Staring down the sometimes troubled and opaque past of medical devices, and upward trend in spending, one national insurer is trying to build momentum for a universal way to compare and track outcomes.
Though perhaps desensitized to auto recalls after 60 million last year, Americans "expect some notification if their car is part of a safety recall," writes Aetna chief medical officer Harold Paz, MD. "Unfortunately, patients with medical implants don't have the same safety net."
As national spending on medical devices surpasses $150 billion, Aetna is leading a charge to make the most out of the nascent universal device identifier system--to track the benefits, costs and risks of medical devices.
But, Aetna, other payers and consumer groups trying to optimize the UDI system have their work cut out for them.
"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," writes Paz in a post on Aetna's news and views site. "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?"
The Food and Drug Administration took a small step last year, requiring medical device companies to embed UDIs in their products, starting with high-risk devices like cardiac valves and artificial joints. But there are many miles to go, Paz argues.
Physicians and hospitals are not required to track devices being implanted into patients, or to report outcomes or even complications, to the FDA or any other source. Less than 400 hospitals nationwide contribute data to the American Joint Replacement Registry, for instance.
"The next step must be to incorporate the UDI into healthcare systems, and one central way to do that is through medical claims," argues Paz, a pulmonologist and former CEO of Penn State Hershey Medical Center and Health System.
Aetna, for one, has partnered with the FDA, several health systems and the Pew Charitable Trusts to lobby for UDIs to be included in medical claims. They're asking the Accreditation Standards Committee X12 to incorporate standardized fields for the UDIs.
"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," Paz envisions. "Health plans and others could perform outcome studies to compare the immediate outcomes and long-term success of the devices."
Of course, this could be greeted as another administrative burden for providers, but Aetna is joined by a number of health systems in seeking to make UDI in claims the industry standard, among them Geisinger, Intermountain, Kaiser Permanente, Mayo Clinic and Mercy. Aetna is also piloting an initiative with Mercy, integrating UDIs with hospital inventory systems and patient records.
As Paz argues, the time is ripe for UDIs: the healthcare industry is trying, and being prodded, to reform, and digital solutions have made data collection and archiving more affordable than ever.
"With UDI information readily available through claim systems, our health care system could track the successes, problems and complications associated with specific implanted devices," Paz writes. "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?"