The Compliance Divas Podcast
Our podcast covers current topics such as infection prevention and control, OSHA and HIPAA compliance for dentistry. We discuss the latest regulatory information, answer frequently asked questions and give suggestions for dental practices to make compliance easy and sustainable. The Compliance Divas are a trusted source for consistent, accurate information based upon current guidelines, standards, science, and recommendations.
The Compliance Divas Podcast
Episode #29 Special Edition: Calif Dentists Now Allowed to Conduct In Office Rapid COVID-19 Tests
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In this special California podcast, the Divas talk about the new law allowing dentists to administer Rapid COVID-19 testing. In addition, the Divas address where dentists can find step by step instructions for obtaining testing licensure, types of rapid tests, reporting obligations, and testing dental team members.
Welcome. I'm Leslie Cannon. I'm Mary Gavoni.
SPEAKER_01I'm Linda Harvey. I'm Olivia Juan. And together we are the Compliance Divas.
SPEAKER_03Hello and welcome to this special edition of the Compliance Divas Podcast. We bring clarity and simplicity to compliance by navigating regulatory compliance to keep you on course. We invite you to subscribe to the Compliance Divas podcast through your favorite podcast channel or on our website, thecompliancedevas.com. Resources we mentioned on our podcast can always be found on the compliancedevas.com website. And we welcome your questions at support at thecompliancedevas.com. Well, today we have a very special podcast edition for you. We're going to be talking about the new California law that permits dentists to process rapid COVID-19 tests in their office. And the information that we present today is current as of November 1st, 2021. So to our listeners that don't live in California, please know this information is still valuable for you all because there may be things that you should be familiar with. And it's possible that legislation could change in your state as well. COVID-19 testing is now within the scope of practice for California dentists. And on October the 8th, 2021, new laws from the California Dental Association sponsored legislation now permit dentists to apply for the requisite laboratory licensure to process wave tests in the dental office. But dentists cannot just order testing kits and start doing the testing for COVID. There are several things to consider before bringing COVID tests into your practice. For example, there are licensure requirements for the lab, billing and reimbursement considerations, plus reporting mandates. In addition, dentists need to know what type of COVID test to use, the cost of the test, how to administer them, and also record those results. So we are so fortunate that one of our divas is our California resident expert. So I'm going to turn to Leslie Cannon right now. And Leslie, please enlighten us to a little bit more about how a dentist can find out more about conducting COVID-19 testing in their practice.
SPEAKER_00Why, certainly, Linda. You know, before a dentist can just go ahead and conduct COVID testing, they have to obtain the appropriate lab licensure in California. And there are two licenses to obtain. Now one is actually a federal license, and it is a CLIA is the nickname, which stands for Clinical Laboratory Improvement Amendment Certificate of Waiver. It is from the Centers for Medicare and Medicaid Services, so CMS. And the second one is a CLIA state counterpart called Lab Field Services. And this is a program within the California Department of Public Health.
SPEAKER_03Leslie, could you also tell our listeners how they can apply for these lab licenses and how much do they cost?
SPEAKER_00Well, Linda, I'm going to start with how much it costs. For both the CLIA and the laboratory field license, it's approximately $293. So it's not a lot of expense for the licenses, but it's actually easy once you follow the steps in obtaining both licenses. Dentists must obtain their CLIA certificate of waiver through the, as I mentioned before, CMS. And this is required in order for them to conduct what's called a waived test. Now, the California Dental Association, again, who sponsored this legislation, has a COVID-19 testing toolkit with step-by-step instructions and resources on everything from performing the test to reporting the requirements, even to how to bill insurance for this reimbursement. And they also have an application that Dennis can use to fill out through that toolkit. So the state testing agency actually processes both the federal and the state laboratory licensing applications. The federal CLIA application form is called CMS 116, and the California field license or field laboratory license is called LAB 155. Again, these are both clickable links on the CDA COVID-19 testing toolkit. California state testing agencies actually process both the federal and the state laboratory license applications. Again, CDA has made it so easy for Dennis to just click the link, fill out the forms online, and then print them. They actually have to print them out and sign them because they need to be signed with an original signature. And they can send both of these forms to one address.
SPEAKER_03Well, thank you, Leslie. It certainly sounds like with the CDA resources, it would be a very simple process process for the doctors to follow. But I'm going to take it a little bit deeper with some of our conversations, if you don't mind, because I think there's this is so much new information for doctors and teams to learn. And first, I'd like to just mention the fact that you mentioned CLIA wave and non-wave test. And until our listeners really have a chance to look at the accompanying resources, either on the CDA website or on the compliance diva's website, I'd like to clarify a few points for those who are listening and learning about this for the first time. And the first is the whole nomenclature certificate of waiver. And I would just like to be very basic for a moment, if I may, and spell the word waiver. It's W-A-I-V-E-R or WAV, W-A-I-V-E-D, not wave as in saying hello to somebody. It can sound confusing. And I mention that because a waiver is simply an exemption from something. And so exempt when you have a clear wave test, you're exempt from certain aspects. And let's talk about what the aspects are and what does it mean to have a clear wave test versus a non-wave test at the federal level. And when you look at these pieces of the puzzle, if you will, basically it involves three primary agencies. First is the Food and Drug Administration. They are responsible for approving CLIA wave tests. Then it becomes the responsibility of CMS, the Centers for Medicare and Medicaid, to notify its contractors of the new test so that the contractors, such as the laboratories, can accurately process the claims and change information to contractors. So they actually have the new CLIA wave test and the codes that go with it. So when you think about CMS, CMS regulates all laboratory testing performed on human beings in this country through the clinical laboratory improvement amendments that you mentioned, Leslie. But this does not include lab testing related to research. That's entirely separate. So we're not talking about that piece today, just lab tests performed on people, us. CLIA was passed in 1988, and the objective of CLIA, the program was to ensure quality laboratory testing. So in total, CLIA covers approximately 260,000 different laboratory entities across the country, quite a few. So those are the first two agencies. The third primary agency is the Centers for Disease Control. And in specific, the Clinical Laboratory Improvement Advisory Committee. Now that's a mouthful. The Clinical Laboratory Improvement Advisement Committee is managed by the CDC. And the purpose of this committee is to improve provide scientific and technical guidance and advice to the Department of Health and Human Services. CMS, as we know, is an agency under the Department of Health and Human Services. So I didn't separate out HHS as a fourth agency, but they are in the mix. So now that we've come full circle, let's revisit the terms waived and non-waived. So essentially, lab tests are classified as waived if the risk of misinterpretation is low, and if the administration of these tests, Leslie, can be followed by adhering to the manufacturer's instructions for use, which is why we see the ones that are approved for dentists in California. So although CLIA requires that wave tests must be simple and have a low risk for erroneous results, we have to be mindful of the fact that a wave test is not completely error-proof. Errors can occur anywhere in the testing process, particularly if the manufacturer's instructions are not followed. And where have we heard that before, Davis? That happens with everywhere in the dental setting, all the different pieces of equipment that we use and products that we use, we all have to always rely on the manufacturer's instructions for use. And then an error could also occur when testing personnel. And in this case, our dental team members or the doctor are not familiar with all aspects of the testing system that's being used. Because we know that some wave tests have the potential for serious health impacts if they're performed incorrectly. And just think of the fact of what might seem like a simple glucose monitoring test. If that test is performed incorrectly or the results are read incorrectly, that could have an impact for a patient who has type 1 diabetes, for example. So to increase the risk, to pardon me to decrease the risk of erroneous results, the test definitely needs to be performed correctly by trained personnel in an environment where good laboratory practices are followed. So we found some great resources from the CDC website on good laboratory practices that we're going to post for our listeners on the Compliance Divas website. So let's say I just wanted to give a little bit of a background and share that before we go a little bit deeper. And now, Mary, I'd like if to call on you if I can. Can you please talk to us about the types of rapid COVID tests and what kind of tests can the doctors actually administer now in California?
SPEAKER_02Absolutely, Linda. Thank you. And thank you for that explanation for our listeners as to what the waved and non-wave tests mean. This is such important information. So essentially, there are two types of COVID tests. One is called a viral test, which tests for a current infection. And the other is an antibody test, which tests for past infection. So when we're doing screening, whether it's for employees or patients, we want a viral test which tests for a current infection. We want to know if they have an active infection right now. And that further then breaks down into two other types of tests. One is called a NATS test, which means a nucleic acid amplification test. So it's testing for RNA in a virus, and the other is an antigen test. And they both are testing for current infection. So if you're trying to decide what kind of tests you would use in your practice, you need to have one of those, a NATS NAAT test or an antigen test. And again, we have great resources that we will have available on our website that give you even more information on these types of tests. Then you need to look at one that's a rapid test, meaning that you know it's going to give you the results within 15 to 30 minutes, because there are other antigen or gnats tests that may take one to three days for particularly the NATS tests, may take one to three days if they're not classified as a rapid test. Some are saliva tests where you spit into a little tube, some are nasal swabs. Most of the ones on the market are the nasal swabs, but you really need to do your research to understand which is the most appropriate one for you to use.
SPEAKER_03Thank you, Mary. That really gives us a good breakdown of the different types of tests so we can begin to learn more about that aspect. It's so important to for our teams to realize that there are differences and different types of tests they may be using. Olivia, would you mind addressing the standard of care for us and the vaccination mandates or the weekly testing? Um, can a dentist in California test their employees?
SPEAKER_01Sure. Thank you, Linda. I think it's important for our California listeners to be aware that screening patients prior to performing dental treatment is actually the standard of care and actually a California OSHA requirement. Cal OSHA requires dentists to have a written protocol on conducting screening, and employees must be trained on screening procedures. So it's important that their policies and procedures be updated to reflect this information. And the in-office rapid COVID testing can be implemented as a screening tool at the dentist's discretion. Keep in mind that the employees should monitor their own health daily for COVID-19 symptoms as part of a COVID prevention plan. Now, for all health care workers in California, the vaccination mandates require that unvaccinated employees should have weekly testing. Now, the local local county public health departments can have more stringent orders. For example, San Francisco and Los Angeles counties require vaccination, and healthcare workers cannot opt out of vaccination by getting weekly testing. So it's very critical for our listeners in California to check with their local public health departments.
SPEAKER_03Thank you, Olivia. What valuable information regarding the standard of care. This is that's this new area. That's I feel like it's a new area that's evolving for dental professionals when we think about standard of care and using even COVID-19 testing as a screening tool. So we are called to maintain high standards there. That's a very important point. Mary, one of the things we talked about earlier was the different types of test. And I think we've talked about in our earlier conversations reporting of the tests. Would you mind making a couple of comments on for our listeners about reporting COVID test results? What are the requirements in California?
SPEAKER_02Great question, because it's not enough just to do the testing. There's some record keeping that must go along with performing those tests, whether you're doing them to screen patients or whether you're doing the testing for screening employees. In any case, whether it's a patient or an employee, the results by California state law must be reported. So the reporting is not just for positive cases, it's for positive, negative, or indeterminate cases, because there are some occasions when the test is indeterminate or inconclusive. So you must report those, and we will provide a link to the reporting portals for you to be able to do that. So there's a little bit of paperwork that goes along with doing this testing. Now, the additional provision is that if you are testing employees, then you also must keep a record of that testing in their employee medical file. It should not be stored in their personnel file, but their employee medical file, where you would put, for example, documentation of hepatitis B vaccination or exposure incident reports, those types of things. So you must report to the state of California all the test results, patients or employees, and then additional reporting or recording of test results for screening employees. And Leslie will give us some information about some of the counties within California that do not accept testing as an alternative to the vaccine mandate.
SPEAKER_03Thank you, Mary. Yes. And once we once they report that vaccine information or the testing information, pardon me, then let's talk about can the dentist bill medical insurance for any of this testing? And yes, the doctor can submit claims to the patient's medical insurance. And according to federal and state guidance, group health plans and individual health insurance covers and coverage coverage does include the administration of COVID-19 tests with the requirement that such tests are FDA authorized. And please know there are certain CPT codes that can be used for billing COVID testing from the American Medical Association. And both the California Dell Association and the ADA have instructions on how to bill and links for that. So we'll have all that information available. And if you're an ADA member, there's that you that information is available to you as a toolkit for members only. So the billing is possible. So that kind of takes us along that whole chain of progression that not only do you have to have the required documentation maintaining your practice, but then how to take it a step further and go ahead and bill for that. Livia, can I turn back to you for a minute? And we talked about the standard of care, but actually, who can perform the rapid COVID test in the dental office? And what are any other considerations that a practice may need to think about?
SPEAKER_01Sure. Thank you, Linda. It's important to recognize that this is not something that we can delegate to a dental assistant or hygienist because it is not in their scope of duties. But the test administration is within the scope of duties for a licensed registered nurse and now also for a dentist. Now the over-the-counter self-administered tests do not require the licensure, but we have to keep in mind that those tests were designed for at-home self-testing. For personal protective equipment when conducting the testing, we need to be sure that when collecting specimens at one within six feet of patients of those that are suspected to be infected with SARS-CoV-2, the Centers for Medicare and Medicaid Services recommends, of course, that we maintain proper infection control and use the appropriate recommended personal protective equipment, which includes an N95 or higher-level respirator, or face mask if a respirator is not available with a shield, eye protection, gloves, and gown when collecting these specimens. And there's more information that we will provide with the links on the compliance diva's website.
SPEAKER_03Thank you, Olivia. So thinking about all the components that we've talked about during this podcast, it's wonderful to see that the doctors can now offer this new service in their practice. But I think it's always important to go through all the details and understand the processes and ramifications of doing it properly and getting this new service set up properly from the very beginning in their practice. Leslie, as we get ready to wrap up the podcast, is there anything additional that you have about the California rapid testing that you can share with our listeners? Anything we haven't considered yet?
SPEAKER_00Well, actually, not anything that we haven't considered. We did talk about employees and self-testing. I did want to mention that there are self-test or at-home tests for COVID-19 and they're available for purchase online, but they're actually designed to be used at home. And when an employee is not feeling well and has signs or symptoms of COVID-19, an at-home test allows them to collect their own sample and test it with a system that gives them results in minutes. So rather than come into the dental practice and say, Can you test me? I'm not feeling well today, we ought to supply our team members with an at-home test or make that available to them so that they can test themselves and determine with their own sample whether they have potential of being positive for COVID-19. The other part I wanted to mention is that while this podcast did make some of the steps sound overwhelming, this bill that allows dentists to administer the rapid tests is also something that can be simplified by using the toolkits. It's a step-by-step protocol. If you take a look at the California Dental Association website, uh listen to this podcast, and then also utilize the resources that the compliance divas have provided, it should be fairly simple once you have the licenses, once you've obtained the kit, and once you have a protocol of steps to follow to actually perform this rapid testing and being reimbursed for it so that it would be worth not only your while for time, but also the peace of mind that comes with knowing that your patients are fairly safe to work on. Now, no rapid test is going to be 100% accurate. We recognize that. So standard precautions are still in place whenever we're working with any patient. It's the same as when we're working with blood and body fluid. We don't know if a patient is HIV positive or has hepatitis. We just treat all blood and body fluid as though it was potentially infectious. Now, just one other quick point about this uh new rapid testing uh scope of practice duty. The same bill that allows dentists to administer these rapid tests also gives them permanent authority to prescribe and administer influenza and COVID vaccinations. And the bill codifies the Department of Consumer Affairs waiver authorizing dentists to provide COVID-19 vaccination for dentists who obviously have to complete that required training. There's a CDC uh training program on how to administer vaccinations. Now, even dental hygienists were given uh authorization to provide these vaccinations under an emergency uh statute. And the bill also specifies that the CDC vaccination training on learning how to give the vaccination actually count towards a dentist's continuing education requirement. So it's a win-win-win. And I hope that our uh clients or and our audiences and the listeners to our podcast will consider all the steps uh needed for actually conducting that COVID-19 rapid testing in their practices. I know last year uh it seemed that the battle cry in 2020 was oh, if we only had a way to test our patients for COVID, wouldn't that make us feel more comfortable when we're providing treatment? Well, here it is. The steps are simple. As long as you use one of the toolkits, and I am a big advocate, California Dental Association has knocked the ball out of the park again when it comes to COVID resources with this COVID-19 testing toolkit that they have. And it is not a members-only document. This information is available to everyone. I encourage even our non-California listeners to take a look at this wonderful toolkit. And when the time comes for your state to allow rapid testing, and I bet that's going to be soon, you'll have the kit, the toolkit in place, and the steps that you need.
SPEAKER_03Thank you, Leslie. You beautifully wrapped up today's podcast regarding this new California law that permits dentists to process rapid COVID-19 tests. And as you mentioned, there are multiple steps, and as we all discussed, there are multiple steps and implementing those processes in your practice. And we hope that you all will take advantage of the toolkit from CDA, whether or not you're located in California. And wrapping up this podcast today, the compliance divas bring clarity and simplicity to compliance by navigating regulatory compliance to keep you on course. We invite you to subscribe to the Compliance Divas podcast through your favorite podcast channel or on our website, thecompliancedeivas.com. And today we mentioned a wealth of resources. So these will all be posted on our compliancedivas.com website. And we also invite your questions at support at the compliancedivas.com. Thank you for joining us.