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This
article defines coding and coverage for zoledronic
acid including off-label indications. National Government Services Local
Coverage Determination (LCD) “Coverage of Drugs and Biologicals
for Label and Off-Label Uses” allows coverage for off-label indications
only if the United States Pharmacopeia Drug Information (USP-DI), the
American Hospital Formulary Services (AHFS) and/or Thomson Healthcare DrugPoints® (as described in the LCD) define such
indications or if National Government Services has published an article or
LCD expanding such coverage. Providers may request approval for additional
off-label indications by submitting this request in writing with supporting
medical literature. The aforementioned National Government Services LCD,
which describes the requirements for such a request, can be accessed on our
contractor Web site at www.NGSMedicare.com or on the Medicare Coverage
Database at www.cms.hhs.gov/mcd.
Abstract:
Zoledronic acid marketed under the brand name Zometa® (4mg/5ml) is an FDA approved intravenous bisphosphonate drug for treatment of patients with hypercalcemia of malignancy. Approximately 10% of
cancer patients experience elevated serum calcium levels which overload the
kidneys' processing capability, leading to complications such as
dehydration, generalized muscle weakness, fatigue, nausea, and confusion.
This drug has been shown in clinical trials to normalize the serum calcium
concentrations in 88.4% of patients tested.
Zoledronic acid marketed under the brand name Reclast® (5mg/100ml) is FDA approved for the treatment
of Paget's disease of bone in men and women.
The infusion time for this drug is normally under 1 hour.
Indications:
Zoledronic acid is covered: (NDA 21-223)
- For Zometa®, the FDA approved indications of:
- hypercalcemia of
malignancy;
- documented
bone metastases from solid tumors;
- multiple myeloma with at least one osteolytic
lesion;
- prostate cancer only
after treatment failure with at least one hormonal therapy.
- For Reclast®, the FDA approved indication of: (NDA
21-817)
- Paget’s
disease. Treatment is indicated in patients with Paget’s disease of
bone with elevations in serum alkaline phosphatase
of two times or higher than the 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);
- Effective
August 17, 2007, Reclast® is FDA approved
for treatment of osteoporosis in post-menopausal women in a 5 mg dose,
once per year.
Indications
expanded by this Article:
For Zometa® only, when used:
- To manage
osteoporosis secondary to the endocrine management of malignancy.
Currently breast cancer and prostate cancer are the two entities that
demonstrate this malady.
Limitations:
- Zoledronic acid is
contraindicated in patients with clinically significant
hypersensitivity to zoledronic acid or other
biphosphinates.
- Zoledronic acid is contrainidated in pregnant or breast feeding
patients or those who may become pregnant.
Utilization:
- For an
indication of hypercalcemia of malignancy
(HCM), the albumin-corrected serum calcium level must be ≥ 12 mg/dl.
- Infusion time
for zoledronic acid is under 1 hour.
Therefore, the administration time reported should not exceed one
hour.
- Single doses
of Zometa® should not exceed 4 mg and the
infusion should take no less than 15 minutes.
- For treatment
of Pagets or post-menopausal osteoporosis, Reclast® is limited to a single dose, not to
exceed 5 mg and the infusion should take no less than 15 minutes.
- For
management of osteoporosis secondary to endocrine management of breast
cancer patients - one infusion per year and for prostate cancer
patients - one infusion per 3 months.
Documentation:
- Physician
order;
- Medication
administration record;
- Clinical
records must document the appropriate conditions necessitating the
infusion; and
- In the case
of patients intolerant of oral bisphosphonates,
records should clearly indicate the history.
Coding Guidelines:
General Guidelines for claims submitted to Carriers or Intermediaries:
When submitting claims for patients with osteoporosis secondary to
endocrine management of malignancy or management of patients with
osteoporosis who are intolerant of oral bisphosphonates,
a primary and secondary diagnosis must be reported on the claim. For
patients who are intolerant of oral bisphosphonates,
the secondary diagnosis is ICD-9-CM code 995.29. For patients with a GI
contraindication to oral bisphosphonates, the
secondary diagnosis ICD-9-CM code is V12.79.
For management of hypercalcemia of malignancy, a hypercalcemia diagnosis and the related malignancy code
are required.
Infusion of fluids for hydration (e.g., saline) can be reported on the same
day as zoledronic acid, using the appropriate
hydrating solution and infusion codes. All codes must be reported on the
same claim.
For claims submitted to the carrier:
Zoledronic acid should not be billed using
chemotherapy administration codes and is payable in the following places of
service: office (11), nursing facility for patients not in a Part A stay
(32), independent clinic (49), and state or local public health clinic
(71), only when supplied as an “incident to” service b the physician.
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