March 26, 2015

SGR is on Congress’ Agenda This week: What is It? A Primer for Diabetes Advocacy

SGR is in health news. MedPage Today ran a piece March 25 by Joyce Frieden titled, "Bill to Kill SGR Likely to Pass House, but Fate in Senate Less Certain." Her opening sentence is:

WASHINGTON -- Negotiators are working feverishly and President Obama has a pen at the ready, but whether a permanent repeal of the widely disliked "sustainable growth rate" (SGR) formula for Medicare reimbursement can happen this week is still up in the air.
Wait. The house and the President are interested in the same thing passing. In health. What the... is SGR.

SGR is a process Congress created in 1997, to restrain the cost Medicare pays doctors. The idea is that growth in Medicare cost should be linked to the growth rate in the US economy. SRG triggers cuts in physician payments if doctor costs exceed targets. It is very formula heavy. Congress has to March 31 to step in before there are cuts to doctors for seeing Medicare patients. Those cuts would be over 20%. The fear is then that doctors would stop seeing Medicare patients.

For the last decade, Congress has prevented these cuts with short term fixes. The Brookings Institute says, “However, since 2002, Congress has stepped in with short-term legislation (often referred to as the “doc fix”) to avert the payment reduction. These patches have kept increases in physician payments below inflation over time.” There are voices calling for a longer term process as well as those less concerned with regular consideration congressional action.

There are concerns over the SGR patch process as well. For example, since payments are on a fee for service basis they encourage volume of services billable Medicare over quantity of care. The process does not consider doctors or practices based on performance. Cuts may limit seniors access to care.

Because Congress has consistently passed SGR patches, the legislation often attracts other issues as riders. CHIP programs for children and  funding for the Special Diabetes Program are advocacy priorities of the American Diabetes Association and JDRF.

Here are some resources to learn more about SGR:

The Brooking Institute:
A primer on Medicare physician payment reform and the SGR

MedPage Today
Bill to Kill SGR Likely to Pass House, but Fate in Senate Less Certain

Internal Medicin News
FAQ: What’s in the House proposal to fix the SGR?

American Diabetes Asscocation Call to Action

JDRF Call to Action

March 18, 2015

Transparency on Insulin %&#%Problems

%&#% = pump

What were you thinking?

In "Experts call for transparency on insulin pump problems" - Kathryn Doyle - Reuters, there is a call for better data on insulin pump errors. It would be easy to read into this that pumps increase risk. I doubt that is the case.  All the data I have seen suggest that people on pumps do better with their diabetes management.

So when talk of Insulin Pump Problems, should be made in the context of insulin. Taking Insulin is risky - Diabetes is a Problem. Pumps are an imperfect but valuable mitigation of diabetes and its risk.

I would hope/think that clear direction on Medical Device Reports (MDR) to FDA and access to those MDRs would be useful in getting the information needed. I ma reasonably confident that pump companies are diligent about MDRs. Yes - Data is useful, so are pumps. Insulin is dangerous and THAT should be kept in mind when talking about pumps. People on pumps do better.

So how about transperencey on insulin problems too?

No throwing the baby out with the bathwater.

March 16, 2015

UnConference = UnBelievable

The UnConference was UnBelievable.

Full disclosure: I was and am a believer. I was part of the planning. I was a facilitator. I am an officer of the The Diabetes Collective, Inc... In short, I had high expectations.

This collection of people with diabetes exceeded my hopes, in spades.* 

The magic was the high degree of attention we gave to each other. We  were there, not on our phones. A huge part of success was respect and trust. To keep the resect for other's stories and the trust they invested in me by sharing those stories, I will only share my experiences. I hope others choose to share theirs as well. That is their choice.

I can say, I was moved by the stories shared. I have heard a lot of diabetes stories, none were more moving. I was empowered by the stories I heard, engaged by the trust of sharing them and honored to respond by sharing my story, knowing it was safe to do so. I was even more moved to be allowed to hear, hold, and help. Oh and pass the Kleenex.

Nobody every asked to have diabetes. Nobody. 



It is a disease. In every case, disease.

I was moved by a metaphor I picked up at the UnConference. I will use it, a lot. Diabetes is complex patch work quilt of metabolic diseases. That is true of all diabetes and that makes it an even better mental image.  

Rationally, I know that. I have been a patient reviewer of scientific grants by both PICOR and CDMRP. In my role for them, I was in rooms with a dozen and a half PhD physicians reviewing scores of research proposals. Each looked at a part of the patchwork of health. Those were intense intellectual process - detailed, rational, clear examinations of the finest threads of the various patches of life's quilt. By the nature of science, those are cold processes. 

I felt the warm comfort of the quilt at the UnConference. I was a patch, at teeny piece of cloth, in a multi color mix of parts new and old. Collectively we were so much more than scraps. Together we became a blanket of almost two thousand years of individual experience of living with diabetes. It feels great to be embraced by two millennia of wisdom. It is an UnBelievably good feeling to be able to help old friends, particularly the you just met.

I was trusted to hug, hand hold and say it not your fault. I could draw on those rooms full of PhDs and their microscopic views to say with confidence, this isn't your fault.

It is mix of metabolic diseases and we made a quilt. A warm embracing patchwork that a seemstress makes something amazing from what other may see as scraps.

I look forward seeing other share their experiences and together we will patch together thee UnConference  story. 

*(Obligatory Vegas gaming reference.) 

March 2, 2015

February 27, 2015

Finance Geeks are Talking Artificial Pancreas. James Cagney Wants a Cut.

Ok, I'm a business news kinda guy. My undergrad degree is finance; I was a banker (I apologize for what I did to the American Economy, it was clearly all my fault, I'm sorry.)

Interestingly this week a number of earnings calls (aka where businesses talk about their results to analysts each quarter) Artificial Pancreas was a topic:

Here's a few I just posted about:
Home Grown & Startup

Then there is Medtronic's latest not-in-the-USA-yet launch.

What I find interesting as a finance geek is the shift in tone from a kinda distant, "Hey this is some research someplace,"  to wall street asking, "Yo. Where's da product? And how'z youz gonna get a cut?" (Yes - analyst are James Cagney in some shoot 'em up film)

In my twisted mind, this is a significant sign of progress.

Keep it coming.

AP will come incrementally. These all suggest incremental steps. Like diabetes care perfection shouldn't be the Public Enemy of the good. 

Dexcom and Artificial Pancreas

We met with several groups utilizing G4, CGM and developing closely* and partially close with our efficient pancreas type systems. 
And a significant progress has been made by many of these groups, but the pathway to commercialization for many of these projects remains unclear and we will continually evaluate our own path to the artificial pancreas closely. 
With the world’s most accurate and reliable CGM system we intend to play in this arena. We left the meeting very confident that with execution of our plant, product portfolio we will remain the world’s leader in continues glucose monitoring 
With our new insertion system, the G6 and other advanced sensor platforms, expanding connectivity with user-friendly apps and the ability to perform advanced analytics, one CGM and other diabetes data is in the cloud we believe we are position to lead this industry for a very, very long time.

OmniPod's & Artificial Pancreas

OmniPod's CEO spoke of artificial pancreas in Q&A at the most recent earnings call:
Patrick Sullivan - President & CEO
Yes, I would say our strategy is that as it relates to the artificial pancreas, we are putting together strategy so that OmniPod is a very significant part of the artificial pancreas product offering in the future. And with that you need to have a CGM product offering, as well as an offering to put the three units together if you will, and as you know we have been working internally on our own CGM development which continues but also we have an agreement with - already have an agreement with Dexcom to use their CGM sensor along with our new PDM to integrate that those two products together, and I think with that combination used in algorithm and we're looking at opportunities to have an algorithm that we could then provide the full package. I'd also say that we would evaluate and look at opportunities with Abbott and others that would have potential CGM integration opportunities for us. So in the short term we're looking at other people that have CGM capabilities and algorithm capability, but at the same time we are continuing at a low level our own efforts in our own CGM product development.

Tandem and Artificial Pancreas

Beginning in 2013 and throughout 2014, we’ve actively supported leading investigators in advancing this development of artificial pancreas solutions by providing Bluetooth enabled pump, hardware and software. We are committed to continue advancing the clinical applications of Tandem’s technology.
To this effort, in 2014, we initiated the R&D concept phase of our artificial pancreas offering. Our first AP product will utilize Tandem’s proprietary technology platform and will partially automate insulin delivery based on CGM information and predictive algorithms to aid a user and maintaining their targeted blood glucose level and may reduce the frequency and severity of hyper or hypoglycemic events.
In the second half of 2015, we plan to file an Investigational Device Exemption or IDE with the FDA for a clinical study in rolling our first AP product. Our discussions with FDA surrounding this IDE will help decline regulatory pathway, which we anticipate will require preliminary approval and will include data from one or more clinical studies.

Dexcom - At least 5 as many as 10 product launches in 2015.


Kevin Sayer - President, Chief Executive Officer

Thank you, Steve. For our business update today I would like to discuss several major initiatives for 2015. Let’s start with innovation. On a worldwide basis we launched a total of five new products in 2014, compared to a total of three worldwide product launches in the previous two years combined. We are currently planning at least five more launches in 2015 and depending upon execution and regulatory time frames we can see that number go up to as many as ten product launches in 2015.
Our nearest term innovation is the DexCom SHARE Receiver. Work on the receiver of this nature commenced more than two years ago, when we received the research grant from the Juvenile Diabetes Research Foundation to develop better Juveniles to support artificial pancreas research. We want to take the opportunity to recognize JDRF support of this project. This is a great example of how industry and research collaborations can greatly benefit both parties.

February 19, 2015

Dexcom Announces Continued Partnership with NASCAR Driver Ryan Reed

from Dexcom:

Dexcom Announces Continued Partnership with NASCAR Driver Ryan Reed

Raising Awareness of the Benefits of Continuous Glucose Monitors for People with Diabetes
SAN DIEGO--(BUSINESS WIRE)-- Dexcom, Inc., (NASDAQ:DXCM), the leader in continuous glucose monitoring (CGM), announced today that they are continuing their partnership with NASCAR driver Ryan Reed, the face of the American Diabetes Association's national diabetes awareness initiative, Drive to Stop Diabetes℠ presented by Lilly Diabetes. Through the collaboration, Dexcom will continue its support of Ryan Reed while reinforcing the partners' common quest of creating awareness of CGM among people with diabetes. The campaign highlights the importance of daily monitoring and tracking of glucose trends in the management of diabetes.
With nearly 10 percent of the American population currently living with diabetes, education on disease management is necessary.1 The rise of continuous glucose monitoring systems, like the Dexcom G4® PLATINUM, has helped patients with both type 1 and type 2 diabetes to understand valuable information about their glucose levels and trends.
"This initiative has made it possible for me to educate people who may be living with type 1 or type 2 diabetes about managing their disease and understanding their glucose levels. As an advocate for patients fighting the disease, it's been important for me to actively inspire those who feel that they have to give up on their dreams after diagnosis," says Ryan ReedNASCAR driver. "With the help of my Dexcom G4®PLATINUM, I've never let diabetes slow me down." more