LCD/NCD Portal

L29009

 

ZOLEDRONIC ACID

 

 

10/15/2011

 

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Zometa®

• Medicare will consider zoledronic acid (Zometa®) medically reasonable and necessary when provided to patients for the treatment of the following FDA approved indications:

o Hypercalcemia of malignancy.

o Multiple myeloma.

o Documented 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.

o Note: Prostate cancer should have progressed after treatment with at least one hormonal therapy.

• Medicare will consider zoledronic acid (Zometa®) medically reasonable and necessary for the FDA approved uses, as well as for the treatment of the following off-labeled indication:

o Drug-induced osteopenia, secondary to androgen-deprivation therapy in prostate cancer patients (prophylaxis).

Reclast®

• Medicare will consider zoledronic acid (Reclast®) medically reasonable and necessary when provided to patients for the following FDA approved indications:

o Paget’s disease of bone in men and women. (for dates of service on or after 04/16/2007).

o Treatment of osteoporosis in postmenopausal women. (for dates of service on or after 08/17/2007).

o Treatment to increase bone mass in men with osteoporosis. (for dates of service on or after 12/19/2008).

o Treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who are expected to remain on glucocorticoids for at least 12 months. (For dates of service on or after 03/13/2009).

• Treatment is indicated for Paget’s disease of the bone with:

o Elevations in serum alkaline phosphatase of two times or higher than upper limit of the age-specific normal reference range.

o Those who are symptomatic.

o Those at risk for complications from their disease.

 To induce remission (normalization of serum alkaline phosphatase).

 

 

Limitations:

 

• Zoledronic acid (Reclast®) - J3488, used for prevention of osteoporosis in postmenopausal women WILL NOT BE COVERED because it’s not considered medically reasonable and necessary in the diagnosis and treatment of a specific illness or injury as defined under section 1862(a)(1)(A) and as stated in Publication 100-02, Medicare Benefit Policy Manual, chapter 15, section 50.4

• Reclast® is CONTRAINDICATED in the following conditions:

o Hypocalcemia.

o Hypersensitivity to the active substance or to any of the excipients.

o Pregnancy and lactation.

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.

 

13x Hospital Outpatient

22x Skilled Nursing - Inpatient (Medicare Part B only)

23x Skilled Nursing - Outpatient

85x 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

 

For Zometa bill the following HCPCS code:

J3487 INJECTION, ZOLEDRONIC ACID (ZOMETA), 1 MG

 

For Reclast bill the following HCPCS code:

J3488 INJECTION, ZOLEDRONIC ACID (RECLAST), 1 MG

 

 

ICD-9 Codes that Support Medical Necessity

 

For J3487 (Zometa) the following ICD-9-CM codes are medically necessary

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

733.90 DISORDER OF BONE AND CARTILAGE UNSPECIFIED

For J3488 (Reclast®) the following ICD-9-CM codes are medically necessary:

 

731.0 OSTEITIS DEFORMANS WITHOUT BONE TUMOR

733.01 SENILE OSTEOPOROSIS

733.09* OTHER OSTEOPOROSIS

E932.0* ADRENAL CORTICAL STEROIDS CAUSING ADVERSE EFFECTS IN THERAPEUTIC USE

Note: 733.09 and E932.0 must be billed together.

Diagnoses that Support Medical Necessity

See ICD-9 Codes that Support Medical Necessity

 

 

Documentation Requirement

 

• Medical record documentation maintained by the ordering/referring physician/nonphysician practitioner must substantiate the medical need for the use of these drugs by clearly indicating the condition for which the drug is being used.

• For treatment of Paget’s disease, the medical record must indicate an elevated serum alkaline phosphatase prior to treatment with Reclast®.

• Diagnostic test done to confirm the diagnosis of Paget’s disease of the bone should be maintained in the medical record.

• When retreating for Paget’s disease, the medical record must support that the patient’s disease is flaring as evidenced by the lab values indicated below underutilization guidelines.

• This documentation is usually found in the history and physical or in the office/progress notes.

 

 

Utilization Guidelines

 

• It is expected that these services would be performed as indicated by current medical literature and/or standards of practice and should follow all guidelines for administration and safety found in the FDA approved labels for these drugs.

o When services are performed in excess of established parameters, they may be subject to review for medical necessity.

• Reclast® contains the same active ingredient found in Zometa®.

o A patient that is already receiving Zometa® should not be treated with Reclast®.

• Zometa®

o Serum creatinine should be monitored prior to each dose of Zometa®.

o A single dose of Zometa® should not exceed 4mg and must be given intravenously for no less than 15 minutes. Retreatment with Zometa® 4 mg may be considered if serum calcium does not return to normal or remain normal after treatment.

 It is recommended that a minimum of 7 days elapse before re-treatment, to allow for full response to the initial dose.

 Renal function must be carefully monitored in all patients receiving Zometa® and possible deterioration in renal function must be assessed prior to re-treatment with Zometa®.

• Reclast®

o Paget’s disease

 A single dose of Reclast® should not exceed 5mg and the duration of infusion should be no less than 15 minutes.

 The dosage of Reclast® is 5mg in a 100mL ready to infuse solution administered intravenously as a single treatment.

 Patients with Paget’s disease should receive 1500 mg elemental calcium and 800 IU vitamin D daily, particularly during the 2 weeks after dosing.

o Re-treatment of Paget’s Disease

 After a single treatment with Reclast® in Paget’s disease an extended remission period is observed.

 Specific re-treatment data are not available.

 However, re-treatment with Reclast® may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase, or in those patients who failed to achieve normalization of their serum alkaline phosphatase, or in those patients with symptoms, as dictated by medical practice.

o Postmenopausal osteoporosis

 The recommended dosage of Reclast® for postmenopausal osteoporosis is a single 5 mg infusion given once a year.

• It should be administered intravenously over no less than 15 minutes.

 For osteoporosis treatment, and to reduce the risk of hypocalcemia, patients must be adequately supplemented with calcium and vitamin D if dietary intake is not sufficient.

• Postmenopausal women require an average of 1200 mg calcium and 400-800 IU vitamin D daily.

o Osteoporosis in Men

 The recommended regimen is a 5 mg infusion once a year given intravenously over no less than 15 minutes.

 Patients must be adequately supplemental with calcium and vitamin D if dietary intake is not sufficient. 1200 mg calcium and 800-1000 IU vitamin D is recommended.

o Treatment and prevention of Glucorticoid-Induced Osteoporosis

 The recommended regimen is a 5 mg infusion once a year given intravenously over no less than 15 minutes.

 Patients must be adequately supplemental with calcium and vitamin D if dietary intake is not sufficient. 1200 mg calcium and 800-1000 IU vitamin D is recommended.

Treatment Logic

• Zoledronic Acid (Zometa® and Reclast®) is a bisphosphonic acid, which is an inhibitor of osteoclastic bone resorption.

• This class of drug, also known as a bisphosphonate, binds to the bone matrix, which decreases osteoclastic activity, prevents bone resorption and skeletal calcium release induced by various stimulatory factors released by tumors.

 

 

Sources of Information and Basis for Decision

 

Berenson, J., Rosen, L., Howell, A., Porter, L., Coleman, R., Morley, W., Dreicer, R., Kurose, S., Lipton, A., & Seaman, J. (2001). Zoledronic acid reduces skeletal-related events in patients with osteolytic metastases. Cancer, 91(7), 1191-1200.

 

Compendia-Based Drug Bulletin, (August 2005). The Association of Community Cancer Centers. Available: http://www.accc-cancer.org/.

 

FCSO LCD 29312, Zoledronic Acid, 10/15/2011. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Novartis Pharmaceuticals Corporation (2007). Reclast® product label.

 

Novartis Pharmaceuticals Corporation (2008). Reclast® product label.

 

Novartis Pharmaceuticals Corporation (2009). Reclast® product label.

 

Rosen, L.S., Gordon, D., Kaminski, M., Howell, A., Belch, A., Mackey, J., Apffelstaedt, J., Hussein, M., Coleman, R., Reitsma, D., Seaman, J., Chen, B., & Ambros, Y. (2001). 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, 7(5), 377-387.

 

The United States Pharmacopeia Drug Information (USP DI). (August 2005). Oncology drug information. The Association of Community Cancer Centers (ACCC). Available: http://www.accc-cancer.org/.

 

 

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 L29009 ZOLEDRONIC ACID