Medicare and CGM's

Decision Moves Continuous Glucose Monitors One Step Closer to Medicare Coverage
January 12, 2017
Continuous glucose monitoring (CGM) devices approved by the FDA for use in making diabetes treatment decisions are durable medical equipment, according to a decision today by the Centers for Medicare & Medicaid Services (CMS). That determination removed a major roadblock to the devices’ coverage under Medicare. Today’s decisions mean that CGMs approved by the FDA for use in making diabetes treatment decisions are eligible for reimbursement under Medicare.
Today’s decision creates a pathway for Medicare coverage for the devices that will bring the nation’s largest insurer in line with the vast majority of the country’s private payers. Although the significant benefits of CGM use have been known since 2008, CMS had previously refused to consider covering the devices under Medicare, saying they did not meet the statutory definitions of durable medical equipment or any other category the agency could cover. Today’s decision removes that impediment.
“JDRF is encouraged by this decision, which will bring us closer to Medicare coverage for continuous glucose monitors,” said Aaron J. Kowalski, PhD, JDRF’s Chief Mission Officer. “I want to thank the tireless JDRF advocates and Congressional champions who have made this progress possible.”
JDRF has been the leading advocate for widespread adoption of CGM technologies to manage T1D and for public and private payer coverage for their purchase and use. JDRF has spearheaded the drive to obtain Medicare coverage for CGM devices, marshalling research, expert testimony, allied organizations, and JDRF advocates from across the nation. JDRF met numerous times with officials at CMS and with others in the executive branch to urge them to provide access to this life-changing technology using the agency’s existing authority. At the same time, JDRF engaged Congress, persuading 50 Senators and 275 Representatives to support legislation to require Medicare to provide CGM coverage.
JDRF wants to thank everyone who made today’s decision possible, especially the Centers for Medicare & Medicaid Services, Diabetes Caucus co-chairs Senators Susan Collins (R-ME), Senator Jeanne Shaheen (D-NH), Representative Tom Reed (R-NY), and Representative Diana DeGette (D-CO), our Congressional supporters, our allies, and the thousands of JDRF advocates who made their voices heard in Washington, D.C.
Today’s decision was more than a decade in the making. In 2006, JDRF launched a multi-center clinical trial that conclusively demonstrated that CGM use improved health outcomes for people with T1D of all ages, including reduced HbA1c levels, increased time in range, and a significant drop in incidents of hypoglycemia. The results from that trial led to national diabetes clinical organizations changing their treatment guidelines for T1D to recommend CGM use and to broad coverage of the technologies by most private insurers. Today’s recognition of CGMs as durable medical equipment is just one example of the advances JDRF has been able to achieve for the T1D community because of our unique position as a trusted advisor to lawmakers, government administrators and health care thought leaders.
JDRF is heartened by today’s decision and will continue to work as necessary to ensure robust coverage of CGMs for people with T1D on Medicare. We look forward to working with the incoming Congress and administration to ensure broad and affordable access to exciting new T1D therapies like the artificial pancreas systems and to advance the interests of the T1D community at every level.
Why is it important?
CGMs enable superior blood-glucose management for people with T1D. Because they sense glucose levels every five minutes, night and day, they allow users to see whether their levels are trending high or low before they become dangerous. Extensive clinical evidence shows that CGM use significantly improves diabetes management, enabling users to avoid potentially deadly low blood-sugar crises (hypoglycemia) and the devastating long-term complications associated with chronic high blood-sugar (hyperglycemia). Insulin-dependent seniors in particular are at elevated risk for hypoglycemia, leading not only to bad health outcomes, but increased use of costly emergency room visits and hospitalizations. The government’s refusal to recognize CGMs as durable medical equipment meant they couldn’t be considered for coverage under Medicare, forcing those with T1D who rely on such coverage—even those who had been successfully managing their disease with the devices when they were covered by private insurance—to pay out-of-pocket for CGMs or go without.
By crucas • JDRF

During a conversation with Medtronics today on another subject, “Medicare will not cover CGMs anytime soon!”.

Bummer!

Medicare does not cover Medtronic but has now approved Dexcom G5 as a DME. Call Dexcom and talk to them.

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The Dexcom G5 is the only CGM on the market approved by the FDA to use in making treatment decisions. My understanding is that Medicare has shifted its CGM policy from a firm “no” to consideration on a case-by-case basis. It is hoped that the agency will make a more permanent national determination decision sometime this year. Things are moving in our direction!

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Terry, I think the case by case would work only when the patient’s doctor/endo would write a letter of medical necessity. I do not think my endo would write a letter like that since I can feel my lows in the 70s 75% of the time. If my BG drops slowly, my body adjusts enough that I do not notice a low. If I am sleeping, it would not awaken me under those circumstances. There is probably not enough reason for my endo to write a coinvincing letter.

I’m not sure what “case-by-case” basis means to Medicare. If I were faced with this scenario, I would find out what is needed to apply for the exception.

In your case, Richard, you are saying you catch your lows 75% of the time. I think even that data could be used in a letter of medical necessity. You are not able to sense low blood glucose 25% of the time. That’s a big number to me.

It would be nice to read an account of someone who has gone through the process since the January CMS announcement. Good luck. I am on Medicare but my employer-based retiree insurance pays for CGM equipment and supplies for me.

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I am pushing 70, on Medicare and have also been denied CGM coverage. I can have a BG of 35 and no symptoms at all. I think it is a normal accomodation to keeping BG low, which is the only way to survive without complications. I understand that, if you persist and have physician support, you can eventually succeed. Dr Steve Edelman, an endocrinologist from UCSD, says that we apparently are no longer type 1 diabetic once we turn 65.

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Hello Calferness, I looked for Dr Edelman’s statement. I think he was referring to the actual diagnosis made after an individual is 65. Then it is LADA, and not the typical type 1.

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It was actually a sarcasm relating to the lack of CGM coverage for t1s by Medicare. He made it with reference to his soon turning 65 (he’s been t1d since childhood). This particular comment might not be something you could find in a search.
Clif

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Ah, right. I didn’t catch that it was snark either. Pretty decent snark too.

I just found out that as of about a week ago Medicare will cover CGM’s. They are still figuring out the paperwork but they are now covered.
Dexcom told me that because of a classification change Medicare is now supporting them.
Go to Dexcom.com fill out form with your information and they will get back to with info.
Been a long road getting here and I don’t know who to thank. That’s all the info I have right now.

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good info here about this development

I have read that the only CGM that will be covered by Medicare is the Dexcom G5. Have you read something different? I am using the Dexcom G4, and I love it so much! I am thinking that the G4 will not be covered. I have also heard that the people asking to be covered will be handed on a case by case basis. There is a list of criteria that must be met to get coverage. One of them requires that we do not feel our lows and we depend on our CGM for that reason. If I get my endo to write a letter of medical necessity, I don’t think she would say that I do not feel my lows. Occasionally I don’t, but usually I do feel them. On that point alone I probably would not be approved.

@MarieB I have been told that there will be more information from Medicare soon and probably more suppliers will be contracted. I have been told April 15 by more than one source. I don’t know whether more strict criteria will be implemented, but I have been told that there were be more regulations.

Some people are already getting supplies from Liberty, but most are having to say that they will pay the cost if Medicare does not approve them or their secondary does not pay. At the same time, some of those people say that they did not have to give credit card info to Liberty and were still shipped supplies.

I started Medicare on Saturday and am starting with getting organized for pump supplies before tackling CGM. I have to get a C-Peptide test along with a fasting BG before I am eligible for pump supplies. This will be my first C-Peptide test ever because I was diagnosed long before the test existed. Fortunately I have enough sensors to carry me through for a couple of months. I use each sensor for 3 weeks, so 2 months is only 3 sensors.

@Richard157 The G4 will not be covered by Medicare because it has not been approved by the FDA for dosing insulin. I doubt that Dexcom will try to have that changed because they want to move away from G4 except for those who require it for certain pumps. They do not make as much money off of the G4 because the transmitters last a long time. The G5 is a better financial model because you are required to purchase a new transmitter every 100 days. The G6 is expected within a year and will have more accuracy, fewer calibrations, and a new inserter. That is Dexcom’s future, not the G4. I would be very disappointed if my endo would not be willing to write a letter of medical necessity for me and IMO it only takes 1 low that you don’t feel to cause an emergency.

On another subject–If I had to guess, I would think that Medtronic will not try to get the Enlites approved by the FDA for insulin dosing and will instead put all of their eggs in the basket of the new sensor system to be released with the 670G. Since the 670G will be dispensing insulin continuous based on sensor readings, it seems hard to think it isn’t approved by the FDA for dosing insulin. The Enlites have a higher MARD than the Dexcom G5 and it is very possible that they wouldn’t be approved for therapeutic use by the FDA anyway. That’s of course my own opinion. :grinning:

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Thanks Laddie, that is good information.

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Again the paperwork/wording hasn’t been finished yet. Latest date ia April 15 but that is the 3rd 15th Liberty has been told. :confused: Goverment ?

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Richard, I don’t mean to be flippant, but you can point out to your doctors that you don’t feel low when you are sleeping. This, to me, is good enough reason for the MD to write you a letter of medical necessity.

In my 33 years with T1D, I’ve gone from feeling almost every low to not feeling any low to now feeling most lows. Do you really feel every low? “Usually feeling a low” is not good enough when you treat with insulin.

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@Terry4, when my BG drops fast I always feel the lows. My body does not have time to adjust under those circumstances, and I can feel the lows when I am in the high 70s. When I drop slowly my body does adjust enough that I am much less likely to feel lows, and I may not notice until I am in the 50s. That is when I need a CGM that will enable me to see the trend long before I reach the 50s. That can happen both day and night. I think my endo will write a letter for me. I am expecting Medicare to be very stubborn, and not accept every request for coverage. I am thinking it will be handled on a case by case basis.

Richard – The last I’ve read is that the process has moved beyond the “case by case” basis stage. This March 24, 2017 Dexcom press release shows four criteria that must be met for Medicare coverage. The process is new yet coverage seems imminent.

If I were you, I’d closely follow Laddie’s coverage of this topic as she’s new to Medicare as of just a few days ago and has this process under scrutiny. She intends to get Medicare coverage for a Dexcom G5 CGM.

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Hi All,
It is interesting to note that there are some hidden factors in the original CMS Ruling CMS-1682-R. It would be wise to read the document in total. What the ruling has accomplished is to wipe out all of the prior successful appeal winners.
Meaning no coverage at all under the new bill. Next, read the historical section in the beginning. The FDA was real clear sensors have a warranty period of six or seven days for safety reasons. When one changes a sensor each and every seven days, 365/7 = 52 sensors. The Medicare plan is to only cover one box per month. For a Dexcom user that would mean a total of 48 sensors. Four sensors to a box would mean that we would be missing coverage for 28 days. There has been a May 4 release. You cannot use the connection factor to share your results with another friend or family member. If you do you will lose coverage for supplies. The last major point is an attempt to force linkage of the number of blood glucose strips. Medicare is requiring a substantial drop, cut, reduction in the number of blood glucose strips. Liberty Medical out of FA was the supplier for primary Medicare. Liberty Medical has left the marketplace effective May 28th. There are no
medical suppliers for the Dexcom 5. What happened to me was a complete blackout of the prior approvals for Dexcom G 4 products. I have had two back up back denials for an upgrade to a Dexcom 5. Your physician is being required to use an entire set of new codes. Wrong codes and language you will be denied. This a major mess with no clear direction except for total control by Medicare. Be careful. Be sure you and your physician are up to speed with the ever-changing rules and reg.

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