Medicare (Part B) Guidelines for Pump Approval

Does anyone know the specific guidelines or clinical information that Medicare uses to review and approve a pump for diabetics.

I don't know the answer, but will be interested to hear for when my warranty runs out in 2015.

But I did just start on Medicare and am in the process of figuring it all out. My insurance is a bit different as I have calPers (California state retirement) which is an integrated system with Medicare (great insurance, but nobody seems to know how to bill it). But I did learn something that should apply to all Medicare recipients. You know how testing supplies were switched to part B in July. Well, generally insulin remains part D, except for people who use it in a pump in which case it's billed on Part B. For me that means it's free so it's a big deal. Worth checking to see what it means for my other Medicare D pals!

Zoe you are lucky. I think since you are on the pump you would fall under:

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.

Below is the rest of the guidelines FYI:

Medicare NCD Manual 280.14, Section A.5)

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.

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.

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Animas just requested I send in a c-peptide done with a concurrent fasting glucose - don't know what the 110% of lower limit of normal is; I'm pretty sure my fasting glucose will be less than 225. I don't meet the other criteria listed as "A", so it's good I already have my pump. I guess I'll be going to the doctor every three months. I thought you were asking what the criteria was, but it sounds like you already know!

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I'm sorry Zoe. I did ask, but I Googled and found it. Forgot to say that when I replied to you. Here is what My Endo told me about C-pep testing. when you go for your test get your fasting glucose as low as you can. Around 80mg should do. The reason for this is the lower your fasting is the lower you C-pep will be. My fasting was 90 and I got a .7 C-pep. I think the closer you get to .5 the better off you are. I think normal low end starts at 1. I was told I met the C-pep requirement by my insurance company, Humana Advantage Plan, Medicare, but my Endo screwed up the other information and my request for a pump was deny. That is the reason I was asking about the injection ports (I-port). Since I started on insulin a little over a year age I have an average A1C of 5.5% and my fastings are around a 100mg. I have a Dexcom G4 CGM, which allows me to see my glucose level every 5 minutes 24/7. I was wanting to add the pump to create a manual controlled artificial pancreas.

Good Luck

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I'm sorry you are not able to get a pump, Bob. It seems so unfair, that the best way of managing Type 1 is only allowed if you are doing poorly! Not to mention the method that allows for an improved quality of life which is more and more important as we age. Are you already on Medicare so it's too late for you to meet criteria B?

I actually woke up with a fasting of 65 the day I was going to get my lab work done and don't like to drive that low. But I wanted to get the lab work over with so I went anyway, and that sounds good from what you explain. My c-peptide was either .70 or .38 (two labs) when I last got it 4 years ago so I should be even lower now. I guess if I had to give up my pump I'd live with it, but I'm glad I probably will get to keep it. I hope you find a way to get one or that I-port idea works as a back-up.

If you were denied based on incorrect data you should appeal the denial. There is a process for this. Make sure the info is correct and fight for your rights. You will find that many do get the pump once they go through the second set of hoops! It can be a PITA big-time but would be worth it in the long run.

I am looking into an appeal, but I am trying to find out what specify Medicare guidelines that I didn’t meet. I know one was the diabetic educational course. A course was discussed with my Endo at my first appointment, but she didn’t believe that I needed it base on my diabetic knowledge at the time. Little did I know, but my Endo should have known that Medicare required it for a pump approval. I suspect that I will more then likely have the OmniPod people file a new request after I know I can meet Medicare’s dumb requirements for me to use a pump. Thanks for your support.

I would check with the omnipod crew, they would have a better idea than your doc on how to do the work around. Possibly a letter from you doc testifying to your level of knowledge, or possibly one visit with CDE to document your pump readiness with documentation.

You should file an appeal to get a pump if you want one. The variable basal profile alone makes the pump medically justified. You probably could fine-tune a MDI routine but I think that's harder. I now deliver most of my meal boluses as a "combination bolus," that is I deliver some insulin immediately and then follow that with a meal dose delivered over a 2-5 hour period. That is a feature harder to duplicate with MDI. This gives me very good post-meal control on my lower carb diet. The extended portion of the meal bolus is used to cover protein and fat in my meals.

There's one concern I have if you're successful in your appeal. Have you actually used an Omnipod system? I've used many insulin pumps since the middle '80s, mostly Medtronic but also two Animas pumps. Last year I tried the Omnipod for five months and could not make it work for me. I had many problems with occlusions and inconsistent insulin absorption.

I know there are many successful Omnipod pumpers but I'd hate to see you go through all the trouble of getting a pump and then discover that that pump will not work for you. My reading here and other places found that my case with the Omnipod was not an isolated incident.

It would be ideal if you could try a pump system before making a more permanent commitment. Good luck with your quest. Insulin pumps are an excellent way to administer insulin once you learn how to run them.

Good suggestion 2hobbit1 I will see if my insurance will accept a letter from my doctor or the visit with CDE.


Terry,I agree with your comments, but I like the tubeless feature that the OmniPod offers. I also understand that OmniPod has a 45 day return policy. I am sure that other insulin pumps have problems. I am just trying to make my diabetic life a little better.


Bob, you need to double check that omnipod is covered by Medicare. I know the test strips that the meter/control uses are not covered any more. Meaning you hold need to manually enter a BG from a different meter that is covered. And I seem to remember other discussions that stated the pods were not covered by Medicare due to cost.

Thanks for the update. Don't really care about the test strips coverage, I use the Dexcom G4 (CGM). I am concerned about the Pods being covered. I have ask Insulet to confirm if they are covered. In the mean time I have a box of the new I-port headed my way. I will paid for them, but if they work my belly can take a break from all the needles.



Also be aware that Medicare does not cover CGMs so you will be OOP for those as well. Not sure if you have a Medicare supplement policy but if you do you will need to check if they offer any coverage. The Medicaid plus programs usually will pay the 20% balance for what Medicare cover but if Medicare does not cover any part they will not pick up the slack. Straight Medicare with a supplement may be the way to go if you can find a plan to cover pump, supplies and insulin.
I've been looking at the same stuff since I will lose my medical when i retire. For now I'm 100% covered for any diabetic needs so will be a huge change since I'm Dex G4 and t:slimming it for now. Becoming a T1 at 60 really f@#ks with the retirement plans!!!! I can get a fully covered pump every 4years now, so will have to go at least another 8 years before I leave my current situation. Will want the most up to date tech when I go since you never know where the health system will go by then

THANK YOU so much for this info. It is a great help for me. I have been on the pump for about 10 yrs. This is the first time I have had to order supplies ( long story why…not go into it…too long LOL) Now medicare needs or wants blood tests etc. For me Just to get supples,anyway…thank you again.

:tired_face::grimacing::slight_smile: Darn medicare. Don’t they know the money can save keeping healthy. Guess making sure I guess.