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ADVOCATE: n. [ad-vuh-kit, -keyt]: a person who speaks or writes in support or defense of a person, cause, etc.

It’s really not very hard … and it’s really important. After all, who’s more important to your own life than you? It is survival.

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21th Annual Shooting Stars JDRF Walk to Cure Diabetes Sunday, October 23, 2016 in Newport Beach, CA at The Waffle House

For a contribution of $50 (or MORE!), walkers will receive a VERY COOL Shooting Stars Team T-Shirt while supplies last. Contact Joanne if you are interested in attending the event. joanne@TheSavvyDiabetic.com. To donate on-line, please go to: http://tinyurl.com/z5c2x8e.

Medicare and CGM: New Potential Issues?

Debra Parrish is an attorney who has been working with T1 appeals on Medicare denials of CGM coverage.  Her email about Medicare coverage with the first one I received in January.  But today, she put out a caution that there still may be obstacles. 

Parrish Law Offices: Durable Medical Equipment Update – CMG

March 2017 Issue

Medicare’s Coverage of CGM Still Raises Issues

In January 2017, CMS issued Ruling 1682-R indicating that continuous glucose monitors (“CGM”) that are FDA-approved to replace finger sticks, “therapeutic CGM,” are eligible for Medicare coverage.  Although the Medicare contractors have not revised the article that states Medicare considers all CGM to be “precautionary,” on March 23, 2017, the Medicare contractors issued another article stating “therapeutic CGM” will be covered.   The Medicare contractors have indicated that they will revise the existing local coverage determination and policy article and make them retroactive until January 12, 2017, the date CMS issued Ruling 1682-R which found that the Dexcom G5 satisfied the statutory definition of durable medical equipment and thus could be covered by Medicare.  The new article indicates that other than the Dexcom G5, Medicare will not cover CGM.

Articles are supposed to convey only coding and billing information, but the new article also lays out coverage criteria for the Dexcom G5:  (1) the beneficiary has diabetes;  (2) the beneficiary has been using finger stick testing at least four times a day;  (3) the beneficiary is insulin-treated;  and (4) the beneficiary’s insulin treatment requires frequent adjustment.   

Unfortunately, the article indicates more hurdles for Medicare beneficiaries. 

First, all the claims associated with a “therapeutic CGM,” i.e., Dexcom G5, must billed using miscellaneous codes – E1399 and A9999.  Typically items billed under a miscellaneous code initially are denied by Medicare and […]

Savvy LOOPing: their language!

I am far from even being semi-technical but I can, very slowly following instructions and ask questions kindly, always saying please and thank you. 

But I just saw an exchange on a site about figuring out how to break the codes on other pumps:
This week, there’s been some discussion on the Slack channel about how to get a bit deeper into the radio packets involved in the communication protocol. I’m semi-technically literate, but no where near the group of folks that are actively banging away on this problem, so I asked for an explanation of the current problem. Dan was kind enough to reply: 
Think of the radio packet like an onion. it has several “layers.” the network layer is the outermost layer. we understand all of those fields. inside that layer is the data layer, which we understand many of the commands and fields. but there are a few bits of data that are used to verify the integrity of the command. think of this like a wax seal from the middle ages, used to verify the integrity of a letter from a king. we need to be able to re-create that wax seal, (the verification bytes) in order to reliably craft packets of data which the pod will accept.  
There is an algorithm, which we think is a CRC style algorithm, that is used to generate that wax seal. I believe it’s a 16-bit CRC. Pete has pointed out that there is some “bit-masking” going on, which makes it hard to crack.
Got it?!  Me neither, only a bit.  HOWEVER, I am EXTREMELY grateful for these passionate, dedicated programmers/hackers for good to help the D community.  I don’t know most of them but I love them […]

Savvy Updates 3.27.2017: Immune Response, 2 Types of Beta Cells, Wearable CGMs, Health Apps, Twins

children and twins concept – two identical twin girls in red dresses looking somewhere

As always, lots of news in the T1d community.  Here goes!

Preventing the Immune Response to Implanted Diabetes Devices was reported by Jessica Apple on ASweetLife.org last week. 
JDRF announced a report of one of the first studies to deeply examine the fundamentals of how the immune system interacts with implantable biomaterials. The study was conducted by researchers at MIT and Boston Children’s Hospital and was reported in the journal Nature Materials.
According to JDRF’s press release, tens of millions of people in the United States are living with implanted biomedical devices or devices that penetrate the skin. “By understanding how to target and prevent unnecessary immune responses to the materials used in medical devices, we can provide therapies that work more effectively and with fewer negative side effects,” said Aaron Kowalski, Ph.D., JDRF Chief Mission Officer. The new report, “Colony stimulating factor-1 receptor is a central component of the foreign body response to biomaterial implants in rodents and non-human primates,” could influence the future ability to prevent immune rejection of devices that treat type 1 diabetes.
Read more:
Preventing the Immune Response to Implanted Diabetes Devices
New Research Identifies Novel Target for Controlling Immune Response to Implanted Materials
Colony stimulating factor-1 receptor is a central component of the foreign body response to biomaterial implants in rodents and non-human primates
 
There are Two Types of Beta Cells and One Resists Immune System Attacks, according to a new study published in Cell Metabolism, 7 March 2017, which details a subpopulation of insulin-making beta cells that can resist immune system attacks while type 1 diabetes is developing.
In type 1 diabetes, the immune system attacks the insulin producing beta cells, which over time […]

Medicare Criteria is PUBLISHED!

 It’s finally here!!!  Type 1 and Type 2 diabetes patients covered by Medicare who are on intensive insulin therapy may now get reimbursed for their Dexcom G5 CGM!

Dexcom’s G5 Mobile system is the only CGM classified as “therapeutic.” A therapeutic CGM is used to inform treatment decisions. Most CGMs are FDA-approved as adjunctive devices, meaning the information they provide is to be used alongside data from other devices, such as blood glucose monitors.

The CMS criteria are that the patient must

have diabetes
use a home blood glucose monitor to test for glucose levels frequently
be treated with multiple daily injections of insulin or with an insulin pump, and
need to frequently adjust his or her insulin therapy based on data from a therapeutic CGM

“This is a new era and a huge win for people with diabetes on Medicare who can benefit from therapeutic CGM,” said Dexcom CEO Kevin Sayer in a statement. “This decision supports the emerging consensus that CGM is the standard of care for any patient on intensive insulin therapy, regardless of age.”

This is CAUSE FOR CELEBRATION!!!

Read more: Medicare unveils coverage criteria for Dexcom G5 continuous glucose monitor

Afrezza, the Amazing Inhalable Insulin

 

I’ve been using Afrezza intermittently for the past 2 years … and am continually amazed at how well and how fast it works! 

What is Afrezza?  Developed by Al Mann (who also developed the insulin pump and the cochlear hearing implat, among many other great advances – see a tribute to him in my blog archives), Afrezza is the only inhalable insulin available on the market today. 

Afrezza is dried human insulin produced in a lab from recombinant DNA. The powder is placed into carrier particles (called Technosphere particles) that are so small that once inhaled they can reach your deep lungs, which have the surface area of about half the size of a tennis court.

Just take a moment and visualize one side of a tennis court … that’s the amount of surface that is reached when you inhale Afrezza into your lungs. 

It comes in 4-unit, 8-unit and 12-unit cartridges, which equate, roughly, to 2.5U, 5U and 7.5U of liquid fast-acting insulin. 

 

 

But there are very distinct advantages:

Enhanced absorption: this is due to the very large, accessible surface area within the alveoli of the lungs
Rapid onset of action: Since the lung tissue consists of a large alveoli-capillary network, protein molecules such as insulin cross a thin barrier formed by the alveolar wall and the capillary wall, allowing for rapid delivery into the bloodstream.  Indeed it starts working within 10 minutes of inhaling and is mostly out of your system within 2 hours (as opposed to injectable insulin with an onset of 1/2 hour and duration up to 4 hours)
Absence of digestive enzymes that can inactivate insulin

 

 

On the downside:

About 1/4 of patients using Afrezza have reported a cough
Some decline in pulmonary function

My take on using Afrezza:

I think Afrezza […]

Savvy LOOPing: Running Open Loop

Here’s my LOOPing update.  I’ve been running the RileyLink for about 8 weeks.  I started running it OPEN, which means that it is ON but not making and implementing decisions with my insulin pump, based on the algorithm and CGM and carb inputs.  After about 2 weeks, I CLOSED THE LOOP!  Just overnight!  It was exciting.  NOTHING BAD HAPPENED!  In fact, my blood sugars seemed to run flat all night, between 100 and 140.  A miracle.  The next few nights were more bouncy but still good.  I never had a low while running the OPEN loop. 

About 3 weeks ago, I decided that I needed to tweak my pump settings, which haven’t been re-evaluated since I started pumping over 14 years ago.  And I think I may have entered some wrong settings when I was setting up basals on a new pump (I mean, really, how can my I:C ratio exactly equal my Insulin Sensitivity?!?!).  So I’ve been basal and ratio testing.  After all, GIGO (garbage in, garbage out) … I need to be sure the LOOP has as accurate settings as possible. 

I expect to CLOSE the loop soon … just running it CLOSED sometimes through the night. 

My take on using the CLOSED loop so far:

It’s safe!
It’s interesting to see how many corrections it makes throughout a 24 hour period
Seeing my data on Nightscout is a WEALTH of information.  THANK YOU, Nightscout folks for all the hard work you’ve given to make our lives better, using our own data!  #WeAreNotWaiting.

More to come on how to test your settings. 

Medicare, CGM and Liberty Medical: How to Work with Liberty

Let me start by saying that I am tempering my frustration with Liberty Medical.  It has been a rocky road dealing with them.  And they only get a one star rating on Yelp.  This doesn’t bode well.  But …

Liberty Medical is the ONLY way to buy Dexcom cgm supplies if you have Medicare coverage, at this time.  THE ONLY ONE!  And they are based in Florida, with only local EST time zone hours.  You’d think they might consider at least extending their hours to cover the US business hours … but no, not yet.

 

Given that we must get along, here’s what I’ve learned:

Liberty and Dexcom were caught by surprise by the sudden Medicare decision, and were totally unprepared for the “onslaught” of the demand.  Liberty was apparently considered the only medical supply company that could handle the volume of orders.  As a result, they’ve had to add staff and train them. 
According to Tim Jones, senior patient rep, about 80% of the staff are truly able to answer our questions.  Strange, huh?!  Why not give them an answer sheet AND POST THE ANSWER SHEET ON THEIR WEBSITE?!  Not yet.
They’ve reduced the on-hold time to under 30 minutes to reach a rep.
However, if you did get put on hold for longer than 10 minutes, you can call Dexcom directly, who will then patch you in to the Liberty direct line and get answers right away.
The Medicare billing codes were published on March 13, 2017, allowing Liberty to take your order and bill Medicare. You do NOT have to pay upfront and hope that Medicare will reimburse you.  However you must sign an ABN form that allows them to bill Medicare and, if Medicare does not determine […]

Savvy Top 15: Here are the Top 15 Pharma Companies of 2016

I just found this really interesting.  As published in FiercePharma.com, 14 March 2017, here’s the list of the top 15 pharma companies by 2016 revenue … and these are some BIG revenues! Don’t see Novo Nordisk in there.

 

 

1. Johnson & Johnson (who own Animas and One Touch in the Diabetes Care unit, whose revenue drops 7.2% to $1.8 billon)
2. Pfizer (Lyrica for neuropathy)
3. Roche (who recently dropped out of the insulin pump market)
4. Novartis
5. Merck & Co. (Januvia)
6. Sanofi (Lantus)
7. GlaxoSmithKline
8. Gilead Sciences
9. AbbVie
10. Bayer
11. AstraZeneca (Farxiga)
12. Amgen
13. Teva
14. Eli Lilly (Humalog, Trulicity and Jardiance)
15. Bristol-Myers Squibb

Savvy Humor: Mankoff’s “Not Covered”

Just a little “giggle” from Bob Mankoff, the cartoon editor of The New Yorker for the past 20 years.  He is stepping down from that post but certainly not retired! Thanks Mr. Mankoff for all your humor!

Savvy Updates 3.12.17: Alexa, Live Stem Cell Imaging, New Cause of T1

Wow, some really neat stuff in the news!
Merck aims to put Amazon’s Alexa to work on voice-enabled diabetes tools, according to a post on FiercePharma.com by Beth Snyder Bulik, 8 March 2017 … thanks to Mike Hoskins for the heads up.
Using Amazon Lex, the brains behind the Amazon Echo device and its well-known voice-enabled assistant Alexa, Merck & Co, in a new partnership with Amazon Web Services, plans to initially work on diabetes. Its first initiative will be a call to entrepreneurs, techies and industry types for an innovation challenge expected to begin within the next month.
The yet-to-be-named challenge will be run by strategy and innovation consultancy Luminary Labs. While specifics haven’t been released, the call to action will “be open to solutions broadly enough that innovators of all stripes can come up with really novel ideas but being narrow enough to provide guidance and carefully evaluate submissions,” said Sara Holoubek, founder and CEO of Luminary Labs.
Read more: Merck aims to put Amazon’s Alexa to work on voice-enabled diabetes tools
 

Live stem cell imaging technique opens new windows into pancreatic regeneration, as posted on www.diabetes.co.uk, by Camille Bienvenu, 3 March 2017. 
Richard Tan, a PhD student from the Heart Research Institute, in Sydney, Australia, has developed so called “bioluminescent” (that emit a light signal in order to track their fate in real time once injected into the body) stem cells as a non-invasive way to give scientists immediate feedback on whether organ tissue regeneration is actually working.
In type 1 diabetes, stem cell-based therapies hold promise to regenerate cells of the pancreas. The goal is to have the stem cells transform into insulin-producing cells.
Read more: Live stem cell imaging technique opens new windows into pancreatic regeneration
Stem cells are […]