[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:
[[Page 15756]]
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
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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
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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