Notice2024-06802
Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption of Laboratories Licensed by the State of Washington
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 1, 2024
Effective
April 1, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This notice announces that laboratories located in and licensed by the State of Washington that possess a valid license under the Medical Test Site law, chapter 70.42 of the Revised Code of Washington, are exempt from the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for a period of 4 years.
Full Text
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<title>Federal Register, Volume 89 Issue 63 (Monday, April 1, 2024)</title>
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[Federal Register Volume 89, Number 63 (Monday, April 1, 2024)]
[Notices]
[Pages 22406-22408]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-06802]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3441-N]
Medicare, Medicaid, and CLIA Programs; Clinical Laboratory
Improvement Amendments of 1988 Exemption of Laboratories Licensed by
the State of Washington
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This notice announces that laboratories located in and
licensed by the State of Washington that possess a valid license under
the Medical Test Site law, chapter 70.42 of the Revised Code of
Washington, are exempt from the requirements of the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) for a period of 4 years.
DATES: The exemption granted by this notice is effective from April 1,
2024 to April 1, 2028.
FOR FURTHER INFORMATION CONTACT: Mary Hasan, (410) 786-6480.
SUPPLEMENTARY INFORMATION:
I. Background and Legislative Authority
Section 353 of the Public Health Service Act (PHSA), as amended by
the Clinical Laboratory Improvement Amendments of 1988 (CLIA) (Pub. L.
100-578), which was enacted on October 31, 1988, generally provides
that no laboratory may perform tests on human specimens for the
diagnosis, prevention or treatment of any disease or impairment of, or
assessment of the health of, human beings unless it has a certificate
to perform that category of tests issued by the Secretary of the
Department of Health and Human Services (HHS). Under section
1861(s)(17)(A) of the Social Security Act (the Act), the Medicare
program will only pay for laboratory services if the laboratory has an
appropriate CLIA certificate for the testing they conduct. Under
section 1902(a)(9)(C) of the Act, State Medicaid plans will generally
only pay for laboratory services furnished by CLIA-certified
laboratories. Thus, although subject to specified exemptions and
exceptions, laboratories generally must have a current and valid CLIA
certificate to test human specimens for the purposes noted above to be
eligible for payment for those tests by the Medicare or Medicaid
programs. Regulations implementing section 353 of the PHSA are
contained in 42 CFR part 493.
Section 353(p)(2) of the PHSA provides for the exemption of
laboratories from CLIA requirements in States that enact legal
requirements that are equal to or more stringent than CLIA's statutory
and regulatory requirements. Section 353(p)(2) of the PHSA is
implemented in subpart E of our regulations at 42 CFR part 493.
Sections 493.551(a) and 493.553 provide that CMS may exempt from CLIA
requirements, for a period not to exceed 6 years, all State-licensed or
State-approved laboratories in a State if the State licensure program
meets the specified conditions. Section 493.559(a) provides that CMS
will publish a notice in the Federal Register when CMS grants an
exemption to an approved State licensure program. Section 493.559(b)
provides that the notice will include the following:
<bullet> The name of the State licensure program.
<bullet> A description of how the laboratory requirements of the
State are equal to or more stringent than those of part 493.
<bullet> The basis for granting the exemption.
<bullet> The term of approval, not to exceed 6 years.
A. State of Washington's Application for CLIA Exemption of Its
Laboratories
The State of Washington has applied for exemption of its
laboratories from CLIA program requirements. The State of Washington
submitted all the applicable information and attestations required by
Sec. Sec. 493.551(a), 493.553, and
[[Page 22407]]
493.557(b) for State licensure programs seeking exemption of their
licensed laboratories from CLIA program requirements. Examples of
documents and information submitted include: a comparison of its
laboratory licensure requirements with the comparable CLIA condition-
level requirements (that is, a crosswalk); and a description of the
following: its inspection process; its proficiency testing (PT)
monitoring process; its data management and analysis system; its
investigative and response procedures for complaints received against
laboratories; and its policy regarding announced and unannounced
inspections.
B. CMS Analysis of Washington's Application and Supporting
Documentation
To determine whether CMS should grant a CLIA exemption to
laboratories licensed by a State, CMS reviews the application and
additional documentation that the State submits to us and conducts a
detailed and in-depth comparison of the State licensure program and
CLIA's statutory and regulatory requirements to determine whether the
State licensure program meets the requirements in part 493.
In summary, the State generally must demonstrate that:
<bullet> It has State laws in effect that provide for a State
licensure program that has requirements that are equal to, or more
stringent than, CLIA condition-level requirements for laboratories.
<bullet> It has implemented a State licensure program with
requirements that are equal to, or more stringent than, the CLIA
condition-level requirements such that a laboratory licensed by the
State program would meet the CLIA condition-level requirements if it
were inspected against those requirements.
<bullet> The requirements under that State licensure program meet
or exceed the requirements of Sec. Sec. 493.553, 493.555, and
493.557(b) and is suitable for approval by CMS under Sec.
493.553(b)(3). For example, among other things, the program would need
to:
++ Demonstrate that it has enforcement authority and administrative
structures and resources adequate to enforce its laboratory
requirements.
++ Permit CMS or CMS agents to inspect laboratories within the
State.
++ Require laboratories within the State to submit to inspections
by CMS or CMS agents as a condition of licensure.
++ Agree to pay any costs associated with our activities to
validate its State licensure program as specified in Sec.
493.557(b)(4) as well as the State's pro rata share of the general
overhead to develop and implement CLIA as specified in Sec.
493.649(a).
++ Take appropriate enforcement action against laboratories found
by CMS or CMS agents to be out of compliance with requirements
equivalent to CLIA requirements, as specified in Sec. 493.557(b).
As specified in our regulations at Sec. Sec. 493.555 and
493.557(b), our review of a State licensure program includes (but is
not necessarily limited to) an evaluation of the following:
<bullet> Whether the State's requirements for laboratories are
equal to, or more stringent than, the CLIA condition-level
requirements.
<bullet> The State's inspection process requirements to determine
the following:
++ The comparability of the full inspection and complaint
inspection procedures to those of CMS, including, but not limited to,
inspection frequency and the ability to investigate and respond to
complaints against its laboratories.
++ The State's enforcement procedures for laboratories found to be
out of compliance with its requirements.
<bullet> The ability of the State to provide CMS with electronic
data and reports with the adverse or corrective actions resulting from
PT results that constitute unsuccessful participation in CMS-approved
PT programs and with other data CMS determines to be necessary for
validation review and assessment of the State's inspection process
requirements.
<bullet> The State's agreement with CMS that requires the State to
do the following:
++ Notify CMS within 30 days of the action taken against any CLIA-
exempt laboratory that has had its licensure or approval suspended,
withdrawn, revoked, or limited; been in any way sanctioned; or had any
adverse action taken against it.
++ Notify CMS within 10 days of any deficiency identified in a
CLIA-exempt laboratory in cases when the deficiency poses an immediate
jeopardy to the laboratory's patients or a hazard to the general
public.
++ Notify each laboratory licensed by the State under its approved
State licensure program within 10 days of a withdrawal of our approval
of the State's licensure program, and the resulting loss of the
laboratory's exemption from CLIA based on its licensure under that
program.
++ Provide CMS with written notification of any changes in the
State's licensure (or approval) and inspection requirements.
++ Disclose to CMS or CMS' agent any laboratory's PT results in
accordance with the State's confidentiality requirements.
++ Take appropriate enforcement action against laboratories that
CMS or CMS agents find to be out of compliance with CLIA condition-
level requirements and report these enforcement actions to CMS.
++ Notify CMS within 30 days of all newly licensed laboratories,
including the specialty and subspecialty areas of testing, and notify
CMS of any changes in the specialties and subspecialties for which any
licensed laboratory in the State performs testing.
++ Provide CMS with inspection schedules, as requested, for
validation purposes.
In keeping with the process described above, CMS evaluated the
application and supporting materials that were submitted by Washington
State to verify that the laboratories licensed through its program will
meet or exceed the requirements of the following subparts of part 493:
<bullet> Subpart H, Participation in Proficiency Testing for
Laboratories Performing Nonwaived Testing;
<bullet> Subpart J, Facility Administration for Nonwaived Testing;
<bullet> Subpart K, Quality Systems for Nonwaived Testing,
<bullet> Subpart M, Personnel for Nonwaived Testing;
<bullet> Subpart Q, Inspection; and
<bullet> Subpart R, Enforcement Procedures.
CMS found that Washington State's laboratory licensure program
requirements mapped to all the CLIA condition-level requirements. The
State licensure program's inspection process and PT monitoring
processes were adequate. Other materials that were submitted
demonstrated compliance with the other above-referenced requirements of
subpart E of part 493. As a result, CMS concluded that the submitted
documents supported exempting laboratories licensed under that program
from the CLIA program requirements. Furthermore, a review of our
validation inspections conducted by the CMS office in Seattle,
Washington, supported this conclusion.
The Federal validation inspections of CLIA-exempt laboratories, as
specified in Sec. 493.563, were conducted on a representative sample
basis, as well as in response to any substantial allegations of
noncompliance (complaint inspections). The outcome of those validation
inspections has been and will continue to be our principal tool for
verifying that the laboratories located in, and licensed by, the State
are in compliance with CLIA requirements.
[[Page 22408]]
The CMS office in Seattle, Washington, has conducted validation
inspections of a representative sample of the laboratories inspected by
the Washington State Office of Laboratory Quality Assurance (LQA). The
validation inspections were primarily of the concurrent type; that is,
our surveyors accompanied Washington State's inspectors, each
inspecting against his or her agency's respective regulations. Analysis
of the validation data revealed no significant differences between the
State and Federal findings. The validation surveys verified that the
State of Washington inspection process covers all CLIA conditions
applicable to each laboratory being inspected and also verified that
the State laboratory licensure requirements meet or exceed CLIA
condition-level requirements. The validation surveys found the State
inspectors highly skilled and qualified. The LQA inspected laboratories
in a timely fashion; that is, all laboratories were inspected within
the required 24-month cycle. All parameters monitored by the CMS office
in Seattle, Washington, to date, indicate that the State of Washington
is meeting all requirements for approval of CLIA exemption. This
Federal monitoring will continue as an on-going process.
C. Conclusion
Based on review of the documents submitted by the Washington State
licensure program under the requirements of subpart E of part 493, as
well as the outcome of the validation inspections conducted by the CMS
office in Seattle, Washington, CMS finds that the State of Washington's
licensure program meets the requirements of Sec. 493.553(a), and that,
as a result, CMS may exempt all State-licensed laboratories from CLIA
program requirements.
Approval of the CLIA exemption for laboratories located within and
licensed by the State of Washington laboratory licensure program is
subject to removal if CMS determines that the outcome of a
comparability review or a validation review inspection is not
acceptable, as described under Sec. Sec. 493.573 and 493.575, or if
the State of Washington fails to pay the required fee every 2 years as
required under Sec. 493.649.
D. Laboratory Data
The approval of this exemption for laboratories located within and
licensed by the State of Washington is conditioned on the State of
Washington's continued compliance with the assertions made in its
application, including the provision of information to us in accordance
with our regulations at Sec. 493.557(b)(8) about changes to a
laboratory's specialties or subspecialties based on the State's survey,
and changes to a laboratory's certification status.
E. Required Administrative Actions
CLIA is a user-fee funded program. The registration fee paid by
laboratories is intended to cover the cost of the development and
administration of the program. However, when a State's application for
exemption is approved, CMS does not charge a fee to laboratories in the
State. The State's share of the costs associated with CLIA must be
collected from the State, as specified in Sec. 493.649.
The State of Washington must pay for the following:
<bullet> Costs of Federal inspections of laboratories in the State
to verify that standards are being enforced in an appropriate manner.
<bullet> Costs incurred for investigations of complaints against
State of Washington laboratories if the complaint is substantiated.
<bullet> The State's pro rata share of general overhead to
administer the laboratory certification program under section 353 of
the PHS Act.
To estimate the State of Washington's proportionate share of the
general overhead costs to develop and implement CLIA, CMS determined
the ratio of laboratories in the State to the total number of
laboratories nationally. Approximately 1.9 percent of the registered
laboratories are in the State of Washington. CMS determined that a
corresponding percentage of the applicable CMS, CDC, FDA, and their
respective contractor costs should be borne by the State of Washington.
The State of Washington has agreed to pay the State's pro rata
share of the anticipated overhead costs and costs of actual validation
(including complaint investigation surveys) as specified in Sec.
493.655(b). A final reconciliation for all laboratories and all
expenses will be made. CMS will reimburse the State for any overpayment
or bill it for any balance.
II. Approval
In light of the foregoing, CMS grants approval of the State of
Washington's laboratory licensure program under subpart E. All
laboratories located in and licensed by the State of Washington under
the Medical Test Site law, chapter 70.42 of the Revised Code of
Washington, are CLIA-exempt for all specialties and subspecialties
until April 1, 2028.
The Administrator of the Centers for Medicare & Medicaid Services
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this
document, authorizes Trenesha Fultz-Mimms, who is the Federal Register
Liaison, to electronically sign this document for purposes of
publication in the Federal Register.
Trenesha Fultz-Mimms,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2024-06802 Filed 3-29-24; 8:45 am]
BILLING CODE 4120-01-P
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</html>Indexed from Federal Register on April 1, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.