TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) ("TearLab" or the "Company") and COLA, a private, non-profit clinical laboratory education, consultation and accreditation organization, announced today that they have partnered to help make the TearLab™ Osmolarity System available in the U.S. at the point-of-care.
As previously announced, the TearLab™ Osmolarity test will be reimbursed by the Centers for Medicare and Medicaid Services (CMS), effective January 1, 2011. Reimbursement will only be available, however, for offices that have a Moderate Complexity CLIA certificate until such time that TearLab receives a CLIA Waiver categorization from the U.S. Food and Drug Administration ("FDA"). This waiver is currently under review by the FDA.
In order to help make the groundbreaking TearLab Osmolarity™ test available through some of the estimated 50,000 U.S. eye care practitioners that do not currently operate with Moderate Complexity CLIA certifications, the Company has partnered with COLA to provide interested doctors with a customized package of education, consulting and accreditation services designed to allow them to meet CLIA standards and qualify as a Laboratory Director for Moderate Complexity testing in their field. As such, they will be able to supervise up to five individual doctor locations where the TearLab™ Osmolarity test can be performed and reimbursed.
Elias Vamvakas, TearLab's Chief Executive Officer said, "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. This collaboration will make the process simple and straightforward for doctors, with all of the paperwork and bureaucracy being handled by COLA. Simplifying the process will allow for greater access to the TearLab™ Osmolarity System -- raising the standard of care while, at the same time, providing the necessary economics for doctors to build a successful Dry Eye practice."
Douglas Beigel, COLA's Chief Executive Officer commented, "As an organization dedicated to promoting excellence in laboratory medicine and patient care, 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 TearLab Osmolarity 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 (TJC)."
SOURCE TearLab Corporation