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Year : 2011 | Volume:  2 | Issue Number:  1


Costs and frequency of DQoff-labelDQ use of INFUSE for spinal fusions at one institution in 2010

Epstein Nancy E, Schwall Garry S

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1 Donald Dietze, 2/24/2012 5:02:41 PM
Interesting article of no particular value in my opinion.
I am not sure of the implication regarding the usage of FDA approved products in an "Off-Label" application. Licensed physicians are given the authority to use FDA approved products in the best interest of their patient's treatment. It is a logical authority granted since FDA studies must be done in a restrictive study to obtain adequate statistical data though it is understood the product even used "On-Label" will be exposed to multiple new variables in the "real world". In fact, the FDA collects data for an additional 2 years after release and may extend this follow up based on this newly collected data.
Regarding the reported costs, I wonder if these numbers are the charges submitted versus the expected payment versus the actual payment for this product. I find the charge of $26,000 per case excessive representing a 6-7X up charge since a large Infuse generally runs about $4,000 to the facility. Perhaps the value of this article is for the institution studied and their utilization of Infuse per case.
I greatly understand that in this "New World" we must become conscientious about the costs of the products used in relation to the outcome of our treatment, but at this time I am not aware of any fair and accurate method for documenting this cost. I only see the "Charges" listed. We know that for Medicare the facility receives a DRG regardless of whether Infuse is used or not. A methodology to assess actual payments that vary depending on insurance carrier and physician relationship to the insurance carrier needs to be determined and standardized before articles such as this that emphasizes "Cost Utilization" can be appropriately evaluated adding to our understanding and knowledge.
I am disappointed that a comment is made at all that implies potential complications related to Infuse usage as this article is not designed in any way to evaluate this question.