Modifying requirements and approval periods for qualified clinical data registries

Section 1848(m)(3)(E) of the Social Security Act (42 U.S.C. 1395w–4(m)(3)(E)) is amended— (1) in clause (i), by adding at the end the following: Beginning January 1, 2027, such requirements shall include a requirement that the entity— (I) be established and operated by a professional society that is controlled or led by a designated practitioner (as defined in section 1866H) and that has demonstrated expertise in developing evidence-based clinical practice guidelines and quality measures for improving patient outcomes; (II) demonstrates adherence to data quality and fidelity standards, including standards relating to data elements, data completeness, and validation processes; (III) demonstrates capacity to generate timely, actionable feedback to participating practitioners to support continuous quality improvement and track practitioner use of such feedback; (IV) demonstrate transparency in measure development (including the methodology used in such measures and any risk adjustment used in such measures); and (V) has established self-audit or review processes focusing on data accuracy, measure integrity, and appropriate use of results.; and (2) in clause (v), by adding the following flush matter at the end: A determination or designation made under this clause on or after January 1, 2027, shall be effective for a period of 3 years. At the end of such period, the Secretary (or, in the case of a designation made by an organization, such organization) may extend such determination or designation (as applicable) for subsequent 3-year periods based on a showing by such entity that such entity continues to meet the requirements of clause (i)..