Appeal type: Drugs
Decision: Partially Favorable

 
We decided that the Plan has to pay for the injection, immune globulin (Hizentra), 100 mg (code J1559) 
provided from October 5, 2022, to October 26, 2022. We decided that the Plan does not have to pay for home 
infusion therapy, immunotherapy, administration services, professional pharmacy services, care coordination, 
and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem (code S9338) 
provided from October 5, 2022, to October 26, 2022.  
 
You asked the Plan to pay for an injection, immune globulin (Hizentra), 100 mg (code J1559) and home 
infusion therapy, immunotherapy, administration services, professional pharmacy services, care coordination, 
and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem (code S9338) 
provided from October 5, 2022, to October 26, 2022. You say that you have provided the medical records and 
that prior infusions have been approved and paid for since 2017. The Plan says that additional medical records 
were needed. 
 
We decided that the Plan has to pay for an injection, immune globulin (Hizentra), 100 mg (code J1559) 
provided from October 5, 2022, to October 26, 2022. 
 
The Plan follows Medicare rules. 
 
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 injection, immune globulin 
(Hizentra), 100 mg (code J1559). Our reviewer says that the requested injection, immune globulin (Hizentra), 
100 mg (code J1559) is considered medically necessary in this case. Our physician reviewer found that the 
enrollee has a history of asthma and Common Variable Immunodeficiency ( CVID).  Hizentra is indicated for 
primary immunodeficiency; this includes, but is not limited to, common variable immunodeficiency (CVID), 
X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe 
combined immunodeficiencies. Individualize dose based on patient's clinical response and serum IgG trough 
levels; obtain baseline serum IgG trough level to guide subsequent dosage adjustments. Before initiating, 
ensure that patients have received intravenous immunoglobulin (IGIV) treatment at regular intervals for at least 
three months. The review has determined that the documentation supports that the Hizentra is medically 
reasonable and necessary for the enrollee. The documentation supports that the Hizentra is safe and effective 
for the enrollee.  
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of an injection, immune globulin (Hizentra), 100 mg (code J1559) have been met.  
Therefore, we decided that the Plan has to pay for an injection, immune globulin (Hizentra), 100 mg 
(code J1559) provided from October 5, 2022, to October 26, 2022.  
 
We also decided that the Plan does not have to pay for home infusion therapy, immunotherapy, 
administration services, professional pharmacy services, care coordination, and all necessary supplies 
and equipment (drugs and nursing visits coded separately), per diem (code S9338) provided from 
October 5, 2022, to October 26, 2022.  
The Plan must follow Medicare rules. Medicare rules say that providers must report services correctly. 
Providers must report services with the appropriate procedure code. 
 
We find that procedure code S9338 has a Status Indicator of I on the Physician Fee Schedule. This means that 
procedure code S9338 is not valid for Medicare purposes. Based on this information, we decided that Medicare 
rules for coverage of S9338 have not been met. Therefore, we decided that the Plan does not have to pay for 
home infusion therapy, immunotherapy, administration services, professional pharmacy services, care 
coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem 
(code S9338) provided from October 5, 2022, to October 26, 2022.   
 
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.