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.