Coverage Policy Manual
Policy #: 1998026
Category: DME
Initiated: January 1993
Last Review: April 2018
  Insulin Infusion Pumps, External

Description:
An external infusion pump is a portable device intended to provide continuous ambulatory drug infusion therapy over an extended time period.   An external insulin infusion pump is composed of a pump reservoir similar to that of an insulin cartridge, a battery–operated pump, and a computer chip that allows the user to control the exact amount of insulin being delivered.    Typically, the syringe has a two to three day insulin capacity and is connected to an infusion set attached to a small needle or cannula which the individual inserts into the subcutaneous tissue.  Pumps deliver insulin two ways: in a continuous flow called a “basal rate” and in a quick burst (at mealtime) called a “bolus.”  The purpose of the insulin pump is to provide an accurate, continuous, controlled delivery of insulin which can be regulated by the user to achieve intensive glucose control objectives and to prevent the metabolic complications of hypoglycemia, hyperglycemia and diabetic ketoacidosis.
  
This policy only addresses the use of external infusion pumps for insulin therapy. Continuous glucose monitoring is discussed in policy #2001009.

Policy/
Coverage:
Effective March 2012
External ambulatory insulin infusion pumps (Continuous ambulatory insulin infusion pump therapy (CSII)) are considered medically necessary when all of the following prerequisites are met and are clearly documented in the patient’s medical record:
    • The patient must have type I diabetes mellitus which has been treated for 6 months or greater; with intermittent insulin injections, and is inadequately controlled (see notes below), or type II diabetes mellitus, with either a fasting C-peptide less than or equal to 110% of the lower limit of the testing laboratory normal with concurrently obtained fasting glucose equal to or less than 225 mg/dL, or has the presence of beta cell auto antibody; and
    • The patient/parent or caregiver of a dependent child has demonstrated ability and willingness to monitor blood glucose levels more than 4 times per day; and
    • The patient/parent or caregiver of a dependent child is motivated to achieve and maintain improved glycemic control/ and
    • The patient/parent or caregiver is capable physically and intellectually to operate the CSII pump; and
    • The patient demonstrates compliance with dietary and insulin regimen, and
    • The pump must be ordered by and follow-up care of the patient must be managed by a physician and health care team who are knowledgeable in the use of CSII.
 
In addition to the above prerequisites, the patient must also meet one or more of the following indications:
    • Two glycosylated hemoglobin (HbA1c) greater than 7.0% (where the upper range of normal is less than 6.05% (for other assays, 1% absolute over upper range of normal) within a 120-day time span;
    • History of severe glycemic excursions commonly associated with brittle diabetes, such as hypoglycemic unawareness, nocturnal hypoglycemia, extreme insulin sensitivity and/or very low insulin requirements; Wide fluctuations in blood glucose before mealtimes (e.g., preprandial blood glucose level commonly exceeds 140 mg/dL;
    • Dawn phenomenon where fasting blood glucose level often exceeds 200 mg/dL; Day-to-day variations in work schedule, mealtime, and/or activity level, which confound the degree of regimentation required to self-manage glycemia with multiple insulin injections;
    • Preconception or pregnancy with a history of suboptimal glycemic control; and
    • Suboptimal glycemic and metabolic control post-renal transplant
 
Back-up external insulin infusion pumps are not covered.
 
Replacement of a functioning external insulin infusion pump with a newer advanced model is not covered.
 
Replacement of a non-functioning external insulin infusion pump with a subsequent pump is covered if the patient has demonstrated compliance with the current pump.
 
The above medical criteria do not have to be met again for the pump to be replaced.
 
Payments for insulin infusion pumps accrue to the annual DME limit.
 
Effective prior to March 2012
The use of an external infusion pump for insulin therapy meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the treatment of 1) Type I diabetes for patients taking insulin, or 2) Type II diabetes for patients taking insulin who also have a low c-peptide who meet the following criteria:
 
    • Verification of the suitability of the patient for use of this device by a board eligible/certified endocrinologist or by a physician with verified supplemental training beyond standard residence training in the treatment of patients with diabetes mellitus and the use of an insulin pump;
    • Verification that a physician with experience in the management of patients being treated with an insulin pump, and complications from the use of an insulin pump is available at all times for emergent patient contact;
    • Verification that the patient is motivated to achieve and maintain glycemic control;
    • Verification that the patient is reliable and capable of learning the proper care needed to maintain the pump;
    • Verification that the patient has severe glycemic variations (hypoglycemic unawareness, nocturnal hypoglycemia, extreme insulin sensitivity, day to day variations in activity levels, mealtimes and/or daily schedule confound the degree of regimentation required to self-manage glycemia with multiple insulin injections.
 
Effective prior to November 2011
Use of the EIP for the administration of the following drugs meets primary coverage criteria for effectiveness and is covered for selected patients on:
    • Morphine and other parenteral analgesics for treatment of severe, chronic cancer pain that is resistant to conventional therapy.  Acceptable routes are subcutaneous (SC) and intravenous (IV);
    • Insulin for treatment of insulin-dependent diabetes mellitus in patients who cannot be controlled by intermittent dosing.  Acceptable routes are SC and IV;
    • Heparin for treatment of severe thromboembolic disease than cannot be managed conventionally (e.g., complicated pregnancy).  Acceptable routes are SC and IV;
    • Chemotherapeutics for treatment of cancer.  
Acceptable routes are stipulated in the drug labeling and might include either IV or intraarterial (IA).
 
Patient selection is key to appropriate utilization of the 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 (or pulsatile) 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; and
    • Presence of favorable technical factors, such as a convenient, safe, and reliable EIP delivery system along with correct placement of the needle and catheter, exist.
 
EIP meets primary coverage criteria for effectiveness and is covered for the administration of morphine or other parenteral analgesics that may be administered via an external infusion pump for the treatment of severe, chronic cancer pain that is resistant to conventional therapy.
 
EIP meets primary coverage criteria for effectiveness and is covered for the treatment of 1) Type I diabetes for patients taking insulin, or 2) Type II diabetes for patients taking insulin who also have a low c-peptide. who meet the following criteria:
    • Verification of the suitability of the patient for use of this device by a board eligible/certified endocrinologist or by a physician with verified supplemental training beyond standard residence training in the treatment of patients with diabetes mellitus and the use of an insulin pump;
    • Verification that a physician with experience in, and complications from the use of an insulin pump is available at all times for emergent patient contact;
    • Verification that the patient is motivated to achieve and maintain glycemic control;
    • Verification that the patient is reliable and capable of learning the proper care needed to maintain the pump;
    • Verification that the patient has severe glycemic variations (hypoglycemic unawareness, nocturnal hypoglycemia, extreme insulin sensitivity, day to day variations in activity levels, mealtimes and/or daily schedule confound the degree of regimentation required to self-manage glycemia with multiple insulin injections.
 
EIP meets primary coverage criteria for effectiveness and is covered for treatment of thromboembolic disease that cannot be managed with self-injected heparin or oral warfarin drugs.
 
EIP meets primary coverage criteria for effectiveness and is covered for delivery of chemotherapeutics for treatment of cancer.
 
EIP meets primary coverage criteria for effectiveness and is covered for treatment of chronic spasticity problems in patients who are unresponsive to appropriate oral medication.

Rationale:
2012 Update – CSII in type 2 DM
Some patients who have been diagnosed with type 2 diabetes may have a condition more closely related to insulin dependent diabetes.
 
Many of these patients have been shown to have islet cell antibody positivity or antibodies to glutamic acid decarboxylase, with a decreased C-peptide response to glucagon stimulation and a propensity for primary oral medication failure.  A study of 102 patients with onset of diabetes after the age of 35 were classified according to glucagon-stimulated C-peptide levels into an insulin-deficient group and non-insulin deficient group.  Anti-GAD antibody was significantly higher in the insulin deficient group (Tuomi, 1993).  These individuals are now labeled with the condition “latent autoimmune diabetes in adults [LADA]” (American Diabetes Asso, 2004).
 
Insulin pump therapy has not been fully evaluated in patients with type 2 diabetes, and the studies that have been published have been done on small groups.  There are a number of randomized controlled trials on CSII in type 2 DM, but most of them are small, and the results of the larger trials are conflicting.  The two largest RCTs were reported in 2003 and 2005.  In the first, a total of 132 patients were randomized to CSII or multiple dose injection (MDI).  CSII and MDI significantly reduced mean HbA1c but there was no statistical difference, and neither group reached ADA-recommended HbA1c levels (Raskin, 2003).  In the second trial, 107 patients 60 years of age or older, were randomized to CSII versus MDI for 1 year. Both therapies significantly reduced mean HbA1c from baseline, but again, there was no significant difference between those on pump therapy and those on MDI (Herman, 2005).
 
There are ongoing studies, with the largest being an industry sponsored phase IV trial of 400 patients, with a projected completion date of June 2013 (NCT01182493).
 
Insulin pump therapy is recommended by some in patients with type 2 diabetes who require insulin but who have not achieved glycemic control and subcutaneous injections, and who have antibodies to pancreatic beta cells, or who have decreased C-peptide response to glucagon simulation.  
 
A Health Technology Assessment on the clinical effectiveness and cost-effectiveness of CSII for diabetes, concluded, “Based on the totality of evidence, using observational studies to supplement the limited data from randomized trials against best MDI, CSII provides some advantages over MDI in type 1 diabetes mellitus for both children and adults.  However, there was no evidence that CSII is better than analogue-based MDI in type 2 diabetes mellitus or in pregnancy.  Further trials with larger numbers and longer durations comparing CSII and optimized MDI in adults, adolescents and children are needed.  In addition, there should be a trial of CSII versus MDI with similar provision of structured education in both arms.  A trial is also needed for pregnant women with pre-existing diabetes, to investigate using CSII to the best effect (Cummins, 2010).”
 
May 2012
In a recent review article on insulin pumps for type 1 diabetes, the author states, “Insulin-pump therapy should be initiated by a specialized hospital team comprising a physician, a diabetes nurse, and a dietitian trained in pump procedures.  Initiation of pump therapy by primary care physicians is not recommended…Starting insulin pump therapy is generally contraindicated when a clinical team that specializes in this treatment is not available, when the patient is unwilling or unable to use the pump, or when the patient has major psychiatric problems” (Pickup, 2012). This article further supports our coverage position to require the pumps be ordered and managed by a physician and health care team who are knowledgeable in the use of CSII.
  
2014 Update
A literature search conducted through March 2014 did not reveal any new information that would prompt a change in the coverage statement.
 
2015 Update
A literature search conducted through March 2015 did not reveal any new information that would prompt a change in the coverage statement.
 
2017 Update
A literature search conducted through March 2017 did not reveal any new information that would prompt a change in the coverage statement.
 
2018 Update
A literature search conducted through March 2018 did not reveal any new information that would prompt a change in the coverage statement.

CPT/HCPCS:
E0784External ambulatory infusion pump, insulin

References: American Diabetes Association. Diabetes Dictionary, 2004. Available at http://222.diabetes.org/dictionary.jsp.

Bode, BW(2010) Insulin Pump Use in Type 2 Diabetes DIABETES TECHNOLOGY & THERAPEUTICS Volume 12, Supplement 1, 2010

Cummins E, Royle P, Snaith A, et al.(2010) Clinical effectiveness of continuous subcutaneous insulin infusion for diabetes: systematic review and economic evaluation. Health Technol Asses, 2010; 14:1-181.

Herman WH, Ilag LL, Johnson SL, et al(2005) A clinical trial of continuous subcutaneous insulin infusion versus multiple daily injections in older adults with type 2 diabetes. Diabetes Care, 2005; 28:1568-1573.

Pickup JC.(2012) Insulin-Pump Therapy for Type 1 Diabetes-Mellitus. New Engl J Med, 2012; 266:1616-1624.

Tuomi T, Groop LC, Simmet PZ, et al.(1993) Antibodies to glutamic acid decarboxylase reveal latent autoimmune diabetes in adults with a non-insulin dependent onset of disease. Diabetes, 1993; 42:359-362


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2019 American Medical Association.