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Medical Policy

Policy Num:       07.001.001
Policy Name:     Insulin Pump 
Policy ID:          [07.001.001][Ar L M+ P+ ][0.00.00]

Last Review:       November 14, 2018
Next Review:     November 14, 2019
Issue:                November 2018

Related Policies: None

ARCHIVED

Insulin Pump

Summary

Since early in the 1970s, there was evidence that supported the theory that firm control of diabetes prevented or slowed the complications of Type I diabetes. This was helped by the development of reliable methods of assessing glycemic control (Hb A1c) and the development of accurate methods of assessing diabetes. 

The "Diabetic Control and Complication Trial" (DCCT) proved that tight control of diabetes prevented or slowed the chronic complications of this condition. In the study arm in which patients received intensive treatment, either by multiple daily injections (MDI) or by continuous subcutaneous insulin infusion (CSII) there was a 70% reduction in the progression of diabetic retinopathy; 50% reduction in diabetic nephropathy and 64% reduction in diabetic neuropathy. Based on these results the "American Diabetes Association" revised its standard of care and recommended target glycemic control at normal levels in most patients with Type I Diabetes. 

The continuous infusion system ("Continuous Subcutaneous Insulin Infusion- CSSI") is a system of subcutaneous insulin infusion using a programmable pump that provides a continuous and stable flow. This flow can be programmed to manage the amount depending on the metabolic needs of the patient who is using it. It can be programmed to supply greater amounts of insulin to cover meals intake. This provides the patient more flexibility to suit their lifestyles.

Some studies show that users of this system maintain levels of glycosylated hemoglobin (Hb A1c) within normal ranges, hypoglycemic episodes are reduced, and fewer emergency room visits and hospitalizations.

This system has the following advantages:

Improves metabolic control and glucose levels are achieved near normal

• Reduce the risk of micro and macrovascular complications:

1.         retinopathies reduce the risk of developing it by 76%, if there is reduced progression by 54%

2.         Kidney Diseases-proteinuria is reduced by 54%

3.         Neuropathies- risk is reduced by 60%

• CSSI uses only rapid-acting insulin that provides a reproducible and predictable absorption

• Use a single area for injection thus avoiding variations in absorption of body parts

• Insulin does not accumulate in a subcutaneous depot, reducing the risk of mobilizing the deposit at a given moment and produce hypoglycemia.

• better glycemic control while avoiding hypoglycemia night at dawn is obtained

Patient selection is very important if you want to get the maximum effect of the insulin pump. The following characteristics should serve as a warning about who is not a good candidate for using the insulin pump:

Child, adolescent or adult with poor family support.

• Unwilling or unable to be monitored blood glucose three to four times a day.

• Unwilling or unable to calculate how many meals.

• Difficulty to calculate or adjust insulin doses, or to face difficulties with the pump.

• Difficulty to follow instructions or comply with doctor visits.

• Ashamed to be known diabetic and dependent on a mechanical device.

• unstable psychiatric profile.

Objective

N/A

Policy Statements

The use of the insulin pump is considered for payment for adults and pediatric population with diabetes under the following conditions: 

• The need for improvement in glycemic control in individuals despite properly follow your diet and insulin dose, they cannot maintain Hgb A1c levels at normal levels.

• Hypoglycemia - the insulin pump has been of benefit in reducing hypoglycemic events, especially in people prone to them and persons with a range of erratic glucose levels.

• Pregnancy - hyperglycemia and / or ketoacidosis. Due to increased risk of  having children with congenital anomalies.

• Sensitivity to insulin - individuals with daily doses <20 Units or <0.4 units / kg.

• Hypoglycemia at dawn.

• Diabetic complications such as nephropathy, retinopathy stable, early neuropathy.

• Lifestyles - Itineraries that preclude follow a strict pattern of power due to external factors

Policy Guidelines

N/A

Benefit Application

BlueCard/National Account Issues

N/A

Background

N/A 

Regulatory Status

N/A

Rationale

Population Reference No. 1 Policy Statement

For individuals with diagnosis of diabetes. Interventions of interest are continuous subcutaneous insulin infusion (CSSI). Comparators of interests are other pharmacotherapy and lifestyle modification. Relevant outcomes include the improvement of metabolic control and glucose levels and reduce the risk of micro and macrovascular complications.

Supplemental Information

N/A

Practice Guidelines and Position Statements

N/A

Medicare National Coverage

N/A

References

1. Zeng C, Li H, Yang T, et al. Electrical stimulation for pain relief in knee osteoarthritis: systematic review and network meta-analysis. Osteoarthritis Cartilage. Feb 2015;23(2):189-202. PMID 25497083

2. Fuentes JP, Armijo Olivo S, Magee DJ, et al. Effectiveness of interferential current therapy in the management of musculoskeletal pain: a systematic review and meta-analysis. Phys Ther. Sep 2010;90(9):1219-1238. PMID 20651012

3. Defrin R, Ariel E, Peretz C. Segmental noxious versus innocuous electrical stimulation for chronic pain relief and the effect of fading sensation during treatment. Pain. May 2005;115(1-2):152-160. PMID 15836978

4. Taylor K, Newton RA, Personius WJ, et al. Effects of interferential current stimulation for treatment of subjects with recurrent jaw pain. Phys Ther. Mar 1987;67(3):346-350. PMID 3493493

5. Atamaz FC, Durmaz B, Baydar M, et al. Comparison of the efficacy of transcutaneous electrical nerve stimulation, interferential currents, and shortwave diathermy in knee osteoarthritis: a double-blind, randomized, controlled, multicenter study. Arch Phys Med Rehabil. May 2012;93(5):748-756. PMID 22459699

6. Gundog M, Atamaz F, Kanyilmaz S, et al. Interferential current therapy in patients with knee osteoarthritis: comparison of the effectiveness of different amplitude-modulated frequencies. Am J Phys Med Rehabil. Feb 2012;91(2):107-113. PMID 22019968

7. Koca I, Boyaci A, Tutoglu A, et al. Assessment of the effectiveness of interferential current therapy and TENS in the management of carpal tunnel syndrome: a randomized controlled study. Rheumatol Int. Dec 2014;34(12):1639-1645. PMID 24728028

8. Lara-Palomo IC, Aguilar-Ferrandiz ME, Mataran-Penarrocha GA, et al. Short-term effects of interferential current electro-massage in adults with chronic non-specific low back pain: a randomized controlled trial. Clin Rehabil. May 2013;27(5):439-449.. PMID 23035006

9. Facci LM, Nowotny JP, Tormem F, et al. Effects of transcutaneous electrical nerve stimulation (TENS) and interferential currents (IFC) in patients with nonspecific chronic low back pain: randomized clinical trial. Sao Paulo Med J. 2011;129(4):206-216. PMID 21971895 10. Albornoz-Cabello M, Maya-Martin J, Dominguez-Maldonado G, et al. Effect of interferential current therapy on pain perception and disability level in subjects with chronic low back pain: A randomized controlled trial. Clin Rehabil. Mar 14 2016. PMID 26975312 11. Dissanayaka TD, Pallegama RW, Suraweera HJ, et al. Comparison of the effectiveness of transcutaneous electrical nerve stimulation and interferential therapy on the upper trapezius in myofascial pain syndrome: a randomized controlled study. Am J Phys Med Rehabil. Mar 4 2016. PMID 26945216

12. Kajbafzadeh AM, Sharifi-Rad L, Nejat F, et al. Transcutaneous interferential electrical stimulation for management of neurogenic bowel dysfunction in children with myelomeningocele. Int J Colorectal Dis. Apr 2012;27(4):453-458. PMID 22065105

13. Clarke MC, Chase JW, Gibb S, et al. Improvement of quality of life in children with slow transit constipation after treatment with transcutaneous electrical stimulation. J Pediatr Surg. Jun 2009;44(6):1268-1272; discussion 1272. PMID 19524752

14. Coban S, Akbal E, Koklu S, et al. Clinical trial: transcutaneous interferential electrical stimulation in individuals with irritable bowel syndrome - a prospective double-blind randomized study. Digestion. 2012;86(2):86-93. PMID 22846190

15. Koklu S, Koklu G, Ozguclu E, et al. Clinical trial: interferential electric stimulation in functional dyspepsia patients - a prospective randomized study. Aliment Pharmacol Ther. May 2010;31(9):961-968. PMID 20136803

16. Suh HR, Han HC, Cho HY. Immediate therapeutic effect of interferential current therapy on spasticity, balance, and gait function in chronic stroke patients: a randomized control trial. Clin Rehabil. Sep 2014;28(9):885-891. PMID 24607801

17. Chou R, Qaseem A, Snow V, et al. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. Oct 2 2007;147(7):478-491. PMID 17909209

18. American College of Occupational and Environmental Medicine (ACOEM). Shoulder Disorders. www.guideline.gov. Accessed May 15, 2016.

19. American College of Occupational and Environmental Medicine (ACOEM). Low Back Disorders. www.guideline.gov. Accessed May 15, 2016.

20. American College of Occupational and Environmental Medicine (ACOEM). Knee Disorders. www.guideline.gov. Accessed May 15, 2016.

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Appplicable Modifiers

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Policy History