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CPT codes, descriptions and other data only are
copyright 2008 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.
Primary
Geographic Jurisdiction
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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. Effective for dates of service
on or after 11/25/2008, American Hospital Formulary Services (AHFS),
Clinical Pharmacology, NCCN Drugs and Biologics Compendium and/or Thomson
Micromedex DrugDex®
compendium has replaced the USP-DI and Thomson
Healthcare DrugsPoints®. 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:
Zometa®, is approved for:
- 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.
Reclast®,
is approved for:
- 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.
Effective June 2, 2008, Reclast® is FDA approved for patients at
high risk of fracture defined as recent low-trauma hip fracture.
Indications
expanded by this Article:
For Zometa® only, when used:
- To manage
osteoporosis or osteopenia secondary to
the endocrine management (including
aromatase inhibitors) of malignancy. Currently breast
cancer and prostate cancer are the two entities that demonstrate this
malady.
For Reclast® only, when used:
- To
treat senile osteoporosis in male patients.
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 or senile 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 (including aromatase
inhibitors) 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 or Part A or Part B MAC:
When submitting claims for patients with osteoporosis or osteopenia secondary to endocrine management (including aromatase inhibitors)
of malignancy a primary and secondary
diagnosis must be reported on the claim. ICD-9-CM code 733.90 should be
used to report osteopenia.
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 or Part B
MAC:
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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