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Is that a defective medical device? Medicare usually isn't sure

The Centers for Medicare & Medicaid Services -- the CMS -- recently revealed a chilling fact: it has no idea how much money is being spent on defective devices. A single defective medical device can cause profound damage for multiple patients in California, who often must then go on to receive additional care and treatment. Until CMS is sure of how much it spends on related injuries, there likely cannot be any action to curb the impact.

Claim forms that are submitted to health insurance companies do not include medical device information that could be used to identify inherently defective products. Since the CMS never actually sees which devices are used with patients who are adversely affected by them, it has no way of figuring out what it has paid until a device has been recalled. A review of Medicare expenses discovered that seven recalled cardiac devices cost ultimately $1.5 billion in additional care. For the affected patients, that impact totaled up to $140 million worth of copayments.

The inspector general for the U.S. Department of Health and Human Services proposed a solution. In order to address the rising costs and injuries associated with this problem, he suggested that unique device identification -- UDI -- numbers to be included on claim forms. Not only would this allow CMS to carefully track costs associated with specific medical devices, it could also help the agency identify defective devices in a timelier manner.

Proponents of the HHS' inspector general's suggestion agree that these changes could likely identify a defective medical device more quickly than is currently possible. On the other hand, opponents believe that implementing the changes could cost more than they are worth. However, it is difficult -- if not impossible -- to put a price on California patients' health and well-being and use it as an excuse to refuse changes to the system. Until such a time when systemic changes help prevent patients from being wrongly harmed, manufacturers who disregard the value of health and safety by distributing a defective medical device can be held accountable through the successful actions of a products liability suit.

Source:, "HHS inspector general calls for unique IDs on claims forms", Shelby Livingston, Oct. 4, 2016

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