On April 23rd, 2010 the Agency for Research and Quality released an assessment that found no evidence of improved health outcomes for most off-label use of BMP's to promote healing following a fracture. Off course, this research was conducted by BCBS Association Evidence Based Practice Center. This report assessed on-label and off-label use of INFUSE and OP-1.
Both Medtronic and Stryker have come under scrutiny in recent years for their off label use of these products. Medtronic has been subject to inquiries by the DOJ and the US Senate over off label use of INFUSE, while Stryker Biotech was charged by a federal grand jury with wire fraud, device misbranding and making false statements related to off-label use of OP-1. Last spring an FDA advisory panel recommended against approving a spinal fusion indication for OP-1 Putty.
So TSB must ask our readers, are you down with OPP, yeah you and me, who's down with OPP Stryker and me, You down with OPP, yeah you and me, Who's down with OPP, all my spine homies.
As a former OP-1 rep (that did things the right way, to my demise), I truly believe in the product. It worked well, as any BMP would in the spine. In my opinion, BMPs should only be used for revisions. The majority of virgin spines will fuse just fine with most other bone graft materials, hence why most surgeons could care less about the "science" of the products.
ReplyDeletePrimarily I believe in "OPP" because it works and Infuse needs competition and competition just makes good business sense.
Of course, on a different subject, I could see insurance companies and hospitals have a checklist for the premium devices/biologics that we will pay out of pocket for in the future.
I agree with Anonymous - Insurance companies have effectively made up their minds that certain premium products will not be reimbursed - they do this by conducting clinical reviews and concluding the devices are "unproved and/or experimental." This also includes many devices within indication. By historical standards, these devices often have substantial scientific evidence to support their use well beyond preceding devices.
ReplyDeleteWord to ya mutha
ReplyDelete