Fueled by the increase of portable testing instruments and the need for quick test results, the number of physician office labs has grown, according to Kalorama Information.
According to Kalorama's “Physician Office Laboratory (POL) Testing Markets Worldwide: Status Quo and Future Trends,” the number of labs in the United States grew from 95,000 in 2000 to more than 111,000 in 2010. The New York-based healthcare market research publisher said this growth has created a significant market niche for diagnostic companies.
The term 'POL' is diverse, encompassing physician practices of one to five doctors performing a few tests to large practices of some 200 physicians that operate labs similar to small hospital laboratories. Kalorama estimates a $2 billion market for revenues earned from sales to POLs.
According to Kalorama, most of the labs in this category don't need to meet Clinical Laboratory Improvement Amendments (CLIA), which were passed by Congress in 1988 to ensure the laboratory testing procedures are timely, accurate and dependable regardless of where they're conducted. Most of the tests conducted in POLs are simple and use standardized equipment, making errors unlikely.
“This is not surprising given the requirements and the tests that can be performed in non-waived facilities,” said Shara Rosen, lead diagnostics analyst for Kalorama Information and author of the report. “A CLIA certificate costs $150 every two years; non-waived facilities may incur volume-related fees of up to several thousand dollars for the same time period.”
Despite current growth, the future of POL testing is far from clear, according to the report. Healthcare systems are taking a closer look at expenses and the additional cost of new technologies and reimbursement for POL tests has not been automatic.
Kalorama notes that POLs still only perform a fraction of total IVD tests each year.