Diabetes Supplies Now a Patient Safety Dilemma

Friday, September 19, 2014 9:48 am EDT

Dateline:

JACKSONVILE, Fla.

JACKSONVILE, Fla.--(BUSINESS WIRE)--The following is by Amy Johnson, AACE content creator:

Happy 65th birthday indeed! Gladys T.* was stunned to learn that as of this milestone birthday her insurance no longer covered the cost of her continuous glucose monitor (CGM) – a medical device that she considers “a lifesaver.” That is because her new insurance provider is Medicare, which steadfastly refuses to pay for these CGMs, which provide real-time measurements of sugar levels to people with diabetes. Gladys, and many others like her, calls her CGM a lifesaver because she is a recent widow who lives alone and has a history of severe hypoglycemia (low blood sugar), which can result in loss of consciousness. Her CGM has helped her feel safe living alone in her home.

Diabetes patients are faced with challenges every day relating to blood sugar monitoring, medicine dosing and carbohydrate intake. Often they have to deal with the many medical issues resulting from the disease – cardiovascular risks, kidney problems, vision issues, even lower limb amputations. As if that is not enough, many of these folks are facing big problems related to access, reimbursement and quality of diabetes testing devices and supplies.

Medicare coverage for seniors does not include the cost of continuous glucose monitors.

Physicians struggle with the fact that they have to tell their 64 year old patients that once they turn 65, Medicare will not pay for their continuous glucose monitors. Ironically, as a result, many patients often wind up in the emergency room with severe hypoglycemia, costing the Centers for Medicaid and Medicare (CMS), the government agency which administers Medicare, even more money. Further, CMS states that CGMs do not qualify as Durable Medical Equipment (DME), because the devices do not serve a medical purpose, even though Gladys, and many clinicians, believe that is not the case.

Mark S.* uses a glucose meter and test strips to measure his blood sugar levels and has to limit the number of strips he uses each day because his insurance only provides for a certain number per month. Recently, it has been particularly difficult because his blood glucose meter has been providing widely varying and possibly faulty readings causing Mark to run out of strips before he is able to obtain a refill. So because he is unsure about his meter’s accuracy – though the device had been approved by the United States Food and Drug Administration (FDA) – Mark has two choices: ration the test strips or go without testing at the end of each month.

Insufficient monitoring of quality and safety of devices and supplies after they have been approved by the FDA and placed on the market

The FDA regulates blood glucose monitors and testing strips that are currently on the market. Devices that are approved after initial manufacturer testing may not maintain the accuracy levels in post-market use. Inaccurate results from faulty diabetes testing supplies can lead to incorrect insulin dosing and increased hypoglycemic events.

Rick M.* is a general contractor who has insulin-dependent diabetes and is enrolled in Medicare. Rick has learned in 47 years in the construction business that it is not always the best bet to go with the lowest bidder. Corners can be cut; safety can be compromised; what started out providing a bit of initial savings can end up costing far more in the future. To Rick, a policy of always choosing the lowest bidder is just unsound business. Little does Rick know that the diabetes supplies he receives through Medicare are the result of a lowest-bid competition. Instead of his business being at risk, now his health and well-being could be in jeopardy.

Competitive bidding can lead to lowest-bid products of questionable quality and safety.

Medicare’s competitive bidding program is intended to provide cost savings by only paying for supplies such as diabetes test strips that are provided at the lowest bid cost - a laudable objective in a system that has been plagued by fraud and over-charges. However, such a program could compromise the safety of those patients with diabetes receiving supplies as the economics of this process often result in the lowest bid equating to lower quality. Post-marketing surveillance is a term used to describe the monitoring of products after they have been approved and are on the market. The accuracy and safety of diabetes monitors and tests strips could slip if the post marketing surveillance is insufficient, a concern held by physicians and patients alike.

To be clear, diabetes is an extremely difficult disease to control. It is a drain on resources and dollars, a hardship for those with the condition and, unfortunately, has reached the level of national crisis as the number of those afflicted continues to rise. It is also big business, with patients, physicians and the medical community, insurance companies including Medicare, researchers, employers and advocacy organizations all having a stake in the process of caring for more than 29 million Americans with diabetes and the 83 million with pre-diabetes. With so many “stakeholders” involved, finding solutions to problems through consensus is not easy, but it is possible. That is the objective of the gathering of representatives from all of these groups in Washington, D.C. on September 28-30 which is being organized by the American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE). Endocrinologists are the physicians who specialize in hormone and metabolic health and, as such, are the acknowledged experts in diabetes care. The AACE/ACE Consensus Conference on Glucose Monitoring will address concerns and issues surrounding the quality, safety, access, and pre-and post- marketing scrutiny of optimal glucose monitoring for both glucose strips and continuous glucose monitoring. The conference will culminate in a published consensus statement and specific recommendations to federal healthcare policy makers that will be presented during a congressional briefing.

It seems that nearly everyone is in one of two situations: Either you have diabetes or pre-diabetes, or you know someone who does. At this stage of the game, doing nothing to improve the management and care of patients with diabetes will only lead to more and more severe outcomes and ratchet up the price tag exponentially. But there is hope that solutions can be found when private and public stakeholders gather in the nation’s capital to reach consensus for benefit of the greater good. Consensus…that is a concept which used to be pretty popular in Washington.

*Actual scenarios reported by physicians. Names are fictional.

Amy Johnson is content creator with the American Association of Clinical Endocrinologists.

Contact:

American Association of Clinical Endocrinologists (AACE)
Amy Johnson, 904-404-4150
ajohnson@aace.com