Appeal type: Drugs
Decision: Partially Favorable

 
We decided that the Plan has to pre-approve the first dose of 1,200mg of Orbactiv. We decided that the Plan 
does not have to pre-approve the second dose of 1,200mg of Orbactiv.  
 
You asked the Plan to pre-approve two doses of 1,200mg of Orbactiv and infusion services. You say that the 
enrollee has taken a single 1,200mg dose of Orbactiv at one time. You also say that the second dose was to be 
provided at a later date. The Plan says that the medication has not been prescribed according to FDA-approved 
dosing. 
 
We decided that the Plan has to pre-approve the first dose of 1,200mg of Orbactiv.  
 
The Plan must follow Medicare rules. The rules say that Medicare pays for a drug or biological only if it is safe 
and effective and otherwise reasonable and necessary.  
 
We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pre-approve the first dose of 1,200mg of Orbactiv. 
Our reviewer says that the first dose is supported based on the records provided. Our physician reviewer found 
that there is indication in the Medicare-approved drug compendia for a single dose of 1,200mg of Orbactiv for 
treatment of skin or subcutaneous tissue infection, but not for a second dose 14 days later. 
 
 
 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of the first dose of 1,200mg of Orbactiv have been met. Therefore, we decided that 
the Plan has to pre-approve the first dose of 1,200mg of Orbactiv.  
 
We also decided that the Plan does not have to pre-approve the second dose of 1,200mg of Orbactiv. 
 
The Plan must follow Medicare rules. The rules say that Medicare pays for a drug or biological only if it is safe 
and effective and otherwise reasonable and necessary.  
 
We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pre-approve the second dose of 1,200mg of 
Orbactiv. Our reviewer says that the second dose is not supported based on the Medicare-approved drug 
compendia. Our physician reviewer found that there is indication in the Medicare-approved drug compendia for 
a single dose of 1,200mg of Orbactiv for treatment of skin or subcutaneous tissue infection, but not for a 
second dose 14 days later. Our physician reviewer also found that based on the medical records provided and 
the Medicare-approved drug compendia there is no documentation that two doses of 1,200mg of Orbactiv are 
safe and effective for the patient. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of the second dose of 1,200mg of Orbactiv have not been met. Therefore, we 
decided that the Plan does not have to pre-approve the second dose of 1,200mg of Orbactiv. 
 
If the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again 
if we believe there was a mistake or if there is new information to review. The Plan has to show us the mistake 
and/or send us the new information. This does not happen often. If we decide to open the case again, we will 
send you a letter.