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 state that continuous subcutaneous insulin infusion (CSII) and related drugs/supplies are covered as 
medically reasonable and necessary in the home setting for the treatment of diabetic patients who: (1) either 
meet the updated fasting C-Peptide testing requirement, or, are beta cell autoantibody positive; and, (2) satisfy 
the remaining criteria for insulin pump therapy as described below. Patients must meet either Criterion A or B 
as follows: 
 
Criterion A: The patient has completed a comprehensive diabetes education program, and has been on a 
program of multiple daily injections of insulin (i.e., at least 3 injections per day), with frequent self-adjustments 
of insulin doses for at least 6 months prior to initiation of the insulin pump, and has documented frequency of 
glucose self-testing an average of at least 4 times per day during the 2 months prior to initiation of the insulin 
pump, and meets one or more of the following criteria while on the multiple daily injection regimen: 
 
    Glycosylated hemoglobin level (HbAlc) > 7.0%; 
    History of recurring hypoglycemia; 
    Wide fluctuations in blood glucose before mealtime; 
    Dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dl; or, 
    History of severe glycemic excursions. 
 
Criterion B: The patient with diabetes has been on a pump prior to enrollment in Medicare and has documented 
frequency of glucose self-testing an average of at least 4 times per day during the month prior to Medicare 
enrollment. 
 
General CSII Criteria 
 
In addition to meeting Criterion A or B above, the following general requirements must be met: 
 
The patient with diabetes must be insulinopenic per the updated fasting C-peptide testing requirement, or, as an 
alternative, must be beta cell autoantibody positive. 
 
Updated fasting C-peptide testing requirement: 
 
    Insulinopenia is defined as a fasting C-peptide level that is less than or equal to 110% of the lower limit of 
normal of the laboratory's measurement method.     For patients with renal insufficiency and creatinine clearance (actual or calculated from age, gender, weight, 
and serum creatinine) = 50 ml/minute, insulinopenia is defined as a fasting C-peptide level that is less than or 
equal to 200% of the lower limit of normal of the laboratory's measurement method. 
    Fasting C-peptide levels will only be considered valid with a concurrently obtained fasting glucose = 225 
mg/dL. 
    Levels only need to be documented once in the medical records. 
 
Continued coverage of the insulin pump would require that the patient be seen and evaluated by the treating 
physician at least every 3 months. 
 
The pump must be ordered by and follow-up care of the patient must be managed by a physician who manages 
multiple patients with CSII and who works closely with a team including nurses, diabetes educators, and 
dietitians who are knowledgeable in the use of CSII. 
 
You can find this information in the National Coverage Determination (NCD) Infusion Pumps 280.14. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.