Access

Election Countdown: Hello, CGM Bill? We’re Keeping Score.

For those of us keeping score about the CGM Bill in Congress at home…

Wait, why bother keeping score at home when you can easily do so at DPAC’s website?

Here’s where we are sitting with the Medicare CGM Access Act of 2015, giving Medicare beneficiaries coverage for continuous glucose monitoring systems:

Medicare CGM Access Act of 2015

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62 % of the House and 50% of the Senate think that this is something important for people with diabetes on Medicare in order to save taxpayer money AND the safety of those beneficiaries.

What about the other 38% of the House and 50% of the Senate? Do they hear us?

Perhaps they’ve forgotten about diabetes.

Let’s Remind Them about Diabetes

Let’s remind them that this is an important bill that needs to be passed.

Let’s remind them they can pass this even if they’re campaigning for re-election.

Let’s remind them they can pass this even if they’re not re-elected during the lame duck session.

They can pass the bill before the end of 2016. There’s no reason why they shouldn’t – or couldn’t.

Ask them now why wouldn’t they? 

Click on the link above and send a message to your Congressional representatives asking for them to remember the diabetes vote…. there are 29 million families worth of votes.

And we’re keeping score.


Most private insurance plans covers continuous glucose monitors (CGM) because it adds value and safety to traditional finger sticks. For people using insulin and other medications that can cause low blood sugars, CGM can help prevent dangerous hypoglycemia. Seniors are more at risk than others for hospitalization from hypos, but currently Medicare will not cover CGM. 

CGM is the ongoing measurement of glucose in the body. It is a tool that gives people with diabetes blood glucose values over time, showing how quickly blood glucose values can change and in which direction it changes on a graph. You can think of it as gathering a string of information similar to what you would get testing with a meter every few minutes, but without all the finger sticks. 

Let help Congress see the value in CGM and have Medicare cover CGM usage. 

Guest Post: A DME Owner’s Perspective on Competitive Bidding

sam-headAs the owner of a durable medical equipment company, pharmacy and the parent of a Type 1 diabetic child, I participated in Medicare’s competitive bid program and watched closely as Medicare decimated the reimbursement amounts for diabetes supplies.

My company successfully bid and was offered a contract for the initial round of mail order diabetes testing supplies in addition to other DME equipment. This was a trial for mail order diabetic supplies before it was rolled out nationwide.

I chose not to accept the bid for diabetes supplies but did accept other DME contracts. In hindsight, I should have accepted that contract but it also prepared me for the national bid that was to come. I looked at it as practice for the success of my future business.

I bid the first round of the national roll out along with many of my peers. The statistical numbers were something like 2500 DME providers that had billed for diabetic testing supplies prior to the national bid. Medicare awarded 15 contracts. Medicare estimated 10 million beneficiaries had diabetes and 60% used mail order for diabetes supplies. (That gives you some idea of how many patients would be affected.)

Competitive Bidding Program

The Competitive Bidding Program was flawed from the start, allowing any qualified bidder to submit “lowball” bids and then decide whether or not to accept the bids after the bid amounts were published. Basically, you could bid well below your cost, get a contract offer, and then decide to accept the bid or not.

If your business relied on that product category, then you bid low and crossed your fingers. Unfortunately, this creates an artificial price point in the bid amounts because if the low ball bidder chooses to not accept the bid price, the median price was not recalculated by Medicare.  Many economists and scholars evaluated the Medicare bid process and published article about how the entire process was flawed.

Quality

Now let’s talk diabetic supplies. Even before competitive bidding I was looking for quality, inexpensive meters and strips that I could provide to my Medicare patients. I would test the “off brand strips” on my Type 1 diabetic son compared to name brand strips to see how the readings compared. My son was already checking his sugar up to ten times a day as a very active, very self-managed type 1 diabetic so it didn’t even require an extra finger stick.

If I could find good off brand strips that only required small sample sizes and no-coding they would be offered to my Medicare patients. I did not consider strips that required coding or the large “hanging drop” of blood sample size. I had thousands of Medicare patients, so I was able to get very good contract pricing from large name brand companies. If a small percentage of patients chose less expensive strips, I would be saving a considerable amount on my cost of goods because the Medicare reimbursement was the same on every strip regardless of brand or quality.


If what you’ve read so far disturbs you, you can do something about it. Click the image below and send a message to Congress, letting them know this isn’t acceptable. 

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The Math

To simplify pricing we will only discuss pricing on 50 strips. Meters were almost always free from the manufacturers or distributors because they wanted the strip business. My contract pricing on name brand strips was about $20 for 50 strips. Medicare reimbursed about $32. Most patients got either 100 strips every 3 months (if they needed them) or 300 strips every 3 months depending on if they were Type 1 or Type 2.

Factor in shipping costs of about $5.50 per shipment and the profit was pretty good. Keep in mind, there is a lot of administrative cost associated with the required paperwork, delivery confirmation, and billing Medicare. Depending on the scale of your business this cost varies. I did not buy the super cheap strips that had 10 year old technology, required giant sample size, needed to be coded and the readings were very poor. The cost on those was about $9.00 and were most often a never heard brand.

Here is the breakdown on how Medicare’s competitive bidding changed diabetics’ lives.

  • – The small market trial reduced the reimbursement to about $18.00.
  • – The first round of nationwide competitive bidding reduced the thousands of providers to just 15 providers for the entire country and a few other markets like Puerto Rico.
  • – The reimbursement dropped to $10.41 per 50 test strips.
  • – In 2016, the National Mail Order contracts were re-bid again, reducing the providers to just 11 providers and the price came in at $8.32 for 50 test strips.

What’s Happening Now

$8.32 is the reimbursement as of July 1, 2016 through December 31, 2018. The last I checked, my contacts in the industry said they could buy cheap, inaccurate strips for about $5.00. Then you add in your shipping cost, administrative cost and billing cost. Also, because of rampant fraud, Medicare conducts a lot of audits and denies a lot of claims for supplies. That eats in to your profit substantially.

I ask you to add those few figures up that I have given you. There are other rules built into to the bid process that are supposed to protect the end user of diabetic supplies; rules designed to keep the companies from switching your meter/strip brand to another model (because they are cheaper) but the rules can be manipulated.

Gone are the good, modern meters. You can call and ask for a known name brand but the suppliers will tell you they don’t stock that brand and to call someone else.

All I can say is I’m glad I am not a Medicare patient. Competitive bidding has been implemented on most highly utilized DME products like oxygen and CPAP supplies. The suppliers have been forced to file bankruptcy or just close their doors, leaving patients to suffer. The diabetic supply competitive bid is an example of how bad other DME categories will get; it is not an if, but when.

I sold my business to a national competitor in 2013 because I was able to successfully “win” many bids for home oxygen and CPAP supplies. Because my son is a Type 1 diabetic, I volunteer and donate to JDRF as they actively fund many other businesses that develop new devices and medicines that help all diabetics.


Note: Curious as to what meters and strips are currently offered through the Medicare Competitive Bidding Mail-Order program?

Out of nine national mail-order suppliers, three “household” name brands are offered: Bayer Contour/Contour Next, Abbott Freestyle Lite, and Roche Accu-Chek Aviva.

The others? How many of these have you heard of?

On Call Express, On Call Plus, Solus V2, True Balance, True Result, True Test, Prodigy Autocoder, Clever Choice, Clever Choice Voice, Advocate Redi-Code, Advocate Redi-Code Plus, Evencare, Embrace, True Metrix, Glucocard Expression, Glucocard Expression Vital, Caresens, Caresens N, Novammax, Unistrip I, Easy Plus II, Easy Step, Easy Talk, Easy Track, Gmate.

It’s important to not lose access to quality, accurate meters and strips.

Use this link to learn more and take action. 

 

Guest Post: Victor Walsh on Competitive Bidding

victor-a-walshDPAC shares stories about access and the issues patients have encountered in getting the diabetes supplies, medications, and services they need. Dr. Victor Walsh, Ph.D and PWD (person with diabetes),  gives his thoughts and comments about the Medicare Competitive Bidding program for diabetes testing supplies by sharing his story.


On the morning of January 21, 2014, I went into insulin shock and lost consciousness on the front porch of my home in Santa Cruz, CA. A passerby called 911 and a medic alert team revived me intravenously with glucose and then took me to nearby Dignity Hospital.

Several months later, I contacted the Centers for Medicare and Medicaid Services (CMS) in San Francisco. In my email to David Sayen, the Regional Administrator, I mentioned that this episode could have been prevented, “if I had coverage for more test strips to check my blood glucose.” I also noted that I had a recent second medical emergency, in which I went into insulin shock asleep, but somehow woke up. Unable to call anyone or talk, I crawled into the kitchen and revived myself by licking up apple juice that I had spilled on the floor.

Competitive Bidding Program (CBP)

What is happening to me and other insulin-treated diabetics is an unfolding disaster that has eluded the media and public awareness. In 2011, Medicare launched its Competitive Bidding Program (CBP) as required by the 2003 Medicare Modernization Act (MMA) to reduce costs, prevent waste and streamline acquisition of medical equipment and supplies for Part B beneficiaries.

Under CBP, coverage of test strips is limited to 300 over three months or three per day. Additional strips may be covered provided the treating physician can justify their usage as “medically necessary and reasonable.” The physician must provide the beneficiary’s testing logs to the supplier to confirm a higher frequency in use. The process is unwieldy and prone to error; burying physicians in paper work that detracts from time with patients.

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To learn more about this program, click the image.

Claims and appeals on my behalf have been repeatedly denied resulting in lapses of coverage and mounting out-of-pocket expenses, including for continuous glucose meters, transmitters, sensors and other diabetic equipment that Medicare does not cover. Many seniors simply do not understand how CBP works or are unable to record logs and thus slip through the safety net.

Diabetes is expensive to treat, especially in a patient’s later years when ongoing difficulty to control glucose levels often leads to other serious complications. In 2014, 28% of Medicare’s beneficiaries had been diagnosed with diabetes. Almost one in every three Medicare dollars was spent on their care.

Controlling Fraud And Waste, But At What Cost?

Medicare’s unprecedented growth over the past decade has triggered an epidemic of fraud, abuse and improper claim payments amounting to an estimated $60 billion now. In 2014, improper payment for durable medical equipment and supplies totaled $5.1 billion. This includes big-ticket items like wheelchairs, respirators and oxygen concentrators, as well as blood glucose test strips.

Clearly, there is a compelling need to control fraud and waste, but CBP’s focus on documentation is not the right approach, especially as it relates to cases like mine. It creates real barriers to attaining necessary testing supplies and is dinosaurian in a digital age.

Hypoglycemia and CBP

Furthermore, CMS’s staff does not understand the life-threatening consequences of a diabetic condition called hypoglycemia unawareness—the inability to recognize the onset of rapidly dropping blood glucose levels. Not all diabetics experience it, but older, long-term, insulin-treated diabetics like me are prime candidates.

Hypoglycemia occurs because continual and erratic blood glucoses eventually incapacitate the brain’s glucose-sensing neurons from transmitting symptoms. The brain does not store glucose, but draws it directly from the bloodstream. Rapidly declining glucose levels seriously affect its cognitive, locomotive and visual functions and, if untreated, lead to convulsions, comas, brain damage or death.  

Limiting coverage of diabetics vulnerable to hypoglycemia to three strips a day is not only foolish but irresponsible and dangerous. They must check their blood sugar before and after every meal and always at bedtime; otherwise, they may not wake up. Ask any endocrinologist.

Restricting Access

Another problem is the ongoing difficulty to acquire essential testing supplies. In June, my mail-order supplier CCS Medical withdrew from supplying branded test strips because CMS cut the reimbursement rate by 20%. I never heard from CMS. It took me over a month to find another supplier  that carried One Touch Ultra Blue strips that I use for my blood glucose meter. Service ended abruptly severally weeks later when the mail order company stopped carrying them. There is only one mail order supplier in my area that still carries this brand. As for local pharmacies, only one accepts Medicare beneficiaries whose test strip usage exceeds the local coverage limit of three per day.

Jeopardizing Safety

Such disruptions and delays, along with long wait times for follow-up calls, jeopardize patient safety. I have repeatedly called or emailed CMS staff in San Francisco asking questions about how the mail-order suppliers are monitored, but answers almost always focused on coverage requirements, not supplier service, and now I know why.

First, beneficiaries are required under law to order supplies and equipment from either a CBP mail-order supplier or local pharmacy contracted by Medicare. The contracts differ in one critical respect: Pharmacies are not part of CBP and thus have the option to bill beneficiaries, while the small number of mail-order suppliers must accept as full payment the amount approved by Medicare for each item. Reimbursements are substantially less than Medicare’s fees for services, but the trade-off is that the mail-order suppliers gain a monopoly on a burgeoning market of millions of new Medicare customers.

Second, the law exempts CBP from any safety monitoring or oversight restrictions. Given the low, volatile profit margin, this has prompted mail-order suppliers to reduce overhead. The new rate of reimbursement for glucose test strips is only $6.65 per vial of fifty. As a result, mail-order channels have limited the availability of branded test strips needed by diabetics. The outcome has been a disaster for them and probably other Part B beneficiaries.   

In April 2016, the American Diabetes Association (ADA) published a report in its journal Diabetes Care that is highly critical of CBP’s impact on the safety of insulin-treated diabetics and to access to testing supplies. In the program’s nine pilot test markets, the proportion of insulin-treated diabetics that switched from full to partial or no testing supplies increased by 58% compared to a 14% decrease in non-test sites.

The report found that death and hospitalization rates of diabetics in those markets were nearly twice those of Medicare’s other insulin-dependent beneficiaries. Despite the report’s recommendation to suspend the program immediately, it was expanded to the entire nation in July 2013.

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You can act now to tell Congress this must stop by clicking this link.

Programs to reduce costs, though necessary, should never be pursued if they risk patient safety. CMS has never explained how or if it assessed the risk to diabetic recipients before launching CBP and how this program is “reasonable and necessary” in accordance with the Social Security Act of 1965 that it is charged to uphold and administer.

Living with a chronic, incurable disease can be overwhelming and life-threatening. It demands rigorous adherence to a daily regimen and vigilant self-monitoring. This is my responsibility, but it is Medicare’s responsibility to provide the essential tools to manage it.  For me this means CBP should not invalidate my right to manage my health as prescribed by my endocrinologist. In this capacity, CBP has failed miserably and must be repealed by the next Congress in order to prevent further loss of human life.


Diagnosed 54 years ago as a type 1 diabetic, Dr. Victor A. Walsh, Ph.D, is a retired California State Parks historian.  Now a Medicare Part B beneficiary, he is concerned about coverage and management issues involving diabetic testing supplies. His historical and literary essays have appeared in the Christian Science Monitor, Rosebud, California History, Journal of the West, Travel Thru History, San Antonio Express-News, Irish America, Literary Traveler, among other publications.

We Deserve Answers from Medicare.

As people impacted by diabetes living in the United States, we know that any disruption in accessing our supplies can be catastrophic. Many individuals fight to get the supplies, medications, and services they need to stay healthy with diabetes.

We need to tell Congress that we need answers about the Medicare Competitive Bidding Program before we go to the voting booths.

 

The current situation for individuals on Medicare is this: if you have diabetes, your blood glucose testing supplies are part of CMS’s Competitive Bidding Program. The program requires mail order suppliers to bid to CMS to get contracts.

Contracts that are given aren’t based on quality; they’re based on price. In fact, a supplier can bid ridiculously low and after winning the bid, decide not to sign the contract. But that bid becomes part of the pricing scheme, pushing the reimbursement cost for blood glucose testing supplies lower.

If you are on Medicare and want to use one particular brand of test strips, you may find that the suppliers no longer carry them and offer you a substitution (that isn’t accurate). Or that the mail order company you have used no longer has a contract. Good luck finding a new one on your own. This program restricts access to testing supplies by making it difficult for Medicare beneficiaries to get the supplies they need.

Studies have shown that the Competitive Bidding Program currently pushed by CMS is flawed. It’s not saving anyone money. It’s costing taxpayers money though increased hospital stays and it’s costing patients their lives. 

This spring, the diabetes community and concerned constituents sent letters to Congress, asking them for an oversight hearing on the Competitive Bidding Program for diabetes supplies for Medicare Beneficiaries.

Congress has done little (if nothing) to demand accountability and data from CMS.

In June, Senator Orrin Hatch sent a letter to CMS requesting that the agency “share the specific indicators the agency is monitoring to determine if beneficiaries experience access problems or adverse outcomes and to report the results publicly on the agency’s website.” To date, this request has been ignored, and CMS continues to claim that competitive bidding is causing no harm or disruption and that there have been significant cost savings. CMS ignores the dramatic rise in costs associated with increased hospitalizations and emergency care.

We are asking you to contact your Senators and Representatives and tell them to step up before the election and demand the data showing if CMS is even monitoring this dangerous and deadly program. Click here and send a letter to your Congressional representative today.

 

Ask An Expert: Access Matters – Gary Scheiner, MS, CDE

 

If you’re frustrated with what’s going on with insurers and finding access to the tools, medications, and services you need to stay healthy with diabetes, play back this DPAC Ask An Expert with Gary Scheiner.

Gary Scheiner, MS, CDE (and PWD)

DPAC_AAE Gary ReplayGary Scheiner, MS, CDE joins the DPAC Ask an Expert series with a webinar on why access to the appropriate diabetes tool matters. Gary is internationally recognized for his expertise in helping individuals to successfully engage with their diabetes, the author of a number of prominent books on diabetes care and is himself a person with diabetes. He brings his diverse experience to the conversation on access. Click here to play the free webinar recorded on August 31. (Registration required.)

Gary is the owner and clinical director of Integrated Diabetes Services (http://integrateddiabetes.com/). He is an award-winning Certified Diabetes Educator, Masters-level Exercise Physiologist and person with type-1 diabetes since 1985, Gary Scheiner has dedicated his professional life to improving the lives of people with insulin-dependent diabetes. He was recently named 2014 Diabetes Educator of the year by the American Association of Diabetes Educators.

To learn more about #diabetesaccessmatters and why it should matter to you, visit the Diabetes Access Action Center

Do They Think We’re Dumb?

I’ve jumped through hoops of fire (or so it feels) to manage the insurance side of my diabetes. After thirty-three years of Type 1 diabetes, I sadly understand that I have to be vigilant and, at times, downright aggressive in demanding the services, supplies, and medications I need to stay healthy.

  • – Hours spent on hold with insurance customer representatives who act as gatekeepers, never allowing me to talk to individuals making decisions? Been there.
  • – Forcing my health care team to fill out paperwork for authorization overrides for test strips and letters of medical necessity and charts and notes to get devices? Been there.
  • – Researching health plans that don’t want to put benefits information online to be easily accessible and read so that I can make the right decision and not go bankrupt? Been there. 

And they claim that if you really need this medication, device, or service… well, you’ll just have to appeal.

And appeal.

And appeal.

What they hope is that you will give up and give in and let someone who has never met you or sat and discussed the best course of treatment decide your course of treatment. And in the end, you might lose the appeal.

Do they think we are dumb?

They must.

Do they think we’ll stop asking?

They must.

Do they think we don’t care because we’ve been quiet as a community?

They must.

You’ve been through there, haven’t you? Those hoops of fire?

You’ve been told that despite what your health care team has prescribed as being the best individualized plan to manage your diabetes, your insurance company says:

“We know you better. You don’t need this.” 

Did you know that you can do something?

The #DiabetesAccessMatters movement is our community’s way of saying that we are not dumb.

We will continue to ask.

We continue to care. 

And we won’t stop. 

#DiabetesAccessMatters Act Now (3)What Can YOU Do?

Your first course of action is to email the top executives of health care plans to let them know that “One size does not fit all when it comes to diabetes.”

You can do this right now by clicking here.

It takes one minute to do.

Let them all know that our health care team knows us best and prescribes the tools, devices, medications that is best for each individual.

What’s next for #DiabetesAccessMatters?

We want to change the way that insurance companies view diabetes.

If that takes contacting state insurance commissioners, we will.

If that takes Congressional mandates, we will.

Because while we each have individual diabetes treatment plans, we all have to fight to manage them.

Do they think we’re dumb?

Let’s prove them wrong. 

If you are unfamiliar with the #DiabetesAccessMatters movement, please click here and learn why the diabetes community is so concerned about recent insurance decisions that override the prescriptions written for medications, devices, and services. 

Anthem Responds to #DiabetesAccessMatters

media300x300actA DPAC Insider shared that Anthem, one of the companies receiving emails about the importance of access to prescribed diabetes treatments, has responded.

Dr. John S. Yao, M.D., M.P.H., F.A.C.P, the Staff VP Medical Policy Development, Office of Medical Policy & Technology Assessment stated in an email:

Anthem’s position regarding coverage for insulin pumps has not changed per CG-DME-01 and there have been no changes to our members’ access to insulin pumps based upon that document.  However, Anthem has adopted CG-DME-38, which is a new guideline that considers the use of continuous interstitial glucose monitoring (CIGM) devices by individuals with type 1 diabetes as Medically Necessary when criteria have been met.  For individuals with type 2 diabetes, the use of CIGM is considered Not Medically Necessary.  Anthem members with type 2 diabetes who are already receiving care with CIGM will continue to have coverage for their CIGM devices and supplies.

Disturbing News For Type 2 Diabetes Anthem Members

For individuals with Type 2 diabetes who are prescribed insulin or insulin pump therapy for diabetes management, this policy guideline is disconcerting, as the Type 2 diabetes community grows each day and more individuals are being prescribed insulin.

Anthem Insulin Pump Coverage

If you are wondering how the decision to provide insulin pump coverage is made at Anthem, this is what Dr. Yao has to say:

Please be aware that decisions of medical necessity regarding insulin pumps are made by Anthem’s Medical Policy and Technology Assessment Committee (MPATC).  MPTAC consists of physicians external to Anthem who are in active academic and community practice, as well as internal Anthem medical directors.  Anthem clinical guidelines are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, national physician specialty society recommendations, and the views of medical practitioners in relevant clinical areas, and any other relevant factors.  The available published medical evidence is reviewed regularly and monitored for new studies and data regarding the safety and efficacy of a wider variety of medical therapies, including insulin pump devices.

Future Anthem CGM Coverage

And in relation to Continuous Glucose Monitoring (CGM) coverage, Dr. Yao states:

In developing our position on CIGM devices, the MPTAC carefully reviewed and discussed the available scientific studies as well as the recommendations from the American Diabetes Association (ADA), American Association of Clinical Endocrinologists (AACE), the American College of Endocrinology (ACE), and the Endocrine Society.   Our current position is generally consistent with the recommendations from the ADA. The opinions and recommendations of “device salespeople and formulary purchasing agents” play no role and have no influence in the MPTAC decision-making process.

Earlier this year, DPAC participated in the AACE/ACE Consensus Conference for Continuous Glucose Monitoring. The summary statement is here. Those in attendance included patients and organizations, but the majority were the top endocrinologists in diabetes care. What was the consensus? The short answer is this:

…real-time glucose monitoring should be available to ALL insulin-using patients regardless of type.

accelogoThey are a top “authoritative organization,” so we hope that Anthem will include this statement in their analytical review of medical evidence. If they need studies, that statement alone includes 68 scientific studies that confirm the overarching need for CGM device coverage to anyone taking insulin. 

 

What You Can Do Right Now

If you think that one email won’t make a difference, here is the takeaway… it can. Because this is how Dr. Yao ends this email:

We are pleased to let you know that a full review of the medical evidence and updated recommendations from authoritative organizations regarding this issue is currently underway. The resulting analysis will be presented to the MPTAC at our upcoming 3rd quarter meeting. The outcome of MPTAC’s review of this topic will be made available later this year in the form of an updated policy document on our publicly accessible websites.  Please follow the instructions below to view those sites.
–              http://www.anthem.com/home-providers.html
–              To enter site, click a state – for example, <Indiana> <Enter>
–              Scroll down and click on <Anthem Medical Policies and Clinical UM Guidelines.

We look forward to reading the updated Anthem policy document. We would like to see more responses, which involves our community taking action: a few clicks to send emails. It’s easy, like most DPAC actions, but it does make a difference.

Act NOW to show your support of #DiabetesAccessMatters.

#DiabetesAccessMatters Act Now (3)

 

They Are Not Waiting. Neither Should We.

Can the Diabetes Community respond to FDA’s Challenge?

FDA is holding a hearing on July 21 to consider a labeling change application by Dexcom for  the Dexcom G5®. This panel will not wait for patient voices; they will vote on the 21st with or Sand of timewithout our input.

The hearing will consider labeling for the G5 to be a “replacement for their blood glucose meters and make treatment decisions based on the interstitial fluid glucose concentration reported by the CGM.” This would mean less fingersticks beyond calibration. Many individuals are already making treatment decisions off CGM readings, but currently, this is considered “off-label.”

FDA flat out Challenged the DOC – Are We 5,000 Strong?

During FDA’s Artificial Pancreas Webinar with DPAC on June 2, Dr. Lias spoke specifically about the July 21 hearing. From my perspective, and I was there, FDA flat out challenged our community, “If people want to organize together and submit… a single comment with a lot of signatures that’s one thing… ‘this comment represents 5,000 of us.’”

Why Your Signature Matters

Coverage is based on labels. The change FDA is considering will help people with diabetes get and keep CGM access. time4changeCGM coverage hinges on providers seeing it as a primary, necessary tool in diabetes care, rather than just secondary to fingerstick blood glucose monitoring. Medicare currently does not cover and continuous glucose monitoring because, they say, CGM is not a primary tool. Some private payers are following Medicare’s lead and putting up access barriers to CGM. This replacement labeling is critical to covered access to CGM.  

DPAC Makes It Easy To Matter

DPAC has drafted a letter of support. (Full text as PDF)

Here’s an excerpt:

We enthusiastically support the application to advance the label for accurate continuous glucose monitoring systems. 

As people living with diabetes, we have a unique perspective of risk. Insulin is a very dangerous drug; too much or too little have both immediate and long-term complications. Those who use insulin daily manage dosages to mitigate these risks. We rely on a complex combination of treatment protocols created in collaboration with our healthcare professionals to make rapid self-management steps throughout the day.

We intimately understand there is no perfect diabetes path. 

The American Diabetes Association Standards of Care recognize that “one size does not fit all.” They go on to emphasize that “for optimal outcomes, diabetes care must be individualized for each patient. A critical part of optimization is putting the appropriate tools, with the right labels, in the hands of the patient.

All devices, medications and management plans have risks. We accept these tradeoffs as part of the balance of daily life. We seek out high-quality tools to help successfully take careful steps that strike a balance between the possibility of an immediate health emergency from too much insulin and the likelihood of long-term health complications from not enough.

Signing takes a few clicks and adds your support to the 5,000 signatures needed. Click, fill in your name, and submit.

They are not waiting.

Act by July 14th and we will get the letter and signatures to FDA to be part of the materials circulated as part of the panel packet before the meeting.

What are you waiting for?

Act Now.

Guest Post: Chris Clement on Why #DiabetesAccessMatters

We will be sharing stories about access and the issues patients have encountered in getting the diabetes supplies, medications, and services they need. Chris Clement of Diabetic Ink,  gives his thoughts and comments about access and technology by sharing his story.


ChrisClementLiving with type 1 diabetes for 19 years (this week) I have seen a lot of diabetes technology innovation. I’ve used numerous glucose meters, a few different insulin pumps, various types of insulin, and now a CGM for the past year. Each time I am able to choose new tech to manage diabetes I see a significant improvement in my health. On the other hand, there are times when I have no choice, and I am left to figure out how to navigate around the speed bumps, attempting to adjust my medications or tools with the least amount of disruption. It’s discouraging and affects every aspect of the already-difficult journey.

Diabetes technology works best when it can reduce worry, human error, and blood sugar fluctuations. Innovators have found ways to combine technologies like glucose meters or constant glucose monitors that can talk to an insulin pump. Some pumps have settings that protect users and help individuals get the best possible results. Innovators find gaps in blood sugar management and fill them with solutions. The results can make a world of difference for our daily life and our health outcomes.

Choice in Technology

The problem is that people can be so different from one another. We don’t all have the same needs, we don’t all have the same gaps, we don’t all have the same lifestyle. It is so important to have a choice in technology that will best support our individual lives and needs.

The reality is that doctors, pharmacists, tech innovators, and insurance companies do not manage our diabetes. We do.

It’s Up To Us

It’s up to us to stay alive and to live well. It’s up to us to feed this complicated beast every single day. And yet it seems that the more great tools become available, the more red tape and restrictions are raised.

When I received my CGM a year ago my life changed quickly. My A1c dropped from 8.5 to 6.8 in three months. Improvements like this are common. But so is restriction to this technology. The battle to obtain coverage or even continued coverage of what is working best adds so much strain it nearly cancels the desire to fight for it. And yet, we fight because we have seen the results, we have found our individual paths, we know what we need in order to live well.

But, now we are seeing a new dilemma emerging. Alliances between insurers and providers, I believe, are the beginning of a dangerous new normal that further limits access to the treatments that we have grown to rely on for our health. These agreements can cause distress for the individuals that rely on these treatments and threaten to erode much of the progress that has been made for people with chronic conditions. It is very important to take a stand now. Share your story and strengthen the collective.

As has been stated by many diabetes advocates: We didn’t choose diabetes, but we should be able to choose how we manage our diabetes.



access_™ 612x300If you would like to share your story about access and why #diabetesaccessmatters to you and your family, please do so here. Our voices and our stories are powerful. Share yours.

Guest Post: Richard Vaughn on Why #DiabetesAccessMatters

We will be sharing stories about access and the issues patients have encountered in getting the diabetes supplies, medications, and services they need. Richard Vaughn of Richard’s Rambling Reviews,  gives his thoughts and comments about access by sharing his story.


10537874_1522101764744303_7846710536180999057_nI was diagnosed with diabetes in 1945, when I was 6. After 62 years of type 1 diabetes I was having some diabetes complications, and decided to use an insulin pump for the first time. The pump gave me much more stability with my blood sugar levels, with fewer highs and lows. My complications improved a lot, but a few years ago I started having complications again.

The likelihood of complications increases with the length of time since diagnosis. Then I read about the Dexcom CGM, and many of my friends were praising it highly. I wanted a CGM so much, but Medicare would not cover the expenses involved. My endocrinologist wrote a letter of medical necessity, but I was still turned down by Medicare. A friend was changing from the Dexcom G4 model, to the G5, and she sent me her older G4 equipment.

I love the Dexcom, and it has helped me so much!! The equipment will expire soon, and I cannot afford new equipment out of pocket. My good diabetes management will suffer, and my complications will probably resurface. I do not want neuropathy and retinopathy in my life in the years ahead.

If Medicare would agree to cover a CGM for me, I would have much better control of my diabetes. I feel that my health and life expectancy would improve significantly, without any serious complications, if Medicare would cover a Dexcom CGM.

Help Richard & Others Get CGM Medicare Coverage!

Act now and with a few clicks, send a message to your Congressional representatives, asking them to co-sponsor the CGM Medicare Act!


access_™ 612x300If you would like to share your story about access and why #diabetesaccessmatters to you and your family, please do so here. Our voices and our stories are powerful. Share yours.

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