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RPS Announces FDA Clearance of Rapid, Point-of-Care Test for Dry Eye Disease – InflammaDry®
Date:11/25/2013

ammaDry process takes less than two minutes to complete and can be performed by a technician during a patient’s initial workup. Results are available for the clinician in just ten minutes, allowing a treatment plan to be established with the patient during their initial office visit. Similar to the company’s other diagnostic test, AdenoPlus®, the test displays a blue control line for a negative result, or blue and red lines for a positive result.

Providers should not face reimbursement or coding obstacles when using this test. According to Eric Donnenfeld, MD, FAAO, president of the American Society of Cataract and Refractive Surgery (ASCRS), “providers should bill CPT code 83516, immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method, for the InflammaDry test.” Medicare payment for this code is currently $15.86. “The ability to report a CPT code and receive a reasonable payment for this test will help to facilitate patient access,” said Donnenfeld.

“Of course, providers should always follow specific payer guidelines and contact the specific payer if they have any questions regarding billing or payment,” said Sambursky. “Reimbursement is dynamic and new codes and changes are implemented annually.”

The 510(k) clearance allows the InflammaDry test to be used in physician offices that are certified to perform moderately complex tests under the Centers for Medicare and Medicaid Services’ Clinical Laboratory Improvement Amendments (CLIA). The InflammaDry test will also be submitted to FDA for CLIA waiver review. If granted, a waived status would allow the test to be used in any CLIA-waived physician office. For more information, visit http://www.InflammaDry.com. To pre-order the InflammaDry test, email info(at)InflammaDry(dot)com or call 941.556.1850.

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