Appeal type: unknown
Decision: unknown

 
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 say that Medicare may cover a drug or biological if it is safe and effective and otherwise reasonable 
and necessary. You can find this rule in the Centers for Medicare and Medicaid Services, Internet Only 
Manual, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.4.1. 
  
Medicare rules also allow the plan to use step therapy. This is the process of beginning drug therapy for a 
medical condition with "preferred" (or more cost-effective) on-formulary drug alternative(s) and progressing to 
other drug therapies only as necessary. A plan must grant an exception to its step therapy rules if it determines 
that the requested drug is medically necessary, consistent with the prescriber's statement. The statement must 
show that the step therapy drugs: have been ineffective in treating the enrollee; or are likely to be ineffective or 
adversely affect the drug's effectiveness or patient compliance; or are likely to cause an adverse reaction or 
other harm to the enrollee.  
 
Medicare Advantage plans should ensure that new step therapy requirements do not disrupt ongoing Part B 
drug therapies for enrollees. Step therapy may only be applied to new prescriptions or administrations of Part B 
drugs for enrollees that are not actively receiving the affected medication. You can find this information at 42 
CFR Sections 422.2 and 422.136. 
 
The rules say the record indicates that the enrollee has age related osteoporosis without osteoporotic fracture.  
The requested medication is a new start.  The provided records do not indicate that the enrollee has tried and 
failed the plan's preferred step one alternative. The record does not indicate that the enrollee has a 
contraindication to, or would have an adverse effect from the plan's preferred step one alternative.  The 
elements of the coverage criteria are not satisfied.  The requested service cannot be recommended. 
 
Prolia for all patients is allowed under the following circumstances: 
 
    the oral health of the patient was discussed 
    the patient was instructed to take 1,000 mg of calcium and at least 400 IU of vitamin D per day  
 
Prolia for Men and Postmenopausal Women with Osteoporosis is allowed under the following circumstances: 
 
    criteria for the diagnosis of osteoporosis is met, and 
    there is a history of treatment as related to progression of disease and ongoing risk factors, and 
    The patient meets the definition of osteoporosis with high risk for fracture, or     The patient has failed or is intolerant of other available osteoporotic therapy 
 
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 
 
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  
 
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 
 
Prolia is contraindicated for the following conditions: 
 
    Hypocalcemia 
    Patients receiving Xgeva 
 
You can find this information in Medicare's Local Coverage Determination (LCD): Bisphosphonates 
(Intravenous [IV]) 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. The Plan 
contract says that they have a link that will take you to a list of Part B drugs that may be subject to step therapy. 
You can find this information in Chapter 4 on page 78 of the Plan's 2022 Evidence of Coverage.