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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