Access to continuous glucose monitors (CGMs) shouldn't be a battle in 2014, but for those people with diabetes covered by Medicare, that's sadly the case. Now there's a movement afoot to do something about that.
A new Diabetes Online Community initiative found at hashtag #MedicareCoverCGM on Twitter brings together a new D-Advocacy effort called CGM Safely, Facebook discussions on the CGM in the Cloud group, and offline conversation about how important these diabetes devices can be. Dexcom even created an "unbranded CGM video" that steps beyond company boundaries to tout the benefits of CGMs in general.
Today we're pleased to bring you a report by fellow type 1 D-blogger Dan Fleshler, a frequent correspondent here at the 'Mine, on how this is a time for action, Friends! Dan has the scoop on what we can do to make a difference on this topic.
Special to the 'Mine by Dan Fleshler
I've got good news and infuriating news.
The good news is that a new bill in the U.S. Senate tells Medicare to cover continuous glucose monitors (CGMs).
The infuriating news is that it should not have been necessary, and there's no guarantee it will pass into law. Not unless we, the Diabetes Community, do something about it.
This new legislation — S. 2689, known as the Medicare CGM Access Act of 2014 — is sponsored by Senate Diabetes Caucus co-chairs Susan Collins (R-ME) and Jeanne Shaheen (D-NH). But it's the brainchild of a coalition that includes the JDRF, endocrinologists, nurse educators and CGM manufacturers Medtronic, Dexcom and JnJ's Animas. This collaboration has been in the works since late 2012, and the group has been patiently explaining to the Centers for Medicare and Medicaid Services (CMS) why these devices should be covered. The major stumbling block: CMS stubbornly refuses to consider CGMs to be "durable medical equipment."
The Senate bill bypasses this problem by creating an entirely new benefit category for CGMs and requiring Medicare to cover them. It will also pave the way for coverage of integrated devices, artificial pancreas systems and other next-gen technology.
Deciphering CMS Language
I've spent a few weeks trying to cut through a fog of bureaucratic doublespeak to understand why our civil servants force PWDs to pay money out of their own pocket for CGMs once they turn 65. The truth is worse than I had imagined: this policy is NUTS!
Just before the Senate bill was introduced on July 31, a CMS public affairs spokesperson emailed me an explanation. Even if you have no patience for dry insurance-speak, please take a deep breath and wade through this and then I'll explain why it's irrational. Here's the first half of the statement:
We have reviewed the CGM devices/technology and found that they do not meet the statutory definition of DME [durable medical equipment]. Unlike other home blood glucose monitors, the CGM device is not intended to be used directly for making therapy adjustments based on a patient's current medical condition, but rather to indicate when a finger stick and use of a covered home blood glucose monitor may be required.
This conveys the main way that CMS decision-makers have "dug in their heels," one advocate who met with them told me. To avoid covering these tools, they've honed in on the FDA's labeling of CGMs as devices for "detecting trends and tracking patterns," but not for making decisions about insulin dosages, which allows the FDA to deem CGM "an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices." Therefore it's not essential, right?
But if that's CMS's argument, then why does Medicare now cover lancets and test strips as durable medical equipment? Those supplies are also "adjunctive" and should not be "used directly for making therapy adjustments." I don't stick a lancet into my finger and suddenly decide how much insulin to take. It's part of a package that includes test strips and non-continuous meters. Why has CMS concluded that an additional tool, which research shows makes this therapy package much better, isn't worth paying for?
The CMS message to me also noted:
When used in conjunction with an insulin infusion pump, the device performs a safety function by alerting the pump to shut off if the glucose level falls below or rises above preset values. Thus, based on our understanding of the device, it is a precautionary or safety device, which does not qualify as DME. (bold emphasis added)
Let's leave aside the fact that FDA just very recently approved the first CGM system that can "alert" an insulin pump directly and shut down dosing (the controversial low-glucose suspend feature) and that very few patients in the U.S. have access to this new system. The more important point here is that CGM described as a "safety device." That's certainly one way to look at it. But canes and walkers are considered durable medical equipment by CMS, and Medicare covers them. Aren't they also "safety devices"? Some Medicare recipients can get around without them, but need to be protected from falling down. I'm glad our government tries to keep them safe.
Apparently the bureaucrats are unmoved by the fact that, by beeping when my blood sugar goes too low, my CGM can stop me from collapsing on the street or ramming my car into a wall and being rushed to the emergency room because of hypoglycemia. In fact, low blood sugar makes elderly people particularly vulnerable to falls, fractures and other complications (I'm 60, and I'll be worrying about this very soon).
The word "precautionary" also shows up in the last sentence of that masterpiece by Kafka, I mean, CMS. That's the word thrown around when Medicare recipients, like Susan Berger's husband Mark, are denied coverage and go through an arduous appeals process -- which are almost never successful. I tried to find out precisely how they define the term "precautionary," but CMS wouldn't give me an answer. No one else seems to know, including the administrative law judges who rule on appeals of Medicare's decisions. A lawyer for someone fighting to get a CGM covered said she has argued that non-continuous blood glucose monitors are also "precautionary." It didn't work.
The CMSers were shown research indicating that regular CGM use improves diabetes control for PWDS of all ages, and that CGMs dramatically reduce severe hypoglycemia. That didn't matter to them.
Officials were shown a study that indicated insulin pumps together with CGMs led to better blood sugar control, and were superior to other glucose monitoring and insulin delivery methods. That didn't matter, either. Neither did recommendations from The Endocrine Society, the American Association of Clinical Endocrinologists (AACE) and the American Association of Diabetes Educators (AADE), all of whom explained how important CGMs are to patients.
Clearly, CMS is worried about costs -- although it's actually not supposed to make coverage decisions on that basis. Still, in this time of budget austerity, it's understandable that the agency is wary of a major increase in government spending to pay for CGM coverage. But if ever there was a tool that will SAVE money and cut health care costs, it's the continuous glucose monitor.
Making the Case for CGM Coverage
It's very hard to prove precisely how much money CGMs could save, but this study shows that CGMs are cost effective and worth the investment of public dollars. Other research shows the high incidence of emergency room and inpatient visits from hypos alone, and calculates the total cost at about $640 million. You'd think CMS would look for every opportunity to reduce hospital expenses for PWDs, based on that info. But sadly, you'd be wrong.
On April 28th, the CGM coalition sent a letter to Secretary of Health and Human Services Katherine Sebelius, explaining why Medicare policies on CGMs "impede public health." As Murphy's Law would have it, that was the very day that Sebelius resigned, and so it's fallen on deaf ears. According to Medtronic's government affairs chief, no one at HHS has responded to this letter and it just adds to the lack of responsiveness our federal government has given to CGM access through the years.
That is unacceptable. So now's the time for the Diabetes Community to make some noise. There are two specific ways we can take action and get involved:
- Tell your Senator you support the new bill. We need as many endorsements as possible from other senators. This is a key time for us to contact them and make our case as to why CGM access is so important. There is also a House bill introduced by Rep. Shea-Porter (D-NH) that calls for better Medicare CGM coverage, but those familiar with the legislation worry it doesn't go far enough. A new House bill could be coming soon to mirror the one in the Senate, so stay tuned for that and make sure to let everyone in Congress know how important this CGM access issue is to patients.
- Keep pressure on CMS. Unfortunately, we can't count on a laughingly dysfunctional Congress to do... anything, ever. That means it's critically important for us to continue pressing CMS to do what it should have already done: cover CGMs, regardless of whether there's a new law. Add your name to the new JDRF petition here. And don't forget you can ping CMS on Twitter, too, at @CMSgov.
Petitions and emails to the Senate are important, but I think it's also time to get creative here. I daydreamed about organizing Medicare recipients with diabetes to visit Congress and pretend that they have hypoglycemia. They could stagger around Capitol Hill, babbling incoherently and looking dazed, a kind of "Night of the Living Diabetic Dead."
That would get TV coverage... but I realized it would be hard to distinguish these PWDs from Members of Congress and their staffers, so I dropped the idea.
Raising Our Voices
Seriously though, our D-Community needs to take action. We don't need to be as polite as the clinicians and established organizations that are still trying to talk with CMS, but it's important that we all work together in raising our voices so that Congress and Medicare officials hear our concerns.
There's a whole group of Diabetes Advocates tuned into this issue, including D-Dad and T2 PWD Bennet Dunlap leading the StripSafely initative that caught the FDA's attention and sparked hundreds of comments on the regulatory docket for more accurate glucometers. He's now taking on this issue with the creation of the new CGM Safely site to push for change on CGM access.
We can and should get into high gear on this grassroots advocacy for sane CGM access. Really, it's very simple by following the two steps above.
Above all, we implore you to not just sit there reading your meters or laughing at the idea of Night of the Living Diabetic Dead. Go do something about it!