An osmolarity system (TearLab, TearLab Corp.) is now available in the United States at the point of care, thanks to a partnership between its manufacturer and COLA, a private, non-profit clinical laboratory education, consultation, and accreditation organization.
San Diego-An osmolarity system (TearLab, TearLab Corp.) is now available in the United States at the point of care, thanks to a partnership between its manufacturer and COLA, a private, non-profit clinical laboratory education, consultation, and accreditation organization.
As previously announced, the Centers for Medicare and Medicaid Services began reimbursing for the osmolarity test Jan. 1. Reimbursement, however, only is available for offices that have a moderate complexity Clinical Laboratory Improvement Amendments (CLIA) certificate until the company receives a CLIA Waiver categorization from the FDA. This waiver application currently is under review.
The partnership with COLA will help make the osmolarity test available through some of the estimated 50,000 U.S. eye-care practitioners whose practices currently do not operate with moderate complexity CLIA certifications. Interested physicians will be provided with a customized package of education, consulting, and accreditation services designed to allow them to meet CLIA standards and qualify as laboratory directors for moderate complexity testing in the field. As such, they will be able to supervise up to five individual doctor locations where the test can be performed and reimbursed.
“The majority of eye-care practitioners are unaccustomed to the requirements of CLIA regulations and, as a result, may be reluctant to enter into the certification process on their own,” said Elias Vamvakas, TearLab's chief executive officer (CEO). “This collaboration will make the process simple and straightforward for doctors, with all of the paperwork and bureaucracy being handled by COLA.”
Douglas Beigel, COLA’s CEO, said, “We welcome the opportunity to work with eye-care practitioners interested in qualifying as a laboratory director for moderate complexity, to help them meet CLIA requirements to provide [this] testing. Completing COLA's program means that they will be in compliance with CLIA, which also is recognized by the Joint Commission on Accreditation of Healthcare Organizations.”