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Rule2023-28170

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

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Published

December 28, 2023

Effective

January 27, 2024

Issuing agencies

Health and Human Services DepartmentCenters for Medicare & Medicaid Services

Abstract

This final rule updates the Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees and clarifies the CLIA fee regulations. This final rule implements a process for sustainable funding for the CLIA program through a biennial two-part increase of CLIA fees. We are finalizing the incorporation of limited/specific laboratory fees, including fees for follow-up surveys, substantiated complaint surveys, and revised certificates. We are also finalizing the distribution of the administrative overhead costs of test complexity determination for waived tests and test systems with a nominal increase in Certificate of Waiver (CoW) fees. In addition, we are finalizing the clarification of the methodology used to determine program compliance fees. This final rule ensures the continuing quality and safety of laboratory testing for the public. This final rule also amends histocompatibility and personnel regulations under CLIA to address obsolete regulations and update the regulations to incorporate technological changes. In addition, this final rule amends 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 on CoW laboratories.

Full Text

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[Federal Register Volume 88, Number 248 (Thursday, December 28, 2023)]
[Rules and Regulations]
[Pages 89976-90044]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-28170]

[[Page 89975]]

Vol. 88

Thursday,

No. 248

December 28, 2023

Part III

Department of Health and Human Services

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Centers for Medicare & Medicaid Services

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42 CFR Part 493

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

Federal Register / Vol. 88 , No. 248 / Thursday, December 28, 2023 /
Rules and Regulations

[[Page 89976]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 493

[CMS-3326-F]
RIN 0938-AT47

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

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.

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SUMMARY: This final rule updates the Clinical Laboratory Improvement
Amendments of 1988 (CLIA) fees and clarifies the CLIA fee regulations.
This final rule implements a process for sustainable funding for the
CLIA program through a biennial two-part increase of CLIA fees. We are
finalizing the incorporation of limited/specific laboratory fees,
including fees for follow-up surveys, substantiated complaint surveys,
and revised certificates. We are also finalizing the distribution of
the administrative overhead costs of test complexity determination for
waived tests and test systems with a nominal increase in Certificate of
Waiver (CoW) fees. In addition, we are finalizing the clarification of
the methodology used to determine program compliance fees. This final
rule ensures the continuing quality and safety of laboratory testing
for the public. This final rule also amends histocompatibility and
personnel regulations under CLIA to address obsolete regulations and
update the regulations to incorporate technological changes. In
addition, this final rule amends 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 on CoW
laboratories.

DATES: These regulations are effective January 27, 2024, except for
instruction 3, amending Sec. 493.2; instructions 14 through 19,
amending Sec. Sec. 493.945, 493.1273, 493.1274, 493.1278, 493.1359,
and 493.1405; instruction 20 removing Sec. 493.1406; instructions 21
through 30, amending Sec. Sec. 493.1407, 493.1411, 493.1417, 493.1423,
493.1443, 493.1445, 493.1449, 493.1451, 493.1455, and 493.1461;
instruction 31 removing Sec. 493.1462; and instructions 32 through 36,
amending Sec. Sec. 493.1463, 493.1469, 493.1483, 493.1483, 493.1489,
and 493.1491, which are effective December 28, 2024.

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

SUPPLEMENTARY INFORMATION:

Executive Summary

A. 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.

B. Summary of the Major Provisions

1. Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees
On October 31, 1988, Congress enacted the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) (Pub. L. 100-578), which revised
in its entirety section 353 of the Public Health Service Act (PHSA).
Section 353(m) of the PHSA requires the Secretary to impose two
separate types of fees: ``certificate fees'' and ``additional fees.''
Certificate fees are imposed for the issuance and renewal of
certificates and must be sufficient to cover the general costs of
administering the CLIA program, including evaluating and monitoring
approved proficiency testing (PT) programs and accrediting bodies and
implementing and monitoring compliance with program requirements.
Additional fees are imposed for inspections of nonaccredited
laboratories and for the cost of evaluating accredited laboratories to
determine overall if an accreditation organization's standards and
inspection process are equivalent to the CLIA program. These
evaluations are referred to as validation inspections. The additional
fees must be sufficient to cover, among other things, the cost of
carrying out such inspections. Certificate and additional fees vary by
group or classification of laboratory, based on such considerations as
the Secretary determines relevant, which may include the total test
volume and scope of the testing being performed by the laboratories,
and only a nominal fee may be required for the issuance and renewal of
Certificates of Waiver (CoWs).
We issued a notice with comment period in the December 31, 2018
Federal Register (83 FR 67723 through 67728) \1\ (hereinafter referred
to as the December 31, 2018 notice). The December 31, 2018 notice
increased fees for laboratories certified under CLIA. The December 31,
2018 notice increased CLIA fees by 20 percent to help ensure the CLIA
program could continue to be self-sustaining, as required by law. The
2018 increase was intended to give CMS time to propose a process
through rulemaking to allow for ongoing changes to the CLIA fees.
Despite that increase, the level of carryover funding available to
cover program expenses is projected to decline continuously. As such,
the CLIA program will not be self-supporting by the end of FY 2023
without an additional fee increase. The changes finalized in this rule
will result in a continuous level of funding that increases as the
obligations to the CLIA program increase and keep the program
adequately funded over time.
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\1\ See Medicare Program: Clinical Laboratory Improvement
amendments of 1988 (CLIA) Fees; 83 FR 67723; <a href="https://www.federalregister.gov/documents/2018/12/31/2018-28359/medicare-program-clinical-laboratory-improvement-amendments-of-1988-clia-fees">https://www.federalregister.gov/documents/2018/12/31/2018-28359/medicare-program-clinical-laboratory-improvement-amendments-of-1988-clia-fees</a>.
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On July 7, 2022, we published a proposed rule (87 FR 44896) \2\
(hereinafter referred to as the July 2022 proposed rule) that would
make changes to the methodology for determining the amount of the CLIA
fees as described in the February 28, 1992 final rule with comment
period (57 FR 7002) (hereinafter referred to as the February 1992 final
rule) and codified in 42 CFR part 493, subpart F--General
Administration. The fees for the CoW, Certificate for Provider-
performed Microscopy (PPM) Procedures, and the provisional certificate
that we refer to as the Certificate of Registration (CoR) were based on
the cost of issuing the

[[Page 89977]]

certificates. The Certificate of Accreditation (CoA) and Certificate of
Compliance (CoC) fees were based on the annual test volume and scope of
testing that separated the laboratories into schedules or groups of
laboratories. We generally proposed, and are finalizing in this rule,
to continue basing these fees on either the costs of issuing the
certificates (CoW, CoR, and PPM) or annual test volume and scope of
testing (CoA and CoC). However, we are now including in this final rule
additional government costs that were not accounted for in the
calculation method outlined in the February 1992 final rule. As one
such change, we proposed to allocate, directly from the CoW fees, the
administrative overhead costs of the Food and Drug Administration (FDA)
process to categorize clinical laboratory tests as waived as described
in the memorandum of understanding (MOU) between CMS and FDA (IA19-23).
In addition, we proposed to implement certificate fees for the issuance
of replacement and revised certificates. Thousands of replacement and
revised certificates are generated and mailed annually. We believe this
additional certificate fee will encourage laboratories to better manage
their certificates, provide accurate information when applying for or
updating a CLIA certificate, and cover the costs of producing duplicate
or revised documents.
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\2\ <a href="https://www.federalregister.gov/documents/2022/07/26/2022-15300/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and">https://www.federalregister.gov/documents/2022/07/26/2022-15300/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and</a>. The public comment period was
extended and closed on September 26, 2022 (87 FR 52712). <a href="https://www.federalregister.gov/documents/2022/08/29/2022-18558/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and">https://www.federalregister.gov/documents/2022/08/29/2022-18558/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and</a>.
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The February 1992 final rule also stated at Sec. 493.645(b)(1)
that laboratories issued a CoA would be assessed a fee to cover the
cost of evaluating the individual laboratories to determine whether an
accreditation program's standards and inspection policies are
equivalent to the Federal program. We proposed at the new Sec.
493.645(a)(1) to clarify that all accredited laboratories share in the
validation inspections cost. Under Sec. 493.645(b)(1), the accredited
laboratories currently pay a fee even though HHS inspects only 5
percent of them annually. The fee is 5 percent of what the inspection
cost of an equivalent nonaccredited CoC laboratory would pay based on
the test volume and scope (that is, the schedule or group) of the
laboratories.
In the February 1992 final rule, the inspection fees for
laboratories holding a CoC were based on estimates of the length of
time required to perform a laboratory survey in the different schedules
multiplied by the estimated hourly rate of three different entities,
the State agency, contracted surveyors, and Federal surveyors, that
perform surveys. Of these three entities, an hourly rate was
established solely for the State agencies, as any contracted surveyors'
salaries are paid by their contractual amount. The Federal surveyors
perform their surveys in conjunction with non-survey work plus actual
costs for travel to those surveys. Given this diversity of costs, it is
not feasible to determine a Federal hourly rate for just the survey
activities. In the July 2022 proposed rule, we proposed to cease using
the hourly rate outlined in current regulations as the basis for
determining compliance inspection fees for laboratories holding a CoC
and replace it with the methodology proposed in the proposed rule, and
which we are finalizing in this final rule. We proposed to keep
inspection fees separated by the schedules as previously determined.
The additional fees allowed for in section 353(m) of the PHSA are
fees for determining compliance with the CLIA regulations. Some of
these fees were previously included in subpart F but were not
implemented due to technical limitations. However, we stated in the
proposed rule that a new data system that can implement these
requirements is under development. Therefore, as discussed further in
this final rule, we are finalizing the implementation of additional
fees as outlined in the February 1992 final rule, to be effective 30
days after the publication of the final rule, although collection may
not begin until the new data system is implemented. We believe the
collection of these additional fees will help bridge the shortfall
between program expenditures and collections as discussed in section
I.A.1.a. of this final rule.
The February 1992 final rule provisions codified at 42 CFR part
493, subpart F--General Administration were numbered too close together
to allow new provisions or the separation of existing provisions, for
clarification, to stay in numerical order. Therefore, we proposed to
redesignate and renumber some provisions so that the flow of this
section is easier to follow. For example, we proposed to redesignate
current Sec. 493.646 as new Sec. 493.655 to maintain thematic order
in that Sec. 493.655, which outlines the payment of fees, is better
placed after the provisions discussing the different types of fees.
Each such change, including this example, is explained in full at its
designated provision within section II. of this final rule.
Upon the final rule effective date, which will be 30 days following
publication, we proposed implementing fee increases as described
previously in this rule. Using the more recent data available for this
final rule, we expect the fee increase to be larger than subsequent fee
increases. The fee increase includes an across-the-board increase of 18
percent and an inflation factor (CPI-U) of 1.049598. We utilized the
CPI-U factors promulgated by OMB as part of their economic assumptions
for budgetary estimates. To calculate the 4.9598 percent compound
factor for the 2-year increase, we multiplied together factors for each
of the 2 years as follows:

<bullet> Factor Year 1 (Budgeted Rate for Fiscal Year (FY) 2024) =
1.026
<bullet> Factor Year 2 (Budgeted Rate for FY 2025) = 1.023

The compounded factor = 1.026 x 1.023 = 1.049598.
The 18 percent across-the-board (ATB) increase was determined as
the amount that, including newly charged fees and inflation, is the
difference necessary to fund total annual projected program obligations
and allow for the gradual accumulation of 6 months' worth of
obligations as an operating margin at the start of the year. We have
calculated that the one-time 18 percent across-the-board increase would
generate approximately 12.1 million dollars annually while the
inflation factor would generate approximately 4.6 million dollars.
Based on the more recent data available for this final rule, the other
proposed fees would generate approximately 7.7 million dollars for a
total of approximately 24.4 million dollars per year.
We believe this will stabilize the CLIA program and allow us to use
the inflation factor for future biennial increases. Should future
across-the-board percentages be required, CMS will calculate them as
stated in Sec. 493.680(a). The revised certificate fee found at
proposed Sec. 493.639(a); the replacement certificate fee found at
proposed Sec. 493.639(b); the fees for the follow-up surveys,
substantiated complaint surveys, and unsuccessful PT on CoC
laboratories found at proposed Sec. 493.643(d)(1) through (4); follow-
up surveys on CoA laboratories found at proposed Sec. 493.645(a)(2);
and substantiated complaint surveys on CoW, PPM, or CoA laboratories
found at proposed Sec. 493.645(b) will be implemented on the effective
date of the final rule. However, the collection of the fees is
dependent on the new data system being online.
This final rule finalizes the proposed CLIA fee provisions with the
modifications described in section II of this final rule.
2. CLIA Requirements for Histocompatibility
The CLIA regulations include requirements specific to certain

[[Page 89978]]

laboratory specialties such as microbiology and subspecialties such as
endocrinology. Histocompatibility is a type of laboratory testing
performed on the tissue of different individuals to determine if one
person can accept cells, tissue, or organs from another person. The
CLIA regulatory requirements for the specialty of histocompatibility at
Sec. 493.1278, including the crossmatching requirements, address
laboratory testing associated with organ transplantation and
transfusion and testing on prospective donors and recipients. As of
January 2023, 247 CLIA-certified laboratories perform testing in this
specialty. The specialty of histocompatibility has not been updated
since the February 1992 final rule (57 FR 7002). Many of the changes
finalized in this rule will remove histocompatibility-specific
requirements from Sec. 493.1278 that we have determined are addressed
by the general QC requirements at Sec. Sec. 493.1230 through 493.1256
and 493.1281 through 493.1299. We believe that removing specific
requirements for obsolete methods and practices and eliminating
redundant requirements will decrease the burden on laboratories
performing histocompatibility testing. We have heard from interested
parties, particularly the transplantation community, that physical
crossmatches are a barrier to modernized decision-making approaches on
organ acceptability based on risk assessment.
For the crossmatching regulations that this final rule will amend,
HHS requested input from the Clinical Laboratory Improvement Advisory
Committee (CLIAC) on the acceptability and application of newer
crossmatching techniques in lieu of physical crossmatching. At its
November 2014 meeting, CLIAC made the following recommendations \3\ for
CMS to explore:
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\3\ <a href="https://www.cdc.gov/cliac/docs/summary/cliac1114_summary.pdf">https://www.cdc.gov/cliac/docs/summary/cliac1114_summary.pdf</a>.
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<bullet> Regulatory changes or guidance(s) that would allow virtual
crossmatching to replace physical crossmatching as a pre-requisite for
organ transplant.
<bullet> Appropriate criteria and decision algorithms, based on
CLIAC's deliberation of the Virtual Crossmatch Workgroup's input, under
which virtual crossmatching would be an appropriate substitute for
physical crossmatching. The determination of appropriate criteria and
decision algorithms should involve a process that includes an open
comment period.
In the 2018 RFI (83 FR 1005 through 1006, 1008), we requested
comments and information related to histocompatibility and
crossmatching requirements that may have become outdated and requested
suggestions for updating these requirements to align with current
laboratory practice. The comments we received in response to the 2018
RFI recommended updating the current histocompatibility and
crossmatching requirements to align with current laboratory practices.
The CLIAC recommendations and the comments from the 2018 RFI informed
the changes that we proposed in the July 2022 proposed rule, and which
we are finalizing in this final rule.
This final rule finalizes the proposed histocompatibility
provisions of the proposed rule with the modifications described in
section III.A. of this final rule.
3. CLIA Requirements for Personnel
The CLIA regulations related to personnel requirements were updated
with minor changes to the doctoral high complexity LD qualifications in
the 2003 final rule (68 FR 3713, Jan. 24, 2003), but otherwise have
remained unchanged since we published the February 1992 final rule with
comment period (57 FR 7002). In the 2018 RFI (83 FR 1005 through 1006,
1008), we sought public comment and information related to CLIA
personnel requirements in the following areas: nursing degrees;
physical science degrees; personnel competency assessment (CA);
personnel training and experience; and non-traditional degrees. These
are areas that the CDC, CMS, interested parties, and State agency
surveyors identified as relevant to our efforts to update the CLIA
personnel requirements to better reflect current knowledge, changes in
the academic context, and advancements in laboratory testing.
In response to our questions about nursing degrees, the majority of
commenters did not concur that nursing degrees were equivalent to a
biological or chemical sciences degree. However, some interested
parties suggested nursing degrees could be used as a separate
qualifying degree for nonwaived testing personnel (TP). In response to
our questions about physical science degrees as well as non-traditional
degrees, interested parties commented that a physical science degree
was hard to define. In considering how to evaluate physical science and
other non-traditional degrees, some commenters recommended that we
evaluate coursework taken using a semester-hour educational algorithm
to qualify individuals for CLIA personnel positions. In response to the
questions about competency assessment (CA), many commenters stated that
individuals with an applicable associate degree should be permitted to
perform CA on moderate complexity TP. Some commenters stated that
required training should depend on the complexity of the testing to be
performed and that all nonwaived testing should require training
related to the individual's laboratory responsibilities. Several
commenters also stated that any required training and experience should
be in a CLIA-certified laboratory. Many commenters agreed that all
training and experience should be documented; many noted that
documentation from a former employer should be acceptable, assuming it
provided specific details about the individual's job, training, and CA.
We also requested input from CLIAC for recommended changes to the
CLIA personnel requirements found in subpart M--Personnel for Nonwaived
Testing, Sec. Sec. 493.1351 through 493.1495. CLIAC made 12
recommendations at the April 2019 meeting to improve CLIA personnel
regulations, including: (1) making biological science degrees
acceptable for laboratory personnel and considering candidates with
other degree backgrounds based on coursework; (2) removing the degree
in physical science from the CLIA regulations due to its broadness; and
(3) requiring personnel to have training and experience in their areas
of responsibility. Following this, CMS and CDC collaborated to develop
a list of personnel regulation updates that we proposed in the July
2022 proposed rule.\4\
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\4\ <a href="https://www.federalregister.gov/documents/2022/07/26/2022-15300/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and">https://www.federalregister.gov/documents/2022/07/26/2022-15300/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and</a>.
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We are finalizing the proposed provisions for personnel with the
modifications described in section III.B. in this final rule.
4. Alternative Sanctions for CoW Laboratories
As discussed in section III.C. of the proposed rule and this final
rule, we proposed, and are finalizing, an amendment to Sec.
493.1804(c)(1) to allow CMS to impose alternative sanctions on CoW
laboratories, as appropriate. CoW laboratories are laboratories that
only perform waived tests, that is, simple laboratory examinations and
procedures that have an insignificant risk of an erroneous result. For
example, a urine dipstick pregnancy test is a waived test. The current
regulations state that we do not impose alternative sanctions on CoW
laboratories because those

[[Page 89979]]

laboratories are not inspected for compliance with condition-level
requirements (Sec. 493.1804(c)(1)). However, while not subject to the
biennial routine surveys, CoW laboratories are surveyed as a result of
a complaint, and based on the complaint survey, may be found to be out
of compliance with a condition-level requirement. In the absence of
alternative sanctions, our only recourse in cases of compliance issues
found at CoW laboratories is to apply principal sanctions (that is,
revocation, suspension, or limitation of the CLIA certificate). We
believe the ability to levy alternative sanctions (that is, civil money
penalties, a directed plan of correction, a directed portion of a plan
of correction, and onsite State monitoring) on CoW laboratories helps
CMS ensure appropriate sanctions are applied to CoW laboratories, as in
the case of other certificate types (certificate of PPM, CoR, CoC,
CoA).
In addition, we believe that this finalized change will reduce
burden on CoW laboratories. The ability to impose alternative sanctions
will be particularly useful in instances in which we find proficiency
testing (PT) referral violations. PT is the testing of unknown samples
sent to a laboratory by an HHS-approved PT program to check the
laboratory's ability to determine the correct testing results. This
final rule amends the CoW regulations at Sec. 493.1804(c)(1) to allow
for the application of alternative sanctions where warranted, in
addition to or in lieu of principal sanctions.
We are finalizing the provisions for alternative sanctions for CoW
laboratories as described in section III.C. in this final rule.

C. Summary of Costs and Benefits

BILLING CODE 4120-01-P

[[Page 89980]]

[GRAPHIC] [TIFF OMITTED] TR28DE23.000

BILLING CODE 4120-01-C

I. Background

A. Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees

On October 31, 1988, Congress enacted the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) (Pub. L. 100-578), which revised
in its entirety section 353 of the Public Health Service Act (PHSA).
Section 353(m) of the PHSA requires the Secretary to impose two
separate types of fees: ``certificate fees'' and ``additional fees.''
Certificate fees are imposed for the issuance and renewal of
certificates and must be sufficient to cover the general costs of
administering the CLIA program, including evaluating and monitoring
approved proficiency testing (PT) programs and accrediting bodies and
implementing and monitoring compliance with program requirements.
Additional fees are imposed for inspections of nonaccredited
laboratories and for the cost of evaluating accredited laboratories to
determine overall if an accreditation organization's standards and
inspection process are equivalent to the CLIA program. These
evaluations are referred to as validation inspections. The additional
fees must be sufficient to

[[Page 89981]]

cover, among other things, the cost of carrying out such inspections.
Certificate and additional fees vary by group or classification of
laboratory, based on such considerations as the Secretary determines
relevant, which may include the total test volume and scope of the
testing being performed by the laboratories, and only a nominal fee may
be required for the issuance and renewal of Certificates of Waiver
(CoWs).
In January 2018, we published the ``Request for Information:
Revisions to Personnel Regulations, Proficiency Testing Referral,
Histocompatibility Regulations and Fee Regulations under the Clinical
Laboratory Improvement Amendments (CLIA) of 1988'' (83 FR 1004). As
part of the general solicitation for comments related to the CLIA fees,
more than a few commenters noted that the CLIA compliance and
additional fees have not been updated since 1997 and supported
increasing the fees. Some of these commenters suggested that the CLIA
fees be reviewed annually and updated as needed to cover the program
costs of performing surveys.
Based on comments from the public on the Request for Information
(RFI), we issued a notice with comment period in the December 31, 2018
Federal Register (83 FR 67723 through 67728) (hereinafter referred to
as the December 31, 2018 notice). The December 31, 2018 notice
increased fees for laboratories certified under CLIA. The December 31,
2018 notice increased CLIA fees by 20 percent to help ensure the CLIA
program could continue to be self-sustaining, as required by law. The
2018 increase was intended to give CMS time to propose a process
through rulemaking to allow for ongoing changes to the CLIA fees. The
changes finalized in this rule will result in a continuous level of
funding that increases as the obligations to the CLIA program increase
and keep the program adequately funded over time.
In September 2020, we released new tools to reduce burdensome
paperwork and authorization delays for laboratories seeking CLIA
certification. Laboratories now have the option to pay CLIA
certification fees on the CMS CLIA program website. Online payments are
processed overnight, which is substantially faster than hard-copy
checks.\5\
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\5\ <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Index">https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Index</a>.
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In July 2022, we published a proposed rule (87 FR 44896) \6\
(hereinafter referred to as the July 2022 proposed rule) that would
make changes to the methodology for determining the amount of the CLIA
fees as described in the February 28, 1992 final rule with comment
period (57 FR 7002) (hereinafter referred to as the February 1992 final
rule) and codified in 42 CFR part 493, subpart F--General
Administration. The fees for the CoW, Certificate for Provider-
performed Microscopy (PPM) Procedures, and the provisional certificate
that we refer to as the Certificate of Registration (CoR) were based on
the cost of issuing the certificates. The Certificate of Accreditation
(CoA) and Certificate of Compliance (CoC) fees were based on the annual
test volume and scope of testing that separated the laboratories into
schedules or groups of laboratories. We generally proposed, and are
finalizing in this rule, to continue basing these fees on either the
costs of issuing the certificates (CoW, CoR, and PPM) or annual test
volume and scope of testing (CoA and CoC). However, as described below,
we are now including additional government costs that were not
accounted for in the calculation method outlined in the February 1992
final rule.
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\6\ <a href="https://www.federalregister.gov/documents/2022/07/26/2022-15300/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and">https://www.federalregister.gov/documents/2022/07/26/2022-15300/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and</a>. The public comment period was
extended and closed on September 26, 2022 (87 FR 52712). <a href="https://www.federalregister.gov/documents/2022/08/29/2022-18558/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and">https://www.federalregister.gov/documents/2022/08/29/2022-18558/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and</a>.
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As one such change, we proposed to allocate, directly from the CoW
fees, the administrative overhead costs of the Food and Drug
Administration (FDA) process to categorize clinical laboratory tests as
waived as described in the memorandum of understanding (MOU) between
CMS and FDA (IA19-23). We believe this is appropriate because the
functions of the FDA under the MOU are to provide administrative
support to the CLIA program, such as by categorizing tests as waived.
In addition, we proposed to implement certificate fees for the
issuance of replacement and revised certificates. We receive numerous
requests daily for replacements of lost and misplaced certificates and
for revised copies of certificates after demographic, laboratory
director (LD), and/or specialty/subspecialty changes. As a result,
thousands of replacement and revised certificates have been generated
and mailed annually. We believe this additional certificate fee will
encourage laboratories to better manage their certificates, provide
accurate information when applying for or updating a CLIA certificate,
and cover the costs of producing duplicate or revised documents.
The February 1992 final rule also stated at Sec. 493.645(b)(1)
that laboratories issued a CoA would be assessed a fee to cover the
cost of evaluating the individual laboratories to determine whether an
accreditation program's standards and inspection policies are
equivalent to the Federal program. The February 1992 final rule
explained that there would be a random sample of 5 percent of all
accredited laboratories inspected by the Department of Health & Human
Services (HHS), and the findings compared to the findings of the
Accreditation Organizations (AOs). The February 1992 final rule stated
that all accredited laboratories would share the cost of this activity
and that the fees would be the same as for inspections by nonaccredited
laboratories. We proposed new Sec. 493.645(a)(1) to clarify that all
accredited laboratories share in the validation inspections cost. Under
Sec. 493.645(b)(1), the accredited laboratories currently pay a fee
even though HHS inspects only 5 percent of them annually. The fee is 5
percent of what the inspection cost of an equivalent nonaccredited CoC
laboratory would pay based on the test volume and scope (that is, the
schedule or group) of the laboratories.
In the February 1992 final rule, the inspection fees for
laboratories holding a CoC were based on estimates of the length of
time required to perform a laboratory survey in the different schedules
multiplied by the estimated hourly rate of three different entities
that perform surveys. As outlined in the February 1992 final rule, we
believe this methodology was a starting point intended to allow the
methodology to be adjusted as historical data and experience were
gained. The three inspection entities mentioned in the February 1992
final rule were the State agency, contracted surveyors, and Federal
surveyors. Of these three entities, an hourly rate was established
solely for the State agencies, as any contracted surveyors' salaries
are paid by their contractual amount. The Federal surveyors perform
their surveys in conjunction with non-survey work plus actual costs for
travel to those surveys. Given this diversity of costs, it is not
feasible to determine a Federal hourly rate for just the survey
activities.
Due to these difficulties, in July 2022 we proposed to cease using
the hourly rate outlined in current regulations as the basis for
determining compliance inspection fees for laboratories holding a CoC
and replace it with the methodology proposed in the proposed rule, and
which we are finalizing in this

[[Page 89982]]

final rule. We proposed to keep inspection fees separated by the
schedules as previously determined.
The additional fees allowed for in section 353(m) of the PHSA are
fees for determining compliance with the CLIA regulations. Some of
these fees were previously included in subpart F but were not
implemented due to technical limitations. However, we stated in the
proposed rule that a new data system that can implement these
requirements is under development. While initially targeted for
completion in October 2022, the new data system remains under
development. Therefore, as discussed further in this final rule, we are
finalizing the implementation of additional fees as outlined in the
February 1992 final rule, to be effective 30 days after the publication
of the final rule, although collection may not begin until the new data
system is implemented. We believe the collection of these additional
fees will help bridge the shortfall between program expenditures and
collections as discussed in section I.A.1.a. of this final rule.
The February 1992 final rule provisions codified at 42 CFR part
493, subpart F--General Administration were numbered too close together
to allow new provisions or the separation of existing provisions, for
clarification, to stay in numerical order. Therefore, we proposed to
redesignate and renumber some provisions so that the flow of this
section is easier to follow. For example, we proposed to redesignate
current Sec. 493.645(a) as Sec. 493.649(a) and remove the current
regulatory text at Sec. 493.649. In addition, we proposed
redesignating current Sec. 493.646 as new Sec. 493.655 to maintain
thematic order in that Sec. 493.655, which outlines the payment of
fees, is better placed after the provisions discussing the different
types of fees. Each such change, including this example, is explained
in full at its designated provision within section II. of this final
rule.
Upon the final rule effective date, which will be 30 days following
publication, we proposed implementing fee increases as described
previously in this rule. Using the more recent data available for this
final rule, we expect the fee increase to be larger than subsequent fee
increases. The fee increase includes an across-the-board increase of 18
percent and an inflation factor (CPI-U) of 1.049598. We utilized the
CPI-U factors promulgated by OMB as part of their economic assumptions
for budgetary estimates. To calculate the 4.9598 percent compound
factor for the 2-year increase, we multiplied together factors for each
of the 2 years as follows:

<bullet> Factor Year 1 (Budgeted Rate for Fiscal Year (FY) 2024) =
1.026
<bullet> Factor Year 2 (Budgeted Rate for FY 2025) = 1.023

We believe this will stabilize the CLIA program and allow us to use
the inflation factor for future biennial increases. Should future
across-the-board percentages be required, CMS will calculate them as
stated in Sec. 493.680(a). The revised certificate fee found at
proposed Sec. 493.639(a); the replacement certificate fee found at
proposed Sec. 493.639(b); fees for the follow-up surveys,
substantiated complaint surveys, and unsuccessful PT on CoC
laboratories found at proposed Sec. 493.643(d)(1) through (4); follow-
up surveys on CoA laboratories found at proposed Sec. 493.645(a)(2);
and substantiated complaint surveys on CoW, PPM, or CoA laboratories
found at proposed Sec. 493.645(b) will be implemented on the effective
date of the final rule. However, the collection of the fees is
dependent on the new data system being online.
1. CLIA Budget Process
In the proposed rule, Table 1 provided a summary of projected user
fee collections, program obligations, and carryover balances from FY
2021 through the end of FY 2025. In Table 3 of this final rule, we have
expanded the information as presented in Table 1 of the proposed rule
to include actual figures for FYs 2019 through 2022 which show the
effect the 20 percent increase in 2019 had on CLIA's finances and
updated projections for FYs 2023 through FY 2026 reflecting updated
estimates of program spending, user fee collections, carryover, and
inflation. Table 3 does not include any proposed or finalized fee
increases. We are also including additional detail related to total
CLIA obligations. Start of year carryover balances plus anticipated
collections at current rates, net of sequester, equals budgetary
resources available for obligation, or spending, in a given fiscal
year. This amount, less projected program obligations, equals end-of-
year carryover. The continued decrease in the projected end-of-year
carryover shows that despite the 2019 increase, financial obligations
for the CLIA program continue to significantly outpace user fee
collections at current rates. This final rule will create sustainable
funding in a few different ways.
BILLING CODE 4120-01-P

[[Page 89983]]

[GRAPHIC] [TIFF OMITTED] TR28DE23.002

[[Page 89984]]

a. Two-Part Periodic Increase
As we explained in the July 2022 proposed rule, establishing a two-
part periodic increase could be easily implemented and would provide an
understandable calculation of fee increases. CMS will publish future
fee increases in a notice in the Federal Register. CMS will not publish
a notice in the Federal Register if no fee increases are required.
Every 2 years, in preparation for the biennial fee increase, we will
calculate the inflation adjustment using the Consumer Price Index for
all Urban Consumers (CPI-U). At that time, CMS will look back over the
previous 2 years and determine if the calculated CPI-U inflation
adjustment will be sufficient to cover actual program obligations. If
the total fee amounts, including any increase applied, do not match or
exceed actual program obligations based on a review of the obligations
of the previous 2 years, CMS will apply an additional across-the-board
increase to each laboratory's fees by calculating the difference
between the total fee amounts and actual program obligations. If CMS
determines that the inflation adjustment is not enough to cover the
program obligations, an additional across-the-board amount will be
added to the adjustment to ensure that the fee increase is spread
equally across all fees in a flat percentage amount, which will cover
CLIA obligations. The adjusted fees will become part of the baseline
for the next biennial increase. If the level of collections was found
to be sufficient to cover program obligations, CMS will not implement a
biennial inflation adjustment or an across-the-board fee increase. With
any fee increase, the amount of the increase and a summary of CLIA
obligations along with the calculations of the increase using the CPI-U
and any determined shortfall will be published in a notice in the
Federal Register.
Table 4 shows a representation of the change in national average
laboratory fees for the two-part increase of 4.9598 percent over the
current fees with a one-time 18 percent across the board increase at
the time of implementation.

[[Page 89985]]

[GRAPHIC] [TIFF OMITTED] TR28DE23.003

[[Page 89986]]

b. Collection of Other Authorized Fees
The CLIA regulations also authorize the collection of other fees;
however, the program has historically not exercised its authority in
collecting these fees due to technical difficulties. With the
improvement in technology since 1992, we will be enforcing existing
regulatory authority in the collection of these fees as well as
clarifying circumstances when such fees are applicable. This final rule
will implement collection of these other fees, which are laboratory
specific and provide an incentive for laboratories to remain compliant
with all provisions of the CLIA regulations.
The fees include:
<bullet> A fee for follow-up surveys to determine correction of the
deficient practices found in either a CoC survey or a CoA validation
survey;
<bullet> An addition of a specialties survey fee when it is
necessary to determine compliance of testing in one or more additional
specialties outside of the CoC survey cycle;
<bullet> A substantiated complaint survey fee;
<bullet> A fee for a desk review of unsuccessful PT performance;
<bullet> A fee for a replacement certificate when a laboratory
loses or destroys a CLIA certificate and requests a replacement
certificate; and
<bullet> A fee for issuing a revised certificate when the
laboratory changes the laboratory director or other information found
on a certificate and requests a new certificate to reflect the changes.
Table 5 projects the national average fees per incident. These fees
were previously authorized in the February 1992 final rule but were not
collected. We are now finalizing the collection of these additional
fees. We totaled the number of follow-up surveys, substantiated
complaints, and unsuccessful PT events and multiplied them by the
national average number of hours recorded by the State survey agencies
for these activities in FY2019. For follow-up surveys, substantiated
complaints, and unsuccessful PT events we then multiplied that by the
national average unit cost, which is $108.78 in FY2023. The amounts for
the revised certificates and replacement certificates are the fee
amount as discussed in section II.C. of this final rule, specifically
at Sec. 493.639(a).
[GRAPHIC] [TIFF OMITTED] TR28DE23.004

BILLING CODE 4120-01-C
2. CoW Fee Increase
This final rule authorizes a fee increase for the CoW. A CoW
laboratory is limited to performing tests categorized by FDA as waived,
which are simple laboratory examinations and procedures that have an
insignificant risk of an erroneous result, including those that employ
methodologies that are so simple and accurate as to render the
likelihood of erroneous results by the user negligible, or that the
Secretary has determined pose no unreasonable risk of harm to the
patient even if performed incorrectly. Some examples of waived tests
include fingerstick tests for blood glucose or cholesterol. As part of
our financial obligations to administer the CLIA program, we compensate
FDA for its role in determining if tests and test systems meet criteria
to be categorized as waived tests/test systems. This final rule
implements a nominal increase for CoW fees which will offset program
obligations to FDA for its role under the CMS-FDA MOU (IA19-23) in
categorizing tests and test systems as waived. The obligation to CLIA,
defined by the MOU and calculated against the number of CoW
laboratories, is approximately $25 per laboratory to cover the FDA
obligation. The additional $25.00 will increase the current $180.00
biennial CoW fee to $205.00.

B. CLIA Requirements for Histocompatibility, Personnel, and Alternative
Sanctions for CoW Laboratories

CLIA requires any laboratory that examines human specimens for the
purpose of providing information for the diagnosis, prevention, or
treatment of any disease or impairment of, or the assessment of health,
of human beings to be certified by the Secretary for the categories of
examinations or procedures performed by the laboratory. The
implementing regulations at 42 CFR part 493 specify the conditions and
standards that must be met to achieve and maintain CLIA certification.
These conditions and standards strengthen Federal oversight of clinical
laboratories

[[Page 89987]]

and help ensure the accuracy and reliability of patient test results.
CMS is always looking for ways to improve our programs and better
serve our beneficiaries. Concerning laboratory oversight, HHS endeavors
to improve consistency in the application of laboratory standards,
coordination, collaboration, and communication in both routine and
emergent situations, thereby further improving laboratory oversight
and, ultimately, patient care. The regulations related to CLIA
histocompatibility and personnel requirements have not been updated
since 1992 \7\ and 2003,\8\ and the regulations for CoW laboratory
alternative sanctions have not been updated since 1992.\9\ HHS believes
it is time to update these regulations to reflect the current state of
the American health care system and new advances in technology.
---------------------------------------------------------------------------

\7\ See the ``Medicare, Medicaid and CLIA Programs; Regulations
Implementing the Clinical Laboratory Improvement Amendments of 1988
(CLIA)'' final rule with comment period (57 FR 7002) that published
in the February 28, 1992 Federal Register (hereinafter referred to
as the ``1992 final rule with comment period'').
\8\ See the ``Medicare, Medicaid, and CLIA Programs; Laboratory
Requirements Relating to Quality Systems and Certain Personnel
Qualifications'' final rule (68 FR 3640) that published in the
January 24, 2003 Federal Register (hereinafter referred to as the
``2003 final rule'').
\9\ See the 1992 final rule with comment period.
---------------------------------------------------------------------------

HHS sought expert advice to inform our decision-making on the
regulatory updates finalized in this rule. We solicited advice on
several topics addressed in this rule from the Clinical Laboratory
Improvement Advisory Committee (CLIAC), the official Federal advisory
committee charged with advising HHS regarding appropriate regulatory
standards for ensuring accuracy, reliability, and timeliness of
laboratory testing. On January 9, 2018, we also issued a Request for
Information \10\ (RFI) that solicited input from the public on issues
related to CLIA personnel and histocompatibility requirements, and
alternative sanctions for CoW laboratories. We received approximately
8,700 total comments in response to the 2018 RFI. The CLIAC
recommendations and information received in response to the 2018 RFI
helped us determine the policies that were proposed in the July 2022
proposed rule, for which we received 20,574 public comments. We
considered the public comments received in determining the policies
finalized in this final rule.
---------------------------------------------------------------------------

\10\ See the ``Request for Information: Revisions to Personnel
Regulations, Proficiency Testing Referral, Histocompatibility
Regulations and Fee Regulations Under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA)'' RFI (83 FR 1004) that
published in the January 9, 2018 Federal Register (hereinafter
referred to as the ``2018 RFI'').
---------------------------------------------------------------------------

This final rule amends histocompatibility and personnel regulations
to address obsolete regulations and update the regulations to
incorporate changes in technology. This final rule also amends Sec.
493.1804(c) to allow alternative sanctions to be imposed on CoW
laboratories. We summarize and respond to the public comments on these
proposals and summarize our final policies in section III of this final
rule.
1. Histocompatibility
The CLIA regulations include requirements specific to certain
laboratory specialties such as microbiology and subspecialties such as
endocrinology. Histocompatibility is a type of laboratory testing
performed on the tissue of different individuals to determine if one
person can accept cells, tissue, or organs from another person. The
CLIA regulatory requirements for the specialty of histocompatibility at
Sec. 493.1278, including the crossmatching requirements, address
laboratory testing associated with organ transplantation and
transfusion and testing on prospective donors and recipients. As of
January 2023, 247 CLIA-certified laboratories perform testing in this
specialty. The current specialty regulations were published in the 1992
final rule with comment period, and additional changes were made in the
2003 final rule. Specifically, the 2003 final rule changed the
regulations to decrease the number of specialty/subspecialty-specific
quality control (QC) regulations in instances where general QC
requirements would apply. The specialty of histocompatibility has not
yet been similarly updated. Many of the changes finalized in this rule
will remove histocompatibility-specific requirements from Sec.
493.1278 that we have determined are addressed by the general QC
requirements at Sec. Sec. 493.1230 through 493.1256 and 493.1281
through 493.1299. We believe that removing specific requirements for
obsolete methods and practices and eliminating redundant requirements
will decrease the burden on laboratories performing histocompatibility
testing. We have heard from interested parties, particularly the
transplantation community, that physical crossmatches are a barrier to
modernized decision-making approaches on organ acceptability based on
risk assessment.
For the crossmatching regulations that this final rule will amend,
HHS requested input from CLIAC on the acceptability and application of
newer crossmatching techniques in lieu of physical crossmatching. The
CLIAC gathered information on the acceptability and application of
newer crossmatching techniques for transplantation because there have
been advances in the field of transplantation since 1992. These
advances have made the physical crossmatch less significant in non-
sensitized patients. The CLIAC stated that histocompatibility testing
has advanced in technology overtime, from using cell-based assays to
complex testing procedures such as molecular typing and solid-phase
platforms for antibody detection, with improved accuracy and
sensitivity. Significant changes have occurred in the clinical practice
of transplantation (immunosuppression, desensitization practices), and
improvements in anti-rejection therapies have led to improved outcomes
and mitigation of risk due to human leukocyte antigen (HLA) antibodies.
At its November 2014 meeting, CLIAC made the following recommendations
\11\ for CMS to explore:
---------------------------------------------------------------------------

\11\ <a href="https://www.cdc.gov/cliac/docs/summary/cliac1114_summary.pdf">https://www.cdc.gov/cliac/docs/summary/cliac1114_summary.pdf</a>.
---------------------------------------------------------------------------

[[Page 89988]]

2003 final rule (68 FR 3713) but otherwise have remained unchanged
since we published the February 1992 final rule with comment period (57
FR 7002). In the 2018 RFI (83 FR 1005 through 1006, 1008), we sought
public comment and information related to CLIA personnel requirements
in the following areas: nursing degrees; physical science degrees;
personnel competency assessment (CA); personnel training and
experience; and non-traditional degrees. As we explained in the 2018
RFI, these are areas that the CDC, CMS, interested parties, and State
agency surveyors identified as relevant to our efforts to update the
CLIA personnel requirements to better reflect current knowledge,
changes in the academic context, and advancements in laboratory
testing.
We received approximately 8,700 comments in response to the 2018
RFI. In response to our questions about nursing degrees, the majority
of commenters did not concur that nursing degrees were equivalent to a
biological or chemical sciences degree. However, some interested
parties suggested nursing degrees could be used as a separate
qualifying degree for nonwaived testing personnel (TP). In response to
our questions about physical science degrees as well as non-traditional
degrees, interested parties commented that a physical science degree
was hard to define. In considering how to evaluate physical science and
other non-traditional degrees, some commenters recommended that we
evaluate coursework taken using a semester-hour educational algorithm
to qualify individuals for CLIA personnel positions. If an individual
has the appropriate coursework without the traditional chemical or
biological degree, the individual's educational coursework should be
considered when determining whether that individual meets the
educational requirements under CLIA. In response to the questions about
competency assessment (CA), many commenters stated that individuals
with an applicable associate degree should be permitted to perform CA
on moderate complexity TP. Some commenters stated that required
training should depend on the complexity of the testing to be performed
and that all nonwaived testing should require training related to the
individual's laboratory responsibilities. Several commenters also
stated that any required training and experience should be in a CLIA-
certified laboratory. Many commenters agreed that all training and
experience should be documented; many noted that documentation from a
former employer should be acceptable, assuming it provided specific
details about the individual's job, training, and CA.
In addition to the 2018 RFI, we requested input from CLIAC for
recommended changes to the CLIA personnel requirements found in subpart
M--Personnel for Nonwaived Testing, Sec. Sec. 493.1351 through
493.1495. In response, CLIAC established a workgroup that included
laboratory experts, representatives from accreditation organizations
(AOs), and government. The CLIAC Personnel Regulations Workgroup
provided information and data to CLIAC for their deliberation in
recommending to HHS to update the personnel regulations.\12\ CLIAC made
12 recommendations at the April 2019 meeting to improve CLIA personnel
regulations, including: (1) making biological science degrees
acceptable for laboratory personnel and considering candidates with
other degree backgrounds based on coursework; (2) removing the degree
in physical science from the CLIA regulations due to its broadness; and
(3) requiring personnel to have training and experience in their areas
of responsibility.
---------------------------------------------------------------------------

\12\ <a href="https://www.cdc.gov/cliac/docs/summary/cliac0419_summary.pdf">https://www.cdc.gov/cliac/docs/summary/cliac0419_summary.pdf</a>.
---------------------------------------------------------------------------

After the April 2019 CLIAC meeting, CMS and CDC met to review and
consider the recommendations along with the information provided in
response to the 2018 RFI. The following CLIAC recommendations support
proposals included in the July 2022 proposed rule:
<bullet> Coursework should be considered in meeting CLIA personnel
requirements;
<bullet> Degree in physical science should be removed from CLIA
regulations;
<bullet> All personnel should have appropriate training and
experience;
<bullet> Remove the statement ``possess qualifications that are
equivalent to those required for such certification'', as applicable;
<bullet> Laboratory experience should be clinical in nature;
<bullet> 20 credit hours of relevant continuing education should be
required for all LDs except those certified by the American Board of
Pathology, American Board of Osteopathic Pathology, and American Board
of Dermatology;
<bullet> LDs should make at least two reasonably spaced onsite
visits to the laboratories they direct annually. These visits should be
documented;
<bullet> Modify CLIA requirements for technical consultants (TC) to
include an associate degree and training and experience; and
<bullet> Modify the definition of mid-level practitioner to include
registered nurse anesthetists and clinical nurse specialists.
Following this, CMS and CDC collaborated to develop a list of
personnel regulation updates that we proposed in the July 2022 proposed
rule.\13\
---------------------------------------------------------------------------

\13\ <a href="https://www.federalregister.gov/documents/2022/07/26/2022-15300/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and">https://www.federalregister.gov/documents/2022/07/26/2022-15300/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and</a>.
---------------------------------------------------------------------------

3. Alternative Sanctions for CoW Laboratories
As discussed in section III.C. of the proposed rule and this final
rule, we proposed, and are finalizing, an amendment to Sec.
493.1804(c)(1) to allow CMS to impose alternative sanctions on CoW
laboratories, as appropriate. CoW laboratories are laboratories that
only perform waived tests, that is, simple laboratory examinations and
procedures that have an insignificant risk of an erroneous result. For
example, a urine dipstick pregnancy test is a waived test. The current
regulations state that we do not impose alternative sanctions on CoW
laboratories because those laboratories are not inspected for
compliance with condition-level requirements (Sec. 493.1804(c)(1)).
However, while not subject to the biennial routine surveys, CoW
laboratories are surveyed as a result of a complaint, and based on the
complaint survey, may be found to be out of compliance with a
condition-level requirement. In the absence of alternative sanctions,
our only recourse in cases of compliance issues found at CoW
laboratories is to apply principal sanctions (that is, revocation,
suspension, or limitation of the CLIA certificate). We believe the
ability to levy alternative sanctions (that is, civil money penalties,
a directed plan of correction, a directed portion of a plan of
correction, and onsite State monitoring) on CoW laboratories helps CMS
ensure appropriate sanctions are applied to CoW laboratories, as in the
case of other certificate types (certificate of PPM, CoR, CoC, CoA).
In addition, we believe that this finalized change will reduce
burden on CoW laboratories. The ability to impose alternative sanctions
will be particularly useful in instances in which we find PT referral
violations. PT is the testing of unknown samples sent to a laboratory
by an HHS-approved PT program to

[[Page 89989]]

check the laboratory's ability to determine the correct testing
results. This final rule amends the CoW regulations at Sec.
493.1804(c)(1) to allow for the application of alternative sanctions
where warranted, in addition to or in lieu of principal sanctions.
We note that while the regulatory text at Sec. 493.1804(c)(1)
currently specifies that CMS will not impose alternative sanctions on
laboratories that have CoWs because those laboratories are not
inspected for compliance with condition-level requirements, this
distinction is not required by the applicable statute at 42 U.S.C.
263a(h). Therefore, as discussed in section III.C. of this final rule,
we proposed to remove, and are finalizing the removal of, the current
parenthetical at Sec. 493.1804(c), which states ``(Except for a
condition level deficiency under Sec. Sec. 493.41 or 493.1100(a), CMS
does not impose alternative sanctions on laboratories that have
certificates of waiver because those laboratories are not routinely
inspected for compliance with condition-level requirements.)''. We note
that the language ``Except for a condition level deficiency under
Sec. Sec. 493.41 or 493.1100(a)'', which was inadvertently omitted
from the discussion of this parenthetical in the July 2022 proposed
rule, was added in the Medicare and Medicaid Programs, Clinical
Laboratory Improvement Amendments (CLIA), and Patient Protection and
Affordable Care Act; Additional Policy and Regulatory Revisions in
Response to the COVID-19 Public Health Emergency interim final rule
with comment period, published in the September 2, 2020, Federal
Register (85 FR 54820). This language was only effective during the PHE
for COVID-19 which ended on May 11, 2023. Consistent with the finalized
amendment to remove the current parenthetical at Sec. 493.1804(c),
this language will also be deleted as of the effective date of this
final rule.
In responses received from the 2018 RFI, commenters noted that
alternative sanctions instead of principal sanctions should be an
option to create parity for all certificate types, especially in cases
of PT referral. Further, commenters also stated that CoW laboratories
should be held to the same standards and level of compliance as those
that perform moderate complexity and/or high complexity testing.

II. Provisions for CLIA Fees

This final rule will amend subpart F--General Administration in the
CLIA regulations. This section provides an overview of the proposed
revisions to the CLIA fee requirements established by the February 1992
final rule. We also summarize and respond to the public comments on the
July 2022 proposed rule and state our final policies.

A. Definitions of ``Replacement Certificate'' and ``Revised
Certificate'' (Sec. 493.2)

At Sec. 493.2, we proposed to add definitions for ``Replacement
certificates'' and ``Revised certificates.'' After several years of
experience and data analysis, it has been determined that the number of
reissued certificates continues to be remarkable. Reissued certificates
fall into two different categories: revised and replacement
certificates. For further discussion please refer to section II.C. of
this final rule. We proposed that these definitions be added to Sec.
493.2 with the other definitions listed to allow clarity in the
regulations where fees for replacement and revised certificates are
being proposed.
We did not receive any public comments on the proposed definitions
at Sec. 493.2 of ``replacement certificate'' or ``revised
certificate'' and are finalizing those definitions as proposed.

B. Changes to Certificate Fees (Sec. 493.638)

At Sec. 493.638(a), we proposed to amend the regulatory language
to clarify when a laboratory is required to pay a certificate fee and
when the certificate is issued. We removed the listing of the
individual certificates in the first paragraph of this section as all
certificates go through the same process. The current regulation text
specifies when a certificate fee is required, but we wish to clarify
with more specific wording. The certificate fee is currently incurred
when the original certificate is issued; when the certificate is
subsequently renewed; if there is a change in certificate type
requiring a new certificate to be issued; or if a lapsed certificate is
reactivated with a gap in service and therefore reissued. The intent of
the regulation is not changing. We believe adding this clarification
would improve transparency concerning the requirement to pay
certificate fees.
Specifically, at Sec. 493.638(a)(1) for registration certificates,
we proposed to remove the reference to the CoC because we believe the
flat fee charged for a CoR and the temporary nature of the certificate
require a separate section. We proposed to redesignate the fees
associated with a CoC to a new provision at Sec. 493.638(a)(5) to keep
fee information relevant to the different certificate types separate,
rather than referencing the certificate types together.
At Sec. 493.638(a)(2) for CoW, we proposed to add the costs
incurred by FDA to determine whether a test system meets the criteria
for waived status, as specified at Sec. 493.15(d). A CMS
representative reviews an application for a CoW to determine whether
the applicant has requested a CLIA certificate that covers the testing
they have listed on the application that they will be performing. The
cost of such a review is already part of the CoW fee. However, FDA must
expend resources reviewing tests, procedures, and examinations to
determine whether a test meets the criteria to be designated as waived.
This expense is not currently captured in the fee for a CoW, and we
proposed that it should be. HHS had delegated the responsibility to FDA
for the review of test systems and assignment of complexity, including
what is required by Sec. 493.15(d). CMS compensates FDA out of the
CLIA funds for this determination under the CMS-FDA MOU (IA19-23). CoW
laboratories are restricted to using waived tests. We believe that the
regulatory restrictions of test systems for the CoW laboratories and
the CMS requirement to determine what tests can be performed in a CoW
laboratory under Sec. 493.15(d) require us to place this fee on the
CoW laboratories alone. We believe the predicted increase in CoW
laboratories will offset expected increases in the obligation to FDA
for the continued process of review and categorization of tests as
waived.
We proposed to make editorial changes to clarify the current
provision Sec. 493.638(b) that describes certificate fee amounts. We
proposed to separate this section into four shorter paragraphs
designated as Sec. 493.638(b)(1) through (4). Proposed Sec.
493.638(b)(1) stated that CMS will publish a notice in the Federal
Register when assessed fees are adjusted in accordance with Sec.
493.680. This section also includes a brief discussion of the basis for
certificate fees as set forth in Sec. 493.638(c). Proposed Sec.
493.638(b)(2) stated that certificate fees would be collected at least
biennially. Certificate fees may be assessed more frequently than every
2 years if the laboratory changes its certificate type. Proposed Sec.
493.638(b)(3) stated how fees would be determined and proposed Sec.
493.638(b)(4) stated that CMS would notify the laboratories when the
fees are due and the fee amount. This currently takes place in the form
of a fee coupon sent through U.S. Mail by the Billing and Certificate
Issuance contractor.
We also proposed to move the regulatory text currently found at

[[Page 89990]]

Sec. 493.643(c)(1) through (3) to a new provision at Sec. 493.638(c)
to align the provisions more closely for laboratory schedules and
specialties with the related provisions concerning certificate fees.
Our intent is to refer back to this provision when the compliance fees
are discussed. In addition to redesignating this regulatory text, we
proposed making minor changes to clarify the regulatory text related to
specialties of service before those specialties are explained at Sec.
493.643(c)(3).
At the proposed new Sec. 493.638(c)(3), we proposed to redesignate
the regulatory text currently at Sec. 493.643(c)(1) with changes. We
believe that the separation of Schedule A into two parts at Sec.
493.643(c)(1)(i)(A) and (B) was confusing, and we proposed listing them
as separate schedules. The proposed text in the new provision Sec.
493.638(c)(3) included Sec. 493.638(c)(3)(i) through (xi). At Sec.
493.638(c)(3)(i), we proposed describing the low volume schedule as
Schedule V to differentiate it from Schedule A, proposed at Sec.
493.638(c)(3)(ii). Current data processing system requirements have
been built to refer to the low volume A schedule laboratories as
Schedule V and will continue with the new data system.
We received public comments on these proposals. The following is a
summary of the public comments we received and our responses.
Comment: Several commenters supported the proposed increase in
fees, including the fees for replacement certificates. However, several
other commenters expressed concerns about the fee increase and new
fees, specifically, the potential impact on rural areas or smaller
laboratories, including private physician office laboratories.
Commenters stated laboratories in this defined population may need to
limit, reduce or discontinue services, which would negatively impact
the populations served. Commenters stated many laboratories already
experience hardship with growing labor costs, combined with shortages
and increased costs of supplies and that raising CLIA fees presents
another hardship. Several commenters expressed concerns about raising
the CLIA laboratory fees during a time when CMS has made cuts to
laboratory test reimbursement under the Protecting Access to Medicare
Act (PAMA). The commenters stated that broad increases in regulatory
costs may adversely impact the ability to provide clinical laboratory
services, particularly in resource-limited settings.
Response: As a user-fee funded program, CLIA must collect fees to
cover the cost of implementing the program. However, the existing fee
collections are not sufficient to cover total costs of laboratory
oversight. The CLIA fees are structured on annual test volume and
number of specialties so that smaller (lower annual test volume)
laboratories' fees are less than larger (higher annual test volume)
laboratories. The fee increase allows us to fund and sustain the CLIA
program to ensure oversight of laboratory testing. We note that
reimbursement rates are outside the scope of the rule, are set by
statute, and are not related to raising the CLIA fees.
Comment: Several commenters requested CMS provide transparency in
how the 20 percent increase in 2019 stabilized the CLIA program and
publish additional detail related to the CLIA total program costs.
Response: We thank the commenters for these comments. The funds
collected in the CLIA program must maintain funding levels to sustain
the program. The 2019 20 percent across the board increase was used to
shore up the program facing crucial deficiencies at that time. The
increase implemented in this final rule is meant to stabilize the
program so that adjustments based on inflation will apply
automatically. While we proposed a 20 percent across the board
increase, based upon our analysis in section I. of this final rule and
Table 3, we are instead finalizing an 18 percent across the board
increase based on consideration of updated inflation assumptions,
laboratory counts, workload estimates and available funds. CMS reviewed
updated estimates of program spending, user fee collections, carryover,
and inflation. As displayed in Table 3, we found that increases in
actual carryover, actual collections, new and increased fee collections
and estimated changes in CPI-U, when applied to actual program
obligations, allowed CMS to assess a lower across-the-board inflation
factor to the existing user fees and still meet planned carryover
targets.
Comment: A commenter stated that the activities associated with
processing CLIA certificates of waiver at the State Agency should be
allocated more effectively.
Response: We appreciate the commenter's input, but this is outside
the scope of the rule. The fees from all collections are used to
support the whole of the CLIA program including activities for waived
laboratories and the FDA's role in categorizing tests and test systems
as waived.
Comment: Several commenters expressed concerns that the fee
increase will negatively impact the small office laboratories and
private physician laboratories as these types of laboratories will not
be profitable enough to offer services or will severely limit services.
Commenters further expressed concerns that most of these laboratories
are still being negatively impacted by the public health emergency and
requested that CMS consider suspending the fee increase for these
laboratory types for at least 2 years.
Response: The CLIA regulations were framed to establish quality
standards for all laboratories regardless of size or facility type. As
such, collection of fees from all types of laboratories is necessary in
order for the program to be self-funded as mandated by statute. As
previously noted, the CLIA fee schedule is structured so that the
lowest volume laboratories pay the lowest CLIA fees. We appreciate the
commenters sharing these concerns, but believe it is necessary to
finalize the proposed fee increase at this time in order to sustain the
CLIA program.
After consideration of the comments received, we are finalizing the
proposed changes to Sec. 493.638 without modification. As discussed
previously, after recalculating the needs of the program using updated
data, we are finalizing an across the board increase of 18 percent that
will be applied to all fees, except for replacement and revised
certificates.

C. Changes to Fees for Revised and Replacement Certificates (Sec.
493.639)

At Sec. 493.639, we proposed to revise the current section heading
(``Fee for revised certificate'') to read as ``Fee for revised and
replacement certificates'' to match the contents of the section as
amended to include both revised certificates and replacement
certificates. We proposed to define and explain revised and replacement
certificates in section II.A. of the proposed rule. In the proposed
provision at Sec. 493.639, we explained the fees associated with each
type.
At Sec. 493.639(a), we proposed removing the reference to
registration certificates as the section applies to all CLIA
certificate types under the statutes. We also proposed to amend the
circumstances in which a laboratory may request a revised certificate
to include changes to laboratory name and location, LD, or services
offered (specialties and subspecialties). We proposed the fee be based
on the national average cost to issue the revised certificate. However,
due to differing amounts of work required per certificate type, the fee
is not the same for all certificate types. Please see Table 6.

[[Page 89991]]

We determined the time and resources required to enter changes to
laboratory demographics, review of specialties and subspecialties, and
review of LD qualifications using an average of the State survey
agencies' calculated unit hourly cost. The State unit hourly cost is
determined by the CLIA budget office and is based on a formula of total
State costs divided by the total paid hours. The total State costs are
reported to CMS by the State survey agencies and include staff salaries
as determined by each State's civil service pay scale, fringe benefits,
travel costs, and other costs such as office supplies, computers
containing software required to perform and report a CLIA survey, etc.
The total staff year hours are determined by multiplying the number of
full-time employees (FTE) by 1600 hours, representing the productive
work year.
The time and resources for State agencies to enter demographic
changes are less than those where the qualifications of the LD or
services need to be reviewed to ensure CLIA personnel requirements are
met. Review of LD qualifications applies to laboratories holding a CoC,
a certificate for PPM, or CoR.
AOs are responsible for reviewing CoA LD qualifications, and the AO
is also responsible for reviewing the addition of specialties and
subspecialties for the CoA laboratory. As such, State agency staff are
not responsible for reviewing LD qualifications or changes in
specialties/subspecialties for laboratories with a CoA; however, they
are responsible for processing the other demographic change requests
for CoA laboratories. Therefore, a revised certificate for a CoA
laboratory does not include the cost to review the qualifications of
LDs, nor does it include the adding or deleting of specialties or
subspecialties.
For a CoC, a change in services (adding or deleting a specialty or
subspecialty) does not include review to determine compliance with the
regulations for services added; however, the entry or deletion of
specialty or subspecialty changes requires State agency personnel time
and resources.
CLIA personnel requirements are not required for laboratories with
a CoW, nor are there specialty or subspecialty requirements. Therefore,
the time and resources required to enter requested demographic changes
for CoW laboratories are less than for other certificate types. Please
see the section below for the calculations used to determine these fee
amounts.
We proposed the following fees for issuing revised certificates:
[GRAPHIC] [TIFF OMITTED] TR28DE23.005

The revised certificate fee would be paid prior to the issuance of
the revised certificate.
At Sec. 493.639(a)(1), we proposed a new provision explaining that
the addition of services (that is, specialties/subspecialties) for
laboratories with a CoC may result in an additional fee for purposes of
determination of compliance if added services require an inspection.
That addition of the specialties inspection fee is described in a new
provision at Sec. 493.643(d)(2).
We proposed to delete the current provisions at Sec. 493.639(b)(1)
and (2), which provide information on fees for issuing a revised
certificate and scenarios that describe changes that may require a
change in certificate. We proposed to replace them with a new provision
at Sec. 493.639(b) that outlines fees for issuing a replacement
certificate. We believe the current provisions are confusing as written
as is the location of the provisions in the regulations.
At the new provision Sec. 493.639(b), we proposed a fee for
issuance of replacement certificates as discussed in section II.A. of
the proposed rule. The proposed requirement must account for the time
and resources required to issue a replacement certificate when
requested. Historically, replacement certificates have been issued
without additional fees when a laboratory loses or destroys its current
certificate. As discussed in the proposed rule, we have determined that
the actual cost of issuing a replacement certificate is $75.00. A
replacement certificate is one where no changes are being requested.
The fee would be paid prior to the issuance of the replacement
certificate.
The initial calculations used to determine the proposed fee amounts
for replacement certificates, and revised certificates were based on
the time, and the average State unit costs for 2019 when these fees
were set. When these calculations were made, the national average unit
hourly cost in 2019 was $72.06. It was determined that it took State
agency personnel approximately 45 minutes to receive, review, and enter
a request for a replacement certificate and another 15 minutes to print
and mail the certificate. Using these estimates, the cost of the
replacement certificate is calculated to cost the CLIA program $75.00
currently.
Furthermore, CMS determined that additional State agency resources
are expended when issuing revised certificates as follows:
<bullet> An additional 15-20 minutes to review and enter requested
demographic changes or $20.00 for all certificate types.
<bullet> An additional 45 minutes to review and enter requested
laboratory director changes or specialty changes for $55.00 for revised
CoRs, CoCs, and PPMs.
These additional costs are therefore reflected in the proposed fees
for issuing revised certificates. (See Table 6)
We received public comments on these proposals. The following is a
summary of the public comments we received and our response.
Comment: Several commenters suggested CMS establish a process that
would allow a laboratory to print its own certificates, rather than
having to request and pay a replacement certificate fee as proposed.
The commenters asserted that the established process of mailing and
relying on mail delivery service is outdated and antiquated and that
often the laboratory may not receive a copy of the certificate, due to
mail delivery interruptions.
Response: We thank the commenters for this suggestion. As of March
2023,

[[Page 89992]]

CMS began issuing a link to electronic certificates so laboratories
could print their own certificate.
After consideration of the comments received, we are finalizing the
proposed changes to Sec. 493.639 without modification.

D. Changes to Fees Applicable to Laboratories Issued a CoC (Sec.
493.643)

At Sec. 493.643, we proposed renaming the section heading ``Fee
for determination of program compliance'' to ``Additional fees
applicable to laboratories issued a certificate of compliance'' for
clarification.
We proposed adding language at Sec. 493.643(b) to describe the
costs included in the fee for routine inspections to increase
transparency. We proposed deleting the second sentence of Sec.
493.643(b) in consideration of a two-part biennial fee increase as
discussed under section II.H. (Sec. 493.680) of the proposed rule and
this final rule. For clarity, we proposed to redesignate the third
sentence of the current provision at Sec. 493.643(b) as Sec.
493.643(c).
At the new provision Sec. 493.643(c)(1), we proposed that the
inspection fee will be based on the schedules of the laboratories as
defined in the new provision under Sec. 493.638(c)(3). The fee amounts
assigned to the schedules in the February 1992 final rule were based on
an estimated number of hours to perform a survey of a laboratory with
the scope and volume associated with each schedule multiplied by an
estimated 1992 hourly rate for a surveyor of $35.00. The established
hourly rate of $35.00 was intended to be used as a baseline and then
revised after actual data were collected and experience gained (57 FR
7193). In 1992 it was anticipated that the universe of regulated
laboratories would be much greater than those regulated prior to the
implementation of CLIA `88.
The hourly rate for performing laboratory surveys is recalculated
by CMS for each State annually to determine the CLIA obligation to
support the State survey agencies but has not been used to increase
CLIA fees on an ongoing basis. The national average hourly rate in 2023
is $108.78, to reflect updated data. A description of the national
average hourly rate calculation is provided in section II.C. of the
proposed rule.
Extensive data collected over time now enables us to better
estimate the number of hours it takes for a surveyor to perform an
inspection of a laboratory within each schedule. Such estimates are
primarily driven by the scope and volume of tests run by the laboratory
and the laboratory's compliance with the CLIA regulations. A laboratory
with a high-test volume and multiple specialties may have processes and
practices that allow it to meet and exceed CLIA regulations as they
operate with a high degree of quality and efficiency while ensuring
reported results are accurate and timely to provide optimum patient
care. The surveyor will likely spend less time on inspecting that
laboratory. In contrast, if a laboratory with a small test volume and
few specialties does not have processes and practices that allow it to
operate with the same high degree of quality and efficiency, such a
laboratory is likely not to meet the CLIA requirements. Such
laboratories may be reporting test results that may not be accurate and
reliable. While the test volume may be low, the surveyor will likely
spend additional time surveying such laboratories due to the less-than-
optimal operations and processes.
Conversely, the number of hours needed to survey a large laboratory
with poor compliance history could be quite large. The surveyor would
spend more time in this laboratory, and given the size and poor
compliance history, the surveyor would review the prior survey
deficiencies to ensure the laboratory's monitors put into place have
corrected the deficiency. In contrast, a surveyor may not need to spend
as many hours to survey a laboratory with lower test volume and
specialties and a favorable compliance history. Taking each scenario
into account, we believe the average number of hours a surveyor spends
in each laboratory reflects the universe of laboratories within each
schedule. Thus, as we explained in the proposed rule, we will not be
changing the differences between the amounts of the fees within the
compliance fee schedules relative to each other. They will remain in
their relative amounts and be increased across the board by the same
percentage in the proposed two-part fee increase (section II.H. (Sec.
493.680) of the proposed rule and this final rule).
Table 7 illustrates the different scenarios mentioned previously in
the proposed rule and this final rule and how the number of hours spent
on the survey vary based on both the size (the schedule) of the
laboratory and poor compliance with the CLIA regulations. Poor
compliance is being defined for this illustration as a laboratory with
at least one condition-level deficiency cited during a survey. For
information about condition-level deficiencies, please see the CLIA
website for the Interpretive Guidelines for Laboratories, Appendix C:
Interpretive Guidelines.\14\
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\14\ <a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_c_lab.pdf">https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_c_lab.pdf</a>.

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[[Page 89993]]

[GRAPHIC] [TIFF OMITTED] TR28DE23.006

As illustrated in Table 7, survey hours in small laboratories
without condition level deficiencies averaged 12 hours. In contrast,
survey hours in small (schedules V-A) laboratories with condition level
deficiencies averaged 18 hours. In the largest (schedule J)
laboratories, survey hours differed from an average of 32 hours spent
in laboratories without condition level deficiencies compared to 75
hours in those laboratories that had condition level deficiencies
cited.
The February 1992 final rule did not consider other costs involved
in the inspection process, such as continuous training of the State
surveyors and monitoring of the State agency program processes by the
CMS Locations (Regional Offices). The CLIA program has created and
continuously updates periodic training for surveyors through online
training modules, onsite meetings, and conference calls.
The surveyors are individually monitored with a Federal Monitoring
Survey (FMS) process where CMS location (Regional Office) Federal
surveyors observe the individual State surveyor on a survey or perform
a survey of the same laboratory after the State surveyor has completed
their survey to confirm that the State surveyor is competent and
following the prescribed survey process. The CMS locations (Regional
Offices) also perform an annual State Agency Performance Review (SAPR)
for each State survey agency, including a review of the State survey
agency's training processes and monitoring processes for their State
surveyors. This includes a review of the deficiency reports State
surveyors have sent to laboratories to determine that the surveyor is
following the program's principles of documentation and the proper
survey process.
There are also costs to the program to maintain a computerized
system for entering inspection findings and compliance monitoring,
including proficiency testing. The computer system also allows the CMS
locations to run reports to monitor the inspections entered by the
State surveyors.
The compliance fees have historically been based on the costs to
the CLIA program for the State agencies. These aforementioned
activities are obligations outside of the State survey agency annual
budgets. We therefore proposed that inspection fees for laboratories in
each schedule and State will no longer be determined solely by the
estimated hours spent on a survey of a laboratory within each schedule
nor by the surveyor hourly rate of $35.00 established in 1992.
We believe that the compliance fees currently set within the
schedules should continue to be used but that additional fees, as
previously described, should be added to the regulatory scheme. All
fees would be increased biennially following the biennial two-part fee
increase as proposed in the proposed rule in Sec. 493.680.
We believe we are authorized to calculate these fees per laboratory
schedule (or group) even though the fees will no longer be determined
solely by the estimated hours spent on a survey of a laboratory within
each schedule nor by the 1992 surveyor hourly rate of $35.00 based on
section 353(m)(3)(C) of the PHSA, which states that, fees shall vary by
group or classification of laboratory, based on such considerations as
the Secretary determines are relevant, which may include the dollar
volume and scope of the testing being performed by the laboratories. As
discussed in the proposed rule, we believe our proposals are within the
bounds of our authority under the PHSA.
At Sec. 493.643(c)(2), we proposed to redesignate language from
the current Sec. 493.643(b) which states the fees are assessed and
payable biennially. We stated that we believe this will support the
two-part fee increase proposed in the proposed rule and described in
Sec. 493.680.
At the new provision Sec. 493.643(c)(3), we proposed that the fee
amount would be the amount applicable to a given laboratory increase
listed in the most recent published CLIA fee increase notice in the
Federal Register.
We proposed to redesignate current Sec. 493.643(d)(1) and (2)
where additional fees for CoC laboratories are discussed as Sec.
493.643(d)(2) and (3) and to redesignate the fourth and fifth sentences
of current provision Sec. 493.643(b) where an additional fee for a
follow-up survey on a CoC laboratory is discussed as a new provision at
Sec. 493.643(d)(1). We believe the discussion of additional fees for
CoC laboratories should be grouped together.
We proposed to move the current regulatory text at Sec.
493.643(d)(2) to Sec. 493.643(d)(3) with no changes. Current
regulation allows additional fees to be assessed for substantiated
complaints; however, this has not been implemented. The proposed rule
would

[[Page 89994]]

implement fees for substantiated complaints, meaning those complaints
where the allegations against the laboratory were found to be true by
CMS. We believe implementing the fee for substantiated complaints would
cover the costs required to perform such a survey, including
documenting the deficiencies found to be violated, preparing a report
for the laboratory, and review of the laboratory's plan of correction
and monitoring their correction. The fee was proposed to be limited to
the cost of the actual time and resources required for these
activities.
At new provision Sec. 493.643(d)(4), we proposed to establish an
additional fee for CoC laboratories that are found to have unsuccessful
PT through a PT desk review. Current policy requires the review of PT
performance every 30-45 days for each laboratory with a CoC that
performs testing and is enrolled in PT for an analyte or test included
in subpart I. Cases of unsuccessful PT performance require a PT desk
review to confirm. Upon confirmation, the laboratory is notified of its
regulatory requirement to investigate and correct the unsuccessful PT
performance. Currently, such PT desk reviews do not generate an
additional fee; however, conducting the desk review requires surveyor
time and resources. We believe this new fee would cover the costs of
the desk review, including documenting the deficiencies found to be
violated, preparing a report for the laboratory, and reviewing the
laboratory's plan of correction and monitoring their correction. The
proposed fee is to be limited to the cost of the actual time and
resources required for these activities. We stated in the proposed rule
that only laboratories with unsuccessful PT performance would be
impacted if this rule is finalized.
The fees described in Sec. 493.643(d) must be paid, or HHS will
revoke the laboratory's CoC.
We did not receive public comments on the proposed changes to Sec.
493.643 and are finalizing as proposed.

E. Changes to Additional Fees Applicable to Laboratories Issued a CoA,
CoW, or Certificate for PPM Procedures (Sec. 493.645)

At Sec. 493.645, we proposed to change the current section heading
(``Additional fee(s) applicable to approved State laboratory programs
and laboratories issued a certificate of accreditation, certificate of
waiver, or certificate for PPM procedures'') to clarify the contents of
the section as amended. The proposed title was ``Additional fees
applicable to laboratories issued a certificate of accreditation,
certificate of waiver, or certificate for PPM procedures.''
We proposed to move in its entirety the regulatory text regarding
the fee we charge State laboratory programs for costs related to their
CLIA-exempt laboratories in Sec. 493.645(a)(1) through (3) to Sec.
493.649(a)(1) through (3). We believe the fees for approved State
laboratory programs should be listed separately from the other CLIA-
certified laboratories in the regulations. A State laboratory program
is a laboratory program that HHS approves as exempt due to the State
requirements being equal to or more stringent than the CLIA
requirements. Under such programs, the State provides regulatory
oversight of its laboratories in lieu of such laboratories being
regulated by HHS. HHS approves and monitors such State laboratory
programs to ensure that the standards of the State laboratory programs
are and remain at least as stringent as the CLIA regulations. HHS does
not impose fees on laboratories covered by these programs but charges a
fee to the program as described in the new provision at Sec. 493.649.
We proposed making editorial corrections to the references of
Sec. Sec. 493.645(a) and 493.646 noted in Sec. Sec. 493.557(b)(4) and
493.575(i) and replacing those references with Sec. Sec. 493.649(a)
and 493.655(b). The requirements previously included at Sec. Sec.
493.645(a) and 493.646(b) governing applicable fees were proposed to be
redesignated as Sec. 493.649(a) and new Sec. 493.655(b).
We further proposed redesignating current Sec. 493.645(b)(1) and
(2) regarding the payment of inspection fees as new Sec. 493.645(a)(1)
and (2). We proposed new Sec. 493.645(a)(1) to clarify the amount
accredited laboratories pay for their inspection (validation survey)
fees by removing the last sentence of the current regulatory text,
which reads that these costs are the same as those that are incurred
when inspecting nonaccredited laboratories. We believe this does not
fully explain how the fee is determined. This fee is based on fees that
CoC laboratories pay for compliance inspections; however, an accredited
laboratory is only assessed 5 percent of the fee a CoC laboratory pays
because only 5 percent of CoA laboratories are inspected (undergo a
validation survey) annually. For example, a CoC laboratory classified
as ``schedule D'' currently pays an average biennial compliance fee of
$2,336.00. The accredited laboratory classified as ``schedule D'' would
currently pay an average biennial inspection (validation survey) fee of
$117.00.
At new Sec. 493.645(a)(2), we proposed redesignating the provision
from current Sec. 493.645(b)(2), with no changes. This provision
established an additional fee if a laboratory issued a CoA were to be
inspected and follow-up visits were necessary because of identified
deficiencies. Historically this fee had not been implemented due to
technical difficulties described previously in the proposed rule. We
proposed that it be implemented. As stated in the current regulatory
text, the additional fee to cover the cost of these follow-up visits
would be based on the actual resources and time necessary to perform
the follow-up visits. Also, as stated in the regulatory text, HHS would
revoke the laboratory's CoA for failure to pay the fee.
At new Sec. 493.645(b), we proposed redesignating the provision
from current Sec. 493.645(c). This provision established a fee for
substantiated complaint surveys, those in which the allegations against
the laboratory were found to be true, on CoA, CoW, or certificate for
PPM procedures laboratories. Historically, this fee has not been
implemented. We believe implementing the fee for substantiated
complaints would cover the costs required to perform such a survey,
including documenting the deficiencies found to be violated, preparing
a report for the laboratory, and review of the laboratory's plan of
correction and monitoring their correction. The fee is limited to the
actual time and resources required for these activities.
We did not receive public comments on the proposed changes to
Sec. Sec. 493.557, 493.575, and 493.645 and are finalizing as
proposed.

F. Changes to Additional Fees Applicable to Approved State Laboratory
Programs (Sec. 493.649)

At Sec. 493.649, we proposed to delete the current language in its
entirety and replace it with language from Sec. 493.645(a)(1) through
(3). We stated in the proposed rule that the current provision at Sec.
493.649 would no longer be needed as the methodology for determining
inspection fees because the proposed rule was not based on a surveyor
hourly rate. At new Sec. 493.649, we proposed revising the current
section heading (``Methodology for determining fee amount'') to give a
clear meaning of the contents of the section as amended. The proposed
title was ``Additional fees applicable to approved State laboratory
programs.'' We proposed replacing the current language with current
provisions Sec. 493.645(a)(1) through (3) with minor changes (removing
``costs of'' from current

[[Page 89995]]

493.469(a)(3)). The provisions at Sec. 493.645(a)(1) through (3)
outline the fees applicable to approved State laboratory programs and
have been comingled with the provision that outlines the fees for
accredited PPM and CoW laboratories. We believe separating this
provision from the other laboratory certificate types will allow for
improved readability and understanding.
We did not receive public comments on the proposed changes at Sec.
493.649 and are finalizing as proposed.

G. Changes to Payment of Fees (Sec. Sec. 493.646 and 493.655)

At Sec. 493.646, we proposed redesignating the current provision
with minor changes corresponding to the validation survey cost as new
Sec. 493.655 and including a reference to Sec. 493.563 that contains
the validation inspection information. We believe this provision which
outlines the payment of fees, is better placed after discussions of the
different types of fees.
We proposed redesignating Sec. 493.646(a) and (b) where the
payment of fees is discussed to new provisions at Sec. 493.655(a) and
(b) with a minor change referencing approved State laboratory programs
instead of State-exempt laboratories. The State program pays CMS, not
the individual laboratories.
We did not receive public comments on the proposed changes at
Sec. Sec. 493.646 and 493.655 and are finalizing as proposed.

H. Methodology for Determining the Biennial Fee Increase (Sec.
493.680)

At new provision Sec. 493.680, we proposed a biennial two-part fee
increase, which would be calculated as described in section I.B. of the
proposed rule and published as a notice with a comment period at least
biennially. Should the off-year of the biennial increase result in
unexpected program obligations, CMS may need to calculate an additional
fee increase based on either the CPI-U or difference in obligations and
total collected fees or a combination of both. Any unexpected program
obligations that are identified during the off-year would be
incorporated into the biennial increase. All fees, existing and
proposed, mentioned in the proposed rule would also be subject to the
biennial two-part fee increase.
We did not receive public comments on proposed Sec. 493.680 and
are finalizing as proposed.

III. Provisions for CLIA Requirements for Histocompatibility,
Personnel, and Alternative Sanctions for CoW Laboratories

This final rule amends subpart K--Quality System for Nonwaived
Testing, subpart M--Personnel for Nonwaived Testing, and subpart R--
Enforcement Procedures in the CLIA regulations. This section provides
an overview of the proposed revisions to the CLIA requirements for
histocompatibility, personnel, and application of alternative sanctions
for CoW laboratories originally established by the February 1992 final
rule with comment period (57 FR 7002), subsequently modified in 1995
\15\ and 2003,\16\ and currently specified in subpart A--General
Provisions, subpart K--Quality System for Nonwaived Testing, subpart
M--Personnel for Nonwaived Testing, and subpart R--Enforcement
Procedures. We also summarize and respond to comments on the July 2022
proposed rule in this section and summarize the final actions for each
of the new or revised sections of the regulations.
---------------------------------------------------------------------------

\15\ 60 FR 20047, April 24, 1995 (<a href="https://www.govinfo.gov/content/pkg/FR-1995-04-24/pdf/95-9953.pdf#page=13">https://www.govinfo.gov/content/pkg/FR-1995-04-24/pdf/95-9953.pdf#page=13</a>).
\16\ 68 FR 3640, January 24, 2003 (<a href="https://www.govinfo.gov/content/pkg/FR-2003-01-24/pdf/03-1230.pdf">https://www.govinfo.gov/content/pkg/FR-2003-01-24/pdf/03-1230.pdf</a>).
---------------------------------------------------------------------------

We received 20,574 public comments in response to the July 2022
proposed rule. The commenters represented individuals, laboratory
accreditation organizations, laboratory professional organizations,
government agencies, healthcare organizations, and businesses,
including in vitro diagnostics manufacturers. The majority of the
comments were a standard ``form letter'' opposing the proposal to
include nursing degrees in the qualifications for high complexity
testing personnel. In addition to the duplicate form letters, we
received over 750 comments related to the inclusion of nursing degrees
for moderate and high testing personnel qualifications.

A. Changes to Histocompatibility Requirements

In the proposed rule, we proposed to amend the histocompatibility
regulations under CLIA by removing obsolete regulations and removing
requirements that are also imposed under the general requirements. We
also proposed to update the histocompatibility regulations to
incorporate current practices and technological changes in Human
leukocyte antigen (HLA) typing, antibody screening and identification,
crossmatching and transplantation.

1. General, Human leukocyte antigen (HLA) Typing, Disease-Associated
Studies, and Antibody Screening and Identification (Sec. 493.1278(a)
through (d))

At Sec. 493.1278(a)(1), we proposed to amend the requirement by
changing ``an audible alarms system'' to ``a continuous monitoring and
alert system'' because this allows the laboratories more flexibility in
determining the best way to monitor refrigerator temperatures. It is
very important to monitor temperatures continuously, so that recipient
and donor specimens and reagents are stored at the appropriate
temperature to ensure accurate and reliable testing.
At Sec. 493.1278(a)(2), we proposed to modify the requirement by
expanding the regulatory language to include that the laboratory must
establish and follow written policies and procedures for the storage
and retention of patient specimens based on the specific type of
specimen because the type and duration of specimen storage are equally
important as ease of retrieval. We are retaining the requirement that
stored specimens must be easily retrievable.
At Sec. 493.1278(a)(3), we proposed deleting the labeling
requirement for in-house prepared typing sera reagent. If a laboratory
is performing histocompatibility testing, this requirement under the
general reagent labeling requirements for all test systems must be met
under Sec. 493.1252(c) and, therefore, is duplicative.
At Sec. 493.1278(a)(4), we proposed to revise this requirement by
removing the examples (that is, antibodies, antibody-coated particles,
or complement) to clarify that these technologies, as well as current
and future technologies, are allowed for the isolation of lymphocytes
or lymphocyte subsets. We also proposed clarifying the requirement by
adding ``identification'' of lymphocytes, or lymphocyte subsets. In
this type of testing, lymphocytes can be isolated, but the subsets (B
and T cells) are identified rather than isolated. Due to the proposed
changes to Sec. 493.1278(a)(3), we also proposed to redesignate Sec.
493.1278(a)(4) as revised to Sec. 493.1278(a)(3).
We proposed the current requirement at Sec. 493.1278(a)(5) would
be redesignated as Sec. 493.1278(a)(4). This requirement remains
unchanged.
At Sec. 493.1278(b)(1) through (3), we proposed deleting these
requirements pertaining to establishing HLA typing procedures. The
requirement that the laboratory must establish and have written
procedures that ensure quality

[[Page 89996]]

test results are already addressed by the general requirements for all
test systems under current Sec. 493.1445(e)(1) and (e)(3)(i) and
revision at Sec. 493.1278(f), respectively, and therefore, are
duplicative.
The July 2022 proposed rule inadvertently omitted a technical
change at proposed redesignated Sec. 493.1278(b)(1) to reflect the
current name of the World Health Organization (WHO) committee that
determines HLA nomenclature, the ``Nomenclature Committee for Factors
of the HLA System.'' The finalized regulation text at newly
redesignated Sec. 493.1278(b)(1) incorporates this change and is shown
in its entirety in the final regulatory text.
At Sec. 493.1278(b), we proposed to redesignate the provisions at
paragraph (b)(4) to paragraph (b)(1). At newly redesignated paragraph
(b)(1), we proposed deleting the language that states potential new
antigens not yet approved by this committee must have a designation
that cannot be confused with WHO terminology because new alleles are
approved monthly, which makes this requirement obsolete.
At Sec. 493.1278(b)(5)(i) through (iv), we proposed deleting the
requirements for preparation of cells or cellular extracts, selecting
typing reagents, ensuring that reagents used for typing are adequate,
and assignment of HLA antigens as they are already addressed by the
general requirements for all test systems under Sec. Sec.
493.1445(e)(1) and (e)(3)(i), 493.1251, and 493.1252, and therefore,
are duplicative.
At Sec. 493.1278(b)(5)(v), we proposed to modify the requirement
to add ``allele'' and delete the ``re'' prefix in the word ``retyping''
in this paragraph and to redesignate the provisions at paragraph
(b)(5)(v) to paragraph (b)(2). We proposed inserting ``allele'' because
the regulation only has antigen typing, but there is typing done at the
allele level. We proposed deleting the ``re'' prefix to remove
redundancy under the proposed revision at Sec. 493.1278(b)(2) which
requires the laboratory to have written criteria to define the
frequency for performing typing.
At Sec. 493.1278(b)(6)(i) through (iii), we proposed deleting
requirements for HLA typing control materials procedures as they are
addressed by the general requirements regarding quality control
materials and procedures for all test systems under Sec. 493.1256(a)
through (d) and (f) through (h), and therefore, are duplicative.
At Sec. 493.1278(c), we proposed deleting this requirement for
control procedures and materials regarding disease related studies
because this is addressed by the general requirements for all test
systems under Sec. Sec. 493.1256(d) and 493.1451(b)(4), and therefore,
is duplicative.
At Sec. 493.1278(d), we proposed changing the name of this section
from ``Antibody Screening'' to ``Antibody Screening and
Identification'' for clarification as both processes apply to
histocompatibility testing. The provisions covered under this section
apply to both screening and identification. We proposed moving Sec.
493.1278(d) as revised to Sec. 493.1278(c).
At Sec. 493.1278(d)(1) through (3) and (5) through (7), we
proposed deleting these requirements for antibody screening laboratory
procedures as they are addressed by the general requirements for all
test systems under Sec. Sec. 493.1445(e)(1) and (e)(3)(i), 493.1251,
493.1252, and 493.1256, and therefore, are duplicative.
We received public comments on these proposals at Sec. 493.1278(a)
through (d). The following is a summary of the public comments we
received and our responses.
Comment: A commenter supported the modification under Sec.
493.1278(a)(1) requiring the use of a continuous monitoring system and
alert system to monitor the storage temperature of specimens but added
that this may result in an additional burden for smaller laboratories
with limited funds.
Response: Many continuous monitoring systems have alerts built into
the system. Laboratories can also develop policies and procedures for
an alert system built upon the results of the continuous monitoring
system. We believe that the risk associated with the incorrect storage
temperature of specimens and reagents warrants the requirement for an
alert system.
Comment: A commenter proposed new language for existing standards
at Sec. 493.1278(d)(1) to ``use a technique that detects HLA-specific
antibody that is equivalent or superior to the solid phase assays'' and
Sec. 493.1278(d)(3) to ``use a panel composition that contains all
major HLA specificities'' to remain in alignment with the United
Network for Organ Sharing (UNOS) requirements.
Response: In the proposed rule, we proposed to delete Sec.
493.1278(d)(1) and (d)(3) as we believe they are addressed by the
general requirements for all test systems under Sec. Sec.
493.1445(e)(1) and (e)(3)(i), 493.1251, 493.1252, and 493.1256. LDs can
choose to implement UNOS requirements as part of their responsibilities
indicated under Sec. 493.1445(e)(3)(i). Therefore, we are not making
any language change and are finalizing the proposed deletion of Sec.
493.1278(d)(1) and (d)(3).
Comment: A commenter suggested the inclusion of current Sec.
493.1278(d)(5) ``have available and follow a written policy consistent
with clinical transplant protocols for the frequency of screening
potential transplant beneficiary sera for preformed HLA-specific
antibodies.''
Response: We believe the general requirements for all test systems
under Sec. 493.1251 address the requirement for laboratories to have
available and follow written policies. Therefore, we are finalizing the
proposed deletion of Sec. 493.1278(d)(5).
Comment: Several commenters suggested the removal of the word
``serologic'' in the proposed language for crossmatching at Sec.
493.1278(d)(2)(iv) to account for allele-specific antibody detection.
Another commenter stated that serologic typing is insufficient for
current clinical histocompatibility testing due to its many
limitations, including low specificity at certain loci and the
potential for certain false negative results, and suggested changing
the language to ``typing of the donor by molecular methods at the
serologic split antigen equivalent.''
Response: We agree with the commenters that removing ``serologic''
will maintain flexibility with the evolution of testing practices. We
are not specifying molecular methods, but instead, are modifying our
proposed revisions to remove reference to the ``serologic'' level at
revised Sec. 493.1278(d)(2)(iv).
We received no comments on proposed Sec. 493.1278(a)(2) through
(4) and (c) and are finalizing these provisions as proposed.
After consideration of the comments received, we are finalizing the
proposed changes at Sec. 493.1278(a) through (d), with the following
modifications to the proposed revisions at (b)(1) and (d)(2)(iv):
<bullet> To update the regulation at redesignated Sec.
493.1278(b)(1) to incorporate the revised name of the World Health
Organization (WHO) committee that determines HLA nomenclature,
``Nomenclature Committee for Factors of the HLA System.''
<bullet> To finalize the proposed revisions at Sec.
493.1278(d)(2)(iv) with modification, to remove ``at the serologic
level''.

2. Crossmatching and Transplantation (Sec. 493.1278(e) and (f))

At Sec. 493.1278(e)(1) through (3), we proposed removing these
three requirements regarding the laboratory

[[Page 89997]]

having crossmatch procedures and controls as we believe the provisions
to be removed are addressed by the general requirements for all test
systems under Sec. Sec. 493.1445(e)(1), 493.1251, 493.1256, and
493.1451(b)(4), and therefore, are duplicative.
Since 1992, there have been important advances in the field of
transplantation and histocompatibility. Based on comments received in
response to the 2018 RFI and interested parties and CLIAC input, we
understand the current regulations at Sec. 493.1278 do not reflect the
standard practice for laboratories performing testing in the specialty
of histocompatibility and are viewed by the transplantation community
as a barrier to modernized decision making approaches for organ
acceptability. Additionally, we understand that the use of risk
assessment and alternative immunologic assessment procedures are
currently the standard practice for laboratories performing testing in
the specialty of histocompatibility. Therefore, we proposed to add the
requirements summarized below, at Sec. 493.1278(d), to increase
flexibility in the regulations and remove perceived barriers. These
requirements include:
<bullet> Defining donor and recipient HLA antigens, alleles, and
antibodies to be tested;
<bullet> Defining the criteria necessary to assess a recipient's
alloantibody status;
<bullet> Assessing recipient antibody presence or absence on an
ongoing basis;
<bullet> Typing the donor at the serological level, to include
those HLA antigens to which antibodies have been identified in the
potential recipient, as applicable;
<bullet> Describing the circumstances in which a pre- and post-
transplant confirmation testing of donor and recipient specimens is
required;
<bullet> Making available all applicable donor and recipient test
results to transplant team;
<bullet> Ensuring immunologic assessments are based on the test
report results obtained from a test report from CLIA certified testing
laboratory(ies);
<bullet> Defining time limits between recipient testing and the
performance of crossmatch; and
<bullet> Requiring that the test report must specify what type of
crossmatch was performed.
At Sec. 493.1278(f), we proposed to change the words
``transfusion'' and ``transfused'' to ``infusion'' and ``infused'',
respectively. The relevance of HLA testing and the decisions of the
extent of testing in both a transplant and transfusion setting are
critical to both organ and cell acceptance in the host recipient. The
use of the word ``transfusion'' is inappropriate given that the product
itself is the transfusion but the action of introducing the product is
the process of infusion. Transfusion is more specific to
immunohematology. There are specific transfusion regulations in the
immunohematology section at Sec. 493.1271 that should not be confused
with histocompatibility requirements. Since histocompatibility
addresses materials that are not always blood products, we believe the
term ``infusion'' would be more appropriate. We proposed moving Sec.
493.1278(f) as revised to Sec. 493.1278(e).
At Sec. 493.1278(f)(1), we proposed revising this requirement to
state that laboratories performing histocompatibility testing must
establish and have written policies and procedures specifying the types
of histocompatibility testing. We proposed moving this language to
Sec. 493.1278(e). In addition, we proposed adding ``identification''
after ``antibody screening'' in the revised Sec. 493.1278(c), as
identification is an important part of the process for crossmatching.
Finally, we proposed removing ``compatibility testing'' at Sec.
493.1278(f)(1) because this activity is specific to immunohematology,
and crossmatching is a more appropriate description of what we
understand is the current histocompatibility procedure used by
laboratories. We proposed moving Sec. 493.1278(f)(1) as revised to
Sec. 493.1278(e).
At Sec. 493.1278(f)(1), we further proposed modifying the current
general requirement to specify that the laboratory must establish and
follow written policies and procedures that address the transplant type
(organ, tissue, cell) donor type (living, deceased, or paired) and
recipient type (high risk vs. non-sensitized). The following
terminologies were also updated to reflect current practices: ``cadaver
donor'' is replaced by ``deceased donor,'' ``transfused'' is replaced
by ``infused,'' and ``combined'' is replaced by ``paired.'' In
addition, we believe that clarifying the current regulatory language
allows the laboratories to make decisions based on existing
technologies and practices for determining what testing is applicable
for those transplant programs they serve. We proposed moving Sec.
493.1278(f)(1) as revised to Sec. 493.1278(e)(1).
At Sec. 493.1278(f)(2) through (3), we proposed to remove these
requirements for renal and nonrenal transplantation crossmatch
procedures which are perceived as obstacles to current practices by the
transplant community and instead allow for alternative immunologic
assessment procedures to be used in the designated specialty of
histocompatibility. The requirements that the laboratory must establish
and follow written policies and procedures are already addressed in the
general requirements for all test systems under Sec. Sec.
493.1445(e)(1) and (e)(3)(i), 493.1251, 493.1256(c) through (h), and
493.1451(b)(4) and, therefore, are duplicative. In addition, we
proposed adding a new requirement for pre-transplant recipient
specimens under the proposed Sec. 493.1278(e)(3). Under this new
proposed requirement, the laboratory must have written policies and
procedures to obtain a recipient specimen for a crossmatch, or to
document its efforts to obtain a recipient specimen, collected on the
day of transplant. We recognize that the laboratory may not be able to
obtain a recipient specimen collected on the day of a transplant since
this collection process depends upon the physician obtaining the
specimen and submitting it to the laboratory.
At Sec. 493.1278(f)(1)(ii), we proposed modifying this requirement
for laboratory policies and procedures as it would be included in the
amended protocol requirements under the proposed regulation at Sec.
493.1278(e)(1)(i) and (iii), and therefore, would be duplicative. The
proposed revised requirement reflects current practices in the
histocompatibility community.
At Sec. 493.1278(f)(1)(iii), we proposed replacing ``the level
of'' with ``type and frequency'' to clarify this revised requirement
refers to the type and frequency of testing practice to support the
clinical transplant protocols. We also proposed removing the examples
of antigen and allele level in the regulation as these examples may not
be all-inclusive and generally are reflected in guidance rather than
regulatory text. We proposed redesignating Sec. 493.1278(f)(1)(iii) as
Sec. 493.1278(e)(2).
The requirement at Sec. 493.1278(g) would be redesignated as Sec.
493.1278(f). This requirement remains unchanged.
We received public comments on these proposals at Sec. 493.1278(e)
through (f). The following is a summary of the public comments we
received and our responses.
Comment: Several commenters stated that virtual crossmatch is an
immunologic assessment, not a test. One of the commenters added that a
``test'' requires a specific procedure to be performed, and virtual
crossmatches are often assessments of existing candidate and donor test
results to determine potential immunologic compatibility or

[[Page 89998]]

the need for additional testing to occur. The commenters suggested
modification of the proposed language at Sec. 493.1278(d)(3) and Sec.
493.1278(e) to include immunologic assessment language.
Response: The CLIA regulations refer to ``test'' and ``test
systems,'' and do not refer to ``immunologic assessment.'' We believe
this would cause confusion by introducing a new term to the regulations
without defining the term. Therefore, we will incorporate information
related to immunologic assessment in updated guidance related to Sec.
493.1278(d)(3) and Sec. 493.1278(e).
Comment: Several commenters requested clarification of the proposed
new requirement for pretransplant recipient specimens at Sec.
493.1278(e)(3). Another commenter questioned if the proposed
requirement means that (1) laboratories must obtain a specimen on the
day of the transplant or document the attempts made to obtain a
specimen on the day of the transplant, or (2) laboratories must collect
a specimen on the day of the transplant or have documentation of
attempts to obtain such a specimen, but documentation could be after
the day of the transplant. The second commenter requested additional
clarity around the intended use of the proposed recipient specimen for
crossmatch to be obtained on the day of the transplant and what the
required use of that sample would be, adding that the laboratory and
clinical team should be able to define how current a sample must be for
candidate testing, as already required in the proposed Sec.
493.1278(d)(2)(viii). The commenter believes the laboratory and
clinical team should be able to assess the need for an updated sample
after considering timing, potential sensitizing events, and previous
candidate alloantibody levels and that it may not be necessary to draw
an additional recipient specimen in all cases. The same commenter
requested flexibility on pre-transplant samples drawn for young
pediatric candidates, stating that the small size of some pediatric
candidates can make additional blood volume drawn immediately pre-
transplant harmful.
Response: As explained in the proposed rule, we recognize that the
laboratory may not be able to obtain a recipient specimen collected on
the day of a transplant since this collection process depends upon the
physician obtaining the specimen and submitting it to the laboratory.
Therefore, we proposed at Sec. 493.1278(e)(3) that the laboratory has
a process to obtain a recipient specimen, if possible, for crossmatch
collected on the day of the transplant. If the laboratory cannot obtain
a recipient specimen on the day of the transplant, it must have a
process to document its efforts to obtain the specimen. The laboratory
documentation does not have to be on the day of the transplant but
could be after the day of the transplant. In this final rule, we are
also adding clarification at Sec. 493.1278(e)(3) that the recipient
specimen be collected prior to transplantation on the day of the
transplant. Also, as proposed under Sec. 493.1278(e), laboratories
must establish and follow written policies and procedures specifying
the histocompatibility testing to be performed for each type of cell,
tissue, or organ to be infused or transplanted. The laboratory or
clinical team must have policies and procedures in place to define when
there is a need for additional recipient specimens for immunologic
assessment and the circumstances when the collection of additional
recipient specimens is not needed, such as in pediatric cases. The
laboratory is allowed flexibility to determine its policies and
procedures under proposed revised Sec. Sec. 493.1278(e)(3) and
493.1251.
After consideration of the comments received, we are finalizing the
proposed changes at Sec. 493.1278(e) and (f), with modification to the
proposed revisions at Sec. 493.1278(e)(3) related to the laboratory
process to obtain a recipient specimen, if possible, for crossmatch
collected on the day of the transplant and prior to transplantation.

B. Changes to Personnel Requirements

We stated in the proposed rule that CMS recognizes that the COVID-
19 public health emergency (PHE) requires flexibility, and that we are
committed to taking critical steps to ensure America's clinical
laboratories can respond during a PHE to provide reliable testing while
ensuring patient health and safety. As such, we requested that the
public provide comments regarding how the CLIA personnel requirements
in subpart M have affected the health system's response to the COVID-19
PHE and any potential opportunities for improvement to such
requirements. We welcomed suggestions regarding potential improvements
that may be specific to a pandemic or PHE context, as well as broader
recommendations.
1. Definitions (Sec. 493.2)
a. Mid-Level Practitioner
At Sec. 493.2, we proposed amending the definition of midlevel
practitioner by adding a nurse anesthetist and clinical nurse
specialist to the definition. CLIA currently defines a midlevel
practitioner as a nurse midwife, nurse practitioner, or physician
assistant. We stated in the proposed rule that we agree with CLIAC's
recommendation to include nurse anesthetists and clinical nurse
specialists in the definition of midlevel practitioner. We believe
including nurse anesthetists and clinical nurse specialists in the
definition will be inclusive of current types of mid-level
practitioners. For example, the American Association of Nurse
Anesthetists \17\ scope of practice states that the practice may
include performing point-of-care testing.
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\17\ <a href="https://www.aana.com/">https://www.aana.com/</a>.
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We received public comments on this proposed definition. The
following is a summary of the comments we received and our responses.
Comment: A commenter expressed concern about updating the midlevel
practitioner definition to include registered nurse anesthetists and
clinical nurse specialists to be considered mid-level practitioners in
the laboratory testing scope. The commenter noted that MTs have more
courses designed to prepare them to work in a laboratory setting as
compared to nursing students.
Response: The definition of a midlevel practitioner only applies to
a site with a Certificate for Provider-performed Microscopy Procedures.
PPM procedures, as described under Sec. 493.19, are a select group of
moderately complex microscopic tests that do not meet the criteria for
waiver because they are not simple procedures; they require training
and specific skills for test performance, and they must meet certain
other standards. Since these procedures are performed at the time of a
physician office visit, including registered nurse anesthetists and
clinical nurse specialists as part of the definition of a midlevel
practitioner allows greater access to PPM testing. The curriculum for
the midlevel practitioners including RNAs and CNSs covers this type of
testing.
After consideration of public comments, we are finalizing the
proposed definition of ``midlevel practitioner.''
b. Continuing Education (CE) Credit Hours
At Sec. 493.2, we proposed adding a definition for ``Continuing
education (CE) credit hours'' to state that it means either continuing
medical education (CME) or CE units. Generally, CME refers to
continuing education credits earned by physicians (by which we mean
doctors of medicine, osteopathy, or podiatric medicine). We proposed

[[Page 89999]]

that CE would be a broader term used for individuals seeking to qualify
as LDs who are not physicians. We noted that in the current CLIA
regulations at Sec. 493.1405(b)(2)(ii), CME is considered as
acceptable training or experience for individuals to qualify as a LD
overseeing moderate complexity testing.
We stated in the proposed rule that because we were proposing in
section III.B. of the proposed rule to require all individuals seeking
to qualify as a LD for both moderate and high complexity testing to
have 20 CE credit hours, we believed we needed to establish a more
general term for purposes of the proposed requirement. As described
below, the CE credit hours would cover all of the LD responsibilities
defined in the applicable regulations and must be obtained prior to
qualifying as a LD. For example, we proposed at Sec.
493.1405(b)(2)(ii)(B), the 20 CE credit hours would be required to
cover all of the LD responsibilities defined in Sec. 493.1407
(moderate complexity testing).
The term CME was originally used because it was only required at
Sec. 493.1405(b)(2)(ii)(B), which is a provision specifically related
to doctors of medicine, osteopathy, or podiatry. We believe that
including a definition for CE credit hours in the CLIA regulations will
respect that historic use, afford a means of referring to a broader
range of professionals who may qualify as LDs, and alleviate confusion
between the terms.
We received public comments on this proposed definition. The
following is a summary of the comments we received and our responses.
Comment: A commenter noted that organizations provide CME for
physicians that the Accreditation Council for Continuing Medical
Education (ACCME) approves as CME providers. The commenter stated that
CME programs are subject to strict rules about conflict of interest,
commercial interests, and course design, which includes learning
objectives. The commenter suggested that the definition of CE credit
hours be modified to meet equivalent or similar standards as CME.
Response: The proposed definition of CE credit hours under Sec.
493.2 includes CME as a CE option. As previously discussed, the term
CME was originally used because it was only required at Sec.
493.1405(b)(2)(ii)(B), which is a provision specifically related to
doctors of medicine, osteopathy, or podiatry. We proposed and are now
finalizing a continuing education requirement for non-physician LDs who
do not have an earned doctoral degree in biology, chemistry, clinical
or medical laboratory science or medical technology. Because the term
CME generally refers only to continuing education credits earned by
physicians, we are finalizing a broader term, CE, which is defined to
include either CME or CEUs. CLIA regulations do not regulate either CME
or CE providers regarding conflict of interest, commercial interests,
and course design, which includes learning objectives. CLIA regulations
do however require that to be qualified as an LD, the candidate must
obtain CME credits, or under this final rule CE credits, which cover
all of the LD responsibilities defined in the applicable regulations.
After consideration of public comments, we are finalizing the
proposed definition of ``continuing education (CE) credit hours''
without modification.
c. Doctoral Degree
At Sec. 493.2, we proposed adding a definition for ``doctoral
degree'' to state that it means an earned post-baccalaureate degree
with at least 3 years of graduate level study that includes research
related to clinical laboratory testing or advanced study in clinical
laboratory science or medical technology. Originally, degrees were
given in medical technology; however, the naming convention for medical
technology degrees has changed since the regulations were first
published in the February 1992 final rule with comment period. We
stated in the proposed rule that the degree is now referred to as
clinical laboratory science and that a clinical laboratory science
degree is synonymous with a medical technology degree. For purposes of
42 CFR part 493, doctoral degrees would not include doctors of medicine
(MD), doctors of osteopathy (DO), doctors of podiatry, doctors of
veterinary medicine (DVM), or honorary degrees.
We proposed this modification to CLIA regulations to clarify what
we mean by the term ``doctoral degree.'' It seems this general term has
created confusion as various interested parties have inquired about the
following.
<bullet> Are doctors of medicine degrees considered to be a type of
doctoral degree?
<bullet> Does a doctoral degree include traditional (for example,
Doctor of Philosophy (Ph.D.), doctorate in science (DSc) and
professional (for example, Doctorate in Clinical Laboratory Science
(DCLS)) degrees or does doctoral degree only mean a Ph.D.?
The CLIA regulations for personnel qualifications separate doctors
of medicine, osteopathy, and podiatry from other non-medical doctoral
degrees by including specific qualification requirements for these
three types of degrees. MD and DO degrees pertain to post-graduate
level education, specifically in medicine, and are associated with
treating illnesses and medical conditions. In contrast, doctoral
degrees can be obtained in various fields like biology and chemistry.
Historically, we intended a doctoral degree to mean a Ph.D. in a
science field related to laboratory work. However, we have come to
understand that our doctoral degrees could be interpreted more broadly
to include both traditional and professional doctoral degrees. Doctoral
degree is a general term used to describe post-graduate level education
for various non-medical specific degrees and includes both traditional
(for example, Ph.D., DSc) and professional (for example, DCLS) degrees.
A traditional earned doctoral degree is generally focused on research
and may include academic coursework and professional development. In
contrast, a professional earned doctoral degree emphasizes specific
skills and knowledge for success in a particular profession without a
concentrated focus on research. For example, the DCLS is an advanced
professional doctorate designed for practicing clinical laboratory
scientists (CLSs) or medical technologists (MTs) who have at least a
bachelor's degree and wish to further their level of clinical expertise
and develop leadership and management skills. Individuals with a DCLS
are experts in clinical laboratory testing. Individuals must have a
bachelor's degree in medical technology or clinical laboratory science
and the requisite experience in order to be admitted to a DCLS graduate
program. The DCLS contributes to increasing laboratory efficiency and
improves timely access to accurate and appropriate laboratory
information. A graduate of a DCLS program will be able to: provide
appropriate test selection and interpretation of test results; monitor
laboratory data and testing processes; improve the quality, efficiency,
and safety of the overall diagnostic testing process; and direct
laboratory operations to comply with all State and Federal laws and
regulations. We would consider a DCLS an acceptable doctoral degree.
For the purposes of qualifying under the CLIA personnel
regulations, we do not consider a MD or DO to be the same as a non-
medical doctoral degree. Therefore, these individuals must continue to
qualify under the applicable CLIA personnel regulations, that is, MDs
and DOs must qualify under doctors of medicine or osteopathy
requirements.

[[Page 90000]]

Those individuals with non-medical doctoral degrees as outlined
previously in this final rule must qualify under the doctoral degree
requirements. We stated in the proposed rule that if finalized, the
State Operations Manual (SOM) \18\ will be updated accordingly.
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\18\ <a href="https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/som107c06pdf.pdf">https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/som107c06pdf.pdf</a>.
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The CLIA regulations aim to ensure accurate and reliable testing on
specimens derived from the human body for the purposes of providing
information for the diagnosis, prevention, or treatment of any disease
or impairment of, or the assessment of health of human beings.
Therefore, we stated in the proposed rule that we believe that DVM
should be removed from the qualifying doctoral degrees as it is not
relevant to testing on specimens derived from the human body. We
understand many of the methodologies may be the same; however, testing
on human specimens is clearly specified in the statutory language and
regulatory definition of a laboratory under CLIA. Therefore, testing of
animal specimens does not meet the intent of the CLIA regulations. Of
the nine boards approved by HHS for qualification of applicants with
doctoral degrees, only one allows individuals with DVMs to sit for
board certification. Since 1965, American Board of Medical Microbiology
has granted certification to four individuals. We stated that
individuals who have previously qualified under a provision requiring a
doctoral degree will continue to qualify under the new rule, if
finalized. We further stated that if finalized, we would remove the
reference to DVMs in the SOM, Chapter 6 (that is, Interpretive
Guidelines) under Sec. 493.1443(b)(3) (page 353).
Finally, as discussed previously in this rule, we proposed that a
doctoral degree must be an earned post-baccalaureate degree with at
least 3 years of graduate level study that includes research related to
clinical laboratory testing or advanced study in clinical laboratory
science or medical technology. As such, honorary degrees do not meet
the intent of a qualifying doctoral degree as an individual has not
completed the necessary course and laboratory work required for the
post-baccalaureate degree or necessary to ensure quality testing, for
example, accurate and reliable results. We believe that qualifying
individuals who hold only honorary degrees is not consistent with the
public health purposes of the CLIA statute. Furthermore, we believe
that this would impede CMS' ability to ensure health and safety of the
public and individuals served by CLIA-certified laboratories.
We received public comments on this proposed definition. The
following is a summary of the comments we received and our responses.
Comment: Several commenters referenced the 2022 decision by the
American Medical Technologists (AMT), ASCP, and the American Society
for Clinical Laboratory Science (ASCLS) to change the MT certification
designation to Medical Laboratory Scientist (MLS). The commenters
stated that this change recognizes the specialized expertise that the
medical laboratory scientist brings to the practice of healthcare
diagnostics, which needs to be adequately reflected in the term
'technologist.' The commenters suggested that medical laboratory
science should be used in addition to clinical laboratory science in
the proposed definition of doctoral degree under Sec. 493.2.
Response: We agree with the commenters that medical laboratory
science should be included in the definition of a doctoral degree,
aligning with the 2022 decision to rename MT to MLS to elevate the
visibility of the laboratory field. As a result, we have incorporated
the change suggested by the commenters to include medical laboratory
science in addition to clinical laboratory science in the finalized
definition of doctoral degree at Sec. 493.2, and elsewhere in these
finalized regulations, where applicable, as discussed later in this
final rule.
Comment: A commenter expressed concern about the proposed
definition of a doctoral degree, stating that many LDs with Ph.D.
degrees come from a basic science background. These degrees require
laboratory experience, yet that experience may not be related to
clinical laboratory testing or clinical laboratory science. The
commenter stated that qualification to direct a clinical laboratory is
ensured by requiring board certification. The commenter believed that
limiting permissible doctoral degrees to those relating directly to
medical or clinical laboratory science would eliminate the vast
majority of the candidate pools many fellowship programs draw from.
Response: We disagree with the commenter. The revised LD
qualifications for moderate (Sec. 493.1405) and high (Sec. 493.1443)
complexity testing expand the LD candidate pool in two ways. One, while
we have removed physical science as a qualifying degree, we are adding
two new degree types: medical laboratory science and medical
technology. Two, if individuals hold non-qualifying degrees, they now
have the opportunity to qualify under the new educational pathways. The
CLIA regulations ensure accurate and reliable testing on specimens
derived from the human body for the purposes of providing information
for the diagnosis, prevention, or treatment of any disease or
impairment of, or the assessment of health of human beings. We believe
that the inclusion of research related to clinical laboratory testing
or advanced study in clinical laboratory science, medical laboratory
science, or medical technology in the doctoral degree definition, as
well as the additional educational option, encompasses the need to
ensure that LDs complete the required course and laboratory work to
ensure quality testing for accurate and reliable results.
Comment: Several commenters disagreed with the proposed removal of
the DVM degree from the qualifying doctoral degrees. Commenters stated
that during the COVID-19 PHE, veterinary diagnostic laboratories (VDLs)
were a significant resource capable of conducting critical public
health diagnostic and surveillance testing. The commenters stated that
VDLs conducted millions of tests that might otherwise not have been
run. Commenters further stated that in some States, the VDL response
capability and capacity served as the primary COVID-19 testing
resource. However, they asserted that incorporating this valuable
resource into the PHE response was often significantly delayed due to
the inflexibility regarding recognizing VDL staff's training,
knowledge, and experience as equal to that mandated under CLIA. Another
commenter indicated that directors of VDLs are board certified in their
specialties and often have Ph.D.s in addition to their DVMs. There were
additional commenters that supported the removal of a DVM degree from
the qualifying doctoral degrees.
Response: Based on the critical role veterinary facilities provided
in rapidly increasing testing capacity during the COVID-19 PHE, we
believe it is appropriate to include DVMs during PHEs and may consider
extending that flexibility in future PHEs. However, for the reasons
previously discussed, these degrees would not be included as qualifying
doctoral degrees outside of a PHE. Personnel with DVM degrees may
qualify through the other routes indicated in subpart M. In addition,
any individual with a DVM who is qualified and employed as an LD as of
the effective date of this final rule will be grandfathered and
continue to qualify as outlined in the grandfather provisions

[[Page 90001]]

discussed elsewhere in this final rule, provided the individual remains
continuously employed as an LD after the effective date.
After consideration of public comments, we are finalizing the
proposed definition of ``doctoral degree'', with modification to
include medical laboratory science. We are also modifying ``doctors of
podiatry'' to ``doctors of podiatric medicine (DPM)'' to be consistent
with current regulations.
d. Training and Experience
At Sec. 493.2, we proposed to add a definition for ``Laboratory
training or experience'' to state that it means that the training or
experience must be obtained in a facility that meets the definition of
a laboratory under Sec. 493.2 and is not excepted from CLIA under
Sec. 493.3(b). Laboratory subject to CLIA would mean the laboratory
meets the definition of a ``laboratory'' under Sec. 493.2. Training
and experience obtained in a research laboratory that only reports
aggregate results or a forensic laboratory does not meet this
definition. These types of facilities are exempt from CLIA under Sec.
493.3(b), and as such, training and experience acquired in these
facilities is not applicable to CLIA laboratories.
In all situations, an individual is required to meet training and/
or experience requirements in addition to the educational requirements
to competently perform their regulatory responsibilities. Because the
CLIA personnel requirements for nonwaived testing are based on the
complexity of testing performed (moderate versus high), we concluded
that appropriate training and experience is necessary. Comments from
the 2018 RFI support this proposal. Comments received from the 2018 RFI
include the following:
<bullet> Training and or experience should be in a CLIA certified
laboratory.
<bullet> Research experience is not equivalent to clinical
experience.
<bullet> Dependent on complexity level of testing, minimum
standards should increase as the complexity level increases.
Further, commenters stated that documentation from a former
employer would be acceptable, provided it included specific details of
the individual's job description, training and competency assessment
(CA) for areas of testing performed. This documentation could be from
an LD, manager or supervisor.
We concur with the CLIAC recommendation, and comments from the 2018
RFI that all personnel should have training and experience in their
areas of responsibility as listed in CLIA for the appropriate test
complexity as shown in Table 8, which shows the specific personnel
categories that have a provision requiring training or experience, or
both, or require experience directing or supervising, or both.
[GRAPHIC] [TIFF OMITTED] TR28DE23.007

This means personnel should have training or experience examining
and performing tests on human specimens for the purpose of providing
information that is used in diagnosing, treating, and monitoring an
individual's condition.
Each individual must have documentation of training or experience
applicable to the types and complexity of testing performed. This
training should be such that the individual can demonstrate that he or
she has the skills required for the proper performance of pre-analytic,
analytic, and post-analytic phases of testing. For example, if the
individual performs blood gas testing on a nonwaived point of care
device, demonstration of skills should include, but is not limited to,
the following:
<bullet> Proper specimen collection, handling and labelling;
<bullet> Proper test performance according to the laboratory's
policies and manufacturer's instructions;
<bullet> Verification of performance specifications;
<bullet> Calibration and preventive maintenance;
<bullet> Proficiency testing; and
<bullet> Proper reporting of patient test results.
Training may include, but is not limited to, attendance at:
<bullet> Seminars given by experts in the field;
<bullet> On-site or off-site instrument trainings given by a
manufacturer;
<bullet> Technical training sessions, workshops, or conferences
given by a professional laboratory organization; or
<bullet> A formal laboratory training program.
Documentation may consist of, but is not limited to:
<bullet> Letters from training programs or employers;
<bullet> Attestation statements of an individual's training and
experience by the LD;
<bullet> Log sheet(s) initialed by the attendees indicating
attendance at a training session or in-service; and
<bullet> Certificates from organizations providing the training
session, workshop, conference, specialty course.
We expect all documentation supporting an individual's education,
training and experience to be independently generated, that is, not
authored by the individual who is trying to meet CLIA personnel
qualification requirements. For example, a curriculum vitae (CV) is not
acceptable verification, in and of itself, to document an individual's
education, training or experience. Letters on letterhead from previous
employment, competency assessment, and comprehensive list of job
responsibilities may be examples of acceptable documentation.
Laboratory testing of non-human specimens is not acceptable
experience, for example, environmental, animal testing, as it is not
used for the purpose of providing information used in the diagnosis,
prevention, or treatment of any disease or impairment of, or the

[[Page 90002]]

assessment of the health of, human beings.
Comments received on the 2018 RFI stated that experience from a
research laboratory should not be accepted. Depending on the
circumstances, research testing can be either exempt from CLIA or
subject to CLIA. Specifically, research laboratories that test human
specimens but do not report patient specific results for the diagnosis,
prevention or treatment of any disease or impairment of, or the
assessment of the health of individual patients, are excepted from the
CLIA regulations at Sec. 493.3(b)(2). In accordance with that
regulation, only those facilities performing research testing on human
specimens that do not report patient-specific results may qualify to be
exempt from CLIA certification.\19\ An example of a non-patient-
specific result would be ``10 out of 30 participants were positive for
gene X.'' The result in this example is a summary of the group data and
is not indicative of an individual's health. An example of a patient--
specific result would be ``participant A was positive for gene X'' in
which the result is specific to participant A. In cases where patient-
specific test results are maintained by a statistical research center
for possible use by investigators in which the results are not reported
out as patient-specific and could not be used ``for the diagnosis,
prevention, or treatment of any disease or impairment of, or the
assessment of the health of, human beings,'' CLIA would not apply.
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\19\ <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/Research-Testing-and-CLIA.pdf">https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/Research-Testing-and-CLIA.pdf</a>.
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Research testing where patient-specific results are reported from
the laboratory, and those results will be or could be used ``for the
diagnosis, prevention, or treatment of any disease or impairment of, or
the assessment of the health of, human beings'' are subject to CLIA.
Therefore, we would consider research experience related to reporting
patient-specific results as applicable experience to meet the CLIA
personnel requirements; however, if the research experience only
included aggregate reporting of results, we would not consider this
acceptable experience to meet CLIA personnel requirements as this type
of research testing is exempt from CLIA (Sec. 493.3(b)(2)).
CLIA regulations at Sec. 493.3(b)(1) specifically exempt
facilities or components of facilities that only perform testing for
forensic purposes from CLIA requirements. This was addressed in a
Survey and Certification policy memo (S&C-08-35) published on September
5, 2008 (<a href="https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions.html">https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions.html</a>). (See the preamble to the February 1992 final rule
with comment period for an important discussion concerning this subject
(57 FR 7014)).
In summary, laboratory results generated purely for the purpose of
detecting illegal substances or illegal amounts of certain substances
in the body may be relevant to legal proceedings. However, there is no
concern in such testing for developing accurate and reliable data for
use by health care professionals for the purpose of diagnosis or
treatment. The determining factor is not the test itself, but the
purpose for which the test is conducted.
In addition, based on the CLIA law, forensic testing is excluded
under CLIA since forensic testing is conducted to determine if there
has been a violation of the law and is not done for the purpose for
providing diagnosis, treatment or assessment of health.
Therefore, we do not consider forensic testing to be an acceptable
experience or training to meet CLIA personnel requirements as this type
of testing is exempt from CLIA (Sec. 493.3(b)(3)).
We received public comments on this proposed definition. The
following is a summary of the comments we received and our responses.
Comment: A commenter suggested expanding the definition of
laboratory training or experience to allow research staff to qualify as
laboratory testing personnel.
Response: The CLIA statute \20\ defines a laboratory as a facility
for the biological, microbiological, serological, chemical, immuno-
hematological, hematological, biophysical, cytological, pathological,
or other examination of materials derived from the human body for the
purpose of providing information for the diagnosis, prevention, or
treatment of any disease or impairment of, or the assessment of the
health of, human beings. Laboratories that are performing research only
(and do not report patient specific results for the diagnosis,
prevention, or treatment of any disease or impairment of, or the
assessment of the health of, human beings) are not subject to CLIA
regulations. Personnel with experience in a research laboratory may
qualify under the methods listed under CLIA subpart M--Personnel for
Nonwaived Testing.
---------------------------------------------------------------------------

\20\ <a href="https://www.govinfo.gov/content/pkg/USCODE-2011-title42/pdf/USCODE-2011-title42-chap6A-subchapII-partF-subpart2-sec263a.pdf">https://www.govinfo.gov/content/pkg/USCODE-2011-title42/pdf/USCODE-2011-title42-chap6A-subchapII-partF-subpart2-sec263a.pdf</a>.
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After consideration of public comments, we are finalizing the
proposed definition of ``laboratory training or experience'' without
modification.
e. Experience Directing or Supervising
At Sec. 493.2, we proposed adding a definition for ``Experience
directing or supervising'' to state that it means that the director or
supervisory experience must be obtained in a facility that meets the
definition of a laboratory under Sec. 493.2 and is not excepted under
Sec. 493.3(b). Experience directing or supervising a research
laboratory that tests human specimens but does not report patient-
specific results for the diagnosis, prevention, or treatment of any
disease or impairment of, or the assessment of the health of individual
patients would not meet this definition (for example, reporting of
aggregate results). Experience directing or supervising any facility or
component of a facility that only performs testing for forensic
purposes also would not meet this definition. The ordering of tests and
interpreting and applying the results of these tests in diagnosing and
treating an individual's illness would not meet this definition because
it is not related to the performance of clinical laboratory testing.
Ordering of tests and interpreting and applying of results falls under
the practice of medicine and are not related to the performance of
clinical laboratory testing. Teaching experience directly related to a
medical technology or clinical laboratory sciences program, or a
clinical laboratory section of a residency program, would be considered
acceptable experience because we understand that such experience from
teaching related to a medical technology or clinical laboratory
sciences program would include all aspects of the entire testing
process (pre-analytic, analytic and post-analytic), as well as quality
control and quality assessment. These are critical responsibilities of
a LD as defined by CLIA. See discussion on proposed definition of
``Laboratory training or experience'' for more information on proposed
treatment of research laboratories and forensic testing experience.
We did not receive public comments on this proposed definition for
``Experience directing or supervising'' and are finalizing as proposed.
2. PPM Laboratory Director Responsibilities (Sec. 493.1359)
At Sec. 493.1359, we proposed clarifying the competency assessment
(CA)

[[Page 90003]]

requirements for PPM laboratories in the Standard for PPM LD
responsibilities, as this testing is moderate complexity per Sec.
493.19(b)(2) and subject to CA. Based on the fact the regulations do
not have a requirement for a TC for PPM laboratories, we believe that
it is currently unclear in the regulation how CA applies to these types
of laboratories. The SOM, Appendix C (that is, Interpretive Guidelines)
on page 151 (<a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_c_lab.pdf">https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_c_lab.pdf</a>) discusses CA for PPM
laboratories. Therefore, we proposed clarifying, via modifications to
this LD responsibilities section of the regulations, the CA requirement
for PPM laboratories. We proposed that the LD evaluate the competency
of all TP to ensure that the staff maintains their competency to
perform test procedures and report test results promptly, accurately,
and proficiently. This would include the following:
<bullet> Direct observations of routine patient test performance,
including patient preparation, if applicable, specimen handling,
processing, and testing;
<bullet> Monitoring the recording and reporting of test results;
<bullet> Review of test results or worksheets;
<bullet> Assessment of test performance through testing internal
blind testing samples or external proficiency testing samples; and
<bullet> Assessment of problem solving skills.
Generally, these requirements mirror the CA provisions for moderate
and high complexity testing at Sec. Sec. 493.1413(b)(8) (technical
consultant responsibilities) and 493.1451(b)(8) (technical supervisor
responsibilities). We did not propose to include ``Direct observation
of performance of instrument maintenance and function checks'' as the
only equipment required for PPM testing is limited to bright-field and
phase-contrast microscopy. Typically, TP do not perform these
activities for PPM testing; rather, they are performed by third-party
entities.
In addition, we proposed at Sec. 493.1359(d) the same CA intervals
as in Sec. Sec. 493.1413(b)(8) and 493.1451(b)(8) apply to mid-level
practitioners for consistency. That is, evaluating and documenting the
performance of individuals responsible for PPM testing at least
semiannually during the first year the individual tests patient
specimens. Thereafter, evaluations must be performed at least annually.
We received public comments on these proposals at Sec. 493.1359.
The following is a summary of the public comments we received and our
responses.
Comment: A commenter suggested that TCs be allowed to perform PPM
procedure CA. The commenter noted that TCs are not defined in the CLIA
regulations but believes they are qualified to conduct CA for PPM
procedures. The commenter also stated that allowing TCs to perform
competency assessments would facilitate flexibility in meeting this
requirement and reduce the burden on the LD.
Response: Testing sites that hold a CLIA Certificate for Provider-
performed Microscopy Procedures are subject to CLIA personnel
regulations for the laboratory director (Sec. Sec. 493.1355, 493.1357,
and 493.1359) and testing personnel only (Sec. Sec. 493.1361,
493.1363, and 493.1365). CLIA does not have a personnel category for TC
in PPM personnel requirements. The proposed CA provisions for LD of a
PPM certificate mirror the CA provisions for moderate complexity
testing at Sec. 493.1413(b)(8) (TC responsibilities). If a CLIA CoC or
CoA laboratory performs PPM procedures, then that laboratory is subject
to all CLIA regulations related to moderate complexity testing. In
those laboratories with a CoC or CoA, a TC can perform CA for moderate
complexity testing including PPM procedures under Sec. 493.1413(b)(8).
However, in a CLIA certificate for PPM, it will be the LD's
responsibility to perform CA.
Comment: A commenter suggested reducing the frequency of conducting
the CA of individuals responsible for PPM testing to every 2 years
rather than annually. The commenter noted that PPM testing is often
performed by physicians or licensed providers with advanced degrees and
extensive training who are highly engaged in the clinical situations
where they are conducting the testing.
Response: PPM testing is moderate complexity per Sec.
493.19(b)(2). The proposed CA intervals were kept the same as those for
moderate and high complexity for consistency.
Comment: A commenter supported requiring PPM LDs to undergo CAs at
the same interval as moderate and high complexity laboratories. The
commenter stated that since PPM laboratories are not inspected
regularly, there currently needs to be a mechanism for State agencies
to monitor CA activities to ensure compliance. The commenter suggested
that CMS devise and implement reporting requirements and inspection
methods for PPM laboratories.
Response: CLIA Certificate for PPM Procedure laboratories must meet
the applicable requirements for inspection under subpart Q of the CLIA
regulations. We further note that reporting and inspection requirements
are outside the scope of this rule.
In the proposed rule, we used the following terms to refer to the
provider-performed microscopy procedure certificate: Certificate for
Provider Performed Microscopy Procedures (PPMP), Certificate of
Provider Performed Microscopy (PPM), and Certificate for Provider
Performed Microscopy (PPM). For internal consistency, we are updating
these terms in this section and throughout this final rule to
``Certificate for Provider-performed Microscopy (PPM) Procedures'' when
referring to the provider-performed microscopy procedures certificate.
We also note that in this final rule, CMS is making technical
changes to proposed section Sec. 493.1359(d) to enhance consistency.
After consideration of public comments, we are finalizing the
changes to Sec. 493.1359 as proposed, with modification for internal
consistency at Sec. 493.1359(d).
3. Laboratory Director Qualifications (Sec. 493.1405)
At Sec. Sec. 493.1405(b)(1)(ii), 493.1411(b)(1)(ii),
493.1443(b)(1)(ii), and 493.1449, we proposed removing ``or possess
qualifications that are equivalent to those required for such
certification.'' In making this proposal, we acknowledge that there are
limited timeframes for an individual to sit for the boards, however, by
allowing any such ``eligible'' individual to qualify under our
regulations, we have found that some individuals may never sit for
exams or may even fail the exams. Such individuals were not who we
intended to be eligible under these provisions. Further, even if we
were to ban such individuals by carving them out of those we considered
to hold ``qualifications that are equivalent to those required for
certification,'' it would be difficult to identify those individuals
and remove them from their LD roles. In making this proposal, we
acknowledged having historically accepted letters from individuals that
have documented proof from the American Board of Pathology or American
Board of Osteopathic Pathology that they are eligible to sit for the
boards based on SOM guidance (<a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_c_lab.pdf">https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_c_lab.pdf</a>, page 351,
D6078). In addition, we proposed eliminating the equivalency standard,
as

[[Page 90004]]

we do not have a means to evaluate equivalency to other boards for
equivalency to American Board of Pathology or American Board of
Osteopathic Pathology as it would be up to the Board to make a
determination of equivalency, and we do not believe in retrospect it
would be appropriate to expect those entities to conduct such analyses.
Furthermore, we had requested that CLIAC consider what ``possessing
qualifications that are equivalent to board certification'' should
mean. CLIAC recommended that this verbiage be removed from relevant
sections of subpart M because it was confusing, and we have no
mechanism to determine when qualifications are ``equivalent to board
certification.'' We concur with the CLIAC recommendation. Further, we
believe that individuals who historically may have qualified under this
provision would still qualify through alternative routes, thus not
disadvantaging individuals seeking to qualify as LDs. We further
proposed that an individual who qualified under the predecessor
regulations and is currently employed as a LD may continue to serve in
that capacity so long as there is no break in service after the
effective date of this final rule. For example, an individual who is
serving as the LD of a CLIA-certified laboratory at the date of the
publication of the final rule, and continues to serve as a LD of CLIA-
certified laboratory that performs nonwaived testing, would continue to
qualify. However, an individual who does not continue as LD of a CLIA-
certified laboratory after the date of implementation of the final rule
would need to requalify under the new provisions.
At Sec. 493.1405(b)(2)(ii)(A), we proposed changing the ``or'' to
an ``and'' to include directing or supervising nonwaived laboratory
testing in the provision. In addition, we proposed to remove
``Beginning September 1, 1993'' from Sec. 493.1405(b)(2)(ii)(B) and
continue to retain the provision for 20 hours of CE credit hours for
moderate complexity LDs who are seeking to qualify without
certification by the American Board of Pathology and the American Board
of Osteopathic Pathology. We believe by requiring the 20 CE credit
hours, the LDs would have a better understanding of their
responsibilities in the overall management and direction of
laboratories, which would result in improved overall compliance.
Historically, LD citations are among the top 10 condition-level
deficiencies cited by surveyors. We believe that this would also
improve the ability of laboratories to report accurate and reliable
test results, thus helping to protect the health and safety of the
public.
At Sec. Sec. 493.1405(b)(2)(ii)(C) and 493.1443(b)(2)(i), we
proposed removing the residency provision for the following reasons.
First, the residency requirement causes confusion with board
certification for doctoral degrees (for example, American Board of
Internal Medicine). It is also challenging for these individuals to
qualify under this provision as the medical residencies generally do
not include the type of laboratory training or require the 1 year of
laboratory training that we would expect to see related to laboratory
administration and operation for which the LD is responsible. We would
expect the residency program to provide an individual with essential
information regarding the principles and theories of laboratory
practice, including quality control and quality assessment; proficiency
testing; the phases of the total process (that is, pre-analytic,
analytic, and post-analytic), as well as general laboratory systems;
facility administration; and development and implementation of
personnel policy and procedure manuals. This training should also
include hands-on laboratory testing. However, a typical residency does
not include a year of laboratory training (defined in interpretive
guidelines as 2,080 hours of laboratory training) nor does it include
essential information on the principles and theories of laboratory
practice. We have observed, and AOs have noted to us, that very few
individuals qualify through the medical residency route. The onus for
providing the documentation related to clinical laboratory experience
during residency is on the applicants (that is, the applicants must
document their clinical laboratory experience during residency).
CLIAC recommended that we clarify the residency requirements by
emphasizing the requisite laboratory training must be ``clinical
laboratory training,'' meaning ``have at least one year of clinical
laboratory training during medical residency or fellowship.'' However,
we believe that 1 year of laboratory training is vague. We also believe
that after removing the residency requirement, there would be several
alternative routes for individuals to qualify as LDs. Individuals
seeking to qualify as a moderate complexity LD may still qualify under
Sec. 493.1405(b)(3) through (5) without a medical residency. We would
continue to accept residency experience as counting toward the
requirement of 2 years of laboratory experience directing or
supervising high complexity testing for doctors of medicine, doctors of
osteopathy, or doctors of podiatry. We would also accept experience
directing or supervising high complexity testing from a medical
fellowship program toward the requirements outlined in the regulations.
Generally, a fellowship program follows a residency program and is for
those individuals who choose to pursue additional training in their
specialty. Section 493.1443(b)(2)(ii) is the current requirement that
allows individuals with at least 2 years of experience directing or
supervising high complexity testing to qualify under paragraph (b)(2).
At Sec. 493.1405(b)(3), we proposed revising paragraph (b)(3)(ii)
to include an educational option that includes a qualification
algorithm for an individual that does not have an earned doctoral
degree in a chemical, biological, or clinical laboratory science or
medical technology (see section I.D.1.a of the proposed rule). We also
proposed adding paragraph (b)(3)(iii) to include the addition of 20 CE
credit hours for doctoral degrees, as well as the current paragraphs
(b)(3)(i) through (ii). This would include the requirement to be
certified by an applicable board and continue to be certified and have
at least 1 year of experience directing or supervising nonwaived
testing. (As discussed later in this section of the final rule, these
provisions in the proposed rule at Sec. 493.1405(b)(3) are being
reformatted and finalized at the revised (b)(3)(i) through (ii).)
The current CLIA regulations at Sec. Sec. 493.1405, 493.1411,
493.1423, 493.1441, 493.1449, 494.1461, and 493.1489 indicate
acceptable degrees for personnel as those in a chemical, physical,
biological science, or clinical laboratory science or medical
technology. Degree names and types have changed since the CLIA
regulations were first published in 1992. As a result, in some cases,
there are degrees for which the area of study may not be clear based on
the name of the degree given. This makes it challenging for CMS, State
agencies, Exempt States (ES), and AOs to determine what types of
degrees are considered acceptable degrees in order to qualify CLIA
personnel. At the time the CLIA regulations were published, individuals
typically received a degree in the areas of biology, chemistry, medical
technology, or clinical laboratory science. Today, we often must
perform an evaluation of transcripts to determine if the individuals
meet CLIA personnel requirements.

[[Page 90005]]

We believe it is important that individuals lacking a traditional
degree in chemical, biological, or clinical laboratory science or
medical technology should be considered if they have completed the
coursework that is equivalent to the aforementioned traditional degrees
and acquired documentation of the equivalent educational coursework. In
addition to the educational requirements discussed in this section,
CLIA also has experience and training requirements (see our proposed
updates to Sec. Sec. 493.1405, 493.1411, and 493.1423), but they will
not be addressed in this educational discussion.
We believe degrees should be in a science that deals in the kind of
clinical laboratory testing, that is related to testing of human
specimens as the definition of a ``laboratory,'' which is defined in
terms of the examination of materials from the human body for the
purposes of providing information for the diagnosis, prevention, or
treatment of any disease or impairment of, or the assessment of the
health of human beings (see Sec. 493.2). In some cases, it is clear
that a degree would meet these standards. For example, degrees in
microbiology, genetics, molecular biology, biochemistry, and organic
chemistry would be considered appropriate degrees. In other instances,
it is not apparent whether the degree would meet such requirements.
Environmental sciences, biotechnology, and marine biology are examples
of degrees that would not appear in keeping with the scope of the CLIA
program. At face value, we do not believe these types of degrees should
qualify an individual under the requirements in subpart M because they
are not related to clinical laboratory testing. Environmental science
degrees may cover such areas as ecosystem management, the impact of
industrialization on the environment, and natural resource management.
Biotechnology degrees focus on developing technologies and products
related to medical, environmental, and industrial areas. Marine biology
focuses on studying marine organisms, their behaviors, and interactions
with the environment. We would not consider these to be appropriate
degrees under the CLIA program because these degrees do not generally
appear to be focused on clinical laboratory testing or focused on the
testing of human specimens, which is the scope of the CLIA regulations.
However, in the proposed rule, we proposed an option for an educational
algorithm based on semester hours (SH) as an alternative qualification
mechanism. We stated in the proposed rule that if finalized,
individuals with degrees that are not clearly biological or chemical in
nature may be evaluated using this algorithm and may qualify for CLIA
personnel positions in subpart M.
In developing the proposed algorithm, we explored the required
courses for bachelor's, master's, and doctoral degrees in the major
studies of biology, chemistry, and medical technology. For purposes of
this discussion, only degrees in biology and chemistry will be
addressed, as degrees in medical technology and clinical laboratory
science do not need to be evaluated for equivalency. Multiple sections
of the CLIA regulations specify that educational degrees in ``chemical,
physical or biological science or medical laboratory technology from an
accredited institution'' constitute appropriate education to qualify
for laboratory roles in the noted complexity and laboratory specialty
areas. In all situations, the educational requirement is based on the
laboratory individual having a sufficient educational background
(coursework) to be qualified to gain the subsequent training and
experience to competently perform their roles.
Three levels (small, medium, and large) of both public and private
accredited universities and colleges were reviewed. For purposes of
this research, small institutions were defined as less than 5,000
students, medium as 5,000 to 15,000 students, and large as greater than
15,000 students. Seven colleges and universities were evaluated for all
three defined types. Table 9 describes the number of SH required across
all three sizes of colleges and universities for both a bachelor's in
Biology and a bachelor's in Chemistry.
[GRAPHIC] [TIFF OMITTED] TR28DE23.008

In general, accredited colleges and universities require general
biology, molecular biology or genetics, general chemistry, organic
chemistry, and biochemistry. We proposed a specific coursework
algorithm to qualify candidates, in lieu of a qualifying degree, for
all testing levels. At present, only Sec. 493.1489(b)(2)(ii) specifies
specific coursework required. This is for an associate degree
individual to perform high complexity testing. Specifying coursework
requirements will allow CMS, State agencies (SA), accreditation
organizations (AO), and exempt States (ES) to consistently evaluate
educational qualifications.
For both the doctoral degree and master's degree curricula, there
were no consistent coursework, thesis or research requirements for
Biology and Chemistry majors of study. For example, evaluation of the
master's degree requirements revealed three tracks that included:
<bullet> Coursework;
<bullet> Coursework and thesis; and
<bullet> Coursework, thesis, and research.
For doctoral degrees, we proposed the following educational
algorithm for those individuals who have a doctoral degree that is not
clearly in a chemical or biological science. We stated that we would
expect those individuals to:
<bullet> Meet master's degree equivalency; and
<bullet> At least 16 SH of additional doctoral-level coursework in
biology,

[[Page 90006]]

chemistry, medical technology, or clinical laboratory science; and
<bullet> A thesis or research project in biology, chemistry,
medical technology, or clinical laboratory science related to
laboratory testing for the diagnosis, prevention, or treatment of any
disease or impairment of or the assessment of the health of human
beings.
CLIAC recommended that other degrees (such as those in the
humanities, physical sciences, and others) may not have the requisite
science coursework, and candidates for positions should be considered
based on a minimum number of hours of courses with laboratory
components with relevance to clinical laboratory testing (which could
also come from post degree curricular work). We concur with CLIAC's
recommendation that relevant science and laboratory coursework should
be considered when evaluating an individual's education qualifications.
The educational algorithm may allow individuals without a
traditional chemical or biological degree to meet the CLIA personnel
education requirements based on their coursework. Individuals who may
have the appropriate coursework would not be disadvantaged by having a
degree that is not considered chemical or biological in nature. Please
note that the requirements for the applicable laboratory training or
experience, or both, found in subpart M (and discussed previously), are
required in addition to the educational requirement.
At Sec. 493.1405(b)(4), we proposed redesignating current
paragraphs (b)(4)(ii) and (iii) as paragraphs (b)(4)(iv) and (v),
respectively. We proposed new paragraphs (b)(4)(ii) and (iii) as
additional educational options that include a qualification algorithm
for an individual that does not have a master's degree in a chemical,
biological, or clinical laboratory science or medical technology (see
section III.B.3. of the proposed rule). We proposed adding a new
requirement at paragraph (b)(4)(vi) to include the addition of 20 CE
credit hours. (As discussed later in this section of the final rule,
these provisions in the proposed rule at Sec. 493.1405(b)(4) are being
reformatted and finalized at the revised (b)(4)(i) through (iv)).
As a result of the above discussion, we proposed that individuals
meet either of the following two options for use as educational
algorithms:
<bullet> Option 1
++ Meet bachelor's degree equivalency; and
++ At least 16 SH of additional graduate level coursework in
biology, chemistry, medical technology, or clinical laboratory science;
or
<bullet> Option 2
++ Meet bachelor's degree equivalency; and
++ At least 16 SH, which may include a combination of graduate
level coursework in biology, chemistry, medical technology, or clinical
laboratory science and a thesis or research project related to
laboratory testing for the diagnosis, prevention, or treatment of any
disease or impairment of, or the assessment of the health of, human
beings.
At Sec. 493.1405(b)(5), we proposed redesignating current
paragraphs (b)(5)(ii) and (iii) to paragraphs (b)(5)(iii) and (iv),
respectively. In addition, we proposed a new paragraph (b)(5)(ii) with
an educational option that includes a qualification algorithm for an
individual that does not have a bachelor's degree in a chemical,
biological, or clinical laboratory science or medical technology (see
section I.D.1.c. of the proposed rule). We also proposed adding a new
requirement at paragraph (b)(5)(v) to include the addition of 20 CE
credit hours. (As discussed later in this section of the final rule,
these provisions in the proposed rule at Sec. 493.1405(b)(5) are being
reformatted and finalized at the revised (b)(5)(i) through (iv)).
In general, an associate degree requires the completion of 60 SH,
and a bachelor's degree requires the completion of 120 SH. In the case
of bachelor's degrees, for this reason, we proposed that the equivalent
educational requirements for associate degrees at the existing Sec.
493.1489(b)(2)(ii) should be doubled. That is, an individual must have
at least 120 SH, or equivalent, from an accredited institution that, at
a minimum, include either 48 SH of medical laboratory technology or
clinical laboratory science courses; or 48 SH of science courses that
include: 12 SH of chemistry, which must include general chemistry and
biochemistry or organic chemistry; 12 SH of biology, which must include
general biology and molecular biology, cell biology or genetics; and 24
SH of chemistry, biology, or medical laboratory technology or clinical
laboratory science in any combination. (Note: We did not propose to
amend the education SH requirements at the existing Sec.
493.1489(b)(2)(ii) in the proposed rule, as there is no need to amend.
However, in the proposed and now final rule, the existing Sec.
493.1489(b)(2)(ii) is redesignated and reformatted as Sec.
493.1489(b)(3)(ii)).
In addition to the degrees discussed previously in this rule, we
proposed a new framework for evaluating non-traditional degrees, a part
of the educational algorithm described previously. One example of a
non-traditional degree may be a Regents Bachelor of Arts (RBA), which
is a baccalaureate degree program designed for adult students. The
basic principle of an RBA is that credit is awarded for what students
know, regardless of how that knowledge was obtained. In other words,
students may earn college equivalent credit for work and life
experiences that can be equated to college courses. It is designed to
provide students with a comprehensive general education. Many times, no
specific courses are required for graduation, allowing students to
design their own programs of study. This degree is usually awarded by a
Board of Regents. It is a general education degree without the
designation of a major. Many of these individuals have an associate
degree in medical laboratory technology (MLT), but not an appropriate
bachelor's degree that would make them eligible to qualify under the
provisions in CLIA personnel requirements that require a minimum of a
bachelor's degree in specified scientific fields. This becomes
problematic because the RBA does not designate a major. Generally, in
these cases, we have seen that these individuals have an associate
degree in MLT and have many years of clinical laboratory experience.
Currently, these individuals cannot meet CLIA personnel qualifications
in subpart M that require a minimum of a bachelor's degree. We believe
that their education and experience should qualify them to be TCs as
long as their associate degree is in medical laboratory technology or
laboratory science. Public feedback from the 2018 RFI supported that a
non-traditional degree should be considered as a means to meet CLIA
requirements for the TC and TP for moderate complexity testing,
provided a minimum number of SH were obtained in chemistry, biology,
and laboratory sciences. We believe a non-traditional degree can be a
means to qualify as TC and TP, provided an adequate number of biology,
chemistry or medical laboratory, or clinical laboratory science courses
is part of the curriculum in addition to meeting the training or
experience requirements. However, we do not believe a nontraditional
degree can be a means to qualify as a laboratory director.
At Sec. 493.1405(b)(6) through (7), we proposed removing the
``grandfather'' provisions as these requirements had to

[[Page 90007]]

have been met by February 28, 1992. Individuals can no longer qualify
under these provisions. A grandfather is a provision in which a
previous rule would continue to apply to individuals already qualified
and employed in the given personnel capacity upon implementing a new
rule. The new rule will apply to all individuals seeking to qualify
after the implementation of said rule. We proposed to revise paragraph
(b)(6) with a new grandfather provision for all individuals who
qualified under this provision, as well as Sec. 493.1406, prior to the
date of the final rule. We stated in the proposed rule that we intend
to allow individuals already qualified and employed in the given
personnel capacity as of the date of the final rule to continue to be
qualified under the new provisions (that is, grandfathered). However,
we stated that we intend to require all individuals becoming employed
by a laboratory or changing assignments within a laboratory after the
final rule's effective date to qualify under the new provisions. This
includes those individuals who may have been previously employed in a
given position prior to the effective date but took a break or a leave
of absence and came back after the date of the final rule.
We received public comments on these proposed provisions at Sec.
493.1405. The following is a summary of the public comments we received
and our responses.
Comment: A commenter suggested a formal recognition of board
certification in MT, CLS, MLS, and other subspecialties instead of
qualifications based on coursework. The commenter added that
accreditation organizations need to recognize board certification
because they are not required in the CLIA regulations. According to the
commenter, those with ASCP and other certifications are higher
qualified laboratory scientists who meet the CLIA minimum. The
commenter further stated that it is often easier to obtain
certification verification than to prove degree coursework, especially
from schools or programs that no longer exist.
Response: We believe this type of documentation is not sufficient
evidence of meeting the personnel qualifications. We have found that
the certifying boards may certify individuals as MT, CLS, and MLS with
a variety of degrees if they meet an educational algorithm. Their
coursework may not meet the minimum CLIA personnel requirements, but
there may be enough science classes to sit for the examination and be
certified as an MT, CLS, or MLS. In addition, not all certifying boards
have the same requirements for certification. We will continue
requiring detailed information, such as degrees, transcripts, or
Primary Source Verification (PSV) documents, to verify educational
credentials per the policy memorandum, S&C: 16-18-CLIA (<a href="https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-18.pdf">https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-18.pdf</a>).
Comment: Several commenters noted the 2022 decision by AMT, ASCP,
and ASCLS to change the MT certification designation to MLS. The
commenters suggested that medical laboratory science should be used in
addition to clinical laboratory science throughout the CLIA personnel
qualifications.
Response: We agree with the commenters that medical laboratory
science should be included in the revised personnel qualifications. We
are incorporating the change suggested by the commenters where
applicable in revised Sec. 493.1405 and other applicable sections of
subpart M.
Comment: Many commenters agreed with the removal of ``physical
science'' as a degree. A commenter stated that defining specific
courses of study which must be completed to qualify as a LD (that is,
biochemistry or organic chemistry; molecular biology, cell biology, or
genetics) unfairly discriminates against degree programs that impart
the necessary knowledge to perform the duties of LD but do not include
these specific courses. The commenter added that foreign and
alternative degrees might also prepare a person to perform the LD
duties better than degree programs that have those specific courses.
Response: We believe it is important that individuals lacking a
traditional degree in chemical, biological, clinical, or medical
laboratory science or medical technology should be considered if they
have completed the coursework equivalent to the aforementioned
traditional degrees and acquired documentation of the equivalent
educational coursework. In response to the 2018 RFI (83 FR 1005 through
1006, 1008), commenters recommended that we evaluate coursework taken
using an SH educational algorithm to qualify individuals for CLIA
personnel positions. CLIAC also stated that degrees (such as those in
the humanities, physical sciences, and others) might require the
requisite science coursework. The courses indicated in the proposed
algorithm meet the CLIAC recommendation for courses with laboratory
components relevant to clinical laboratory testing.
Comment: A commenter opposed lowering of educational standards for
LD and disagreed with the proposal to add a qualification pathway for
moderate and high-complexity LD that includes an educational algorithm
for an individual that does not have an earned doctoral degree in a
chemical, biological, or clinical laboratory science or medical
technology. The commenter suggested that a doctorate-level or medical
doctor degree should be the minimum educational qualification for LD,
given the importance of the role of overseeing the overall management
and operations of the clinical laboratory.
Response: We agree that the doctoral degree algorithm requires, at
a minimum, a doctoral degree and therefore are revising proposed Sec.
493.1405(b)(3)(ii)(A) (finalized at Sec. 493.1405(b)(3)(i)(B)) to
specify that the individual must have an earned doctoral degree for
purposes of the doctoral degree algorithm. However, we do not agree
that LDs of a laboratory performing moderate-complexity testing require
a doctoral degree. Since 1992 the CLIA LD qualifications for
laboratories performing moderate complexity testing (Sec. 493.1405)
have provided pathways for individuals with a master's or bachelor's
degree to qualify as moderate complexity LD. The proposed moderate
complexity LD qualifications for master's and bachelor's degrees
courses indicated in the proposed algorithm meet the CLIAC
recommendation for courses with laboratory components relevant to
clinical laboratory testing.
In this final rule, consistent with our proposed and final policy,
we are also reformatting proposed Sec. 493.1405(b)(3) to clarify that
both individuals qualifying with a traditional doctoral degree and
those qualifying under the new educational pathway, must have the
specified 20 CE credit hours, certification, and experience. As we
explained in the July 2022 proposed rule (87 FR 44914), these
requirements apply to individuals qualifying with doctoral degrees. We
are also reformatting proposed Sec. 493.1405(b)(4) and (5) to clarify
that individuals qualifying with a traditional master's or bachelor's
degree and those qualifying under the new educational pathway must all
have the required laboratory training or experien

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