Last month, we reported on the Diabetes Technology Society's progress on a post-market surveillance program to keep tabs on the accuracy of glucose meters already on the market. Since then, the country's largest formal groups of diabetes doctors, the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE), have joined the discussion to help move this hugely important effort forward!
At the end of September, the two groups hosted a joint "consensus conference" aimed at bringing top minds together and also confront Congressional staff about the need for legislative support. With "top minds" we mean physicians, researchers, payers, and regulatory powers-that-be from the FDA... and most exciting, key advocates from our diabetes patient community.
One of those D-advocates is our good friend Bennet Dunlap, who on top of his roles as a type 2 PWD himself and D-Dad of two type 1 kids, is an outspoken advocate on the issue of glucose meter and strip accuracy; he founded the grassroots campaign StripSafely.
We're happy to bring you an overview report on the joint AACE/ACA conference straight from Bennet, who was of course there representing our D-Community and taking part in the discussions.
A Guest Post by Bennet Dunlap
As someone very interested in accuracy of glucose monitoring I was thrilled to see AACE organize this consensus conference. I was particularly impressed to see the broad participation and the level of evidence brought to the conversation (a lot of academic reporting).
The level of attention given by endocrinology professionals was particularly heartening. The conference was very well-attended, and for the most part, all the physicians and reseachers were fully on board with our calls for improvements. A good number of staffers showed up for congressional hearing and were engaged -- despite the fact that Congress was on session break.
It felt like a basis from which action can be built and the StripSafely campaign is working on that, but our action page is still in development.
Overall, it was great to see our own doctors joining the advocacy effort calling for both accurate strips and CGM reimbursement (a related issue I'm also working on with a new campaign called CGMSafely).
One major disappointment was the absence of CMS/Medicare, which naturally sets precedent for health insurance coverage in this country and is therefore a powerful force. Manny Hernandez, President of the Diabetes Hands Foundation expressed this disappointment when he rose at the close of the event to express how unfortunate this was, given the wide variety of participants and the importance of the issues at hand. (Manny has shared his thoughts on CMS' absence over at the DHF blog.)
Meanwhile, the conference began with a general keynote session, and then broke up participants into four "pillar" groups of Medical and Scientific; Regulatory and Payers; Industry; and Patient Organizations.
Here's how the pillars discussion materialized:
The Big Questions
Each group answered the same four big questions, which included sub-questions that we were all asked to discuss and come to conclusions on. The questions were worded very academically, so I'll include my own "Patient Translation" of I think they're getting at.
The "Conclusions" listed here are summaries of what all four pillar groups agreed upon. The good news is that AACE is coming out in strong support of stricter standards, that can only help patients. IMHO.
Question 1: What data supports glucose monitoring (as distinct from glycemic control) as a means to prevent diabetic macro- and microvascular complications?
* Does frequency of glucose monitoring correlate with better outcomes?
* Which patients benefit the most from structured glucose monitoring?
* Do glucose strip and CGM accuracy correlate with better outcomes?
Patient Translation: Do the authorities really have enough evidence that pushing for better accuracy of these devices is going to make an impact? i.e. why should they invest time and resources?
Conclusion: Glucose monitoring is essential to diabetes care, particularly for reducing hypoglycemia, provided it is structured. Implementing clinical actions based on data gained during glucose monitoring is critical for diabetes control. There seems to be a relationship between higher frequency of glucose monitoring and better glycemic control (no kidding!). The consensus of the participant experts calls for a wider use of glucose monitoring and CGM, and calls for studies that can address efficacy and cost.
(That last sentence is big win for us patients!)
Question 2: Should the FDA improve post-approval surveillance of glucose strips, glucose meters, and CGM quality?
* Does sub-standard glycemic monitoring technology harm patients? If so, what data exists to support such a claim? Are all manufacturers required to report this data to the FDA?
* What is the current state of affairs at the FDA in post-marketing meter and CGM surveillance?
* What enforcement options are available to the FDA, and how are they implemented?
Patient Translation: We need to lay out exactly what we expect FDA and industry participants to do here, and suggest how.
•The FDA is to be commended for their recognition of the need for independent and ongoing pre- and post-marketing testing of blood glucose monitor devices. This could be funded by industry based on a percentage of total strip sales or other methodology.
•AACE recommends periodic ongoing post-marketing manufacturer inspections and audits, both within and outside the country.
•AACE believes that the FDA should rigorously apply existing enforcement options and expeditiously prohibit the sale and marketing of devices that do not meet their ongoing evaluation of quality, including embargoing products if necessary.
•More education for patients and healthcare professionals is necessary for optimal use of the MedWatch Reporting System (new program that's supposed to make reporting problems easier).
•Studies to demonstrate comparative effectiveness should be required.
•ISO 15197:2013 international quality standards should be applied to all blood glucose monitoring devices to ensure accuracy of glucose monitoring.
Question 3: Do current private insurance and Medicare policies balance the need to provide patient access to high quality care and effective glucose monitoring and, if not, what policy changes are needed with respect to:
* Patient Access to BGM supplies;
* Medicare's Competitive Bidding Program;
* Limiting glucose strip brand or meter type;
* Patient access to CGM technology;
* Limited or lack of coverage for sensor-augmented insulin pump therapy; and
* Emerging semi-automated CGM/pump combinations
Patient Translation: It's all about ACCESS, of course!
Conclusion: Access to glucose monitoring technology is not currently provided to an acceptable degree by payers. FDA approval should be a reliable indication for benefit coverage (YES!). Ongoing randomized controlled trials or comparative effectiveness studies would be appropriate.
Question 4: What is the most effective way for the key stakeholders (physicians, allied health care professionals, patients, professional associations, educators, investigators, payers, industry, employers, health care systems, regulators) to achieve appropriate, evidence-based, cost-effective regulation of glucose (blood, continuous) monitoring technology?
Patient Translation: How can we 'regulate' BG monitors in the real world?
Conclusion: It is extremely important to address diabetes-related processes at the Federal government level, since the government is the largest payer and its actions affect every other payer. The sheer number of agencies with their own agendas and complex reporting structure makes it difficult to affect significant change.
Yeah, the incredible complexity of "Federal Diabetes Activities" is illustrated in this graphic from the National Diabetes Clinical Care Commission Act, that was adopted in March 2013 with the goal "to coordinate all agencies related to diabetes and assist them with the direction of clinical experts as a sanctioned advisory body." (Good luck with that!)
As the discussion session came to a close, all participants seemed to agree that we'd benefit from streamlining the processes involved in access to glucose monitoring technology. Kind of a no-brainer, but that's much more easily said than done. One innovation mentioned that help here is a single standardized form for prescription of glucose monitoring and documentation of its Medical Necessity. Now that would be a step forward from the patient perspective, for sure!
It was great to see these various experts underlining the needs here. And even though CMS was a no-show, we can only hope that with AACE/ACA throwing their weight behind these issues, real-world progress will come soon.
Thank you for all your advocacy efforts, Bennet! We look forward to hearing about the next round.