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Series: Audits of Selected Independent Clinical Laboratory Billing Requirements

Announced on  | Last Modified on  | Series Number: W-00-24-35726
Status
Completed
Agency
Centers for Medicare and Medicaid Services

OBJECTIVE

Medicare covers diagnostic clinical laboratory services that are ordered by a physician who is treating a beneficiary and who uses the results in managing the beneficiary's specific medical problem (42 CFR 410.32(a)). These covered services can be furnished in hospital laboratories (for outpatient or nonhospital patients), physician office laboratories, independent laboratories, dialysis facility laboratories, nursing facility laboratories, and other institutions. Previous OIG audits, investigations, and inspections have identified areas of billing for clinical laboratory services that are at heightened risk for noncompliance with Medicare billing requirements. Payments to a service provider are precluded unless the provider furnishes on request the information necessary to determine the amount due (Social Security Act § 1833(e)). We will review Medicare payments for clinical laboratory services to determine laboratories' compliance with selected billing requirements. We will focus on claims for clinical laboratory services that may be at heightened risk for overpayments. For example, our reviews will focus on the improper use of claim line modifiers for a code pair, genetic testing, and urine drug testing services. We will use the results of these reviews to identify laboratories or other institutions that routinely submit improper claims, including providers that regularly bill Medicare for definitive drug testing at the highest reimbursement amount allowed.

There are 3 projects in this series.

CANCELED PROJECTS IN THIS SERIES (1)

Audit of Medicare Payments for Definitive Drug Testing Services - Lab Provider

Project A-09-24-03003 • Canceled on Jan 28, 2025

COMPLETED PROJECTS IN THIS SERIES (2)

Medicare Program Oversight

Project A-09-22-03010 • Completed on June 21, 2023

Medicare Program Oversight

Project A-09-21-03006 • Completed on February 27, 2023

TIMELINE

  • February 15, 2021
    Series Number W-00-24-35726 Assigned
  • February 15, 2021
    Project Announced

    Medicare Program Oversight - A-09-21-03006

  • November 15, 2021
    Project Announced

    Medicare Program Oversight - A-09-22-03010

  • February 27, 2023
    Project Complete - A-09-21-03006

    Medicare Program Oversight has been marked as complete. This audit resulted in 4 recommendations.

  • June 21, 2023
    Project Complete - A-09-22-03010

    Medicare Program Oversight has been marked as complete. This audit resulted in 3 recommendations.

  • June 21, 2023
    Series Complete

    Audits of Selected Independent Clinical Laboratory Billing Requirements has been marked as complete.

  • January 15, 2025
    Project Announced

    Audit of Medicare Payments for Definitive Drug Testing Services - Lab Provider - A-09-24-03003

  • January 28, 2025
    Project Canceled - A-09-24-03003

    Audit of Medicare Payments for Definitive Drug Testing Services - Lab Provider

2 REPORT PUBLISHED

Medicare Could Have Saved up to $216 Million Over 5 Years if Program Safeguards Had Prevented At-Risk Payments for Definitive Drug Testing Services (A-09-21-03006)

23-A-09-045.01 to CMS - Closed Unimplemented
Closed on 04/11/2024
We recommend that the Centers for Medicare & Medicaid Services expand program safeguards to prevent and detect at-risk payments to at-risk providers for the definitive drug testing service with the highest reimbursement amount (procedure code G0483), which could have saved up to $215.8 million for our audit period.

23-A-09-045.02 to CMS - Closed Unimplemented
Closed on 10/01/2024
We recommend that the Centers for Medicare & Medicaid Services review at-risk payments made to at-risk providers during and after our audit period to determine whether payments for procedure code G0483 complied with Medicare requirements and recover any overpayments.

23-A-09-045.03 to CMS - Closed Unimplemented
Closed on 09/24/2024
We recommend that the Centers for Medicare & Medicaid Services notify appropriate providers (i.e., those for whom CMS determines this audit constitutes credible information of potential overpayments) so that the providers can exercise reasonable diligence to identify, report, and return any overpayments in accordance with the 60-day rule and identify any of those returned overpayments as having been made in accordance with this recommendation.

23-A-09-045.04 to CMS - Closed Acceptable Alternative
Closed on 08/31/2023
We recommend that the Centers for Medicare & Medicaid Services educate providers that received payments that did not comply with Medicare requirements for definitive drug testing services.

View in Recommendation Tracker

CMS's Oversight of Medicare Payments for the Highest Paid Molecular Pathology Genetic Test Was Not Adequate To Reduce the Risk of up to $888 Million in Improper Payments (A-09-22-03010)

23-A-09-085.01 to CMS - Closed Implemented
Closed on 10/04/2024
We recommend that the Centers for Medicare & Medicaid Services direct the appropriate Medicare contractors to review claims billed under CPT code 81408 for our audit period to determine whether they complied with Medicare requirements.

23-A-09-085.02 to CMS - Closed Implemented
Closed on 10/04/2024
We recommend that the Centers for Medicare & Medicaid Services direct the appropriate Medicare contractors to determine the amount of improper payments for the claims that did not comply with Medicare requirements and, for those that are within the 4-year claim-reopening period, in accordance with CMS's policies and procedures, recover up to $888,169,038 for claims that were at risk of improper payment during our audit period.

23-A-09-085.03 to CMS - Open Unimplemented
Update expected on 02/28/2025
We recommend that the Centers for Medicare & Medicaid Services direct the appropriate Medicare contractors to based upon the results of this audit, notify appropriate providers (i.e., those for whom CMS determines this audit constitutes credible information of potential overpayments) so that the providers can exercise reasonable diligence to identify, report, and return any overpayments in accordance with the 60-day rule and identify any of those returned overpayments as having been made in accordance with this recommendation.

View in Recommendation Tracker
Work Plan Type
Office of Audit Services
HHS Agencies
Centers for Medicare and Medicaid Services
Issue Areas
Departmental Operational Issues Financial Stewardship
Target Groups
-
Financial Groups
Medicare B