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Last Modified: 9/3/2022 Location: FL, PR, USVI Business: Part A, Part B

Appropriate drug billing for Prolia® (denosumab) injections, J0897

First Coast has identified Prolia injections, J0897, as a top claim denial for claims reviewed by the recovery audit contractor (RAC) during 2021. The main category of error was providers billing incorrect units on the claim. We’d like to remind providers how to properly bill for J0897 to ensure the drug is reported accurately.
Prolia is indicated for the treatment of certain patients with osteoporosis. As approved by the FDA, the labeled indications external link recommended dose for Prolia is 60 mg (1 mL of a 60 mg/mL solution in a single-dose prefilled syringe) every six months as a subcutaneous injection in the upper arm, upper thigh, or abdomen.
When submitting the claim, remember to:
Bill 60 units of J0897 with administration HCPCS 96372 (Therapeutic prophylactic, or diagnostic injection [specify substance or drug]; subcutaneous or intramuscular). J0897 is for 1 mL. Prolia is administered in a single-dose prefilled syringe of 60mg/mL.
Document clearly in the patient’s medical record the actual dose administered in addition to the exact amount wasted and the total amount the vial is labeled to contain if the remainder of a single-use vial must be discarded. Discarded drugs must be reported with the JW modifier on a separate claim line.
Prolia (denosumab) is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa – B ligand). For monoclonal antibodies RANKL inhibitors therapy, the documentation should include the following information:
Criteria for the diagnosis of osteoporosis, and
History of treatment as related to progression of disease and ongoing risk factors, and
Description of treatment failure, or contraindication, or adverse side effects of oral or self-administered drugs for osteoporosis as applicable to the patient that supports monoclonal antibodies via subcutaneous injection therapy in lieu of standard oral treatment protocol
Prolia for all patients is allowed under the following circumstances:
Oral health of the patient was discussed and
Patient was instructed to take 1,000 mg of calcium and at least 400 IU (international units) of vitamin D per day
Please refer to First Coast’s local coverage determination (LCD) LCD ID number: L33270 external link Bisphosphonates (Intravenous [IV]) and Monoclonal Antibodies in the Treatment of Osteoporosis and Their Other Indications (Florida, Puerto Rico/ U.S. Virgin Islands) and billing & coding article A57603 external link for utilization guidelines that apply to the reasonable and necessary provisions outlined.

Discarded drugs

When billing for a single-use vial and part of the drug is being discarded, bill the discarded amount with the drug wastage on a separate line. You may find addition information in the Avoid claim denials: Bill drug wastage correctly using the JW modifier article on our website.
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