Accu-chek Active Chip Replacement
Kansas Eiffel
Jet injectors (e.g., Vita-Jet II, Advanta Jet, Freedom Jet, Medi-Jector EZ, Biojector 2000) as durable medical equipment (DME) when the member or the member's caregiver is physically unable to use a conventional needle-syringe.
To diagnose primary islet cell hypertrophy (nesidioblastosis) or persistent hyperinsulinemic hypoglycemia of infancy (PHHI) (congenital hypoglycemia) in members with symptoms suggestive of recurrent hypoglycemia. For short-term (72 hours to 1 week) diagnostic use, no more than 2 continuous glucose monitoring periods within a 12-month period;
Long-term therapeutic use of a CGM device is considered experimental, investigational, or unproven for all other indications, including the following (not an all-inclusive list), because there is insufficient evidence of the clinical benefits of this approach for these indications:
Reflectance meters with an electronic voice, automatic timers, and specially designed arrangements of supplies and materials to allow the visually impaired to use the equipment without assistance as DME only for legally blind (best corrected visual acuity less than 20/200) members with diabetes.
Intermittently scanned "flash" continuous glucose monitoring systems (FreeStyle Libre Flash Glucose Monitoring System) are an equally acceptable alternative to other continuous glucose monitoring systems for medically necessary indications.
Continuous glucose monitors with implantable glucose sensors (e.g., the Eversense E3 implantable CGM sensor) are an equally acceptable alternative to standard continuous glucose monitors for medically necessary indications.
Aetna considers combination devices that include a home blood glucose monitor combined with a blood pressure monitor, cholesterol screening analyzer, or other devices (e.g., cellular telephone) not specifically indicated for the management of diabetes mellitus as not medically necessary convenience items.
The Lasette laser blood glucose monitoring device (Cell Robotics International Inc., Albuquerque, NM) uses a laser instead of a lancet to perforate the skin to obtain a blood sample for glucose measurement. There is insufficient evidence in the peer-reviewed medical literature that laser skin perforation offers clinically significant advantages over standard lancets.
For home glycated hemoglobin (HbA1c or A1C) monitors (e.g., A1cNow Diabetes Monitor, Metrika Inc., Sunnyvale, CA) there are no prospective clinical studies demonstrating improvements in compliance or other clinically significant benefits of home A1C testing over laboratory A1C testing. Individual-case exceptions to this policy may be made upon medical review for members who are unable to access laboratory A1C testing.
Note: Aetna considers computer software for analyzing blood glucose monitor test results as an integral part of a blood glucose monitor and not separately reimbursed. In addition, software or hardware required for downloading data from a blood glucose monitor to a computer are considered an integral part of the blood glucose monitor and not separately reimbursed.
A personal digital assistant-based blood glucose monitoring device (e.g., TheraSense FreeStyle Tracker, Accu-Check Advantage Module) and module have not been shown in published clinical studies to improve clinical outcomes over standard blood glucose monitors. Note: A personal digital assistant (PDA) does not meet Aetna's definition of covered DME in that the PDA can be used in the absence of illness or injury.
There is insufficient evidence for the effectiveness of an infrared thermometer device (e.g., TempTouch) for the intermittent measurement and monitoring of skin surface temperature in reducing the risk for diabetic foot ulceration.
There is insufficient published evidence of the impact of remote glucose monitoring on clinical outcomes by remote wireless glucose monitoring devices (e.g., mySentry) for managing members with diabetes. Aetna does not cover an attachment to allow wireless transmission from a continuous glucose montor to a smart phone or computer (e.g., MiniMed Connect) because it is considered a convenience feature. Aetna provides no additional reimbursement for a wireless transmission feature that is integrated into a continuous glucose monitor (e.g., Dexcom SHARE) because it is considered a convenience feature.
Note: Except for Medicare plans and where coverage is mandated by state law, generally coverage for diabetic supplies would be provided under a pharmacy rider and not as part of medical coverage. Certain diabetic supplies may also be covered under the medical plan if no pharmacy or diabetic supplies rider is available. Please check plan benefits.
The fructosamine test measures the average of continuous glucose levels over the prior 2- to 3-week period, and is being marketed as an indicator of overall glucose control in diabetics. The American Diabetes Association has determined that measurement of glycated serum protein (GSP) should not be considered the equivalent of measurement of glycated hemoglobin, and that the clinical utility of monitoring GSPs has yet to be established. A randomized clinical trial (Petitti et al, 2001) of 140 patients with diabetes found that patients randomized to home fructosamine monitoring had higher levels of glycated hemoglobin (HbA1c) after 3 and 6 months of follow-up. In a review of GSP and diabetes, Goldstein (1997) concluded that "further studies are recommended to determine whether the use of GSP to document short-term changes (e.g., 1 to 2 weeks) in glycemic status is clinically useful".
Glutamic acid decarboxylase (GAD) is an enzyme that is produced primarily by pancreatic islet cells. A number of recent studies indicate that patients with type 1 diabetes often have antibodies to GAD and several other islet cell antigens. This is consistent with the hypothesis that type 1 diabetes is an autoimmune disease and that autoantibody production is an early step in the development of type 1 diabetes. Autoantibodies can be detected in many cases prior to the onset of glucose intolerance. The presence of GAD autoantibodies has been shown to be a strong predictive marker for the eventual onset of type 1 diabetes.
Measurement of anti-GAD antibodies has been proposed for evaluating the risk of developing type 1 diabetes in persons at high risk. However, the value of such testing is unproven, as there are no measures that have been demonstrated to be effective in preventing the onset of type 1 diabetes. Guidelines from the Canadian Diabetes Association (Ur et al, 2003) explain that the loss of pancreatic beta cells in persons who subsequently develop type 1 diabetes passes through a subclinical prodrome that can be detected reliably in first- and second-degree relatives of persons with type 1 diabetes by the presence of anti-GAD antibodies and other pancreatic islet cell autoantibodies in their sera. While randomized trials testing prevention strategies have been completed or are now underway, safe and effective preventive strategies have not been identified. The guidelines concludde: "Therefore, any attempts to prevent type 1 diabetes should be undertaken only within the confines of formal research protocols."
Measurement of anti-GAD antibody can be of use in distinguishing type 1 from type 2 diabetes when the clinical history is ambiguous. Guidelines from the Royal Australian College of General Practitioners (RACGP, 2007) explained that measurement of GAD can be of particular use in diagnosing Late onset Autoimmune Diabetes in Adults (LADA), a form of late onset diabetes that is autoimmune and requires treatment with insulin within a relatively short period of time after diagnosis (often within the next 2 years). RACGP guidelines explained that persons with LADA tend to be young (30 to 40 years of age, lean, and have a personal and/or family history of other autoimmune diseases (e.g., hypo- or hyper-thyroidism). The guidelines stated that testing for GAD antibodies can confirm the diagnosis in ambiguous cases and prompt counseling the person about the likely time course of diabetes progression and the possibility of other autoimmune disease. In addition, the establishment of the LADA diagnosis may be useful in selecting therapy (Brophy et al, 2007)
Antibodies to GAD are often markedly elevated in patients with the stiff-person syndrome (also referred to as stiff-man syndrome), a condition that is associated with fluctuating stiffness and paroxysmal spasms of the trunk and legs.
The PreDx Diabetes Risk Score (DRS) test is a multiple-biomarker test to identify high-risk individuals who might develop diabetes within 5 years. Using a proprietary algorithm combines seven biomarkers to quantify the risk of developing diabetes within 5 years. The model also includes age and sex. A diabetes risk score between 1 and 10 is calculated, with a higher score indicating an increased likelihood of developing diabetes within 5 years. Since the biomarkers are a combination of proteins and metabolites, they are measured using several different methods: ion-exchange high-performance liquid chromatography (HbA1c), chemiluminescent immunoassay (ferritin and interleukin 2 receptor alpha [IL2-Rα]), enzymatic (glucose), immuno-turbidometric assay (C-reactive protein [CRP]), and an enzyme-linked immunosorbent assay (adiponectin and insulin). The PreDx DRS is used for patients who do not have type 2 diabetes (T2D) but are at increased risk for developing this condition. Patients to be considered include those with impaired fasting glucose, metabolic syndrome, or other risk factors, including family history, age > 45 years, presence of obesity, coronary artery disease, hypertension, low high-density lipoprotein cholesterol (HDL) (i.e., < 35 milligrams per deciliter), increased triglycerides, and belonging to an ethnic group with a higher prevalence of diabetes (for example, African American, Hispanic, Asian or Native American). Currently, two laboratories offer the PreDx DRS multibiomarker test. However, all testing is done at one of these facilities, Tethys Bioscience Inc.
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