This policy applies to the following devices:

• continuous glucose monitoring systems (CGMS)
• automated Insulin Dosing (AID) Device Systems, including Paired Interoperable Insulin Pumps and Integrated Continuous Glucose Monitoring (iCGM) Systems
• Hybrid Closed Loop Systems (Artificial Pancreas System)

Insulin infusion pumps which work independently and do not communicate with or work in conjunction with a CGM device do not require prior authorization.

CGMS may be obtained via DME or pharmacy. See grid below for specifics.

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Continuous Glucose Monitoring and Diabetes Management Devices1

Diabetes is a group of metabolic diseases characterized by impaired secretion and/or function of insulin resulting in high glucose levels. A major goal of diabetes management is adequate glycemic control by keeping the daily blood glucose levels and HbA1c within the recommended target range without frequent hypoglycemia lows. While typically controlled through dietary and activity adjustment and, at times, the administration of insulin, practicing a successful regimen can in some cases be difficult. A continuous glucose monitoring system is a minimally invasive device comprised of a small catheter sensor, generally replaced every one to three weeks depending on the system, that measures interstitial fluid glucose concentration, a monitor that displays and records the readings of the sensor, and a transmission system, typically replaced once to four times a year, connecting the two. While not able to replace self-monitoring of blood glucose (SMBG), these systems can provide detailed data to aid in planning glucose control strategies and warn a user of the need to perform SMBG. Continuous glucose monitoring systems come in two varieties: short-term “professional” systems store data for retrospective analysis by a physician to help develop more successful management regimens and long-term “personal” systems that display readings in real time to help users build more beneficial habits. External insulin infusion pumps consist of computer- controlled pumps that deliver insulin, both at a set basal rate and at user-initiated and determined elevated “bolus doses” in response to food intake, via cannulas inserted just under the skin.

Artificial pancreas device systems, also called “sensor-enhanced insulin pumps” and “sensor-augmented insulin pump therapy,” are systems in which the operation of an insulin pump is modified by the readings of a continuous glucose monitor.

Systems can take the form of integrated devices or separate devices connected by third-party data transfer (either wires or wireless) and software.

Clinical Guideline Coverage Criteria

Professional short term Continuous Glucose Monitors

The Plan covers professional short term continuous glucose monitoring when used for up to 7-14 days as a diagnostic test without prior authorization.

Continuous Long-term Glucose Monitors

The plan considers long-term continuous glucose monitoring systems as reasonable and medically necessary for diabetes when ALL of the following indications are met:

1. The CGM is prescribed by a professional provider with an expertise in treating diabetes; and
2. Member is on one of the following treatment programs:
   • Receiving intensive insulin therapy with multiple (three or more) daily insulin injections; or
   • Continuous subcutaneous external insulin pump
3. Inadequately controlled blood glucose as evidenced by one of the following:
   • Indicated by recurrent unexplained, severe, symptomatic hypoglycemia (generally blood glucose levels less than 50 mg/dl) which puts the Member or others at risk; or
   • Gestational diabetes and poorly controlled diabetes endangering fetal health (e.g., unexplained hypoglycemic episodes, hypoglycemic unawareness, suspected postprandial hyperglycemia, or recurrent diabetic ketoacidosis); or
   • Glycosylated hemoglobin (HbA1c) > 7% on multiple consecutive readings that include a test taken in the past three months
4. Documentation supports the need for a professional CGM device for intensive diabetes management as evidenced by one of the following:
   • To meet individualized glycemic target goals, frequent glucose testing, and insulin adjustment is needed to promote self-management; or
   • Member has participated in, or participation is ongoing in a supervised comprehensive diabetes program and Member is expected to comply with treatment plan
5. Member has demonstrated an understanding of the technology and is capable of using the device to recognize alerts and alarms or has access to a caregiver with such ability

Note: The continuous glucose device must be FDA approved and follow the FDA recommendations for use in children and adults.

Professional short term Continuous Glucose Monitors for Tufts Health Unify

The Plan covers professional short term continuous glucose monitoring when used for up to 7-14 days as a diagnostic test without prior authorization

Continuous Long-term Glucose Monitors for Tufts Health Unify

The guidelines used to determine medical necessity for CGMs include the Center for Medicaid and Medicare Services LCD; L33822. LCD - Glucose Monitors (L33822) (cms.gov) and the MassHealth Guidelines; MassHealth Guidelines for Medical Necessity Determination for Diabetes Management | Mass.gov

The plan considers long-term continuous glucose monitoring systems as reasonable and medically necessary for diabetes when ALL of the following indications are met:

1. The Member has a diagnosis of diabetes mellitus (DM) type-1 or type-2; and
   • The Member for whom a CGM is being prescribed, to improve glycemic control, meets at least One of the following:
     • The Member is insulin-treated; or
     • The Member has a history of problematic hypoglycemia with documentation of at least One of the following;
       • 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;
       • 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

1. Within six (6) months prior to ordering the CGM, the treating practitioner has an in-person or Medicare approved telehealth visit with the Member to evaluate their diabetes control and determined that the above criteria are met; and
2. Every six (6) months following the initial prescription of the CGM, the treating practitioner has an in-person or Medicare approved telehealth visit with the Member to assess adherence to their CGM regimen and diabetes treatment plan.

Tufts Health Unify members with Hypoglycemia due to a diagnosis other than Diabetes mellitus

Initial Authorization Criteria:

The Plan may cover a CGM (receiver, transmitter, sensor pack) when ALL of the following clinical criteria are met:

1. Member has a diagnosis of Hypoglycemia due to a diagnosis other than Diabetes mellitus; and
2. Member has clinical rationale for use of CGM instead of capillary blood glucose monitoring using test strips and a blood glucose meter.

Note: Disorders may include: seizure disorder, insulinoma, genetic conditions causing hyperinsulinemia, effects from post-surgical conditions including post esophagectomy, post fundoplication, post gastrectomy, post gastric bypass, and post sleeve gastrectomy. Documentation should include why the Member is at hypoglycemic risk and other events.

Note: For Reauthorization criteria, see below.

Note: The continuous glucose device must be FDA approved and follow the FDA recommendations for use in children and adults.

Automated Insulin Dosing (AID) Device Systems, Including Paired Interoperable Insulin Pumps and Integrated Continuous Glucose Monitoring (iCGM) Systems

The plan considers automated insulin dosing device systems as reasonable and medically necessary when All the following criteria are met:

1. Member has diabetes treated with insulin; and
2. Member qualifies for both an insulin pump and a long-term continuous glucose monitor; and
3. Member is in need of a new device due to ANY of the following:
   • Scheduled replacement of device previously approved by the Plan, or
   • New qualification, or
   • Persistent insufficient glycemic control, defined as one of the following:
     1. Glycated hemoglobin (HbA1c) concentrations ">= 7%" on multiple consecutive readings that include a test taken in the past three months, or
     2. Recurrent severe hypoglycemia (less than 50mg/dl)
4. Members are willing and able to self-monitor their long-term diabetes stability through All the following:
   • Taking four blood glucose concentration observations (either through device CGM capability or fingerstick) per day; and
   • Maintaining contact with their primary healthcare provider; and
   • Notice warnings, signals, alerts, and alarms from the device (please see section on enhancements and accommodations for visual and auditory impairments).
5. The system requires interaction for post-meal bolusing and retains the functionality of both a standalone glucose monitor and insulin pump.

Note: For replacement of insulin pump or CGM systems, please refer to the replacement criteria below.

In addition, the requested replacement device must, if applicable, be compatible with the remaining device.

Hybrid Closed Loop Systems (Artificial Pancreas System)

For the purposes of these guidelines, a hybrid closed loop device system is defined as an insulin pump that works in conjunction with a CGM, and the pump is able to both automatically stop and adjust the flow of insulin based on readings of the CGM.

The plan may authorize the coverage of an FDA-approved device to be used by a member with Type 1 diabetes mellitus when the member meets all of the criteria above for a continuous glucose monitoring system, and there is documentation by an endocrinologist that the Member has been using or is a good candidate for an insulin pump.

Enhancements and Accommodations for the Visually and/or Auditorily Impaired

The plan considers accessories to, software for, and specialized models of continuous glucose monitoring systems designed to accommodate visual or auditory impairments as reasonable and medically necessary when all the following criteria are met:

1. Member has a visual or auditory impairment that precludes the successful use of a standard model without assistance beyond initial setup and instruction; and
2. The standard model does not come with accommodations sufficient to allow successful independent use; and
3. The accommodation feature being requested is appropriate for the needs of the member.

Replacement

Replacement

The plan considers the replacement of a synonymous continuous glucose monitoring system, insulin pump, or AID system as reasonable and medically necessary when documentation confirms All the following indications are met:

1. Documentation is in the form of clinical notes or letters generated by a clinician overseeing the member’s diabetic condition; and
2. The present monitor has been rendered ineffective or inoperable due to either:

• A change in member condition that the current monitor is unable to accommodate, or
• Being damaged by events outside the control of the user; and

3. Device has been used according to treatment plan; and
4. Continued use of the device is supported; and
5. Device replacement cannot be obtained from the manufacturer or supplier due to the expiration of device warranty; and
6. Loss/damage is not attributable to abuse, sabotage, or neglect on the part of the user; and
7. The cost of replacement rather than repair is justified by the nature of damage and useful lifetime of the device; and
8. The replacement is not an additional/backup monitor; and
9. The replacement device is similar to the device being replaced unless replacement has been necessitated by a change in member condition the old device is unable to accommodate.

Note: In cases where neither the make/model nor comparable make/model from other brands are available for replacement, selection of a new device must be based on compatibility with member's remaining device and member's clinical condition.

Reauthorization of Accessories/Supplies

The initial authorization for a continuous glucose monitoring system or artificial pancreas device system will include one year’s worth of supplies (e.g., transmitter or sensors). Subsequent authorizations for accessories/supplies will require updated documentation from the treating endocrinologist indicating the Member continues to use and require the device and the device continues to meet the Member’s needs.

Note: For requests for accessories/supplies, the request must indicate what device the supplies will be used for, including name and type of device.

Requests for accessories/supplies will not be authorized unless Tufts Health Plan has approved the associated device, except for members who are new to Tufts Health Plan and have been successfully using the device prior to becoming a member (supporting documentation required).

Limitations

The plan considers continuous glucose monitoring, insulin pump, and AID systems as not medically necessary for all other indications. In addition, the plan does not cover:

• CGMS for gastric bypass surgery without the diagnosis of diabetes for long-term use
• CGMS for nesidioblastosis for long-term use; short-term use (7-14 days) for diagnostic purposes may be medically necessary
• Noninvasive continuous glucose monitors
• Remote wireless glucose monitors (e.g., mySentry)
• Hypoglycemic Wristband Alarm (e.g., Sleep Sentry)
• Nonprogrammable transdermal insulin delivery systems
• Accessories, such as shower covers, belt clips, and additional software or hardware for data transfer unless necessitated by a documented disability
• Lasette laser blood glucose monitoring devices

The plan considers the supply of disposable supplies and parts for diabetes management devices (e.g., sensors for CGM systems) as not medically necessary outside of FDA labelling on use and replacement frequency.

Codes