Letter from ANNA to the Centers for Medicare and Medicaid Services regarding the Coverage Decision Memorandum for C-Peptide Levels as a Criterion for Use of Insulin Pumps (Public Comments, S3-02-01).

October 26, 2004

Centers for Medicare & Medicaid Services

Office of Clinical Standards and Quality

Coverage and Analysis Groups

7500 Security Boulevard

Baltimore, MD  21244-1850 

Attn:  Public Comments, S3-02-01

To whom it may concern:

The American Nephrology Nurses’ Association (ANNA) thanks you for the opportunity to provide the Centers for Medicare and Medicaid Services (CMS) with comments regarding the Coverage Decision Memorandum for C-Peptide Levels as a Criterion for Use of Insulin Pumps. ANNA is a professional organization representing over 11,000 nephrology nurses whose main patient population is the hemodialysis population. 

ANNA recognizes that the number of US citizens with potential and actual kidney disease is rising annually. This is due to several factors including an aging population and an increase in chronic diseases such as diabetes, which can cause renal dysfunction. Preventive care for all aspects of kidney disease is proven to slow the progression to end stage renal disease (ESRD), which requires dialysis or transplantation. Prevention of renal failure and preservation of renal function include early diagnosis, patient education, drug therapy, and referrals to specialists. 

Diabetes is the primary diagnosis for new onset kidney disease with most patients having Type 2 diabetes. In addition to nephropathy, complications of untreated or undertreated diabetes include cardiovascular disease, neuropathy, and retinopathy. Patients with compromised renal function are unable to take all of the available oral agents and may need to be treated with insulin. Medicare is the primary insurer for ESRD patients and the cost for care increases when patients are unstable or hospitalized. Preventing complications by optimizing glucose control will decrease these costs. 

ANNA supports the CMS decision to expand the parameters for C-peptide results in people with chronic kidney disease (CKD), (clearance <50ml/min) who are not beta cell autoantibody positive. We are concerned that patients who are already stable on CSII must re-qualify for this therapy after becoming Medicare eligible either through age or by reaching ESRD. We recognize that C-peptides may not be as useful in this population due to the decreased rates of insulin clearance. We recognize that Medicare resources must be used carefully and that only appropriate patients should be managed with CSII.

We would request that some reasonable recourse be available to patients and their providers if it is determined that a patient who meets all other CSII criteria except for the C-peptide measurement can best be managed with CSII. The goal for every person with diabetes is to prevent or delay costly and deadly complications for as long as possible.

ANNA also supports ongoing research to determine the best methods of managing diabetes and preventing complications in the patient with renal dysfunction. 

ANNA members sincerely appreciate your invitation to comment on this draft. I hope that you will feel free to contact me via our national office at 856-256-2320 or by email at lesleyd@nc.rr.com if you have questions regarding these comments or if ANNA can be of any help in the future.

Yours sincerely, 

Lesley Dinwiddie, MSN, RN, FNP, CNN


cc:        ANNA Board of Directors

            Deborah Brooks, MSN, RN, ANP, CNN