Type 1 antibody/c-pep tests and Medicare

Medicare wants your level to be under .4 so it’s easier to achieve when you fast, but when you have no beta cells left it hardly matters. Medicare isn’t looking at weather or not you are fasting only the number

Even though I have been a T1D since 1964, Medicare required that I get a C-Peptide test when I went on Medicare in 2012 because I do use a pump. The result of my test was <0.1 so Medicare approved me to continue receiving pump supplies. Medicare did not require a GAD65 test at that time. Do they require a GAD65 now?

This thread motivated me to go into the CMS document that as far as I know is the current criteria for insulin pump coverage. It is from 2004 but I do not know of a newer official document. If someone knows of a newer CMS document, please share the link.

Go to Section IX Conclusion for some of the info. Interestingly it says that positive autoantibodies or a qualifying c-peptide are required. In reality I think most people get the c-peptide.

“ CMS has determined that the evidence is adequate to conclude that continuous subcutaneous insulin infusion (CSII) is reasonable and necessary for treatment of diabetic patients: 1) who either meet the updated fasting C-peptide testing requirement or are beta cell autoantibody positive; and 2) who satisfy the remaining criteria for insulin pump therapy detailed in the Medicare National Coverage Determinations Manual (Medicare NCD Manual 280.14, Section A.5).”

Here it says that the c-peptide must be accompanied by a fasting BG test:

“ CMS has determined that fasting C-peptide levels will only be considered valid when a concurrently obtained fasting glucose is ≤ 225 mg/dL. Insulinopenia is defined as 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. Alternatively, for patients with renal insufficiency and a 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 percent of the lower limit of normal of the laboratory’s measurement method. Levels only need to be documented once in the medical records.”

Then you must meet either Criterion A or Criterion B for pump coverage.

Medicare NCD Manual 280.14 (formerly CIM 60-14) Section A.5

280.14 – Infusion Pumps

(Rev. 1, 10-03-03)

CIM 60-14

“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:

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 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

Criterion b

  1. 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.

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 by the treating physician at least every three 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.”

1 Like

Dr Faustman’s research showed that even long term type 1 are still producing small amounts of insulin although not enough to survive of course or to prevent dka etc.

But it suggests that the autoimmune attack on our beta cells is ongoing and our bodies are still struggling to produce beta cells and insulin. So if that process can be disrupted or stopped we can need less insulin, or maybe even get off it entirely which the recent stem cell implantations may one day achieve.

In Dr F trials so far the bcg vaccine allowed longterm type 1 to need less insulin and have easier bg management.

I have been following Dr. Faustman’s research for a number of years now and eagerly await when her results are fully completed and published. The use of the BCG vaccine is encouraging indeed, and it is frustrating that she does not receive the regular, ongoing financial commitment from organizations like the JDF to continue her research.

That being said, there are still circumstances where the whole pancreas has suffered injury sufficient that it is not operative. Evidence so far shows mine is one of these as testing indicates the exocrine as well as endocrine functions are lacking. If treatment from the BCG Vaccine once it is available, allows beta cells to regrow and not be further attacked by my immune system that would be great, but the initial assault on my pancreas started with an attack of pancreatitis. I developed type 1 diabetes 10 years later after a serious round with a virus that really threw me for a loop. There was already existing damage to the organ; how much of it was permanently damaged remains unknown but so far it shows no evidence of any sort of activity.

I actually investigated whether I would qualify for one of her trials but was not in the geographic testing area. I think this is definitely one of the bright lights in the future for type 1 diabetes.

1 Like

FYI: I have UnitedHealthcare MedicareAdvantage and it completely covers all my supplies - pump stuff, testing stuff, CGM - except insulin copays which have been $45 monthly until now.

I do understand that some Medicare Advantage (MA) plans cover these items and I’m glad that yours is one of them. All people with diabetes should enjoy this economic benefit and access.

Yet I also understand that this coverage is not universal in the MA market and that these plans are free to change their coverage and formularies at will whenever it suits them. This is the reason I’ve chosen to use traditional Medicare with a supplement plan.

3 Likes

Good to know. Thanks.

1 Like

When I turned 65 I was on Levemir Metformin and Victoza only but I had lots of problems. I was and have remained super variable in my insulin needs. Long acting insulin either left me too high some days or too low and I could not exercise much at all without going seriously low to the point I would collapse on someones lawn for an hour before I could walk home. I had glucose tablets but they didn’t help very quickly.

I therefore got a pump. I had the antibody tests and C-Peptide but nothing good enough for Medicare. I had to buy my own pump and then buy the infusion sets too out of pocket.

My doctor kept testing my C-Peptide and I learned how to lower it for tests.
Sometimes it would read as high as 3 and other times it was like 1. The min level for the lab was 0.8. Continued testing every 3 months and tried to fast extra before the test and treat with extra insulin and exercise to get glucose down near 60 for the test! (I always brought a donut to eat soon as the test was over.)

I continued to generally get lower and lower readings and finally got down to 0.8 and qualified for Medicare coverage.

My pancreas seems to turn on and off every 4 to 8 days and my insullin doses from day to day vary by a factor of 3 to 1 for both basal and meal time boluses. The pump solved my exercise issues mostly because I could turn it off and now the close loop pump does it for me.

I am on a very low carb diet but I have to eat a min carb level daily to keep glucose from going too low now. The C-Peptide often reads 0.8 now and without me trying for it.

1 Like

My endo recently ordered a C-peptide test, my second. Like my first test, the result was 110% of the reference level. However, the reference level was considerably higher. My endo told me the tests results were consistent and the different reference level was due to a different assay method.

The two tests were 4 1/2 years apart and endo says I’m still in honeymoon period after 23 years (first 19 yrs misdiagnosed as T2).