Denied pump--numbers are TOO GOOD? ARE YOU KIDDING ME?

Okay, I will warn you, while I am posting this looking for advice, I am still in complete and utter shock, and to be quite honest, @#$$#& OFF at the news I was given today, so this may sound like more of a RANT than anything. I was diagnosed in February with type 1, with an a1c of 12.3. I was completely devastated by the diagnosis, but the one thing that REALLY had me hanging on was the goal of getting my numbers in line and getting a pump ASAP. I’ve had a dexcom for a couple of months now and LOVE it. I really believe that has helped me take control of my numbers. I got my Endo on board with me getting a pump a couple weeks ago now, and had started the process with Tandem (I REALLY wanted the t:slim that is integrated with the G4 dex). So, I work for a hospital in North Dakota, and we have BCBSND, but it’s an employee cost sharing plan, so if something needs to have prior authorization, they (the hospital) have to do that themselves. I had been in contact with Managed Care for the hospital trying to speed the process up, and they had told me this would have to be approved by the Medical Director of Care (who is a family practice physician who works at this hospital), because in the BCBSND Corporate Medical Policy, one of the requirements is that I have been doing MDI for 6 months, and demonstrate “motivation to achieve and maintain improved glycemic control”, blah blah blah. Well, I had assumed they would be able to see my motivation in my numbers, and maybe cut me a break on the whole six month rule, since I did CUT MY A1C DARN NEAR IN HALF IN LIKE TWO MONTHS!! (Went from a 12.3 to a 6.8). Well, I got a call from Managed Care today, and was informed that the Medical Director denied my request because my numbers are TOO GOOD??? REALLY??? I can appeal it of course, and the new request will go to a different person, but who knows if that will even work! I was basically told I don’t meet ANY of the qualifications, so where do I even begin? I now need to get my Endo to write a letter, with very specific reasons on WHY I don’t agree with their decision. SERIOUSLY?? Has this ever happened to anyone before??? I mean, I had heard of people getting denied because of high numbers, but to get denied for having too much control??? I can’t even begin to explain how discouraged, upset, hurt, and SHOCKED I am. Now I am wondering if I even want to continue working for this place! I understand this is BCBSND “Corporate Medical Policy”, but this physician “Medical Director” has the authority to make an exception, but WON’T! I was so mad and upset and in tears, so I decided to leave work early. I am so sick to my stomach about what they told me. I just need some advice and encouragement right now :disappointed:

If anyone is curious, this is taken directly from the BCBSND Medical Policy on Insulin Pumps


Corporate Medical Policy

Insulin Pump and Continuous Glucose Monitoring Devices

#1.01.20.1

Effective Date: December 1, 2015

Reviewed: November 17, 2015

Revised: November 17, 2015

Note: This policy deals with insulin pumps and stand-alone CGM devices only, not insulin pumps with built-in CGM and low glucose suspend features (aka “artificial pancreas”). For Insulin pumps with built-in CGM and low-glucose suspend features see related BCBSND Corporate Medical Policy Artificial Pancreas Device Systems.

Description
The portable infusion pump (PIP) is a device intended to provide ambulatory continuous drug infusion therapy over an extended time period. The PIP is also known as an external pump, ambulatory pump, or a mini-infuser. The PIP is usually of small size and can be worn on a belt around the patient’s waist or on a shoulder harness. The PIP is much smaller than conventional infusion pumps used in institutional settings. Optimal delivery of insulin is possible with Continuous Subcutaneous Insulin Infusion (CSII).

Continuous glucose monitoring (CGM) systems are minimally invasive or noninvasive devices that measure glucose levels in interstitial fluid at frequent intervals over a period of several days. Unlike the traditional blood glucose monitors that measure glucose levels at a single point in time, CGMS can automatically record interstitial glucose measurements every 5 to 20 minutes, producing data that shows the trends in glucose control.

CGM systems are FDA approved as an adjunct to traditional self-monitoring of blood glucose levels and not intended to replace blood glucose measurements obtained using fingerstick blood samples. Self-monitoring of blood glucose levels remains essential with insulin pump and CGM system use.

Several CGM devices have received U.S. Food and Drug Administration (FDA) approval. The first 2 approved devices were the Continuous Glucose Monitoring System (CGMS®) (MiniMed), which uses an implanted temporary sensor in the subcutaneous tissues, and the GlucoWatch G2® Biographer, an external device worn like a wristwatch that measures glucose in interstitial fluid extracted through the skin with an electric current (referred to as reverse iontophoresis).

Additional devices that have subsequently been approved include those for pediatric use and those with more advanced software, more frequent measurements of glucose levels, more sophisticated alarm systems, etc. Devices initially measured interstitial glucose every 5 to 10 minutes and, with currently available devices the time intervals at which interstitial glucose is measured ranges from every 1 to 2 minutes to 5 minutes. While CGMs potentially eliminate or decrease the number of required daily fingersticks, it should be noted that, according to the FDA labeling, monitors are not intended to be an alternative to traditional self-monitoring of blood glucose levels but rather provide adjunct monitoring, supplying additional information on glucose trends that are not available from self-monitoring. In addition, it is important to note that devices may be used intermittently, eg, time periods of 72 hours, or on a long-term basis.

In addition to stand-alone CGMs, several insulin pump systems have included a built-in CGM. This policy addresses stand-alone continuous glucose monitoring devices, not the insulin pump portion of these systems and not combined insulin pump/CGM with low glucose suspend systems. Regulatory Status

Several continuous glucose monitoring systems have been approved by FDA through the premarket approval process:

The Continuous Glucose Monitoring System (CGMS®) (MiniMed) in 1999 (approved for 3-day use in a physician’s office).
The Guardian®-RT (Real-Time) CGMS (Medtronic, MiniMed) in July 2005. (MiniMed was purchased by Medtronic).
The DexCom® STS CGMS system (DexCom) was approved by FDA in March 2006.
The Paradigm® REAL-Time System (Medtronic, MiniMed) was approved by FDA in 2006. This system integrates a CGM with a Paradigm insulin pump. The second generation integrated system is called the MiniMed Paradigm Revel System.
The FreeStyle Navigator® CGM System (Abbott) was approved in March 2008.
The OmniPod® Insulin Management System (Insulet Corporation), integrating the Freestyle Navigator CGM system with the Pod insulin pump, was approved in December 2011.
The DexCom G4 Platinum (DexCom) CGM was approved for use in adults 18 years and older in October 2012. The device can be worn for up to 7 days. In February 2014, FDA expanded use of the Dexcom Platinum CGM to include patients with diabetes, age 2 to 17 years-old.

Policy/Criteria
Insulin Pump

Written prior approval is required for initial system or replacement/upgrade of the system. Prior approval is not required for supplies once initial approval is granted. Prior approval is not required for FEP.

Use of an FDA-approved insulin pump (HCPCS E0784) may be considered medically necessary in patients who meet ALL of the following criteria as demonstrated in the submitted clinical documentation:

  1.  The patient has diabetes mellitus Type 1 or Type 2 requiring insulin; AND:
    

a. The patient has been recommended as appropriate for an insulin pump by a Certified Diabetes Educator and the member’s health care provider, after having completed a comprehensive diabetes education program (documentation from the CDE is required); AND
b. The patient has demonstrated ability to self-monitor glucose levels (average of > 4 times per day for the last 3 months); AND
Patient has demonstrated motivation to achieve and maintain improved glycemic control by following a program of multiple daily injections of insulin and frequent self-adjustments of insulin doses for the past 6 months; AND
d. The patient has two or more of the following:
· Glycosylated hemoglobin (HbA1C) levels >7 %.
· History of severe glycemic excursions (commonly associated with brittle diabetes, hypoglycemic unawareness, nocturnal hypoglycemia, extreme insulin sensitivity and/or very low insulin requirements.
· Wide fluctuations in blood glucose before mealtime (e.g., preprandial blood glucose level commonly exceeds 140 mg./dL).
· Dawn phenomenon where fasting blood glucose level often exceeds 200 mg/dL.
· Day-to-day variations in work schedule, mealtimes and /or activity level, which confound the degree of regimentation required to self-manage glycemia with multiple insulin injections; OR

  1.  The patient has diabetes mellitus Type 1 or Type 2 requiring insulin; AND:
    

a. Preconception or pregnancy with a history of suboptimal glycemic control; OR
Suboptimal glycemic and metabolic control post-renal transplant.

Use of an insulin pump (HCPS E0784) may be considered medically necessary for infants and toddlers who meet the following criteria:

  1.  The patient has diabetes mellitus Type 1; AND
    
  2.  The patient’s insulin requirements are so small that standard multi-dose subcutaneous injections of insulin are impractical. That is, the doses are so small that they cannot be accurately delivered by standard multi-dose subcutaneous injections, and this places the patient at risk. NOTE: The attending physician must explicitly document and substantiate this in the clinical records.
    

Use of an insulin pump is considered not medically necessary in all other situations.

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I’m sorry to hear you’re experiencing this. As if, diabetes isn’t enough in and of itself, we have to deal with crap like this. The only thing I can think is that he is someone who strictly follows the rules and the 6 month criteria may be the sticking point and possibly the >7% A1C criteria (how STUPID is that?). The stress over this denial is going to increase your bs anyway!

Unfortunately, I don’t have any advice other than I think you should appeal the decision. The next person may be more lenient on the criteria.

My biggest fear is being denied a pump when it comes time for one. :cry:

Keep your chin up. You’ll get this pump approved, I know it!

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I’d be tempted to leave a little glucose residue on my finger or inner arm just before the tech obtains a blood sample for your A1c. Voila! A1c greater than 7%! :wink:

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I’d be tempted to get a good lawyer with a well-known reputation and go nuclear. But that’s just me. I used to be more patient with stupid, potentially life-shortening malfeasance but I’m getting crankier as I age.

Pour l’encourager les autres

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Your rage is justified. [quote=“jtenneson, post:2, topic:53780”]
The patient has two or more of the following:
[/quote]
One question–do you have hypoglycemic unawareness? I may tout that–as well as the Day-to-day variations in work schedule as conditions for needing the pump.

Unfortunately, working the system will get you faster results than beating the system… :frowning:

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1 - Appeal
2 - Take the criteria you provided and demonstrate that where you don’t meet a particular one, you are very close to it. (For example, an A1C of 6.8% is quite close to 7.0%).

I would also take particular note of the items in 1. d. like wide fluctuations in BG, Dawn Phenomenon (if any, for you), variable work schedule. IOW, the more you can show “brittleness” the more likely that you can get approval.

I guess the bottom line, is try to show that you do actually fit into the box they have constructed, or are at least close enough on many of the criteria to allow exception based on the “where there’s smoke, there’s fire” concept.

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Hi,

Same sort of policy here in the UK, you need to prove you are struggling with control on MDI to be funded for a pump.

Seems pretty clear from the document, insulin pumps are not deemed a medical necessity unless you meet the criteria, you don’t as you’re achieving good control via MDI. They are costly pieces of kit. A nice to have, but not an essential.

I don’t feel that it’s particularly ethical, but you can of course manipulate your diabetes easily and provide evidence to meet the criteria. Getting a HbA1c from a 6.8 to a >7.0 may take little more than a retest.

Pumps are not a universal panacea for perfect diabetes control and come with their own issues, I’ve given serious consideration to going back on MDI after 5 years on the pump, due to kinked cannualas, resultant ketones and the other inconveniences pumping can bring.

I find the CGM the most useful piece of diabetes technology.

I’d focus on the positives, you have access to insulin and you halved your HbA1c.

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Appeal. Goes to show a medically trained non-T1 doesn’t know jack and shouldn’t be in charge of this decision.

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Thanks for the replies everyone. I asked my Endo to help me appeal, but unfortunately he feels it is pointless, and should basically just suck it up and wait the 6 months and maybe by then my numbers will be harder to control. I feel like I’m being punished for taking good care of myself!

I would appeal in any event, if only to get them to come back and specifically detail why they are denying you. Put another way, if it’s only the 6 month issue, then you know you will have only that to deal with - and if you were diagnosed in February, that’s only 3 months away.

I would also take the time to write up your appeal, so you can see on paper the strengths/weaknesses of your appeal vs. their policy.

Now, taking the other side for a moment, because you are a recently diagnosed D, there may be issues that haven’t really shown up yet, like Dawn (aka Darn) Phenomenon, plus you might still be honeymooning, so your dosing might have drastic changes ahead of you, plus, this is a PITA disease that has something different for you every day. For many, it can be hard to maintain the “commitment” BCBSND might desire. (NOTE: My opinion, is that a pump should have equal if not preferred position to MDI for newly diagnosed D-peeps. Armed with my opinion and 5 bucks, you can get a drink @ Starbucks, or a drink and change @ Dunkin’)

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I’m wholly supportive of people with diabetes gaining access to all the tools they need. I think it is unfair and short-sighted for your medical plan to deny you a pump at this time. That being said, I’m wondering if placing your time, attention, and energy into fighting to get a pump might better be placed elsewhere.

First of all, two of the most costly treatment items for diabetes are insulin pumps and CGMs. If you were to conduct a poll of people asking if they had to choose one or the other technology, most people would rather retain their CGM and give up their pump, me included. A CGM not only gives you a great way to monitor your blood glucose, in addition you can learn a lot about how your individual body works as you combine food, insulin, exercise and other factors to yield a certain blood glucose level. The CGM is a stellar teaching tool.

An insulin pump does many things well but it is only as good as the person giving it commands. In order to exploit it well you need to learn a lot about how your blood glucose metabolism works as well as the many pump tactics that can be used.

What I’m trying to say is that perhaps you can spend the next few months learning more about insulin and diabetes. There are many good books written about this. Think Like a Pancreas by Scheiner and Using Insulin by Walsh are two good ones.

I wish you luck if you pursue your appeal. I just don’t think you should conclude that getting a pump automatically leads to better outcomes. It’s the knowledge, curiosity, and attitude of the pump operator that drive the best outcomes. Good luck!

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It seems to me (seems being the operative word) as though insurance companies routinely deny paying for things as a way to save / make money. Appealing is usually a simple letter; not a lot of work at all. Yes, it’s annoying, and that’s what they rely on - that nn% of their people will not bother because of that. This is why I routinely appeal all denials. You might be pleasantly surprised to discover that the next tier up grants your CGM simply because you mailed in a letter, demonstrating your willingness to follow through.

Good luck!

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I have to provide some contrary opinion here and I realize I might get some pushback. Being diagnosed in February it has only been 3 months. Not even enough time to actually get a stable A1c reading (remember A1c is an average over three months). It takes time and effort to learn how to do intensive insulin management. It is not trivial. You need to learn to test often and at the right times. You need to carb count and become pretty good at it. You need to learn all the ins and outs of mealtime boluses and correction boluses. You need to learn to take action based on your test results. And it can literally take months to work out all the finer points of establish a stable and effective insulin regime, and that is just with MDI.

And many insurance companies require you to essentially “get a drivers” license. That you have been given appropriate diabetes education. That you demonstrate some extensive time properly testing and managing your diabetes with a basic MDI regime. A pump can be wonderful, it allows you lots of ways to fine tune your control. But it is not a panacea. Insulin pumps with CGMS can be effective and have been shown to decrease A1C levels from 8.3% to 7.5% over 12 months, with further reduction to 7.4% after another 6 months. But these were often veterans (between age 1 and 70), having uncontrolled diabetes. In your case you may well get a much more modest improvement, maybe less than 0.5%, particularly if you don’t have your license.

And I have to tell you, there is some real adverse events that can happen with a pump that are not a concern with MDI. When a site fails you can run dry and go into DKA in just a few short hours.

Eventually you should be able to work with your doctor to get a pump and a CGM by having your doctor plead you case for medical necessity. But I would encourage you to also understand that we don’t have an inherent right to “whatever expensive treatment exists.” We exist in a society burdened by terribly high health care costs and resources are distributed in some way to those who need them. If I get ever a pump and CGM, I realize that I am probably taking a pump and CGM away from someone else who may need it far more than me. And if I do get one, I want to make sure that I use it properly, safely and effectively.

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@Brian_BSC That makes some sense. Although a pump is not a panacea–there are other benefits to having a pump other than reducing A1C. Quality of life. The ability to remotely bolus, for example, is extremely beneficial in many situations. As for the cost–I have a different perspective. As opposed to super expensive pharmaceuticals that are patently protected for long periods of time–pumps are electronic devices that will rapidly decrease in price over time like any other electronic device. The sheer demand and competition of different pump manufacturers ensures it. I know when it comes down to it–it’s just a matter of $$$ to the insurance companies.

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I think that, given that you have a list of criteria and a timeframe, you need to make sure that you meet those requirements before you can get upset with a denial. At the moment, it seems like you don’t meet any of their requirements as you have tight control, have only had diabetes for three months, and (it seems) do not have the full support for needing a pump from your endocrinologist.

A pump is great, but a pump is not easier or better than MDI, just a different way of delivering insulin that can make solving some very specific problems easier. With a pump, though, instead of having those specific problems (like dawn phenomenon) you’ll have other problems instead (like infusion sites that don’t work). If it were me, I’d wait another three months (or more) and then at that time reevaluate if you meet the criteria that they’ve listed and have the full support of your endocrinologist.

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Actually we have not seen pump devices come down in price. Like the computer industry, companies chose to improve the performance of their products and keep the prices up. If we had truly seen the impact of semiconductor advances then desktop computer would cost a penny. That is how companies continue to achieve revenue growth. If insulin pump companies had routed advancements towards cost reduction then we would have $10 pumps, but that would have killed their revenue and profit streams.

Computing power has significantly come down in price over time. When companies offer less expensive pumps–insurance companies elect to switch coverage to that company as their preferred brand. This is seen even recently–as United Healthcare has recently changed it’s preferred pump to Medtronic. Simply cheaper. What is great is that all of the competition will force innovation and less expensive products.

I am just saying the price point of pumps has not dropped. Here is an article from 2002 which quotes an initial insulin pump as costing $5,000 to $6,000. And here is an examination of pump costs by @Christel in 2014, twelve years later. Each of the pumps cost still cost basically $5,000 - $6,000. Yes there is inflation, but we don’t have a $10 pump.

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Great job on handling your diagnosis and bringing down your A1C so much! Here’s the thing…to play devil’s advocate. You’ve probably heard the term “honeymoon period” (not sure why they call it that because it’s no honeymoon) during the first several months up to a year or more after diagnosis where you may still have some functioning beta cells that have not died off yet. So it’s usually not recommended to look at a getting a pump until at least a year following diagnosis, because things can still be too erratic. Now the bit about your numbers being too good doesn’t really make any sense, but I’d probably agree that it’s best to wait until next winter to start the pump, because it’s crazy complicated and takes several weeks to get stabilized even in the most stable of situations.