LCD L38662: Implantable Continuous Glucose Monitors (I-CGM)

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

Covered Indications

I-CGMs are class III medical devices that require premarket approval by the FDA. In order to be considered reasonable and necessary, the FDA approved indication must include use as a therapeutic CGM. 1 The FDA recently approved expanding the indications of an implantable CGM product to replace fingerstick blood glucose measurements for diabetes treatment decisions.

Therapeutic I-CGMs are considered reasonable and necessary by Medicare when all of the following coverage criteria (1-4) are met:

• The beneficiary has diabetes mellitus (Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses); and,

• The beneficiary’s treating practitioner has concluded that the beneficiary (or beneficiary’s caregiver) has sufficient training using the I-CGM prescribed as evidenced by providing a prescription; and,

• The I-CGM is prescribed in accordance with its FDA indications for use; and,

• The beneficiary for whom a I- CGM is being prescribed, to improve glycemic control, meets at least one of the criteria below:

• The beneficiary is insulin-treated; or,

• The beneficiary has a history of problematic hypoglycemia with documentation of at least one of the following:

• Recurrent (more than one) level 2 hypoglycemic events (glucose

CGM Continued Coverage

Every six (6) months following the initial prescription of the CGM, the treating practitioner conducts an in-person or Medicare-approved telehealth visit with the beneficiary to document adherence to their CGM regimen and diabetes treatment plan.

Limitations

I-CGM devices will not be considered reasonable and necessary for short-term (72 hours to 1 week) diagnostic use.

Exception

For those beneficiaries who have previously met the coverage criteria for a non-implantable therapeutic continuous glucose monitor through the Medicare DME benefit and subsequently choose to switch to the implantable device, they may do so with a provider order. However, all other coverage criteria above must be fulfilled in order for Medicare payment.

Diabetes mellitus is a chronic metabolic disease involving an underproduction or resistance to insulin, resulting in elevated blood glucose levels. The two most common types of diabetes are type 1 (T1DM) and type 2 (T2DM). 2 T1DM comprises approximately 5-10% of diabetes cases, and describes an etiology in which an autoimmune response damages the insulin-producing beta cells of the pancreas, resulting in insufficient insulin production. Conversely, T2DM is characterized by insulin resistance. 2,3 In T2DM, an individual’s insulin production fails to offset the deficit that is created by the resistance. 2 T2DM constitutes an estimated 90%-95% of diabetes cases. 3

Approximately 11.3% of Americans have diagnosed diabetes, and an additional 3.4% of Americans are estimated to have undiagnosed diabetes. The prevalence of diabetes is known to increase with age. In Medicare aged populations in the United States (≥ 65 years of age), 22.4% of the population has diagnosed diabetes, with an additional 4.7% estimated to have undiagnosed diabetes. 4 Economic evaluations have estimated that diabetes annually accounts for $237 billion in direct US medical expenditure, and an additional $90 billion in lost productivity. 5

Acute complications of diabetes include hypoglycemia, hyperglycemia, diabetic coma, and nonketotic hyperosmolar coma. Chronic hyperglycemia, resulting from poorly controlled diabetes, may result in serious and life-threatening damage, including dysfunction and failure of the eyes, kidneys, nervous system and cardiovascular system. The complications of diabetes mellitus are far less common and less severe in people who have well-controlled blood sugar levels. 2

To prevent and/or delay the development of both short and long term complications of diabetes, the American Diabetes Association recommends person-centered care aimed at timely treatment decisions following evidence-based guidelines. Person-centered care goals include minimizing the progression of hyperglycemia with more intensive approaches for individuals at higher risk which include those with higher glucose levels (e.g., fasting blood glucose 110-125 mg/dL, 2 hour post-challenge glucose 173-199 mg/dL, A1C > 6.0%). 6