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Audits of Selected Independent Clinical Laboratory Billing Requirements

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.

Announced or Revised Agency Title Component Report Number(s) Expected Issue Date (FY)
Completed (partial) Centers for Medicare & Medicaid Services Audits of Selected Independent Clinical Laboratory Billing Requirements Office of Audit Services A-06-16-02002;
A-09-16-02034;
A-06-17-04002;
A-04-18-08063;
A-09-19-03027;
A-09-20-03027;
A-09-21-03006;
A-09-22-03010;
W-00-17-35726;
W-00-20-35726;
W-00-22-35726;
W-00-21-35726;
WA-24-0023 (W-00-24-35726);
various reviews		 2025