Destruction of Medical Innovation Being Felt

By: Richard G. Fessler, MD, PhD

The period between 1990 and 2005 saw an explosion in medical technologies and, simultaneously, tremendous advancements in medical care.  Ninety percent of those innovations occurred in the United States, and the vast majority of the cost of those innovations was borne by the private sector.¹   Unfortunately, as a result of federal government interference, future innovative prospects are not being initiated, and those currently in development are being scrapped.  Because we are in the early phases of the government’s impact on medical research and development, the American public needs to be aware of this now.  The negative impact of this trend can, and must be, reversed before it is too late.

How does government kill innovation without the public becoming aware?  As an example, take the advances in artificial disc technology for lumbar and cervical spine.  These are devices used to maintain normal motion in young adults who have disc herniations, and would otherwise require fusion of their spine.  Years of data prove that fusion has negative effects on adjacent non-fused levels of the spine.²   These negative effects frequently result in additional surgeries, usually fusing those levels as well.  However, over the past 15 years, artificial discs have been invented and have been in the process of refinement.  These devices eliminate the need for fusion in many patients, and thus also the need for subsequent surgeries.  They would do the same thing for the spine that artificial hips and knees did for those joints, and the improvements in patient function, and quality of life, would have equal impact.  However, the federal government, through the auspices of Center for Medicare and Medicaid Services, (i.e. Medicare) decided that they would not pay for this new technology in patients covered by Medicare and Medicaid.  Seeing an opportunity to limit their payouts, the private insurance industry rapidly followed the CMS’s example for their covered patients.  In both cases, this was done despite ample “class 1” data showing the benefits of these devices for patients.^3,4  As a result of the action of CMS and the insurance industry, there is minimal market for these devices in the United States. And the bottom line is: no payment-no device!

So what happens then?  First, patients are denied access to surgical procedures which would be better for them. It is particularly painful that this same technology has been available throughout the rest of the world for 10 years!  Second, because there is no market for these devices in the US, industry manufacturers have stopped development on most of these products, and are not initiating new innovations.  So, although the immediate effect is significant (i.e. denial of access to state of the art care), the long term effect is even more devastating.  Because the US has been the world leader in technology development, progress of technological progress will slow dramatically worldwide.  Moreover, what progress is made will be available to the rest of the developed world but not to the United States. 

The result is medical rationing, stagnation of quality of care at or below our current level, and the loss of future medical and scientific progress; all initiated via federal denial of reimbursement for advanced technology and medical care.  Many feel that medical rationing will only result if “Obamacare” is passed by Congress.  We all need to realize that it is already here!

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¹

 ² Hilibrand, A. et al. Radioculopathy and myelopathy at segments adjacent to the site of a previous anterior cervical arthrodesis. J Bone Joint Surg 81A:519-528, 1999.

³ Murrey, D. et al. results of the prospective, randomized, controlled multi-center Food and Drug Administration investigational device exemption study of the Pro-disc C total disc replacement versus anterior discectomy and fusion for the treatment of 1-level symptomatic cervical disc disease. The Spine Journal 9:275-286, 2009.

⁴ Heller, J. et al. Comparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: clinical and radiographic results of a randomized, controlled, clinical trial. Spine 34: 101-107, 2009.

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