Tackling Glucose Monitoring Issues Head-On

On the occasion of her 65th birthday, Gladys* should have been celebrating a major life milestone. Instead, she was preoccupied with the unsettling news that her new healthcare insurance provider, Medicare, would not cover the cost of her continuous glucose monitor (CGM), a medical device that provides real-time measurements of blood sugar levels. Gladys considers the CGM a lifesaver in her battle to control her diabetes. A recent widow now living alone, she has a history of severe hypoglycemia (low blood sugar) which has resulted in her losing consciousness on a number of occasions. Gladys always felt safer with the monitor and now, without someone at home to keep an eye on her, she fears for her safety and well-being.

Mark*, an active 30-year-old, uses a blood glucose meter and test strips throughout the day to measure his blood sugar levels, but has had to limit the number of strips he uses daily because his insurance only provides for a certain quantity per month. Recently, it has been particularly difficult to manage his blood sugar because his meter has been providing widely varying (and possibly faulty) readings, causing Mark to test his blood sugar more frequently. Subsequently, he runs out of strips before he is able to obtain a refill. Because he is unsure about his meter’s accuracy – although the device had been approved by the U.S. Food and Drug Administration (FDA) – Mark has two choices, both undesirable and potentially dangerous: ration the test strips or go without testing at the end of each month.

Glucose monitoring is an essential component of their treatment for many of the nation’s 29 million diabetes patients, either in the form of self-monitoring of blood glucose (SMBG), in which the patient performs frequent finger sticks to assess blood glucose values with a small, computerized meter, or continuous glucose monitoring (CGM), which measures interstitial (spaces within tissue) fluid glucose levels every one to five minutes through a sensor/transmitter/monitor system attached to the abdomen. Both approaches provide those with diabetes and their medical caregivers vital information to use in making treatment choices both in the shortand long-term to avoid adverse consequences.

While the development of these glucose technologies has no doubt added immense value to those with ongoing challenges in the management of their disease, the two stories described above are all too familiar to physicians and the patients whom they treat. In fact, similar scenarios are playing out across the nation every day.

At issue are fundamental problems related to access, reimbursement and quality of diabetes testing devices and supplies.

In cases like that of Gladys, federal government-provided Medicare coverage does not include the cost of CGMs. Physicians consequently struggle with the fact that they have to advise their 64-year-old patients – many who are on fixed incomes – that once they turn 65, they will be responsible for the cost of the device. Further, Medicare program administrators at the Centers for Medicare & Medicaid Services (CMS) state that CGMs do not qualify as durable medical equipment (DME) and, thus, are not a covered medical benefit because they do not serve a medical purpose. Gladys and her doctor firmly believe that is not the case. The irony is that this measure intended to produce cost savings ultimately lands many patients in the emergency room with severe hypoglycemia, costing CMS even more money.

In Mark’s situation, the problem is two-fold. First, like Gladys, his health insurance policy comes up short in covering the cost of his blood glucose monitoring supplies. Additionally, there are insufficient safeguards in place to monitor the accuracy of devices and supplies once they have been approved and placed on the market. This results in situations that put a patient at risk, such as with Mark’s potentially faulty meter. As patients and physicians alike will attest, inaccurate results from faulty diabetes testing supplies can lead to incorrect insulin dosing and increased hypoglycemic, as well as hyperglycemic (high blood sugar), events.

..... Glucose monitoring is an essential component of their treatment for many of the nation’s 29 million diabetes patients.....

These critical issues were addressed head-on recently when the American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) gathered an esteemed and diverse group of stakeholders–insurance companies, patient advocacy groups, pharmaceutical and equipment manufacturing companies, government payors, health care associations, physicians and allied healthcare professionals–for a twoday conference to examine in depth the issues surrounding glucose monitoring devices and map out possible solutions.

The consensus conference dovetails with AACE/ACE’s strong support of the National Diabetes Clinical Care Commission Act (H.R. 1074/S. 539), legislation which seeks to establish a commission comprised of diabetes experts (endocrinologists and other specialists that treat the complications of diabetes, patient advocates and representatives from the federal agencies most involved in diabetes care) to streamline existing federal programs that focus on the disease and improve the coordination and clinical care outcomes for people with diabetes and prediabetes.

Conference participants debated four questions that addressed key issues with glucose monitoring such as reimbursement challenges, patient access, and safety and accuracy of devices to reach a consensus, which was then distilled into a consensus statement. The group’s statement was presented to federal healthcare policy makers at a congressional briefing immediately following the conference’s conclusion.

“As someone who has had type 1 diabetes for nearly 30 years, I know well the importance of glucose monitoring as it has allowed me to live a healthier, safer and more normal life,” said Kelly Close, a conference participant and founder of Close Concerns, a healthcare information and patient advocacy company focused exclusively on diabetes and obesity. “The improvements in this technology over the past few years, particularly CGM, fuel my optimism about the future of diabetes care, but nothing is guaranteed.”

“The AACE Consensus Conference provided an outstanding and necessary forum to discuss key issues in glucose monitoring, establishing broad priorities, encouraging commitments from all stakeholders and reinforcing the urgency of our task,” she continued. “Leaving the meeting, I’m more aware of the challenges and also optimistic that we will conquer them in the years ahead.”

A group of AACE physicians is now hard at work developing a comprehensive action plan that will serve as the roadmap for efforts to improve the glucose monitoring landscape.

To view the full conference summary, visit:https://www.aace.com/sites/all/files/consensus/obesity/AACE_Glucose_Monitoring_Conference_Summary.pdf.

To learn more about the National Diabetes Clinical Care Commission Act and how you can send a message to your Congressman, visit: https://www.aace.com/article/220.

*Actual scenarios reported by physicians. Names are fictional.