S. 2761 — RESULTS Act

This section revises data collection and reporting requirements under the private payor rate-based system for Medicare payment for clinical diagnostic laboratory tests (CDLTs) (i.e., bases Medicare payment rates on the weighted median of private payer rates). (As background, the system, established under the Protecting Access to Medicare Act of 2014, requires applicable laboratories to report private payer data on CDLTs, including advanced diagnostic laboratory tests (ADLTs), with payment updates applied annually beginning in 2018 but delayed for non-ADLTs.) Specifically, the section (1) requires reporting of applicable information for data collection periods beginning before January 1, 2027, consistent with current law, and, for periods on or after that date, for each CDLT for which final payment is made under Medicare Part B; (2) directs the Secretary, for reporting periods beginning on or after January 1, 2028, to collect and use applicable information on widely available non-ADLT CDLTs (newly defined) from a qualifying comprehensive claims database (newly defined as an independent database of private payer claims data including at least 50 billion claims) of a qualifying independent claims data entity (newly defined as a national nonprofit organization meeting specified independence, certification, privacy, and quality assurance criteria) via a contract entered as soon as practicable after enactment; (3) extends the initial reporting deadline to 2027 (from 2025), the initial data collection period to January 1 through March 31, 2028 (from 2026), and the lookback period for data to 4 years (from 3 years); and (4) redefines "applicable laboratory" for reporting periods on or after January 1, 2028, as the entity described in 42 CFR 414.502 (as in effect on May 1, 2025), excluding paragraph (3) of that regulation. (Thus, high-volume laboratories continue reporting on non-widely available non-ADLT CDLTs (newly defined), while the Secretary sources data on widely available non-ADLT CDLTs from the third-party database.)