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COVID Testing at the Pharmacy

Author: Sarah Dean, Team Lead, Net-Rx™


Are you considering conducting Coronavirus (COVID-19) testing at your pharmacy?

Pharmacies have long moved beyond safely and accurately filling prescriptions by adding patient services such as administering immunizations and medication management. Due to the COVID-19 pandemic, pharmacies are now conducting COVID-19 testing as well. This will provide patients with convenient access to testing, greatly assisting in the response and recovery from the COVID-19 pandemic.

There are two types of COVID-19 tests that a pharmacy can administer – diagnostic and antibody. A diagnostic test tells you if a patient has an active COVID-19 infection. Currently, there are two different kinds of diagnostic tests- molecular tests that detect the virus’s genetic material, and antigen tests, which detect specific proteins on the surface of the virus1. An antibody test detects the presence of antibodies made by the immune system in response to the COVID-19 virus, indicating that the patient had the virus in the past.

The first step to administering COVID-19 tests at the pharmacy is obtaining a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver. CLIA requires that any facility examining human specimens for diagnosis, prevention, and treatment of a disease must register with the Centers for Medicare & Medicaid Services (CMS) and obtain CLIA certification. An application for CLIA certification can be found here, or at your state’s health department.2

COVID diagnostic and antibody tests can be billed under Medicare Part B. Once a CLIA number has been assigned to the pharmacy, the pharmacy may enroll as an Independent Clinical Diagnostic Laboratory under Medicare. Steps for this will differ depending on whether or not the pharmacy is enrolled in Medicare. 

If the pharmacy is not enrolled in Medicare:

  • Complete a CMS-855B application and submit it to the Medicare Administrative Contractor (MAC) serving your area.3
  • The pharmacy’s designated MAC will collect the pharmacy information, including CLIA number, and notify the pharmacy of temporary Medicare billing privileges and effective date via email.

 If the pharmacy is enrolled in Medicare:

  • The pharmacy will need to initiate enrollment as an Independent Clinical Diagnostic Laboratory by calling the Provider Enrollment Hotline in the pharmacy’s MAC Jurisdiction. To locate a pharmacy’s designated MAC and the associated Provider Enrollment Hotline information, please click here.4  

Depending on the state, pharmacists may not be permitted to order, interpret, or administer laboratory tests under their state’s pharmacy practice act. However, many states have enacted or are considering executive actions and orders to provide broader authority for pharmacists to order, collect samples, and administer FDA-authorized COVID-19 tests. Please visit https://ncpa.org/covid-advocacy to view specific actions that have been taken for your state.5

CMS is working on guidance that will outline how states will reimburse pharmacists for conducting COVID-19 tests. There are important areas that still need clarification, including what billing codes should be used, and whether or not pharmacists need a formal “order” for testing. 

Globally, pharmacists continue to provide critical services during the pandemic, demonstrating their immense value, knowledge, and accessibility to vulnerable populations. The ability to administer COVID-19 testing will further illustrate how vital pharmacists are to our communities. 

Read Next: Top 5 Ways Pharmacies Can Optimize Their Prescription Reimbursement from Third-Party Payers

 

REFERENCES:

1 - https://www.fda.gov/consumers/consumer-updates/coronavirus-testing-basics#
2 - https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/HowObtainCLIACertificate.pdf
3 - https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/cms855b.pdf
4 - https://www.cms.gov/Medicare/Medicare-Contracting/FFSProvCustSvcGen/MAC-Website-List

5 - https://ncpa.org/covid-advocacy  
6 - https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/HowObtainCertificateofWaiver.pdf
7 - https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/HowObtainCertificateofWaiver.pdf
8 - CDC Website - CLIA Certificate of Waiver - How to Obtain a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver
9 - https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index?redirect=/CLIA/06_How_to_Apply_for_a_CLIA_Certificate_International_Laboratories.asp
10 - https://www.cms.gov/files/document/se20017.pdf
11 - https://ncpa.org/covid-testing#why-test
12 - https://ncpa.org/covid-testing
13 - https://www.fda.gov/media/138094/download
14 - https://ncpdp.org/NCPDP/media/pdf/pressrelease/Emergency-Preparedness-COVID-19-PR-050420.pdf
15 - https://www.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative-Contractors/Downloads/MACs-by-State-June-2019.pdf
16 - https://ncpa.org/sites/default/files/2020-05/cms-ifc-2-ncpa-member-summary.pdf
17 - https://ncpa.org/sites/default/files/2020-05/COVID-19-testing-reimbursement-bulletin.pdf
18 - https://nabp.pharmacy/wp-content/uploads/2020/04/APhA-Pharmacists-Ability-to-Test-COVID19-April-2020.pdf

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