There's been a lot of talk in the diabetes patient community lately about the accuracy of existing glucometers and issues of access to these and other, more advanced diabetes devices like insulin pumps and continuous glucose monitors (CGMs). Now, two of the nation's biggest endocrinologist groups are entering the conversation in a way that no other group of diabetes physicians has done before!
While this is great news, there seems to be some contention in the ranks of the various groups working to "address issues tied to quality, safety and access to glucose monitoring devices and related supplies that patients use to ensure that their disease is under control" (in the AACE's words).
Here's the skinny:
In late May, the American Association of Clinical Endocrinologists (AACE) and American College of Endos (ACE) -- announced their plan to host a "consensus conference" on these topics Sept. 29, 2014. The event will be held in Washington D.C. and may include a Capitol Hill visit in which the endos and other advocates can join together to urge Congress to support legislation that aims to increase access to these supplies and expand education for people with diabetes.
That legislation, known as the National Diabetes Clinical Care Commission Act (H.R. 1074/S. 539), would create a 3-year "Diabetes Clinical Care Commission" made up of endos, diabetes specialists, patient advocates and federal agency officials to examine the U.S. investments and improve clinical outcomes for diabetes and pre-diabetes.
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Other orgs like ADA, AADE, JDRF, the Endocrine Society, and so on have endorsed the legislation, which needs to be passed during this session with a vote before December 31.
Per the news release: "The blood glucose monitoring initiative will be uniquely structured to gather input from all major stakeholders involved in the diabetes arena and will examine critical factors such as regulatory challenges, post-FDA-approval monitoring of safety and accuracy of glucose strips, glucose sensors and devices, patient access and economic/reimbursement issues."
Michigan endocrinologist Dr. George Grunberger, chair of the task force for this conference and president-elect of AACE, says they intend to be collaborative, and are inviting "a range of stakeholders" including the Diabetes Technology Society (DTS) that's already making headway on a post-market surveillance program announced in May, and "heavy representation" from patient advocates, i.e. the StripSafely initiative leaders (the invite list is still being developed and not public yet).
But in the same breath, Grunberger wasn't shy about noting that "other efforts" on the points of diabetes accuracy and access aren't good enough. This conference "goes way beyond any of the past individual efforts," he says.
"Past or ongoing initiatives (in which AACE has participated) dealing with competitive bidding at Medicare, CGM coverage by CMS, any planned post-marketing strip quality surveillance studies, etc. are all important and ongoing. They are just part of the overall picture (and will be covered at the consensus conference). Clearly, none of these efforts have yielded anything substantial for our patients and are highly unlikely to result in anything different in the future other than more talking. There will always be individuals at FDA, CMS and other agencies who will hide behind real or perceived legal constraints of their agencies. Something different and bigger is necessary."
Whoa! A little harsh about other efforts happening out there, no?
It's true that as Grunberger says, nothing like this conference has been done before. But if you think about it, that's rather surprising. Why haven't the large national organizations of diabetes physicians gathered or spoken out on the issues of access and accuracy before, given that they're such longstanding and key challenges to patient success? (rhetorical question)
And why is this effort so different?
"The overarching goal of this new gathering is a consensus of all relevant parties about the issues and potential solutions, but mainly to demonstrate to Congress that there is a way of getting action if you allow an objective airing of data-driven views by all stakeholders," he said. "This is how the Diabetes Clinical Care Commission would work. The immediate offshoot will be Congressional briefings and visitations the day after the conference, acquainting Members with the highlights of the consensus and pushing to get more co-sponsors for the bill."
We're actually pretty excited about the new DTS Surveillance Program for Cleared Blood Glucose Monitors, an effort led by Dr. David Klonoff from the University of California San Francisco (UCSF) that's been discussed for years but finally coming to fruition within the past year. This program aims to do the work that FDA practically and by law cannot -- literally buy existing glucose meters and strips off store shelves, test them for accuracy, and then publish the results for the public and regulators to see. Abbott Diabetes Care is currently funding this, and DTS is already creating the groups that would head up activities planned to begin in 2015.
We are very enthusiastic, especially knowing that as part of this effort, FDA is communicating with CMS behind-the-scenes about the bigger accuracy and coverage picture. And if this program has any legs, it could influence decision-makers to start looking at this data in determining which meters and strips to cover and offer through their much-debated competitive-bidding program.
But Grunberger isn't so optimistic.
"Just a word of caution about the DTS efforts: even if it happens, any results won't be available for at least a year and there is no guarantee that FDA will pay them any more attention than it has to date to the independent strip quality studies," he tells us. "If you read the DTS press release, it does not state specifically that FDA supports that particular program since studies have not been formulated yet ... (but) if any data are available by end of September, DTS has already been invited to present them at the conference."
So, we can't wait to see what appears on the agenda for this September gathering.
While the leaders of these efforts may quibble, from the patient's perspective, we should at least be encouraged to see public discussions about these issues and some sort of effort to work together to make positive changes -- right?
And hopefully, with the powerhouse doctor-groups AACE and ACE hitting Capitol Hill, some more of our elected-leaders will get behind the pending legislation to make diabetes care a bigger priority.