SAN DIEGO, Sept. 27, 2017 (GLOBE NEWSWIRE) -- TearLab Corporation (NASDAQ:TEAR) (TSX:TLB) (“TearLab” or the “Company”) today announced that the Centers for Medicare & Medicaid Services (CMS) has published preliminary rates for clinical diagnostic laboratory tests. The preliminary reimbursement rate for the Microfluidic analysis utilizing an integrated collection and analysis device, tear osmolarity (CPT code 83861) is expected to be $22.48 per test for calendar years 2018 through 2020, which is relatively the same as the current rate of $22.66 per test. The preliminary rate is based on the median of private payer payments as part of the market-based payment reforms mandated through the Protecting Access to Medicare Act of 2014 (PAMA). The CMS plans to finalize the rates in November 2017, following a public comment period, and the new rates are scheduled to become effective January 1, 2018.
The Company also announced CMS published preliminary rates for quantitative immunoassay (CPT code 83520) which is expected to be $17.27 per test for calendar years 2018 through 2020 compared to the current rate of $17.76 per test. CPT code 83520 is for quantitative measures for inflammatory biomarkers and is one of the CPT codes the Company plans to utilize for reimbursement for its TearLab Discovery™ System, which is currently CE marked in the European Union and undergoing regulatory trials for FDA 510k clearance in the United States of America (U.S.). When cleared for marketing in the U.S., the TearLab Discovery™ System will include the current osmolarity test as well as two additional, quantitative inflammatory biomarkers. The Company expects that qualifying tests with the TearLab Discovery™ System will utilize both CPT code 83861 for osmolarity and CPT code 83520 for the inflammatory biomarkers.
“We are pleased that the CMS reimbursement rate will remain stable as a result of the PAMA review for both our current osmolarity test as well as for the inflammatory biomarkers we expect to be approved with the TearLab Discovery™ System. We believe this supports the growing importance of dry eye disease and the value our test delivers to physicians and patients as an aid in the diagnosis and management of dry eye disease,” stated Seph Jensen, Chairman and Chief Executive Officer of TearLab.
On June 17, 2016, CMS released a final rule that implemented Section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA), requiring laboratories performing clinical diagnostic laboratory tests to report the amounts paid by private insurers for laboratory tests. After a one year extension, CMS indicated that it would calculate the weighted median of these private insurer rates to determine Medicare payment rates for laboratory tests paid under the Clinical Laboratory Fee Schedule (CLFS) beginning January 1, 2018. Laboratories were required to collect private payer data from January 1, 2016 through June 30, 2016 and report it to CMS by May 30, 2017. Preliminary rates were published on September 22, 2017. CMS plans to finalize the rates in November 2017, following a comment period and make the rates effective January 1, 2018.
About TearLab Corporation
TearLab Corporation (www.tearlab.com) develops and markets lab-on-a-chip technologies that enable eye care practitioners to improve standard of care by objectively and quantitatively testing for disease markers in tears at the point-of-care. The TearLab Osmolarity Test, for diagnosing Dry Eye Disease, is the first assay developed for the award-winning TearLab Osmolarity System. TearLab Corporation's common shares trade on the NASDAQ Capital Market under the symbol 'TEAR' and on the Toronto Stock Exchange under the symbol 'TLB'.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include, among others, statements concerning the reimbursement rates for our TearLab Osmolarity System test in the U.S., the potential reimbursement for tests related to the TearLab Discovery™ System, which is undergoing regulatory trials in the U.S., the future rates that will be paid by the CMS and commercial insurance companies in the U.S. for CPT codes 83861 and 83520, the potential regulatory clearance of the TearLab Discovery™ System in the U.S. as well as the impact that reimbursement or market perception may have on the potential success in developing and commercializing the TearLab Discovery™ System and the TearLab Osmolarity System. These forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are based on management’s current, preliminary expectations and are subject to various risks and uncertainties. Many factors, risks and uncertainties may cause our actual results to differ materially from forward-looking statements, including the factors, risks, and uncertainties detailed in our filings with the Securities and Exchange Commission and Canadian securities regulatory authorities, including but not limited to our Annual Report on Form 10-K for the year ended December 31, 2016, filed with the SEC on March 10, 2017,and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, filed with the SEC on August 14, 2017. We do not undertake to update any forward-looking statements except as required by law.
The Ruth Group