Breaking News! The FDA decision on Dexcom G5 Dosing Is In!

Thanks to Bennet and our friends at DPAC for the up-to-the minute information!

from Diabetes Patient Advocacy Coalition

FDA's Advisory Committee meeting just voted to recommend approval of the expansion of the Dexcom G5 CGM label. 

The results are in and the FDA panel has voted the following for the labeling change of the Dexcom G5 Continuous Glucose Monitoring System: 

1. Is there reasonable assurance that the Dexcom G5 Continuous Glucose Monitoring System is safe for the proposed indications of use? VOTE - YES: 8 NO: 2
2. Is there reasonable assurance that the Dexcom G5 Continuous Glucose Monitoring System is effective for the proposed indications for use? VOTE - YES: 9 NO: 1
3. Do the benefits of the Dexcom G5 Continuous Glucose Monitoring System for the proposed indications of use outweigh the risks of the Dexcom G5 Continuous Glucose Monitoring System for the proposed indications for use. VOTE - YES: 8 NO: 2

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Breaking Dexcom News from the 76th Scientific Sessions

Do You Wish That You Could Be In New Orleans This Weekend For The 76th American Diabetes Association Scientific Sessions?

well, thanks to the juicebox podcast you kinda can be...

Dexcom is presenting information at the event on a number of topics and I have some of the more interesting stuff available right now for you to hear. Dexcom's Director of Clinical Projects tells us about two topics that I think hold a lot of power over how we manage our blood sugar. It's a short interview but well worth your time today.

I don't have a dixieland band but I can offer your breaking diabetes tech news as it's happening.

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10 Steps to Take After Your Insurance Denies an Insulin Pump or CGM

If you haven't already listened to D-Mom and volunteer insurance advocate Samantha Arceneaux on the Juicebox Podcast go ahead and click play on that player you see below. -- Sam is a never ending font of information on how best to appeal your insulin pump or continuous glucose monitor insurance denial and she was kind enough to write this guest post for Arden's Day. The mother to Mikayla a T1 5 year old diagnosed at 22 months old, Samantha has spent the last several years as a volunteer diabetes insurance advocate, helping other parents fight insurance companies for insulin pump and CGM coverage.

Sam is brilliant and these are her 10 steps to take when you've been denied by your evil overlords (medical insurance company). 

guest post

Steps When Being Denied by Your Insurance:

1. Did you receive a denial letter? If not, investigate to find out why. Was the supplier incorrect? Were they in-network?
2. Double check your pharmacy benefits to see if you can gain the item that way.
3. If it’s a company plan, ask your HR department if they might be able to override the denial.
4. Ask your doctor to complete a peer-to-peer review with the insurance company.
5. If still denied, ask the doctor for a letter of medical necessity.
6. Look at why they are denying, then compare against your medical records and the insurance’s medical/clinical policy or guideline. Find if they incorrectly applied their policy to your situation, or if they are using outdated data.
7. Do your research. See if there are new studies that prove your medical request is supported by professional recommendations or research studies. Aim to have 2-5 relevant studies/statements.
8. Go for the appeal. Insurances want a medical need established and why it (the item being requested) has the potential to lower their costs. It cannot be emphasized enough, what you put into it is what you can expect to get out of it.
   a) Include what the system/supply does medically in a few short sentences, don’t assume they know. It will make the rest of your arguments more effective if they understand the concept behind the device/supply.
   b) A modicum of formality can be helpful as well, as the insurance will be unsure of who actually wrote it; was this the patient, an advocate, an attorney, a doctor? It may imply to the insurance reviewer that you are not going away easily.
   c) Fight against any outdated research the insurance uses in their medical policy, or if they failed to gather/review your medical data that supports your need for the device/supply.
   d) Quotes from the research studies or statements are helpful, since they will not be looking up the studies themselves. Paraphrasing is also encouraged. Just remember to cite the study/professional organization each time.
   e) Give real life examples on how this device/product can help you (refrain from convenience examples). For instance, do not talk about how a CGM can be remotely viewed and how this saves the hassle of checking in with your child. Rather, talk about how the device alerts you to rapidly changing glucose values so that you can take steps to prevent a crisis from 
9. So you win the appeal and get approval. I strongly advise getting it in writing before you order the supply/device. This will be your evidence in the event something isn’t properly posted in their system, such as length of approval (should be for 1 year). 
10. If you do not overturn the denial on appeal, try again. Typically you will have two internal reviews that are done by the insurance companies before going on to the external review. The external review is completed by independent reviewers and tends to be more impartial, which means a higher chance of getting approved. (Medicaid/Medicare products may have more levels of appeal available).

Other useful information:

For non-covered items: You will need to request a formulary exception. This means that you recognize that it isn’t a covered product but still feel that it is medically necessary and should be covered by your insurance. Treat this as an appeal situation. 

For non-preferred items: If a drug or supply is non-preferred, you will ask for a tier exception. This is basically where you give the insurance company a medical reason why you cannot utilize the preferred item and ask that they give you the non-preferred item AT the preferred rate. This typically is a pharmacy situation. 

Visit Sam's blog to read her other detailed information regarding insurance denials. Sam rocks! 

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Do Germs Trigger Type 1 Diabetes?

I always have this nagging feeling that I forgot to wash my hands or something when Arden was a baby. I know how ridicules it is to wonder but it's difficult at times not to think, "what if I could have done something differently...". Anyway, I thought this was an interesting article that you may like to see. Excerpts below with links to the entire research article if you're interested in reading more. 

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from ScienceDaily.com

Germs could play a role in the development of type 1 diabetes by triggering the body's immune system to destroy the cells that produce insulin, new research suggests.

“Killer T-cells sense their environment using cell surface receptors that act like highly sensitive fingertips, scanning for germs.

”However, sometimes these sensors recognise the wrong target, and the killer T-cells attack our own tissue. We, and others, have shown this is what happens during type 1 diabetes when killer T-cells target and destroy beta cells.”

— Cardiff University's Dr David Cole

Scientists have previously shown that killer T-cells, a type of white blood cell that normally protects us from germs, play a major part in type 1 diabetes by destroying insulin producing cells, known as beta cells.

Now, using Diamond Light Source, the UK's synchrotron science facility to shine intense super powerful X-rays into samples, a team from Cardiff University's Systems Immunity Research Institute found the same killer T-cells that cause type 1 diabetes are strongly activated by some bacteria.

The team hope this research will lead to new ways to diagnose, prevent or even halt type 1 diabetes.

You can read the entire article on Science Daily here.

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Shame on United Health Care and Medtronic

United Health Care has announced that on July 1, 2016 Medtronic will "become the preferred, in-network durable medical equipment (DME) provider of insulin pumps for UnitedHealthcare Community Plan and Commercial members".

Below is text taken from UnitedHealthCareOnline.com. I want to encourage you to share your story in the comments below about why your pump choice matters and then share one of the below images on your social media channels while tagging Medtronic and United Health Care. Greed can not be a driving factor in how you manage your type 1 diabetes. 

FIGHT BACK!

from United Health Care: "As part of our ongoing efforts to provide a better member experience, while increasing quality and lowering the overall cost of diabetes care in the United States, UnitedHealthcare has reached an agreement with Medtronic to become the preferred, in-network durable medical equipment (DME) provider of insulin pumps for UnitedHealthcare Community Plan and Commercial members, effective July 1, 2016. Medtronic is a global healthcare solutions company committed to improving the lives of people through its medical technologies, services, and solutions and has been a leader in diabetes care for more than 30 years.

The preferred relationship excludes UnitedHealthcare Sierra Health and Life Commercial members as well as all UnitedHealthcare Medicare Advantage members.

Our goal is to provide the opportunity for a better care experience by providing our members with access to advanced diabetes technology and comprehensive support services while learning how advanced technology can be applied to improve outcomes and reduce costs. We also aspire to nd new ways to analyze the total cost of care

for diabetes management, bring a value-based approach to diabetes care for UnitedHealthcare members and place greater focus on quality rather than the volume of care delivered.

As part of this agreement, UnitedHealthcare members with diabetes who meet the UnitedHealthcare medical policy criteria will be provided access to multiple models of Medtronic’s insulin pumps, including the MiniMed® 530G pump. The MiniMed 530G system includes safety features that pause insulin delivery when sensor glucose levels fall below a preset limit, helping the patient recover at a quicker rate.

Please note: UnitedHealthcare will continue to cover insulin pump supplies for all brands of insulin pumps that our members currently use while their insulin pumps are in- warranty and are still functioning properly. They do not need to make any immediate change to their pump and will not transition to a MiniMed pump until their pump is both out of warranty and not functioning properly.

What this means for you:

• There has been no change within our medical policy for coverage of insulin pumps; this only applies to the type of device prescribed.

• When UnitedHealthcare members need to obtain their prescribed pump, they can call Medtronic at 800-646-4633 or visit www.medtronicdiabetes.com/ preferred.

• UnitedHealthcare members who are 18 years old and younger may remain on their current insulin pump and are not required to use a MiniMed pump.

• If one of your patients is a UnitedHealthcare Sierra Health and Life Commercial member or a Medicare Advantage member, the preferred relationship does not apply. However, you may still prescribe them to a MiniMed insulin pump as you see t.

We thank you for all that you do as we strive to provide the best possible outcomes for our members with diabetes.

If you have questions, please call the number on the back of your patient’s member ID card. Thank you."

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Medtronic is @MDT_Diabetes on Twitter. United is @myUHC.... Let them hear your voice!