Q: How do you fit millions of people with diabetes into a room that seats 120?
A: Send 10 Patient Voices winners to the Diabetes Mine Innovation Summit.
On November 15th, an eclectic group of people converged on the Stanford School of Medicine for what has proved to be one of the most monumental days in my diabetes career. (OK, so it’s not a vocation that I would have picked for myself, but I treat it like a career, except there’s no time off and no 401K and the medical benefits are tepid at best.) Medical investors, the FDA, representatives from pharma and device manufacturers, non-profit icons, big names in diabetes, physicians, and for the first time ever, payers from a few large insurance companies all talked - sometimes with each other, sometimes at each other, and even at one point, yelling at each other about diabetes.
There was laughter, there was anger, and there was wonderment over the promise of technology and the frustration over the same technology. There were surreal moments and for the first time in what seemed like forever, a moment where I was left speechless, jaw gaping and heart pounding. Intrigued? Thought so.
Amy Tenderich, the woman behind Diabetes Mine and the Innovation Summit, welcomed everyone with a brief overview and the Patient Voices video, which I have already provided for you in a previous post. This summit was to share ideas surrounding the topic: “delivering on the promise of diabetes technology”. I’m going to give you a spoiler early in the post: the diabetes world is not even close to delivering on that promise.
Strip Safely and the FDA
Dr. Courtney Lias, the FDA representative of the In-Vitro Diagnostics division (overseeing pumps, strips, etc.) was first-up on the podium, giving an overview of the role that the FDA plays in the technology innovation machine. She stressed the importance of an open dialog between manufacturers and the FDA well before the tech is submitted for FDA approval. Requests for more data slow everything down, but if the FDA and the device manufacturer are skipping down the yellow brick road together, there are fewer surprises. (I don’t know how close a relationship the FDA and Dexcom, Tandem, and Animas have. There was a collective sigh heard around the country when the integration of Dexcom and these two pump companies were delayed for “more data”. Case in point.)
But what was a proud moment was the mention of the Strip Safely advocacy campaign held up as an example of advocacy that is working (for better or worse, I’m sure, in the FDA’s mind). As her slide titled: Patient Interaction stated: If our goals are aligned, can support our efforts. If not aligned or in sync, they can hurt policy implementation. Good communication is key. Bennet Dunlap, my partner in Strip Safely (He’s Batman. I’m Robin. I get to say “HOLY…..” a lot.) and I were tickled to see Strip Safely mentioned. We made a few waves with the FDA initially, but we also understand that they’re just as frustrated as we are. We need to work together to find a way to enforce the accuracy of the technology that is currently on the market.
Swept Away by Tidepool
This, my dear readers, was the reason I believe in the power of our community. Tidepool is a California Public Non-Profit that is putting into action my dream… or to be more accurate, it went beyond my dreams and straight into my fantasy. (No, not that one. Shhh…)
Tidepool is providing an open-source platform for real-time data from all devices I wear to the cloud, securely, sharing the data in real-time with anyone who should see it. Text messages to parents if their children go hypoglycemic while at school? Yep. Text message to physicians if a certain parameter is hit? Yep. It hit every one of my requests and some that I hadn’t imagined, including a little app called nutshell, which Brandon Arbiter created. You input a meal (in the example, it was Huevos Rancheros) and the carb count and how much insulin you take to cover it. The next time you eat that, you can look back and see if you went outside your acceptable range - and you can adjust accordingly.
I could type for hours about how much I admire what they are doing - and if they have a fan club, I want to be their President. (Heck, I’d make T-shirts and do spirit hands while cheering in their office. Too much? Probably.) They are a non-profit and as such, need a little financial help. Take a look at what they do and if you like what you see, you can donate to them. Out of all that I saw in relation to technology at the summit, this is the one thing that I am most excited over. That data would help a lot of us make good decisions in real-time. We need to support projects like this that will help us use the technology that we pay dearly to use.
Third Verse, Same As The First (Hat Tip to The Violent Femmes*)
Anna McCollister-Slipp, co-founder of Galileo Analytics and a T1 to boot, was blunt. Since the last DM Innovation Summit, nothing has really changed. We are still stymied by proprietary technology, frustration of the complexity and the cost, and the stall on the innovation disruption needed to make our lives with diabetes easier and more manageable. She was an excellent speaker, but left me feeling deflated and a little depressed. It’s not as if I didn’t know this already, but sometimes I want it
sugar-coated Splenda-coated just a bit.
Passion With Payers
And now begins the heated, passionate part of the summit. As I mentioned earlier, my jaw dropped during the summit - and it happened more than once during the panel presentation of five different payers. It began rather sedately and I’m sure that those sitting up at the front of the room, including the moderator (who was incredibly patient), expected this to muddle along smoothly.
They obviously haven’t met the lot of us in the wild.
Insurance companies are not altruistic. They are a cross of risk-management gamblers, firefighters, and paper pushers looking to keep as much money in their pockets as they can. Despite my description, this isn’t a bad thing all the time. Capitalism is what it is.
Like Anna’s earlier discussion, they were blunt, but unlike Anna, they didn’t understand their audience. We are patients and doctors and manufacturers who were stunned to hear them talk, quite frankly, too openly about how they try to avoid new technology and paying out more than they have to, and that patients are not their customers.
My jaw was already unhinged, but another Patient Voices winner, Corinna, sent it crashing to the floor when she stood up and confronted the panel, interrupting the moderator, shouting:
“I don’t give a shit about your spreadsheets!”
If I had a pin, I could have dropped it and heard it jingle jangle on the floor.
The silence was complete.
She wasn’t done. She told them what she thought and the floodgates opened, with other Patient Voices, advocates, clinicians and manufacturers representatives letting the panel understand what they thought of their policies and ideas.
The insurance company representatives became understandably defensive, with one stating that he felt personally attacked. In my opinion, if you’re in the insurance business and are sitting in a room of people who are denied over and over again for the items that keep them and their patients alive and healthy, please don’t expect to have roses laid at your feet or people thanking you for your cost-cutting limits and restrictions on strips and insulin.
Will they be back next year? Time will tell. I’m sure that some of them will wear thicker skin if they do attend.
Diabetes Mine surveyed a large group of people with diabetes about technology and the results were presented by Kyle and… Oh, look. Me.
We’ve got concerns. And complaints. And wishes. And if you want to see the survey results, the data is all right here.
Once again, I was struck with the feeling that none of this data is surprising to people with diabetes, but it may be to those who design the technology for us (and even a greater surprise to those insurance companies who often prohibit us from using the technology that does work).
That’s Not All
I haven’t even gotten to share the afternoon’s interactive creativity session and the closing presentation that rocked my world by Dr. Joe Smith of Westhealth. (Promise you I’ll give you that later. It’s worthy of a post entirely on the topic he covered.) I walked out of that room, my heart filled with the hopes and dreams of millions of us… and the desire to fight for the technology innovation that we need.
You want to hear some other perspectives? You should!
Scott Strange - I’m Sure All Patient Concerns Are Absurd
Amy Tenderich - Exploring Disconnects & Black Boxes
Wil DuBois - A Skeptic’s View of Our Summit: Anger and Hope in Palo Alto
My thanks to Amy Tenderich and the sponsors of the Diabetes Mine Innovation Summit. As a scholarship recipient, I was reimbursed for my flight, lodging, and some meals while attending. I also received a free registration for the summit and a bag that included a Misfit Shine from Target.
*Prove My Love by The Violent Femmes is one of those songs that makes me think of my youth…and laugh.
If you want the (mostly) objective summation of what happened at the Diabetes Technology Society’s meeting on September 9th in Bethesda, MD regarding blood glucose monitoring accuracy, you can go to the Strip Safely blog post that I wrote.
If you want to read my top five completely subjective thoughts on the DTS meeting, read on…
They’ve already got the process/system in place over there that doesn’t allow inaccurate meters and strips onto the market. It’s basically what DTS has proposed to do here in the U.S. and it works brilliantly over there because the government believes in the program (called SKUP) and it’s mandatory. I don’t believe that the same thing will happen in the U.S. without it being mandated by Congress, which will take a while.
Dr. Grete Monsen of Norway gave an amazing presentation and gave a lot of advocates in the room a glimmer of hope.
(I’m kidding about moving to Norway. I love their sweaters, but I’m not big on the cold weather.)
2. They’re going to have to build a bigger boat.
Yes, a Jaws reference. Why? Because diabetes advocates have teeth.
A post-market testing program is going to need a lot of people involved and a lot of funding to go with it. The room was filled with representatives from industry, clinicians, government, and patient advocates. It wasn’t a ballroom, but there was a lot of dancing around issues that must be addressed. Most of it is regulatory and governmental and financial, but Dr. David Klonoff, the president of the Diabetes Technology Society said that they will be building a roster for a steering committee to start… and it must include patient advocates. When he first mentioned the steering committee, patient advocates were not included. Someone quickly reminded him of us and we were added during his final comments.
3. Dr. Gary Puckrein is my new hero.
Sitting at the end of the esteemed panel of clinical and patient representatives who all gave their views on the need for glucose monitoring accuracy, he waited patiently as others gave their views. I’m sure that he had his talking points and was ready to add his approval to the collective voice when Dr. Elizabeth Koller began reading her prepared statement….about how for her “patient population” (i.e. Medicare and CMS), accuracy really doesn’t matter and that the tools currently available are just fine.
(Look. I’m paraphrasing, because I began to see red and stream poured from my ears. With such dispassion, she essentially told all of us that we were wasting our time sitting here, because as long as the FDA approves a meter, it’s fair game for Medicare and they’ll choose what millions of people will use. Sort of a “nanny-nanny-boo-boo - suck it up and we don’t care because we’ll do what we want and what’s cheapest” attitude.)
Dr. Puckrein was called upon to speak and instead of launching into his prepared statement, he turned to her and (again, I’m paraphrasing) told her that what she was saying was scary and that if this is how Medicare and CMS was going to play…
“We are going to come after you like dogs.”
My hero. I want that man in our corner and thankfully, he is.
4. The FDA needs a good public relations firm.
I have to tip my hat to the FDA representatives at the meeting. They’re like Timex watches - they take a licking and keep on ticking. Diabetes advocates asked over and over about enforcement and what it would take to remove an inaccurate meter and strips from the market. They never wavered in their vagueness. We expect that. What we didn’t expect was the admission that they don’t do a very good job of explaining what they can and cannot talk about in terms of enforcement. I’d love to see a PR firm get their hands dirty and revamp the forward-facing portion of the “What we do” part of the FDA’s device division website, giving all of us a better idea of what steps they can and cannot take… so that we don’t have to repeated ask and get repeatedly shut down. It was frustrating to all of us - advocates and the FDA alike.
So, you may be asking… what’s next? Didn’t you get what you wanted? Aren’t we going to get better accuracy from our strips?
Answer…. Not without enforcement and making it mandatory. And funding.
It’s one thing to have a proposal. It’s another thing to make it happen.
Funding, whether through Congress or private philanthropic organizations, has to happen. This is not a “let’s get this on Kickstarter” project… this is a Dr. Evil putting his pinky up to his mouth amount of money… And it needs to continue to be funded.
Support from the government is essential and not just the “we think this is a great idea” lip service. Once the program is up and running, the data given to them has to be acted upon, especially if it is determined that some meters and strips aren’t meeting standards (Hint: some already aren’t…). Without enforcement and “if you show us the data, we’ll act on it”, this becomes another pie in the sky project. The only benefit is for those who can afford to pick and choose their meters and supplies without suffering financial setbacks because their insurance company won’t pay for the accurate ones. That’s unacceptable.
We have a long way to go…. and we will all be right there, because we want industry and government to see the faces of those that accuracy and diabetes impacts.
Every meeting. Every discussion. Every time.
Disclosure: The Diabetes Hands Foundation compensated my travel and lodging to attend the Diabetes Technology Meeting on September 9, 2013. My thoughts and feedback are my own and are not representative of the DHF or the Diabetes Advocates program.
We’re having some sleep issues in our house. In addition to my overnight lows, which has me up at odd hours, the toddler has chosen to eschew her afternoon nap and normal nighttime sleep routine. I could regale you with knee-slapping tales of her antics to avoid sleeping in her own bed, but I’m too busy trying to cat nap in the corner. This week’s FFF edition is, therefore, a hodgy-podgy free for all.
1) Remember how I told you that not everything I will share with you will be diabetes related? Ta-da!
We’re huge Beatles fans in our house. How huge? Our daughter’s nursery décor was Yellow Submarine inspired. As a tiny infant, she would immediately calm down when she heard John, Paul, Ringo, and George singing to her. (Truthfully, it calmed all of us down; still does.)
I’m also a Beastie Boys fan. (My husband, not so much, but he accepts my wide range of musical tastes.) So, I was thrilled when I heard about this mash up: The Beastles. (Thank you dj BC.)
2) I got my Lauren’s Hope medical ID bracelet and it’s pretty spiffy. The neato thing about the majority of the bracelets they sell allow you to interchange the bracelets because the medical ID portion can be switched out. Check them out if you’re looking for something different. (They have guy’s bracelets/necklaces, too.)
3) If you’ve ever been curious about the upcoming changes to the U.S. healthcare system, have I got a video for you. (Hat tip to my husband, who finds amazing stuff out in the Interwebz.) It’s in plain English, doesn’t get into the politics of it all, and explains what the heck we should expect. (And it’s a cartoon! Who doesn’t love cartoons?!) In all seriousness, it’s one of the best overviews of what’s happening now and what’s going to happen in the years to come.
4) I’m bastardizing lyrics from The Music Man.
We’ve got trouble. Right here in River City. With a capital T…
and that stands for Test Strips.
You’ve heard my plea about test strip accuracy. Lots of other people and organization are also hitching their wagons up to StripSafely.com’s campaign to get our voices heard. Why? Because of news like this. (62 million. Yikes!) What will it take for you to raise your voice? StripSafely.com has given you the mic and the script and a pretty kickin’ bass line. Raise your voice with us.
5) Kim over at Texting My Pancreas has joined the No Sleep ‘Til Brooklyn group of Type 1 Kick Ass Mommies With Gorgeous Kids. (The acronym is way too long, but it could totally fit on a T-shirt.) She and her child are happy and healthy and I love hearing this! Kim also created the You Can Do This Project. This video, shot at the Friends For Life conference this year, has a lot of my Friends For Life in it… and me, too.
The house is silent right now, which means that my kid is either sleeping…or planning to take over a small island nation. I should probably go check on her…
I was excited. Our new insurance prescription coverage was so much better than the last one and finally, I’d be able to stop cringing when I handed my money over to the pharmacist for insulin and strips.
Christel, I’ve got them all ready….wait…your new insurance is denying the amount of strips on your prescription. They are saying that you can’t have that many per month. They’ll authorize…
Oh, you have got to be kidding me.
50 strips per month.
Less than two blood sugar checks per day, so you better make it count.
I thanked the pharmacy tech, wryly laughing as I explained that I knew I had to call my insurance company.
Hi. I’m calling to find out what I need to do to get an override for your ridiculous assumption that a Type 1 diabetic on an insulin pump can get by on 50 blood glucose test strips per month.
My Glenda The Good Witch demeanor was melting faster than you can say: “And your little dog, too!”
Christel, you’ll need to have your doctor call in to this special number and speak to The Great And Powerful Oz (but don’t look behind the curtain because I’m sure it’s someone who thinks Type 1 diabetes could be cured by a brisk walk and some cinnamon). They’ll review your doctor’s request and make their decision.
(OK, so that wasn’t exactly what she said. I may have taken a few liberties, but truthfully, I was conjuring flying monkeys and donning my striped socks so I wasn’t listening intently with both of my green, pointy ears.)
I thanked the customer service representative, but I wasn’t laughing anymore.
And Oz, the Decider of my Strip Amount per Month person doesn’t know that today, despite being on a CGM, I’ve pricked my finger 14 times today because I’ve run from 324 to 38 (and all points inbetween) in the last 12 hours alone. And not on purpose, lest you think I’m wasting strips for no good reason.
I get that Type 1 diabetics are special and that the majority of diabetics in the world don’t check their blood sugars as often as we do, but my doctor wrote that prescription for more than 50 strips per month for a good reason. She is going to have to call to justify why she wrote the script and why I need more than 1.66666667 strips per day? She went to medical school. I’m going to take a wild walk down the yellow brick road and say that Oz didn’t, and yet, Oz will decide what’s best for me.
There is something very wrong with this. Wrong. I can’t wait until we start in on my other supplies that help keep me alive and healthy. I foresee a “first name basis” conversation with many an insurance rep in my future. Like I have nothing else to do.
I can’t even pet Toto and say that I’m not in Kansas anymore because it’s the same insurance company we had last week. Just a different plan. It’s not like I magically became another person who didn’t need the same amount of strips I purchased before.
Meet Christel. And you thought the Wicked Witch was a bitch…
noun. A fool or simpleton.
I inherited my looks from my mother’s side, but got most of my core personality from my dad’s strong French Canadian stock. Dad’s family’s annual pool party with almost a hundred cousins/aunts/uncles (second, third, twice removed, and even an ex-husband whose company was still enjoyed by all were invited…) was always filled with laughter, sing-a-longs, and smatterings of jokes that the kids weren’t supposed to hear. My love of language came from the desire to understand the French that the older family members spoke. It was a gregarious bunch, and while we’ve scattered to the four corners of the earth (and some beyond), it was clear we shared a lot of the same traits - good and bad.
I got my patience - or lack thereof - from my father. He got his lack of patience from his father. I’m sure there is a long line of us dating back to when we sailed across the Atlantic from La Rochelle, France. (We were probably annoying the captain asking when we were going to get there…)
The phrase “We don’t suffer fools” should be our family motto, because it’s true. Is it that I have high expectations of others? Perhaps. But when disappointed or angered, I’m quick to cut. I’ve gotten better at lengthening my short fuse, but I just don’t take much guff. (This also applies to me; when I fail in my own high expectations of myself, I’m tough to live with. Perfectionists R Us - I own the franchise.)
(At this point, you’re probably grumbling: “What the hell are The Nincompoop Letters? When will she get to that?” Hold your horses, boys. It’s a comin’…)
Advocacy begins at home, much like charity. I got a taste of advocacy in the weirdest way possible through The Nincompoop Letters that my father wrote in my teens.
I love Joslin Clinic and despite my quest to find doctors and staff that I admire and love and trust as much, no one has measured up to the care I was given while I was under their roof. (If I had a bunch of money, I’d fly up there to Boston just to go to Joslin a few times a year for appointments.) But they’re not perfect. No one is. Cue the Nincompoop music…
Enrolling in clinical studies from the get go was important to me. Still is. If I have an opportunity to help someone have it a little easier because of a study, I’m going to do it. After a lengthy discussion, I was enrolled in a multi-year study at Joslin which required some extra time there as well as a bunch of labs that wouldn’t have normally been ordered (and extra vials of blood sucked out). In return, we got free parking (that’s a big deal - hospital/clinic parking is stupid expensive…) and we weren’t supposed to have to pay for the labs.
Except it didn’t work out that way. My dad was (and still is) fastidious at reviewing medical bills when they come in, and he noticed that our insurance company was being billed for those extra labs and additional fees. He called Joslin’s accounting department to get it straightened out, giving the information about the study. They apologized, said that they’d take care of it, and he thought that was the end.
The second time insurance was charged, he called the study coordinator and asked what was going on. Another round of apologies, another call to the accounting department, and…
I think you know where this is going…
It happened again. And one more for good measure. Each time, my father would go up the food chain, asking to speak with the accounting manager, the person above the study coordinator, asking what was so hard about coding the lab tests to the study so that we wouldn’t be charged. Apology, assurances, blah blah blah…
My father knows how to turn a phrase and how to write a letter to get a point across. He wrote the first of the Nincompoop Letters after yet another bill. It went to the President of Joslin Clinic. He was done dealing with managers and coordinators. (I believe he also sent copies to various members of the Board of Directors.) He documented the series of events and gave his take on the state of things in the billing department and the management of the billing morass.
He called someone a nincompoop.
My father didn’t want to pull me out of the study, he told the President. He wanted them to stop billing our insurance company and he wanted the President to get involved because he had exhausted the chain of command (and he was exhausted dealing with, as I believe he said, incompetency.)
The phone call came quickly after the letter was posted. The President of Joslin Clinic and my father had a nice, long chat. And my father got what he wanted. For the remainder of the study, not a single additional bill for those labs came to our house. We learned that my file was flagged to be reviewed before any bill went out - and let’s just say it wasn’t reviewed by Accounting.
It wasn’t about the money. Insurance paid the labs that were supposed to be charged to the study. It was the principle. And he stood on his until I could stand on mine later on in life. I learned to advocate from him. Over the past thirty years, he’s written other Nincompoop letters. All of them were used as last resorts and got action from the responsible parties who had dropped the ball. He often points out that he does it so that others can benefit. He may not have advocated for my medical condition, but without his advocacy, people wouldn’t have been helped by the study.
I wrote my first Nincompoop Letter in 2004, when my insurance company denied a new insulin pump that was out of warranty and failing on occasion, saying that my blood sugars were, in their estimation, “fine”. I went up the chain, got the denial, issued the appeal, provided the documentation, and then wrote my letter (Yes, I used the word nincompoop)… and copied my congressman who happened to be involved with an insurance committee on Capitol Hill. I emailed my Nincompoop Letter to all parties.
My approval came back via fax two hours later.
I will continue to write Nincompoop Letters as long as there is a need for advocacy for myself - or others, no matter how big or small the issue may be, because it’s the principle of it all…
And thanks to my bloodline, I don’t suffer
(I love that word. Love. That. Word. It makes me chortle.)