Good Guys, Bad Guys, or Just Big Money? The Push to Link Patient-Claims Data to Device Outcomes

Two US Senators are ramping up the pressure on the Centers for Medicare & Medicaid Services (CMS) to include unique device information in patient-claims databases in order to better track the safety and efficacy of devices after they are approved for use.

Sen. Chuck Grassley (R-IA) and Sen. Elizabeth Warren of (D-MA) wrote a letter to the Department of Health and Human Services (HHS), CMS, and Food and Drug Administration (FDA). While both the FDA and HHS have been supportive of the unique device identifier (UDI) plan, the CMS “has expressed contradictory views on the policy,” a press statement from Grassley’s office notes.

“Given the importance of this issue, we hope you will ensure that CMS works collaboratively with FDA and other stakeholders to ensure that the next update of the claims form will incorporate UDIs,” the letter reads.

One expert asked to comment on the situation, Mitchell Krucoff, MD (Duke Clinical Research institute, Durham, NC), insists there are “no good guys and bad guys” in the push to link devices with data—just different priorities.

The Path of the Impella

Grassley and Warrens’ efforts coincide with the publication of a viewpoint in the fledgling JAMA Cardiology that takes a hard look at the unusual “515” path to market required of a range of high-risk medical devices, including the Impella percutaneous ventricular assist device (PVAD; Abiomed). Under the 515 program, certain medical products approved for sale prior to amendments that would have required more stringent studies, are being given a second look. The Impella first obtained market clearance in 2008 on the grounds that it was substantially equivalent to approved nonroller cardiopulmonary bypass pumps—devices that were subsequently targeted under the 515 program. As such, the Impella was also earmarked for reevaluation.

Authors of the viewpoint, led by medical student Vinay K. Rathi (Yale University School of Medicine, New Haven, CT), make the point that the FDA dropped the ball when it declined to require the manufacturer, Abiomed, to conduct a new, “robust” clinical trial. Instead, the agency permitted the device-maker to use previously submitted data, including a randomized trial that had been terminated early for futility and registry data compared with historical controls. Premarket approval (PMA) was granted in March 2015.

As such, the Impella case also speaks to the very point the senators are hammering, since neither the manufacturer nor the FDA could tap into richer postmarketing data. “Large-scale, real-world outcomes assessments of the Impella could not be conducted with electronic health records and administrative claims data, as there is no way of identifying which type of PVAD patients receive,” the JAMA Cardiology paper argues.

Speaking with TCTMD, senior author Joseph Ross, MD (Yale University School of Medicine), explained that the motives for writing the article were “less about the Impella” and more about how and what the FDA requires evidence from device manufacturers.

“The argument usually is—particularly with premarket approval devices that have to generate clinical data for approval—it’s expensive, it’s hard to design a robust study, and you don't want to delay therapy to patients so you can't impose really high regulatory burden requirements,” Ross explained. As a result, he said, even some high-risk devices get PMA on the backs of a single feasibility study and a single, short-term pivotal trial, both typically with limited patient numbers.

“This 515 initiative was like the perfect storm,” he said, noting that Impella is only one of several cardiovascular devices that have undergone this particular form of FDA reclassification. “This is a device that’s already being used, [and the company] is already potentially deriving revenue from it—this is the best case scenario for when you could require a robust clinical study [because] it's going to stay on the market while they do it. Why couldn’t we use this as an opportunity to get the kind of robust evidence that we need as physicians when we’re making recommendations to patients?”

Asked to comment on the viewpoint, Seth Bilazarian, VP of Interventional Cardiology Programs at Abiomed, noted a number of factual errors in Rathi et al’s paper. “The Abiomed position is that FDA executed, for the first time, a pathway for PMA approval that was extremely rigorous (patient-level auditing of data) and that included randomized controlled trial and registry data in over 1,000 patients using Impella, while allowing continued access to the therapy for patients,” he said in an email. “The difficulty in achieving success in the 515 process is so high that no other company has succeeded (or even begun) the process for PMA approval using this pathway."

Richard Page, MD (University of Wisconsin School of Medicine and Public Health, Madison), chaired the FDA’s Circulatory System Devices Panel reviews for a number of 515 devices, nonroller bypass pumps—and the Impella—among them. In a companion viewpoint in the same issue of JAMA Cardiology, he writes that while the data were “imperfect,” he believes “the FDA got it right.”

According to Page, “It would have been unreasonable to expect new, randomized, prospective studies of this device, and it would have been unfair to withhold this therapy pending such study.”

Linking Identifiers and Datasets

Of course, another way to gather these data, as Grassley and Warren are arguing, is for better postmarketing surveillance. While the FDA started mandating unique device identifiers in 2014, CMS has said that adding these claims data is not a priority at this time. Indeed, in February 2015, Marilyn Tavenner, the CMS Administrator at the time, replied to an earlier letter from Warren, stating that “including UDIs on claims would entail significant technological challenges, costs, and risks to normal claims processing for Medicare and other payers.”

There’s also the price of updating the CMS systems, Tavenner wrote, noting that a recent claim form update cost $700 million. More changes to accommodate UDI would likely be “much more complicated” and, it’s implied, most costly.

Tavenner left her post at the CMS two weeks later.

Ross, too, says the inability to link routinely collected data to individual devices puts everyone in a bind, including the device makers themselves. “They are allowed to collect patient information on whose getting devices, but [that] can only be used for the purposes of issuing recall notices, they can’t use it to then go find those patients in their routinely collected data to do analyses. It’s crazy,” he said. “Whenever I talk to chief scientific officers at major device companies, they talk about the lack of data and their inability to know what is happening with their products after they sell them and when problems arise. Their hands are tied just like everybody else’s. . . . They’re among the biggest proponents of the UDI getting better and being linked to the electronic health records.”

‘Committed to Capturing Data’

Contacted by TCTMD, CMS press officer Jibril Boykin said only that the agency had received the senators’ letter and was in the process of preparing a reply: “Our response is now in the clearance process. I am not able to comment on a letter that is still being prepared for response.”

Likewise, an FDA spokesperson offered a similarly careful response, telling TCTMD in an email: “The FDA, the Office of the National Coordinator for Health IT (ONC), and the Centers for Medicare & Medicaid Services are working closely on the shared goal of incorporating Unique Device Identifiers into electronic health records. CMS and the FDA look forward to continuing to explore options that would improve surveillance in a timely and effective manner. Both agencies are committed to capturing appropriate data and sharing information transparently to improve the quality and safety of care delivered to people across the nation.”

Krucoff has worked with the FDA and others on a task force addressing the needs of medical device registries. Speaking with TCTMD about the senators’ letter to CMS, he stressed, “It’s not about good guys and bad guys, it’s about bandwidth and alignment of priorities. And that’s true across multiple federal agencies, for the manufactures themselves, for regulatory authorities, professional societies, and electronic health record manufacturers.” But to “create a better device evaluative system nationally,” he added, “there are a lot of different conversations that have to happen.”  

The UDI, he said, is a “critical lynchpin,” but only if it is linked with an infrastructure that supports “device dimensionality.” The combination, if done well, will be “a no-brainer,” Krucoff predicted.

“We’re progressively recognizing that medical claims data, billable services, repeat procedures, and rehospitalizations are all very valuable repositories of adverse event ascertainment,” he commented. Indeed, this is already being done in some areas of cardiology—the missing link, currently, is the addition of the UDI to medical claims and medical records, and the ability to pull everything together.

Ultimately, he stressed, it comes down to what initiatives get funding and which ones take priority, given the current restraints within key federal groups.

“Look at how Medicare and CMS currently are staffed, and how much the appropriations don’t cover the real needs of CMS, and what it takes to then expand appropriations with the US Congress. This is where it’s not surprising that UDI isn’t first on the list of priorities at CMS,” Krucoff said.

Big Data? Big Dollars

US lawmakers are currently debating bills that could become part of a larger piece of legislation aimed at boosting funding for the National Institutes of Health and the FDA. Earlier this month, the Health Education, Labor, and Pensions Committee approved a range of bills that will affect how medical devices pass through the FDA, including special concessions for “breakthrough” devices. Some senators have said any further support for expedited medical reviews will be contingent on federal health agencies getting better funding.

To TCTMD, Krucoff acknowledged that agencies strapped for cash and manpower are a key factor in getting the FDA’s plans for linking Big Data to individual devices off the ground.

“I don’t want to get into too sensitive an area,” he said, “but I would say that . . . for medical devices, a lot of very critical congressional appropriation negotiations are going on right now.”

• Rathi VK, Kesselheim AS, Ross JS. The US Food and Drug Administration 515 program initiative. Addressing the evidence gap for widely used, high-risk cardiovascular devices? JAMA Cardiol. 2016;Epub ahead of print. 
• Page RL. The US Food and Drug Administration premarket approval process and the 515 program initiative View from a panel chair. JAMA Cardiol. 2016;Epub of print.

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