HR 5269S 2761119th CongressIntroduced

RESULTS Act

Introduced: Sep 10, 2025

Economy & Taxes

Chamber Versions:

Standard Summary

Comprehensive overview in 1-2 paragraphs

The RESULTS Act (Reforming and Enhancing Sustainable Updates to Laboratory Testing Services Act of 2025) would change how Medicare sets payments for clinical diagnostic laboratory tests (CDLTs) by tying Medicare payment rates to private payor rates gathered from a new, data-driven system. The core idea is to use a qualifying independent nonprofit claims data entity and its comprehensive private-payer claims database to determine “final payment rates” for laboratory tests, with the goal of more accurately reflecting market payments and improving long-term stability for Medicare beneficiaries who rely on these tests. The bill creates strict data-collection rules, definitions for test categories (widely available non-ADLT tests, non-widely available non-ADLT tests, and ADLTs), and a framework for how data will be collected, validated, and used to set rates. It also provides fallback mechanisms when data aren’t available, public explanations of rates, and a sunset/verification provision. In short, the bill aims to make Medicare CDLT payments more market-based and predictable by basing updates on systematically collected private-payor data, while building in privacy protections, data quality standards, and transparency. It includes a phased timeline, with data collection periods and rate determinations evolving from 2027 onward, and technical and governance requirements for the data entities that would supply the information.

Key Points

1Data-driven private-payor basis for rates: Medicare payments for clinical diagnostic laboratory tests would be determined using private payor-based market data collected from a qualifying comprehensive claims database, reported by a qualifying independent claims data entity under contract with the Secretary.
2New data-entity framework: The bill creates a framework for a qualifying independent claims data entity (a national nonprofit, unaffiliated with government or health-care organizations) that maintains a qualifying comprehensive claims database with strict privacy, security, and QA requirements.
3Test categories defined: The bill distinguishes between widely available non-ADLT tests, non-widely available non-ADLT tests, and ADLTs, with different data requirements and rate calculations for each category.
4Data collection periods and final payment rates: For data collection periods beginning in 2027 or 2028, the Secretary would collect applicable information and determine final payment rates based on data from the qualifying database. For widely available non-ADLT tests, the final rate is tied to the latest payment data; for non-widely available tests or ADLTs, the final rate is derived from the data period and definitions in the bill.
5Default and fallback mechanisms: If the Secretary cannot contract with a qualifying independent entity or if there is no applicable information, there are default payment rules (including CPI-based adjustments) and fallback processes (e.g., cross-walking or gap-filling) to determine payments for those tests.
6Public explanation of rates: The Secretary must publicly explain the payment rate and provide necessary data to laboratories to help assess rate accuracy.
7Data quality and privacy: The bill imposes strict data-quality standards, version control, and adherence to HIPAA and other privacy/security laws for the data in the qualifying comprehensive claims database.
8Timeline and rulemaking: The act includes a schedule for when data collection parameters and rules must be established or updated, including future-oriented rulemaking for periods beginning after 2027 and updates to data-collection periods.
9Medicaid MCO data exclusion: For market-based data used before 2028, rates from Medicaid managed care organizations are excluded to keep private-payor data as the basis for rate-setting.
10Sunset/verification: The act requires a sunset-style review or performance check and places a time-bound limitation on certain review provisions, with a deadline before January 1, 2029, to evaluate the process.

Impact Areas

Primary group/area affected- Medicare beneficiaries who rely on clinical diagnostic laboratory tests (CDLTs) will see how their lab test payments are determined and may benefit from more stable, market-reflective pricing and greater transparency about how rates are set.Secondary group/area affected- Clinical laboratories and testing facilities: Will be affected by how rates are calculated (data-driven final payment rates) and by the administrative requirements to submit data and participate in the data-collection framework or rely on fallback mechanisms if data aren’t available.- Private payors and claims data entities: The law would create a central role for a qualifying independent claims data entity and its database, increasing demand for standardized data submission and privacy compliance.Additional impacts- Data privacy and security: Laboratories and data entities will need to comply with HIPAA and related privacy/security requirements; quality assurance and data validation processes become more central.- Transparency and accountability: Public explanations of payment rates and the data used to derive them would be required, potentially increasing transparency but also scrutiny of rate-setting methods.- Administrative and implementation considerations: Significant setup and ongoing maintenance would be needed for the data-collection contracts, data standards, and rulemaking timeline, with potential transitional periods before fully market-based rate-setting is implemented.- Possible impact on price volatility and access: If rates move more toward private-payor data, there could be changes in variability of payment for CDLTs, which can affect access in some markets depending on payer mix and lab pricing strategies.ADLT: Advanced Diagnostic Laboratory Test, a subset of laboratory tests that typically require more complex analysis or specialized technology.Widely available non-ADLT test: A non-ADLT test that a substantial number of providers perform; defined in part by a threshold (e.g., more than 100 providers receiving payment for the test in a given period).Final payment rate: The rate used for payment purposes in a given data collection period, defined differently for widely available vs. less common tests.Qualifying comprehensive claims database: A large, independent private-payer claims database meeting specific size, representativeness, privacy, and QA requirements.Qualifying independent claims data entity: A national nonprofit entity that collects data and has access to the qualifying database, certified to meet standards and contractually bound to report applicable information to the Secretary.

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