[Federal Register Volume 89, Number 44 (Tuesday, March 5, 2024)]
[Rules and Regulations]
[Pages 15755-15756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04590]



[[Page 15755]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 493

[CMS-3326-CN2]
RIN 0938-AT47


Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; 
Histocompatibility, Personnel, and Alternative Sanctions for 
Certificate of Waiver Laboratories; Correction

AGENCY: Centers for Medicare & Medicaid Services (CMS) and Centers for 
Disease Control and Prevention (CDC), Department of Health and Human 
Services (HHS).

ACTION: Final rule; correction.

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SUMMARY: This document corrects technical and typographical errors in 
the final rule that appeared in the December 28, 2023, Federal Register 
entitled, ``Clinical Laboratory Improvement Amendments of 1988 (CLIA) 
Fees; Histocompatibility, Personnel, and Alternative Sanctions for 
Certificate of Waiver Laboratories'' (referred to hereafter as the 
``December 2023 final rule'').

DATES: This correction is effective March 5, 2024, and is applicable 
beginning January 27, 2024.

FOR FURTHER INFORMATION CONTACT: Penny Keller, CMS, (410) 786-2035; or 
Heather Stang, CDC, (404) 498-2769.

SUPPLEMENTARY INFORMATION:

I. Background

    In FR Doc. 2023-28170 of December 28, 2023, the December 2023 final 
rule (88 FR 89976), there were technical and typographical errors that 
are identified and corrected in this correcting document. These 
corrections are applicable beginning January 27, 2024, as if they had 
been included in the December 2023 final rule.

II. Summary of Errors

    On page 89985, in the first footnote to the table titled, ``TABLE 
4: Examples, Two-part Increase per Certificate Type'', we inadvertently 
included incorrect amounts for the current and updated Certificate of 
Registration (CoR) fees. As stated in the proposed rule that appeared 
in the July 26, 2022, Federal Register entitled, ``Clinical Laboratory 
Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, 
Personnel, and Alternative Sanctions for Certificate of Waiver 
Laboratories'', the correct current CoR fee was $100. With application 
of the one-time across-the-board (ATB) increase of 18 percent along 
with the biennial two-part fee increase of 4.9598 percent, the correct 
updated fee amount is $123.
    Similarly on page 90027, in the table titled, ``TABLE 17: Two-part 
Biennial Certificate Fee'', in the Certificate of Registration (CoR) 
row, we inadvertently included incorrect amounts in the ``Current fee'' 
and ``New average fee'' columns. We are correcting as described 
previously.
    On page 90028, in the table titled, ``TABLE 18: CLIA Replacement 
and Revised Certificates FY 2019'', we made typographical errors in the 
``Cost of Revised Certificate'' entries for the Certificate of 
Accreditation (CoA) and Certificate for Provider-performed Microscopy 
(PPM) certificate types. The amounts were reversed in the table. The 
corrected certificate fees for each of these revised certificate types 
corresponds to the fees in Table 6, ``CMS Proposed Fee for Issuance of 
Revised Certificate'' in the final rule.

III. Waiver of Proposed Rulemaking and Delay in Effective Date

    Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), 
the agency is required to publish a notice of the proposed rulemaking 
in the Federal Register before the provisions of a rule take effect. 
Section 553(d) of the APA ordinarily requires a 30-day delay in 
effective date of final rules after the date of their publication in 
the Federal Register.
    Section 553(b)(B) of the APA authorizes an agency to dispense with 
normal rulemaking requirements for good cause if the agency makes a 
finding that the notice and comment process is impracticable, 
unnecessary, or contrary to the public interest. In addition, section 
553(d)(3) of the APA allows the agency to avoid the 30-day delay in 
effective date where such delay is contrary to the public interest and 
an agency includes a statement of support.
    We believe this correcting document does not constitute a rule that 
would be subject to the notice and comment or delayed effective date 
requirements. This document merely corrects technical and typographical 
errors in the December 2023 final rule but does not make substantive 
changes to the policies that were adopted in the December 2023 final 
rule. Instead, this correcting document is intended to ensure that the 
information in the December 2023 final rule accurately reflects the 
policies adopted in that document.
    In addition, even if this were a rule to which the notice and 
comment procedures and delayed effective date requirements applied, we 
find that there is good cause to waive such requirements. Undertaking 
further notice and comment procedures to incorporate the corrections in 
this document into the December 2023 final rule or delaying the 
effective date would be contrary to the public interest because it is 
in the public's interest to ensure that the December 2023 final rule 
accurately reflects the policies finalized in that final rule. 
Furthermore, such procedures would be unnecessary, as we are not 
altering our policies, but rather, we are simply correctly implementing 
the policies we finalized. This final rule correction is intended to 
ensure that the December 2023 final rule accurately reflects those 
policies. Therefore, we believe we have good cause to waive the notice 
and comment and delayed effective date requirements.

IV. Correction of Errors

    In FR Doc. 2023-28170 of Thursday, December 28, 2023 (88 FR 89976), 
the following corrections are made:
    1. On page 89985, in the first footnote to the table titled, 
``TABLE 4: Examples, Two-part Increase per Certificate Type'', the 
language that reads, ``Note: The Certificate of Registration (CoR) fee 
would increase from the $150 to $184.'' is corrected to read, ``Note: 
The Certificate of Registration (CoR) fee would increase from the $100 
to $123.''
    2. On page 90027, in the table titled, ``TABLE 17: Two-part 
Biennial Certificate Fee'', the last row that reads:

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                                   Table 17--Two-Part Biennial Certificate Fee
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                                                                    New average
                                                                    (n) ATB and                      Number of
    Type of CLIA Certificate      Laboratory schedule   Current      biennial        Number of     laboratories
                                                        fee (c)   increase = 18%  laboratories *   divided by 2
                                                                      * 4.96%                           **
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Certificate of Registration       Not applicable.....       $150            $184            2891         1,445.5
 (CoR).
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is corrected to read:

                                   Table 17--Two-Part Biennial Certificate Fee
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                                                                    New average
                                                                    (n) ATB and                      Number of
    Type of CLIA Certificate      Laboratory schedule   Current      biennial        Number of     laboratories
                                                        fee (c)   increase = 18%  laboratories *   divided by 2
                                                                      * 4.96%                           **
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Certificate of Registration       Not applicable.....       $100            $123            2891         1,445.5
 (CoR).
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    3. On page 90028, in the table titled, ``TABLE 18: CLIA Replacement 
and Revised Certificates FY 2019'', rows 4 and 5 that read:

                          Table 18--CLIA Replacement and Revised Certificates FY2019 *
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                                             Number of
                                            replacement          Cost of       Number of revised      Cost of
            Certificate type                certificates       replacement        certificates        revised
                                          issued in FY2019     certificate      issued in FY2019    certificate
----------------------------------------------------------------------------------------------------------------
CoA....................................                496                $75                505            $150
PPM....................................                525                 75                984              95
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are corrected to read:

                          Table 18--CLIA Replacement and Revised Certificates FY2019 *
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                                             Number of
                                            replacement          Cost of       Number of revised      Cost of
            Certificate type                certificates       replacement        certificates        revised
                                          issued in FY2019     certificate      issued in FY2019    certificate
----------------------------------------------------------------------------------------------------------------
CoA....................................                496                $75                505             $95
PPM....................................                525                 75                984             150
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Elizabeth J. Gramling,
Executive Secretary to the Department, Department of Health and Human 
Services.
[FR Doc. 2024-04590 Filed 3-4-24; 8:45 am]
BILLING CODE 4120-01-P