Post PHE Changes to Coverage of Continuous Glucose Monitoring (CGM) Devices
Medicare Local Coverage Determination (LCD) specify that patients must meet certain clinical indications to qualify for coverage benefits for obtaining a continuous glucose monitor (CGM). Throughout the public health emergency (PHE), CMS has not enforced these clinical indications in order for Medicare benefits to cover and pay for a CGM. In fact, because of the increased risk to patients with COVID-19 who have a chronic condition of diabetes, Medicare wanted to ensure access to these devices to help them better track and monitor their blood sugars so they could more readily adjust their insulin doses from home without the added exposure and risk of spreading the virus.
Now, as the end of the PHE has been slated for May 11, 2023, CMS has published certain PHE waivers that will be reverting back to pre-PHE status, and access to coverage for these CGMs is on the list to revert back to the coverage requirements listed in the LCDs as of the end of the PHE.
To better understand how this change can impact the diabetic community, let’s review what diabetes is, how it is managed, and the indications required to qualify a patient for CGM coverage.
Diabetes A Chronic Condition
According to the Centers for Disease Control (CDC), diabetes is a chronic condition described as follows:
"Diabetes is a chronic (long-lasting) disease that affects how your body turns food into energy. There are three main types of diabetes: type 1, type 2, and gestational diabetes (diabetes while pregnant). More than 133 million Americans are living with diabetes (37.3 million) or prediabetes (96 million)."
When we eat food, the body digests or breaks it down into glucose that travels through the bloodstream. Insulin, a powerful hormone, transports glucose out of the bloodstream and into the body’s cells to store as energy. The liver is like a back-up generator for energy so it stores a specific amount of glucose for emergency use and the muscles and fat cells store the rest. In diabetes, there is a malfunction in either the quantity or the function of insulin in the body, leading to a dangerous buildup of glucose in the bloodstream. An overabundance of glucose in the bloodstream can lead to ketoacidosis, diabetic coma, and death, if not quickly treated.
Here are some diabetic terms we should all be aware of:
- Insulin resistance (IR): Also known as metabolic syndrome, is the result of the body’s cells not responding well to insulin to the point that they resist the attempts to store excess glucose as fat or stored energy. Diet, exercise, lifestyle changes can often reverse this condition. ICD-10-CM: E88.71 Metabolic syndrome
- Prediabetes: Sustained, higher blood glucose levels measured by testing via fasting blood glucose, glycated hemoglobin A1c, or an oral glucose tolerance test. Manageable and considered reversible by diet, exercise, and lifestyle changes. ICD-10-CM: R73.03 Prediabetes
- Gestational diabetes: Onset during later stages of pregnancy due to an overabundance of hormones circulating throughout the body and accompanying weight gain impeding insulin function. Gestational diabetes has been considered a precursor or warning of future susceptibility for type 2 diabetes later in life. ICD-10-CM Chapter 15 codes (O00-O9A) are used to report pregnancy-related conditions, such as gestational diabetes. ICD-10-CM: O24.4- Gestational diabetes
- Type 1 diabetes (T1D): Hereditary form of diabetes caused by abnormal functioning of the pancreas producing insufficient amounts of insulin or no insulin. T1D patients must monitor blood glucose constantly to know when to inject themselves with insulin for blood glucose management. Most T1Ds use a CGM device to manage their condition. ICD-10-CM: E08-E13 Diabetes
- Type 2 diabetes (T2D): Acquired through lifestyle choices resulting in weight gain and high blood glucose levels. Management of prediabetes through diet was either not done or didn’t work, resulting in the need for oral hypoglycemic drugs, insulin injections, or a combination of the two. ICD-10-CM: E08-E13 Diabetes
The following statistics on diabetes can be found on the Center for Disease Control and Prevention (CDC) website:
- Total: 96 million people aged 18 years or older have prediabetes (38.0% of the adult US population)
- 65 years or older: 26.4 million people aged 65 years or older (48.8%) have prediabetes
Continuous Glucose Monitors (CGM)
More advanced than ever and significantly easier to use, these devices come with a tiny sensor that is inserted under the skin of the belly or upper arm that measures glucose in the fluid between cells, just under the skin. Continuous means blood glucose is tested every few minutes 24 hours a day and the data is transmitted wirelessly to a monitor where readings can be tracked and even downloaded for review by a physician. This means less finger sticks, manual record keeping, and better blood glucose management throughout the day.
Benefits of Using a CGM
According to a One Drop study presented at the American Diabetes Association's (ADA) 82nd Scientific Sessions Conference, approximately 70% of T1D patients currently use CGM technology to manage their diabetes while only 3-4% of all T2D patients currently use CGM, despite the known advantages of doing so, such as:
- Hospitalizations for diabetic ketoacidosis (DKA), severe hypoglycemia, diabetes-related coma, and hyperglycemia fell by 49% for people with type 1 and 39% for people with type 2 diabetes.
- DKA fell by 56% for people with type 1 and 52% for people with type 2 diabetes.
- Diabetes-related comas fell by 40% for people with type 1 and 32% for people with type 2 diabetes.
- Hospitalizations for hypoglycemia in those with type 2 diabetes fell by 11%.
- Hospitalizations for hyperglycemia in those with type 2 diabetes fell by 27%.
Post-PHE CGM Coverage
Due to the lack of enforced coverage restrictions for CGM access and continuous coverage, more T2D beneficiaries benefitted from CGM coverage through an opportunity to really try out the device to see how manageable it is and how much easier it is to monitor blood glucose levels and insulin dosing. Additional benefits have included the rapid glucose response to the food choices they make during the day and a better idea of how glucose spikes or doesn’t with consumption of specific foods, making it even easier to make better food choices throughout the day.
With the announcement that the PHE will end on May 11, 2023, CMS published the “Physicians and Other Clinicians: CMS Flexibilities to Fight COVID-19” PDF, which includes the announcement that CGM waivers will return to pre-PHE status (with some exceptions) when the PHE ends. To best prepare for this return to pre-PHE status, active LCDs should be carefully reviewed to ensure providers document all the criteria met in the patient’s medical record and ongoing coverage requirements are met at each interval patient encounter, whether it be through a telehealth service (if allowed) or an in-person encounter. Additionally, providers should review payer policies to determine which will adhere to Medicare's post-PHE policies, and which payers may develop their own.