Indications and Limitations of Coverage and/or Medical Necessity
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.
Medicare will consider Zoledronic Acid (Zometa®) medically reasonable and necessary when provided to patients for the treatment of the following FDA approved indications:
· hypercalcemia of malignancy;
· multiple myeloma; and/or
· 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.
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:
· Drug-induced osteopenia, secondary to androgen-deprivation therapy in prostate cancer patients (prophylaxis).
Medicare will consider Zoledronic Acid (Reclast®) medically reasonable and necessary when provided to patients for the following FDA approved indications:
· Paget's disease of bone in men and women (for dates of service on or after 04/16/2007)
· Treatment of osteoporosis in postmenopausal women (for dates of service on or after 08/17/2007)
Treatment is indicated for Paget's disease of the bone with elevations in serum alkaline phosphatase of two times or higher than upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease, to induce remission (normalization of serum alkaline phosphatase).
Reclast is contraindicated in the following conditions:
· Hypersensitivity to the active substance or to any of the excipients
· Pregnancy and lactation
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, Chapter 1, Section 30-30.5
CMS Manual System, Pub. 100-02, Medicare Benefit Policy, Chapter 8, Section 50.5
CMS Manual System, Pub. 100-02, Medicare Benefit Policy, Chapter 15, Section 50
CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 17, Section 10
CMS Manual System, Pub. 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.1.3
CMS Manual System, Pub. 100-20, One Time Notification, CR 3631 and CR 3818
CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Change Request 5645, Transmittal 1260, dated June 1, 2007
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 under utilization guidelines. This documentation is usually found in the history and physical or in the office/progress notes.
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. 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. A patient that is already receiving Zometa should not be treated with Reclast.
Serum creatinine should be monitored prior to each dose of Zometa.
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.
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.
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.
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.
LCD Determination ID:
Original Determination Effective Date:
Latest Revision Effective Date:
Contractor Name(Contractor Number) - Contractor Info
First Coast Service Options, Inc. (09101) - Oversight Region I
Revision History Explanation
Start Date of Comment Period:02/20/2009
Start Date of Notice Period:05/01/2009
Revised Effective Date: 06/30/2009
Explanation of Revision: This LCD is being revised and presented for notice and comment in order to add the applicable ICD-9 CM codes for J3487 and J3488. The effective date of this revision is based on date of service.
Start Date of Comment Period:N/A
Start Date of Notice Period:12/04/2008
Revised Effective Date:02/16/2009
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 (L29009) replaces LCD L2962 as the policy in notice. This document (L29009) is effective on 02/16/2009.
Start Date of Comment Period:
End Date of Comment Period:
Start Date of Notice Period:
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/ .
Novartis Pharmaceuticals Corporation (2007). 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/ .
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.
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.13 - Hospital-outpatient (HHA-A also) (under OPPS 13X must be used for ASC claims submitted for OPPS payment -- eff. 7/00)
21 - SNF-inpatient, Part A
22 - SNF-inpatient or home health visits (Part B only)
23 - SNF-outpatient (HHA-A also)
85 - Special facility or ASC surgery-rural primary care hospital (eff 10/94)
Revenue Type Codes:
0636 - Drugs requiring specific identification-detailed coding (eff 3/92)
|For Zometa bill the following HCPCS code:|
|For Reclast bill the following HCPCS code:|
ICD-9 Codes that Support Medical Necessity:
Diagnoses that Support Medical Necessity:
ICD9 Not Covered
ICD-9 Codes that DO NOT Support Medical Necessity: