CLIA Waived testing in pharmacy


Attention CLIA Certified Pharmacies:

Over ten thousand Pharmacies have a CLIA Certificate of Waiver.  Most of these Pharmacies have been providing CLIA waived testing as a cash service only, increasing revenue and helping to offset dropping reimbursements and DIRS. But earlier this month,  CMS issued an MLN Matters Article allowing Pharmacies with CLIA Certification already enrolled in Medicare to fast-track a temporary enrollment as an independent clinical diagnostic laboratory to help combat the spread of COVID-19 during the public health emergency. Pharmacies will need to contact their Medicare Administrative Contractor (MAC) via phone and provide them with the following information:

  • Legal Business Name
  • NPI
  • Tax Identification Number
  • State License (Pharmacy and Laboratory (if applicable))
  • CLIA Certificate Number
  • Address Information
  • Contact Information.

Once this information is provided to the MAC, they will email your temporary billing privileges within two (2) business days.  At that point, you will be eligible to submit COVID-19 testing claims to Medicare.

Once the public health emergency has ended, you will have 30 days to complete the CMS-855b (or PECOS) to retain your diagnostic laboratory billing privileges.

Do Not Already Have a CLIA Certificate of Waiver

In most States, Pharmacies can start providing CLIA waived testing relatively easily by just completing the CMS-116  and submitting payment to your State Agency – you may need to submit a State Application also.  We would recommend contacting your State Agency to determine if there is an additional application and if there are any other requirements for a CLIA Certificate of Waiver in your State.  It can take 1 to 3 months to get your CLIA Certificate of Waiver once you have submitted your CMS-116 and other documents requested by your State.

Not Already Enrolled In Medicare

Pharmacies not already enrolled in Medicare will need to go through the usual process to complete the CMS-855b (or PECOS) and send it to their local MAC. In the past, this process has taken several months for Pharmacies to get their Medicare Part B Immunization billing privileges.


If you have any questions, please do not hesitate to give PRS a call at 1-800-338-3688, and if you are looking for best practices for Pharmacies seeking a CLIA Certificate of Waiver, check out our POCTTrack Program.