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«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»

-- [ Page 67 ] --

This medical management guideline contains clinical practice and utilization criteria to assist professionals in PacifiCare’s medical management practice when making medical necessity determinations prior to, subsequent to, or concurrent with the provisions of health care services. This medical management guideline is intended to support consistent, appropriate medical necessity determinations, but it does not replace an individualized case-by-case review and medical necessity determination for each PacifiCare member.

Member benefit coverage and limitations may vary based on the member’s benefit plan.

This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation. Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supersede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.

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Description After evaluating relevant benefit document language (exclusions or limitations), refer to Coverage sections of this document to determine coverage.

This policy describes the use of long-term continuous glucose monitoring systems alone, or in combination with external insulin pumps for managing diabetes.

Continuous Glucose Monitoring and Insulin Pumps for Managing Diabetes - Commercial Medical Management Guideline Coverage All reviewers must first identify member eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this policy.

Coverage Rationale External insulin pumps that deliver insulin by continuous subcutaneous infusion are proven for treating patients with diabetes. Disposable external insulin pumps are considered equivalent to standard insulin pumps.

Implantable insulin pumps are investigational and unproven.

No implantable insulin pumps have received U.S. Food and Drug Administration approval at this time.

Long-term continuous glucose monitoring (greater than 72 hours), alone or in combination with an external insulin pump, is proven as a supplement to self-monitoring of blood glucose (SMBG) for type 1 diabetes patients who meet EITHER of the following criteria AND have demonstrated adherence to a physician ordered diabetic treatment

plan:

- Have been unable to achieve optimum glycemic control as defined by the most current version of the American Diabetes Association (ADA) Standards of Medical Care in Diabetes OR

- Have experienced hypoglycemia unawareness ADA Standards of Medical Care in Diabetes http://professional.diabetes.org/CPR_Search.aspx Accessed February 3, 2009.

Long-term continuous glucose monitoring is unproven for patients with type 2 diabetes or gestational diabetes.

There is limited evidence that the use of long-term continuous glucose monitoring leads to improvement of glycemic control in persons with type 2 or gestational diabetes. Although a few studies have included type 2 insulin dependent diabetics, their number was small. Large, randomized controlled trials of CGM with prolonged follow-up are needed to determine if these devices enable long-term and sustained improvements in glycemic control for patients with type 2 diabetes.

Limited evidence suggests that the use of CGMs in pregnant women with gestational or type 1 diabetes may result in a reduction in undetected hyperglycemia and nocturnal hypoglycemic events. However, further large-scale studies are needed to evaluate whether CGM's guided initiation and adjustment of antihyperglycemic therapy results in improved perinatal outcomes.

External insulin pumps and continuous blood glucose monitors, combined into a single closed-loop system not requiring direct patient interaction, are investigational and unproven.

No closed-loop systems have received U.S. Food and Drug Administration approval at this time. Study results fail to provide conclusive evidence that closed-loop systems lead to improved health outcomes in persons with type 1 diabetes.

Although in some studies closed-loop insulin management was associated with better maintenance of glucose levels in the targeted range, it was not reported whether this association was statistically significant. Furthermore, this system has only been tested in closed-loop mode for short periods of time in a small number of patients who were receiving more intensive medical care than is typical for most persons with diabetes. Therefore, it is not clear whether this treatment will provide long-term benefit for patients under "real world" conditions. Controlled studies with larger numbers of patients and longer periods of closed-loop insulin management are needed to assess the safety and efficacy of these systems.

Clinical Considerations As part of the ongoing effort to improve diabetes care, the National Diabetes Education Program, the American Association of Clinical Endocrinology, and others have recommended the term "A1c" be used for GHB or hemoglobin A1c (HbA1c) measurement in health care Continuous Glucose Monitoring and Insulin Pumps for Managing Diabetes - Commercial Medical Management Guideline

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Regulatory Requirements U.S. Food and Drug Administration (FDA): For additional information on continuous glucose monitors, see the following website (use product code MDS or NDT). Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm Accessed February 4, 2009.

For additional information on external insulin pumps, see the following web site (use product code LZG). Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm Accessed February 4, 2009.

No implantable insulin pumps or closed-loop combination systems have received FDA approval at this time.

Research Evidence Background Diabetes mellitus is one of the leading causes of death in the United States. If poorly controlled, diabetes can lead to complications such as heart disease, stroke, peripheral vascular disease, retinal damage, kidney disease, nerve damage and impotence. In gestational diabetes, fetal and maternal health can be compromised.

Improved glycemic control has been shown to slow the onset or progression of the major neuropathic and microvascular complications. Management of diabetes involves efforts to maintain blood glucose levels near the normal range. Currently, self-monitoring of capillary blood glucose and laboratory testing of glycosylated hemoglobin (A1C) to measure longer term glycemic control are the standard methods for glucose testing. Self-monitoring of blood glucose (SMBG) is vital to monitoring and treating fluctuations in blood glucose levels. (AACE, 2007; ADA, 2009) Even compliant diabetics rarely perform self-monitoring of blood glucose (SMBG) frequently enough to obtain an accurate picture of their glucose levels throughout the entire day. Evidence from the Diabetes Control and Complication Trial (DCCT) indicates that as many as seven measurements per day may not be sufficient to identify all of the fluctuations in a person's blood glucose, especially those that occur during the night. (AACE, 2007; ADA, 2009) Measurements of glucose in the interstitial fluid have been developed as a technique of automatically measuring glucose values throughout the day, producing data which shows the trends in glucose measurements, in contrast to the isolated glucose measurements of the traditional SMBG. Continuous glucose monitoring using noninvasive or minimally invasive Continuous Glucose Monitoring and Insulin Pumps for Managing Diabetes - Commercial Medical Management Guideline techniques, coupled with the ability to sound an alarm in response to glucose readings above or below user-selected alert levels, could improve glycemic control while minimizing the risk of hypoglycemia in patients undergoing intensive insulin therapy.

Minimally invasive interstitial glucose monitoring systems consist of three parts: a disposable, short-term sensor that measures glucose levels in interstitial fluid; a transmitter that is attached to the sensor; and a receiver that displays and stores the glucose-value information. According to the FDA labeling, none of the devices are intended to be an alternative to traditional SMBG, but rather serve as an adjunct, supplying additional information on glucose trends that are not available from self monitoring.

The MiniMed Paradigm REAL-Time System is currently the only system to integrate an insulin pump with real-time continuous glucose monitoring. According to the device manufacturer, the continuous glucose sensor readings cannot be used to adjust insulin therapy. Therefore, the MiniMed Paradigm REAL-Time System cannot currently be used as a closed-loop system.

Research External insulin pumps Pickup and Sutton conducted a meta-analysis of 22 studies comparing severe hypoglycaemia and glycaemic control during continuous subcutaneous insulin infusion (CSII) and multiple daily insulin injections (MDI). The severe hypoglycaemia rate in type 1 diabetes was markedly less during CSII than MDI, with the greatest reduction in those with most severe hypoglycaemia on MDI and those with the longest duration of diabetes. The biggest improvement in HbA(1c) was in those with the highest HbA(1c) on MDI (Pickup, 2008).

In a meta analysis, Jeitler et al. compared the effects of continuous subcutaneous insulin infusion (CSII) with those of multiple daily insulin (MDI) injections on glycaemic control, risk of hypoglycaemic episodes, insulin requirements and adverse events in type 1 and type 2 diabetes mellitus. 22 studies were included (17 on type 1 diabetes mellitus, two on type 2 diabetes mellitus, three on children). CSII therapy in adults and adolescents with type 1 diabetes mellitus resulted in a greater reduction of glycated haemoglobin. Total daily insulin requirements were lower with CSII than with MDI therapy.

No beneficial effect of CSII therapy could be detected for patients with type 2 diabetes mellitus. No overall conclusions were possible for severe hypoglycaemia and adverse events for any of the different patient groups due to rareness of such events, different definitions and insufficient reporting (Jeitler, 2008).

In a Cochrane review, Farrar, et al. compared continuous subcutaneous insulin infusion (CSII) with multiple daily injections (MDI) of insulin for pregnant women with diabetes. The review found a lack of robust evidence to support the use of one particular form of insulin administration over another for pregnant women with diabetes. The data are limited because of the small number of trials appropriate for meta-analysis, small study sample size and questionable generalisability of the trial population. Conclusions cannot be made from the data available and therefore a robust randomised trial is needed (Farrar, 2007).

The Diabetes Control and Complications Trial (DCCT) demonstrated that intensive insulin therapy is effective in reducing the chronic metabolic complications of diabetes and in delaying the onset and progression of secondary complications.

The investigators found that in comparison to single day injections, multiple daily injections and external pump therapy significantly delayed the onset and slowed the progression of the late complications of diabetes (DCCT, 1993).

Continuous glucose monitors Evidence evaluated for this policy was obtained primarily from a search of the peer-reviewed literature through March

2008. The published evidence consists of randomized controlled trials (RCTs), prospective and retrospective controlled and uncontrolled studies. Only studies that reported clinical outcomes were selected for review. To date, the best available evidence on the effects of using the CGM devices on diabetes-related morbidity uses A1C as a surrogate outcome. Several Continuous Glucose Monitoring and Insulin Pumps for Managing Diabetes - Commercial Medical Management Guideline studies also evaluated levels and duration of hyperglycemic and hypoglycemic events including nocturnal hypoglycemia, and a few studies evaluated the value of alerts in detecting hyperglycemia or hypoglycemia. Studies were excluded from detailed review if they only evaluated validity, diagnostic or performance accuracy of CGM devices. The majority of reviewed studies evaluated the first-generation physician-use MiniMed CGMS, its successor the CGMS System Gold and the GlucoWatch G2 Biographer. The MiniMed CGCM is indicated for one-time or occasional use and does not provide real-time results. The CGMS studies were designed for retrospective analysis of trends in blood glucose levels. Duration of CGM varied; several studies reported that patients used CGM for up to 72 hours or 3 days while in the other studies, CGM was used for between 30 days and 24 weeks, often in combination with intensive insulin therapy. Study size ranged from small to large (n=11 to n=404). Only one RCT was found that compared 2 different CGMS, the MiniMed CGMS and the GlucoWatch G2 Biographer. This study was selected for review although the full report has not yet been published.

The Juvenile Diabetes Research Foundation sponsored a multicenter, randomized controlled trial evaluating the use of continuous glucose monitoring in the management of type I diabetes mellitus. The investigators randomly assigned 322 adults and children who were already receiving intensive therapy for type 1 diabetes to a group with continuous glucose monitoring or to a control group performing home monitoring with a blood glucose meter. All the patients were stratified into three groups according to age and had a glycated hemoglobin level of 7.0 to 10.0%. The primary outcome was the change in the glycated hemoglobin level at 26 weeks. The changes in glycated hemoglobin levels in the two study groups varied markedly according to age group (P=0.003), with a significant difference among patients 25 years of age or older that favored the continuous-monitoring group (mean difference in change, -0.53%; 95% confidence interval [CI], -0.71 to

-0.35; P Adult Patients Several RCTs were identified that evaluated the first generation devices including the GlucoWatch Biographer or the physician-use device MiniMed CGMS.



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