Today, Wednesday, August 30, 2006, the Medicare Coverage Advisory Committee will hold a meeting to discuss glycemic control in patients with diabetes. The meeting will be held in Baltimore, MD with sessions from 8:00am to 4:30pm EST and the purpose of the meeting will be to determine the efficacy and need for self-monitoring of blood glucose (SMBG) for the Centers for Medicare and Medicaid Services (CMS). Importantly, the meeting will address the issue of reimbursement for continuous blood glucose monitoring. How there could be a need for a meeting to assess whether SMBG has efficacy is positively beyond us ... we are eager to see what the prevailing views are on CGM.
The MCAC meeting must fit a significant amount of information and discussion into one day - let's hope it starts out strongly and gains in strength! The Committee plans to review research on: glycemic control using a continuous glucose monitor, the relationship in glycemic control between outpatient and Medicare populations, the linearity of effects of glycemic control, and the correlation between an increase in hypoglycemic risk and clinical outcomes. As for desired clinical outcomes, the MCAC will be looking for a diminished progression of the disease, reversing of diabetic complications, and alteration of morbidity/mortality in the Medicare population. All these are hard to prove since long-term outcomes trials are needed. The Committee plans to not only review the available data but to identify topics that require further investigation, which will be very interesting.
On July 17, 2006, the MCAC posted questions for its panel on the topic of glycemic control. The responses to these questions will constitute the frame of tomorrow’s meeting. Many groups, including AADE, Abbott, and AAFP, submitted answers to these questions. We note that originally there were quesitons that didn't address continuous monitoring, but the more updated set does.
Many organizations and doctors and nurses have spent significant time in preparing presentations for the meeting, and they are all online at www.jdrf.org/mcac. By and large, we're blown away by the work that has gone in, though we are not that optimistic about the likely findings. We're frustrated that the government doesn't appear to be in "prevention pays" mode ~ we keep hoping that changes and with the slew of thought leaders on tap tomorrow - Irl Hirsch, Howard Wolpert, Ann Peters, Steve Edelman, Bruce Bode, Aaron Kowalski - can help change some prevailing views.
As to what the various organizations said! First, in their comments to the MCAC, AADE included a Position Statement on Self-Monitoring of Blood Glucose (SMBG): Benefits and Utilization, which will be published in the November/December, 2006 issue of “The Diabetes Educator,” the organization’s journal. AADE’s sentiments towards SMBG are clearly strongly felt, and extremely positive, unsurprisingly. The firmly-established organization of diabetes educators suggests that SMBG has revolutionized diabetes care by improving patients’ glycemic control. In fact, SMBG is an essential component to the AADE’s 7 Self-Care Behaviors. AADE cites the DCCT and UKPDS studies as having confirmed the numerous benefits of tight glycemic control for patients with diabetes, among them a reduction in both microvascular and macrovascular complications (shown through DCCT and EDIT).
The AADE comments for the MCAC meeting cite several studies to support the point that SMBG is successful in increasing glycemic control. Among many pieces of evidence, the AADE cites the Schwedes et al. study (2002), which showed that meal-related SMBG for patients with type 2 diabetes lowered their A1C levels. AADE recommends the use of SMBG to all individuals with diabetes and urges all healthcare professionals to support and use SMBG with their patients. AADE goes even further than recommending when they say that, “safe and appropriate blood glucose monitoring methods need to be taught…”
According to the AADE comments, SMBG is important for diabetes care because it allows for patients to learn more about their condition and to take a more active role in their care. A patient who is more focused on his or her care will be more likely to reach glycemic control goals. With all the additional information SMBG offers to patients about their blood glucose levels, patients gain an invaluable sense of their health and well-being. Not only is this important in motivating the patient to achieve their glycemic control goals, but it helps patients to discover a personal regimen that works for them.
Abbot, like AADE, confirms the benefits of SMBG and strict glycemic control, as measured by A1c levels. Abbot aims to present scientific-based evidence linking frequent testing and the improved glycemic control to a decrease in unfavorable outcomes of Type I and Type 2 diabetes among Medicare patients. Abbott has synthesized findings from multiple studies in an impressive, comprehensive white paper, entitled, “Clinical Value of Glucose Monitoring and Glycemic Control in the Medicare Diabetes Population and the Promise of Continuous Glucose Monitoring.”
Abbott maintains that existing evidence of the benefits of SMBG in the Medicare population is strong and ample enough to permit an adequate comprehensive assessment of outcomes. Abbot also references large clinical studies, such as the DCCT and UKPDS to make its case for SMBG. Referencing the updated analysis of the UKPDS study in 2000, Abbot also makes a strong case for the impact of reduced A1c levels in diabetes-related mortality.
However, the same confidence extended towards SMBG cannot yet be extended to Continuous Glucose Monitoring (CGM). Compared to SMBG, CGM, is new technology. Thus, Abbott maintains that, at this time, evidence for CGM among Medicare patients is only promising, as more research among the elderly population is required. While, a current assessment of CGM benefits among these patients is still premature, Abbott will discuss the emerging data in this arena.
While Abbott focuses much of the evidence on a reduction of A1c levels, AAFP’s Kevin A. Peterson paints a different picture regarding glucose monitoring and A1c levels. Taking into consideration the unique needs of and barriers faced by the elderly population, he insists that the measured impact of SMBG using A1c values provides a “very incomplete assessment” of the benefit of blood glucose monitoring. Further, in response to one of the questions posed by MCAC, Dr. Peterson, states that he is not confident that an increase in the frequency of glucose monitoring will automatically improve A1c levels in elderly patients.
Most of AAFP’S comments, as delivered by Dr. Peterson, are cautious in nature due to what the doctor believes is lack of evidence of glucose monitoring in large cohorts of elderly patients, as well as less faith in the patient’s A1c level as the single most important indicator of glycemic control. Personally, we believe strongly that A1c is important but not the only measure - we think it is crazy to even question whether SMBG reimbursement is too high.
In addition to AADE, Abbott and AAFP, we will listen to remarks by JDRF, Medtronic, IHPM, LifeScan, and several others. We look forward to reporting on tomorrow's MCAC meeting in our next issue of DCU - this has enormous implications for the health and future of traditional as well as continuous blood glucose monitoring and we are watching and waiting and will report back...