MEMO-QSO-24-03-CLIA: Updates and revisions to CLIA fees, sanctions and requirements
Publication of Final Rule: CMS-3326-F was published on December 28, 2023. This final rule updates the Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees and clarifies the CLIA fee regulations. Specifically, the final rule will: 1) implement a process for sustainable funding for the CLIA program through a biennial two-part increase of CLIA fees; 2) amend histocompatibility and personnel regulations under CLIA to address obsolete regulations and update the regulations to incorporate technological changes; and 3) amend the provisions governing alternative sanctions (including civil money penalties, a directed plan of correction, a directed portion of a plan of correction, and onsite State monitoring) to allow for the imposition of such sanctions against non-compliant laboratories operating under Certificates of Waiver, rather than being limited only to imposing principal sanctions of revocation, suspension or limitation of a laboratory’s CLIA certificate.
Final rule purpose
This final rule clarifies and updates CLIA regulations that protect the health and safety of laboratory consumers and address the financial stability of the CLIA program. Specifically, the final rule: (1) adjusts laboratory fees to provide sustainable funding for the user-fee-funded CLIA program; (2) revises certain requirements for both the histocompatibility test specialty as well as personnel qualifications and responsibilities for CLIA laboratories; and (3) provides additional discretion to CMS by allowing it to impose alternative sanctions against non-compliant Certificate of Waiver laboratories, rather than being limited only to imposing principal sanctions of revocation, suspension or limitation of a laboratory's CLIA certificate.
Federal Register :: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories
CLIA fee schedule for the State of Minnesota
- State agency rate for revisit surveys — $111.81 per hour for all time to prepare for, perform, and document a revisit survey including travel.
- Registration fee for compliance laboratories — $123
- Certificate of Waiver fee — $248
- Provider Performed Microscopy Procedures fee — $297
| Laboratory Schedule | Annual Test Volume | # of Specialties | Biennial Certificate Fee ($) | Biennial Survey Inspection Fee ($) |
|---|
| V (Low Volume) | < or = 2,000 | Not Specified | $223 | $446 |
|---|
| A | 2,001-10,000 | < 4 (3 or less) | $223 | $2,020 |
|---|
| B | 2,001-10,000 | > 3 (4 or more) | $223 | $2,093 |
|---|
| C | 10,001-25,000 | < 4 (3 or less) | $639 | $3,366 |
|---|
| D | 10,001-25,000 | > 3 (4 or more) | $654 | $3,955 |
|---|
| E | 25,001-50,000 | n/a | $966 | $4,545 |
|---|
| F | 50,001-75,000 | n/a | $1,635 | $5,133 |
|---|
| G | 75,001-100,000 | n/a | $2,304 | $5,723 |
|---|
| H | 100,001-500,000 | n/a | $3,032 | $6,312 |
|---|
| I | 500,001-1,000,000 | n/a | $9,244 | $6,901 |
|---|
| J | > or = 1,000,001 | n/a | $11,801 | $7,489 + 588 for every additional 500,000 tests |
|---|
Replacement certificate
A replacement certification is an active CLIA certificate that is reissued with no changes made.
- All certificate types — $75.00
Revised certificate
A revised certificate is an active CLIA certificate that is reissued with changes to one or more fields displayed on the certificate, such as the laboratory’s name, address, laboratory director, or approved specialties/subspecialties. For purposes of this part revised certificates do not include the issuance, renewal, change in certificate type, or reinstatement of a terminated certificate with a gap in service.
- Certificate of Waiver/Certificate for Provider Performed Microscopy Procedures — $95.00
- Certificate of Registration/Certificate of Compliance/Certificate of Accreditation — $150.00
Additional fees
- Adding a specialty and determining compliance with testing in additional specialties outside of the Certificate of Compliance survey cycle.
- Performing follow-up surveys or revisits to determine the correction of deficient practices found in either a Certificate of Compliance survey or a Certificate of Accreditation validation or complaint survey.
- Performing a substantiated complaint survey.
- Conducting desk reviews of unsuccessful proficiency testing performance to ensure successful laboratory proficiency testing.