LCD/NCD MedicationsL28944-LCD

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Local Coverage Determination (LCD) for Pamidronate (Aredia®, APD) (L28944)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09101

Contractor Type MAC - Part A

LCD Information

Document Information

LCD ID Number L28944

LCD Title Pamidronate (Aredia®, APD)

Contractor's Determination Number AJ2430

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/16/2009

Original Determination Ending Date

Revision Effective Date

Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See § 1869 (f)(1)(A)(i) of the Social Security Act.

Unless other wise specified, italicized text represents quotation from one or more of the following CMS sources: CMS Manual System, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50

Indications and Limitations of Coverage and/or Medical Necessity

Pamidronate, a bisphosphonate which is administered intravenously, is used to inhibit bone resorption and to decrease serum calcium. In Paget’s disease (osteitis deformans), Pamidronate reduces the rate of bone turnover by an initial blocking of bone resorption, resulting in a decrease in serum alkaline phosphatase and a decrease in urinary hydroxyproline excretion.

Medicare will consider Pamidronate medically reasonable and necessary for any of the following FDA approved indications:

• Hypercalcemia of Malignancy – pamidronate, in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases.

• Paget’s Disease – pamidronate is indicated for the treatment of patients with moderate to severe Paget’s disease of bone.

• Osteolytic Bone Metastases of Breast Cancer and Osteolytic Lesions of Multiple Myeloma – pamidronate is indicated, in conjunction with standard antineoplastic therapy, for the treatment of osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma.

FDA Recommended Dosage and Administration

Hypercalcemia of Malignancy – intravenous infusion, 60mg – 90mg given as a single-dose over 2 to 24 hours for moderate hypercalcemia; and intravenous infusion, 90mg given as a single-dose over 2 to 24 hours for severe hypercalcemia.

Moderate to Severe Paget’s Disease of Bone – intravenous infusion, 30mg daily over 4 hours, on 3 consecutive days for a total dose of 90mg.

Osteolytic Bone Lesions of Multiple Myeloma – intravenous infusion, 90mg over 4 hours given on a monthly basis. Osteolytic Bone Metastases of Breast Cancer – intravenous infusion, 90mg over 2 hours given every 3-4 weeks.

Medicare will consider Pamidronate medically reasonable and necessary for any of the following off-label indications, when there has been a failed trial of oral biphosphonates or when there is a valid medical reason for the parental form of Pamidronate:

• Treatment of postmenopausal osteoporosis

• Treatment of the prevention of glucocorticoid-induced osteoporosis

It is expected that the dosage and administration of Pamidronate for the above off-label indications be given according to accepted standards of medical practice.

Coding Information

Bill Type Codes:

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.

013x Hospital Outpatient

021x Skilled Nursing - Inpatient (Including Medicare Part A) 023x Skilled Nursing - Outpatient

085x Critical Access Hospital

Revenue Codes:

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.

0636 Pharmacy - Drugs Requiring Detailed Coding

CPT/HCPCS Codes

J2430 INJECTION, PAMIDRONATE DISODIUM, PER 30 MG

ICD-9 Codes that Support Medical Necessity

174.0 - 174.9* MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST - MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE

175.0 - 175.9* MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST - MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST

198.5* SECONDARY MALIGNANT NEOPLASM OF BONE AND BONE MARROW

203.00 - 203.02 MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - MULTIPLE MYELOMA, IN RELAPSE

275.42 HYPERCALCEMIA

731.0 OSTEITIS DEFORMANS WITHOUT BONE TUMOR

733.01 SENILE OSTEOPOROSIS

733.09 OTHER OSTEOPOROSIS

V10.3* PERSONAL HISTORY OF MALIGNANT NEOPLASM OF BREAST

NOTE: The billing of Pamidronate for osteolytic bone metastases breast cancer requires a dual diagnosis. ICD-9- CM code 198.5 must be billed with the related neoplasm code (174.0-174.9, 175.0-175.9, or V10.3). The starred (*) ICD-9-CM codes listed above may NOT be billed alone.

Diagnoses that Support Medical Necessity

See ICD-9 Codes that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity

All other diagnosis codes not listed as covered in the “ICD-9 Codes that Support Medical Necessity” section of this policy.

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

All other diagnoses not listed as covered in the “ICD-9 Codes that Support Medical Necessity” section of this policy.

General Information

Documentations Requirements

Medical record documentation maintained by the performing physician/nonphysician practitioner must substantiate the medical necessity for the use of Pamidronate by clearly indicating the condition for which this drug is being used. This documentation is usually found in the history and physical or in the office/progress notes. In addition, the medical record must clearly indicate the drug was administered.

If the provider of the service is other than the ordering/referring physician/nonphysician practitioner, that provider must maintain copies of the ordering/referring physician/nonphysician practitioner’s order for the drug. The physician/nonphysician practitioner must state the clinical indication/medical need for using this drug in the order.

For off-label indications:

In addition to the above requirements, the following documentation must be maintained in the medical record: Documentation that oral biphosphonates were tried and were unsuccessful or that there is a valid medical reason why the patient cannot take oral agents and must use a parenteral agent. Physician or patient preference for route of administration is not a valid reason to give Pamidronate IV. For the prevention of glucocorticoid-induced osteoporosis, the medical record must reflect that the patient is receiving a glucocorticoid medication and must reflect that it was administered.

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity.

ICD-9-CM code 733.01 should be used for the off-label indication of postmenopausal osteoporosis. ICD-9-CM code 733.09 should be used for the off-label indication for prevention of glucocorticoid-induced osteoporosis.

Sources of Information and Basis for Decision

Cauza, E., Etemad, M., et al (2004). Pamidronate increases bone mineral density in women with postmenopausal or steroid-induced osteoporosis. Journal of Clinical Pharmacy and Therapeutics, 29, 431-436. Blackwell Publishing Ltd.

Compendia-Based Drug Bulletin (February 2006). Association of Community Cancer Centers. Available: http://www.accc-cancer.org/.

Epstein, S. (2006). Update of Current Therapuetic Options for the Treatment of Postmenopausal OsteoporosisI. Clinical Therapeutics, 2(28) 151-173.

Facts and Comparisons 4.0. Pamidronate Disodium. Retrieved from http://online.factsandcomparisons.com on 08/08/2006.

Miller, P. (2005). Optimizing the management of Postmenopausal Osteoporosis with Biphosphonates: The emerging role of intermittent therapy. Clinical Therapeutics, 27(4), 361-376.

Morabito, N. Gaudio, A., et al (2003). Three-year effectiveness of intravenous pamidronate versus pamidronate plus slow-release sodium fluoride for postmenopausal osteoporosis. Osteoporosis International 14:500-506.

Unites States Pharmacopeia Drug Information (USP DI) (February 2006). Oncology Online for Health Care Professionals. Micromedex, Inc. Available: http://www.thomsonhc.com/home/dispatch.

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or contractor medical director. Although the final decision rests with the contractor, this LCD was

developed in cooperation with advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 12/04/2008

Revision History Number Original

Revision History Explanation Revision Number:Original Start Date of Comment Period:N/A

Start Date of Notice Period:12/04/2008 Revised Effective Date:02/16/2009

LCR A2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the fiscal intermediary predecessors of First Coast Service Options, Inc. (COSVI and FCSO).

For Florida (00090) this LCD (L28944) replaces LCD L1064 as the policy in notice. This document (L28944) is effective on 02/16/2009.

8/1/2010 - The description for Bill Type Code 13 was changed 8/1/2010 - The description for Bill Type Code 21 was changed 8/1/2010 - The description for Bill Type Code 23 was changed 8/1/2010 - The description for Bill Type Code 85 was changed

8/1/2010 - The description for Revenue code 0636 was changed

Reason for Change