Reimbursement - United States

Beginning January 1, 2011, the new Current Procedural Terminology (CPT)¹ Code 83861 - Microfluidic analysis utilizing an integrated collection and analysis device, tear osmolarity - becomes effective for the TearLab test. The Centers for Medicare and Medicaid Services (CMS) will reimburse this new code at $24.01 per eye tested. Use the "-59" modifier when billing for the second eye tested to indicate that it is a "Distinct Procedural Service" and both eyes should be reimbursed at the full amount of $24.01 per eye.

The TearLab Osmolarity System is an in vitro laboratory device and as such testing is billed under the Clinical Laboratory Fee Schedule. Unlike the Physician Fee Schedule, patient co-payments or deductibles do not apply to services billed under the laboratory fee schedule, so payment to providers is 100% reimbursed. Payment by the Centers for Medicare and Medicaid Services (CMS) is the lesser of either (a) the amount billed, (b) the local fee for a geographic area, or (c) a national limit. For more information, please visit the CMS website at CMS Laboratory Fee Schedule or The Dry Eye Review / Understanding the Laboratory Fee Schedule and TearLab Reimbursement.

IMPORTANT:
Under the laboratory fee schedule, CMS will only reimburse providers performing laboratory tests who maintain a current certificate as required by the Clinical Laboratory Improvement Amendments (CLIA). Currently the TearLab Osmolarity System is classified by the FDA as a CLIA Moderate Complex test. Re-categorization to CLIA Waived is pending. For more information on how to obtain a CLIA certificate please visit TearLab CLIA Support.

¹CPT is a copyright and registered trademark of the American Medical Association (AMA). Please consult with the current CPT Manual for full descriptors and instructions regarding the use of these codes.

Disclaimer: The information provided on this website is current as of November 2010, and was obtained from third-party sources and is subject to change without notice as a result of changes in reimbursement laws, regulations, rules, policies, and payment amounts. All content on this website is informational only, general in nature, and does not cover all situations or all payers' rules and policies. This content is not intended to instruct hospitals and/or physicians on how to use or bill for healthcare procedures, including new technologies outside of Medicare national guidelines. A determination of medical necessity is a prerequisite that TearLab Corporation assumes will have been made prior to assigning codes or requesting payments.

Under Federal and State law, it is the individual provider's responsibility to determine appropriate coding, charges and claims for a particular service. Policies regarding appropriate coding and payment levels can vary greatly from payer to payer and change over time. TearLab Corporation recommends that providers contact their own regional payers to determine appropriate coding and charge or payment levels.

If you are a provider participating in a clinical trial, TearLab recommends that you contact your payers, including Medicare/Medicaid and private insurers, to verify correct coverage and reimbursement policies for investigational devices.

This website information represents no promise or guarantee by TearLab Corporation concerning coverage, coding, billing, and payment levels. TearLab Corporation specifically disclaims liability or responsibility for the results or consequences of any actions taken in reliance on information on this website.