# FAIL

Let's cut to the chase, shall we? A few years ago, Medicare, in an effort to save money, decided to roll out a nationwide mail order program for diabetes blood glucose testing supplies. DPAC has been providing data and analysis through our #SuspendBidding program that shows that not only is money not being saved, but people with diabetes have higher hospitalization rates and... sadly... higher mortality rates in the test markets where the mail order supplies are being shipped. (You can learn more here.)Today, under the latest round of the Medicare Competitive Bidding Program, only 11 companies across the country are allowed to provide testing supplies through mail order.

ONLY ONE BLOOD GLUCOSE METER CURRENTLY OFFERED TO MEDICARE BENEFICIARIES THROUGH MAIL ORDER MEETS CURRENT FDA ACCURACY STANDARDS.

The Diabetes Technology Society recently released a study through their Blood Glucose Monitoring System Surveillance Program which shows that out of 18 blood glucose monitoring systems, representing 90% of the U.S. market when the study was conducted in 2015, only 6 passed the FDA accuracy standards. As stated on the Diabetes Technology Society's website:

The Diabetes Technology Society Blood Glucose Monitor System (BGMS) Surveillance Program was established because of evidence that cleared BGMSs do not always achieve levels of accuracy matching either: 1) their performance that resulted in becoming cleared by FDA; or 2) international standards of accuracy. Poor performance of these devices can lead to adverse clinical and economic consequences. This surveillance program assessed the accuracy of 18 blood glucose monitoring systems (BGMSs) marketed in the USA across a wide range of blood glucose levels in the hands of trained professionals. These 18 BGMSs represented approximately 90% of the commercially available systems that were used from 2013 to 2015 by diabetes patients and obtained from consumer outlets.

For Medicare beneficiaries, it's grim. Only one system offered through the mail order program designed by the Medicare Competitive Bidding program passed. All the others?

FAIL.

Only one blood glucose monitoring system and only through one mail order company.

[bctt tweet="Is your #diabetes BG meter on the #FAIL list? What to do: http://bit.ly/2uJfehx" username="DiabetesPAC"]

FDA Accuracy Standards

The others? They do not meet the FDA accuracy standards, which is +/- 20% for blood glucose readings of over 75 mg/dl and +/- 15 mg/dl for when blood glucose is 75 mg/dl or less.

What does that mean to people with diabetes?

If you are on Medicare and receive your blood glucose testing supplies through mail order, you run the risk of not having a meter that is accurate. This increases the risk, especially when you take insulin to manage diabetes, that you are dosing insulin based on an inaccurate blood glucose reading. This increases the risk of hyperglycemia (high blood sugar) or hypoglycemia (low blood sugar).

As people with diabetes age, the risk increases of hypoglycemic unawareness (not being able to feel a low blood glucose level). Imagine checking your blood glucose level with a meter that is part of the FAIL list and dosing insulin or driving or operating heavy machinery. What happens if the meter has been shown to FAIL, giving you a reading that is higher than what an accurate blood glucose system would give you. You run the risk of going into a hypoglycemic state... putting you and the people around you at risk.

Why Would Medicare Pay for a Failed Blood Glucose Monitoring System?

Great question.Wouldn't you like to know why they are wasting taxpayer money AND putting our diabetes community at risk by offering mostly meters that FAIL current FDA accuracy standards to those on Medicare?We should know.And we think that Seema Verma, the current Administrator for the Centers of Medicare and Medicaid Services, and Tom Price, the current U.S. Secretary for Health and Human Services, should answer that question.

What Can You Do Right Now to Stop the Meters on the FAIL List from being used by Medicare?

1. Send an email message to Tom Price and Seema Verma, asking them why people on Medicare using the mail order program are being offered blood glucose monitoring systems that FAIL accuracy standards.
2. Share this post with your family, friends, and colleagues via email or other social media means. (Use the easy share buttons below.)
3. Sign up for the latest alerts on this and other important diabetes policy through DPAC.

We must tell the policy makers at Medicare and Health & Human Services that by offering blood glucose monitoring systems scientifically proven to FAIL, they are FAILING the diabetes community. As an immediate first step, they must SUSPEND Medicare's Competitive Bidding Program and stop offering meters that FAIL.