Medical Necessity of Tear Osmolarity Testing in the Diagnosis and Management of Dry Eye Disease Confirmed in Recently Published Medicare Local Coverage Determination


TearLab announced that First Coast Service Options (Medicare Area Contractor for Florida, Puerto Rico and the US Virgin Islands) has published a Local Coverage Determination (LCD) that confirms the role of tear osmolarity testing in the diagnosis and management of moderate to severe dry eye patients, according to a company news release.

The First Coast LCD- L36232, titled "Diagnostic Evaluation and Medical Management of Moderate-Severe Dry Eye Disease (DED)," was recently published on the CMS website. The LCD states that tear osmolarity testing remains medically reasonable and necessary to aid in the diagnosis of moderate to severe dry eye disease, in addition to determining disease severity and monitoring therapeutic effectiveness. This determination is consistent with clinical guidelines recently published by the Sjogrens Syndrome Foundation on the value of tear osmolarity testing in the management of dry eye disease.

First Coast concluded that tear osmolarity testing is appropriate when performed on an initial patient visit, prior to any ocular surface altering diagnostic tests (e.g., Schirmer test, vital dye staining,
tear film break up time, etc.), for patients qualified via a recognized dry eye symptom questionnaire (SPEED, OSDI, DEQ-5). In addition, patients identified with dry eye symptoms and a tear osmolarity test result of 312 mOsm/L or greater, who are placed on treatment, are eligible for a repeat tear osmolarity test at 6 weeks and 3 months to assess the effectiveness of the therapeutic intervention.

"We are pleased that the First Coast LCD recognizes the medical necessity of tear osmolarity testing and provides guidance on usage. This LCD will provide needed clarity to reimbursement questions that many doctors raise as to when and how the test can be used," Elias Vamvakas, TearLab chief executive officer, said in the news release.


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