Prolia

Prolia® (Denosumab) reduces the possibility of fractures of the hip and vertebral and non-vertebral fractures. The recommended dose is 60 mg every six months. Denosumab is administered by subcutaneous injection.

Prolia® is a RANK Ligand (RANKL) inhibitor indicated in individuals with the following:

• 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 of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
• Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer
• Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer

Xgeva® (Denosumab) inhibitor is indicated for:

• Prevention of skeletal-related events in patients with multiple myeloma and 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

While Prolia® and Xgeva® have the same generic name (denosumab), they are prescribed differently and have different indications. Prolia® is given, as mentioned above, as a 60 mg dose. Xgeva® is administered at a higher dose.

Medicare Coverage for Drugs and Biologicals
As outlined in CMS Publication 100-02, Chapter 15, Medicare 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. Also, as per 42 CFR 410.26, the physician (or other practitioner) supervising the auxiliary personnel need not be the same physician (or other practitioner) who is treating the patient more broadly. However, only the supervising physician (or other practitioner) may bill Medicare for incident to services. Generally, drugs and biologicals are covered only if all of the requirements below are met.

• They meet the definition of drugs or biologicals
• They are not usually self-administered
• They meet all the general requirements for “incident to”
• They are reasonable and necessary for the diagnosis or treatment of the illness or injury for which they are administered
• They are not excluded
• They have not been determined by the FDA to be less than effective

When billing Prolia®, documentation must be maintained to support all Medicare coverage requirements for drugs and biologicals are met. Providers are encouraged to review their records for the items below to support requirements.

• Is there documentation of an order/intent to order Prolia® (denosumab)?
• Is there documentation to support the billing physician is the supervising physician?
• Does documentation support that Prolia® (denosumab) was administered according to FDA label?
• Is there documentation to support Prolia® is reasonable and necessary and administered in accordance with accepted standards of medical practice?
  • Supporting documentation may include, but is not limited to:
  • History and physical to include prior treatment and response
  • Current progress notes

Medical necessity can also be met under the following circumstances:

• Radiology results
  • Bone mineral density (BMD)/Dual-energy X-ray absorptiometry (DXA): The World Health Organization (WHO) defines osteoporosis as a BMD of 2.5 or more standard deviations below that of a normal young healthy female (a T score of ≤ −2.5 SD) for postmenopausal women and men over 50 years.
  • Osteoporotic fractures
    • Fracture Risk Assessment Tool (FRAX) calculated for patients who have NOT received treatment: 10-year risk scores of > or = 3% for hip fracture or > or = 20% for major osteoporotic fracture, to reduce their fracture risk
• Does documentation support specific indications are met for the applicable condition/diagnosis?

Resources

• Social Security Act 1861(s)(2)(A), Medical and Other Health Services
• 42 CFR 410.26, Services and Supplies Incident to Physician's Professional Services
• 42 CFR 410.29, Limitations on Drugs and Biologicals
• Publication 100-02, Chapter 15 (PDF), Section 50, Drugs and Biologicals
• Reasonable and Necessary Criteria (CMS IOM 100-08, Chapter 3.6.2.2 (PDF))
• Local Coverage Article: Self-Administered Drug Exclusion List (A53066)
• Prolia — FDA (PDF)
• The clinical diagnosis of osteoporosis: a position statement from the National Bone Health Alliance Working Group
• Bone Mass Measurement (nih.gov)
• The Assessment of Fracture Risk (nih.gov)
• Primary Use of FRAX (nih.gov)