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CDA COVID-19 testing toolkit now available

Advocacy efforts still ongoing; beware of COVID-19 testing marketing emails

November 24, 2020 5920

Quick Summary:

The toolkit provides a holistic overview of lab testing and assist dentists in maintaining regulatory compliance with COVID-19 rapid tests once CDA advocacy is complete to permit dentists to apply for state lab testing licensure.

In October, the ADA released a COVID-19 and Lab Testing Requirements Toolkit to assist dentists preparing to implement COVID-19 testing as part of the patient screening process. To assist members with California-specific requirements, CDA’s Clinical Care Workgroup has released additional guidance in the form of a new toolkit resource to provide a holistic overview of lab testing and assist dentists in maintaining regulatory compliance with COVID-19 rapid tests once CDA advocacy is complete to permit dentists to apply for state lab testing licensure. This toolkit has been structured in a way that will be updated and amended based on the status of current CDA advocacy efforts on LFS licensure and benefit plan reimbursement in addition to general testing technology that is appropriate for both dental settings and asymptomatic individuals. 

Landscape of COVID-19 tests 

Diagnostic testing is categorized by complexity. Higher complexity tests, such as the nasal swab tests administered at community testing sites, are considered “high complexity” tests and require calibration, equipment maintenance and specialized training on testing processes. The lowest complexity of tests are classified as “waived,” have a low risk of test result misinterpretation and the ability to administer the test can be obtained through adherence to manufacturer instructions (such as A1C glucose tests). Although performing waived tests, as they pertain to the safe provision of dental services, is within the scope of practice for dentists in California, doing so requires both federal and state lab testing licensure. 

Dentists currently can obtain the federal CLIA certificate but are not eligible under state law to obtain a California Department of Public Health Laboratory Field Services (LFS) lab registration. This is because currently, state law does not specifically list dentists as individuals who can hold a permit to conduct waived tests. Conversely, federal regulations around CLIA lab testing permits list dentists as eligible permitholders for waived tests. 

Additionally, while there are several point-of-care rapid COVID-19 tests that have been approved by the FDA under the Emergency Use Approval process, there are no rapid tests that have been approved for use on asymptomatic patients. In addition to the lack of affordability, lackluster accurate rates and general availability of currently approved rapid COVID-19 tests, the inability to perform tests on asymptomatic patients remains the largest technological hurdle to implementing testing as part of the patient screening process in dental offices. 

Advocacy still needed 

CDA is working with the governor’s office, state Legislature and the California Department of Public Health to allow dentists to immediately obtain LFS laboratory licensing and is advocating at state and federal levels to receive priority access to government-distributed COVID-19 tests for staff and patients if stockpiles become available in the future.  

Additionally, CDA is working with the appropriate entities to advocate for reimbursement for rapid COVID-19 tests by medical and/or dental benefit plans, including Medi-Cal. As these advocacy objectives are achieved, additional tools will be made available in the CDA COVID-19 Testing Toolkit, such as instructions on how to complete the LFS application process and guidance on how to appropriately bill medical and/or dental benefit plans for reimbursement. 

Beware of COVID-19 testing supply marketing efforts 

With the regulatory and technological hurdles discussed above, it is not possible for dentists to obtain the requisite licensure for lab testing or administer rapid COVID-19 tests to patients right now. Dentists must first be able to obtain state and federal laboratory licensure and should only use a rapid test that is cleared for use on asymptomatic individuals. Beware of emails or marketing outreach attempting to sell COVID-19 tests to dental practices or billing strategies that claim to help dental practices bring in thousands of dollars each day for administering tests. CDA will continue to keep members updated on ongoing advocacy efforts and the status of FDA-approved COVID-19 tests that can be used on asymptomatic patients in dental settings. 

Get started with the CDA COVID-19 Laboratory Testing Toolkit.