mp-046
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External Ambulatory Insulin Infusion Pump

Policy Number: MP-046

Latest Review Date: April 2021

Category:  Durable Medical Equipment                               

Policy Grade:  A

POLICY:

For Dates of Service May 31, 2020 and after:

External ambulatory insulin infusion pumps may be considered medically necessary when all the following prerequisites are met and are clearly documented in the patient’s medical record.

  1. Patient must have had the diagnosis of and been treated for diabetes for six months or greater;
  2. Patient/parent of dependent child has demonstrated ability and willingness to monitor blood glucose levels more than four times per day;
  3. Patient/parent of dependent child is motivated to achieve and maintain improved glycemic control;
  4. Patient/parent of dependent child is capable physically and intellectually to operate pump;
  5. Patient demonstrates compliance with dietary and insulin regimen;
  6. Completion of a diabetes self-management education program.

In addition to the above prerequisites, the patient must also meet one or more of the following indications:

  1. Two glycosylated hemoglobin (HbA1c) greater than 7.0% (where upper range of normal is less than 6.05%; for other assays, 1% over upper range of normal) within a 120-day time span;
  2. 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;
  3. Wide fluctuations in blood glucose before mealtimes (e.g., pre-prandial blood glucose level commonly exceeds 140 mg/dL);
  4. Dawn phenomenon where fasting blood glucose level often exceeds 200 mg/dL;
  5. 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;
  6. Preconception or pregnancy with a history of suboptimal glycemic control;
  7. Suboptimal glycemic and metabolic control post-renal transplant.

Back up external insulin infusion pumps are considered not medically necessary.

Replacement or upgrade of existing, properly functioning equipment, even if warranty has expired, is considered not medically necessary.

Replacement of a non-functioning external insulin infusion pump with a subsequent pump may be considered medically necessary for coverage.  If the patient has demonstrated compliance with the current pump, the above medical criteria do not have to be met for the pump to be replaced.

The V-Go™ Disposable Insulin Delivery Device is considered investigational.

Coverage for non-medical items, even when the items may be used to serve a medical purpose, such as smart devices (smart phones, tablets, personal computers, etc.) are non-covered. This includes smart devices used in conjunction with Insulin pumps/Continuous Glucose Monitors.

For coverage information regarding Medtronic’s MiniMed 530G/630G and 670G, or Tandem’s t:slim with CONTROL IQ or BASAL IQ refer to medical policy #636 Artificial Pancreas Device Systems.

For Dates of Service prior to May 31, 2020:

External ambulatory insulin infusion pumps may be considered medically necessary when all the following prerequisites are met and are clearly documented in the patient’s medical record.

  1. Patient must have had the diagnosis of and been treated for diabetes for six months or greater;
  2. Patient/parent of dependent child has demonstrated ability and willingness to monitor blood glucose levels more than four times per day;
  3. Patient/parent of dependent child is motivated to achieve and maintain improved glycemic control;
  4. Patient/parent of dependent child is capable physically and intellectually to operate pump;
  5. Patient demonstrates compliance with dietary and insulin regimen

In addition to the above prerequisites, the patient must also meet one or more of the following indications:

  1. Two glycosylated hemoglobin (HbA1c) greater than 7.0% (where upper range of normal is less than 6.05%; for other assays, 1% over upper range of normal) within a 120-day time span;
  2. 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;
  3. Wide fluctuations in blood glucose before mealtimes (e.g., pre-prandial blood glucose level commonly exceeds 140 mg/dL);
  4. Dawn phenomenon where fasting blood glucose level often exceeds 200 mg/dL;
  5. 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;
  6. Preconception or pregnancy with a history of suboptimal glycemic control;
  7. Suboptimal glycemic and metabolic control post-renal transplant.

Back up external insulin infusion pumps are considered not medically necessary.

Replacement or upgrade of existing, properly functioning equipment, even if warranty has expired, is considered not medically necessary.

Replacement of a non-functioning external insulin infusion pump with a subsequent pump may be considered medically necessary for coverage.  If the patient has demonstrated compliance with the current pump, the above medical criteria do not have to be met for the pump to be replaced.

Coverage for non-medical items, even when the items may be used to serve a medical purpose, such as smart devices (smart phones, tablets, personal computers, etc.) are non-covered. This includes smart devices used in conjunction with Insulin pumps/Continuous Glucose Monitors.

For coverage information regarding Medtronic’s MiniMed 530G/630G and 670G, or Tandem’s t:slim with CONTROL IQ or BASAL IQ refer to medical policy #636 Artificial Pancreas Device Systems.

DESCRIPTION OF PROCEDURE OR SERVICE:

External insulin pumps are designed to provide continuous subcutaneous insulin infusion in patients with diabetes mellitus. The external insulin pump is a programmable battery-powered mechanical syringe/reservoir regulated by a miniature computer that delivers a steady, continuous (“basal”) amount of insulin and releases a bolus dose at meals or smaller amounts at programmed times. Pumps may be combined or integrated with standard finger-stick glucose monitoring system. Frequent monitoring of the blood glucose (e.g., four times per day) is essential to ensure appropriate delivery of insulin dosage. The pump is worn continuously day and night. However, there is a disconnect feature on the infusion set which allows the diabetic person to safely disconnect from the pump for short periods of time.

Types of Diabetes

Type 1 Diabetes:

Previously called insulin-dependent diabetes mellitus (IDDM) or juvenile onset diabetes. Type 1 diabetes develops when the body's immune system destroys pancreatic beta cells, the only cells in the body that make the hormone insulin that regulates blood glucose. This form of diabetes usually strikes children and young adults, although disease onset can occur at any age. Type 1 diabetes may account for 5% to 10% of all diagnosed cases of diabetes. Risk factors for Type 1 diabetes may include autoimmune, genetic, and environmental factors.

Type 2 Diabetes:

Previously called non-insulin-dependent diabetes mellitus (NIDDM) or adult-onset diabetes. It usually begins as insulin resistance, a disorder in which the cells do not use insulin properly. Type 2 diabetes is associated with older age, obesity, family history of diabetes, history of gestational diabetes, impaired glucose metabolism, physical inactivity, and race/ethnicity. Type 2 diabetes is increasingly being diagnosed in children and adolescents.

Gestational diabetes:

Gestational diabetes is a form of glucose intolerance that is diagnosed in some women during pregnancy. It is more common among obese women and women with a family history of diabetes. During pregnancy, gestational diabetes requires treatment to normalize maternal blood glucose levels to avoid complications in the infant.

For coverage information regarding Medtronic’s MiniMed 530G/630G and 670G, or Tandem’s t:slim with CONTROL IQ or BASAL IQ refer to medical policy #636 Artificial Pancreas Device Systems.

KEY POINTS:

Literature review completed through April, 8, 2021.

KEY WORDS:

Insulin pump, Continuous Subcutaneous Insulin Infusion, CSII, MiniMed Paradigm 522 or 722 insulin pumps, MiniMed Paradigm Real-Time Insulin Pump and Continuous Glucose Monitoring System, combined continuous subcutaneous insulin infusion and blood glucose monitoring device, Guardian stand-alone device, OmniPod™ Insulin Management System, iXL-II Diabetes Management System with Blood Glucose Measurement, Animas Model IR 1250 Insulin Infusion Pump, Animas ezManager Plus, Deltec Cozmo® Insulin Infusion Pump, CoZmonitor™ Glucose Monitor, t:slim™ Insulin Delivery System, t:slim, V-Go

U.S. Preventive Services Task Force Recommendations

Not applicable. 

APPROVED BY GOVERNING BODIES:

Most external insulin pumps are approved by the FDA as 510(k) Class II devices for the continuous infusion of insulin. There are over 600 different models of pumps, most of which have received clearance for marketing by the Food and Drug Administration (FDA).

Examples of FDA approved devices include:

Brand Name

Manufacturer

Omnipod® (with PDM)

Insulet Corporation

Accu-Chek® Aviva Combo System or Spirit Combo

Roche Diagnostics

T:slim X2™ (stand-alone pump)

Tandem Diabetes Care, Inc.

 

V-Go® Zealand Pharma

For Tandem T:slim X2 with CONTROL-IQ or BASAL-IQ technology, refer to Medical Policy #636 Artificial Pancreas Device Systems.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts:  Special benefit consideration may apply.  Refer to member’s benefit plan.

CURRENT CODING:

HCPCS:

A4225

Supplies for external insulin infusion pump, syringe type cartridge, sterile, each

A4230

Infusion set for external insulin pump, non-needle cannula type

A4231

Infusion set for external insulin pump, needle type

A4232

Syringe with needle for external insulin pump, sterile, 3cc

A9274

External ambulatory insulin delivery system, disposable, each, includes all supplies and accessories

E0784

External ambulatory infusion pump, insulin

REFERENCES:

  1. American Diabetes Association. Standards in Medical Care in Diabetes, 2014. 2014; //care.diabetesjournals.org/content/37/Supplement_1/S14.full.pdf+html. American Diabetes A. Standards of medical care in diabetes--2013. Diabetes Care 2013; 36 Suppl 1:S11-66.
  2. American Diabetes Association. Care of Children and Adolescents with Type I Diabetes. Diabetes Care 2005; 28:186-212.
  3. American Diabetes Association. Continuous Subcutaneous Insulin Infusion, Diabetes Care 2004; 27: S110.
  4. American Diabetes Association.  Standards of medical care for patients with diabetes mellitus. Diabetes Care 1995; 18:8-15.
  5. American Diabetes Association.  Implications of the diabetes control and complications trial, Diabetes Care 2002; 25: 25-27.
  6. American Diabetes Association.  Implications of the United Kingdom Prospective Diabetes Study. Diabetes Care 2002; 25: 28-32.
  7. American Diabetes Association (ADA). Diabetes Forecast. 2018 Consumer guide. Accessed Mar 12,2018. Available at URL address: http://forecast.diabetes.org/consumerguide
  8. American Diabetes Association (ADA). Diabetes Forecast. 2009-2018 Insulin pumps. Accessed Mar 12, 2018. Available at URL address: http://www.diabetesforecast.org/landing-pages/dtpage.html?blood_glucose=cg-pumps
  9. Bell D.S.H. and Fernando O.  Improved glycemic control with use of continuous subcutaneous insulin infusion compared with multiple insulin injection therapy. Endocrine Practice 2000; 6:257-360.
  10. Bergenstal RM, Tamborlane WV, Ahmann A, Buse JB, Dailey G, Davis SN, Joyce C, Peoples T, Perkins BA, Welsh JB, Willi SM, Wood MA; STAR 3 Study Group. Effectiveness of sensor-augmented insulin pump therapy in type 1 diabetes. N Engl J Med. 2010 Jul 22;363(4):311-20.
  11. Bergenstal RM, Klonoff DC, Garg SK et al. Threshold-based insulin-pump interruption for reduction of hypoglycemia. N Engl J Med 2013; 369(3):224-32.
  12. Binder C., Lauritzen T., Faber O., and Pramming S.  Insulin pharmacokinetics. Diabetes Care 1984; 7:2.
  13. Bode B.W., Steed R.D., and Davidson P.C. Reduction in severe hypoglycemia with long-term continuous subcutaneous insulin infusion in Type I diabetes, Diabetes Care 1996; 19:4.
  14. Boland E.A., Grey M., and et al. Continuous subcutaneous insulin infusion; a new way to lower risk of severe hypoglycemia, improve metabolic control, and enhance coping in adolescents with Type I diabetes. Diabetes Care 1999; 22: 11.
  15. Carlton F.B.  Recent advances in the pharmacologic management of diabetes mellitus. Emergency Medical Clinics of North America 2000; 18:4.
  16. Chantelau E., Schiffers T., Schutze J., and Hansen B.  Effect of patient-selected intensive insulin therapy on quality of life. Patient Education and Counseling 1997; 38: 167-713.
  17. Crawford L.M., Sinha R.N., Odell R.M., and Comi R.J.  Efficacy of insulin pump therapy: mealtime delivery is the key factor. Endocrine Practice 2000; 6:3.
  18. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Eng J of Med 1993; 329: 977-986.
  19. The Diabetes Control and Complications Trial Research Group.  Progression of retinopathy with intensive versus conventional treatment in the diabetes control and complications trial. 1994.
  20. The Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Report of the expert committee on the diagnosis and classification of diabetes mellitus. Diabetes Care 2001; 24:1.
  21. Fatourechi MM, Kudva YC, Murad MH, Elamin MB, Tabini CC, Montori VM. Clinical review:Hypoglycemia with intensive insulin therapy. A systematic review and meta-analyses of randomized trials of continuous subcutaneous insulin infusion versus multiple daily injections. J Clin Endocrinol Metab. 2009 Mar;94(3):729-40.
  22. Floyd J.C., Cornell R.G., and et al. A prospective study identifying risk factors for discontinuance of insulin pump therapy. Diabetes Care. 1993; 16:11.
  23. Garg S, Brazg RL, Bailey TS, et al. Reduction in duration of hypoglycemia by automatic suspension of insulin delivery: the in-clinic ASPIRE study. Diabetes Technol Ther. Mar 2012; 14(3):205-209.
  24. Haakens K., Hanssen K.F., and et al. Continuous subcutaneous insulin infusion (CSII), multiple injections (MI) and conventional insulin therapy (CT) in self-selecting insulin-dependent diabetic patients. A comparison of metabolic control acute complications and patient preferences., J of Inter Med 1990; 228: 457-464.
  25. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  26. Lajara R, Davidson JA, Nikkel CC, Morris TL. Clinical and cost-effectiveness of insulin delivery with V-Go (®) disposable insulin delivery device versus multiple daily injections in patients with type 2 diabetes inadequately controlled on basal insulin. Endocr Pract. 2016;22(6):726-735.
  27. Ly TT, Nicholas JA, Retterath A, et al. Effect of sensor-augmented insulin pump therapy and automated insulin suspension vs standard insulin pump therapy on hypoglycemia in patients with Type I diabetes: a randomized clinical trial. JAMA. Sep 25 2013;310(12):1240-1247.
  28. Marcus A.O. and Fernandez M.P.  Insulin pump therapy; acceptable alternative to injecting therapy. Postgraduate Medicine 1996; 99:3.
  29. Medical Policy Reference Manual.  External infusion pumps. 1996; 1.01.08.
  30. Merck Manual. Diabetes mellitus. 2017. Accessed Mar 12, 2018. Available at URL address: http://www.merckmanuals.com/professional/endocrine_and_metabolic_disorders/diabetes_mellitus_and disorders_of_carbohydrate_metabolism/diabetes_mellitus_dm.html
  31. Mudaliar S. and Edelman S.V.  Insulin therapy in Type II diabetes. Endocrinology and Metabolism Clinics 2001; 39:4.
  32. Primary Care Education Consortium (PCEC). Primary Care Metabolic Group (PCMG). Practical insulin strategies for family physicians. Aug 2009. Accessed Mar 12, 2018. Available at URL address: http://www.pcmg-us.org/UserFiles/FINAL_VERSION-BASAL_BOLUS_SUPP_7.16.09.pdf
  33. Schifferdecker E., Schmidt K., Boehm B.O., and Schatz H.  Long-term compliance of intensified insulin therapy.  Diabetes Research and Clinical Practice 23 (1994) 17-23.
  34. Reznik Y, Cohen O, Aronson R, Conget I, Runzis S, Castaneda J, Lee SW; OpT2mise Study Group.Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open-label controlled trial. Lancet. 2014 Oct 4;384(9950):1265-72.
  35. Tsui E.Y.L, Chiasson J.L, and et al.  Counterregulatory hormone responses after long-term continuous subcutaneous insulin infusion with lispro insulin.  Diabetes Care 1998; 21:1.
  36. Wainstein, J. et al. Insulin pump therapy vs. multiple daily injections in obese Type II diabetic patients. Diabetes Medicine 2005; 22(8): 1037-1046.
  37. White RD. Insulin pump therapy (continuous subcutaneous insulin infusion). Prim Care. 2007 Dec;34(4):845-71.

POLICY HISTORY:

TEC, 1996

Medical Policy Group, 1996

Medical Policy Group, April 1999

Medical Policy Group, May 2002

Medical Policy Administration Committee, June 2002

Available for comment July 9-August 22, 2002

Medical Policy Group, April 2003 (2)

Medical Policy Administration Committee, May 2003

Available for comment May 23-July7, 2003

Medical Policy Group, September 2004 (2)

Medical Policy Administration Committee, September 2004

Available for comment October 5-November 18, 2004

Medical Policy Group, May 2006 (2)

Medical Policy Administration Committee, June 2006

Available for comment July 7-August 21, 2006

Medical Policy Group, March 2007 (2)

Medical Policy Group, April 2007 (2)

Medical Policy Administration Committee, April 2007

Available for comment July 3-August 29, 2007

Medical Policy Group, May 2008 (2)

Medical Review Committee, June 2008

Medical Policy Administration Committee, July 2008

Medical Policy Group, December 2008 (2)

Medical Policy Group, April 2014 (5): Policy statement added for coverage of sensor-augmented insulin pump therapy with the low glucose threshold suspend feature; Sensor-augmented insulin pump therapy with the low glucose threshold suspend feature is considered investigational in children younger than 16 years; Replacement or upgrade of properly functioning equipment, even if warranty has expired, does not meet medical criteria for coverage; Artificial pancreas systems are considered investigational.  Description, Key Points, Key Words, and References updated to support Policy Statements.

Medical Policy Administration Committee, April 2014

Available for comment April 4 through May 19, 2014

Medical Policy Group, May 2014 (5):  Added new code S1034 effective 7/1/2014.

Medical Policy Group, January 2015 (6):  2015 Updates – Key Points and References; no change to policy statement.

Medical Policy Group, June 2015 (6):  Added under coding section – S1035, S1036 and S1037

Medical Policy Group, June 2016 (6): Added MD-Logic artificial pancreas to Key Words. Removed Policy section older than 2008.

Medical Policy Group, December 2016: 2017 Annual Coding Update.  Added new CPT code A4225 to current coding.

Medical Policy Group, February 2017 (6): Removed Artificial Pancreas information from Description, Policy Statement, Key points, Coding, References and Key Words. Information moved to medical policy #636 Artificial Pancreas Device Systems.

Medical Policy Group, May 2017 (6): Removed old policy statement, updated coding. No change to policy statement.

Medical Policy Group, December 2019 (6): 2020 Annual Coding Update, Added A4226,E0787.

Medical Policy Group, April 2020 (6): Updates to Description, Policy Statement to include V-Go as investigational (previously investigational per internal processing, no change),addition of completion of diabetes education program, Key Points, Governing Bodies, Key Words (V-Go) and References. 45 day DRAFT until May 31, 2020.

Medical Policy Group, July 2020 (6): Removed coding A4226/E0787.

Medical Policy Group, April 2021 (6): Updates to Key Points, Governing Bodies and References. No change to policy intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.