Compliance Guidelines

Quidel has a Reimbursement Support Specialist available to assist you with questions about InflammaDry and AdenoPlus coding and reimbursement. For reimbursement support, please contact technicalsupport@quidel.com or call 800.874.1517.

InflammaDry Compliance Guidelines

Reimbursement code
The assigned CPT® (Current Procedural Terminology)1 code for the InflammaDry test is 83516, “immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semi-quantitative, multiple step method.” The 2019 CMS national limit for this code is $12.81. Offices submitting reimbursement for claims are required to have a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver.2

Compliance
Concept of chief complaint and medical necessity In order to make your medical record compliant for clinical lab testing, it is important to have a complaint, symptom or clinical sign that is recorded in the record to provide the basis for ordering the test. This would help to establish a “chief complaint” for the lab test. It is also critical to have a statement of medical necessity in the file that ties together the basis for ordering and performing the tests. This carries additional weight when ordering sequential tests over time.

Modifiers and their use
Medicare and Medicaid claims
The modifier “QW” is added to the CPT code to report the use of a CLIA-waived test. The RT and LT modifiers are also used to specify laterality of the test to correspond with the appropriate ICD-10 codes used. CPT code 83516QW is paid from the Clinical Laboratory Fee Schedule (not the Physician Fee Schedule as with other CPT codes).

Bilateral testing
Ocular surface inflammation often presents asymmetrically, and therefore testing both eyes with the InflammaDry test is recommended. The InflammaDry test is a single use item, so bilateral testing requires two separate InflammaDry tests.

When billing for bilateral testing, it is necessary to use a modifier. Given the many and varied payers and policies, it is possible that certain payers may have different coding requirements; Quidel offers reimbursement support to assist you with questions about InflammaDry coding, compliance and reimbursement.

Medicare/Medicaid Commercial Payers 2019 National Limit
1st Eye 83516QW-RT/LT 83516-RT/LT $12.81
2nd Eye 83516QW-RT/LT 83516-RT/LT $12.81

Bilateral alternative
83516QW-50 (when using the -50 modifier, leave the number of units as “1” but double the price)

Related diagnostic codes
There can be many ICD-10 codes that will be related to your need to provide clinical lab testing for a dry eye diagnosis and/or dry eye symptoms. It is important when providing diagnoses related to the testing performed, that you provide the most specific diagnoses that you can in accordance with ICD rules and guidelines. That means relating both laterality and severity if possible. Generalized diagnoses may get reimbursed but are more difficult to defend should your record be scrutinized.

Advance Beneficiary Notice of Noncoverage (ABN)

About
The Advance Beneficiary Notice of Noncoverage (ABN), Form CMS-R-131, is issued by providers (including independent laboratories, home health agencies, and hospices), physicians, practitioners, and suppliers to Original Medicare (fee for service – FFS) beneficiaries in situations where Medicare payment is expected to be denied. The ABN is issued in order to transfer potential financial liability to the Medicare beneficiary in certain instances.[1]

ABN Forms
An ABN form in its original format must be used for all Medicare Part B patients.  The forms (in English and Spanish) and instructions for filling out the form are linked below.

Please note: If your patient is a Medicare Part C (Medicare Advantage) patient, each carrier may have their own specific format that they will require you to use.  Please check with the individual carrier for specifics.  Commercial carriers will generally accept the CMS format for having an ABN on file.

Please remember that the ABN must be completed prior to the procedure being performed.

ABN Form: Quidel InflammaDry product
Linked below is an ABN template specific to Quidel’s InflammaDry test, pre-filled out for Medicare Part B patients.

ABN MMP-9: https://quideleyehealth.com/wp-content/uploads/2019/06/ABN-MMP9-1.pdf

Inflammadry Intended Use
InflammaDry is a rapid, immunoassay test for the visual, qualitative, in vitro detection of elevated levels of the MMP-9 protein in human tears, from patients suspected of having dry eye.[2] It is a product that tests for Dry Eye Disease (DED).

Please visit the Quidel InflammaDry page for more information about the product.

Links:

CMS ABN Form: https://www.cms.gov/medicare/medicare-general-information/bni/abn.html

CMS ABN Form Instructions: https://www.cms.gov/Medicare/Medicare-General-Information/BNI/Downloads/ABN-Form-Instructions.pdf

American Society of Cataract and Refractive Surgery, Volume 45 Issue 5 May 2019

Questions:

For questions regarding the Quidel ABN form, please contact Quidel at 800.874.1517 Option 2, or e-mail technicalsupport@quidel.com.

[1]https://www.cms.gov/medicare/medicare-general-information/bni/abn.html
[2] https://www.quidel.com/sites/default/files/product/documents/EF1344100EN00.pdf

QuickVue Adenoviral conjunctivitis test Compliance Guidelines

Reimbursement code
The assigned CPT® (Current Procedural Terminology)1 code for the QuickVue Adenoviral conjunctivitis Test is 87809, “infectious agent antigen detection by immunoassay with direct optical observation; adenovirus.” The 2019 CMS national limit for this code is $21.76. Offices submitting reimbursement for claims are required to have a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver.2

Compliance
Concept of chief complaint and medical necessity
In order to make your medical record compliant for clinical lab testing, it is important to have a complaint, symptom or clinical sign that is recorded in the record to provide the basis for ordering the test. This would help to establish a “chief complaint” for the lab test. It is also critical to have a statement of medical necessity in the file that ties together the basis for ordering and performing the tests. This carries additional weight when ordering sequential tests over time.

Modifiers and their use
Medicare and Medicaid claims
The modifier “QW” is added to the CPT code to report the use of a CLIA-waived test. The RT and LT modifiers are also used to specify laterality of the test to correspond with the appropriate ICD-10 codes used. CPT code 87809QW is paid from the Clinical Laboratory Fee Schedule (not the Physician Fee Schedule).

Given that there are many varied payers and policies, it is possible that certain payers may have different coding requirements; Quidel offers reimbursement support to assist you with questions about QuickVue Adenoviral conjunctivitis Test coding, compliance and reimbursement.

CPT Code Medicare/Medicaid Commercial Payers 2019 National Limit
87809QW-RT/LT 87809-RT/LT $21.76

Related diagnostic codes
There can be many ICD-10 codes that will be related to your need to provide clinical lab testing for adenoviral conjunctivitis. It is important when providing diagnoses related to the testing performed, that you provide the most specific diagnoses that you can in accordance with ICD rules and guidelines. That means relating both laterality and severity if possible. Generalized diagnoses may get reimbursed but are more difficult to defend should your record be scrutinized.

1CPT is a copyright and registered trademark of the American Medical Association (AMA). Please consult the current CPT Manual for full descriptors and instructions regarding the use of CPT codes.
2CLIA stands for Clinical Laboratory Improvement Amendments and is a registration with the U.S. Department of Health and Human Services that allows physicians or medical office personnel to collect a sample and perform a laboratory test within their office.
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. Quidel Corporation strongly recommends that providers contact their own regional payers to determineappropriate coding and charge or payment levels prior to submitting claims.