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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. 
 
The rules say that the following bisphosphonate injections (administered intravenously [IV]) will be considered 
medically reasonable and necessary when administered as outlined in this LCD. The coverage of IV 
bisphosphonates must be supported in the medical record. 
 
-Criteria for the diagnosis of osteoporosis, and 
-History of treatment as related to progression of disease and ongoing risk factors, and 
-Description of treatment failure, or contraindication, or adverse side effects, of oral or self-administered drugs 
for osteoporosis as applicable to the patient that supports IV therapy in lieu of standard oral treatment protocol. 
 
The following IV bisphosphonate injections are considered medically reasonable and necessary when 
administered as outlined in this LCD: Ibandronate sodium injection (Boniva), Pamidronate (Aredia), 
Zoledronic acid injection (Reclast), Zoledronic acid injection (Zometa). 
 
You can find this information in the Local Coverage Determination (LCD): Bisphosphonates (Intravenous 
[IV]) and Monoclonal Antibodies in the Treatment of Osteoporosis and Their Other Indications (L33270). 
  
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. 
 
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 contract 
says that the Plan has step therapy requirements for certain Medicare Part B covered drugs/biologicals. 
Enrollees may be required to try a preferred drug before the Plan will approve the requested medication. You 
can find this information in Chapter 4 on page 82 of the Plan's 2023 Evidence of Coverage (EOC).