Disagreement Between Fed Agencies Thwarts Medical Device Safety

Eight years ago, Congress passed legislation to include identification numbers on individual medical devices so that if one caused a problem, its origin could be determined and whether the malfunction was rare or of a broader concern of which the public should be aware. The program still isn’t operational.

As reported in the Wall Street Journal, (WSJ) the FDA had intended to use billing claim data bearing the “unique device identifier” (UDI) by 2012 to monitor the safety of devices such as implanted heart defibrillators and artificial joints. Not until last year did manufacturers start embedding the numbers on their products. (The UDI is different from model numbers and serial numbers, which have been on medical devices for a long time.)

But in what the WSJ calls a “behind-the-scenes bureaucratic conflict,” The Centers for Medicare & Medicaid Services (Medicare, or CMS) steadfastly has opposed the FDA’s plan to monitor safety via claims data and UDIs. CMS, the paper reported, contends that including the UDI on the medical claim forms it receives from hospitals is technically difficult and too expensive.

In February, former Medicare Administrator Marilyn Tavenner voiced support for some other way than claims reporting for collecting UDIs, and although she has left the agency, the WSJ said other Medicare officials toe the same line.

That’s in opposition to Sylvia Mathews Burwell, the secretary of Health and Human Services (HHS), which oversees CMS and the FDA. During her Senate confirmation last year, Burwell indicated that the Sentinel Initiative – the FDA’s national electronic system to track the safety of drugs, biologics and medical devices once they reach the market – would benefit by incorporating UDIs into its claims data sources.

Mark McClellan, a former Medicare administrator, told the WSJ that “what you’re hearing now is CMS channeling the concerns of hospitals” that billing changes could be expensive for them, too.

So are patient safety and transparency once again taking a back seat to special interest pressure?

As readers of this blog know, deficient medical devices are huge contributors to adverse medical outcomes. For example, endoscopes; one type is responsible for the recent outbreak of the superbug CRE (carbapenem-resistant Enterobacteriaceae) that has killed some people and harmed others undergoing diagnoses for gastroenterological problems.

Other common devices with notable records of failure in recent years include defibrillator wires, and metal hip joints. As the WSJ noted, such devices have “killed or injured thousands of people before the FDA – or the companies themselves – realized the scale of the malfunctions.”

Medicare has opposed committees of experts who have worked on how the UDI might appear in billing data. One such panel, the Accredited Standards Committee X12, sets the details of electronic medical bills.

A cardiologist who has served on it and another UDI-related committee told the WSJ that Medicare and insurers could do well financially from the UDI by identifying unsafe devices before they became widespread.

An executive with insurer Aetna told the paper that it’s “critically important” for Medicare to proceed with the program, partly because private insurers generally follow Medicare’s lead in formatting their bills, and that the UDI system not only would improve quality and lower cost, but that its data, with the model and the brand, would provide the ability to do comparative studies with other devices.

“Yet in recent emails within the X12 standards committee,” the paper reported, “Medicare staffers wrote that Medicare ‘does not support any scenario wherein the UDI is integrated into a claim transaction, stored in claims history, or utilized anywhere in the claims adjudication and payment process.'”

Tavenner had suggested that including device-specific numbers into electronic medical records or device registries kept by companies could be enough to promote safety, but what if a patient gets a heart device in one state, then travels to another and has a fatal complication of it? UDI supporters say insurance databases are the best way to capture these data.

Three years ago, the FDA’s medical-device chief scientist told the WSJ that “the unique identifier is the real game-changer” when it’s part of an insurance claim. FDA officials declined to be interviewed for the paper’s recent article, but said the device identifier “can provide important benefits.”

Other consumer and medical interest groups are joining the call for UDI, including AARP, Pew Charitable Trusts, the American College of Cardiology and the Leapfrog Group.

It’s time for the competing agencies within the federal government to get it together, and adopt a plan that Congress intended and that patients deserve.

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