Industry News

COVID-19 Testing

 

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.

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

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

 

Where do I report results?

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

CDC Reporting COVID-19 Laboratory Data

 

How do I bill for testing?

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.

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

National Testing Plan Overview

National Testing Blueprint

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