Denosumab injection 1 mg, HCPCS J0897 Targeted Probe and Educate Review Results - JF Part A
Denosumab injection 1 mg, HCPCS J0897 Targeted Probe and Educate Review Results
The Jurisdiction F, Part A Medical Review Department is conducting a Targeted Probe and Educate (TPE) review of for Healthcare Common Procedure Coding System (HCPCS) J0897 - Injection, denosumab, 1 mg. The quarterly edit effectiveness results from July 1, 2024 through September 30, 2024 are as follows:
Review Results
- 67 claims were reviewed with 49.07% error rate
Top Trending Errors
- Indications and Usage of Prolia® (denosumab)
- Indications and Usage of Xgeva® (denosumab)
Educational Resources
- Documentation Requirements
- Local Coverage Article: Billing and Coding: JW and JZ Modifier Billing Guidelines (A55932)
- CMS Internet Only Manual (IOM), Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50
- CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 17
- CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 3
Education
Indications and Usage of Prolia® (denosumab)
As referenced in the Food and Drug Administration (FDA) prescribing information, Prolia® is a RANK ligand (RANKL) inhibitor indicated for treating:
- Postmenopausal women with osteoporosis at high risk for fracture
- Men with osteoporosis at high risk for fracture
- Glucocorticoid induced osteoporosis in men and women at high risk for fracture
- Men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
- Women receiving adjuvant aromatase inhibitor therapy for breast cancer at high risk for fracture
Documentation must include appropriate imaging commonly supported by dual-energy x-ray absorptiometry (DEXA) to support the indication for Prolia®. Per the World Health Organization, osteoporosis is supported with a bone density score that is 2.5 standard deviations or more below the young adult mean or a T score of < -2.5. If imaging has improved with the use denosumab, but continued use is warranted, documentation must support a previous finding supporting an approved indication.
Prolia® may also be appropriate for patients at high risk for fractures. Examples of patients with a high risk for fracture include but are not limited to:
- Patients with osteopenia and a bone density between 1-2.5 standard deviations below the young adult mean or a T score of -1 to -2.5 and a history of a fragility fracture
- Patients with a high fracture risk assessment (FRAX) score defined as a 10-year probability of a major osteoporosis related fracture of > 20% or hip fracture of > 3%.
Indications and Usage of Xgeva® (denosumab)
As referenced in the Food and Drug Administration (FDA) prescribing information, Xgeva® is a RANK ligand (RANKL) inhibitor indicated for:
- Prevention of fracture in patients with multiple myeloma
- Prevention of fractures in patients with bone metastases from solid tumors
- Treatment of patients 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
Documentation must include appropriate imaging, labs, or biopsy to support the indication for Xgeva®.
