Good data is critical to gauge the quality and safety of medical devices.
Good data is critical to gauge the quality and safety of medical devices.
In July, Medicare proposed a new initiative to lower costs and improve care for seniors who receive treatment for a heart attack or are at high risk for having one. Unfortunately, this program misses an opportunity to gather critical information that could help protect the safety of millions of patients who rely on medical implants.
Under the proposed policy, hospitals would no longer receive reimbursement from the Centers for Medicare & Medicaid Services (CMS) for each individual test or service they provide to heart attack patients or those who undergo coronary bypass surgery. Instead, hospitals would receive a standard amount—or “bundled” payment—that covers all relevant care. This proposal follows a similar policy that uses bundled payments for patients undergoing hip and knee replacement surgeries. These programs are intended to give hospitals incentives for providing the highest-quality care while helping to control overall costs.
Many cardiac and joint replacement procedures involve the use of medical implants—like cardiac stents and artificial knees and hips—that can influence the quality and safety of patient care. Better data on each device would equip physicians and Medicare with more information on whether certain models are better for patient subpopulations, detecting things such as possible differences between men and women, or between younger and older patients. Yet the claims forms hospitals send to CMS for reimbursement do not include the unique codes that identify the specific make and model of an implant. Since these forms are also used for research, this is a missed opportunity to gather critical information that can protect patient safety, improve device performance, and control costs.
Recording the unique device codes would also help track faulty devices and facilitate quicker, more effective recalls, saving lives and sparing patients needless pain. For example, better data might have accelerated the discovery that metal-on-metal hip replacements fail at much higher rates than prosthetics made of other materials—a finding that came to light only after approximately half a million patients received these devices.
Good data is critical to gauge the quality and safety of medical devices. As CMS pursues policy changes that would shift 90 percent of traditional Medicare payments toward alternative models like those recently unveiled, the agency must integrate device information into those programs, giving clinicians the data they need to understand how medical implants affect patient outcomes.