On behalf of STS’s 7,600 member surgeons and their clinician partners, Thomas MacGillivray, MD, president of The Society of Thoracic Surgeons, testified before the US House of Representatives Committee on Energy and Commerce, Subcommittee on Health, about Medicare coverage pathways for innovative drugs, medical devices, and technology that saves lives.
In his statement, Dr. MacGillivray highlighted how the STS’s National Database provides a true clinical benchmark and contains data on more than 9.4 million cardiothoracic surgeries performed by more than 4,300 surgeons. The Database is a powerful quality improvement tool that facilitates increased patient access to break-through technology. He explained the value of real-world evidence and using data to monitor new technology and expand indications for new therapies. And he underscored that through big data, cardiothoracic surgeons across the country and around the world can work together to find solutions and transform patient care.
Dr. MacGillivray’s key talking points:
- The STS National Database is the gold standard for clinical registries.
- The Database allows hospitals and cardiothoracic surgeons to identify best practices and potential gaps, and evaluate their performance against national and regional competitors. The Database is updated continuously and participants can monitor their progress and make critical decisions daily.
- Without ongoing evidence collection in the real-world setting coupled with access to longitudinal claims data, the efficacy and appropriateness of emerging innovative technologies is uncertain, impairing physicians’ ability to make the best decisions for our patients.
- The STS believes it is essential that any reforms to coverage for emerging therapies:
- Prioritize the collection of real-world data, particularly for new, innovative medical devices. Data collection creates opportunities to fill post-market evidence gaps and better define patient benefits and risks.
- Permit early discussions and coordination between the agency and relevant stakeholders to allow sufficient time for the appropriate application, design, and implementation of any CED requirements.
- Provide flexibility for data collection mechanisms to adjust based on new developments in the evidence.
- Registries need timely, cost-effective, and continuous access to Medicare claims data to perform longitudinal studies.
- Dr. MacGillivray urged Congress to advance reforms such as the H.R. 5394, the Meaningful Access to Federal Health Plan Claims Data Act of 2021, from Reps. Larry Bucshon, MD, and Kim Schrier, MD, which would require that enhanced access to Medicare claims data be provided to clinician-led registries, such as the STS National Database.