UPDATE: FDA warns that genetic variants of SARS-CoV-2 may lead to false negative results. Pharmacies should note that one of the three tests listed at this time is the CLIA-waived Accula SARS-Cov-2 Test. Information on surveillance for this strain is available from CDC.

COVID-19 Testing Basics

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.

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. 

• How to obtain a CLIA Certificate of Waiver

  • Video How-to (updated 7/23/2020)

    • How to update your CLIA Certificate of Waiver

  • Form CMS-116

  • CLIA State Agency Information

• CDC Considerations for Waived Testing

• State Guidance on Pharmacist Authority to Administer COVID-19 Tests - Download Spreadsheet

• State CLIA-waiver requirements - Download Spreadsheet (updated 7/23/2020)

• Joint Letter to Pennsylvania Governor regarding onerous state testing requirements

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 the following table are authorized by the FDA for the waived setting or point-of care.

^{1. NP = Nasopharyngeal swab, NS = nasal swab
Current as of January 7, 2021}

Saliva Sample Collection

The following manufacturers have developed COVID-19 diagnostic tests which utilize saliva as analyte. These tests are not considered waived for point-of-care use, however, pharmacies can partner with labs to do sample collection using these test kits, which may be a more favorable method than performing nasal or nasopharyngeal swabs. 

The following companies are utilizing these saliva-based test kits and may provide an opportunity for pharmacies to be involved in testing and sample collection. 

• Azova
• Physician360

NCPA Community Pharmacy COVID-19 Test Vetting

List of FDA Emergency Use Authorized Tests

FDA FAQs on Testing

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

• Information for Laboratories
• Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with COVID-19
• Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for COVID-19
• Testing by Laboratories FAQs

Our recommendation is to contact your local department of health for more information. 

CDC Reporting COVID-19 Laboratory Data

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. 

• NCPA Summary of CMS Rules Regarding Pharmacists Ability to Provide COVID-19 Testing
• MLN Matters: Temporarily enroll as Independent Clinical Lab 
• CMS Form 855b - Enrollment Application
• PECOS - Online Medicare Enrollment Application

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.

• Maryland Medicaid pharmacy COVID-19 testing reimbursement advisory

• New York Medicaid pharmacy COVID-19 billing advisory

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 5/1/20.

• 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.

Excerpt from a pre-publication draft of the NCPDP Emergency Preparedness Document (6/26/2020)

Question: When the specimen collection product does not have a product ID, 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. 

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)

• HRSA COVID-19 Claims Reimbursement

Companies that assist with medical billing

• Change Healthcare

• FDS

• Electronic Billing Services

• OmniSYS

Pharmacists given authorization to order and administer COVID-19 tests - HHS Announcement (April 8, 2020)

• Advisory opinion on the PREP Act (April 14, 2020) | HHS Advisory Opinion (May 19, 2020)

State Testing Plans

Pharmacists are key to break free from COVID-19 paralysis - Executive Update (April 17, 2020)

National Testing Plan Overview

National Testing Blueprint