We need some answers first. We can answer some general questions here. But if you will be billing Medicare for any of the lab work, your people seriously need to hire a health-care attorney who knows the rules for lab billing for your state.
1. You said
When we have billed for labs performed in our office ... Where are the labs being performed now, the ones you are trying to set the billing up for? That is, what are you setting the billing up for - an independent laboratory, or a laboratory for a group of doctors, or a laboratory for a solo practitioner who does lab work for other doctors?
2. Are any of the referring physicians participating providers with Medicare?
3. Are any of the labs being billed to Medicare? If
no, do you anticipate any future lab work being billed to Medicare?
4. Is this lab in California?
5. What level of complexity is your lab certified for?
6. Are you familiar with the information at the following link?
7. You asked
do we need to use the referring physician ... We can't answer that until you have answered the questions listed above.
http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/CLIABrochure.pdfCLIA standards are national and are not Medicare-exclusive. CLIA applies to all providers rendering clinical laboratory services, whether or not Medicare claims are filed.
CLIA regulations are based on the complexity of the test method. Test methods are categorized into three levels of complexity:
Waived Complexity;
Moderate Complexity, including Provider-Performed
Microscopy Procedures (PPMP); and
High Complexity.
The more complicated the test, the more stringent the requirements. CLIA specifies quality standards for PT, facility administration, general laboratory systems, preanalytic, analytic, and postanalytic systems, personnel qualifications and responsi-bilities, quality control, quality assessment, and specific cytology provisions for laboratories performing moderate and/or high complexity tests.