S.2761 (RESULTS Act) changes how Medicare sets payment rates for clinical diagnostic laboratory tests under section 1834A of the Social Security Act. For widely available non‑ADLT tests, the bill requires CMS to obtain validated, private payor ‘‘final payment’’ data from a contracting, independent national nonprofit that maintains a qualifying comprehensive claims database; for other tests it tightens rules for crosswalking and gapfilling.
The bill also amends definitions, shifts data collection windows, and requires CMS to publish explanations of calculated rates.
The statute aims to make Medicare’s private payor‑based fee schedule more accurate and administrable by standardizing data sources and definitions. But it also creates a single‑source pathway for market data, establishes high entry standards for the database, and builds default payment and timing rules to govern periods without usable data — all changes that materially affect labs, payors, CMS, and patients relying on Medicare lab access.
At a Glance
What It Does
The bill directs CMS to contract with a qualifying independent nonprofit claims data entity to supply validated ‘‘final payment’’ private‑payor data for widely available non‑ADLT lab tests beginning with reporting periods in 2028, and it revises how CMS calculates weighted medians and handles missing data (including CPI defaults and crosswalk/gapfill processes). It also sets strict technical requirements for the claims database and requires public explanations of payment rates.
Who It Affects
This targets clinical diagnostic laboratories (especially those billing Medicare for common tests), qualifying claims‑database vendors, private payors that supply claims data, and CMS’s rate‑setting team and contractors. Indirectly it affects Medicare beneficiaries and providers who rely on laboratory testing access and pricing stability.
Why It Matters
By changing the data source and specifying ‘‘final payment’’ as the unit of analysis, the bill shifts the evidentiary foundation for market‑based Medicare lab rates — potentially improving accuracy but concentrating influence in certified database operators and changing how shortfalls in data availability are handled.
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What This Bill Actually Does
The RESULTS Act rewrites parts of section 1834A so that, for common (what the bill calls “widely available non‑ADLT”) lab tests, CMS must rely on private‑payor data from a contracted independent nonprofit that runs a qualifying comprehensive claims database. The bill gives a deadline for CMS to set a contract ‘‘as soon as practicable’’ and requires the database to be nationally representative, validated by quality‑assurance processes, and to include only ‘‘final payment’’ amounts — not denied, appealed, mistaken, or recouped payments.
For timing and coverage, the statute moves the routine six‑month data collection window to January 1–June 30 of the year before a reporting period, and it phases in the new data source for reporting periods beginning January 1, 2028 (with rulemaking parameters due by December 31, 2026). It defines ‘‘widely available’’ tests as those billed by more than 100 providers in the first six months of the preceding year, and it treats other tests (non‑widely available non‑ADLTs and ADLTs) under the existing laboratory reporting regime but with clarified crosswalk and gapfill rules when data are missing.The bill alters the rate‑setting and fallback logic.
CMS must use weighted medians of private‑payor ‘‘final payment’’ rates when available. If CMS cannot contract with a qualifying independent data entity or the database lacks applicable information for a widely available test, the statute prescribes a default: payment remains at the prior year’s level and is increased by the annual CPI‑U percentage during a defined ‘‘qualified rate period.’’ For non‑widely available tests without reported data, CMS must either crosswalk to the most appropriate existing code or use the section 1834A gapfilling process.
Finally, CMS must publish explanations and supporting data for each calculated payment rate so laboratories can assess accuracy.
The Five Things You Need to Know
The Secretary must contract with a qualifying independent nonprofit claims data entity to supply private‑payor ‘‘final payment’’ information for widely available non‑ADLT tests for reporting periods beginning January 1, 2028.
A qualifying comprehensive claims database must contain at least 50,000,000,000 claims and data from more than 50 private payors/claims administrators, be statistically representative of all 50 states plus DC, and use version control and QA validation.
A test is ‘‘widely available’’ for a reporting period if, during the first six months of the year immediately preceding the data collection window, more than 100 distinct providers or suppliers billed Medicare for that test.
If CMS cannot contract with a qualifying data entity or the database lacks applicable information for a widely available test, payment during the applicable ‘‘qualified rate period’’ equals the prior year’s payment increased by the Consumer Price Index for All Urban Consumers (CPI‑U) for the previous year.
For non‑widely available non‑ADLTs with no reported applicable information, CMS must either crosswalk the test to an existing comparable test (per 42 C.F.R. §414.508(a) logic) or apply the 1834A gapfilling process; ‘‘final payment rate’’ is defined as the last payment made in the relevant year/period and excludes denials, appeals, erroneous payments, and recoups.
Section-by-Section Breakdown
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Short title
Names the legislation the Reforming and Enhancing Sustainable Updates to Laboratory Testing Services Act of 2025 (RESULTS Act). This is purely formal but frames subsequent references to the act throughout the statute and rulemaking.
Require CMS contract with independent nonprofit claims entity for widely available tests
Amends 1834A(a)(1) to require CMS to collect and use applicable information for widely available non‑ADLT tests from a ‘‘qualifying comprehensive claims database’’ of a ‘‘qualifying independent claims data entity’’ with which CMS has a contract. The provision instructs CMS to identify and contract with such an entity "as soon as practicable" and shifts the data source away from relying solely on laboratory self‑reporting for those broadly used tests.
Tight technical standards for qualifying entity and database
Adds granular definitions: the qualifying independent claims data entity must be a national nonprofit unaffiliated with payors or providers, certified as a ‘‘qualified entity’’ by CMS (per section 1874(e) standards), comply with HIPAA and state privacy/security rules, and apply QA and statistical testing. The qualifying comprehensive claims database must include at least 50 billion claims from over 50 payors/administrators, be representative of all states, keep version control to reflect final payments, and include the relevant tests. These are high bars that change who can satisfy CMS’s statutory data source.
Weighted medians, default CPI escalation, and public explanations
Updates 1834A(b) so CMS uses the weighted median of ‘‘final payment’’ private‑payor rates when available. It creates a statutory default for widely available tests when no contract or no applicable information exists: payments for the qualified rate period equal the prior year’s payment increased by CPI‑U. It also requires CMS to publish an explanation and supporting data for each payment rate so labs can evaluate calculations — shifting transparency expectations in rate setting.
Defines ‘‘final payment,’’ changes collection windows, and limits data sources
Defines ‘‘final payment rate’’ as the last payment made in the applicable year or period and excludes denied payments, payments under appeal, payments made in error, and recouped payments. It sets the data collection period for non‑ADLT tests to January 1–June 30 of the year preceding the reporting period (effective for reporting beginning 2028), and limits the prior inclusion of Medicaid MCO data to reporting periods beginning before January 1, 2028. These mechanics change which transactions count toward market measures.
Modifies limits on payment reductions, sunsets, and other technical fixes
Alters the statutory caps and timing in 1834A(b)(3) — adjusting phrasing around years and lowering the scheduled maximum reduction to 5% for 2029 and later — and inserts a deadline for CMS rulemaking parameters (December 31, 2026) for data collection rules beginning 2027. Also adds a statutory sunset qualifier for a prior review limitation. These edits affect the tempo and ceiling for future payment changes.
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Explore Healthcare in Codify Search →Who Benefits and Who Bears the Cost
Every bill creates winners and losers. Here's who stands to gain and who bears the cost.
Who Benefits
- Medicare beneficiaries — Stabilized access and clearer pricing methodology for common lab tests may reduce sudden payment shocks that could otherwise disrupt access to testing in some areas.
- Clinical diagnostic laboratories performing high‑volume tests — For widely performed non‑ADLTs, reliance on a validated, nationally representative private‑payor dataset should produce more predictable, market‑aligned payments rather than ad hoc or widely varying local rates.
- Policymakers and CMS rate‑setters — Standardized, QA‑validated private‑payor data simplifies comparability across payors and supports defensible rulemaking and published explanations of calculation methods.
- Independent nonprofit data entities (that qualify) — The statute creates a potential contracting opportunity and de facto gatekeeper role for entities that meet the demanding technical, privacy, and coverage thresholds.
- Commercial payors and claims administrators — Standardized, version‑controlled reporting may reduce ad hoc data pull requests and provide a clearer template for how private‑payor payments are evaluated for Medicare purposes.
Who Bears the Cost
- Clinical laboratories (especially smaller or specialty labs) — New data definitions and the emphasis on ‘‘final payments’’ and market medians can reduce reimbursement for some tests and create reporting ambiguity or compliance costs when payments are recouped or appealed.
- Private payors and claims administrators — Meeting the database’s representation and validation requirements and responding to contract or data requests will impose operational and potentially contractual costs.
- Qualifying independent claims data entities — They must meet massive data and quality thresholds (50B claims, >50 payors), comply with privacy/security standards, and perform extensive QA; initial setup and ongoing validation are costly even if they secure a CMS contract.
- CMS and HHS — Contract oversight, certification tasks, rulemaking to implement the statute, and public explanation duties will require staff time and technical capacity, possibly requiring new contractor support or agency resources.
- Local or niche labs and innovators — Crosswalks and gapfilling for low‑volume or novel tests risk mispricing and can leave innovators with temporary underpayment while CMS applies gapfill logic.
Key Issues
The Core Tension
The statute tries to resolve a classic trade‑off: it demands a single, high‑quality, nationally representative private‑payor data source to make Medicare lab prices more accurate and defensible, but doing so concentrates power in the qualifying database operator (and in CMS’s contracting choices) and risks payment inertia when that source is unavailable — creating a tension between accuracy/standardization and vendor concentration, access, and timeliness of payments.
The bill improves data quality by specifying ‘‘final’’ payments and by requiring QA‑validated, version‑controlled claims data. But it centralizes the source of market data in a single contracted nonprofit that must meet very high coverage and validation thresholds (e.g., the 50 billion claim floor and more than 50 payors).
That concentration reduces heterogeneity in data inputs — which can increase comparability — but also concentrates negotiating and operational leverage in the hands of the qualifying entity and in CMS’s selection process. The statute leaves open the practical question of how many organizations can meet the criteria and how quickly CMS can complete contracting "as soon as practicable." If no entity qualifies or the database lacks applicable information, the statute prescribes CPI‑based defaults for widely available tests and crosswalk/gapfill for others — rules that stabilize short‑term payments but may diverge from contemporaneous market rates for extended periods.
Operationally, several implementation details are unresolved or delegated to rulemaking: how CMS will certify the qualifying entity, the specific QA standards and statistical tests required, timelines for data transfers and format standards, and the mechanics for version control to identify ‘‘final payments.’’ The bill also creates potential bias in the ‘‘final payment’’ construct: excluding payments under appeal, recoups, and denials may move reported rates away from gross negotiated prices toward net settled amounts in ways that favor some provider types or payor arrangements. Finally, the high technical bar for database inclusion and the representativeness requirement interact with state privacy laws and contractual protections in private payor agreements, creating legal and logistical challenges for data acquisition and use.
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