HME providers are anticipating a policy update related to the Medicare coverage criteria for continuous subcutaneous insulin infusion (CSII) pumps. For now, interested readers may view CMS’ Decision Memo for “Insulin Pump: C-peptide Levels As a Criterion for Use of Insulin Pumps,” dated December 17, 2004, at www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=109.  

CMS has determined that subcutaneous insulin pumps fall within the “durable medical equipment” benefit category as set forth in Section 1861(n) of the Social Security Act. In August 1999 and May 2001, CMS (then known as the Health Care Financing Administration) issued decision memoranda regarding C-peptide testing levels as a criterion for the use of CSII pump therapy, requiring physicians to document type 1 diabetes mellitus with a C-peptide level of less than 0.5 ng/mL for CSII coverage. In January 2002, CMS revised the cut-point for the C-peptide testing requirement to less than or equal to 110% of the lower limit of normal of the laboratory’s measurement method for coverage of CSII pump therapy.

Coverage of CSII for the treatment of diabetic patients in the home setting is currently defined by criteria outlined at 280.14, Section A.5 of the Medicare National Coverage Determination (NCD) Manual—which states that for services performed on or after April 1, 2000: an external infusion pump and related drugs/supplies are covered as medically necessary in the home setting in the treatment of diabetes; and to be covered, patients must meet criterion A or B.

Criterion A states that the patient has completed a comprehensive diabetes education program, and has been on a program of multiple daily injections of insulin (at least three 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 at an average of at least four times per day during the 2 months prior to initiation of the insulin pump.

Under criterion A, a patient must also meet one or more of the following while on the multiple daily injection regimen:
            • glycosylated hemoglobin level (HbA1c) > 7.0%;
            •history of recurring hypoglycemia;
            •wide fluctuations in blood glucose before mealtime;
            •dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dl;
            •history of severe glycemic excursions.

Criterion B: The patient with diabetes 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 four times per day during the month prior to Medicare enrollment. Effective for services performed on or after January 1, 2002: diabetes needs to be documented by 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.

Continued coverage of the insulin pump and supplies requires that the patient has been 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.

CMS’ December 2004 Decision Summary for Insulin Pump Therapy
CMS has determined that the evidence is adequate to conclude that CSII is reasonable and necessary for treatment of diabetic patients who: either meet the updated fasting C-peptide testing requirement (see discussion below) or are beta cell autoantibody positive; and satisfy the remaining criteria for insulin pump therapy detailed in the NCD Manual 280.14, Section A.5 (see previous discussion of criterion A and criterion B).

Updated Fasting C-peptide Testing Requirement
CMS has determined that fasting C-peptide levels will be considered valid only when a concurrently obtained fasting glucose level is less than or equal to 225 mg/dL. 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. Alternatively, for patients with renal insufficiency whose creatinine clearance (actual or calculated from age, gender, weight, and serum creatinine) is less than or equal to 50 mL/min, 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.

Levels only need to be documented once in the patient’s medical records. CMS will also continue to allow coverage of all other uses of CSII in accordance with the Category B investigational device exemption (IDE) clinical trials regulation (42 CFR 405.201) or as a routine cost under the clinical trials policy (Medicare NCD Manual 310.1).

In the final analysis, CMS’ decision will require Medicare patients who are not beta cell autoantibody positive to meet the updated C-peptide testing requirement. It is CMS’ opinion that the current requirement of a low C-peptide test level should continue to be a selection criterion for those patients who are not beta cell autoantibody positive. Following its evaluation of current medical evidence, CMS has determined that fasting C-peptide levels to be valid only with a documented, concurrently obtained fasting glucose level of less than or equal to 225 mg/dL. CMS has indicated that it considered the needs of those diabetic patients who meet all CSII criteria except for the C-peptide testing requirement. As an alternative to C-peptide testing, CMS will allow a positive beta cell autoantibody test to be an adequate diagnostic criterion for CSII use. Therefore, CMS will allow a positive beta cell autoantibody test to be a criterion for CSII use provided that all remaining coverage criteria detailed in the updated Medicare NCD Manual are met.

CMS has determined that to not preclude the potential benefits of CSII in patients who may have a certain artifactually elevated C-peptide, the C-peptide requirement will be modified for patients who are not beta cell autoantibody positive, and who have decreased renal function to less than or equal to 200% of the lower limit of normal of the laboratory’s measurement method. Therefore, for those patients with renal insufficiency and a creatinine clearance of less than or equal to 50 mL/min, CMS will update its coverage and also allow insulinopenia to be 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.

This article is not intended to be legal advice or legal opinion on any specific facts or circumstances. The contents are intended for general information purposes only.

Marcia Castillo, RHIT, CCS, is a paralegal medical information analyst with the Health Care Group of Brown & Fortunato PC, an Amarillo, Tex-based law firm. She can be reached at (806) 345-6354 or via email: mcastillo@bf-law.com.