Clinician-led clinical data registries, such as the STS National Database, are sources of real-world evidence that are uniquely positioned to drive quality improvement and meaningful health care research, but they face significant regulatory barriers that stifle their potential. It is essential that clinician-led clinical data registries have timely, broad, and continuous access to Medicare claims data to enhance our understanding of the long-term impacts of innovative therapies.
Priorities
- Secure Reasonable Clinician-led Clinical Database Access to Federal Health Plan Claims Data: Access to Medicare data is critical to facilitating longitudinal outcomes-based research that improves health care quality, cost efficiency, and ensures patients access to emerging technologies through processes like Medicare coverage with evidence development.
- Update, Modernize, and Utilize Social Risk Data: Develop widely adopted national industry standards for the collection of race, ethnicity, and language (REL) data or social determinants of health (SDOH) data and include data in risk-modeling.
Endorsed Legislation
H.R. 9805, the Access to Claims Data Act of 2024
Resources
- STS Comments on Transitional Coverage for Emerging Technology (TCET) (Aug. 23, 2023)
- STS President Addresses Congress on Medical Innovations & Role of Big Data (July 23, 2023)
- STS Comments on Updated Interoperability Standards (May 17, 2023)
- STS Comments on Proposed Update to Race and Ethnicity Standards (April 4, 2023)
- STS Comments on Advancing Interoperability and Prior Authorization Proposed Rule (March 8, 2023)
- STS Comments on Algorithms on Racial and Ethnic Disparities in Healthcare (March 8, 2023)
- Request to Remove the Ban on a National Patient ID: House
- Request to Remove the Ban on a National Patient ID: Senate
- STS Comments on FDA Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
- Letter to Congress Urging Telehealth Expansion