This information is from the Medicare Coverage Issues Manual for Durable Medical
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Section 60-14, Infusion Pumps, revises the C-peptide requirement to be less than or equal to 110 percent of the lower limit of normal of the laboratory's measurement method. This change expands the value of the laboratory test to be considered in determining coverage of the insulin infusion pump for all diabetic patients. (Type II diabetics are no longer excluded.)
This section of the Coverage Issues Manual is a national coverage decision made under §1862(a)(1) of the Social Security Act (the Act). National coverage determinations (NCDs) are binding on all Medicare carriers, intermediaries, Peer Review Organizations, and other contractors. Under 42 CFR 422.256(b) an NCD that expands coverage is also binding on a Medicare+Choice Organization. In addition, an administrative law judge may not disregard, set aside, or otherwise review a national coverage decision issued under §1862(a)(1) of the Act. (42 CFR 405.732, 405.860.)
DISCLAIMER: The revision date and transmittal number only apply to the redlined material. All other material was previously published in the manual and is only being reprinted.
60-14 INFUSION PUMPS
THE FOLLOWING INDICATIONS FOR TREATMENT USING INFUSION PUMPS ARE COVERED UNDER MEDICARE:
A. External Infusion Pumps.--
sections 1 - 4 deleted, not about insulin infusion pumps
5. Continuous subcutaneous insulin infusion pumps (CSII) (Effective for Services Performed On or After 4/1/2000).--
An external infusion pump and related drugs/supplies are covered as medically necessary in the home setting in the following situation: Treatment of diabetes
In order to be covered, patients must meet criterion A or B:
(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 selfadjustments 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 while on the multiple daily injection regimen:
(1) Glycosylated hemoglobin level (HbAlc) > 7.0 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
(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.
REVISED, see above
Diabetes needs to be documented by a fasting C-peptide level that is less than or equal to 110 percent of the lower limit of normal of the laboratory’s measurement method. (Effective for Services Performed on or after January 1, 2002.)
Continued coverage of the insulin pump would require that the patient has been seen and evaluated 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.
6. Other uses of external infusion pumps are covered if the contractor's medical staff verifies the appropriateness of the therapy and of the prescribed pump for the individual patient.
Payment may also be made for drugs necessary for the effective use of an external infusion pump as long as the drug being used with the pump is itself reasonable and necessary for the patient's treatment.