TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) announced today that, further to its press release of October 8, 2010, a unique new Current Procedural Terminology ("CPT") code that will apply to the TearLab® Osmolarity test has now been published by the American Medical Association ("AMA"). The new code will become effective January 1, 2011.
The new CPT code for the TearLab Osmolarity test is: 83861; Microfluidic analysis utilizing an integrated collection and analysis device, tear osmolarity (For microfluidic tear osmolarity of both eyes, report 83861 twice). This code falls under the Chemistry sub-section of the Pathology and Laboratory section of the CPT Codebook and will be listed under the Clinical Laboratory Fee Schedule by the Centers for Medicare and Medicaid Services (CMS). Reimbursement by CMS has been set at $24.01 per eye and will only be available for offices that have a Moderate Complex CLIA certificate until TearLab receives a CLIA Waiver categorization from the U.S. Food and Drug Administration ("FDA"). This waiver is currently under review by the FDA. Patient co-payments and deductibles do not apply to services paid under the Medicare clinical laboratory fee schedule.
CPT codes are the most widely accepted form of medical nomenclature used to report medical procedures and services under public and private health insurance programs in the U.S. The purpose of the CPT codes is to provide a uniform language that accurately describes medical, surgical, and diagnostic services. Physicians, hospitals, and other health care providers use CPT codes to report medical services to private and public health insurance systems for purposes of reimbursement. A standard system of coding also allows for reliable nationwide data collection. CPT is trademarked by the AMA, which first published the codes in 1966.
Among the AMA's stated criteria for a new Category I CPT code are requirements that: (1) the service/procedure has received approval from the FDA for the specific use of devices or drugs; (2) the service/procedure is a distinct service performed by many physicians/practitioners across the United States; (3) the clinical efficacy of the service/procedure is well established and documented in U.S. peer review literature and (4) the service/procedure is neither a fragmentation of an existing procedure/service nor currently reportable by one or more existing codes.
Elias Vamvakas, TearLab's Chief Executive Officer, said, "We are very pleased that the AMA has created this CPT code that describes the TearLab Osmolarity test. The establishment of this code demonstrates the uniqueness, utility and value of our patented lab-on-a-chip technology."
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