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Experts bring glucose monitoring concerns to Capitol Hill
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WASHINGTON — Today, experts in diabetes management held a congressional hearing to present a consensus on glucose monitoring and address the National Diabetes Clinical Care Commission Act, a bill currently with Congress for consideration.
“Endocrinologic disease has impact on everything. It has impact on whether you’re going to get cardiovascular disease. It influences whether you’re going to get cancer. And if you get cancer, you do worse if you have diabetes,” said R. Mack Harrell, MD, FACP, FACE, ECNU, president of the American Association of Clinical Endocrinologists. “Calling it a disease is very limiting. It’s not a disease, it’s more than that.”
R. Mack Harrell
Harrell and George Grunberger, MD, FACP, FACE, who chaired the Consensus Conference on Glucose Monitoring in the 2 days leading up to this congressional hearing, presented the findings and recommendations of the conference.
Technology, need for regulation
Grunberger explained the conference process and lauded those involved in answering the “hard questions” put forth by the conference organizers.
“These are hard questions. This is why we needed the conference because obviously we don’t know the answers,” Grunberger said.
He presented the findings and recommendations of the conference, focusing first on technology.
“You cannot stop the progress. The technology is happening,” Grunberger said. “The question is what do we do with it once it’s approved.”
George Grunberger
He said the goal of physicians like himself is to put the appropriate technology in the hands of the appropriate patients to improve patient outcomes.
“The technological advancements that will improve patient outcomes and reduce health care costs are impeded today because of our restrictive regulatory climate,” Grunberger said.
Within that technology, Grunberger and the consensus writers called for standardization of reports from devices as well as adverse event data reporting.
To enforce adverse event reporting, the consensus also calls for a larger role for the FDA.
“FDA should implement more rigorous post-market surveillance and apply enforcement options — they have those options — such as prohibiting the sale and marketing of devices that do not meet current standards for quality, including those that are made in other countries,” Grunberger said.
Economic impact, cooperation
In their appeal to the congressional representatives present, both Harrell and Grunberger discussed the economic impact of diabetes, the potential cost efficiencies of glucose monitoring and the call for passage of the bills forming the Diabetes Clinical Care Commission.
“The economic costs [of diabetes] are staggering,” Harrell said. “This is the disease that consumed the Medicare budget. … This is not just a disease; it’s bankruptcy.”
Harrell said $1 of every $3 in the Medicare budget is spent on diabetes and its complications. The expenditure is expected to reach $514 billion by 2025.
“We cannot manage this disease without glucose monitoring,” Harrell said.
Grunberger agreed, and said, “More than 50% of those dollars is spent on hospitalizations for patients with diabetes.”
Last year, Grunberger said, hospitalizations for hypoglycemia exceeded that for hyperglycemia for the first time.
One solution, not currently covered by Medicare due to a lack of benefit category for it, is continuous glucose monitoring (CGM), Grunberger said.
“In Medicare alone, there are 500,000 type 1 diabetics, thousands of whom had CGM devices before they turned 65 and now have no funding for it,” Harrell said. “This is not a crazy endocrinology niche-y problem. It’s a huge problem.”
There are currently bills in the House and Senate to create that category, according to staffers at the hearing.
“The problem is it’s not cheap. How do we balance the long-term benefits with this immediate cost of technology?” Grunberger said.
The next step in finding that balance and improving patient outcomes overall is cooperation among the different stakeholders, Grunberger said.
“Productive private and public stakeholder engagement can foster the provision of cost-effective health care and real improvement in patient outcomes,” Grunberger said. “Our meeting was an attestation that we can talk and play nice and come up with solutions.”
Harrell echoed that sentiment: “We are not going to relent until we get these legislative acts passed.”
For more information: See the Endocrine Today Twitter feed for live updates of the congressional hearing: www.Twitter.com/EndocrineToday.
Perspective
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Katherine A. Roberts , MD, FACE
The consensus conference is showing that we need the FDA to really look at these monitors to do post-marketing surveillance to see they work correctly. We also need CMS to cover continuous glucose monitoring systems because you have these frail elderly who always end up in the ER and in the hospital because they have hypoglycemic episodes. When I put my patients on these devices, that occurrence is reduced phenomenally. The patients know when they’re going to have a problem and they don’t end up in the ER. They treat themselves at home and it saves so much money.
It’s about taking care of the patients and saving all of our dollars.
The Diabetes Clinical Care Commission offers one voice for the country, instead of all of these little, tiny voices. It gives us a good, total perspective and it will utilize all the billions of dollars much more efficiently. It will reduce cost; it will reduce mortality. It will help us so much in the long run to cut down what is spent on diabetes because it will be better controlled.
People will live longer and healthier, and that’s what we want.
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