The Office of Inspector General (OIG) recently issued a report pointing out "widespread problems" with the Clinical Laboratory Improvement Amendments (CLIA) administered by CMS. According to the report, Enrollment and Certification Process in the CLIA Program (OEI-05-00-00251, August 2001), infractions include labs operating without a certificate, and certified labs providing tests they are not authorized to perform or conducting procedures without appropriate protocols to ensure accuracy. "In order to get paid for services provided, and to avoid OIG scrutiny, laboratories must ensure that they correctly perform and report only tests that fall within their certification levels," says Laurie Castillo, MA, CPC, CPC-H, CCS-P, member of the National Advisory Board of the American Academy of Professional Coders and president of Physician Coding and Compliance Consulting in Virginia.
CLIA certificates fall into three main categories based on the complexity of testing conducted by the lab: high complexity, moderate complexity (which includes a sub-category of provider-performed microscopy, or PPM) and waived. The Food and Drug Administration categorizes all laboratory test methods into one of the certification categories based on test complexity. Laboratories can only perform tests at their approved complexity level or below. The test lists are updated frequently, and are available on the Internet at
www.fda.gov/cdrh/clia/index.html.
PPM and Waived-Status Labs Are Under Scrutiny
Based on state surveys and random inspections in two states, the OIG estimates that about half of the waived and PPM laboratories may be noncompliant. The chief infractions of waived labs involved testing outside their certificate level and not having or not following manufacturers' instructions for tests performed. PPM labs were also out of compliance by testing outside their certificate level and lacking written procedures, but they also lacked quality-assurance protocols for test accuracy and staff competency.
"Based on OIG recommendations, which CMS fully concurs with, waived and PPM laboratories should expect further oversight from CMS, and improve compliance accordingly," Castillo says. Here are four changes labs can expect CMS to implement:
Requiring labs applying for waived and PPM certificates to identify which testing systems they will use.
Establishing a mechanism for Medicare carriers to inform CLIA oversight agencies (CMS regional offices or approved state agencies) about claims denials for labs billing outside of their certificate.
Conducting random onsite "surveys" (inspections) of some waived and PPM labs each year.
Using periodic paper self-assessment tools for waived and PPM laboratories.
"To stand up to increased scrutiny, PPM and waived-status labs need to ensure they are accurately conducting only appropriate tests and that they are coding them correctly," says Ken Wolfgang, MT (ASCP), CPC, CPC-H, director of coding and analysis for National Health Systems Inc. in Camp Hill, Pa., who serves on the National Advisory Board and the Executive Board [...]
