National Coverage Analysis (NCA) View Public Comments

Outpatient Intravenous Insulin Treatment (Therapy)

Public Comments

Commenter Comment Information
Aoki, M.D., Thomas Title: Director of Research
Organization: Aoki Diabetes Research Institute
Date: 10/24/2009
Comment:

I appreciate the effort by CMS to make their review. This is a very complex subject, a new area of medical therapeutics, and the procedures within the category of OIVIT are not all clearly defined. I also appreciated the opportunity to present the scientific aspects of the therapy I developed, metabolic activation therapy (MAT®), in person to staff from CMS and the FDA. Unfortunately my brief presentation must not have answered all of the questions on the subject since there were

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Arcangeli, Michael Date: 10/24/2009
Comment:

Thank you for again letting me respond to this NCA.I think it is important to keep in mind the stated reasons for this internally initiated NCA.From the Medicare NCA:“Diabetes is an important disease in the Medicare beneficiary population. Diabetes in this population is primarily type 2 diabetes, reflecting the older age of most beneficiaries. Diabetic beneficiaries younger than 65 years of age frequently have either type 1 disease and disability from diabetic complications or type 2

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Parsons, Bruce Title: President
Organization: International Technology Ventures
Date: 10/24/2009
Comment:

October 24, 2009

This opinion is written by Mr. Bruce Parsons, an individual who has first hand knowledge of the history of and a keen interest in attempting to make Metabolic Activation Therapy available to diabetic patients worldwide. Mr. Parsons is a member of the class of 1962 from West Point.

Summary of Issues with CMS NCA

I. CMS Conclusion:
“The evidence is adequate to conclude that outpatient intravenous insulin therapy does not improve health

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Scott, Gordon V. Title: Secretary
Organization: CARE for Diabetics
Date: 10/21/2009
Comment:

I failed to detect any internal logic in the Proposed Decision Memo.

The first item under the proposed decision states: “The evidence is adequate to conclude that outpatient intravenous insulin therapy does not improve health outcomes in Medicare beneficiaries.” How is “adequate” measured? Where is it defined?

No evidence is presented that MAT does not improve health outcomes. The Proposed Decision bases its findings on reservations about the 28 cited published studies of MAT. If

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Weinrauch MD, Larry A. Date: 10/18/2009
Comment:

Addition of pulsatile infusions of insulin to a standard DCCT protocol blunted progression of renal deterioration of type 1 DM in a pilot study published in 2000. A threefold increase in time to dialysis (2 years vs. 7 years) was estimated. Cost savings for 3 dialysis treatments per week vs. one insulin infusion per week are potentially substantial.

Symptoms related to neuropathy were extracted from a quality of life questionnaire. A high correlation of positive responses was

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Chewning, Virgil Title: Mr
Organization: None
Date: 09/29/2009
Comment:

This looks like preparation for Goverment Ran Healthcare for all. Are you getting prepared to cut Seniors out of the system??