Last Friday we held the 2014 DiabetesMine Innovation Summit, the fourth of these events we've done at the Stanford University School of Medicine -- which exceeded expectations, if we do say so ourselves ;) This year's Summit was standing-room-only, attended by 135 passionate diabetes "stakeholders," ranging from players to payers. Present were key individuals from industry, finance, research, medical care, insurance, government, technology, and patient advocacy.
Many attendees who came under the guise of one of the other categories had insulin pumps on their belts, in their pockets, or tucked into their bras.
Of course, we were very happy to welcome our 2014 Patient Voices Winners to this year's Summit. We build the program around patient sentiments and needs, so these folks are at the heart of this gathering.
As you may know, we pick a new theme for the Summit each year, reflecting the hottest issue(s) that we see as crying out for attention. This year's official theme was "Emerging Models for Improving Life with Diabetes." And as our fearless leader and host Amy T put it in her opening presentation:
"The notion behind that is that we've reached a tipping point with Innovation in Diabetes. There's massive change happening on every level, from the hackers and DIYers creating their own technology to entrepreneurial companies using a mix of high-tech and high-touch to improve care, to large clinics leading tech innovation and finding amazing new ways to share their best practices.
"Today's program is aimed at exploring a smattering of all of this progress, in order to 'take the pulse' of all that's going on and explore what makes some innovations 'stick.' To a degree, we're here today to celebrate all of this progress — but we still need to look at the remaining hurdles..."
As you can see from the agenda above, the day led us through a fast-track tour of exciting innovations happening at many levels, with rich discussions about those hurdles we all still face:
- identifying which new tools and programs have most impact on outcomes and are realistically scalable
- addressing whatever challenges stand in their way
- we STILL have a ways to go integrating patient voices into shaping these advancements
- and last not least: ACCESS!! (the fact that many patients do not have the necessary education and resources they need, and high costs and healthcare coverage limitations are huge barriers)
Clearly, there was a lot of content covered in a packed day. You can see all the Summit presentations online here.
Here's our team report on the main topics and top impressions that we took away from the day:
The Open Data Rally Cry
Aside from the Summit, Amy hosted a pre-day event focused on data and device interoperability -- the Fall 2014 DiabetesMine D-Data ExChange (report coming on that soon) -- and that theme and the incredible momentum in this area spilled over into the Summit in a big way.
As things have historically stood, our care and community has been described as being in "silos" where our devices and many players haven't worked together nor "talked" to each other effectively. But that's been changing, and after years of talking about this and seeing only gradual shifts towards interoperability, we are now finally seeing the results materialize.
At the forefront of this coming tidal wave of change is Tidepool, the Palo Alto-based non-profit open source org that's creating a "device agnostic" cloud-based platform that will allow people with diabetes to upload data from various diabetes devices and merge it into one display to help us better understand the intersection of diabetes, therapy, and gear. Today, the vast majority of diabetes devices will talk only to software supplied by the manufacturer (proprietary systems) and to change that, Tidepool is calling for all D-device makers to release their APIs (Application Programming Interface), the key to openness in the tech world.
The problem is, from the perspective of a device company, that's like asking the Colonel to give up the Secret Recipe.
But we've come a long way in just the past year.
The presentation by Tidepool CEO and D-Dad Howard Look spelled it out clearly: Last year, no diabetes device company had signed on with Tidepool, despite assurances that opening the AIPs would be done in a way to protect competitive advantages.
But between then and now, five partners in the diabetes device industry have agreed to open up their data protocols -- pump maker Asante, followed by CGM-manufacturer Dexcom, and OmniPod maker Insulet, and announced at this year's Summit the two newest additions: Abbott Diabetes Care and Tandem Diabetes. Tidepool also showed off the latest on its Blip application, the visual interface that pulls data together into one spot. Now it seems the only remaining question is, which device manufacturer will be the last to join the party? (Note that Medtronic and JnJ/LifeScan/Animas remain the two noticeable names missing from the list).
Creating Diabetes Industry Standards
Beyond sharing APIs, the key to true interoperability would be universal tech/data standards. Think USB, in terms of what using computer equipment was like before we had that universal plug-in. Dr. Joe Cafazzo, of the Centre for Global eHealth Innovation in Toronto, Canada, has been working with a small team on creating these standards for several years now. He told the crowd that the lack of standards is actually stalling work on Artificial Pancreas projects, saying it's "killing researchers doing AP work" due to the layers of time-consuming, redundant, and wasteful work trying to get proprietary devices to talk to each other.
So far most diabetes device industry have been quite reluctant to support standards. Cafazzo even laid out all their reasons for pushing back. Still, he is optimistic and related an interesting lesson from the world of medical digital imaging. Twenty years ago no medical imaging devices talked to each other in any way. An MRI from one manufacturer could not be compared to one from a second manufacturer in the same software. X-ray machines, MRIs, CAT scanners, and ultrasounds even within the same hospital could not communicate in the same language. Radiologists spent much of their time struggling with widely different software. Cafazzo says it got so bad that hospitals actually started delaying purchase decisions. Millions upon millions of dollars were locked up.
Finally, market pressures (in this case a lack of sales) forced a universal standard. Think JPEG for medical images. Suddenly any software designed for the standard could read any image captured using any device that used the standard. Sales blossomed, and more. The existence of a standard led to the creation of an "ecosystem" of third-party software and apps. Cafazzo says imaging analysis undreamed-of a few years ago is now possible. Rather than cannibalize sales from the manufacturers, this new app ecosystem drives greater need for their high-ticket machines. It ended up being win-win for everyone.
The message to the diabetes device guys in the room was clear: No fear, you won't lose your shirt by adopting a universal standard. In fact, you might get a whole new wardrobe. Development of standards is moving forward independently, but it remains to be seen which companies will sign on.
What Patients Want
Of course, it wasn't all technology, because there's a human component that needs to be addressed to make tech really work for real people. And to address that, Richard Wood of Close Concerns' dQ&A Market Research arm gave a fascinating look at the organization's ongoing surveys of PWDs. Since 2009, these statistical wizards have conducted 100,000 detailed online surveys with PWDs revealing some interesting results, and, according to Wood, some stories that made him want to cry.
In a nutshell, Wood said what they ask is: "Short of a cure, what do you want?"
His outfit looked at 150 diabetes products or services, as with most tech advances in this world, familiarity seems to breed contempt. That is, we routinely give high marks to shiny new gear, then less so over time. Presumably, the novelty wears off, we start to notice the real-world drawbacks of said gear, and our expectations are reset as new technology appears. Not surprisingly, dQ&A research shows that few of us download the data from our devices regularly; but interestingly, one of the key reasons given for this is a lack of Mac-friendly software!
During the conference breaks I talked to any number of the device people about the Mac software issue and always got the same answer: There are just too few people using Macs, so it's not worth the cost. What? The data from dQ&A makes me question this, along with the fact that virtually every D-peep I know has a Mac on their desk at home. I think someone needs to do a study of OS preference amongst people with diabetes.
Looking away from the gear itself to what motivates us T1s and T2s to actually use it, some startling differences emerge. T1s are most motivated by family and friends, but T2s, on the other hand, report being most motivated by their doctors.
When asked how we feel about ourselves, much to my surprise, T1s feel much more stigmatized than type 2s, with 76% of us feeling judged, while only 45% of our T2 cousins feel that way. Well, that's probably inside our heads, but clearly you're more noticeable in public as a T1 wearing a pump or CGM or pulling out other gear. When dQ&A asked how many D-folks shared their D-status with their Facebook friends, fully 73% of T1s do, whereas only 38% of T2s do the same. Wood also shared some exclusive data on who patients are in touch with, and what type of "engagement" they think works best:
FDA = "Zero to Hero"
Popular FDA device chief Stayce Beck was back again this year with yet another remarkably candid report from her agency. I remain convinced that she and her colleagues have done more to eliminate the agency's Evil Empire image than 1,000 PR firms could have done. She respectfully refers to us as "the community," rather than diabetics, patients, or persons with diabetes. She said, "We really have been listening and we've heard loud and clear that you want safer test strips," giving a nod to the power of the StripSafely campaign that has led to two new FDA draft guidance documents that will lead to changes in strip regulation. There was also a recent Town Hall meeting that crashed the FDA's servers, which she said shows the FDA computer systems need some work, a candid understatement that drew chuckles from the crowd.
She advised the device makers to engage with the agency earlier in the development process, and told them that A1C is not the only end point acceptable to her agency to show improvement in diabetes care. (This is important because some therapies that reduce hypos actually have the side effect of raising A1Cs.)
I was also pleasantly surprised to hear her say that, "AP (Artificial Pancreas) devices do not need to be perfect for approval," and that the "FDA realizes that people with diabetes are willing to accept some risk" for progress in our devices.
At the start of the Summit, Amy noted that this year's conference was only a few days after the 25th Anniversary of the fall of the Berlin Wall. In five short years we've seen more than one wall fall in the diabetes universe. First the wall between activated patients and device companies fell. Physicians (at least the good ones), too, have recognized that we exist in partnership with them, not in servitude. Then the wall between the FDA and the patient community, as well as the wall between the FDA and some of the device makers fell.
As Amy put it: The agency that we once blamed for every device delay under the sun has accomplished an incredible turnaround in recent years, and that was pretty evident from everything said at the Summit.
@AmyDBMine to @FDADeviceInfo Stayce Beck: FDA has def gone from zero to hero in the #diabetes community in the past 3 yrs #dbminesummit #DOC
— Anna McCollister-Slipp (@annamcslipp) November 21, 2014
If I'd fallen into a time machine a decade ago, I would not recognize this new world we live in.
Let's Talk About Paying
The last wall standing is the one between the payers and the rest of us. And I think at this year's Summit, I saw a crack or two, but it's a tough wall to breach.
This concluding panel discussion of the day was entitled "Ensuring Access to Innovative Diabetes Therapies." Moderated by JDRF advocacy and policy leader Cynthia Rice, this included four experts on the payer (insurer) world and reimbursement issues: Amanda Bartelme, Director of Reimbursement at Avalere Health (who happens to be a fellow T1D whose CGM beeped at least a few times during the discussion!); Margaret Rehayam of the Midwest Business Group on Health; David Sayen, a longtime regional administrator for CMS; and lawyer and healthcare consultant Dr. Bruce Quinn (who wrote a paper on Diabetes Tech, Innovation, and the U.S. Health Insurance System).
From what Bartelme of Avalere said, there remains a cultural gap between the payers and the rest of us, despite some elements of common goals. We want to be healthy. They want to be rich. (My paraphrasing, not her words.) They are, after all, financial risk companies, not healthcare companies. The problem is that insurance companies don't think in terms of the long run. They think in one-year cycles, she says.
For the first time this year, CMS was represented on the panel. While we avoided the fireworks of last year's Summit, there were strong emotions in the room, especially in regard to Medicare's approach to coverage of diabetes devices. Medicare will not cover "disposable" pumps such as the OmniPod or Snap, and even more contentiously, will not currently cover Continuous Glucose Monitors (CGMs), leading to many seniors who had the gear on commercial employer plans losing it at retirement.
It was reassuring to hear that insurers and payers are looking more to hypoglycemic episodes when considering coverage, even though the A1C remains the gold standard. The onus is on the device makers to show data on better outcomes from this tech, the panel told us.
One of the best comments came from Bartelme on the panel, who made the observation that CGM tech really doesn't cost a lot compared to the extraordinary high costs of not having one (see also: dangerous hypos and long-term complications that payers will ultimately have to cover). She gave an example of a breakthrough hepatitis drug that costs $85-90k, and is basically 10% of a payer's yearly drug budget).
Our D-Advocate friend Manny Hernandez also had an interesting comment about payers conducting pilot studies on coverage, to determine what might work and would might not.
Still, there was a glaring disconnect between the payers and, well, the rest of us in the room.
Example: Quinn compared a CGM to a diagnostic lab test in how we might look to that data, which made many of us scratch our heads in confusion and disbelief. Then there was Sayen of CMS, who prefaced a comment about CGMs not being accurate enough to use for management decisions by saying "I hope I don't get stoned for saying this."
He didn't, but as soon as "not accurate enough" came across his lips, you could see the room get restless and the patient advocates start raising their hands.
Patient winner Melissa Lee was one of those, indicating that the payers had a "fundamental misunderstanding" of what CGMs do in helping us better manage our health. She made a passionate plea for CMS to understand that CGM is an important "trending tool" and not just an expensive fingerstick, which thus far, seems to be the attitude of the agency. She quoted statistics showing a 12% increase for hospitalizations for hypos among seniors that could be avoided with CGM.
.@sweetlyvoiced explains use of #CGM in plain terms= #hypoglycemia prevention tool #medicarecoverCGM #dbminesummit pic.twitter.com/urRmZAKrQv
— Manny / Diabetes (@askmanny) November 22, 2014
When she went on to point out the fundamental unfairness of a senior citizen surviving a challenging life with type 1 diabetes only to not be able "to enjoy their retirement" due to loosing the very gear that got them to that point, she drew a strong round of applause and cheers from the crowd.
Sayen says CMS personnel are "civil servants" who are "saddled with" benefit categories form the 1960s, before insulin pumps, CGMs, or even fingersticks, which fellow panel member and CMS expert Quinn called a "fossilized system" of coding and reimbursement. Some of the panel members credited the agency with being amazingly creative within their congressional mandate, while others, such as Bartelme, feel they are taking the most conservative possible interpretation of the mandate and could do much more.
I think Sayen walked away from the panel with a better understanding of CGM from a patient perspective, and even admitted that he personally felt CGM should be covered in the future. And I have to admit that I walked away with a better understanding of how Medicare works thanks to him. I had always wondered why on earth they couldn't see what a money-saver CGM (and disposable pumps) would be for them. The answer will surprise you. Quoting Sayen: "We're prohibited by law from considering money in coverage decisions," and added, "We don't get a bonus for not spending the money."
Still the bottom line I read between the lines from Sayen was that if you don't like what CMS is doing, you'd better take it to the Hill.
The discussion certainly highlighted the fact that there isn't a patient voice directly at the table when these decisions are being considered by payers. It should and could soon happen, but as it stands now, we patients must go through our docs, elected officials, or other indirect paths to tell payers what we think. We're still trying to figure out how to reach these payers.
Fellow type 1 Adam Brown of diaTribe piped up and suggested that, just as we've built a great relationship with FDA in recent years through these forums, perhaps it's time to do the same with payers and CMS. Perhaps time for a #DOCAsksPayer virtual meeting, like the successful one our D-Community had recently with the FDA? That also brought on applause.
.@asbrown1 @diaTribeNews asks the payer panel where is it that payers are, so that we can meet them where they are. #dbminesummit
— Manny / Diabetes (@askmanny) November 22, 2014
Finally, Quinn suggested that the issue of CGM coverage by Medicare will right itself in history. "It'll be something like gay marriage... People will look back on this in 15 years and say, 'Why did this take so long?'"
That's nice. But 15 years is a long time. How many seniors will perish before we do the obvious? Brothers and sisters, it's time to take this to the Hill.
Change in the Air
Like last year, and the years before, the day was a fast-moving blur with more to report than we can possibly fit in. Of course there was a patient panel, a review of the effect of "Obamacare" on diabetes care, and a look at what large cutting-edge diabetes clinics such as Joslin, Sansum, and Stanford are doing now. We also had three speakers presenting different innovative models of care (going outside the system, rebuilding the system, and automating the system) that made for interesting comparisons.
We have come a long way, but there's still much to do.
I've had the honor of attending all but the first of these Summits and I can honestly say that what amazes me most is the change in the atmosphere. At early Summits, the various groups of manufacturers, investors, clinicians, and patients huddled more with their own kind and eyed each other with some suspicion. Now I see it more like a family reunion. Sure, maybe that one annoying uncle is there; and sure, you can't abide by the views of your cousin's spouse, but hey, we're all family. And we have a common goal to thrive.
We PWDs have felt like family for a long while. But it's nice to see us open our arms to the other people in our world, too -- the manufacturers, the moneymen, the docs, the regulators, and maybe, someday, the payers.
Note: The Summit, as is now tradition, wrapped with a small group brainstorming session. Look for our report on the results of that after Thanksgiving.