The explosion of cardiovascular data registries, and their vast research output, has become the major proof point for field’s commitment to continuous quality improvement (QI). Now, registries have been assigned another purpose. Positioned front and center in the Medicare Access and CHIP Reauthorization Act’s (MACRA) proposed rule, registries that garner the approval of the Centers for Medicare & Medicaid Services (CMS) also may impact reimbursement calculations.
Measurement & management
Over the last three decades, registries have been launched in many cardiovascular subspecialties. The American College of Cardiology (ACC), with various partners, runs 10 registries focusing on therapies as well as cardiovascular-related conditions. Registries also are the QI centerpieces for other medical societies, such as the American Association of Cardiovascular and Pulmonary Rehabilitation, American Society of Nuclear Cardiology and Society of Thoracic Surgeons.
These organizations promote their registries to health providers and institutions as tools for improving performance on quality metrics; however, registries also have been recognized as data troves that researchers can mine—at much less cost than conducting randomized clinical trials (RCTs)—to uncover sometimes-controversial truths about real-world cardiovascular practice.
“The NCDR robust datasets hold answers to complex questions related to patient risk factors and outcomes; procedure and treatment trends; guidelines adherence; and device, facility and provider characteristics,” promises the ACC-National Cardiovascular Data Registry (NCDR) website, where nearly 900 NCDR-derived published manuscripts and presented abstracts are listed. The answers to such questions are the key to better management of cardiovascular disease, says Ralph G. Brindis, MD, MPH, the NCDR’s senior medical officer for external affairs. “We can’t manage things unless we measure them,” Brindis said when he joined Cardiovascular Business for a conversation about the future of registries and how they are perceived.
What do you wish physicians knew about registries?
First, there’s the incredible bandwidth of registries for patients and physicians. Registries support opportunities for clinicians and hospitals to improve their own quality of care. This is even more true today than in the past, as we transition from the SGR [sustainable growth rate], which rewarded volume, to MACRA, with its focus on value and reimbursing physicians for the quality of our work. The NCDR’s PINNACLE and CathPCI registries are already approved by CMS as Qualified Clinical Data Registries (QCDRs), which means they will meet the needs of physicians who will be reimbursed under MIPS [the Merit-Based Incentive Payment System outlined in the MACRA proposed rule]. Not only will clinicians who are enrolled in these registries avoid penalties but they’ll also be positioned to earn greater reimbursement.
Another reality of our times is that consumers, payers and purchasers expect increased transparency of the clnical outcomes of the care that we provide. Much of the public reporting data available today are from sources that are not transparent to clinicians and other external stakeholders. In fact, it’s possible for a physician or hospital to be ranked high in one system and poorly in another, which underscores the need for public reporting based on true clinical data, as is most accurately found in registries.
Another often-overlooked benefit of registries is that they allow physicians to deliver innovative therapies much earlier than in the past. An example is TAVR [transcathether aortic valve replacement], where data in the ACC’s TVT registry allowed the FDA to expand clinical indications for TAVR use much earlier than would have been possible if the FDA had required an RCT.
What should policymakers and patients know about registry data?
Policymakers understand registries, but their challenge is that cardiology is so far ahead of the rest of medicine. For them to have broad-based policies, particularly surrounding payment reform focused on quality of delivered care that is well captured in our NCDR, won’t be reasonable until other specialties catch up.
Additional value for the FDA and patients is in the potential for registry-based sentinel systems to pick up device- and drug-related safety issues. In many cases, previous methodology for post-market surveillance was not well-positioned for picking up signals of low-frequency