LCD/NCD Portal

L29250

 

PAMIDRONATE (AREDIA®, APD)

 

 

02/02/2009

 

 

Indications and Limitations of Coverage and/or Medical Necessity

 

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

• Hypercalcemia of Malignancy:

o 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:

o 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:

o 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.

o Intravenous infusion.

o 60mg – 90mg given as a single-dose.

o Over 2 to 24 hours for moderate hypercalcemia.

OR

o Intravenous infusion.

o 90mg given as a single-dose.

o Over 2 to 24 hours for severe hypercalcemia.

• Moderate to Severe Paget’s Disease of Bone.

o Intravenous infusion.

o 30mg daily over 4 hours.

o On 3 consecutive days.

o For a total dose of 90mg.

• Osteolytic Bone Lesions of Multiple Myeloma.

o Intravenous infusion.

o 90mg over 4 hours.

o Given on a monthly basis.

• Osteolytic Bone Metastases of Breast Cancer.

o Intravenous infusion.

o 90mg over 2 hours.

o 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:

o Treatment of postmenopausal osteoporosis.

o 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.

 

 

CPT/HCPCS Codes

 

J2430 INJECTION, PAMIDRONATE DISODIUM, PER 30 MG

 

 

ICD-9 Codes that Support Medical Necessity

 

174.0 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST

174.1 MALIGNANT NEOPLASM OF CENTRAL PORTION OF FEMALE BREAST

174.2 MALIGNANT NEOPLASM OF UPPER-INNER QUADRANT OF FEMALE BREAST

174.3 MALIGNANT NEOPLASM OF LOWER-INNER QUADRANT OF FEMALE BREAST

174.4 MALIGNANT NEOPLASM OF UPPER-OUTER QUADRANT OF FEMALE BREAST

174.5 MALIGNANT NEOPLASM OF LOWER-OUTER QUADRANT OF FEMALE BREAST

174.6 MALIGNANT NEOPLASM OF AXILLARY TAIL OF FEMALE BREAST

174.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF FEMALE BREAST

174.9* MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE

175.0 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST

175.9* MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST

198.5* SECONDARY MALIGNANT NEOPLASM OF BONE AND BONE MARROW

203.00 MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION

203.01 MULTIPLE MYELOMA IN REMISSION

203.02 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 of 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

 

 

Documentation 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.

o 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.

o The physician/nonphysician practitioner must state the clinical indication/medical need for using this drug in the order.

• For off-label indications:

o 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.

Utilization Guidelines

• 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.

 

 

Treatment Logic

 

• 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.

 

 

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 Therapeutic 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.

 

FCSO LCD 29250, Pamidronate (Aredia®, APD), 02/02/2009. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

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.

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2011 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.

 

 

CMS LCD L29250 PAMIDRONATE (AREDIA®, APD)