centers for Medicare & Medicaid Services. Medicare Program: Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY2018 Rates Final Rule, 82 Fed. Reg. 37990-38589. https://www.gpo.gov/fdsys/pkg/fr-2017-08-14/pdf/2017-16434.pdf. Published August 14, 2017. Accessed September 21, 2017 and Correction 82 Fed. Reg. 46138-46163 https://www.gpo.gov/fdsys/pkg/fr-2017-10-04/pdf/2017-21325.pdf. Published October 4, 2017. Accessed October 5, 2017. 2. U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services. International Classification of Diseases, Tenth Revision, Procedure Coding System (ICD-10-PCS). http://www. cms.gov/medicare/coding/icd10/2018-icd-10-pcs-and-gems.html. Updated October 1, 2017. Accessed November 21, 2017. 3. AHA ICD-10-CM and ICD-10-PCS Coding Handbook 2016, p.306-307. 4. Payment is based on the average standardized operating amount ($5,572.53) the capital standard amount ($453.95). Centers for Medicare & Medicaid Services. Medicare Program: Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Changes and FY2018 Rates; 82 Fed. Reg. 38548. Tables 1A-1D. https://www.gpo. gov/fdsys/pkg/fr-2017-08-14/pdf/2017-16434.pdf. Published August 14, 2017. Accessed September 21, 2017 and Correction 82 Fed. Reg. 46146 https://www.gpo.gov/fdsys/pkg/fr-2017-10-04/ pdf/2017-21325.pdf. Published October 4, 2017. Accessed October 5, 2017. The payment rate shown is the standardized amount for facilities with a wage index greater than one. The average standard amounts shown also assume facilities receive the full quality update. The payment will also be adjusted by the Wage Index for specific geographic locality. Therefore, payment for a specific hospital will vary from the stated Medicare national average payment levels shown. Also note that any applicable coinsurance, deductible, and other amounts that are patient obligations are included in the national average payment amount shown.

AMBULATORY SURGERY CENTERS CODING AND PAYMENT JANUARY 1, 2018 - DECEMBER 31, 2018 ASCs use CPT codes for their services. Medicare payment for procedures performed in an ambulatory surgery center is based on Medicare s ambulatory patient classification (APC) methodology for hospital outpatient payment. However, Comprehensive APCs are used only for hospital outpatient services and are not applied to procedures performed in ASCs. Each CPT code designated as a covered procedure in an ASC is assigned a comparable relative weight as under the hospital outpatient APC system. This is then converted to a flat payment amount using a conversion factor unique to ASCs. Multiple procedures can be paid for each claim. Certain ancillary services, such as imaging, are also covered when they are integral to covered surgical procedures, although they may not be separately payable. In general, there is no separate payment for devices; their payment is packaged into the payment for the procedure. Many payers use a similar type of fee schedule to reimburse ASCs, while other payers use alternate mechanisms depending on their contracts with the ASC. CPT 1 PAYMENT INDICATOR 2 FY18 MEDICARE PAYMENT 3 22513 Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device, (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; thoracic G2 $2,721 CHECK 22514 - lumbar G2 $2,721 CHECK +22515 - each additional thoracic or lumbar vertebral body N1 N/A CHECK 0200T 0201T Percutaneous sacral augmentation (sacroplasty), unilateral injection(s), including G2 $2,721 CHECK imaging guidance and bone biopsy, when performed 4 the use of a balloon or mechanical device, when used, 1 or more needles, includes Percutaneous sacral augmentation (sacroplasty), bilateral injections, including G2 $2,721 CHECK imaging guidance and bone biopsy, when performed 4 the use of a balloon or mechanical device, when used, 2 or more needles, includes 1. CPT Copyright 2017 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. 2. The Payment Indicator shows how a code is handled for payment purposes. G2 = surgical procedure, non-office-based, payment based on hospital outpatient rate adjusted for ASC; N1 = packaged service, no separate payment 3. Medicare national average payment is determined by multiplying the relative weight by the ASC conversion factor. The 2018 ASC conversion factor is $45.575. The conversion factor of $45.575 assumes the ASC meets quality reporting requirements. Centers for Medicare & Medicaid Services. Medicare Program: Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment Systems... Final Rule. 82 Fed. Reg. 52561. https://www.gpo.gov/fdsys/pkg/fr-2017-11-13/pdf/2017-23932.pdf Published November 13, 2017. Accessed November 21, 2017. Payment is adjusted by the wage index for each ASC s specific geographic locality, so payment will vary from the stated national average Medicare payment levels displayed. Also note that any applicable coinsurance, deductible, and other amounts that are patient obligations are included in the national average payment amount shown. 4. Codes 0200T and 0201T are used for kyphoplasty of the sacrum (sacroplasty). Code 0200T is defined as unilateral and represents kyphoplasty of either the right or left side of the sacrum, regardless of the number of sacral levels. Code 0201T is defined as bilateral and represents kyphoplasty of both the right and left side of the sacrum, regardless of the number of sacral levels. MEDICAL NECESSITY Prior Authorization Some payers may require prior authorization to preform vertebral augmentation. For questions regarding prior authorization contant the carrier. In many cases prior authorization requests for balloon kyphoplasty may require the following items: Progress notes X-ray and/or MRI reports Medicare or other coverage policies Clinical literature (available from Medtronic upon request or at www. kyphon.com) Medical record documentation is key to communicating essential information for making a decision as to whether a procedure was reasonable and necessary for a particular patient.at minimum, the medical record should convey information about a patient s medical condition, the rationale for why balloon kyphoplasty was needed, and the outcome of the procedure.medical record documentation should include a detailed history and physical, which enables billing personnel to verify that a claim is coded specifically and accurately. For example, some payers require documentation that conservative care has been tried and has failed.see payer policy for specific documentation and clinical coverage criteria. Site of Service Medical necessity will dictate site of service for each individual patient. Physicians should confirm inpatient or outpatient admission criteria before selecting site of service.

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