CLIA Waivers: What They Are And Why You Must Have One

If you have been in clinical practice for any time, either in your own practice or as an employee, you’ve been doing point of care testing; simple tests like UA dips, finger sticks, rapid tests, and the like.

And even though these tests are done every day, many clinicians are unaware that CLIA covers these tests. What does that mean? It means that to perform these simple tests in your office, you must have a current CLIA waiver. Otherwise, you are out of compliance.

What is a CLIA Waiver?

For starters, let’s define what a CLIA waiver is? CLIA stands for Clinical Laboratory Improvement Amendments, and it allows for point of care testing in your practice.

Now, for a test to be CLIA waived, it has to be simple. There must be a low risk for erroneous results. And notice, I didn’t say the tests were error-proof because they’re not. Nothing is. However, the tests must be simple enough to be done in the office and can be delegated to medical staff.

Whatever the space used to perform these tests, you ensure that specimens are collected appropriately and that you understand and follow all manufacturer’s instructions. Furthermore, you confirm that you and your staff know how to perform the tests, document the results, and identify inaccurate results or test system failures.

Like results that make you think, “this can’t be right.” Things like… the urine looks horrible, but everything looks normal, and you know you need to dig deeper.

You’ve also must ensure you’re following “good laboratory practices for waived testing sites.” The correct practices are reviewed in a little booklet published by CMS, a requirement when signing up for the CLIA waiver.

Point Of Care Tests

So what are some examples of the different types of CLIA waived tests you can do in your office?

Most of us are familiar with the most routine tests, including:

  • Urine testing for pregnancy, infection, or a variety of other things
  • Finger sticks, such as for glucose, A1C monitoring
  • Tests for some blood chemistries and ESR counts, hormones, etc.
  • Colorectal screening for blood,
  • Swabs to identify the flu and strep

Select COVID testing may also be CLIA waved. Be aware some of it may be provisional for the duration of the public health emergency. So if you plan to continue with these tests after the public health emergency, make sure that they indeed are cleared for continued use.

CMS, the Centers for Medicare and Medicaid Services, has a complete list of tests that have been deemed CLIA waived.

And after administering a test, you must then use the appropriate CPT code for it so that you can bill and get reimbursed. After all, you must purchase the tests before performing them in your practice.

How to Get A CLIA Waiver?

There are a couple of ways to get a CLIA Waiver. You may either apply through your state or the CMS website.

And if you happen to practice in New York State or Washington State, those states run, manage, and oversee their own program, and you would apply directly through the state.

What’s the Cost?

The cost to obtain the CLIA Waiver certificate is $150, and it’s been at that level for several years. Once issued, the certificate is good for two years.  

On average, it will take about two months to receive your CLIA Waiver certificate. So remember that you cannot perform any laboratory testing until you have the CLIA Waiver for your office, no matter if you are billing insurance or doing cash.

So mark your calendar now to give yourself plenty of time to renew the certificate at the end of the two years. That way, you avoid getting stuck in a service gap where you can’t do any testing because your certification has expired.

And here’s another thing to keep in mind …

The CLIA Waiver needs to be updated, in line with current practice ownership and location. For example, if an office has moved to another location or there has been a change in ownership, the waiver needs to reflect that. Otherwise, you may find yourself out of compliance, or someone may not want to reimburse you, or any number of things that might result from an expired certificate.

Your CLIA waiver must be posted in your office, preferably in the testing area. You will find insurance companies may ask for an updated copy of the certificate when doing the quarterly attestation or at other times, just like they ask for the updated face sheet of your liability policy.

Sometimes practice owners tell me they don’t need a waiver because they’re only doing a fingerstick here and there, maybe one or two a month. But that belief is wrong! You need to have a current CLIA waiver, no matter if you do or do not bill Medicare or insurance for it.

No waiver, no test… end of story!

Cost vs. Reimbursement

It would be best if you exercise caution here. You see, reimbursement rates don’t always match or exceed the cost of a test. In other words, you may find yourself in a situation where you spend $50 for a test but then only get reimbursed $30. And you are left holding the bag for the $20…

This is a situation you don’t want to get caught in. So make sure you know the cost and reimbursement rates of any test. It should not cost you money to provide point of care testing for your patients.

Like most other information about CLIA, you will also find the standard reimbursement rates on the CMS website. Now, this won’t tell you the reimbursement for Medicaid or commercial insurance, but it’ll give you an idea.

Another thing to look for on the Medicare site is if a test from a particular manufacturer is approved for testing and reimbursement. Be sure and check the list for updates and changes regularly.

So, where can you buy these tests? Everywhere!

Start with a google search. Frequently you will find CLIA waived tests where you purchase your other clinic supplies. And of course, prices (and quality) can vary significantly between suppliers, so be sure to comparison shop.

Do your due diligence to make sure you purchase quality products. Don’t get stuck with low-quality tests peddled by some fly-by-night company.

In Summary…

If you do any point of care testing in your office, you must have a current CLIA Waiver. No waiver, not test; that is if you care to stay in compliance!

The CLIA certificate must be posted clearly in your “laboratory area.” You can find the point of care tests listed on the CMS website, along with CPT codes and reimbursement rates.

Not only does point-of-care testing offer convenience to your patients, but it also adds a stream of revenue to your practice.

Let us know if you have any questions and what you think, just leave your comment below the article! We want to hear from you…

Additional Resources:

Leave a Reply

Your email address will not be published. Required fields are marked

This site uses Akismet to reduce spam. Learn how your comment data is processed.

  1. Is there a special form to send in updates if we change a manufacturer? Do I complete the origninal form again?

  2. Hi – would CLIA be required if I do lab draws that I send out every day? I don’t do any other POC testing. I have a cash practice & the lab bills the patient’s insurance.

  3. Also important to know that staff who perform these tests in your practice are required to have the minimum of a high school education or it’s equivalent. This has implications for hiring for these roles as medical assistants.

{"email":"Email address invalid","url":"Website address invalid","required":"Required field missing"}