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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 

In order to be covered by Medicare, a drug or biological must be safe and effective and otherwise reasonable 
and medically necessary. Drugs and biologicals approved for marketing by the Food and Drug Administration 
(FDA) are considered safe and effective when used for indications specified in the FDA labeling. The FDA 
labeling lists the safe and effective indications, dosage, and frequency of the agents. Please refer to CMS IOM 
(Centers for Medicare and Medicaid Services Internet Only Manual) Publication 100-02, Medicare Benefit 
Policy Manual, Chapter 15, Section 50 Drugs and Biologicals. 

In addition to FDA approved indications, Medicare may consider coverage of off-label uses based on guidance 
provided in the CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.4.2 for 
Unlabeled Use of Drug. 

Zoledronic acid (Reclast and Zometa) is a bisphosphonic acid, which is an inhibitor of osteoclastic bone 
resorption. Zoledronic acid binds to the bone matrix, which decreases osteoclastic activity, prevents bone 
resorption and skeletal calcium release induced by various stimulatory factors released by tumors. 

See the FDA drug label for the FDA approved indications and dosages for Reclast and Zometa. 
https://labels.fda.gov  

Reclast for Glucocorticoid-Induced Osteoporosis in Men and Women is allowed under the following 
circumstances: 

- the patient is either initiating or continuing to take system glucocorticoids in a daily dosage of 7.5 mg or 
greater of prednisone and who are expected to remain on glucocorticoids for at least 12 months 
- the patient is taking at least 1,200 mg calcium and 800-1,000 IU vitamin D per day 

Reclast for Women or Men with Osteoporosis is allowed under the following circumstances: 

- the patient is taking at least 1,200 mg calcium and 800-1,000 IU vitamin D per day Reclast for Paget's Disease is allowed under the following circumstances: 
- the patient has been instructed to take 1,500 mg elemental calcium daily in divided doses (750 mg two 
times per day, or 500 mg three times per day) and 800 IU vitamin D per day, particularly in the 2 weeks 
following the administration of Reclast 
- the patient has one of the following:  
o An elevated serum alkaline phosphatase of two times or higher than the upper limit of the age-
specific normal reference range, or 
o The patient is symptomatic, or 
o The patient is at risk for complications from the disease, to induce remission (normalization of 
serum alkaline phosphatase) prior to treatment with Reclast 

Reclast for Re-Treatment of Paget's Disease is allowed under the following circumstances: 

- the patient is experiencing a relapse based on serum alkaline phosphatase, or 
- the patient has failed to achieve normalization of their serum alkaline phosphatase, or 
- the patient has symptoms as dictated by current standard medical practice. 

Zometa is allowed under the following circumstances: 

- the patient is not on any other bisphosphonate medication(s) 
- the renal status of the patient has been monitored 
- Retreatment with Zometa 4 mg may be considered if serum calcium does not return to normal or 
remain normal after treatment. 

Zometa for Hypercalcemia of Malignancy is allowed under the following circumstance: 

- the patient has an albumin-corrected serum calcium of greater than or equal to 12 mg/dL (3.0 mmol/L) 

Zometa for Multiple Myeloma and Metastatic Bone Lesions of Solid Tumors is allowed under the following 
circumstances: 

- the patient was co-administered oral calcium supplements of 500 mg and a multiple vitamin containing 
400 IU of vitamin D per day 

The following Off-label Indication for Zometa Injection will be considered medically reasonable and 
necessary: 

- Drug-induced osteopenia, secondary to androgen-deprivation therapy in prostate cancer patients 
(prophylaxis). 

You can find this rule in the Local Coverage Determination (LCD): Bisphosphonates (Intravenous [IV]) and 
Monoclonal Antibodies in the Treatment of Osteoporosis and Their Other Indications (L33270). 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.