I agree that testing is good. Yes, the FDA sometimes saves us from overzealous, too early adoption of unproven technology. In other extremes, our process keeps us from having access to proven technology that is just better. For example, the uncoated version of the Charite' was approved in 2004. When the trial was submitted, the uncoated version was in use. By 2004, the Hydroxyapitite coating was standard on so many other orthopedic devices. It was 17 months before we stopped using the inferior version.
Last year, I attended the California Technology Assessment Forum, a panel that meets twice a year to provide Blue Cross/Blue Shield political cover for denying coverage. One of the presenting surgeons told me about a cancer treatment that was pending approval. Over the years, technology has advanced that allows us to direct targeted energy more and more accurately. This is hugely important because it allows the surgeons to more accurately destroy cancerous tissue while doing less damage to surrounding tissue. He told me that the new system had been accepted as superior and had excellent data behind it. About 40% of the providers had adopted it as standard even though the insurance companies were not paying for it. The equipment is expensive and it's difficult for providers to gain access to the technology without adequate reimbursement.
Many of the providers provided treatment at a loss. May patient self pay for the superior procedure. His amazing point was that generating class 1 data in this case will NEVER happen. In his opinion, it would be malpractice to enroll people into a study and allow them the get inferior treatment for the purpose of providing class 1 data. Who would enroll if informed consent was appropriately done? For the insurers to hang their hat on the lack of class 1 data and continue to deny reimbursement for the treatment that cancer patients need is a horrible abuse of the system.
I don't know how we got to this place... I understand the harsh realities of providing services after the 70's and 80's when medical costs spiraled out of control. The pendulum has swung the other way and all I know is that I can hardly afford insurance and now have to compromise care because it's too costly.
Sorry for the rant.
Mark
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