This article contains billing and coding guidelines that complement the Local Coverage Determination (LCD) Drugs and Biologicals, Coverage of, for Label and Off-Label Uses.
Denosumab is a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor. Binding to the transmembrane or soluble protein RANKL inhibits the formation, function, and survival of osteoclasts resulting in decreased bone resorption and increased bone mass and strength.
Supplemental calcium and vitamin D are required.
Hypocalcemia must be corrected prior to initiation of denosumab therapy.
The FDA has approved the use of denosumab (Prolia™). 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.
The patient's medical record should contain documentation that fully supports the medical necessity for the administration of either formulation. Requirements specific to each formulation are as follows:
Patient adequately supplemented with calcium and vitamin D (calcium 1000 mg daily and at least 400 IU vitamin D daily).
For postmenopausal osteoporosis at high risk for fracture, documentation should include but is not limited to:
- Menopausal status (for female beneficiaries only)
- Patients age and sex.
- Documentation supporting the diagnosis of osteoporosis.
- Previous treatment of osteoporosis, agents used, outcomes and adverse reactions if any.
- History of previous fractures, including type of fracture, cause and time since occurrence.
- Risk factors for future fracture including preventive measures.
For the treatment of cancer treatment-induced bone loss (CTIBL) due to hormone ablation such documentation should include, but is not limited to:
- Documentation supporting the diagnosis of breast cancer or nonmetastatic prostate cancer.
- Use of adjuvant aromatase inhibitor (AI) therapy or androgen deprivation therapy (ADT).
- Additional diagnosed risk factors, if any.
Documentation should include, but is not limited to:
For treatment of bone metastasis from a solid tumor:
- Patient adequately supplemented with calcium and vitamin D
For management of hypercalcemia of malignancy (ICD-10-CM code E83.52)
- The related malignancy
- The rationale for the use of the drug
Dose and frequency should be in accordance with the FDA label or recognized compendia (for off-label uses). When services are performed in excess of established parameters, they may be subject to review for medical necessity.
- HCPCS code J0897 should be used to report denosumab (Prolia™, Xgeva™) for claims submitted to the Part A and Part B MAC.
- The administration of denosumab, when billed, should be billed using the therapeutic administration code 96372 (Therapeutic prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular.
- Correct coding requires that a bone metastasis diagnosis (ICD-10-CM code C79.51) be present on the claim as the primary diagnosis and the original cancer or history of cancer be included as the secondary diagnosis. This article does not limit the primary cancer (as long as it is a solid tumor and not a myeloma or other cancer of the blood). Effective for dates of service on or after 01/04/2018, the FDA has approved denosumab (Xgeva®) for the treatment of skeletal-related events in patients with multiple myeloma.
- Any significant and separately identifiable E&M service billed should accurately reflect the level of the components documented. Observation of the patient by the physician post-injection may be included in the E&M service. Only face-to-face time with the physician may be considered. Observation and treatment time by the office or hospital staff may not be billed separately or counted towards a physician E&M service.
FDA and Compendia Review
Clinical Pharmacology Web site. http://www.clinicalpharmacology.com/. Accessed 12/07/2022.
FDA label for Prolia® https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s202lbl.pdf
FDA label for XGEVA® https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s196s199lbl.pdf
Lexi-Drugs Web site. http://online.lexi.com. Accessed 12/07/2022.
Micromedex DrugDex®. http://www.thomsonhc.com/home/dispatch. Accessed 12/07/2022.
National Comprehensive Cancer Network Web site. http://www.nccn.org/index.asp. Accessed 12/07/2022.
Prolia Web site. http://www.proliahcp.com/. Accessed 10/01/2010.