*Beginning January 1, 2012, a new HCPCS procedure code has been assigned to the drug denosumab.
J0897 Injection, denosumab, 1 mg
The drug denosumab has two brand names with two different indications. The brand names and their indications are:
* Prolia® – indicated to treat osteoporosis in women after menopause.
* Xgeva® – indicated for the prevention of Skeletal-Related Events (SREs) in patients with bone metastases from solid tumors.
When billing the drug denosumab (Prolia®) for patients with postmenopausal osteoporosis, the following ICD-9-CM code must be present on the claim:
* 733.01 – Senile osteoporosis
When billing the drug denosumab (Xgeva®) for patients with bone metastases from solid tumors, the following ICD-9-CM code must be present on the claim:
* 198.5 – Bone and bone marrow
Please also indicate in the comment section of the claim which drug is being administered, Prolia® or Xgeva®.
Note: When denosumab (Prolia® or Xgeva®) is reported for Medicare payment using the recommend diagnosis code above, the medical record must clearly demonstrate the patient has, in fact, been so diagnosed. Utilizing the recommended diagnosis code in situations where medical records do not support the reported diagnosis is not appropriate.
DENOSUMAB (PROLIA™) AND (XGEVA™): ARE YOU CODING CORRECTLY?
The FDA has approved the use of denosumab (PROLIA™) and (Xgeva™). Medicare has determined under Section 1861(t) that this drug may be paid when it is administered incident to a physician’s service and is determined to be reasonable and necessary. Such determination of reasonable and necessary is currently left to the discretion of the Medicare contractors.
Indications:
Indications for denosumab (PROLIA™):
• For the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, or multiple risk factors for fracture;
• For the treatment of postmenopausal women with osteoporosis who have failed or are intolerant to other available osteoporosis therapy.
• Indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
• Indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer.
• For treatment in men to increase bone mass with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
Indications for denosumab (Xgeva™):
• Xgeva™ is approved for the treatment of patients with bone metastases from solid tumors for the prevention of skeletal-related events.
• Xgeva™ is approved for the treatment of adult and skeletally mature adolescent patients with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
• Xgeva™ is approved for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy.
Limitations:
• Denosumab (PROLIA™) is contraindicated in patients with hypocalcemia.
• Denosumab (PROLIA™) is contraindicated in patients with pregnancy.
• Denosumab (Xgeva™) is not approved for patients with multiple myeloma or other cancers of the blood.
Coding Guidelines:
• Effective January 1, 2014, for claims submitted to the contractor, denosumab (PROLIA™, Xgeva™) should be billed using HCPCS code J0897, Injection, denosumab, 1mg.
• Denosumab may not be billed using a chemotherapy administration code. The administration of the product should be billed using CPT code 96372, (Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular).
How does Prolia work?
Prolia was developed as a result of a scientific understanding of how bones stay strong.
It helps stop the development of bone-removing cells before they can reach and damage the bone.
Prolia works by targeting a molecule that the bone-removing cells need in order to work.
Important Safety Information
Prolia can cause serious side effects. Possible serious side effects include serious allergic reactions, low blood calcium, severe jaw bone problems, unusual thigh bone fractures, serious infections, skin problems, and severe bone, joint, or muscle pain
Without Prolia
When you have postmenopausal osteoporosis, there is an excess of bone-removing cells.
Prolia® targets a molecule that the bone-removing cells need to work.
With Prolia
Prolia has helped stop most of the bone-removing cells from getting to the bone and causing bone loss.
Why Prolia is different.
• Prolia is the first and only prescription medicine for postmenopausal osteoporosis that is a shot given 2 times a year in your doctor’s office
• It’s not a pill, so it doesn’t go down your esophagus or through your stomach
Important Safety Information
You should take calcium and vitamin D as your doctor tells you to while you receive Prolia
Drug Name CPT Code Dosage Covered Diagnosis
Expression Denosumab (Prolia, Xgeva)
For dates of service 01/01/2 012 and forward :
96372
J0897
Part A only C9399
For dates of service 12/31/2 011 and prior: 96372 C9272 C9399 J3590
For the treatment of patients with bone metastases from solid tumors correct coding requires that a bone metastasis diagnosis be present on the claim as the primary diagnosis and the original cancer or history of cancer be included as the secondary diagnosis. The claim must include ICD.9 code 198.5 plus the ICD.9 code for the patient’s original cancer or
history of cancer.
For treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. The clinical documentation must clearly support this use and the claim must include both ICD-9 code 733.09 plus an ICD-9 code from one of the following ranges:
174.0-174.9,
175.0-175.9
For treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer The clinical documentation must clearly support this use and the claim must include both ICD-9 codes 733.09 plus 185
For the treatment of postmenopausal women with osteoporosis at high risk for fracture and women with osteoporosis who have failed or are intolerant to other available osteoporosis therapy both a primary and secondary diagnosis must be reported: 733.01
.
The recommended dose of Denosumab (Prolia™) for the treatment of osteoporosis in postmenopausal women is 60 milligrams (mg) subcutaneously once every 6 months, plus calcium 1000 mg orally once daily and at least vitamin D 400 international units orally once daily. Administer Denosumab (Prolia™) via subcutaneous injection in the upper arm, the upper
thigh, or the abdomen. Denosumab (Prolia™) is supplied in a single-use prefilled syringe with a safety guard or in a single-use vial.
Denosumab (Xgeva™) is administered at a dose of 120mg every four weeks as a subcutaneous injection in the upper arm, upper thigh, or abdomen for bone metastasis from solid tumors.
Denosumab (Xgeva™) is administered at a dose of 120mg every four weeks with an additional 120mg dose on day 8 and 15 of the first month of therapy as a subcutaneous injection in the upper arm, upper thigh, or abdomen for Giant Cell Tumor of the bone. Administer calcium and vitamin D as necessary to treat or prevent hypocalcemia. Denosumab (Xgeva™) is administered at a dose of 120 mg every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy for hypercalcemia of malignancy. Administer subcutaneously in the upper arm, upper thigh, or abdomen
Coding Guidelines:
• Effective January 1, 2014, for claims submitted to the contractor, denosumab (PROLIA™, Xgeva™) should be billed using HCPCS code J0897, Injection, denosumab, 1mg.
• Denosumab may not be billed using a chemotherapy administration code. The administration of the product should be billed using CPT code 96372, (Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or
intramuscular).
DRUG ADMINISTRATION CODING
The list below is not an all-inclusive list and may be subject to further revision.
The administration of the following drugs in their subcutaneous forms should not be billed using a chemotherapy administration code. Instead, the administration of the following drugs in their subcutaneous forms should be billed using CPT code 96372, (therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular).
Generic Name Trade Name HCPCS Code
denosumab Prolia/Xygeva® J0897
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