Enforcement of CLIA and Billing Regulations

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As most laboratorians are painfully aware, the laboratory is already a highly regulated healthcare service, and is becoming increasingly so. While we support regulation that ensures that we provide high quality services and keeps our patients safe, we may also be challenged by the time demands of the details that compliance requires.

The Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) were intended to ensure that patients receive accurate, reliable test results regardless of the setting in which their tests are performed. The Center for Medicare and Medicaid Services (CMS) has responsibility for administering the CLIA regulations. The Office of Inspector General (OIG) looks for areas of non-compliance and has the authority to take enforcement action. Each year the OIG publishes a “work plan” that lists areas of concern that they expect to focus on in the coming year. The work plan is lengthy and covers many areas of healthcare. In this article we will discuss those from the 2004 work plan that are of most direct interest to the laboratory.

• Laboratory Proficiency Testing: OIG will assess laboratory compliance with CLIA requirements to participate in proficiency testing. Proficiency testing is a statutorily mandated condition of participation in which laboratories are graded for their accuracy in analyzing clinical specimens. It is one of the primary mechanisms for ensuring quality testing. Medicare pays over $4 billion annually for clinical laboratory services, all of which must meet CLIA requirements.

  Laboratories performing moderate and high complexity testing (CLIA categories) are required to participate in…