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This
article defines coding and coverage for pamidronate
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:
Pamidronate disodium is
a bisphosphonate compound that inhibits bone resorption.
Indications:
Pamidronate disodium is
covered for the treatment of:
Moderate or severe hypercalcemia associated with
malignancy:
- Moderate or
severe hypercalcemia associated with
malignancy, with or without bone metastasis. In moderate hypercalcemia the albumin-corrected serum calcium
(CCa) is approximately 12.0-13.5 mg/dL, and in severe hypercalcemia,
the CCa is >13.5 mg/dL.
The CCa equals serum calcium (in mg/dL) + 0.8[(4.0 - serum albumin, g/dL)].
- For moderate hypercalcemia, the recommended dose of pamidronate disodium is
60 to 90 mg given as a single-dose, intravenous infusion over 2 to 24
hours. (See package insert for additional information.)
- For severe hypercalcemia, the recommended dose of pamidronate disodium is
90mg given as a single-dose, intravenous infusion over 2 to 24 hours.
(See package insert for additional information.)
- Re-treatment
with the same dosage regimens may be covered if the initial response
to this drug is complete or partial, the serum calcium does not remain
normal or return to normal and the interval between the initial
treatment and re-treatment is at least 7 days. (See package insert for
additional information.)
Moderate to severe Paget’s disease of bone:
- Treatment has
been shown to be most effective for patients with a serum alkaline phosphatase greater than or equal to 3 times the
upper limit of normal.
- The
recommended dose of pamidronate disodium in patients with moderate to severe
Paget’s disease of bone is 30 mg daily, administered as a 4-hour
infusion on 3 consecutive days for a total dose of 90 mg. (See package
insert for additional information.)
- When
clinically indicated, patients should be retreated at the dose of
initial therapy. (See package insert for additional information.)
Osteogenesis Imperfecta (Pediatric)
Postmenopausal osteoporosis
Complex regional pain syndrome, type I
Osteolytic bone metastasis of breast
cancer and osteolytic lesions of multiple myeloma:
- The
recommended dose of pamidronate disodium for patients with osteolytic
bone lesions of multiple myeloma is 90 mg
administered as a 4-hour infusion. (See package insert for additional
information.)
- Re-treatment
at monthly intervals with the same dosage regimen can be covered, if
clinically indicated. (See package insert for additional information.)
- For osteolytic bone metastases of breast cancer, the
recommended dose of pamidronate disodium is 90 mg administered over a 2-hour
infusion given every 3-4 weeks.
Hypercalcemia, Associated with tamoxifen-induced tumor flare
Osteopenia - Quadriplegic cerebral
palsy
Glucocorticoid-induced
Osteoporosis
- Intravenous
pamidronate disodium
is indicated for those patients with glucocorticoid-induced
osteoporosis.
- A
typical regimen is an initial dose of pamidronate,
90 mg intravenously, with subsequent doses of 30mg every third month.
Drug-induced osteoporosis, prophylaxis-gonad regulating hormone
adverse reaction
Indications
expanded by this Article:
Senile osteoporosis in male
patients
Coverage for intravenous pamidronate will be
allowed when one or more of the following clinical circumstances are
documented in the clinical record.
The patient must have aggressive, rapidly progressive and severely
disabling osteoporosis
- Bone Density
T score below – 2.5
- Rapid
shortening of stature.
- Documented
compression fractures of the axial skeleton or peripheral fractures.
- Constant pain
or difficulty ambulating due to fractures.
Documented failure of patient response to a 12 month course of treatment
with established alternatives for osteoporosis.
The patient is unable to tolerate and/or comply with established
alternative treatments because of severe side effects or allergic reaction
to ingredients or;
The patient’s condition has severely deteriorated and their osteoporosis is
so significant that a trial on alternative treatments including oral bisphosphorates is not clinically warranted.
Limitations:
Pamidronate disodium
for injection will not be covered for:
- mild hypercalcemia associated with malignancy, with or
without bone metastasis.
- mild-to-moderate Paget’s
disease of bone unless intolerance to oral polyphosphonates
has been clearly documented.
- treatment of hypercalcemia associated with hyperparathyroidism
or with other non-malignancy related conditions.
Documentation Requirements:
The patient’s medical record must contain documentation, including
laboratory and radiology reports, fully supporting the medical necessity
for treatment and re-treatment with pamidronate disodium for injection (see “Indications”). This
documentation includes, but is not limited to, relevant medical history,
physical examination, and results of pertinent diagnostic tests or
procedures.
When reporting ICD-9-CM 756.51 (osteogenesis imperfecta) the medical record must document the
history of fractures.
Utilization:
Due to the risk of clinically significant deterioration in renal function,
which may progress to renal failure, single doses of pamidronate
disodium should not exceed 90 mg. (See package
insert for additional information.)
Coding Guidelines:
General
Guidelines for claims submitted to Carriers or Intermediaries or Part A or Part B MAC:
Claims for the administration of pamidronate disodium for injection for moderate-to-severe hypercalcemia associated with malignancy must be
submitted with the ICD-9-CM code for hypercalcemia
(275.42) along with the ICD-9-CM code that pertains to the malignancy.
Claims for the administration of pamidronate disodium for injection for osteolytic
metastasis of cancer must be submitted with the ICD-9-CM code for secondary
malignant neoplasm of bone (198.5) along with the ICD-9-CM code that
pertains to the primary site of cancer (V10.11, V10.12, V10.3, V10.46, 185,
209.21 or from the 162.0-162.9, 174.0-174.9 or 175.0-175.9 series of
ICD-9-CM codes).
Claims for the administration of pamidronate disodium for injection for glucocorticoid-induced
osteoporosis or gonad regulating hormone
must be submitted with ICD-9-CM code 733.09 (for glucocorticoid-induced
osteoporosis) along with ICD-9-CM code V58.65 (for long-term [current] use
of steroids) or V58.69 for gonad regulating
hormones.
For claims submitted to the carrier or Part B
MAC:
Pamidronate should not be billed using
chemotherapy administration codes and is payable in the following places of
service: office (11), home (12), assisted living facility (13), group home
(14), custodial care facility (33), independent clinic (49) and state or
local public health clinic (71), only when supplied as an “incident to”
service by the physician.
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