LCD for ZOLEDRONIC ACID (DL27257)



|LCD for ZOLEDRONIC ACID (DL27257) |

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Please note: This is a Future LCD.

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Please note: This is a Draft policy.

Draft LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Draft LCDs are not necessarily a reflection of the current policies or practices of the contractor.

|Contractor Information |

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|Contractor Name back to top |

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|Palmetto GBA  |

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|Contractor Number back to top |

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|00880  |

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|Contractor Type back to top |

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|Carrier  |

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|LCD Information |

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|LCD ID Number back to top |

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|DL27257  |

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|LCD Title back to top |

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|ZOLEDRONIC ACID  |

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|Contractor's Determination Number back to top |

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|ZA.0908  |

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|AMA CPT / ADA CDT Copyright Statement back to top |

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|CPT codes, descriptions and other data only are copyright 2007 American Medical Association (or such other date of |

|publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including|

|procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental |

|Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.   |

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|CMS National Coverage Policy back to top |

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|Internet-Only Manual (IOM) Publication 100-02, Medicare Benefit Policy, Chapter 15, Section 50, 50.1, 50.2, 50.3, 50.4.1, |

|50.4.2, 50.4.3 and 50.4.5 outlines coverage for drugs and biologicals. |

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|Internet-Only Manual (IOM) Publication 100-04, Medicare Claims Processing, Chapter 17, Section 20, 20.1 and 40 outlines |

|payment allowance limits for drugs and biologicals and discarding of same. |

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|Internet-Only Manual (IOM) Publication 100-08, Medicare Program Integrity Manual, Chapter 13. Section 13.1.3, 13,3-13.5.4, |

|13.6-13.7.2, Local Coverage Determinations. |

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|Primary Geographic Jurisdiction back to top |

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|South Carolina |

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|Oversight Region back to top |

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|Region IV |

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|Projected Determination Effective Date back to top |

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|For services performed on or after 09/01/2008   |

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|Original Determination Ending Date back to top |

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|Revision Effective Date back to top |

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|Revision Ending Date back to top |

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|Indications and Limitations of Coverage and/or Medical Necessity back to top |

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|Intravenous Zoledronic acid is currently available under the brand names Zometa® and Reclast®. |

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|Zometa® (J3487) is indicated for the treatment of: |

|Hypercalcemia of malignancy; |

|Multiple myeloma; |

|Bone metastases from solid tumors in conjunction with standard antineoplastic therapy, including bone metastases from |

|multiple myeloma, breast carcinoma, prostate carcinoma, and other solid tumors. Patients with prostate cancer should have |

|received at least one hormonal therapy. |

|Drug-induced osteopenia, secondary to androgen-deprivation therapy in prostate cancer patients (prophylaxis); and |

|Cancer treatment-induced bone loss in breast cancer. |

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|Reclast® (J3488) is indicated for treatment of: |

|Paget’s disease of bone |

|Disabling osteoporosis |

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|Intravenous zoledronic acid is covered for patients with disabling osteoporosis who meet the following criteria: |

|1. An axial bone mass measurement T-score below -2.5, and one of the following: |

|Aggressive, rapidly progressive osteoporosis with unrelenting pain resulting in impaired ambulation |

|Demonstrated compression fractures of axial skeleton or peripheral fractures |

|Demonstrated rapid loss of height |

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|2. Documented allergy to shellfish and/or salmon derivatives, |

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|3. Failed a trial of calcitonin therapy, |

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|4. Intolerance of oral bisphosphonate therapy due to medical or surgical conditions including but not limited to: |

|Severe esophageal disease (e.g., ulcerations, strictures) |

|Inability to take anything by mouth, or |

|Inability to sit or stand for at least 30 minutes |

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|5. Patient has failed an acceptable response to a 6 month trial of oral bisphosphonates, or because the degree of severity |

|of osteoporosis does not medically warrant an oral trial of bisphosphonates. |

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|The World Health Organization defines osteoporosis as a bone density or bone mass that exceeds 2.5 standard deviations (SD)|

|below peak normal mass in healthy adults aged 18-30 years. SD from the mean peak bone mass is termed the “T” score. Thus, a|

|T score of the lumbar spine or hip at least 2.5 SD below the norm defines the condition of osteoporosis. |

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|Coverage Topic back to top |

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|Chemotherapy (Outpatient) |

|Doctor Office Visits |

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|Coding Information |

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|Bill Type Codes: back to top |

|Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. |

|Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill |

|Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all |

|claims. |

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|999x |

|Not Applicable |

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|Revenue Codes: back to top |

|Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service.|

|In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue |

|Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is |

|not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes. |

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|99999 |

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|CPT/HCPCS Codes back to top |

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|HCPCS Codes |

|J3487 |

|Zoledronic acid |

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|J3488 |

|Reclast injection |

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|ICD-9 Codes that Support Medical Necessity back to top |

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|Use of these codes does not guarantee reimbursement. The patient's medical record must document that the coverage criteria |

|in this policy have been met. |

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|Covered ICD-9 Codes for HCPCS code J3487 |

|185 |

|MALIGNANT NEOPLASM OF PROSTATE |

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|198.5 |

|SECONDARY MALIGNANT NEOPLASM OF BONE AND BONE MARROW |

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|203.00 |

|MULTIPLE MYELOMA WITHOUT REMISSION |

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|203.01 |

|MULTIPLE MYELOMA IN REMISSION |

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|275.42 |

|HYPERCALCEMIA |

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|733.00 - 733.09 |

|OSTEOPOROSIS UNSPECIFIED - OTHER OSTEOPOROSIS |

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|733.10 - 733.19 |

|PATHOLOGICAL FRACTURE UNSPECIFIED SITE - PATHOLOGICAL FRACTURE OF OTHER SPECIFIED SITE |

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|Covered ICD-9 codes for HCPCS code J3488 |

|731.0 |

|OSTEITIS DEFORMANS WITHOUT BONE TUMOR |

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|733.00 - 733.09 |

|OSTEOPOROSIS UNSPECIFIED - OTHER OSTEOPOROSIS |

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|733.10 - 733.19 |

|PATHOLOGICAL FRACTURE UNSPECIFIED SITE - PATHOLOGICAL FRACTURE OF OTHER SPECIFIED SITE |

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|995.29 |

|UNSPECIFIED ADVERSE EFFECT OF OTHER DRUG, MEDICINAL AND BIOLOGICAL SUBSTANCE |

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|Diagnoses that Support Medical Necessity back to top |

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|ICD-9 Codes that DO NOT Support Medical Necessity back to top |

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|All other ICD-9 codes not listed under “ICD-9 Codes that Support Medical Necessity” will be denied as not medically |

|necessary. |

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|ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation back to top |

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|Diagnoses that DO NOT Support Medical Necessity back to top |

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|General Information |

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|Documentation Requirements back to top |

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|The patient's medical record must document the medical necessity of services performed for each date of service submitted |

|on a claim, and documentation must be available to Medicare on request. |

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|When intravenous Zoledronic acid is used, the medical record must be legible and clearly reflect that oral bisphosphonates |

|were tried unsuccessfully, or provide a valid indication why parenteral, rather than oral, therapy was utilized. |

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|Appendices back to top |

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|Utilization Guidelines back to top |

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|Services performed for excessive frequency are not medically necessary. Frequency is considered excessive when services are|

|performed more frequently than generally accepted by peers and the reason for additional services is not justified by |

|documentation. |

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|The dose and frequency of administration should be consistent with the FDA approved package insert and/or USP DI monograph.|

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|Sources of Information and Basis for Decision back to top |

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|The development and coverage guidelines in this policy were based on a review of pertinent medical literature, policies |

|from other Medicare contractors, and discussions with appropriate specialists. |

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|Berenson J et al. Zoledronic Acid reduces Skeletal-Related Events in Patients with Osteolytic Metastases. Cancer. |

|2001;7:91. |

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|Calis K A, Pucino F. Zoledronic Acid and Secondary Prevention of Fractures. NEJM. 2007; 357:1861–2. |

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|Hillner B E et al. American Society of Clinical Oncology 2003 Update on Role of Bisphosphonates and Bone Health Issues in |

|Women with Breast Cancer. Journal of Clinical Oncology. 2003;21:4042-57. |

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|Lyles K et al. Zoledronic Acid and Clinical Fractures and Mortality After Hip Fracture. NEJM. 2007;357:1799–809. |

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|Major P et al. Zoledronic Acid is Superior Pamidronate in the Treatment of Hypercalemia of Malignancy: Pooled Analysis of |

|Two Randomized Controlled Clinical Trials. Journal of Clinical Oncology. 2001;19(2):558-67. |

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|McClung M et al. Intravenous Zoledronic Acid 5 mg in the Treatment of Postmenopausal Women with Low Bone Density Previously|

|Treated with Alendronate. Bone. 2007,41:122–8. |

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|Raisz L Screening for Osteoporosis. NEJM. 2005;353(2):164-71. |

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|Reid I R et al. IV Zoledronic Acid in Postmenopausal Women with Low Bone Mineral Density. NEJM. 2002;346(9):653-61. |

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|Rosen L S et al. Zoledronic Acid versus Pamidronate in the Treatment of Skeletal Metastases in Patients with Breast Cancer |

|or Osteolytic Lesions of Multiple Myeloma: A Phase III, Double-Blind, Comparative Trial. The Cancer Journal. |

|2001;7(5):377-87. |

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|Smith M R et al. Randomized Control Trial of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation |

|Therapy for Non-metastatic Prostate Cancer. Journal of Urology. 2003;170:2392-3. |

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|United States Pharmacopoeia (USPDI), Volume I; Drug Information for the Health Care Professional, 27th ed, Greenwood |

|Village, CO: Thomson Micromedex; Copyright© 2007;2946-50. |

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|Zometa package insert. Novartis Pharmaceuticals Corporation. |

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|Reclast package insert. Novartis Pharmaceuticals Corporation. |

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|FDA CDER Priority Drug and Biologic Approvals in Calendar Year 2007; FDA approved Reclast by Novartis. Available at: |

| . Accessed on March 10, 2008. |

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|Advisory Committee Meeting Notes back to top |

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|SC 04/02/2008 |

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|This policy does not reflect the sole opinion of the contractor or contractor medical director. Although the final decision|

|rests with the contractor, this policy was developed in cooperation with advisory groups, which includes representatives |

|from allergy, immunology, otolaryngology, and dermatology.  |

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|Start Date of Comment Period back to top |

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|04/02/2008  |

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|End Date of Comment Period back to top |

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|05/17/2008  |

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|Start Date of Notice Period back to top |

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|Revision History Number back to top |

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|Revision History Explanation back to top |

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|Reason for Change back to top |

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|Last Reviewed On Date back to top |

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|03/19/2008  |

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|Related Documents back to top |

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|This LCD has no Related Documents. |

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|LCD Attachments back to top |

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|There are no attachments for this LCD |

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|Draft Contact back to top |

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|Elaine Jeter, MD - B.policy@ |

|PO Box 100190 |

|Columbia, SC 29202 |

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