Wednesday, March 11, 2015
Defibrillators, artificial hips and other implants would be tracked under the government system, but behind-the-scenes conflict delays initiative
The ideal way to protect the public from hazardous medical devices, the Food and Drug Administration says, is a brand-specific identification number on devices like implanted heart defibrillators and artificial hips.
If one goes haywire, the thinking goes, doctors can quickly tap large insurance databases to find out whether the malfunction was rare—or part of a broader public-health threat. Further implants would be stopped before the faulty device is widely used.
Congress passed this “unique device identifier” concept into law in 2007. By 2012, the FDA planned to use billing-claims form data—with that “UDI” number—to monitor medical-device safety. Last year, manufacturers started placing numbers on their products. (The UDI number is distinct from model numbers and serial numbers that have long been on medical devices.)
But the overall safety effort has hit a barrier. The Obama administration’s Medicare agency, in a behind-the-scenes bureaucratic conflict, has dug in its heels and opposes the FDA’s plan to use claims data with ID numbers to monitor safety, according to people familiar with the events. The Centers for Medicare & Medicaid Services, or CMS, says putting the identifying number—the UDI—on medical claims forms it receives from hospitals poses big technical hurdles and costs too much.
The issue isn’t theoretical. Defibrillator wires, filters to catch blood clots, metal hip joints and other devices have failed catastrophically in recent years. They have cumulatively killed or injured thousands of people before the FDA—or the companies themselves—realized the scale of the malfunctions.
Recently departed Medicare administrator Marilyn Tavenner spelled out her agency’s opposition in a Feb. 23 letter to two senators, writing that “including UDIs on claims would entail significant technological challenges, costs and risks” for Medicare. “Mechanisms other than claims reporting for collecting UDIs would avoid the significant challenges and risks” of putting a number on Medicare bills. A wide range of medical safety experts rejects this contention. Ms. Tavenner left the agency at the end of February, but other Medicare officials have been taking the same stance, documents show.
Apart from inciting a possible showdown with the FDA, her position contrasts directly with that of Health and Human Services Secretary Sylvia Mathews Burwell, who oversees both agencies.
In response to senators’ questions during her confirmation last year, Ms. Burwell wrote that the FDA’s national drug-product safety net—the Sentinel Initiative—“will ultimately benefit” by “incorporating UDIs into its claims data sources.”
Mark McClellan, a senior fellow at the Brookings Institution and a former Medicare administrator, explained that “what you’re hearing now is CMS channeling the concerns of hospitals” that billing changes could be expensive for them, too.
In a statement for this article, HHS said FDA and Medicare are “working closely” with government computer staffers “on the shared goal of incorporating UDIs into electronic health records.”
The Medicare agency has also expressed its opposition in committees convened to work out how the number might appear in billing data. One such panel, a public-private entity called the Accredited Standards Committee X12, sets the details of electronic medical bills.
Joseph Drozda Jr., a cardiologist at the Midwest-based Mercy Health system who has served on this and another UDI-related committee, said Medicare officials have also cited the cost of software changes in that committee. He and other experts on medical-device safety say that Medicare and insurers could reap huge financial benefits from the UDI—by pinpointing unsafe devices and halting further implants.
The national medical director of Aetna Inc., Phillip Lerner, said it is “critically important” for Medicare to proceed, in part because private insurers generally follow Medicare’s lead in formatting their bills.
A completed UDI system “will improve quality and lower costs,” said Dr. Lerner. “If we had those data, the model and the brand, we would have the ability to do clinical outcome studies comparing a device to another device.”
One such instance where a national ID would have helped was Medtronic Inc. ’s Sprint Fidelis defibrillator wire, or “lead.” In January 2007, doctors at the Minneapolis Heart Institute had seen several patients whose defibrillators erroneously gave them multiple shocks. The hospital and several others soon stopped using the lead.
By the time Medtronic and the FDA concluded the lead was failing at a high rate and pulled it from the market in October 2007, 268,000 leads had been implanted. It was the top-selling lead in the world, and for months the agency and company lacked the data to gauge the extent of the danger.
University of Chicago and Northwestern University researchers wrote in the journal Heart Rhythm in 2011 that the Medtronic device could cost Medicare between $287 million and $1.19 billion over five years.
‘If we don’t have information on the devices that are implanted, it makes it hard to know their quality and cost.’
—Dr. David Lansky, president and chief executive of the Pacific Business Group on Health
Yet in recent emails within the X12 standards committee, 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.”
Likewise, Ms. Tavenner’s recent letter suggests that putting the device-specific number into electronic medical records or device registries kept by companies could be enough to promote safety. But medical safety experts note the flaw in that approach: A patient could get a heart device in Minnesota, go on vacation and have a fatal event in Florida; insurance databases are by far the best way to capture such data, they say.
In a brief written statement, the agency said it is working “to better understand and document the value, benefits and cost” of the medical-device tracking system.
In a 2012 interview with The Wall Street Journal, the FDA’s medical-device chief scientist, William H. Maisel, said “the unique identifier is the real game-changer” when included in insurance claims. In congressional testimony, he said such a system would be “transformative.” FDA officials declined to be interviewed for this article, but said the device identifier “can provide important benefits.”
Now, groups including AARP, Pew Charitable Trusts, the American College of Cardiology and business coalitions like Leapfrog Group and Pacific Business Group on Health are urging the numbers be placed on Medicare bills.
“If we don’t have information on the devices that are implanted, it makes it hard to know their quality and cost,” said Dr. David Lansky, president and chief executive of the Pacific Business Group on Health. “We want to know which ones do the best job.”
Last December, in a letter that prompted Ms. Tavenner’s response, Sens. Elizabeth Warren (D., Mass.) and Charles E. Grassley (R., Iowa) wrote, “We understand…that CMS has been a dissenting voice” regarding “incorporation of UDI information in claims.”
“Given that the same claims form is used by both public and private payers,” they wrote, “CMS dissent could prevent other health plans from collecting and utilizing UDI data.”
http://www.wsj.com/
