New Legislation Speeds Progress on Patient Access to New Technologies

Longtime society efforts advance connecting clinical outcomes and claims data 

WASHINGTON, DC (October 21, 2021) — The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) applaud Representatives Larry Bucshon, MD (R-IN), and Kim Schrier, MD (D-WA), for introducing the Meaningful Access to Federal Health Plan Claims Data Act of 2021.

The legislation would provide clinician-led clinical data registries—such as the STS National Database, ACC National Cardiovascular Data Registry (NCDR), and STS/ACC Transcatheter Valve Therapy (TVT) Registry—with meaningful access to federal health care claims data to help track patient outcomes, assess the safety and effectiveness of medical treatments, and provide necessary information to assess the long-term effectiveness of therapies.

“I’ve believed over the years that clinicians need to lead when it comes to quality data. What is quality? Well, that should be determined by the professionals, not insurance companies and certainly not the federal government,” said Rep. Bucshon during an STS web-based event last month. 

“I'm proud to co-lead the Meaningful Access to Federal Health Plan Claims Data Act,” said Rep. Schrier. “When providers and clinicians have access to the best quality data, patient care improves. Legislation that improves data flow helps all parties."

Currently, regulatory barriers prevent meaningful access to claims data. Removing these barriers would allow surgeons, physicians, hospitals, health systems, and others to conduct longitudinal analyses and gain new insights into long-term outcomes for patients undergoing procedures such as coronary artery bypass grafting (CABG)—the most common operation performed by cardiac surgeons. 

“This legislation, if passed, would help us see the bigger picture and allow us to design treatment strategies that would offer the best long-term outcomes for our patients,” said Alan M. Speir, MD, Chair of the STS Council on Health Policy and Relationships. “For example, we have a lot of meaningful data on outcomes from CABG procedures and transcatheter aortic valve replacement in the short term. This data linkage would help us tailor the right treatments for the right patients and even help project outcomes far into the future.”

The linkage also would allow registries to continue providing critical information for approval and coverage of innovative medical interventions and preserve the government’s authority to authorize Medicare Coverage with Evidence Development (CED). 

After a medical device or intervention has been proven to be safe and effective and reasonable and necessary for coverage, CED requires innovators to monitor how their technology performs in the real world. This process leads to earlier and safer patient access to new technologies and a more direct pathway to coverage for innovators. 

“NCDR, ACC’s suite of cardiovascular data registries, has been helping hospitals and private practices measure and improve the quality of care they provide for decades. Delivering optimal care outcomes for patients when seeking and receiving cardiovascular care has always been a primary commitment for the ACC, and access to CMS claims data provides a novel and efficient opportunity to broaden the ability of medical society registries to deepen clinical care teams’ understanding of how patients are doing over time,” said ACC President Dipti Itchhaporia, MD. “The ACC looks forward to working with Reps. Bucshon and Schrier on this important bill which will not only have a measurable impact on clinical research, but also make a difference in cardiovascular clinicians’ efforts to transform cardiovascular care and improve heart health.”

STS and ACC will continue working hard to ensure that the Bucshon-Schrier bill receives enough support to pass during this Congress.

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Contacts
STS: Jennifer Bagley, jbagley@sts.org, 312-202-5865
ACC: Katie Glenn, kglenn@acc.org, 202-375-6472

About STS
Founded in 1964, The Society of Thoracic Surgeons is a not-for-profit organization representing more than 7,600 cardiothoracic surgeons, researchers, and allied health care professionals worldwide who are dedicated to ensuring the best possible outcomes for surgeries of the heart, lung, and esophagus, as well as other surgical procedures within the chest. The Society’s mission is to advance cardiothoracic surgeons’ delivery of the highest quality patient care through collaboration, education, research, and advocacy. Learn more at sts.org.

About ACC
The American College of Cardiology envisions a world where innovation and knowledge optimize cardiovascular care and outcomes. As the professional home for the entire cardiovascular care team, the mission of the College and its 54,000 members is to transform cardiovascular care and to improve heart health. The ACC bestows credentials upon cardiovascular professionals who meet stringent qualifications and leads in the formation of health policy, standards and guidelines. The College also provides professional medical education, disseminates cardiovascular research through its world-renowned JACC Journals, operates national registries to measure and improve care, and offers cardiovascular accreditation to hospitals and institutions. For more, visit acc.org.

About the STS National Database
The STS National Database was established in 1989 as an initiative for quality improvement and patient safety among cardiothoracic surgeons. The Database has four components—Adult Cardiac, General Thoracic, Congenital Heart Surgery, and the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) Database. Participation in the Database is global, currently spanning nine countries.

About NCDR
NCDR is ACC's suite of data registries helping hospitals, health systems, and practices measure and improve the quality of cardiovascular care they provide. More than just data collection, NCDR is a comprehensive network of cardiovascular care providers committed to ensuring evidence-based care, improving patient outcomes and lowering health care costs.

About the STS/ACC TVT Registry
The STS/ACC TVT Registry, created by a collaboration between The Society of Thoracic Surgeons and American College of Cardiology, monitors patient safety and real-world outcomes related to transcatheter valve replacement and repair procedures. The TVT Registry has been approved by the Centers for Medicare and Medicaid Services to meet registry requirements outlined in the national coverage decisions for transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve repair (TMVR).