Understanding Diabetes Mellitus

Diabetes mellitus (commonly referred to as diabetes) is a chronic (long-term) medical condition characterized by high blood glucose (sugar). This may be because the pancreas (an organ in the belly) does not make enough insulin (a hormone), or because the body is not responding to insulin the way it should. Insulin helps glucose get into cells in the body, giving it energy. With diabetes, sugar builds up in the blood because the body stops responding to insulin, or because there is not enough of it.

• Type 1 diabetes - the pancreas make no insulin, or a very small amount
• Type 2 diabetes - cells in the body do not respond to insulin the way they should; sometimes, the pancreas also does not make enough insulin

Diabetes requires regular monitoring and treatment. Treatment of Type 1 and Type 2 DM includes a combination of lifestyle changes, self-care measures, and often medications to control blood glucose levels and minimize further risk of diabetes-related complications.

Plan members who have been diagnosed with Type 1 or 2 DM, and meet certain medical necessity criteria and standards of care developed by the American Diabetes Association (ADA), may be eligible for specific supplies and equipment subject to plan benefits, such as those used to monitor blood sugar and inject insulin. Members with more advanced disease or those requiring more frequent insulin may qualify for continuous glucose monitoring and specialized insulin delivery systems.

• For information on medical necessity criteria of medical nutrition counseling, please refer to the Plan Clinical Guideline: Medical Nutrition Therapy (CG010).
• For information on clinical criteria of continuous glucose monitoring, implantable continuous glucose monitoring, and insulin infusion pumps, please refer to the Plan Clinical Guideline: Insulin Delivery Systems and Continuous Glucose Monitoring (CG029).
• The Plan also covers home glucose monitors and products for self-monitoring of blood sugar as an alternative to CGMs. Please contact CVS/Caremark, the Plan's Prescription Benefit Manager, to obtain a standard blood glucose meter from the preferred brand.

Definitions

Blood Glucose

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There are a variety of oral and parenteral medications that can increase insulin production, increase the body’s sensitivity to existing insulin and reduce blood sugar. Insulin can also be injected or infused when lifestyle changes and non-insulin medications are inadequate.³“Type 1 Diabetes” is an autoimmune condition that occurs when the beta cells of the pancreas are unable to produce enough insulin and therefore blood glucose cannot enter cells to be used for energy. Type 1 diabetes is often referred to as “insulin-dependent” because these patients require insulin daily to maintain their blood glucose at acceptable levels.“Type 2 Diabetes” is a condition that occurs when either the pancreas doesn't produce enough insulin or the body cells become resistant to insulin. Type 2 diabetes is much more common than Type 1, and is often treated with combinations of lifestyle changes and non-insulin medications, although insulin can be required later in the disease course. Many individuals with Type 2 Diabetes are “insulin-requiring”.

Medical Necessity Criteria for Authorization

General Criteria

The Plan considers diabetes equipment and supplies medically necessary when ALL of the following criteria are met:

1. The member has a diagnosis of diabetes mellitus; AND
2. Recent clinical documentation (within the last 12 months) is provided showing ALL of the following:
   • A prescription for the requested product with ALL of the following:
     1. Product to be dispensed; and
     2. Quantity to be dispensed (or frequency of testing); and
     3. Prescriber’s signature and date; and
   • Hemoglobin A1c test results; and
   • Medical necessity statement (i.e., documentation) from the treating provider confirming the need for the requested product.

NOTE: All of the above documentation must be updated every 12 months to show compliance with treatment options. If any of the required documentation is more than 12 months old, it must be updated as soon as possible before any renewal request for coverage.

3. Additional criteria, as outlined below, must also be met depending on the specific equipment and supplies requested:

Blood Glucose Monitors

Standard Home Blood Glucose Monitors

The Plan considers standard home blood glucose monitors once annually when ALL of the following criteria are met:

1. The “General Criteria” for diabetes equipment and supplies above are met; AND
2. The member or member’s guardian is capable of being trained to use the particular device in an appropriate manner; AND
3. The blood glucose monitor is designed for home use, and not the clinical office setting.

NOTE: Disposable blood glucose monitors are an acceptable alternative to a standard home blood glucose monitor when all criteria are met.

Specialized Home Blood Glucose Monitors

The Plan considers specialized home blood glucose monitors medically necessary for the visually impaired once annually when ALL of the following general criteria are met:

1. The criteria (A-C) for Standard Home Blood Glucose Monitors above are met; AND
2. The member’s physician certifies that the member’s visual impairment is of a severity that requires specific supplies, which include, but are not limited to:
   • Voice synthesizers; or
   • Automatic timers; or
   • Specially designed supplies to promote self-management; or
   • Integrated lancet/monitoring devices.

Alternate Site Blood Glucose Monitors

The Plan considers alternate site blood glucose monitors medically necessary once annually when ALL of the following general criteria are met:

1. The criteria (A-C) for Standard Home Blood Glucose Monitors above are met; AND
2. The member meets ONE or more of the following:
   • Is a child age 12 or younger; or
   • Have been using a conventional finger-stick blood glucose monitor for at least 30 days and have been non-compliant with testing because of pain or heavily calloused fingertips.

Replacement Blood Glucose Monitors

The Plan considers replacement of a blood glucose monitor medically necessary when BOTH of the following criteria are met:

1. Approval for replacement glucometer models will not exceed more than once per calendar year; AND
2. Documentation is provided showing ONE of the following:
   • The current glucometer is unsafe, inaccurate, or no longer applicable to the member’s level of monitoring required; or
   • The current glucometer is not functioning properly or has been irreparably damaged, lost, or stolen, requiring replacement.

NOTE: Replacement is limited to one glucometer per calendar year. Exceptions may be considered with documentation for special populations (e.g., children who may accidentally damage monitors) where monitoring needs cannot be met with the approved replacement limit.

Needle-Free Insulin Injection Systems (e.g., Jet Injectors)

The Plan considers needle-free insulin injection systems medically necessary when ALL of the following criteria are met:

1. The member meets the “General Criteria” above; AND
2. The member meets at least ONE of the following:
   • Member has needle-phobia; or

Member and/or caregiver is unable to use standard syringes.

Diabetic Supply Quantities

When the General Criteria are met, the Plan considers the following quantities medically necessary:

• Blood test strips (glucose, ketone) - 100 strips (not on insulin), 400 strips (on insulin) | Suggested quantity limits per 3 months
• Blood test strips (glucose, ketone) - 400 strips (not on insulin), 1600 strips (on insulin) | Suggested quantity limits per year
• Automatic and manual lancets - 100 lancets (not on insulin), 400 lancets (on insulin) | Suggested quantity limits per 3 months
• Automatic and manual lancets - 400 lancets (not on insulin), 1600 lancets (on insulin) | Suggested quantity limits per year

*The Suggested Quantity Limits are intended to provide guidance and are subject to review of the medical record and prescription. Requests that exceed the suggested quantity must be submitted with clinical documentation of medical necessity.

Exceptions to the Suggested Quantity Limits may be authorized on a case-by-case basis for high-utilization members when ALL of the following criteria are met:

1. All “General Criteria” above for diabetic supplies and/or equipment are met; AND
2. The member’s physician has evaluated the member within the past six (6) months and has documented the medical necessity for quantities exceeding the utilization guidelines; AND
3. There must be documentation of how often the member is testing their blood sugar or administering insulin that corresponds with the request; AND
4. The member meets at least ONE of the following:
   • Member is 12 years of age or younger; or
   • Member has newly diagnosed diabetes or gestational diabetes; or
   • Member is on an insulin pump; or
   • Member is on an insulin regimen such that blood glucose testing greater than (>) three (3) times per day is indicated.

Experimental or Investigational / Not Medically Necessary

The following products, supplies, or indications are considered experimental, investigational, or convenience features and are therefore NOT considered medically necessary:

1. Devices to measure glycated serum proteins (fructosamine assay)
   • Rationale: The literature has not demonstrated the clinical benefit of GSP measuring devices...
2. GlucoWatch Biographer Monitor or any other hypoglycemic wristband alarm
   • Rationale: The clinical utility of these devices has not yet been demonstrated in any randomized clinical trials...
3. Home Glycated Hemoglobin Monitors (e.g. A1cNow Diabetes Monitor)
   • Rationale: Evidence does not demonstrate improved compliance or benefits with home A1c testing over lab A1c testing during scheduled office visits...
4. Infrared Thermometer Devices
   • Rationale: There have been several studies demonstrating the predictive ability of infrared thermometer devices for foot ulcers, and that they may serve as an “early warning sign”...
5. Personal Digital Assistant-based Blood Glucose Monitors (e.g., TheraSense FreeStyle Tracker, Accu-Check Advantage Module)
   • Rationale: The ENHANCE trial was a randomized controlled study of PDA-based self monitoring vs. standard care in 151 patients...
6. Subcutaneous insulin infusers, including but not limited to, i-Port
   • Rationale: There is a lack of clinical evidence supporting the use of insulin infusers and diabetes outcomes...

A1c levels were similar among all subjects at the initiation and completion of the study, demonstrating no observable clinical benefit. Patients did report that it was more difficult to control their blood sugar levels with standard insulin injections; however, the differences were non-significant (p=0.16).2587.

Other excluded devices or products:

• Combination devices (e.g., blood glucose monitor combined with lipid measuring device or cell phone)
• Remote glucose monitoring devices (e.g., mySentry, MiniMed Connect, Dexcom SHARE)
• Lasette™ Laser Blood Glucose Monitoring Device or other similar laser lancets [E0620]
• Skin autofluorescence to measure glycation end-products

8. Blood glucose monitoring devices or supplies for indications other than diagnosed diabetes mellitus