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April 5, 2018

Continuous Glucose Monitor (CGM) Use – Alternative Testing For Fingerstick Testing Requirements For Insulin Pumps

Joint DME MAC Article

Recently the DME MACs have received questions regarding the requirement in the External Infusion Pump Local Coverage Determination and related Policy Articles that a beneficiary must be self-testing their blood glucose levels an average of at least 4 times per day during the two months prior to initiation of the insulin pump or, for the beneficiary who has been on a pump prior to enrollment in Medicare, self-testing an average of at least 4 times per day during the month prior to Medicare enrollment. Questions have arisen in the context of continuous glucose monitor use.

A beneficiary using a CGM is inherently testing more than the 4x/day glucose monitoring requirement outlined in the DME MAC External Infusion Pump LCD and related Policy Articles; therefore, this would meet the testing requirement in the LCD. The LCD in Criterion V states (in pertinent part):

IV. Administration of continuous subcutaneous insulin for the treatment of diabetes mellitus (See Diagnosis Codes Group 1 that Support Medical Necessity section below) if criterion A or B is met and if criterion C or D is met:

  1. C-peptide testing requirement – must meet criterion 1 or 2 and criterion 3:
    1. C-peptide level is less than or equal to 110 percent of the lower limit of normal of the laboratory's measurement method.
    2. For beneficiaries with renal insufficiency and a creatinine clearance (actual or calculated from age, weight, and serum creatinine) less than or equal to 50 ml/minute, a fasting C-peptide level is less than or equal to 200 per cent of the lower limit of normal of the laboratory's measurement method.
    3. A fasting blood sugar obtained at the same time as the C-peptide level is less than or equal to 225 mg/dl.
  2. Beta cell autoantibody test is positive.
  3. The beneficiary has completed a comprehensive diabetes education program, 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 dose 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 (1 - 5) while on the multiple injection regimen:
    1. Glycosylated hemoglobin level (HbA1C) greater than 7 percent
    2. History of recurring hypoglycemia
    3. Wide fluctuations in blood glucose before mealtime
    4. Dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dL
    5. History of severe glycemic excursions
  4. The beneficiary has been on an external insulin infusion 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. [Emphasis Added]

If criterion A or B is not met, the pump and related accessories, supplies, and insulin will be denied as not reasonable and necessary. If criterion C or D is not met, the pump and related accessories, supplies, and insulin will be denied as not reasonable and necessary.

Additional information on the coverage, coding and documentation requirements for external infusion pumps may be found in the External Infusion Pumps Local Coverage Determination (L33794) and related Policy Articles (A52507 and A55426) on the DME MAC web sites and the CMS Medicare Coverage Database.

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