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Thread: New Pump
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  #13 (permalink)  
Old 07-15-2007, 08:55 PM
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duck duck is offline
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Since this stuff is publically available for DL on my insurance's website, I'm gonna copy and paste here (in reference to their Position Paper on Pumps, Pumps with Glucose Monitors that communicate with them, and Pumps with CGMS)...Funnygrl, unfortunately, there doesn't seem to be an HCPCS code for CGMS yet:

Quote:
CSII-BGM Systems with Continuous Glucose Monitoring: The MiniMed Paradigm® REAL-Time Insulin Pump (Medtronic MiniMed, Northridge, CA) is currently the only device that includes a continuous glucose monitor as opposed to the standard glucose monitor. It is used in conjunction with the Guardian RT® Continuous Glucose Monitoring System (Medtronic MiniMed, Northridge, CA), FDA-approved April 7, 2006 and June 14, 2006, respectively. This combined system received PMA approval, as implantable infusion pumps or closed-loop devices require PMA by the FDA.

Literature Review:
CSII-BGM Systems: Minimal literature has been published specifically related to the clinical use of combined continuous subcutaneous insulin infusion and blood glucose monitoring devices. There are no clinical trials that report outcomes comparing the use of a combined continuous insulin infusion and blood glucose monitoring system to the use of separate external insulin pumps and blood glucose monitoring devices. In the 510(k) approval document, the FDA determined that the combined CSII-BGM systems using wireless technology to communicate between the insulin pump and BGM are substantially equivalent to the predicate devices (i.e., separate pump and meter). There is insufficient evidence to assess the safety and efficacy of combined CSII-BGM devices (Hayes, Oct 10, 2005).

CSII-BGM Systems with Continuous Glucose Monitoring: Halvorson et al. (2007) conducted a pilot study using the Paradigm Real Time – MMT-522 to treat ten children, mean age 14.1 ± 2.6 years, with type 1 diabetes. A1C values at the end of four weeks demonstrated an improved A1C level in seven subjects. Participants did not experience severe hypoglycemia, and there were no episodes of DKA. An observational study by Mastrototaro et al. (2006) using a prototype CSII-BGM device involved 20 adult, volunteer, Medtronic employees with type 1 diabetes, five of whom dropped out of the trial. Results at the end of three months demonstrated an improvement in A1C levels. Proposed advantages of the use of these devices include: access to glucose values, trending of data, hypo- and hyperglycemic alerts with the ability to adjust insulin dosages, energy intake and activity to ward off the episodes.
There remains insufficient evidence to assess the safety and efficacy of the MiniMed Paradigm REALTime Insulin Pump and Continuous Glucose Monitoring System (Hayes, Aug 14, 2006).

Summary
External insulin pumps are designed to provide continuous subcutaneous insulin infusion (CSII) in patients with diabetes mellitus. The external insulin pump is a programmable, battery-powered mechanical syringe regulated by a miniature computer. The Diabetes Control and Complications Trial (DCCT) demonstrated that intensive insulin therapy is effective in reducing the chronic metabolic complications of diabetes and in delaying the onset and progression of secondary complications of type 1 diabetics. Evidence in the peer-reviewed literature supports the safety and efficacy of CSII in type 1 diabetics nonresponsive to insulin administration by multiple daily insulin injections (MDI) as demonstrated by persistent glycated hemoglobin level > 7.0%, recurring hyper- or hypoglycemic episodes, and wide fluctuations in blood glucose levels, dawn phenomenon and/or a history of severe glycemic excursions.

The published literature contains little information regarding the safety and efficacy of CSII in type 2 diabetics, and the benefits of intensive insulin therapy delivered via either MDI or external pump are not well established. There is no information available in the peer-reviewed literature regarding the replacement of pumps with newer models nor which features might provide additional health benefits and which are primarily for convenience or ease of use. There is insufficient evidence in the published, peerreviewed scientific literature to assess the safety and efficacy of combined CSII with continuous glucose monitoring.

Coding/Billing Information
Note: This list of codes may not be all-inclusive.

Covered when medically necessary:

CPT®* Codes Description
No specific codes

HCPCS Codes/Description
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
E0784 /External ambulatory infusion pump, insulin
S9145 /Insulin pump initiation, instruction in initial use of pump (pump not included)
I'd like to note that they make no reference to the fact that the Paradigm 522 and 722 have CGMS capability built into them...this Position Paper states you need the Guardian. Interesting. And the revised date was February of this year.
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