1

Medical Policy Continuous or Intermittent Monitoring of Glucose in Interstitial Fluid and Automated Insulin Delivery Systems
Table of Contents • Policy: Commercial • Description • Information Pertaining to All Policies
• Authorization Information • Policy History
• Endnotes • Coding Information • References

Policy Number: 107 BCBSA Reference Number: 1.01.20; 1.01.30 (For Plan internal use only) Related Policies
• Insulin Delivery Devices, #332 • Islet Transplantation, #324 Policy1 Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity

TYPE 1 DIABETES Continuous glucose monitoring (CGM) of glucose levels in interstitial fluid as a technique of diabetic monitoring is considered MEDICALLY NECESSARY for individuals with type 1 diabetes.

Use of FDA cleared or approved automated insulin delivery system with a low-glucose suspend feature may be considered MEDICALLY NECESSARY in individuals with type 1 diabetes age 6 and older.

Use of FDA cleared or approved automated insulin delivery system designated as hybrid closed- loop insulin delivery system (with low glucose suspend and suspend before low features) may be considered MEDICALLY NECESSARY in individuals with type 1 diabetes who meet ALL of the following criteria: • Meets above criteria for long-term CGM monitoring, OR • Over age 6 and meets criteria for external insulin pump (see medical policy #332 Insulin Delivery Devices), AND • Age 2 to 6 years
o Clinical diagnosis of type 1 diabetes for 3 months or more, o Used insulin pump therapy for more than 3 months, o Glycated hemoglobin level <10.0%, o Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.

2 All other uses of monitoring of glucose levels and automated insulin delivery systems in interstitial fluid as a technique of diabetic monitoring for type 1 diabetes are considered INVESTIGATIONAL.

TYPE 2 DIABETES CGM monitoring (including implantable CGM devices) of glucose levels in interstitial fluid may be considered MEDICALLY NECESSARY in the following scenarios:
• In individuals with type 2 diabetes who experience significant hypoglycemia and on daily insulin or an insulin pump in the setting of insulin deficiency, OR • In individuals with type 2 diabetes whose diabetes is poorly controlled* and require daily insulin

*Significant hypoglycemia may include recurrent, unexplained, severe (generally blood glucose levels <50 mg/dL) hypoglycemia or impaired awareness of hypoglycemia that puts the patient or others at risk.

**Poorly controlled type 2 diabetes in individuals with persistent hyperglycemia and A1C levels above 7% for adults and children.

Use of FDA cleared or approved automated insulin delivery system with a low-glucose suspend feature may be considered MEDICALLY NECESSARY in individuals with type 2 diabetes who meet ALL of the following criteria: • Age 6 and older, AND • Meets criteria for external insulin pump (see medical policy #332 Insulin Delivery Devices), AND • Meets above criteria for CGM monitoring.

Use of FDA cleared or approved automated insulin delivery system designated as hybrid closed- loop insulin delivery system (with low glucose suspend and suspend before low features) may be considered MEDICALLY NECESSARY in individuals with type 2 diabetes who meet ALL of the following criteria: • Meets above criteria for long-term CGM monitoring, • Over age 6 AND
o Meets criteria for external insulin pump (see medical policy #332 Insulin Delivery Devices) AND • Age 2 to 6 years AND
o Clinical diagnosis of type 2 diabetes for 3 months or more o Used insulin pump therapy for more than 3 months o Glycated hemoglobin level <10.0% o Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units. • Age 18 years and older AND o Diagnosed with type 2 diabetes, on current insulin regimen for at least 12 months o On multiple daily injections (insulin administration > 3x/day or use of insulin infusion pump) for at least 3 months o Glycated hemoglobin level > 7% or experience significant hypoglycemia.

All other uses of CGM monitoring of glucose levels in interstitial fluid as a technique of diabetic monitoring for type 2 diabetes and automated insulin delivery systems are INVESTIGATIONAL.

Use of an automated insulin delivery system is INVESTIGATIONAL for individuals who do not meet the above criteria.

Use of an automated insulin delivery system not cleared or approved by the FDA is INVESTIGATIONAL.

GESTATIONAL DIABETES CGM device monitoring of glucose levels in interstitial fluid in individuals with gestational diabetes is considered MEDICALLY NECESSARY.

3 Automated insulin delivery systems with a low-glucose suspend feature and automated insulin delivery systems designated as hybrid closed-loop insulin delivery systems (with low glucose suspend and suspend before low features) are considered INVESTIGATIONAL in individuals with gestational diabetes.

Prior Authorization Information
Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) Prior authorization is not required. Commercial PPO
Prior authorization is not required. CPT Codes / HCPCS Codes / ICD Codes Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The following codes are included below for informational purposes only; this is not an all-inclusive list. For members with a pharmacy benefit: A9276: Sensor; invasive (e.g., subcutaneous), disposable, for use with interstitial continuous glucose monitoring system, one unit=1-day supply

Note: If a member does not have a pharmacy benefit, the above noted item would be covered according to the member’s benefit and certificate language.

The above medical necessity criteria MUST be met for the following HCPCS codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, and Medicare HMO Blue and Medicare PPO Blue:

HCPCS Codes:
HCPCS codes: Code Description A4238 Supply allowance for adjunctive continuous glucose monitor (cgm), includes all supplies and accessories, 1 month supply = 1 unit of service A4239 Supply allowance for non-adjunctive, non-implanted continuous glucose monitor (cgm), includes all supplies and accessories, 1 month supply = 1 unit of service A9277 Transmitter; external, for use with interstitial continuous glucose monitoring system

The following ICD Diagnosis Codes are considered medically necessary when submitted with the CPT codes above if medical necessity criteria are met:

ICD-10 Diagnoses Codes ICD-10 Code Description E10.10 Type 1 diabetes mellitus with ketoacidosis without coma
E10.11 Type 1 diabetes mellitus with ketoacidosis with coma
E10.21 Type 1 diabetes mellitus with diabetic nephropathy
E10.22 Type 1 diabetes mellitus with diabetic chronic kidney disease

4 E10.29 Type 1 diabetes mellitus with other diabetic kidney complication
E10.311 Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema
E10.319 Type 1 diabetes mellitus with unspecified diabetic retinopathy without macular edema
E10.3211 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye E10.3212 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye E10.3213 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral E10.3219 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye E10.3291 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye E10.3292 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye E10.3293 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral E10.3299 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, unspecified eye E10.3311 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye E10.3312 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye E10.3313 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral E10.3319 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye E10.339 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema
E10.3391 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye E10.3392 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye E10.3393 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral E10.3399 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, unspecified eye E10.3411 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye E10.3412 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye E10.3413 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral E10.3419 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye E10.3491 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye E10.3492 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye E10.3493 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral E10.3499 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, unspecified eye E10.3511 Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye

5 E10.3512 Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye E10.3513 Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral E10.3519 Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye E10.3521 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye E10.3522 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye E10.3523 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral E10.3529 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, unspecified eye E10.3531 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye E10.3532 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye E10.3533 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral E10.3539 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, unspecified eye E10.3541 Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye E10.3542 Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye E10.3543 Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral E10.3549 Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, unspecified eye E10.3551 Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, right eye E10.3552 Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, left eye E10.3553 Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, bilateral E10.3559 Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, unspecified eye E10.3591 Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye E10.3592 Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye E10.3593 Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral E10.3599 Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, unspecified eye E10.36 Type 1 diabetes mellitus with diabetic cataract
E10.37X1 Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, right eye E10.37X2 Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, left eye E10.37X3 Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral E10.37X9 Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, unspecified eye E10.39 Type 1 diabetes mellitus with other diabetic ophthalmic complication
E10.40 Type 1 diabetes mellitus with diabetic neuropathy, unspecified
E10.41 Type 1 diabetes mellitus with diabetic mononeuropathy

6 E10.42 Type 1 diabetes mellitus with diabetic polyneuropathy
E10.43 Type 1 diabetes mellitus with diabetic autonomic (poly)neuropathy
E10.44 Type 1 diabetes mellitus with diabetic amyotrophy
E10.49 Type 1 diabetes mellitus with other diabetic neurological complication
E10.51 Type 1 diabetes mellitus with diabetic peripheral angiopathy without gangrene
E10.52 Type 1 diabetes mellitus with diabetic peripheral angiopathy with gangrene
E10.59 Type 1 diabetes mellitus with other circulatory complications
E10.610 Type 1 diabetes mellitus with diabetic neuropathic arthropathy
E10.618 Type 1 diabetes mellitus with other diabetic arthropathy
E10.620 Type 1 diabetes mellitus with diabetic dermatitis
E10.621 Type 1 diabetes mellitus with foot ulcer
E10.622 Type 1 diabetes mellitus with other skin ulcer
E10.628 Type 1 diabetes mellitus with other skin complications
E10.630 Type 1 diabetes mellitus with periodontal disease
E10.638 Type 1 diabetes mellitus with other oral complications
E10.641 Type 1 diabetes mellitus with hypoglycemia with coma
E10.649 Type 1 diabetes mellitus with hypoglycemia without coma
E10.65 Type 1 diabetes mellitus with hyperglycemia
E10.69 Type 1 diabetes mellitus with other specified complication
E10.8 Type 1 diabetes mellitus with unspecified complications
E10.9 Type 1 diabetes mellitus without complications
E11.00 Type 2 diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic- hyperosmolar coma (NKHHC)
E11.01 Type 2 diabetes mellitus with hyperosmolarity with coma
E11.10 Type 2 diabetes mellitus with ketoacidosis without coma E11.11 Type 2 diabetes mellitus with ketoacidosis with coma E11.21 Type 2 diabetes mellitus with diabetic nephropathy
E11.22 Type 2 diabetes mellitus with diabetic chronic kidney disease
E11.29 Type 2 diabetes mellitus with other diabetic kidney complication
E11.311 Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema
E11.319 Type 2 diabetes mellitus with unspecified diabetic retinopathy without macular edema
E11.3211 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye E11.3212 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye E11.3213 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral E11.3219 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye E11.3291 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye E11.3292 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye E11.3293 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral E11.3299 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, unspecified eye E11.3311 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye E11.3312 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye E11.3313 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral

7 E11.3319 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye E11.3391 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye E11.3392 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye E11.3393 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral E11.3399 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, unspecified eye E11.3411 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye E11.3412 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye E11.3413 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral E11.3419 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye E11.3491 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye E11.3492 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye E11.3493 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral E11.3499 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, unspecified eye E11.3511 Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye E11.3512 Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye E11.3513 Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral E11.3519 Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye E11.3521 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye E11.3522 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye E11.3523 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral E11.3529 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, unspecified eye E11.3531 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye E11.3532 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye E11.3533 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral E11.3539 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, unspecified eye E11.3541 Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye E11.3542 Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye

8 E11.3543 Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral E11.3549 Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, unspecified eye E11.3551 Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, right eye E11.3552 Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, left eye E11.3553 Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, bilateral E11.3559 Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, unspecified eye E11.3591 Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye E11.3592 Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye E11.3593 Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral E11.3599 Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, unspecified eye E11.36 Type 2 diabetes mellitus with diabetic cataract
E11.37X1 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, right eye E11.37X2 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, left eye E11.37X3 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral E11.37X9 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, unspecified eye E11.39 Type 2 diabetes mellitus with other diabetic ophthalmic complication
E11.40 Type 2 diabetes mellitus with diabetic neuropathy, unspecified
E11.41 Type 2 diabetes mellitus with diabetic mononeuropathy
E11.42 Type 2 diabetes mellitus with diabetic polyneuropathy
E11.43 Type 2 diabetes mellitus with diabetic autonomic (poly)neuropathy
E11.44 Type 2 diabetes mellitus with diabetic amyotrophy
E11.49 Type 2 diabetes mellitus with other diabetic neurological complication
E11.51 Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene
E11.52 Type 2 diabetes mellitus with diabetic peripheral angiopathy with gangrene
E11.59 Type 2 diabetes mellitus with other circulatory complications
E11.610 Type 2 diabetes mellitus with diabetic neuropathic arthropathy
E11.618 Type 2 diabetes mellitus with other diabetic arthropathy
E11.620 Type 2 diabetes mellitus with diabetic dermatitis
E11.621 Type 2 diabetes mellitus with foot ulcer
E11.622 Type 2 diabetes mellitus with other skin ulcer
E11.628 Type 2 diabetes mellitus with other skin complications
E11.630 Type 2 diabetes mellitus with periodontal disease
E11.638 Type 2 diabetes mellitus with other oral complications
E11.641 Type 2 diabetes mellitus with hypoglycemia with coma
E11.649 Type 2 diabetes mellitus with hypoglycemia without coma
E11.65 Type 2 diabetes mellitus with hyperglycemia
E11.69 Type 2 diabetes mellitus with other specified complication
E11.8 Type 2 diabetes mellitus with unspecified complications
E11.9 Type 2 diabetes mellitus without complications
O24.410 Gestational diabetes mellitus in pregnancy, diet controlled O24.414 Gestational diabetes mellitus in pregnancy, insulin controlled O24.415 Gestational diabetes mellitus in pregnancy, controlled by oral hypoglycemic drugs O24.419 Gestational diabetes mellitus in pregnancy, unspecified control O24.420 Gestational diabetes mellitus in childbirth, diet controlled

9 O24.424 Gestational diabetes mellitus in childbirth, insulin controlled O24.425 Gestational diabetes mellitus in childbirth, controlled by oral hypoglycemic drugs O24.429 Gestational diabetes mellitus in childbirth, unspecified control O24.430 Gestational diabetes mellitus in the puerperium, diet controlled O24.434 Gestational diabetes mellitus in the puerperium, insulin controlled O24.435 Gestational diabetes mellitus in puerperium, controlled by oral hypoglycemic drugs O24.439 Gestational diabetes mellitus in the puerperium, unspecified control

The above medical necessity criteria MUST be met for the following HCPCS codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, and Medicare HMO Blue and Medicare PPO Blue:

CPT Codes: CPT codes: Code Description 0446T Creation of subcutaneous pocket with insertion of implantable interstitial glucose sensor, including system activation and patient training
0447T Removal of implantable interstitial glucose sensor from subcutaneous pocket via incision

Description AUTOMATED INSULIN DELIVERY SYSTEMS
Diabetes and Glycemic Control Tight glucose control in patients with diabetes has been associated with improved health outcomes. The American Diabetes Association has recommended a glycated hemoglobin level below 7% for most patients. However, hypoglycemia may place a limit on the ability to achieve tighter glycemic control. Hypoglycemic events in adults range from mild to severe based on a number of factors including the glucose nadir, the presence of symptoms, and whether the episode can be self-treated or requires help for recovery. Children and adolescents represent a population of individuals with type 1 diabetes who have challenges in controlling hyperglycemia and avoiding hypoglycemia. Hypoglycemia is the most common acute complication of type 1 diabetes.

Table 1 is a summary of selected clinical outcomes in type 1 diabetes clinical management and research.

Table 1. Outcome Measures for Type 1 Diabetes Measure Definition Guideline type Organization Date Hypoglycemia

Stakeholder survey, expert opinion with evidence review Type 1 Diabetes Outcome Programa1 2017 Level 1

Level 2

Level 3 Glucose <70mg/dl but ≥ 54 mg/dl

Glucose <54 mg/dl

Event characterized by altered mental/physical status requiring assistance

Hypoglycemia Same as Type 1 Diabetes Outcome Programa Professional Practice Committee with systematic literature review

ADA2 2019

10 Hypoglycemia

Clinical alert for evaluation and/or treatment

Clinically important or serious

Severe hypoglycemia

Glucose <70mg/dl

Glucose <54 mg/dl

Severe cognitive impairment requiring external assistance by another person to take corrective action

Clinical Practice Consensus ISPAD3 2018 Hyperglycemia

Level 1

Level 2

Glucose >180 mg/dL and ≤250 mg/dL

Glucose >250 mg/dL

Type 1 Diabetes Outcome Programa1 2017 Time in Rangeb Percentage of glucose readings in the range of 70–180 mg/dL per unit of time

Type 1 Diabetes Outcome Programa 2017 Diabetic ketoacidosis (DKA) Elevated serum or urine ketones

ULN Serum bicarbonate <15 mEq/L Blood pH <7.3

Type 1 Diabetes Outcome Programa3 2017 ADA: American Diabetes Association, ISPAD: International Society for Pediatric and Adolescent Diabetes; ULN: upper limit of normal. aSteering Committee: representatives from American Association of Clinical Endocrinologists (AACE), American Association Diabetes Educators, the American Diabetes Association (ADA), the Endocrine Society, JDRF International. The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, type 1 diabetes Exchange. bTime in range: has also been adopted by researchers evaluating the precision and effectiveness of emerging glucose monitoring and automated insulin delivery technologies.

Outcome measures for type 2 diabetes have been published, including those used for clinical trials focused on non-surgical treatments addressing hyperglycemia in adults with type 2 diabetes.5,

Treatment Type 1 diabetes is caused by the destruction of the pancreatic beta cells which produce insulin, and the necessary mainstay of treatment is insulin injections. Multiple studies have shown that intensive insulin treatment, aimed at tightly controlling blood glucose, reduces the risk of long-term complications of diabetes, such as retinopathy and renal disease. Optimal glycemic control, as assessed by glycated hemoglobin, and avoidance of hyper- and hypoglycemic excursions have been shown to prevent diabetes-related complications. Currently, insulin treatment strategies include either multiple daily insulin injections or continuous subcutaneous insulin infusion with an insulin pump.

Restoration of pancreatic function is potentially available through islet cell or allogeneic pancreas transplantation. Evidence reviews of these interventions are in policy #324 and policy #328 respectively.

11 CONTINUOUS OR INTERMITTENT MONITORING OF GLUCOSE IN INTERSTITIAL FLUID

Blood Glucose Control The advent of blood glucose monitors for use by individuals in the home revolutionized the management of diabetes. Using fingersticks, individuals can monitor their blood glucose levels both to determine the adequacy of hyperglycemia control and to evaluate hypoglycemic episodes. Tight glucose control, defined as a strategy involving frequent glucose checks and a target hemoglobin A1c (HbA1c) level in the range of 7%, is now considered the standard of care for diabetic individuals. Randomized controlled trials assessing tight control have demonstrated benefits for individuals with type 1 diabetes in decreasing microvascular complications. The impact of tight control on type 1 diabetes and macrovascular complications such as stroke or myocardial infarction is less certain. The Diabetes Control and Complications Trial (2002) demonstrated that a relative HbA1c level reduction of 10% is clinically meaningful and corresponds to approximately a 40% decrease in risk for progression of diabetic retinopathy and 25% decrease in risk for progression of renal disease.1

Due to an increase in turnover of red blood cells during pregnancy, HbA1c levels are slightly lower in women with a normal pregnancy compared with nonpregnant women. The target A1c in women with diabetes is also lower in pregnancy. The American Diabetes Association recommends that, if achievable without significant hypoglycemia, the A1c levels should range between 6.0% to 6.5%; an A1c level less than 6% may be optimal as the pregnancy progresses.2

Tight glucose control requires multiple daily measurements of blood glucose (ie, before meals and at bedtime), a commitment that some individuals may find difficult to meet. The goal of tight glucose control has to be balanced with an associated risk of hypoglycemia. Hypoglycemia is known to be a risk in individuals with type 1 diabetes. While individuals with insulin-treated type 2 diabetes may also experience severe hypoglycemic episodes, there is a lower relative likelihood of severe hypoglycemia compared with individuals who had type 1 diabetes.3,4, An additional limitation of periodic self- measurements of blood glucose is that glucose levels are seen in isolation, and trends in glucose levels are undetected. For example, while a diabetic patient’s fasting blood glucose level might be within normal values, hyperglycemia might be undetected postprandially, leading to elevated HbA1clevels.

Management Measurements of glucose in the interstitial fluid have been developed as a technique to measure glucose values automatically throughout the day, producing data that show the trends in glucose levels. Although devices measure glucose in the interstitial fluid on a periodic rather than a continuous basis, this type of monitoring is referred to as continuous glucose monitoring (CGM).

Currently, CGM devices are of 2 designs; real-time CGM (rtCGM) provides real-time data on glucose level, glucose trends, direction, and rate of change and, intermittently viewed (iCGM) devices that show continuous glucose measurements retrospectively. These devices are also known as flash-glucose monitors (FGM).

Approved devices now include devices indicated for pediatric use and those with more advanced software, more frequent measurements of glucose levels, or more sophisticated alarm systems. Devices initially measured interstitial glucose every 5 to10 minutes and stored data for download and retrospective evaluation by a clinician. With currently available devices, the intervals at which interstitial glucose is measured range from every 1-2 minutes to 5 minutes, and most provide measurements in real-time directly to individuals. While CGM potentially eliminates or decreases the number of required daily fingersticks, it should be noted that, according to the U.S. Food and Drug Administration (FDA) labeling, some marketed monitors are not intended as an alternative to traditional self-monitoring of blood glucose levels but rather as adjuncts to monitoring, supplying additional information on glucose trends not available from self-monitoring. The devices must be calibrated twice daily with blood glucose measurements from fingersticks and are less reliable when used after exercise or post-prandial. Devices may be used intermittently (i.e., for periods of 72 hours) or continuously (i.e., on a long-term basis).

12 Summary Description Automated insulin delivery systems, also known as artificial pancreas device systems, link a glucose monitor to an insulin infusion pump that automatically takes action (e.g., suspends or adjusts insulin infusion) based on the glucose monitor reading. These devices are proposed to improve glycemic control in patients with insulin-dependent diabetes, in particular, reduction of nocturnal hypoglycemia.

Summary of Evidence For individuals who have type 1 diabetes who receive an automated insulin delivery (AID) system with a low-glucose suspend feature, the evidence includes 3 randomized controlled trials (RCTs) conducted in home settings. Relevant outcomes are symptoms, change in disease status, morbid events, resource utilization, and treatment-related morbidity. Primary eligibility criteria of the key RCT, the Automation to Simulate Pancreatic Insulin Response (ASPIRE) trial, were ages 16 to 70 years, type 1 diabetes, glycated hemoglobin levels between 5.8% and 10.0%, and at least 2 nocturnal hypoglycemic events (≤65 mg/dL) lasting more than 20 minutes during a 2-week run-in phase. Both trials required at least 6 months of insulin pump use. Both RCTs reported significantly less hypoglycemia in the treatment group than in the control group. In both trials, primary outcomes were favorable for the group using an automated insulin delivery system; however, findings from 1 trial were limited by nonstandard reporting of hypoglycemic episodes, and findings from the other trial were no longer statistically significant when 2 outliers (children) were excluded from analysis. The RCT limited to adults showed an improvement in the primary outcome (area under the curve for nocturnal hypoglycemic events). The area under the curve is not used for assessment in clinical practice but the current technology does allow user and provider review of similar trend data with continuous glucose monitoring. Results from the ASPIRE study suggested that there were increased risks of hyperglycemia and potential diabetic ketoacidosis in subjects using the threshold suspend feature. This finding may be related to whether or not actions are taken by the user to assess glycemic status, the etiology of the low glucose reading (activity, diet or medication), or to resume insulin infusion. Both retrospective and prospective observational studies have reported reductions in rates and severity of hypoglycemic episodes in AID system users. The evidence suggests that the magnitude of reduction for hypoglycemic events in the type 1 diabetes population is likely to be clinically significant. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have type 1 diabetes who receive an AID system with a hybrid closed-loop insulin delivery system, the evidence includes multicenter pivotal trials using devices cleared by the U.S. Food and Drug Administration (FDA), supplemental data and analysis for expanded indications, and more recent studies focused on children and adolescents. Relevant outcomes are symptoms, change in disease status, morbid events, resource utilization, and treatment-related morbidity. A 13-week multicenter RCT found that the first FDA-approved tubeless AID system significantly increased time in range by 4.2 hours per day and lowered HbA1c levels compared to continuous glucose monitoring (CGM) pump therapy. The AID system also resulted in fewer high glucose events and no serious adverse events. A second multi-center 6-month RCT comparing AID systems to multiple daily injections showed greater HbA1c reduction, improved time in range, and fewer high/low glucose events in the AID group with similar safety outcomes. Furthermore, 2 (of 3) crossover RCTs using a first-generation device, studied and approved outside the United States, found significantly better outcomes - such as reduced time in nocturnal hypoglycemia and increased time in the preferred glycemic range - compared to standard care. The third study yielded mixed results, showing significant improvement in nocturnal hypoglycemia but no significant change in time spent in the preferred glycemic range. Additional evidence from device performance and clinical studies demonstrates reductions in hypoglycemia, improved time within the range of 70 to 180 mg/dL, rare instances of diabetic ketoacidosis, and few device-related adverse events. The evidence suggests that the magnitude of reduction for hypoglycemic events in the type 1 diabetes population is likely to be clinically significant. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have type 1 diabetes who receive an AID system with a closed-loop insulin delivery system, the evidence includes a 13-week multicenter RCT of the iLet Bionic Pancreas System compared to usual care in 219 individuals ages 6 to 79 years with type 1 diabetes. Comparator group participants continued their pre-study subcutaneous insulin delivery (either multiple daily injections, an insulin pump without automation of insulin delivery, an insulin pump with predictive low glucose suspend feature, or an

13 insulin pump as part of an HCL system) plus real-time CGM. The glycated hemoglobin level decreased from 7.9% to 7.3% in the closed-loop insulin delivery system group and did not change (7.7% at both time points) in the standard-care group (mean adjusted difference at 13 weeks, −0.5%; 95% CI, −0.6% to −0.3%; p<.001). The rate of severe hypoglycemia was 17.7 events per 100 participant-years in the closed-loop insulin delivery system group and 10.8 events per 100 participant-years in the standard-care group (p=.39). No episodes of diabetic ketoacidosis occurred in either group. The trial's results for the subgroups of adults (ages 18 and older) and youth (ages 6-17 years) have additionally been reported and were similar to the main results for the full cohort. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with type 2 diabetes using AID systems with hybrid closed-loop insulin delivery, the evidence includes multicenter pivotal trials and feasibility studies using devices cleared by the FDA. Relevant outcomes are symptoms, change in disease status, morbid events, resource utilization, and treatment- related morbidity. A US multicenter clinical trial of 305 adults using the Omnipod 5 AID system showed a significant average reduction in HbA1c levels from 8.2% to 7.4% over 13 weeks (treatment effect: -0.8%, 95% CI, -1.0 to -0.7, p<.001). The greatest improvements were noted in individuals with higher initial HbA1c levels. An 8-week study followed by a 6-month extension with Omnipod demonstrated significant reductions in high sensor glucose levels and HbA1c, increased time in the target range by 22%, and no significant changes in BMI or insulin requirements. A second US and Canadian multicenter RCT reported on 319 adults, randomly assigned to either the AID group using the t:slim X2 insulin pump equipped with Control- IQ+ technology or their existing insulin method, both utilizing CGM. The AID group showed a notable reduction of 0.9 percentage points in HbA1c (from 8.2±1.4% at baseline to 7.3±0.9% at 13 weeks), compared to a modest 0.3 percentage point decrease in the control group (from 8.1±1.2% to 7.7±1.1%). The mean adjusted difference was -0.6 percentage points (95% CI, -0.8 to -0.4; p<.001). Individuals in the AID group showed an increased percentage of time maintaining glucose within the target range, with low hypoglycemia frequency and consistent results across various sensitivity analyses. These studies demonstrate favorable glycemic outcomes in type 2 diabetes patients using hybrid closed-loop insulin delivery systems, similar to the benefit observed in trials involving adults with type 1 diabetes. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

CONTINUOUS OR INTERMITTENT MONITORING OF GLUCOSE IN INTERSTITIAL FLUID
Tight glucose control in individuals with diabetes has been associated with improved health outcomes. Several devices are available to measure glucose levels automatically and frequently (e.g., every 5-10 minutes). The devices measure glucose in the interstitial fluid and are approved as adjuncts to or replacements for traditional self-monitoring of blood glucose levels. Devices can be used on a long-term (continuous) or short-term (often referred to as intermittent) basis.

Type 1 Diabetes For individuals with type 1 diabetes who are willing and able to use the device, and have adequate medical supervision, who receive long-term (continuous) glucose monitoring (CGM), the evidence includes randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are symptoms, morbid events, quality of life (QOL), and treatment-related morbidity. Systematic reviews have generally found that at least in the short-term, long-term CGM resulted in significantly improved glycemic control for adults and children with type 1 diabetes, particularly highly compliant individuals. A 2017 individual patient data analysis, pooling data from 11 RCTs, found that reductions in hemoglobin A1c (HbA1c) levels were significantly greater with real-time CGM than with a control intervention. Two RCTs in individuals who used multiple daily insulin injections and were highly compliant with CGM devices during run-in phases found that CGM was associated with a larger reduction in HbA1c levels than previous studies. One of the two RCTs prespecified hypoglycemia-related outcomes and reported that time spent in hypoglycemia was significantly less in the CGM group. One RCT in pregnant women with type 1 diabetes, which compared real-time CGM with self-monitoring of blood glucose, has also reported a difference in change in HbA1clevels, an increased percentage of time in the recommended glucose control target range, a smaller proportion of infants who were large for gestational age, a smaller proportion of infants who had neonatal intensive care admissions lasting more than 24 hours, a smaller proportion of infants who had neonatal hypoglycemia requiring treatment, and reduced total hospital

14 length of stay all favoring CGM. The evidence is sufficient that the long-term use of CGM provides an improvement in net health outcomes for persons with type 1 diabetes mellitus.

For individuals with type 1 diabetes who have poor control of diabetes despite the use of best practices or when basal insulin levels need to be determined prior to insulin pump initiation who receive short- term glucose monitoring, the evidence includes RCTs and systematic reviews. The relevant outcomes are symptoms, morbid events, QOL, and treatment-related morbidity as well as intermediate outcomes related to measures of glucose control such as frequency and time in hypoglycemia and hyperglycemia. The evidence for short-term monitoring on glycemic control is mixed, and there was no consistent in HbA1c levels. Some trials have reported improvements in glucose control for the intermittent monitoring group but limitations in this body of evidence preclude conclusions. The definitions of control with short-term CGM use, duration of use and the specific monitoring protocols varied. In some studies, short-term monitoring was part of a larger strategy aimed at optimizing glucose control, and the impact of monitoring cannot be separated from the impact of other interventions. Studies have not shown an advantage for intermittent glucose monitoring in reducing severe hypoglycemia events, but the number of events reported is generally small and effect estimates imprecise. The limited duration of use may preclude an assessment of any therapeutic effect. Two RCTs of short-term CGM use for monitoring in pregnancy included women with both type 1 and 2 diabetes, with most having type 1 diabetes. One trial reported a difference in HbA1c levels at 36 weeks; the proportion of infants that were large for gestational age (>90th percentile) favored CGM while the second trial did not. The differences in the proportions of infants born via cesarean section, gestational age at delivery, and infants with severe hypoglycemia were not statistically significant in either study. Limitations of the published evidence preclude determining the effects of the technology on net health outcome. Evidence reported through clinical input supports that this use provides a clinically meaningful improvement in net health outcome and is consistent with generally accepted medical practice when used in specific situations such as poor control of diabetes despite the use of best practices or when basal insulin levels need to be determined prior to insulin pump initiation. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Type 2 Diabetes For individuals with type 2 diabetes who receive long-term CGM, the evidence includes RCTs. The relevant outcomes are symptoms, morbid events, QOL, and treatment-related morbidity. Most RCTs of CGM in individuals with type 2 trials found statistically significant benefits of CGM regarding glycemic control. However, the degree of HbA1c reduction and the difference in HbA1c reduction between groups might not be clinically significant. Moreover, additional evidence would be needed to show what levels of improvements in HbA1c levels over the short-term would be linked to meaningful improvements over the long-term in health outcomes such as diabetes-related morbidity and complications. Also, the variability in entry criteria as well as among interventions makes it difficult to identify an optimal approach to CGM use; the studies used a combination of intermittent and continuous monitoring with a review of data in real-time or at study visits only. Only the DIAMOND RCT (n=158) has used real-time CGM in type 2 diabetes. Selected individuals were highly compliant during a run-in phase. The difference in change in HbA1clevels from baseline to 24 weeks was -0.3% favoring CGM. The difference in the proportion of individuals with a relative reduction in HbA1clevel by 10% or more was 22% favoring CGM. There were no differences in the proportions of individuals with an HbA1c level of less than 7% at week 24. There were no events of severe hypoglycemia or diabetic ketoacidosis in either group. The treatment groups did not differ in any of the QOL measures. RCTs using flash glucose-sensing technology as a replacement for self-monitoring of blood glucose for the management of insulin-dependent treated type 2diabetes found no difference in HbA1c change at 6 and 12 months between groups. However, time in severe hypoglycemia (<45mg/dL) was reduced for intervention participants. Two trials of CGM have enrolled pregnant women with type 2 diabetes, but the total number of women with type 2 diabetes included in both trials is only 58. One study reported a difference in HbA1c levels at 36 weeks, and the proportion of infants that were large for gestational age (>90th percentile) favored CGM while the second study did not. Neither trial reported analyses stratified by diabetes type. Limitations of the published evidence preclude determining the effects of the technology on net health outcome. Evidence reported through clinical input for long-term (continuous) CGM in individuals with type 2 diabetes who do not require insulin did not

15 provide strong support of a safety benefit and clinically meaningful improvement in net health outcome. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with type 2 diabetes who are willing and able to use the device and have adequate medical supervision and who experience significant hypoglycemia on multiple daily doses of insulin or an insulin pump in the setting of insulin deficiency who receive long-term (continuous) glucose monitoring, the evidence includes a systematic review and non-randomized study with 12-month follow-up. The relevant outcomes are the frequency of and time spend in hypoglycemia, the incidence of hypoglycemic episodes, complications of hypoglycemia, and QOL. The available studies demonstrate that CGM can significantly reduce time in hypoglycemia and frequency of hypoglycemia events both during the day and at night. At 12-month follow-up, hypoglycemic events were reduced by 40.8% to 61.7% with a greater relative reduction in the most severe thresholds of hypoglycemia. The published evidence supports a meaningful improvement in the net health outcome. Evidence reported through clinical input provides additional clinical context and based on both the published evidence and clinical input the following patient selection criteria are associated with a clinically meaningful improvement in net health outcome and are consistent with generally accepted medical practice: selected individuals with type 2 diabetes who are (1) willing and able to use the CGM device and have adequate medical supervision and (2) experiencing significant hypoglycemia on multiple daily doses of insulin or an insulin pump in the setting of insulin deficiency. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals with type 2 diabetes who require multiple daily doses of insulin and have poor control of diabetes despite the use of best practices or when basal insulin levels need to be determined prior to insulin pump initiation who receive short-term CGM monitoring, the evidence includes RCTs and systematic reviews. The relevant outcomes are symptoms, morbid events, QOL, and treatment-related morbidity. Systematic reviews of three to four RCTs have found statistically significant benefits from CGM regarding glycemic control. However, the degree of HbA1c reduction and the difference in HbA1c reductions between groups may not be clinically significant. Also, the limited number of RCTs and variability among interventions make it difficult to identify an optimal approach to CGM or a subgroup of type 2 diabetes individuals who might benefit. Moreover, studies of CGM in individuals with type 2 diabetes have generally not addressed the clinically important issues of severe hypoglycemia and diabetic complications. Very few pregnant women with type 2 diabetes have been included in RCTs. Limitations of the published evidence preclude determining the effects of the technology on net health outcome. Evidence reported through clinical input for use of short-term CGM in individuals with type 2 diabetes who require multiple daily doses of insulin supports that this use provides a clinically meaningful improvement in net health outcome and is consistent with generally accepted medical practice when used in specific situations such as poor control of diabetes despite use of best practices or when basal insulin levels need to be determined prior to insulin pump initiation. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Gestational Diabetes For individuals who are pregnant with gestational diabetes who receive long-term CGM or short-term (intermittent) glucose monitoring, the evidence includes an RCT and a prospective study. In one trial, HbA1c levels showed clinically significant reductions from 32-36 weeks gestation compared with women randomized to standard antenatal care. Relevant outcome are symptoms, improvement in maternal and neonatal outcomes in individuals with type 1 or 2 diabetes, QOL, and treatment-related morbidity. Trial reporting demonstrated CGM as a more preferrable alternative than standards of care and diagnosis by way of oral glucose testing. The evidence is insufficient to determine the effects of the technology on health outcomes.

Policy History Date Action 5/2026 Annual policy review. Policy updated with literature review through February 12, 2026; references added. Policy statements unchanged. 10/2025 Clarified coding information.

16 10/2025 Policy title changed from Automated Pancreas Device Systems to Automated Insulin Delivery Systems. Policy updated with new evidence following FDA approval of the t:slim X2 insulin pump with Control-IQ+ technology for adults with type 2 diabetes. Medically necessary policy statement with criteria revised in individuals with type 2 diabetes. Effective 10/1/2025. 8/2025 Annual policy review. Policy updated with literature review through February 17, 2025; references added. New indication and medically necessary policy statement with criteria added for use of an FDA-approved hybrid closed-loop system (eg, Omnipod 5) in individuals ages 18 years and older with type 2 diabetes. Effective 8/1/2025. 4/2025 Clarified coding information. HCPCS codes G0564 and G0565 deleted effective 4/1/2025. 1/2025 Clarified coding information. Added HCPCS codes G0564 and G0565. Effective 1/1/2025. 10/2024 Prior authorization for A4238, A4239 and A9277 removed for type 2 diabetes. Effective 10/1/2024. 9/2024 Annual policy review. References updated. Policy statements unchanged. 12/2023 Prior authorization for A4238, A4239 and A9277 removed for type 1 diabetes. Medically necessary statement added for coverage of Continuous glucose monitoring for gestational diabetes. Policy criteria reformatted and clarified. 12/2023.
3/2023 Clarified coding information. 1/2023 Clarified coding information. Removed K0553 as it was deleted and replaced with A4239. Effective 1/1/2023. 12/2022 Clarified coding information. 10/2022 Policy clarified to include medically necessary policy statements for individuals with type 2 diabetes who require multiple daily doses of insulin and whose diabetes is poorly controlled.
9/2022 Annual policy review. Description, summary, and references updated. Policy statements unchanged.
7/2022 Clarified coding information. 6/2022 Prior authorization information clarified for PPO plans. Effective 6/1/2022. 4/2022 Clarified coding information. 9/2021 Annual policy review. Artificial Pancreas: Medically necessary policy statement added for use of an FDA-approved hybrid closed loop system in children ages 2 to 6 years. Effective 9/1/2021. 2/2021 Annual policy review. Description, summary, and references updated. Policy statement(s) unchanged. 1/2021 Medicare information removed. See MP #132 Medicare Advantage Management for local coverage determination and national coverage determination reference.
8/2020 Annual policy review. Artificial Pancreas: Policy statements clarified to lower age cutoff to 6 years.
6/2020 Annual policy review. Artificial Pancreas: Description, summary and references updated. Policy statements unchanged. Policy statements unchanged. 5/2020 Clarified prior authorization information regarding continuation use for CGM devices. Removed best practices statement. Short term and long term CGM criteria combined. 5/1/2020.
1/2020 Annual policy review.
Continuous or Intermittent Monitoring of Glucose in Interstitial Fluid. Effective 1/1/2020. o Medically necessary indications added for use of short-term or long-term CGM in specific T2DM individuals with criteria. o Prior authorization is required.
Artificial Pancreas. Effective 1/1/2020. o Age criterion changed in the first medically necessary statement.

17 o Medically necessary statement added on FDA-approved automated insulin delivery system (artificial pancreas device system) designated as hybrid closed loop insulin delivery system in individuals with type 1 diabetes who meet specified criteria.
o New investigational statement added on use of an automated insulin delivery system (artificial pancreas device system) for individuals who have not met specified criteria. o Prior authorization is required
Medically necessary criteria for artificial pancreas were transferred to this policy from policy #720. 1/2019 Annual policy review. Description, summary and references updated. Policy statements unchanged. 7/2018 Clarified coding information. 4/2018 Annual policy review. New medically necessary indications on long-term CGM described; background and summary clarified. Clarified coding information. Effective 4/1/2018. 1/2018 Clarified coding information. 11/2017 Clarified coding information. 7/2017 Local Coverage Determination (LCD): Glucose Monitors (L33822) added for Medicare Advantage members. Clarified coding information. Effective 7/1/2017. 10/2016 Clarified coding information.
7/2016 New references added from Annual policy review. 5/2015 Annual policy review. Clarified coding information. Clarified continuous monitoring information. Statement on artificial pancreas system transferred to medical policy

720, Artificial Pancreas Device Systems. Effective 5/1/2015.

11/2014 New coverage for continuous glucose monitors with low glucose suspend described.
Clarified coding information. Effective 11/1/2014. 5/2014 New references added from Annual policy review. Updated Coding section with ICD10 procedure and diagnosis codes. Effective 10/2015. 9/2013 Annual policy review. New investigational indications described. Effective 9/1/2013. 11/2011-4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates.
No changes to policy statements.
5/2011 Reviewed - Medical Policy Group - Pediatrics and Endocrinology. No changes to policy statements. 7/2010 Annual policy review. Coverage statement revised.
2/2010 Reviewed - Medical Policy Group - Psychiatry, Ophthalmology, and Endocrinology. No changes to policy statements. 6/2009 Medical Policy #107 effective 6/2/2009 describing covered and non-covered indications.
Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

References Automated Pancreas Device Systems

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30. Brown SA, Forlenza GP, Bode BW, et al. Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes. Diabetes Care. Jul 2021; 44(7): 1630-1640. PMID 34099518
31. Criego AB, Carlson AL, Brown SA, et al. Two Years with a Tubeless Automated Insulin Delivery System: A Single-Arm Multicenter Trial in Children, Adolescents, and Adults with Type 1 Diabetes. Diabetes Technol Ther. Jan 2024; 26(1): 11-23. PMID 37850941
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34. Forlenza GP, Li Z, Buckingham BA, et al. Predictive Low-Glucose Suspend Reduces Hypoglycemia in Adults, Adolescents, and Children With Type 1 Diabetes in an At-Home Randomized Crossover Study: Results of the PROLOG Trial. Diabetes Care. Oct 2018; 41(10): 2155-2161. PMID 30089663
35. Wood MA, Shulman DI, Forlenza GP, et al. In-Clinic Evaluation of the MiniMed 670G System "Suspend Before Low" Feature in Children with Type 1 Diabetes. Diabetes Technol Ther. Nov 2018; 20(11): 731-
36. PMID 30299976
37. Messer LH, Forlenza GP, Sherr JL, et al. Optimizing Hybrid Closed-Loop Therapy in Adolescents and Emerging Adults Using the MiniMed 670G System. Diabetes Care. Apr 2018; 41(4): 789-796. PMID 29444895
38. Breton MD, Kanapka LG, Beck RW, et al. A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes. N Engl J Med. Aug 27 2020; 383(9): 836-845. PMID 32846062
39. Kanapka LG, Wadwa RP, Breton MD, et al. Extended Use of the Control-IQ Closed-Loop Control System in Children With Type 1 Diabetes. Diabetes Care. Feb 2021; 44(2): 473-478. PMID 33355258
40. Cobry EC, Kanapka LG, Cengiz E, et al. Health-Related Quality of Life and Treatment Satisfaction in Parents and Children with Type 1 Diabetes Using Closed-Loop Control. Diabetes Technol Ther. Jun 2021; 23(6): 401-409. PMID 33404325
41. Sherr JL, Bode BW, Forlenza GP, et al. Safety and Glycemic Outcomes With a Tubeless Automated Insulin Delivery System in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Clinical Trial. Diabetes Care. Aug 01 2022; 45(8): 1907-1910. PMID 35678724
42. DeSalvo DJ, Bode BW, Forlenza GP, et al. Glycemic Outcomes Persist for up to 2 Years in Very Young Children with the Omnipod ® 5 Automated Insulin Delivery System. Diabetes Technol Ther. Jun 2024; 26(6): 383-393. PMID 38277156
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43. Russell SJ, Beck RW, Damiano ER, et al. Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes. N Engl J Med. Sep 29 2022; 387(13): 1161-1172. PMID 36170500
44. Kruger D, Kass A, Lonier J, et al. A Multicenter Randomized Trial Evaluating the Insulin-Only Configuration of the Bionic Pancreas in Adults with Type 1 Diabetes. Diabetes Technol Ther. Oct 2022; 24(10): 697-711. PMID 36173236
45. Messer LH, Buckingham BA, Cogen F, et al. Positive Impact of the Bionic Pancreas on Diabetes Control in Youth 6-17 Years Old with Type 1 Diabetes: A Multicenter Randomized Trial. Diabetes Technol Ther. Oct 2022; 24(10): 712-725. PMID 36173237
46. Lynch J, Kanapka LG, Russell SJ, et al. The Insulin-Only Bionic Pancreas Pivotal Trial Extension Study: A Multi-Center Single-Arm Evaluation of the Insulin-Only Configuration of the Bionic Pancreas in Adults and Youth with Type 1 Diabetes. Diabetes Technol Ther. Oct 2022; 24(10): 726-736. PMID 36173238
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48. Davis GM, Peters AL, Bode BW, et al. Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes: From Injections to Hybrid Closed-Loop Therapy. Diabetes Care. Apr 01 2023; 46(4): 742-750. PMID 36787903
49. Davis GM, Peters AL, Bode BW, et al. Glycaemic outcomes in adults with type 2 diabetes over 34 weeks with the Omnipod® 5 Automated Insulin Delivery System. Diabetes Obes Metab. Jan 2025; 27(1): 143-
50. PMID 39382001
51. Kudva YC, Raghinaru D, Lum JW, et al. A Randomized Trial of Automated Insulin Delivery in Type 2 Diabetes. N Engl J Med. May 08 2025; 392(18): 1801-1812. PMID 40105270
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53. Blonde L, Umpierrez GE, Reddy SS, et al. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. Endocr Pract. Oct 2022; 28(10): 923-1049. PMID 35963508

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    Continuous or Intermittent Monitoring of Glucose in Interstitial Fluid

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    Endnotes

    1 Based on expert opinion