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INFORMATION ABOUT THE ONGOING NOVEL CORONAVIRUS OUTBREAK
Information from TN Dept of Health about the Ongoing Novel Coronavirus Outbreak

User Fees and Payments

CLIA Fees

The Centers for Medicare & Medicaid Services (CMS) is responsible for all fees for CLIA certification. PAYMENT FOR CLIA FEES SHOULD NEVER BE SENT TO THE TENNESSEE CLIA STATE AGENCY (SA).

CMS will automatically generate a user fee coupon when initial applications are processed and when an existing certificate is due to be renewed. When you receive your user fee coupon you should follow the instructions on the coupon on how to make your payment. If at all possible, CLIA payments should be submitted with the fee coupon. If you do not have a copy of the fee coupon then please include your CLIA ID number on your check, make your check payable to CLIA LABORATORY PROGRAM and mail it to:

CLIA LABORATORY PROGRAM
PO BOX 3056
Portland, OR 97208-3056

CMS will send up to three user fee coupons–one coupon every two months. If payment is not received after the third bill, the certificate will be automatically terminated. A certificate can be reactivated if it has expired.

Fee Schedule

Certificate of Waiver
For facilities requesting a Certificate of Waiver (CoW), the laboratory pays a $180 certificate fee. The laboratory is then billed $180 every two years. A user fee coupon is mailed six months prior to the expiration date of the current certificate.

Certificate of Provider Performed Microscopy Procedures (PPMP)
For facilities requesting a Provider Performed Microscopy Certificate (PPM), the laboratory pays a $240 certificate fee. The laboratory is then billed $240 every two years. A user fee coupon is mailed six months prior to the expiration date of the current certificate.

CertificateType

Certificate Fee*

FeeTimeframe

Waiver

$180

6 months before the expiration date

PPMP

$240

6 months before the expiration date

*Automatically billed biennially


Certificate of Compliance
There are 3 separate fees associated with a Certificate of Compliance:

  • Registration Fee. The Registration Fee is a one-time fee of $100 assessed to a laboratory that is initially applying for or changing their existing certificate to a Certificate of Compliance. It is valid for two years during which time a survey will be conducted to determine the laboratory’s actual annual test volume amount and regulatory compliance. A Certificate Fee will then be assessed and, upon receipt of payment, the Certificate of Compliance will be issued to the laboratory.
  • Survey Fee. The Compliance Survey Fee is generated 12 months prior to the current certificate’s expiration date. This fee is assessed for the biennial survey that is conducted.
  • Certificate Fee. Once the survey is completed and the laboratory is recommended for recertification, the laboratory is issued a Compliance Certificate fee. This fee is assessed to pay for the renewed certificate. The amount of the fee may fluctuate biennially due to changes in the laboratory’s annual test volume and number of laboratory specialties performed.
  • For a Certificate of Compliance please DO NOT estimate your fees. CMS will calculate the fee amount based on the annual testing volume and number of laboratory specialties performed, and generate a user fee coupon for the correct amount.

Certificate of Accreditation
There are 3 separate fees associated with a Certificate of Accreditation:

  • Registration Fee. The Registration Fee is a one-time fee of $100 assessed to a laboratory that is initially applying for or changing their existing certificate to a Certificate of Accreditation. It is valid for two years during which time a survey by the accrediting agency will be conducted to determine the laboratory’s actual annual test volume amount and regulatory compliance .
  • Validation Fee. The Validation Survey Fee is generated 6 months prior to the current certificate’s expiration date. This fee must be paid to CMS every two years in addition to fees paid to the accrediting agency.
  • Certificate Fee. The Accreditation Certificate Fee is billed at the same time as the Validation Fee. This fee is assessed to pay for the renewed certificate. The amount of the fee may fluctuate biennially due to changes in the laboratory’s annual test volume and number of laboratory specialties performed. It is typically the same amount as the Compliance Certificate Fee that is charged for a Certificate of Compliance. This fee must be paid to CMS every two years in addition to fees paid to the accrediting agency.
  • For a Certificate of Accreditation please DO NOT estimate your fees. CMS will calculate the fee amount based on the annual testing volume and number of laboratory specialties performed, and generate a user fee coupon for the correct amount.

Methods of Payment

US Mail to the PO Box. Payment made by check or money order should be made payable to CLIA LABORATORY PROGRAM and mailed to:

CLIA LABORATORY PROGRAM
PO BOX 3056
Portland, OR 97208-3056

Always write your CLIA ID number on your check or money order. If possible send your user fee coupon with your payment.

Overnight to the Lockbox. If you want to overnight your payment you will need to send your payment using the United States Postal Service’s Overnight Letter to the PO Box. All questions regarding overnight payment to the PO Box should be directed to your local Post Office.

Online payment by credit card. Facilities that wish to make a payment by credit card can do so online through the Pay.gov website. Instructions to guide you through the process can be found here.

Electronic payment for federal facilities. Federal facilities can set up an electronic payment through the IPAC system to pay their CLIA fees. Follow these instructions or call the phone number on the form for further assistance.

Overview Quick Guide    
  • Payment for CLIA fees should never be sent to the Tennessee CLIA State Agency (SA). Follow the instructions on the user fee coupon generated by CMS to make your payment.
  • Always include your CLIA ID number on your check.
  • Fees for certificates are billed biennially. The amount is based on certificate type (for Certificates of Waiver and PPMP) and the annual volume of testing and number of laboratory specialties performed (for Certificates of Compliance and Accreditation).