Let’s talk about starting a CLIA-Waived Point of Care Testing Program in a Pharmacy setting to diversify your services and bring additional revenue as third parties continually lower reimbursements and we see continual DIR creep. In most cases, your POCT will be a cash service, but CMS and privacy payers may pay for these services. Depending on your State, the Pharmacist can order these Tests and, in some cases, actually prescribe medication (or alter medications that have already been prescribed) based on Collaborative Practice Agreements (or similar) based on the Test results.
In the short term, COVID 19 is also creating interest for pharmacies to provide Point of Care Testing.
What is Point-of-Care Testing in Pharmacy?
Point of Care testing is clinical testing that is performed in the Pharmacy setting within a relatively short amount of time (typically within 20 to 30 minutes). The information can then be quickly used to direct treatment of the patient via collaboration between the Pharmacist and a Physician or used to document a patient care plan.
What are CLIA Waived Tests?
CLIA Waived Tests are simple tests with a low risk of error. The FDA is the federal agency that is responsible for the designations of clinical tests, including CLIA Waived Tests. The FDA has designated some of the devices Testing the below as Waived (this list is not all-inclusive):
- Rapid Strep (Group A)
- Influenza A/B
- SARS-CoV-2 (with an Emergency Use Authorization (EUA) during the Public Health Emergency)
You can find the completed list of CLIA Waived Tests here.
Contact Your State Agency
CMS licenses all CLIA Laboratories and does not have requirements for Laboratories seeing a CLIA Certificate of Waiver beyond the designation of a Laboratory Director and the completion of their Application. The actual licensing is performed through your State via your State Agency responsible for the licensing of Clinical Laboratories. As such, they are the gatekeepers and may have their own rules regarding the minimum requirements for becoming a Clinical Laboratory of Waived Tests. These minimum requirements could include:
- Lab Director education and experience requirements
- Lab setup
- Reference materials
- Policies and procedures
- Who can order a test
- Record keeping
- State reporting of infectious diseases
- Liability insurance
- Personnel training requirements beyond manufacturer training
- And other items
It is crucial to reach out to your State Agency if there are any requirements for Clinical Laboratories performing Waived Tests before starting your applications – they may have none.
Prepare your Application(s)
The CMS-116 (CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA) APPLICATION FOR CERTIFICATION) is the CMS Application that needs to be completed to receive your CLIA Certificate of Waiver. The Application will allow you to perform Clinical Tests on those tests designated by the FDA as waived. In all cases, waived tests are simple and have a low risk of erroneous results.
The CMS-116 will be sent to your local State Agency responsible for the licensing of Clinical Laboratories and not CMS. Your State Agency may require an additional State Application (and other documentation) to be completed and included. In the Application, you will be describing the specific tests you will be providing, so you will need to have already thought about the tests you want to offer and the manufacturers you will be using.
Develop Relationships with Test Manufacturers and Their Distribution Channels
Reach out to your wholesalers and buying groups to see if they have relationships with the Test Manufacturers for the testing devices you wish to provide. If they do not have relations with manufacturers for the tests, reach out directly to the manufacturer.
The POCTTrack program by PRS helps Pharmacies with the best practices and meeting any State requirements. The Program supplies you with the guidance, policies, procedures, and forms to set up your Pharmacy to provide Point of Care Testing. Additionally, the Program will give you the questions you need to ask your State Agency responsible for Clinical Laboratories and State Board of Pharmacy related to state-specific rules.
For more information, please give us a call at 1-800-338-3688 or visit our POCTTrack Website.