BlueCross and BlueShield of Montana Medical Policy/Codes
Insulin Infusion Pumps
Chapter: Durable Medical Equipment
Current Effective Date: September 24, 2013
Original Effective Date: September 24, 2013
Publish Date: June 24, 2013
Revised Dates: This document is no longer scheduled for routine literature review and update.
Description

Diabetes mellitus (DM) is a disease of abnormal glucose metabolism caused by either a deficiency of insulin, or resistance to insulin, and resulting in elevated blood glucose levels. Type 1 DM (also known as insulin-dependent DM [IDDM] or juvenile onset DM) usually has onset in childhood or adolescence and results from immune-mediated destruction of the insulin-producing islet beta cells in the pancreas. Type II DM (also known as non-insulin dependent DM [NIDDM] or adult onset DM) is marked by peripheral resistance to the effect of insulin, rather than absolute insulin deficiency. (2)

Insulin replacement is required treatment for type I DM. Many type II diabetics use oral medication to either stimulate the pancreas to secrete more insulin, or to decrease peripheral resistance. However, disease in type II DM patients may progress to a stage where insulin injections are needed. Conventional therapy includes insulin replacement provided with subcutaneous injections of insulin once or twice per day. Intensive therapy for DM management refers to frequent delivery of insulin, usually by injection 4 times a day or by continuous infusion to maintain tight control of blood glucose in the normal range. (2)

Continuous insulin infusion can be delivered by use of an external insulin pump. An external insulin infusion pump is a portable, programmable, battery-operated mechanical device with a refillable drug reservoir, attached to a subcutaneous needle or catheter that provides continuous subcutaneous infusion (CSII) in patients with DM. The aim of CSII is to try to approximate the insulin delivery more closely to the behavior of the normal pancreas, by providing continuously infused, low volume basal insulin for fasting periods and the delivery of increased rate boluses to cover meals. Only short-acting insulin (crystalline or rapidly absorbed analogues) is used. (2). Newer technology insulin pumps may be wireless. An example of a U.S. Food and Drug Administration (FDA) approved wireless insulin pump is the Omni-Pod™ by Insulet Corporation.

Policy

Prior authorization is recommended. To authorize, call Blue Cross and Blue Shield of Montana (BCBSMT) Customer Service at 1-800-447-7828 or fax your request to the Medical Review Department at 406-441-4624. A retrospective review is performed if services are not prior authorized.

Medically Necessary

BCBSMT may consider an insulin infusion pump (with or without wireless communication capability) medically necessary when all of the following criteria are met:

  • Documented diabetes mellitus; AND
  • Completion of a comprehensive diabetic education program; AND
  • Patient follows a program of multiple daily insulin injections (at least three injections per day); AND
  • Frequent self-adjustments of insulin doses over the past six months prior to initiation of the insulin pump; AND
  • Documented frequency of glucose self-testing an average of at least four times per day during the past month; AND
  • Documentation of any of the following while on a regimen of multiple daily insulin injections:
    • Glycosylated hemoglobin level (HbA1c) > 7.0 percent; OR
    • Severely unstable blood glucose levels (brittle diabetes mellitus) with recurrent episodes of diabetic ketoacidosis, hpoglycemia or both, resulting in recurrent and/or prolongued hospitalization; OR
    • History of recurring hypoglycemia or severe glycemic excursions; OR
    • Wide fluctuations in blood glucose before mealtime; OR
    • Fasting blood glucose levels are much higher on awakening in the morning ("dawn phenomenon") with fasting blood sugars frequently exceeding 200 mg/dl: OR
    • The patient has been on an external insulin infusion pump.  The pump is no longer functional and not under warranty, or is greater than four (4) years old.

NOTE: Patient selection is the key to appropriate utilization of the external infusion pump (EIP). Factors relevant to the selection of EIP candidates may include several of the following conditions:

  • Patient is ambulatory and treatment can be appropriately delivered on an outpatient basis, with an expected improvement in the quality of life;
  • Drug therapy is ongoing and a therapeutic advantage is expected by using continuous infusion rather than intermittent injections;
  • Patient is otherwise treatable only by conventional infusion pump in an institutional setting, or compliance difficulties make intermittent injection ineffective;
  • Patient education protocols are documented and emergency support is available when unexpected adverse events occur; OR
  • Presence of favorable technical factors, such as convenient, safe, and reliable EIP delivery system along with correct placement of the needle and catheter.

Rationale for Benefit Administration

This medical policy was developed through consideration of peer reviewed medical literature, FDA approval status, accepted standards of medical practice in Montana, Technology Evaluation Center evaluations, and the concept of medical necessity. BCBSMT reserves the right to make exceptions to policy that benefit the member when advances in technology or new medical information become available.

The purpose of medical policy is to guide coverage decisions and is not intended to influence treatment decisions. Providers are expected to make treatment decisions based on their medical judgment. Blue Cross and Blue Shield of Montana recognizes the rapidly changing nature of technological development and welcomes provider feedback on all medical policies.

When using this policy to determine whether a service, supply, drug or device will be covered, please note that member contract language will take precedence over medical policy when there is a conflict.

Rationale

This policy is based on the policy of the Centers for Medicare and Medicaid Services (CMS), as well as the recommendations and positions of the American Diabetes Association (ADA and the American Association of Diabetes Educators (AADE), as discussed below.

Centers for Medicare and Medicaid Services (CMS)

The CMS “Decision Memo for Insulin Infusion Pump” (CAG-00041N) provided an analysis of scientific data on continuous subcutaneous insulin infusion (CSII). The CMS analysis included the following information.

Within the past few years, "intensive therapy" for diabetes management has gained favor as it seems to offer the greatest hope of preventing diabetic complications. Intensive therapy refers to frequent delivery of exogenous insulin (usually by injection four times a day or alternatively by continuous infusion) to obtain tight control in the normal blood glucose range. The Diabetes Control and Complications Trial (DCCT) offered compelling evidence that intensive treatment achieving tight glycemic control reduces the occurrence of microvascular and neuropathic complications in patients treated before the development of advanced disease. This trial involved 1,441 Type I diabetics at 29 medical centers. On average, patients were followed for an average of 6.5 years (range 3-9 years) before the study was terminated. The study's principal outcome measure was retinopathy, but it also included data regarding renal, neurologic, cardiovascular, and neuropsychological complications as well as adverse effects from treatment.

The DCCT examined two cohorts, a primary prevention cohort with complication-free disease duration of one to five years, and a secondary intervention cohort with a disease course of one to fifteen years, and the initial signs of diabetic complications. Subjects were randomly assigned to the experimental group receiving intensive therapy or the control group receiving conventional therapy. Subjects in the experimental groups followed an intensive therapy regimen aimed at achieving as close to normal blood glucose levels as possible. Intensive therapy subjects had a choice of two methods of delivery of exogenous insulin; either via three or more daily insulin injections or external pump. [By the end of the study, 42% of the experimental subjects were using insulin pumps]. Subjects assigned to conventional therapy took one or two subcutaneous insulin injections per day. The study's results showed members of the intensive therapy group to have statistically significantly less progression of diabetic complications than the conventional therapy group: reduction in nephropathy of 34% and 43% for the primary prevention and secondary intervention cohorts respectively; 76% and 54% reduction in retinopathy, 69% and 57% reduction in neuropathy. The study found no statistically significant differences in quality of life between members of the conventional and intensive therapy groups (based on a questionnaire). The study's results were so convincing of the benefits of intensive therapy that the independent data monitoring committee recommended early termination of the trial. As the evidence favoring intensive therapy accumulated, investigators could no longer legitimately encourage subjects to remain in the less effective conventional therapy group.

The DCCT demonstrated that intensive therapy offers numerous advantages over conventional therapy by decreasing the development of many long-term diabetic complications. However, in the short-term, the DCCT suggests that intensive therapy may pose some increased risks over conventional therapy. Subjects in the intensive therapy group experienced approximately triple the incidence of severe hypoglycemia (defined as hypoglycemia requiring assistance from another person) compared to the control group (p<0.001). There was however, no statistically significant difference between intensive and conventional therapy groups for occurrence of diabetic ketoacidosis (DKA) or changes in neuropsychological functioning. The increased risk of hypoglycemia prompted the DCCT authors to recommend caution in starting intensive therapy for patients with a history of severe hypoglycemia or hypoglycemia unawareness. Additionally, the DCCT study population excluded prospective subjects who already had advanced diabetic complications. Given that implementing intensive therapy is not risk-free, the authors caution; "The risk-benefit ratio with intensive therapy may be less favorable...in patients with advanced complications."

Another area where CSII may offer additional benefit over multiple daily injections (MDI) is for those diabetics exhibiting "dawn phenomenon." Dawn phenomenon represents early morning hyperglycemia thought to result from insufficient nocturnal insulin. A study by Koivisto suggests that for diabetics using CSII, the dawn phenomenon may be prevented by programming the pump to increase the nocturnal rate of insulin infusion. Although little scientific data currently exists to prove the benefit of decreased early morning hyperglycemia, current beliefs regarding tight glycemic control suggest benefit of avoidance of hyperglycemia at any time.

In a study conducted by Bode et al. on patients who had been on MDI and experienced poor glycemic control including severe hypoglycemia, the authors found that when patients switched to CSII, there were statistically significantly fewer episodes of severe hypoglycemia, and no difference in events of DKA. Of note, HbA1c was not different between the groups, in contrast to other studies which have documented decreased HbA1c for patients on CSII.

In 1991, the Agency for Health Care Policy and Research (AHCPR) issued an assessment of insulin pump therapy. The AHCPR assessment stated that "the overall clinical evidence indicates that CSII is as effective as MDI in attaining normoglycemia in patients with insulin dependent diabetes mellitus who require intensive insulin therapy."  In addition, the report noted: "Results from a number of controlled clinical trials have shown that CSII devices are effective in providing near-normo-glycemia and in improving metabolic control in patients with insulin-dependent diabetes mellitus (IDDM) -- there is as yet no evidence to show that CSII is superior in clinical efficacy to MDI."  AHCPR cautioned that "any form of intensive insulin therapy is also contraindicated for individuals with hypoglycemia unawareness and those with untreated preproliferative or proliferative retinopathy."  Although the report noted that CSII poses risks of DKA, hypoglycemia, and skin infections, AHCPR suggested that these risks might be ameliorated as the technology improves.

In October, 1994 ECRI Institute, a technology assessment firm based in Plymouth Meeting, Pennsylvania, completed an assessment of CSII pumps. ECRI concluded that:

  • insulin pump therapy produces greater metabolic control than conventional therapy; AND
  • insulin pump therapy may produce greater metabolic control than intensive injection therapy; AND
  • the success of insulin pump therapy depends heavily upon proper patient selection, which in turn, depends heavily upon patient motivation.

Regarding risks of severe hypoglycemic events, ECRI suggested that CSII might offer a decreased risk compared to MDI but that this is unproven "even though it seems that fewer severe hypoglycemic episodes are observed during insulin pump therapy than during intensive injection therapy, it would seem clinically prudent to assume that the number of these episodes in these two treatment types is equal."  Of note, ECRI recommended caution in starting pump therapy on elderly patients because they may have difficulty responding to the warning symptoms of hypoglycemia.

In a study conducted in Japan by Ohkubo et al. on insulin-requiring Type II diabetics, the authors found a difference in the incidence and progression of diabetic complications for those patients on intensive insulin treatment. However, the number of patients studied was small and no patients with advanced complications were included. In addition, no patients were on CSII. Of note, the authors state that "the benefit of intensive insulin therapy for Type II diabetics with advanced microvascular complications is not yet established."

American Diabetes Association (ADA) Position

The CMS Decision Memo outlined the ADA position as follows: The ADA is a non-profit organization primarily comprised of health care providers and researchers in the field of diabetes as well as people with diabetes. The ADA maintains a series of Clinical Practice Recommendations which are developed by experts based on scientific references and are subjected to annual peer review. The ADA endorses CSII in a current practice recommendation which states "Both CSII and multiple daily insulin injection therapy are effective means of implementing diabetes management with the goal of achieving near-normal levels of blood glucose ..... pump therapy is as safe as multiple-injection therapy when recommended procedures are followed."  The ADA practice recommendation did not outline specific criteria for which patients are likely to benefit from CSII but it did note the effective use of CSII requires a motivated patient and may be too demanding for some patients. The ADA recommendation further noted that "in many people, CSII or multiple insulin injections can provide equivalent improvements in control" and explained that some clinicians only recommend CSII for patients for whom euglycemia has remained elusive on MDI while other clinicians offer CSII to patients without demonstrated failure of MDI but for whom conventional therapy is not commensurate with their lifestyle. The ADA neither endorsed nor disparaged either of these competing selection paradigms. The Health Care Finance Administration (HCFA) discussed this clinical practice recommendation with several representatives of the ADA at a meeting on August 11, 1999. The published practice recommendation did not specifically address whether the recommendation was for Type I or Type II diabetics, however, the referenced citations were studies conducted on Type I diabetics. At the August 11 meeting the ADA acknowledged the dearth of evidence for CSII in Type II diabetics and expressed its opinion that insulin infusion pump therapy would be reasonable for Type I diabetics in the Medicare population.

The 2012 ADA “Standards of Medical Care in Diabetes” recommendations state “The DCCT clearly showed that intensive insulin therapy (3 or more injections per day of insulin, CSII, or insulin pump therapy) was a key part of improved glycemia and better outcomes.” (4)

American Association of Diabetes Educators (AADE) Position

The CMS Decision Memo outlined the AADE position as follows: The AADE is a non-profit organization comprised of health care providers in the field of diabetes, primarily those involved in diabetes education. The AADE also published an official organization position regarding insulin pump therapy. The AADE position statement asserts "given the results of the DCCT, CSII should be considered a treatment option because it offers increased lifestyle flexibility and enhanced self-management that improves blood glucose control. CSII is appropriate for individuals who:

  • require or desire improved blood glucose control, especially during pregnancy; and/or
  • require the flexibility that CSII offers."

The 2009 “AADE Position Statement—Continuous Subcutaneous insulin Therapy Using a Pump” states “Patients with both type I and type II diabetes are using pumps to deliver insulin as the evidence mounts that early and intensive management of glycemia significantly decreases the development and progression of microvascular and macrovascular complications of diabetes. Successful CSII therapy using a pump requires initial and ongoing education on the technical components of the insulin pump as well as on the enhancement of self-management skills. Behavioral goal setting is an effective strategy to support self-care behaviors. Long-term use should be carefully monitored for technical skills, self-management decisions, and medical care follow-up. For type 1 and type 2 diabetes patients, insulin therapy using an infusion pump is a treatment option that offers increased lifestyle flexibility and improved glucose control, especially for individuals with suboptimal glucose control, wide glucose fluctuations, and/or day-to-day schedule variations. Patient selection for CSII is not based on improved glycemic control over MDI. Hemoglobin A1C level is determined by appropriate insulin dose and not insulin delivery, the literature demonstrating superiority is variable. The data favoring patient selection for CSII over MDI are supported by improved quality of life, decreased hypoglycemia, improved flexibility, and other outcomes. Furthermore, CSII may not be appropriate for all patients receiving insulin, but it has been shown to be very useful for specific populations.” (5)

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

250.00,  250.01, 250.02, 250.03, 250.10, 250.11, 250.12, 250.13, 250.20, 250.21, 250.22, 250.23, 250.30, 250.31, 250.32, 250.33, 250.40, 250.41, 250.42, 250.43, 250.50, 250.51, 250.52, 250.53, 250.60, 250.61, 250.62, 250.63, 250.70, 250.71, 250.72, 250.73, 250.80, 250.81, 250.82, 250.83, 250.90, 250.91, 250.92, 250.93, 648.80, 648.81, 648.82, 648.83, 648.84, V58.67

ICD-10 Codes

E10.10-E13.9, O24.414, O24.424, O24.429, O24.434, O99.810, O99.815, Z79.4

Procedural Codes: A9274, E0784
References
  1. Centers for Medicare and Medicaid Services –National Coverage Determination for Infusion Pumps (280.14) Publication number 100.3, Manual Section number 280.14, Version 2. Durable Medical Equipment (2005 February 18). http://www.cms.hhs.gov .
  2. Bagley GP, Whyte JJ, et al. Decision Memo for Insulin Infusion Pump (CAG-00041N) National Coverage Decision. Centers for Medicare and Medicaid Services August 26, 1999. Available at www.cms.gov (accessed December 6, 2012).
  3. JL Colquitt JL, Green C, et al. Clinical and Cost Effectiveness of Continuous Subcutaneous Insulin Infusion for Diabetes. Southampton Health Technology Assessments Centre. The National Institute of Clinical Excellence. August 2002. Available at www.nice.org.uk (accessed December 6, 2012).
  4. Position Statement: Standards of Medical Care in Diabetes—2012. American Diabetes Association. January 1, 2012; Diabetes Care, Volume 35, Supplement 1.
  5. Childs BP, Shwide-Slavin C, et al. AADE Position Statement—Continuous Subcutaneous Insulin Therapy Using a Pump. American Association of Diabetes Educators. <www.diabeteseducator.org> (accessed December 6, 2012).
History
June 2013  New 2013 BCBSMT medical policy.
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Insulin Infusion Pumps