Unique Device Identifiers: Medicare Claims Should Include Implant IDs

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New findings from Medicare’s independent auditor indicate that faulty medical implants—such as cardiac pacemakers and artificial joints—are harming seniors and costing taxpayers billions of dollars. According to the Department of Health and Human Services inspector general, the solution is a step recommended by patient safety experts and the Food and Drug Administration: collecting device-identifying data in Medicare claims.

In a letter to Senators Chuck Grassley (R-IA) and Elizabeth Warren (D-MA), the inspector general wrote, “Collecting UDI [unique device identification] data on claims forms would add significant long-term value and benefits.” The auditor’s investigation finds that taking this step would not only help the Centers for Medicare & Medicaid Services (CMS) improve care for beneficiaries, but would also strengthen Medicare’s program integrity, because the costs associated with defective devices could reach several billion dollars due to additional hospitalizations, surgeries, and other care.

While FDA and multiple groups of experts have called for this change, the inspector general indicates that, to date, CMS has not taken action or developed plans to support the policy.

In a statement accompanying the findings, Sens. Grassley and Warren call on top Health and Human Services officials to take action: “Given the importance of this issue, we hope you will ensure that CMS works collaboratively with FDA and other stakeholders to ensure that the next update of the claims form will incorporate UDIs.” The senators’ cooperation on this issue reflects bipartisan momentum to advance the policy, which has drawn support from prominent health plans, hospitals, and now the independent auditor of the Medicare program.

A recent Pew fact sheet highlights the many benefits this action would yield for the American health care system by allowing researchers, government regulators, Medicare, and other health plans to analyze the quality of care, identify potential problems, and evaluate health care delivery.

Josh Rising, M.D., is Pew’s director of health care programs, overseeing the medical device initiative and the improving end-of-life care project. This post first appeared on the web site of the Pew Charitable Trusts. 

4 replies »

  1. I’m not opposed to unique identifiers in general. They can be quite useful. I enjoy the fact that my email address and phone numbers are unique and there’s nothing wrong with SSN as a way to deal with certain financial transactions, like credit.

    What I object to is how unique identifiers are used or misused. Combining a unique device identifier that is not voluntary (like the SSN is not voluntary) and is associated with a single individual (like an medical UDID for an implant or a personal app) is no different than tattooing people with a number and then collecting the numbers in various regulated and unregulated databases.

  2. I’m going to go out on a limb and speculate that you’re equally opposed to issuing unique device identifiers for software and apps?

  3. This is an awful idea. We can’t solve a problem that has nothing to do with payment as a side-effect of payment. It’s hard enough to design solutions to today’s technology and health policy problems when we do it directly and transparently. Trying to solve the real problems with devices as a side-effect of payment is completely out of control.

    CMS probably knows this. We are all painfully aware of the costly impact of side-effects when CMS decided to use a tax ID number (the Social Security Number) as a payment identifier. I’m sure it all seemed so easy decades ago when they did it. How many $ Billions is it now going to cost to issue new Medicare payment cards and to put the SSN as a unique person identifier genie back in the bottle?

    If you need more, consider that medical devices are used beyond Medicare. Many are paid by private insurance. Some are paid in cash. Wearables and sophisticated home diagnostics are going to expand the range of devices dramatically in the coming years. Not all of the devices will be regulated, and not all regulated devices will be subject to US regulations in an increasingly global health marketplace.

    The problems with regulating medical devices are real and they need to be dealt with in their own right, not as a side-effect of an already over-complex and often inscrutable health payment system.

  4. Nice work, Josh.

    I thinks this begs the question: should health apps be issued unique device identifiers?

    Based on the above, supporters would seem to have a pretty strong case.