Medicare's Failure to Cover CGM at Odds With Other Health, Research Agencies

As the founder and co-chair of the Senate Diabetes Caucus, I have learned a lot about this disease and the difficulties and heart-break it causes for so many American families as they await a cure. Diabetes is a lifelong condition that affects people of every age, race, and nationality. It is the leading cause of kidney failure, blindness in adults, and amputations not related to injury.

The human and economic toll of diabetes is devastating. Nearly 30 million Americans have diabetes and 86 million more have prediabetes.¹ If pres-ent trends continue, 1 in 3 adults—1 in 2 among minority populations will have diabetes in 2050.² The annual cost of diagnosed and undiagnosed diabetes, gestational diabetes, and prediabetes skyrocketed to $322 billion in 2012.³ This is unacceptable and unsustainable.

The lives of people living with, and at risk for, diabetes are better because of National Institutes of Health (NIH) research and CDC prevention activi-ties. Due to the Special Diabetes Program, which was renewed as part of the Medicare Access and CHIP Reauthorization Act of 2015, 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 mellitus (T1DM).¹ Advances in technology, such as continuous glucose monitors (CGMs), are helping patients control their blood glucose levels, which is key to preventing costly and sometimes deadly diabetes complications. We are also moving closer and closer to our goal of an artificial pancre-as, which would control blood glucose levels automatically and revolutionize diabetes care.

The NIH and the FDA have been extremely supportive of these innovations in diabetes care. As chairman of the Senate Aging Committee, I was surprised and troubled to learn that insulin dependent Medicare beneficiaries with T1DM are being denied coverage for CGM technology because 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 consequence, we are seeing situations similar to what we saw with insulin pumps in the late 1990s—in which individuals with T1DM have had coverage for their CGM on their private insurance, only to lose it when they age into Medicare.

A CGM is a physician-prescribed, FDA-approved medical device that can provide real-time readings and data about trends in glucose levels every 5 minutes, thus enabling someone with insulin-dependent diabetes to eat or take in-sulin 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. Professional medical societies, including the American Association of Clinical Endocrinologists (AACE) and the Endocrine Society, recognize this clinical evidence and have published guidelines recommending CGMs be used in appropriate patients with T1DM.⁴ Today, about 95% of com-mercial insurers provide coverage for CGM devices.

I recently heard about this issue from one of my constituents, a 74-year old woman in Portland, Maine. Diabetes treatments have dramatically changed since she was diagnosed with T1DM in 1954. Testing her glucose levels back then involved test tubes and urine sticks—inaccurate tests that provided 4-hour-old results. Today, she checks her blood sugar with a blood glucose meter, which shows current glucose levels and is significantly more accurate.

While she has led an active and fulfilling life, living with T1DM for more than 60 years has taken its toll. Today, she can no longer feel when her blood glucose is dropping dangerously low; as a result, she loses consciousness and suffers sei-zures more frequently. Nighttime low sugars are particularly concerning, and she fears the possibility of her blood sugar dropping so low during the night that she never wakes up.

The CGM is a potential lifesaver for diabetes patients because it alarms the wearer when blood glucose levels fall or rise to dangerous levels.

Still, even though 95% of private insurers cover CGM technology, Medicare does not. As a consequence, many older Americans do not have access to this potentially lifesaving device because they can’t afford to pay for it out of pocket. Thousands of seniors with T1DM are denied access to the CGM technology that would keep them healthy and safe.

Ironically, it is only because of advances in diabetes care such as the CGM that people with T1DM can expect to live long enough to become Medicare beneficiaries. I am particularly concerned about the implications this coverage decision has for the artificial pancreas systems, which will combine a CGM, insulin pump, and sophisticated algorithm to control high and low blood sugar around the clock.

This coverage decision by CMS which, after all, is also part of HHS is in direct opposition to all of the work that the NIH and the FDA are doing to get new innovative treatments and technologies to patients. At a recent Senate Health, Education, Labor, and Pensions Committee hearing, I had the opportunity to ask outgoing FDA Commissioner Margaret Hamburg whether CMS consults with her agency when making these kinds of coverage decisions. In response to my question, Commissioner Hamburg expressed regret that her agency does not routinely consult with CMS about payments for FDA-approved drugs and devices, saying that the FDA should “look at the whole ecosystem of biomedical product development and use, and recognize that all of the different components that often operate in silos actually are very interdependent.” I completely agree with her assessment.

It is for this reason that I have joined with Senator Jeanne Shaheen, my colleague from New Hampshire and cochair of the Senate Diabetes Caucus, in introducing the bipartisan Medicare CGM Access Act of 2015, to create a separate benefit category under Medicare for the CGM and require coverage of the device for individuals who meet specified medical criteria.⁵

Our legislation is strongly supported by a coalition of organizations, including the AACE, the American Association of Diabetes Educators, the Endocrine Society, and the JDRF. We must change our country’s future with regard to diabetes by immediately addressing the explosive growth in the financial toll and hu-man toll of this epidemic. By including CGM under Medicare, we can help transform the lives of older Americans living with this devastating disease. References

1. Statistics on Diabetes. ADA website. http:// www.diabetes.org/diabetes-basics/statistics/

2. Number of Americans with diabetes projected to double or triple by 2050 [press release]. http://www.cdc.gov/media/pressrel/2010/ r101022.html. Atlanta, GA: CDC newsroom; October 22, 2010.

3. Dall TM, Yang W, Halder P, et al. The economic burden of elevated blood glucose levels in 2012: diagnosed and undiagnosed diabetes, gestational diabetes mellitus, and prediabetes. Diabetes Care. 2014;37(12):3172-3179.

4. AACE/ACE Comprehensive Diabetes Management Algorithm. Endocrin Pract. 2015;21(4)438-447. doi:10.4158/EP15693.CS.

5. S. 804. Medicare CGM Access Act of 2015. https://www.congress.gov/bill/114th-congress/senate-bill/804. Introduced March 19, 2015. Accessed June 22, 2015.

Download PDF: Medicare's Failure to Cover CGM at Odds With Other Health, Research Agencies