HCPCS J0897; Injection, denosumab, 1 mg

In order to fulfill its contractual obligation with CMS, Noridian Healthcare Solutions (Noridian), your Medicare Contractor, performs pre-payment reviews in accordance with CMS direction. CMS is required by the Social Security Act to ensure that payment is made only for those medical services that are reasonable and necessary. Medical review assesses submitted documentation to validate provider compliance with Medicare payment rules and regulations, including coverage, coding and billing guidelines.

This is to update providers of the claim review findings for HCPCS J0897; Injection, denosumab, 1 mg. The results of this focused review are not a reflection on providers' competence as a health care professional or the quality of care provided to patients. Specifically, the results are based on the documentation requested by Medicare and/or your facility's compliance with the required documentation.

The Jurisdiction F Part B Medical Review Department is conducting a Targeted Probe and Educate (TPE) review of HCPCS J0897; Injection, denosumab, 1 mg. The quarterly edit effectiveness results from October 1, 2025, through December 31, 2025, are as follows:

Top Denial Reasons

  • Denial Reason 1 - Failure to return records
  • Denial Reason 2 - The documentation submitted was incomplete and/or insufficient
  • Denial Reason 3 - The documentation submitted does not support medical necessity

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Education

Procedure code J0897 is used for billing of Prolia® and Xgeva®.

As referenced in the FDA prescribing information, Prolia® is a RANK ligand (RANKL) inhibitor indicated for:

  • Treatment of postmenopausal women with osteoporosis at high risk for fracture
  • Treatment to increase bone mass in men with osteoporosis at high risk for fracture
  • Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
  • Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer

As referenced in the FDA prescribing information, Xgeva® is a RANK ligand (RANKL) inhibitor indicated for:

  • Prevention of skeletal-related events in patients with bone metastases from solid tumors
  • Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity
  • Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy

Limitation of use: Xgeva is not indicated for the prevention of skeletal-related events in patients with multiple myeloma.

Documentation must include appropriate imaging to support the indication for Prolia® and Xgeva® through radiographic evidence.

Coverage for this service is discussed in the Internet-Only Manuals (IOM) Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50. The Medicare program provides limited benefits for outpatient drugs. The program covers drugs that are furnished "incident to" a physician's service provided that the drugs are not usually self-administered by the patients who take them. Generally, drugs and biologicals are covered only if all of the following requirements are met: They meet the definition of drugs or biologicals (see Sec.50.1); They are of the type that are not usually self-administered. (see Sec.50.2); They meet all the general requirements for coverage of items as incident to a physician's services (see Sec.Sec.50.1 and 50.3); They are reasonable and necessary for the diagnosis or treatment of the illness or injury for which they are administered according to accepted standards of medical practice (see Sec.50.4); They are not excluded as noncovered immunizations (see Sec.50.4.4.2); and They have not been determined by the FDA to be less than effective. (See Sec.Sec.50.4.4). Medicare Part B does generally not cover drugs that can be self-administered, such as those in pill form, or are used for self-injection. However, the statute provides for the coverage of some self-administered drugs. Examples of self-administered drugs that are covered include blood-clotting factors, drugs used in immunosuppressive therapy, erythropoietin for dialysis patients, osteoporosis drugs for certain homebound patients, and certain oral cancer drugs. (See Sec.110.3 for coverage of drugs, which are necessary to the effective use of Durable Medical Equipment (DME) or prosthetic devices.)

Last Updated Feb 19 , 2026