Question
Our office would like to start performing vestibular evoked myogenic potential (VEMP) testing. Colleagues indicated that we cannot bill third party insurance for this procedure as it is not FDA approved - is this correct?
Answer
Although VEMP uses ABR equipment, it uses a different protocol than what had originally been submitted to the FDA for evoked potential testing - a protocol that the FDA had not specifically approved.
Although it is a matter of opening the filters, adjusting the amplifier, and placing the recording electrodes over a muscle, the FDA told the manufacturers that it will not sanction use of the VEMP protocol using ABR-based equipment until new applications are made and data submitted to the FDA.
I recently learned that at least two manufacturers have submitted data to the FDA with hopes of having approval by the end of 2008, but it is doubtful that it will occur in that timeframe.
The last time I addressed this issue the FDA had not taken any strong action against the manufacturers, however, more recently I found out that it forced one manufacturer to do a recall of the VEMP equipment to remove the VEMP feature. The other manufacturers have issued software "updates" that remove VEMP from the protocol selection. The FDA has no control over the end user who has the VEMP software and amplifier unless you responded to the recall or "updated" your software that resulted in removal of the VEMP program. Restoration of the VEMP software cannot occur until after the FDA approves the protocol for that respective manufacturer's equipment.
I cannot tell you whether you should or should not perform VEMPs if you still have the commercial equipment. The reason I am being so equivocal on this is because there is more than 15 years of data on the VEMP procedure providing a foundation of overall diagnostic benefit. What we have here is a bureaucratic "glitch", but a very important bureaucratic glitch to take into consideration. If anyone who reads this decides to continue to use VEMP before the issuance of FDA approval of the specific protocol, then at the very least, I would have a long talk with your principle third party payers regarding coverage - being very open with them about the FDA situation - and get something in writing that they will cover the procedure. I would also arm yourself with substantial literature demonstrating the diagnostic benefit to the patient. If anyone who reads this decides to wait until sometime (hopefully) early in 2009 to obtain FDA protocol approval for their manufacturer's equipment, I cannot argue with that either. But this is the latest updated information that I could find out about on VEMP to answer your question.
Robert C. Fifer, Ph.D. is currently the Director of Audiology and Speech-Language Pathology at the Mailman Center for Child Development, Department of Pediatrics, University of Miami School of Medicine. He received his B.S. degree from the University of Nebraska at Omaha in Speech-Language Pathology with a minor in Deaf Education. His M.A. degree is from Central Michigan University in Audiology. And his Ph.D. degree is from Baylor College of Medicine in Audiology and Bioacoustics. Dr. Fifer's clinical and research interests focus on the areas of auditory evoked potentials, central auditory processing, early detection of hearing loss in children, and auditory anatomy and physiology. He is the immediate Past-President of the Florida Association of Speech-Language Pathologists and Audiologists, a member of ASHA's Health Care Economics Committee, and the ASHA representative to the American Medical Association's Health Care Professions Advisory Committee for the Relative Value Utilization Committee in addition to being ASHA's representative to the AMA's Practice Expense Advisory Committee. Additional responsibilities at the state level include serving as a consultant to the Florida Department of Health's Children's Medical Services and the audiology representative to the Genetics and Newborn Screening Advisory Council.
