Car owners have come to expect some notification if their car is part of a safety recall. In fact, in 2014 automobile recalls surpassed the 60 million mark for safety recalls for the first time in a single year. Unfortunately, patients with medical implants don’t have the same safety net. No standard process is in place to notify patients if a failure occurs in the pacemakers, artificial joints and other medical devices surgically implanted in their bodies. We can and must do better for the tens of millions of patients living with these devices.
Our nation spends more than $150 billion – 6 percent of total medical costs – a year on medical devices. From cardiac valves and pacemakers to artificial hips and knees, these devices can save lives, relieve pain and restore active lifestyles. Yet we do little to track exactly which devices are implanted in which patients, which models have better outcomes, which are creating problems for patients, or even how much they cost. But what if the pacemaker model implanted in your family member’s chest has bad electrical leads? Or your artificial hip is likely to last only half as long as another manufacturer’s model? If a medical device proves faulty, it is very difficult to determine who needs to know they have a bad part in their body. Often patients won’t know, until their own medical device creates a problem.
The Food and Drug Administration (FDA) took a critical first step in 2014. Device manufacturers now are required to embed unique device identifiers (UDIs) in devices, starting with high-risk devices such as cardiac valves and artificial hips and knees. UDIs are like bar codes, and each device has its own UDI.
This was a great start. However, doctors and hospitals are still not required to track what devices go into what patients, or to report outcomes or complications to the FDA or other databases. For example, fewer than 400 hospitals nationwide contribute data to the American Joint Replacement Registry.
This is an area of health care that is desperately in need of more transparency. Transparency could improve quality and very quickly reduce unnecessary costs throughout the health care system. Aetna is working with a broad-ranging group of health care leaders to help make it happen. Aetna and others testified in favor of adding the UDI to claims before a Health and Human Services (HHS) advisory group in June 2014. Now the advisory group has recommended that HHS support the development of additional pilot programs to voluntarily capture this data.
The next step must be to incorporate the UDI into health care systems, and one central way to do that is through medical claims. Aetna has joined forces with Pew Charitable Trusts, several highly regarded health care systems, the FDA and others to urge that medical claims for implants include the UDI. We are encouraging the Accreditation Standards Committee X12, which decides what fields to include in standardized electronic claims, to incorporate fields for the unique device identifiers.
Some hospitals are concerned about the expense of modifying their claims systems, and have instead suggested sending the device identifiers to payers in some kind of attachment to the claims. However, even if CMS eventually created standards for these kinds of attachments, UDIs submitted this way would not automatically be included in government or insurer claim systems where they would be easily searchable. Aetna and others, including the Pew Charitable Trusts, continue to recommend that UDIs be included in claims, so they can be integrated into databases with other claims and patient data in a structured, electronic way.
The UDI data could be shared in turn with electronic health records, existing (yet limited) device registries, all-payer claim databases, the Centers for Medicare and Medicaid Services (CMS), and the FDA. Health plans and others could perform outcome studies to compare the immediate outcomes and long-term success of the devices. This research would give doctors, hospitals and health plans access to reliable data, so they can make informed decisions about which devices to use.
We understand that tracking the unique device identifiers would create one more administrative step for hospitals, which today simply bill a set rate for the implant procedure, with no indication of what model was implanted or what the device actually cost. However, a number of innovative health systems (Geisinger Health System, Intermountain Healthcare, Kaiser Permanente, Mayo Clinic and Mercy) working together as the Healthcare Transformation Group are advocating for a systemic approach. We believe the extra tracking would offer important benefits: in a pilot program at Mercy that integrated UDIs into hospital inventory systems and patients’ medical records, the change helped improve patient safety, enhanced care quality, and supported operational efficiencies.
Transparency is achievable. With UDI information readily available through claim systems, our health care system could track the successes, problems and complications associated with specific implanted devices. Manufacturers or the FDA could more readily identify and locate patients whose devices may present a risk to them. If you had a faulty part, wouldn’t you want to know?