Dear Health Care Leader,
We seek your support on a critical issue of concern to patients with severe hypoglycemia. As you may know, the Hypoglycemia Support Foundation is a patient advocacy organization with a distinguished 40 year track record. Regarding this urgent matter, the HSF is extremely fortunate to have the support and advice of Mary-Elizabeth Patti, MD, a board-certified endocrinologist, Director of the Joslin Diabetes Center Hypoglycemia Clinic, and a Harvard Medical School Associate Professor of Medicine practicing at Joslin Diabetes Center (a Harvard Medical School affiliate).
Dr. Patti’s clinical practice and research efforts encompass both diabetes and hypoglycemia (low blood glucose levels). Dr. Patti is internationally recognized as an expert in the diagnosis and treatment of hypoglycemia, treats patients referred to her from around the country who are facing this challenging condition, and has published many scientific papers about hypoglycemia. Dr. Patti is frequently asked to speak at national academic meetings (American Diabetes Association, Endocrine Society, etc.) about the diagnosis and management of this disease.
Currently the Medicare statute, Social Security Act Title XVIII, section 1861(n) defines durable medical equipment (DME) coverage of glucose monitoring devices for patients with diabetes. As a physician at Joslin, Dr. Patti can attest that coverage of glucose monitoring is absolutely critical for patients with diabetes, allowing individuals to monitor glucose levels to guide decision-making regarding insulin and other medications, improve health, and improve safety and avoidance of severe hypoglycemia (glucose concentrations less than 3.0 mmol/L or 54 mg/dL) which can occur with diabetes medications.
The reason we are reaching out to you is that the current statute does NOT permit coverage for patients with severe hypoglycemia occurring in the absence of diabetes. This makes no sense, as hypoglycemia is dangerous and life-threatening, whether due to insulin or other medications for diabetes, or whether the body itself makes too much insulin. As a result of this statute, Dr. Patti and all doctors treating this condition are unable to assist with improving the well-being and safety of their Medicare patients experiencing hypoglycemia outside of diabetes. It is currently impossible to request coverage via an appeal process for individual patients. (Dr. Patti’s exceptional attempts to do so have so far been denied.)
Dr. Patti has spoken with Medicare DME Medical Directors from around the country about this matter. These physicians agree that a change in coverage is important from a medical perspective, and have suggested pursuing a change in the relevant Medicare statute on behalf of patients with severe hypoglycemia.
We request your assistance in broadening the statute to provide coverage of glucose testing supplies for those patients afflicted by severe documented hypoglycemia (low blood sugar) without diabetes.
While most people are familiar with the fact that hypoglycemia can occur in response to insulin injection or other medications used for treatment of diabetes, it is less well-recognized that hypoglycemia can also occur when the body itself makes too much insulin, particularly in patients who have genetic disorders of insulin production, tumors which make too much insulin, excessive insulin production after stomach or intestinal surgery, or other hormonal or metabolic disorders. In all these conditions and more, severe hypoglycemia is dangerous and life-threatening. Glucose monitoring, particularly continuous glucose monitors with alarms which activate when glucose levels are falling to dangerous levels, can allow patients to detect hypoglycemia before it becomes severe. This is particularly important for ensuring the safety of those patients with frequent hypoglycemia who are no longer able to sense when glucose levels are falling quickly – a condition called hypoglycemia unawareness.
Lack of coverage of glucose testing supplies for patients with severe hypoglycemia does not make sense from either a personal, medical, or economic perspective: (1) hypoglycemia impairs the safety, well-being, and life of those with this terrible disease, (2) severe hypoglycemia requires the assistance of others, and may require costly 911 calls, ambulance transport, and emergency room visits, and (3) uncontrolled hypoglycemia can cause disability, inability to drive or maintain employment, and increase the burden for both the affected individual, their families, and the community at large.
Thus, we are requesting that you formally support our advocacy efforts to introduce a bill to revise the Medicare statute to extend coverage of glucose testing equipment to those patients with severe hypoglycemia outside of diabetes. Extending coverage of glucose monitoring supplies (both capillary glucose monitoring and continuous glucose monitoring) to patients affected by severe hypoglycemia is essential to improve the health, safety, and well-being of these patients. We specifically seek two action items from you: (1) Cosign a letter addressed to representatives on the House Ways and Means and Health Subcommittees and officials with the Centers for Medicare and Medicaid Services, the federal agency within the United States Department of Health and Human Services that administers the Medicare program, and (2) Join a list of distinguished health care leaders heading a petition that will be shared with the general public supporting this effort.
Following our signatures, please note that we provide additional information about this condition which may be helpful to you or your patients in regards to fully understanding this condition and our request. We thank you in advance for your consideration. Please contact Wolfram Alderson if you are interested in signing on to this effort and adding your name to a group of doctors supporting this initiative.
Hypoglycemia Support Foundation
Mary-Elizabeth Patti MD, FACP
Investigator and Adult Endocrinologist
Joslin Diabetes Center
Associate Professor of Medicine
Harvard Medical School
Background Information about Hypoglycemia Outside of Diabetes
What is hypoglycemia?
While much less common than diabetes (high blood sugar), hypoglycemia (low blood sugar) is also an established medical disease. Severe hypoglycemia can be caused by uncontrollable and excessive insulin production from within the body, due to genetic disorders, tumors of the pancreas (insulinoma), prediabetes, or prior stomach or intestinal surgery, all of which can cause uncontrollable surges in insulin levels; these high insulin levels cause the glucose levels to drop quickly to dangerous levels.
Since glucose is a critical fuel for brain cells, low glucose can cause abrupt change in brain function, as the brain requires glucose as a fuel in order to function properly. This can be dangerous, causing loss of thinking skills, reduced reaction time, loss of consciousness, seizures, motor vehicle accidents, coma, and even death. Many patients with severe hypoglycemia (glucose concentrations less than 3.0 mmol/L or 54 mg/dL) become disabled by this condition, and are no longer able to work due to inability to drive or maintain employment.
If hypoglycemia is mild, it can be treated with food or glucose. Medications and strict dietary measures are used to try to reduce the frequency and severity of low glucose, but these are often not fully effective. Insulin secretion remains uncontrollable, causing glucose levels to drop to dangerous levels at unpredictable times.
If hypoglycemia is severe, patients require the assistance of others in order to treat, and may require injections of a hormone called glucagon which elevates glucose levels back to the normal range. If hypoglycemia happens repeatedly, patients are often unaware of hypoglycemia until it is so severe that they are no longer able to treat it themselves. With loss of warning signs, patients may experience sudden loss of brain function and loss of personal safety without warning.
In what conditions can hypoglycemia occur?
Hypoglycemia occurs most often in diabetes, when the doses of insulin or medications which stimulate insulin release are too high relative to food or activity. However, hypoglycemia can occur also when the body is making too much insulin on its own. This can occur due to an insulin-producing tumor (insulinoma), or when the pancreas makes too much insulin after meals due to abnormal function of the insulin-producing cells, some cases of prediabetes, or due to abnormally high levels of hormones which direct the pancreas to make too much insulin. This can occur after a variety of types of gastrointestinal surgery. These conditions are not as common as diabetes, so are less recognized by the general public. However, for those patients affected by hypoglycemia, it is just as dangerous whether associated with diabetes or whether it occurs outside of diabetes.
Why are glucose monitors helpful in hypoglycemia?
Continuous glucose monitors have been exceptionally powerful tools to assist patients in managing diabetes and to maintain their health and safety. These monitors analyze glucose levels in the fluid under the skin every 5 minutes. Data from the monitor is transmitted to a receiver or phone, which then displays the result. If glucose levels fall below a certain threshold, an alarm is generated which alerts the patient about a dangerous level of glucose, allowing the patient to treat and correct the glucose before it becomes severe and life-threatening. This is especially critical for those patients who do not have awareness of hypoglycemia, as the meter provides the information to them even though they have no symptoms.
We would be happy to provide additional information, including testimonials from patients and medical literature articles about this condition, in order to support this request on behalf of patients.
Hypoglycemia Support Foundation