To obtain better value for health-care dollars, it’s important to evaluate in detail which ones are well-spent and which are not. The $150-billion-a-year market for implantable medical devices in the U.S. – which includes everything from artificial hips to pacemakers – is a good illustration of this challenge and how to meet it.
Examining how well devices are working requires knowing where each one goes. Without tracking, it’s difficult to find out which patients do better with one kind of device, and which ones are better off with another kind.
Effective tracking would also make it possible to recall all those that may turn out to be defective. The Government Accountability Office has found that most recalls of high-risk devices end without all affected devices being fixed or removed. And better tracking would make it easier to detect cases of outright fraud.
It is now feasible to undertake this kind of tracking because the Food and Drug Administration recently began requiring high-risk devices to carry a unique identifier, the equivalent of a bar code. These identifiers are of limited use, however, because they aren’t linked to the people using the devices.
It’s as if each package that FedEx shipped had an identification number, but you couldn’t tell which one was connected to your package.
In some cases, registries are compiled to track specific devices, but these are relatively limited and inefficient because they have to be created one by one for each device, and they often offer no information about or access to the rest of each patient’s medical history.
There is a straightforward way to fix the problem, one that many advocates have been pushing for: Simply include the unique device identifier in the health-insurance filing when the device is put into a patient. Because insurance claims are linked to patients and already provide information about what procedures patients undergo and at what price, they would facilitate much-improved evaluation of how devices are working and would also make it easier to track affected patients if things go wrong.
The idea is so simple that two senators who tend not to agree on many things – Democrat Elizabeth Warren of Massachusetts and Republican Charles Grassley of Iowa – have jointly supported it. Groups as diverse as AARP, Aetna, the Society of Thoracic Surgeons, the American College of Cardiology, Geisinger, and the Pacific Business Group on Health also endorse the move. For what it’s worth, the FDA does, too, though it doesn’t have regulatory oversight on the issue. (Disclosure: Aetna is a client of Citi, my employer.)
An alternative approach would be to include the device identifier in each patient’s electronic health record. That would be helpful, but it should be done in addition to, not instead of, including it in the insurance claim. For reducing fraud and for many types of analyses, it’s crucial that the identifier be included in claims databases.
To be sure, including specific information about devices in insurance claims requires attention to privacy. Yet claims already contain lots of information that needs protecting, and knowing which specific artificial hip was implanted doesn’t seem significantly more problematic than knowing that such an operation occurred – and that information is already in the claims database.
Some have argued that this change would involve too much hassle for providers or the government, but given the benefits, that doesn’t seem too high a price.
To date, the Centers for Medicare and Medicaid Services has been dragging its feet on this proposal. No one seems to know exactly why, beyond the normal bureaucratic inertia. But including the unique device identifier in Medicare claims is crucial to making the idea work, so without that agency’s support, the proposal is stillborn.
Health and Human Services Secretary Sylvia Burwell should step in to fix this problem – and score a win for improved value, lower costs and safety.
This column does not necessarily reflect the opinion of the Bloomberg View editorial board or Bloomberg LP, its owners and investors.
