On September 30, 2016, the Office of Inspector General (OIG) in the U.S. Department of Health and Human Services (HHS) released a memorandum. In it, Daniel Levinson details the initial results of an ongoing audit of Medicare costs incurred due to defective or recalled medical devices. For seven devices, which are as yet unnamed, the audit revealed $1.5 billion in Medicare payments, along with $140 million in copays and deductibles paid directly as out-of-pocket beneficiary expenses for services and procedures involving these failed or recalled devices.
That is a staggering sum of money. What’s more, the figures don’t take into account how these expenditures will likely filter down to taxpayers in the form of the need for continued monitoring, the possibility of future adverse events, and wages lost due to missed work as a result of the recall of these devices. The memo also revealed that between 2003 and 2012, the Food and Drug Administration (FDA) collected data showing that medical device recalls had doubled. Setting aside the measurable fiscal challenges, the physical and emotional cost to the consumers associated with the necessary recall procedures cannot be understated.
The memo goes on to outline the beginning of a plan to track medical devices on claims forms. This would lead to significantly increased costs, including an overhaul of legacy computer systems not equipped for this type of data collection, and changes in workflow processes for claims handlers. Still, some type of intervention is critical to avoid losses of this magnitude and to maintain consumer safety. Of note, the use of evidence in preventing these substantial losses is not discussed in either the memorandum or in any articles concerning the recalls.
Evidence Directly Addresses Safety and Cost
Consider one of the solutions provided by Hayes through our Knowledge Center, the Health Technology Brief (HTB). The HTB is a health technology assessment (HTA) that focuses on new and emerging technologies in the early stages of dissemination or existing technologies that are being used for new applications. HTBs evaluate the peer-reviewed published literature to determine the safety and effectiveness of medical devices, technologies, pharmaceuticals, and procedures. HTBs also assign a Hayes Rating, offering providers and payers a grade for the technology in question. The Rating reflects the strength and direction of the evidence and takes into account efficacy, safety, impact on health outcomes and patient management, indications for use, and for which patients the technology is best suited. The depth of evaluation that we perform is just one of the reasons the Hayes Rating is the industry-standard in the payer market, 83% of whom use our services.
The HTB is just one example of the reports and services from our Knowledge Center that can aid with the challenges of reigning in exorbitant healthcare costs for both payers and consumers. Our Evidence Advisors provide support by developing detailed searches for the investigation of specific devices. In addition, we offer workflow integration to make the process of finding our fiercely unbiased, objective assessments as seamless as possible. With access to this kind of information, in combination with the implementation of device identifier tracking, the potential for increased safety and savings for both consumers and payers cannot be denied.
Don’t just take my word for it. View a sample report here (Verasense (OrthoSensor Inc.) for Use During Total Knee Arthroplasty) or fill out a form for the full report.