I get a lot of searches from people looking for the Medicare c-peptide requirements so I thought that I would add a post with what those requirements are here. I have also seen some “misinformation” being posted on messages boards. The most reliable information is directly from the source itself so I am putting the link to the CMS manual that covers insulin pump requirements.
Please note that besides either meeting Criterion A or B, you must meet the c-peptide requirements. I recently saw someone post that anyone already having a pump would be able to continue pumping because Criterion B includes those already pumping. However, the key words under the General CSII Criteria are “In addition to meeting Criterion A or B above,” so the c-peptide requirement must be met regardless of whether you meet the other requirements or not.
Although I have not seen this in the CMS manuals, it has been my experience that supply companies wanted a copy of my c-peptide test before they would ship any supplies to me. Insulin used in a pump is handled differently under Medicare than insulin used for MDIs – pump insulin gets processed under Part B and MDI insulin is processed under Part D. The pharmacy that I get my insulin from also needed a copy of my c-peptide test before they would sell insulin to me. Unfortunately even if you currently have a pump but do not meet the c-peptide requirements, you will not be able to get supplies for your pump. If you are planning on going on Medicare in the near future and do not know if you have ever had a c-peptide test done, I would recommend getting all your ducks in order so you don’t have a supply interruption.
The infusion pump section is under Section 280.14, with the diabetes section beginning on page 122.
e. Continuous Subcutaneous Insulin Infusion (CSII) Pumps (Effective for Services Performed On or after December 17, 2004)
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 percent;
• 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.