Our Legislative and Regulatory Agenda and Activities
The Physician Clinical Registry Coalition has focused its advocacy efforts on the following legislative and regulatory issues facing clinical data registries:
- Qualified Clinical Data Registries (QCDRs) in the Quality Payment Program—The Coalition has been working to shape the rules for physician reporting on quality measures through QCDRs under the Medicare Physician Quality Reporting System (PQRS) and its successor Merit-Based Incentive Payment System (MIPS). In particular, the Coalition has been advocating for reforms in the self-nomination process for QCDRs and the process for CMS approval of the quality measures used in the MIPS reporting program.
- Access to Medicare and State Death Data—The Coalition worked for the inclusion of registry-related provisions in the Medicare Access and CHIP Reauthorization Act of 2016 (MACRA), including the requirement that the Centers for Medicare and Medicaid Services (CMS) provide QCDRs with meaningful access to Medicare claims data for quality improvement and research purposes. Since then, the Coalition has been working with CMS to implement the MACRA data access requirement while also assessing various options for clinical data registries to gain meaningful access to state death data for quality improvement and research purposes.
- OCR/OHRP HIPAA-Common Rule Issues—The Coalition has been in regular contact with the Office of Civil Rights (OCR) and the Office of Human Research Protections (OHRP) within the U.S. Department of Health and Human Services advocating for streamlining the requirements of the regulations issued the Health Insurance Portability and Accountability Act of 1996 and the Common Rule and file comments on OHRP’s major revision of the Common Rule in 2016.
- Data Protection—The Coalition is actively considering options for protecting clinical registry data from discovery in litigation or subpoenas.