Testing for Coronavirus

OTC COVID-19 Tests for Medicare Patients

OTC COVID Tests Billing | OTC Test FAQs

Why do COVID-19 testing?

Expanding services and working in collaboration with local physicians is a key strategy that progressive pharmacies are pursuing to increase their value in the pharmacy network. Pharmacy now has the ability to administer and order COVID-19 tests. Importantly, that's tests — plural. There are two main types of tests for COVID-19. The first type is used for determining whether a patient is positive for the virus. The second type of test detects the presence of antibodies that may convey immunity. Knowing who might have immunity will allow employees to get back to work, students to go back to school, and families to visit loved ones. In other words, knowing antibody status might allow the country to break free from the paralysis freezing our economy and way of life.

COVID-19 Testing Basics

How do I get started?

If you plan to offer COVID-19 testing in your store, you will need to have a CLIA Certificate of Waiver. For most, this is a very easy process. Fill out a form and send it to your state agency. The form is used for different types of labs, so we've made a short video to show you how a pharmacy would likely want to complete the form. Check with your state pharmacy association and department of health to see if there are additional requirements. 

Which tests can I perform?

Check out this Coronavirus Testing Basics resource from the FDA. There are two main types of tests for COVID-19. The first type is used for determining whether a patient is positive for the virus. This is referred to as a diagnostic test (molecular test or antigen test). The second type of test detects the presence of antibodies that may convey immunity. This test can be referred to as an antibody test or serology test. 

Before you perform a test on a patient, verify that the test is deemed to be authorized for the CLIA-waived setting by checking the list of test kit manufacturers with an FDA emergency use authorization. There must be a "W" in the column titled "Authorized Settings" for any test, regardless of type, to be performed in a CLIA-waived laboratory. This includes test kits that are part of a telehealth bundle. Pharmacies that purchase antibody test kits in anticipation of the product becoming authorized for use in CLIA-waived settings do so at their own risk.

The tests in this table are authorized by the FDA for the waived setting or point-of care.

NOTE: FDA warns that genetic variants of SARS-CoV-2 may lead to false negative results. Check to see if the tests you are offering are impacted by SARS-CoV-2 variants. 

    NCPA Community Pharmacy COVID-19 Test Vetting

    List of FDA Emergency Use Authorized Tests

    FDA FAQs on Testing

    What about safety?

    The SARS-CoV-2 virus is highly contagious so you'll want to be sure to take extra care of your staff, patients and pharmacy once you begin testing. Make sure you have protocols in place for proper use of personal protective equipment, hazardous waste disposal and disinfecting practices. 

    CDC Guidance

    How do I bill for testing?

    OTC COVID Tests Billing

    NCPA FAQs for Over-the-Counter, At-Home COVID-19 Test Coverage and Access

    Reimbursement Pathways for COVID-19 Testing

     

    Medicare

    COVID-19 diagnostic and antibody tests can be billed under Medicare Part B. Watch this video to see how to enroll or how to update your existing enrollment. Note: To bill Medicare, you will need to enroll as an Independent Clinical Laboratory. See page 3 of the NCPA Summary below for step-by-step instructions. 

    Medicaid

    Medicaid may cover COVID-19 tests, including tests administered in non-office settings (such as parking lots or other temporary outdoor locations), and laboratory processing of self-collected COVID-19 tests that are FDA-authorized for self-collection.

    The flexibility would apply not only during the current COVID-19 PHE, but also during any subsequent periods of active surveillance to detect recurrence of the virus.

    CMS is looking to put out guidance to states as to how states can submit amendments to get pharmacists covered to provide tests and get paid.

    Pharmacists should work with their state partners to ensure Medicaid coverage of pharmacist administered COVID-19 tests.

    Private 

    While it is possible to submit prescription claims for COVID-19 tests, including using codes to indicate that a specimen was collected or that the test was performed at the pharmacy, it is not known if health plans will cover this in the pharmacy benefit. Recommendations for processing these claims is available in the NCPDP Emergency Preparedness Information document updated August 2021.

    • Consider contacting the health plan or pharmacy helpdesk for any large employers in your area to determine coverage for COVID-19 testing.
    • Consider contacting large employers in your area directly to propose direct billing for testing.
    • Joining a CPESN USA Network may lead to access to reimbursement opportunities based on submitting care plans. Reach out to your network.

    Question: When the COVID-19 test specimen collection product does not have a product ID which should be submitted, what should be submitted as the Product/Service ID (407-D7) for a specimen collection claim represented with the Professional Service Code (440-E5) value of MA – Medication Administered (Specimen Collection)? 

    Answer: If there is no product identifier on the product being used to collect the specimen during a declared emergency, the Product/Service ID of 99999-0992-11 (COVID-19 Test Specimen Collection), with the Product/Service ID Qualifier (436-E1) of 03 – National Drug Code can be used. Note: This identifier is only for COVID-19 Test Specimen Collection. To obtain an identifier for another emergency situation contact [email protected].
     

    NDC Number

    99999-0992-11

    Product Name

    COVID-19 Test Specimen Collection

    Rx or OTC

    OTC

    Package Size (ml, gm, each)

    1 each

    Manufacturer’s Suggested Wholesale Price (SWP)

    $0.01

    1st Ship Date (New products)

    6/19/20

    Active Ingredients & Strengths

    Does not apply

    Labeler/Manufacturer Name

    NCPDP Emergency Preparedness

     

    FEMA

    At this time, it seems unlikely that FEMA will directly compensate or issue federally sourced test resources to pharmacies.

    • Reimbursement for testing would be possible through the Emergency Prescription Assistance Program, but HRSA has a program for the uninsured.
    • Federally sourced test resources are being distributed through state, local, and tribal health departments. Some of these have chosen to partner with pharmacies to expand testing capability.

    Uninsured

    HRSA is paying for tests for the uninsured (if pharmacies are testing they are eligible for funds)

    Companies that assist with medical billing

    Webinars and Videos