External Insulin Pumps
External continuous subcutaneous insulin infusion pumps, including Omnipod, are proven and medically necessary in certain circumstances when used according to U.S. Food and Drug Administration (FDA)-labeled indications, contraindications, warnings, and precautions. For medical necessity clinical coverage criteria, refer to the InterQual® CP: Durable Medical Equipment, Continuous Glucose Monitors, Insulin Pumps, and Automated Insulin Delivery Technology.
ALL of the following
The external continuous subcutaneous insulin infusion pump is used according to its FDA-labeled indications, contraindications, warnings, and precautions.
The applicable InterQual® medical necessity clinical coverage criteria are met.
External Pumps for Other Diabetes Causes
External continuous subcutaneous insulin infusion pumps are medically necessary for managing individuals with diabetes due to causes other than type 1, type 2, or gestational diabetes when all of the following criteria are met.
ALL of the following
The diabetes is due to a cause other than type 1, type 2, or gestational diabetes. Examples include cystic fibrosis-related diabetes, posttransplant diabetes, and diabetes following pancreatic surgery.
The individual requires intensive insulin therapy, defined as insulin treatment at least three times a day.≥ 3 times daily
Short-Term Continuous Glucose Monitoring
Short-term continuous glucose monitoring is covered when used by a health care provider for diagnostic purposes in managing individuals with diabetes.
A health care provider uses short-term continuous glucose monitoring for diagnostic purposes in managing an individual with diabetes.3–14 days
Long-Term CGM With Intensive Insulin Therapy
For medical necessity clinical coverage criteria for initial and continuation requests, refer to the InterQual® CP: Durable Medical Equipment, Continuous Glucose Monitors, Insulin Pumps, and Automated Insulin Delivery Technology.
The applicable InterQual® clinical coverage criteria for long-term nonimplantable continuous glucose monitoring in individuals receiving intensive insulin therapy are met.
Initial Long-Term CGM With Nonintensive Therapy
Initial long-term continuous glucose monitoring is medically necessary for individuals with diabetes on a nonintensive treatment plan when all of the following criteria are met.
ALL of the following
The individual is on a nonintensive diabetes treatment plan, such as basal insulin and/or oral medications.
ONE of the following
The individual has a history of a level 3 hypoglycemic event.
The individual has recurrent level 2 hypoglycemic events, meaning more than one event.
The qualifying hypoglycemic events persist despite multiple attempts to adjust medication(s) and/or modify the diabetes treatment plan.
Multiple means more than one attempt.
Implantable Continuous Glucose Monitoring
For medical necessity clinical coverage criteria for implantable glucose sensors, such as Eversense, refer to the Indiana Health Coverage Programs, Bulletin BT202520.
The applicable Indiana Health Coverage Programs criteria for implantable continuous glucose monitoring are met.
FDA-Labeled Use of External Pumps
External continuous subcutaneous insulin infusion pumps, including Omnipod, are proven and medically necessary in certain circumstances when used according to FDA labeling.
ALL of the following
The external pump is used for a medically necessary circumstance covered by the applicable clinical criteria.
The pump is used according to U.S. Food and Drug Administration (FDA)-labeled indications, contraindications, warnings, and precautions.
External Pumps for Diabetes From Other Causes
External continuous subcutaneous insulin infusion pumps are medically necessary for diabetes due to causes other than type 1, type 2, or gestational diabetes when the diabetes requires intensive insulin therapy.
ALL of the following
The individual has diabetes due to a cause other than type 1, type 2, or gestational diabetes. Examples include cystic fibrosis-related diabetes, posttransplant diabetes, and diabetes following pancreatic surgery.
The individual is treated with insulin at least three times a day.≥ 3 times daily
Nonprogrammable transdermal insulin delivery systems, including V-Go®, are unproven and not medically necessary for managing individuals with diabetes due to insufficient evidence of efficacy.
Implantable insulin pumps are unproven and not medically necessary because of insufficient evidence of efficacy.
Long-term continuous glucose monitoring is unproven and not medically necessary for individuals with diabetes on a nonintensive treatment plan, such as basal insulin and/or oral medications, for all indications other than an applicable qualifying indication, including a history of a level 3 hypoglycemic event or recurrent (more than one) level 2 hypoglycemic events that persist despite multiple (more than one) attempts to adjust medication(s) and/or modify the diabetes treatment plan.
Implantable insulin pumps are currently available only in a clinical trial setting.
Continuous glucose monitoring systems that are available over the counter without a prescription, such as Dexcom Stelo, Abbott Lingo, and Abbott Libre Rio, are out of scope for this policy. These products are obtained through a local pharmacy and are not supported by mail-order durable medical equipment providers.
Nonprogrammable transdermal insulin delivery systems, such as V-Go®, are not medically necessary due to insufficient evidence of efficacy.
Implantable insulin pumps are not medically necessary due to insufficient evidence of efficacy.
For individuals receiving nonintensive therapy, long-term continuous glucose monitoring is not medically necessary unless the individual has a qualifying history of a level 3 hypoglycemic event or recurrent (more than one) level 2 hypoglycemic events that persist despite multiple (more than one) attempts to adjust medication(s) and/or modify the diabetes treatment plan.