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Coverage criteria policies

Artificial pancreas system

These services may or may not be covered by all HealthPartners plans. Please see your plan documents for your own coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Prior authorization is required for an artificial pancreas system (S1034), transmitter (S1036) and receiver (S1037)

Prior authorization is not required for the following:

  • Continuous Glucose Monitoring Systems (CGMS), transmitter, sensors and receivers
  • Artificial pancreas sensor (S1035)
  • A combined or integrated continuous subcutaneous insulin infusion and blood glucose monitoring system.

Note: Items listed in this policy are covered under Durable Medical Equipment (DME) benefits unless specified otherwise in your plan documents. Please see your plan documents or call Member Services if you need more information.

Coverage

An artificial pancreas system is covered subject to the indications listed below and per your plan documents.

Continuous glucose monitoring system is generally covered subject to your plan documents.

Indications that are covered

An FDA approved artificial pancreas (i.e. MiniMed® 670G hybrid closed looped system) may be covered when the following criteria are met:

  1. The member is 7 years of age or older;
  2. The member has diagnosis of type one diabetes;
  3. The member requires a minimum of eight units per day of insulin;
  4. The prescribing provider must be an endocrinologist;
  5. The member has demonstrated the ability to perform a minimum of four blood glucose tests per day; and
  6. Documentation submitted supports one or more of the following indications are present:
    1. Hypoglycemia unawareness;
    2. Nocturnal hypoglycemia is suspected;
    3. Frequent problems with hypoglycemia and hyperglycemia refractory to multiple adjustments in self-monitoring of blood glucose and insulin administration;
    4. The member has unexplained, large fluctuations in preprandial glucose values;

Coverage of artificial pancreas transmitters & receivers are limited to one per person for expected life of the device because these are covered under warranty. Replacement of eligible equipment may be covered if the estimate for repairs is not cost effective and the item has exceeded manufacturer life expectancy.

Note: Members should contact the manufacturer or vendor for any needed repairs or replacements during the warranty period

Indications that are not covered

  1. An artificial pancreas is not covered for any other conditions, including but not limited to those listed below, because the safety and/or efficacy cannot be established by review of the published peer-reviewed literature:
    1. Pregnant women with pregestational type 1 diabetes;
    2. Gestational diabetes.
  2. Replacement of an artificial pancreas while under manufacturer warranty.
  3. Replacement or repair of any covered items, if the items are (i) damaged or destroyed by member misuse, abuse or carelessness, (ii) lost; or (iii) stolen.
  4. Supplies not listed above that are mainly for comfort or convenience (such as covers to use in the shower), are not covered per your member contract.

Definitions

Closed-loop insulin delivery system (artificial pancreas system) a system that is intended to mimic the body’s own glucose management system, which does not work properly in people with Type I diabetes mellitus. The system is attached to the body and is composed of three parts: a continuous glucose monitor, an insulin pump, and a computer with an algorithm that coordinates blood glucose levels and the corresponding doses of insulin required throughout the day. A hybrid closed-loop system is not fully automated; that is, patients need to manually enter mealtime boluses, but basal insulin doses are automatically adjusted based on CGM results.

Preprandial – before a meal

If available, codes for a procedure, device or diagnosis are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all inclusive.

Codes

Description

A9276

Sensor; invasive (e.g., subcutaneous), disposable, for use with interstitial continuous glucose monitoring system, 1 unit = 1 day supply

A9277

Transmitter; external, for use with interstitial continuous glucose monitoring system

A9278

Receiver (monitor); external, for use with interstitial continuous glucose monitoring system

K0553

Supply allowance for therapeutic continuous glucose monitor (CGM), includes all supplies and accessories, 1 month supply = 1 unit of service

K0554

Receiver (monitor), dedicated, for use with therapeutic glucose continuous monitor system

S1034

Artificial pancreas device system (e.g., low glucose suspend [LGS] feature) including continuous glucose monitor, blood glucose device, insulin pump and computer algorithm that communicates with all of the devices

S1035

Sensor; invasive (e.g., subcutaneous), disposable, for use with artificial pancreas device system

S1036

Transmitter; external, for use with artificial pancreas device system

S1037

Receiver (monitor); external, for use with artificial pancreas device system

CPT Copyright American Medical Association. All rights reserved.  CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy contact Member Services at 952-883-7979 or 1-800-233-9645.

Vendor

Items must be received from a contracted DME vendor for in-network benefits to apply.

References

  1. American Diabetes Association. (2004). Position Statement. Continuous subcutaneous insulin infusion. Diabetes Care, 27(suppl 1),S110
  2. American Diabetes Association. (2018). 6. Glycemic targets: Standards of medical care in diabetes. Diabetes Care, 41(Suppl. 1), S55–S64
  3. Bekiari, E., Kitsios, K., Thabit, H., Tauschmann, M., Athanasiadou, E., Karagiannis, T., … Tsapas, A. (2018). Artificial pancreas treatment for outpatients with type 1 diabetes: Systematic review and meta-analysis. BMJ, 361(k1310). doi: http://dx.doi.org/10.1136/bmj.k1310
  4. ECRI Institute. (2010). Evidence Report: Real-time Continuous Glucose Monitoring for Type 1 and Type 2 Diabetes. Plymouth Meeting, PA: ECRI Institute.
  5. ECRI Institute. (2012). Hotline Response. Insulin pump with continuous glucose monitoring system for managing diabetes. Plymouth Meeting, PA: ECRI Institute.
  6. US Food and Drug Administration (FDA). (2016). MiniMed 670G System Pre-Market Approval Letter. Available from https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160017a.pdf
  7. US Food and Drug Administration (FDA). (2018). MiniMed 670G System Pre-Market Approval supplement. Available from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160017S031
  8. Handelsman, Y., Bloomgarden, Z. T., Grunberger, G., Umpierrez, G., Zimmerman, R. S., Bailey, T. S., … Zangeneh, F.; American Association of Clinical Endocrinologists and American College of Endocrinology. (2015). Clinical practice guidelines for developing a diabetes mellitus comprehensive care plan – 2015 – executive summary. Endocrine Practice, 21 (Suppl 1), 1-87. doi:10.4158/EP15672.GL.
  9. Hayes, Inc. Hayes Medical Technology Directory Report. Implantable insulin pumps. Lansdale PA: Hayes, Inc.; June, 2011. Reviewed May, 2015/ Archived August, 2015.
  10. Hayes, Inc. Hayes Medical Technology Directory Report. Continuous glucose monitoring systems. Lansdale, PA: Hayes, Inc.; August, 2015. Reviewed July, 2017.
  11. Klonoff, D. C., Buckingham, B., Christiansen, J. S., Montori, V. M., Tamborlane, W. V., Vigersky, R. A., & Wolpert, H. (2011). Continuous glucose monitoring: an Endocrine Society clinical practice guideline. The Journal of Clinical Endocrinology & Metabolism. 96(10), 2968-79. doi: https://doi.org/10.1210/jc.2010-2756
  12. Peters, A. L., Ahmann, A. J., Battelino, T., Evert, A., Hirsch, I. B., Murad, M. H., … Wolpert, H. (2016). Diabetes technology—continuous subcutaneous insulin infusion therapy and continuous glucose monitoring in adults: An Endocrine Society clinical practice guideline. The Journal of Clinical Endocrinology & Metabolism, 101(11), 3922–3937. doi: 10.1210/jc.2016-2534
  13. Weisman, A., Bai, J.-W., Cardinez, M., Kramer, C. K., & Perkins, B. A. (2017). Effect of artificial pancreas systems on glycaemic control in patients with type 1 diabetes: A systematic review and meta-analysis of outpatient randomised controlled trials. The Lancet Diabetes & Endocrinology, 5(7), 501-512.

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Policy activity

  • 01/11/2007 - Date of origin
  • 08/01/2018 - Effective date
Review date
  • 05/2018
Revision date
  • 07/06/2018

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