How to get approval for fast COVID-19 testing in your dental practice

In April, Net32 surveyed more than 1,000 practices to determine dentists’ concerns about COVID-19. Interestingly, many dentists felt that COVID-19 testing would be necessary, saying:

• “Quick tests for offices would be great for security of staff and patients.”
• “We will need to test everyone for COVID.”
• “The secret to getting offices up and running is rapid testing of all patients before any and all dental procedures.”
• “Every office will have preappointment testing for all patients and staff. No one that tests positive will be treated.”

The American Dental Association is in strong support of COVID-19 testing, though the association has not endorsed a specific test at this time.ⁱ ADA Executive Director Kathleen O’Loughlin, DMD, has stated, “All dentists need a fast point-of-care test that accurately predicts the presence or absence of COVID-19 in real time. [...] An accurate test for the presence of COVID-19 is the most predictable way for dentists, dental teams, and patients to be safely treated in traditional elective care."¹

In addition, according to the ADA "[l]icensed dentists are eligible to administer COVID-19 diagnostic tests within their scope of practice, provided they obtain a Certificate of Waiver from the Centers for Medicare & Medicaid Services as may be needed.”¹

Applying for testing

How do you get positioned to do testing in your office? The path that my practice has taken is to seek expert consultation (legal counsel) and then apply using Form CMS-116 from the Centers for Medicare & Medicaid Services (CMS), i.e., the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification with Waiver. The application may be found at https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS116.pdf.

The application is long, but you will only need to complete Sections I–VI, IX, and X. A waived test is categorized by CLIA as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.”

For dental office purposes—and given federal regulatory COVID-19 emergency measures—there are very few rapid result tests approved by the FDA with the waiver, so to be as broad as possible I have been advised to fill out Section VI under "Waived Test to be Performed" as “Point of Care COVID-19 testing using a test kit that has received Emergency Use Authorization (EUA) from the FDA for use in patient care settings with a CLIA Certificate of Waiver.” If you do know the specific test kit that you want, include the name of that kit instead of the more broad approach.

For "Estimated Annual Test Volume," I entered the following: “Testing volume as appropriate and necessary to assist patients in my community, and my office personnel, during the COVID-19 pandemic. Estimated total annual test volume approximately [my patient count].” The application is only $150 and is not payable until your office is certified.

While you are waiting for your CLIA Certificate of Waiver, keep an eye on COVID-19 tests that have received an Emergency Use Authorization (EUA) with Waiver at this FDA link: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd.

With Certificate of Waiver in hand you will be ready to conduct testing just as soon as there is a fast test that you wish to use approved by the FDA with Waiver for health-care providers. In my opinion, it is more likely that a fast serology (antibody) test will be available for dental office use prior to a rapid molecular (antigen) test. With a serology test you will at least know if persons have been exposed to the virus.

Please seek a legal opinion before making any final decisions based on the information above.

Editor's note: This article was updated May 29, 2020, to clarify the American Dental Association's position on COVID-19 testing.

Reference

1. ADA advises dentists to follow science-backed guidance regarding COVID-19 testing, avoid 'gray market.' American Dental Association. April 17, 2020. https://www.ada.org/en/publications/ada-news/2020-archive/april/ada-advises-dentists-to-follow-science-backed-guidance-regarding-covid-19-testing

Note

i. The current position of the ADA is as follows: "The ADA is supportive of dentists being able to perform point-of-care testing for COVID-19 at some point in the future. Before a formal recommendation will be made by the ADA, there must be enough scientific evidence related to the reliability of the test administered and it must be practical for dentists to offer tests in their offices." (Source: ADA correspondence May 29, 2020)