S. 2761: Reforming and Enhancing Sustainable Updates to Laboratory Testing Services Act of 2025

This bill, known as the Reforming and Enhancing Sustainable Updates to Laboratory Testing Services Act of 2025 (or RESULTS Act), aims to amend the Social Security Act to improve Medicare payments for clinical diagnostic laboratory tests. Here is a summary of its key provisions:

Key Provisions

1. Data Collection Improvements

The bill focuses on enhancing the accuracy and feasibility of data collection for Medicare payment rates applied to clinical diagnostic laboratory tests. It mandates:

• Using data from a comprehensive claims database maintained by an independent national nonprofit organization.
• Conducting data collection periods to start before January 1, 2027, for certain tests and extending to periods starting on or after January 1, 2028, for others.
• Updating the definitions of applicable laboratories and specific tests used in the data collection process.

2. Medicare Payment Rates

The bill amends how Medicare calculates payment rates for clinical diagnostic laboratory tests that are not classified as advanced diagnostic laboratory tests (ADLTs). The changes include:

• Establishing a weighted median of private payor-based rates for tests, factoring in data from previous years.
• Particular attention is given to widely available non-ADLT tests, with new provisions for payment adjustments if data is lacking.
• Setting default payment rates based on the previous year's payments adjusted for inflation (Consumer Price Index) when appropriate data isn’t available.

3. Transparency and Reporting

The bill requires greater transparency in payment calculations. Specifically:

• The Secretary of Health and Human Services (HHS) must make public explanations of payment rates, including any essential data.
• Issuing reports to ensure that public bodies can access payment information clearly and accurately.

4. Updating Payment Mechanisms

Adjustments also include defining and updating payment mechanisms to reflect true market conditions:

• Incorporating mechanisms to exclude data from Medicaid managed care organizations when calculating payment rates.
• Modifying terms related to payment reduction limits and fee schedule applications to better align with current healthcare dynamics.

5. Oversight and Quality Assurance

The bill emphasizes the need for quality assurance in data collection, such that:

• All data must comply with privacy and security requirements, ensuring patient confidentiality.
• The independent claims data entity must have quality assurance processes in place to validate the collected data.

Implementation Timeline

The provisions of this bill have specific implementation timelines, including deadlines for data collection periods and the establishment of regulations by the HHS Secretary by designated dates.

Relevant Companies

• ABMD (Abiomed, Inc.): This company deals with medical devices related to heart surgery and may be impacted by changes in diagnostic testing services related to cardiac procedures.
• MDT (Medtronic Plc): As a leading medical technology company, changes in laboratory testing services could affect the regulatory landscape and reimbursement for their diagnostic products.
• VAR (Varian Medical Systems, Inc.): Similar to Medtronic, this company's services may be impacted by how clinical diagnostic labs report and are reimbursed, particularly in oncology treatments.