HR5269-119

What This Bill Does

The RESULTS Act changes how Medicare collects private-payor data for clinical diagnostic laboratory test payment rates under Social Security Act section 1834A. For data collection periods beginning on or after January 1, 2027, reporting covers each clinical diagnostic laboratory test for which final payment is made under Medicare Part B. For reporting periods beginning on or after January 1, 2028, widely available non-advanced diagnostic laboratory tests shift to data collected from a qualifying comprehensive claims database maintained by a qualifying independent claims data entity under contract with the Secretary. The bill delays reporting deadlines, changes the applicable-laboratory definition for 2028 forward, defines non-widely available non-ADLT tests, requires a national nonprofit claims data entity independent from government, insurers, health plans, providers, suppliers, and health-sector organizations, and requires a database with at least 50 billion claims from more than 50 payors and claims administrators, all 50 states and D.C. representation, validation, privacy compliance, version control, and final-payment claims. CMS must use final payment rates and may receive information from the contracted claims database instead of only laboratory reports.

Who Benefits and How

Clinical diagnostic laboratories benefit when widely available non-advanced test reporting can rely on a contracted claims database instead of direct laboratory reporting. Independent claims data entities benefit from a new Medicare contract opportunity to supply private-payor claims data. Medicare payment analysts benefit from broader claims data for widely available laboratory tests. Laboratory trade organizations benefit from a delayed reporting cycle and a narrower direct reporting burden for widely available tests.

Who Bears the Burden and How

Centers for Medicare and Medicaid Services staff must identify, contract with, and use a qualifying independent claims data entity. Qualifying claims database operators must meet privacy, security, validation, version-control, and representativeness requirements. Clinical laboratories with non-widely available tests remain responsible for applicable information reporting. Medicare program administrators must update payment-rate calculations, regulations, and disclosure rules for final payment data.

Key Provisions

• Delays the next Medicare clinical laboratory reporting cycle to 2028 and extends reporting frequency to four years.
• Requires CMS to use a qualifying independent claims database for widely available non-advanced laboratory tests beginning with 2028 reporting.
• Defines qualifying claims data entities as national nonprofits independent from government, insurers, plans, providers, suppliers, and health-sector organizations.
• Requires qualifying databases to include at least 50 billion claims from more than 50 payors and claims administrators.
• Updates Medicare payment calculations to use final payment rates from laboratory reports or qualifying claims databases.