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CMS Reimbursement

TearLab Is A Laboratory Test

The TearLab Osmolarity System is an in vitro laboratory device and, as such, testing for Medicare patients is billed under the Clinical Diagnostic Laboratory Fee Schedule. Unlike the Physician Fee Schedule, Medicare patient co-payments or deductibles do not apply to services billed under the laboratory fee schedule, covered services are 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.

2022 CMS Reimbursement $22.48 per test in all 50 states

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)(1).

For additional information or to answer questions regarding reimbursement for the TearLab Osmolarity System please contact: rsc@tearlab.com

Regulations and reimbursement amounts vary from state-to-state, payer-to-payer and can change over time. For up-to-date Medicare reimbursement rates please check the current CMS Clinical Diagnostic Laboratory Fee Schedule, available at Current Laboratory Fee Schedule.  For Medicare reimbursement, your CLIA number is required in box #23 - Prior Authorization Number on the CMS 1500 Health Insurance Claim Form and include the referring providers name and NPI number in boxes #17 and #17b. For customers with a CLIA Waiver certificate, you must use the “QW” modifier when submitting claims to Medicare for CPT 83861.

For additional information or to answer questions regarding reimbursement for the TearLab Osmolarity System please contact: rsc@tearlab.com

(1)CLIA (Clinical Laboratory Improvement Act) - The TearLab Osmolarity System, as an in-vitro laboratory device, is regulated under the Federal CLIA regulations and is categorized as CLIA Waived. The Centers for Medicare & Medicaid Services (CMS) regulate all laboratory testing and if an entity, including a doctor's office, performs in-vitro diagnostic testing, it is considered a laboratory under CLIA and must register with the CLIA program. CMS requires all entities that perform laboratory testing, including a doctor's office (each separate location), to be CLIA registered in order to qualify for reimbursement.

TearLab offers assistance for those doctors who wish to obtain a CLIA Waiver Certificate(2).

For additional information regarding the TearLab Osmolarity System and CLIA please contact customerservice@tearlab.com.

(2)CLIA Waiver Certificate - In order to obtain a CLIA Waiver certificate, TearLab will assist you in the submission of a CLIA application (CMS 116 form and in certain States, State forms). Several weeks after submission a certificate of Waiver and a CLIA number will be sent to you from CMS, together with an invoice for the CLIA fees, which must be paid, and at that time patient testing can begin, including 3rd party billing (CPT 83861 QW). Note that State laws in Nevada and Hawaii currently prohibit optometrists from obtaining CLIA Waiver certificates. Contact TearLab Customer Service at 1-855-TEARLAB (1-855-832-7522) for assistance and information on specific requirements in your State.

The biennial CMS fee for the CLIA Waiver Certificate is $180 and is borne by the practice, as required by law. In some States there may be additional State licensure fees. Contact TearLab Customer Service for more information on fees in your State.

We at TearLab are excited to offer you this avenue to comply with the CLIA regulations, allowing you to accomplish both your clinical and financial goals by integrating the TearLab Osmolarity System into your practice. We will be involved throughout the entire process and are available to answer any questions that you have regarding this program and our technology.

Disclaimer: The information provided on this website is current as of January 2021 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, we recommend 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.

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