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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules state that in order to be covered by Medicare, a drug or biological must be safe and effective and 
otherwise reasonable and medically necessary. Drugs and biologicals approved for marketing by the Food and 
Drug Administration (FDA) are considered safe and effective when used for indications specified in the FDA 
labeling. The FDA labeling lists the safe and effective indications, dosage, and frequency of the agents. Please 
refer to CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50 Drugs and 
Biologicals. In addition to FDA approved indications, Medicare may consider coverage of off-label uses based 
on guidance provided in the CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, 
Section 50.4.2 for Unlabeled Use of Drug. 
 
The rules state that Prolia for all patients is allowed under the following circumstances: 
the oral health of the patient was discussed 
1. The patient was instructed to take 1,000 mg of calcium and at least 400 IU of vitamin D per day 
2. Prolia for Men and Postmenopausal Women with Osteoporosis is allowed under the following 
circumstances: criteria for the diagnosis of osteoporosis is met, and 
3. There is a history of treatment as related to progression of disease and ongoing risk factors, and 
4. The patient meets the definition of osteoporosis with high risk for fracture, or 
5. The patient has failed or is intolerant of other available osteoporotic therapy 
6. Prolia for Treatment of Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast 
Cancer is allowed under the following circumstance: the patient is a woman receiving adjuvant aromatase 
inhibitor therapy for breast cancer 
7. Created on 12/15/2023. Page 7 of 17 
Prolia for Treatment of Bone Loss in Men Receiving Androgen Deprivation Therapy for non-metastatic 
prostate cancer is allowed under the following circumstance: the patient is a man receiving androgen 
deprivation therapy for prostate cancer 
8. Xgeva for all patients is allowed under the following circumstances: 
the patient is taking calcium and vitamin D supplements as necessary to treat or prevent hypocalcemia 
 
Limitations: 

If the drug use is not indicated on the FDA label, and is not included in one of the compendium approved by CMS (American Hospital formulary Services [AHFS], Clinical Pharmacology, NCCN Drugs and Biologicals 
Compendium and/or Thomson Micromedex DrugDex) and the off-label use is not listed above, the drug use 
would not be considered medically reasonable and necessary, and, therefore is not allowed. Not only does the 
indication for the use of the drug need to meet medical necessity requirements, but the route of administration 
is also subject to medical necessity criteria. 
 
Medical necessity is not demonstrated in the cases where a patient has not taken the oral form of a medication 
before the IV form of the drug, either for patient or provider convenience purposes, or for financial or 
emotional reasons. 
 
Combination use of a bisphosphonate and a monoclonal antibody for the treatment of osteoporosis during an 
episode of care is not considered medically reasonable and necessary. Combination use of IV and/or oral forms 
of bisphosphonate therapy as treatment for osteoporosis during an episode of care is not covered. An episode of 
care includes the duration and frequency of the IV drugs in accordance with FDA labels. 
 
Hypocalcemia, hypovitaminosis D, and other disturbances of bone and mineral metabolism must be effectively 
treated before starting therapy. Patients must receive supplemental calcium and vitamin D. 
 
The optimal duration of the use of the drugs listed in this LCD has not been determined. It is expected that 
treatment with these drugs in a Medicare beneficiary meets the evidence-based peer reviewed literature and 
standards of care in the medical community. 
 
Prolia is contraindicated for the following conditions: 
1. Hypocalcemia 
2. Patients receiving Xgeva 
 
You can find these rules in Local Coverage Determination (LCD) Bisphosphonates and Monoclonal Antibodies 
in the Treatment of Osteoporosis and Their Other Indications (L33270). 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.