An Important Step Forward in the Fight for Those with Diabetes

Sen. Susan M. Collins

Since founding the Senate Diabetes Caucus when I first joined the Senate in 1997, I have advocated for the investments that led to breakthroughs in diabetes research and for policies to alleviate the difficulties and heartbreak diabetes causes for so many American families as they await a cure. Medicare has now adopted a policy I have long championed to provide coverage for an effective, lifesaving device – the continuous glucose monitor – that is helping millions of Americans with diabetes who rely on the CGM to successfully manage the disease.

Diabetes affects people of every age, race, and nationality. Nearly 30 million Americans have diabetes, and 86 million more have prediabetes. It is the leading cause of kidney failure, blindness in adults, and amputations not related to injury, and it is the seventh leading cause of death in the United States, claiming some 70,000 lives each year.

The human and economic toll of diabetes is devastating. If present trends continue, one in three adults – one in two among minority populations – will have diabetes in 2050. The annual cost of diagnosed and undiagnosed diabetes and gestational diabetes exceeds $176 billion. This is unacceptable and unsustainable.

The lives of people living with, and at risk for, diabetes are better because of National Institutes of Health research and Centers for Disease Control prevention activities. Due to the Special Diabetes Program and increased investments in diabetes research, we have seen some encouraging breakthroughs and are on the threshold of a number of important new discoveries. We’ve made progress, but much more must be done.

This is particularly true for the estimated 1.2 million Americans living with type 1 diabetes. Advances in technology, like continuous glucose monitors, are helping patients control their blood glucose levels, which is essential to preventing costly and sometimes deadly diabetes complications. In a major step forward that will revolutionize diabetes care, the FDA also recently approved the first artificial pancreas, a device that will automatically control blood glucose levels.

The National Institutes of Health and the Food and Drug Administration have been extremely supportive of these innovations in diabetes care. As Chairman of the Senate Aging Committee, I have been concerned that insulin-dependent Medicare beneficiaries with diabetes were being denied coverage for CGMs because the Centers for Medicare and Medicaid Services (CMS) has determined that they do not meet the Medicare definition of durable medical equipment and do not fall under any other Medicare category. As a result, similar to what we saw with insulin pumps in the late 1990s, individuals with diabetes have had coverage for their continuous glucose monitor on their private insurance, only to lose it when they age into Medicare. Today, about 95 percent of commercial insurers provide coverage for CGM devices.

A CGM is a physician-prescribed, FDA-approved medical device that can provide real-time readings and data about trends in glucose levels every five minutes, thus enabling someone with insulin-dependent diabetes to eat or take insulin and prevent dangerously low or high glucose levels. As demonstrated by extensive clinical evidence, adults using a CGM have had improved overall glucose control and have reduced rates of hypoglycemia or low blood glucose levels. Professional medical societies, including the American Association of Clinical Endocrinologists and the Endocrine Society, recognize this clinical evidence and have published guidelines recommending CGMs be used in appropriate patients with type 1 diabetes.

Diabetes treatments have dramatically improved in recent years. Not long ago, testing glucose levels involved test tubes and urine sticks – inaccurate tests that provided four-hour old results. Today, patients can check with a blood glucose meter, which shows current glucose levels and is significantly more accurate. The CGM is a potential life-saver for diabetes patients because it prevents dangerously low and high blood glucose levels by alarming the wearer when glucose levels fall outside of a safe range.

Even though 95 percent of private insurers cover CGM technology, Medicare did not. Prior to this much-needed rule change, insulin-dependent Medicare beneficiaries were denied coverage for this potentially lifesaving device based on an improper and outdated policy. I am so pleased that our advocacy has spurred this change in policy that will help change our country’s future with regard to diabetes and immediately help to alleviate the financial and human harm caused by this epidemic.