Continuous Glucose Monitoring (CGM) Form

Use of a Continuous Glucose Monitoring (CGM) system

may be considered medically necessary when the clinical criteria described in this Policy are met.

Definitions:

• BGM - Blood Glucose Monitor
• CGM - Continuous Glucose Monitoring / Continuous Glucose Monitor Device
• DM - Diabetes Mellitus
• DME - Durable Medical Equipment - CGM's fall into this category
• Gestational Diabetes - A form of glucose intolerance diagnosed during pregnancy in someone who was not previously diabetic.
• Implantable Glucose Monitor - A system that uses a small sensor that is implanted just under the skin by a qualified health care provider during an outpatient procedure. After implanted, the sensor measures glucose levels in adults with diabetes for up to 90 days. The implanted sensor works with a novel light-based technology to measure glucose levels. The sensor is coated with a fluorescent chemical which, when exposed to blood sugar, produces a small amount of light that is measured by the sensor. Every five minutes, measurements are sent to a compatible mobile device (e.g., smart phone or tablet) that is running a device-specific mobile app.

Severe hypoglycemia:

<50 mg/dl

Severe fasting hyperglycemia:

>180 mg/dl

Type 1 Diabetes

develops when the body's immune system destroys pancreatic beta cells, the only cells in the body that make the hormone insulin, which regulates blood glucose. To survive, people with type 1 diabetes must have insulin delivered by injection or an insulin pump.

Page 1 of 7

HealthFirst Health Plans

Type 2 Diabetes

is the most prominent type of DM. It usually begins as insulin resistance, a disorder in which the cells do not use insulin properly. As the need for insulin rises, the pancreas gradually loses its ability to produce it. Type 2 diabetes is associated with older age, obesity, family history of diabetes, history of gestational diabetes, impaired glucose metabolism, physical inactivity, and race/ethnicity.

Description: Continuous glucose monitors are wearable or implanted technology that makes it easier to track blood sugar levels over time. It measures glucose levels 24 hours a day. By identifying variations in blood glucose levels, physicians can adjust insulin therapy to assist patients in achieving better glycemic control. Delivery of insulin to regulate blood sugar levels at the right time and in the right range can be enhanced with the use of CGM technology.

Clinical Criteria:

Home blood glucose monitors (BGMs) and continuous glucose monitors (CGMs) MAY BE covered under the Medicare Durable Medical Equipment (DME) benefit. In order for members DME to be eligible for reimbursement, the following criteria must be met.

1. To be eligible for initial coverage of a Non-implanted CGM and related supplies,the member must meet all the following coverage criteria (1-6):
   1. The member has diabetes mellitus; and,
   2. The members must utilize insulin; and
   3. The member’s treating practitioner has concluded that the member (or member’s caregiver) has sufficient training using the CGM prescribed as evidenced by providing a prescription; and,
   4. The CGM is FDA approved and is prescribed in accordance with its FDA indications for use; and,
   5. The member for whom a CGM is being prescribed, to improve glycemic control,meets at least one of the criteria below:
      1. The member is insulin-treated; or,
      2. The member has a history of problematic hypoglycemia with documentationof at least one of the following:
         1. Recurrent (more than one) level 2 hypoglycemic events (glucose <54mg/dL (3.0mmol/L)) that persist despite multiple (more than one) attempts to adjust medication(s) and/or modify the diabetes treatment plan; or,
         2. A history of one level 3 hypoglycemic event (glucose <54mg/dL (3.0mmol/L)) characterized by altered mental and/or physical state requiring third-party assistance for treatment of hypoglycemia
   6. Within six (6) months prior to ordering the CGM, the treating practitioner has an in-person or telehealth visit with the member to evaluate their diabetes control and determined that criteria (1-5) above are met.
2. For a member to be eligible for an Implantable CGM, the member must meet all the following criteria:
   1. The member has diabetes mellitus; and,
   2. The members requires insulin-treatment with multiple (three or more) dailyadministrations of insulin or a continuous subcutaneous insulin infusion (CSII) pump.
   3. The insulin treatment regimen requires frequent adjustment by the beneficiary on the basis of blood glucose monitor (BGM) or CGM testing results.
   4. Within six (6) months prior to ordering the I-CGM, the treating practitioner has an in-person visit with the beneficiary to evaluate their diabetes control and determined that criteria (1-3) above are met; and,
   5. Routine recommended follow-up care is expected.
3. A non-adjunctive CGM can be used to make treatment decisions without the need for a stand-alone BGM to confirm testing results. An adjunctive CGM requires the user verify their glucose levels and/or trends displayed on a CGM with a BGM prior to making treatment decisions.
4. For adjunctive CGMs (E2102), the supply allowance (A4238) encompasses all items necessary for the use of the device and includes but is not limited to, CGM sensors and transmitters.
5. For non-adjunctive CGM’s (E2103), the supply allowance specific for non-adjunctive (A4239) encompasses all items necessary. Reference supply code A4239 also includes a home BGM and related supplies, if necessary.for CGM systems when the member uses a stand-alone receiver or insulin infusion pump classified as DME to display glucose data. In addition, coverage is available for a CGM system supply allowance if a non-DME device (watch, smartphone, tablet, laptop computer, etc.) is used in conjunction with the durable CGM receiver (code E2102 or E2103).

Page 2 of 7

HealthFirst Health Plans

Coverage of a CGM supply allowance is available when a member uses a durable CGM receiver to display their glucose data and also transmits that data to a caregiver through a smart phone or other non-DME receiver.

1. Coverage of a CGM system supply allowance is available when a member uses a durable CGM receiver on some days to review their glucose data but uses a non-DME device on other days.

VII. Long-Term CGM (Continued Coverage)

1. Twelve (12) months of coverage at a time after the initial 6 months of long-term CGM will be considered through the prior authorization process based on evidence that the member continues to benefit from CGM according to these criteria:
   1. Members who qualified for coverage of initial long term use; AND
   2. Members who are benefiting from long-term CGM as evidenced by HbA1c levels which show:
      1. HbA1c level of <7.0% OR
      2. maintenance of a stable HbA1c level, as evidenced by HbA1c levels within the previous 12 months

Food and Drug Administration (FDA) Approvals for CGM:

• Dexcom G6 Continuous Glucose Monitoring System: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170088.pdf
• Freestyle Libre Flash Glucose Monitoring System: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160030A.pdf
• Freestyle Libre 2 Flash Glucose Monitoring System: https://www.accessdata.fda.gov/cdrh_docs/reviews/K193371.pdf
• Medtronic Guardian Connect System: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160007A.pdf
• (Implantable) Eversense E3 Continuous Glucose Monitoring (CGM) System: https://www.fda.gov/medical-devices/eversense-e3-continuous-glucose-monitoring-system-p160048s016

Limitations of Coverage

• A. Member does not require insulin therapy.
• B. CGM devices that solely display results on a smartphone and do not have a stand-alone receiver or integration into an insulin infusion pump do not meet the definition of DME and will be denied as non-covered.
• If a member never uses a DME receiver or insulin infusion pump to display CGM glucose data, the supply allowance is not covered by Medicare.
• C. Supplies or accessories billed separately will be denied as unbundling.
• D. Short Term implantation of CGM (72 hours to 1 week) for diagnostic use.

Medicare LCD: CGS Administrators DME MAC Glucose Monitors L33822 and Implantable Glucose Monitors L38664

NOTE: See Glucose Monitor Policy Article A52464 and Implantable CGM Article A58136 for guidance on coding and payment.

Page 4 of 7

HealthFirst Health Plans