H.R. 8890

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8890 Introduced in House (IH)]

<DOC>

119th CONGRESS
2d Session
H. R. 8890

To amend the Public Health Services Act, commonly referred to as the 
``Clinical Laboratory Improvement Amendments'' or ``CLIA'', with 
respect to laboratory developed tests, and for other purposes.

_______________________________________________________________________

IN THE HOUSE OF REPRESENTATIVES

May 19, 2026

Mr. Dunn of Florida introduced the following bill; which was referred 
to the Committee on Energy and Commerce, and in addition to the 
Committee on Ways and Means, for a period to be subsequently determined 
by the Speaker, in each case for consideration of such provisions as 
fall within the jurisdiction of the committee concerned

_______________________________________________________________________

A BILL

To amend the Public Health Services Act, commonly referred to as the 
``Clinical Laboratory Improvement Amendments'' or ``CLIA'', with 
respect to laboratory developed tests, and for other purposes.

Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ``Enhancing Clinical Laboratory 
Innovation and Access Act of 2026'' or the ``Enhancing CLIA Act of 
2026''.

SEC. 2. ENHANCED REGULATION OF LABORATORY DEVELOPED TESTS.

(a) Amendments to the Public Health Services Act, Commonly Referred 
to as the ``Clinical Laboratory Improvement Amendments'' or ``Clia''.--
Section 353 of the Public Health Service Act (42 U.S.C. 263a) is 
amended--
(1) by striking subsection (a) and inserting:
``(a) Scope of Authority; Definitions.--
``(1) Scope of authority.--Laboratory operations shall be 
regulated by the Secretary under this section and not under the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et. seq.).
``(2) Definitions.--In this section:
``(A) Analytical validity.--The term `analytical 
validity' means, with respect to an examination or 
procedure performed by a laboratory, the ability of the 
examination or procedure to provide information that is 
accurate and reliable with respect to the 
identification, measurement, detection, or calculation 
of the target analyte in a specimen, within a 
reportable range.
``(B) Applicable standard.--The term `applicable 
standard' means--
``(i) for a laboratory developed test for 
clinical use, that the test has a reasonable 
assurance of analytical and clinical validity; 
and
``(ii) for a laboratory developed test for 
investigational use, that the test has a 
reasonable assurance of analytical validity.
``(C) Clinical use.--The term `clinical use'--
``(i) means that an examination or 
procedure is used for the purpose of providing 
information for the diagnosis, prognosis, 
identification, monitoring, screening, 
prevention, or treatment of any disease or 
impairment of, or the assessment of the health 
of, human beings; and
``(ii) does not include--
``(I) investigational use;
``(II) research use; or
``(III) forensic use.
``(D) Clinical validity.--The term `clinical 
validity' means, with respect to an examination or 
procedure performed by a laboratory, the ability of the 
examination or procedure to provide information that is 
accurate and reliable for its stated clinical purpose.
``(E) Digital laboratory data.--The term `digital 
laboratory data'--
``(i) means digital data derived from a 
laboratory examination or procedure performed 
by a laboratory on materials taken or derived 
from the human body, including--
``(I) a digital image derived from 
a glass slide;
``(II) flow cytometry plots;
``(III) cytogenetic karyograms;
``(IV) chromatographic, mass 
spectrometric, clinical chemistry, 
immunological, hematological and 
microbiological data;
``(V) electropherograms;
``(VI) gel images;
``(VII) genetic expression, array 
and sequencing data; and
``(VIII) subsequent analyses of 
such data; and
``(ii) is patient-specific when it is 
accompanied by information that can be used to 
identify the individual from whose specimen the 
information was derived.
``(F) Investigational use.--The term 
`investigational use' means, with respect to a 
laboratory developed test, that the test is used in a 
clinical investigation, at least 1 purpose of which is 
to gather data to establish the clinical validity of 
the test.
``(G) Laboratory; clinical laboratory.--The term 
`laboratory' or `clinical laboratory' means a facility 
for the examination of materials taken or derived from 
the human body, including analysis of patient-specific 
digital laboratory data, for clinical use or 
investigational use.
``(H) Laboratory developed test.--The term 
`laboratory developed test'--
``(i) means an examination or procedure, 
including an examination or procedure that 
modifies an in vitro diagnostic device 
regulated under the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.), that is--
``(I) developed in a clinical 
laboratory certified under this section 
to perform tests of high-complexity; 
and
``(II) performed only within--
``(aa) the same clinical 
laboratory in which it was 
developed; or
``(bb) another clinical 
laboratory certified under this 
section to perform tests of 
high-complexity that is 
within--

``(AA) the same 
corporate organization 
and has common 
ownership by the same 
parent corporation as 
the developing 
laboratory; or

``(BB) a public 
health laboratory 
network coordinated or 
managed by the Centers 
for Disease Control and 
Prevention or other 
Federal public health 
agency, if the 
developing laboratory 
is a public health 
laboratory or a 
laboratory managed by 
the Centers for Disease 
Control and Prevention 
or other Federal public 
health agency;

``(ii) does not include a protocol for an 
examination or procedure that is commercially 
distributed for performance in laboratories not 
under common ownership by the same parent 
corporation as the laboratory that developed 
the protocol;
``(iii) is not a medical device subject to 
regulation under the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.), even if 
the laboratory developed test--
``(I) modifies the use of a device 
that is lawfully marketed under the 
Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 301 et seq.);
``(II) requires preparation or 
modification within the laboratory of 
equipment, reagents, instruments, 
software, or other materials for use 
within the laboratory;
``(III) includes processes, 
materials, research, or intellectual 
property developed by third parties if 
the developing laboratory remains 
responsible for compliance with 
applicable requirements for laboratory 
developed tests under this section; or
``(IV) examines a specimen that was 
self-collected by an individual, 
regardless of the setting in which the 
specimen was collected; and
``(iv) is performed in a laboratory 
described in clause (i)(II) even if software 
used in the test is executed outside of the 
laboratory.
``(I) Laboratory operations.--The term `laboratory 
operations'--
``(i) means the conduct of examinations and 
other procedures on material taken or derived 
from the human body and associated activities, 
including analysis of patient-specific digital 
laboratory data, for a purpose described in 
subparagraph (E), including the development and 
performance of laboratory developed tests; and
``(ii) includes--
``(I) the preparation and transfer 
of equipment, reagents, instruments, 
software, or other materials between 
laboratories that are under common 
ownership by the same parent 
corporation; and
``(II) the distribution of specimen 
collection kits for use with laboratory 
developed tests if the components of 
such specimen collection kits are 
intended to be used consistent with the 
established intended uses for which 
they may otherwise be lawfully 
distributed.
``(J) Performance specifications.--The term 
`performance specification' means a value or range of 
values for a characteristic of an examination or 
procedure, such as accuracy, precision, analytical 
sensitivity, analytical specificity, reportable range, 
or other characteristic required for test performance.
``(K) Research use.--The term `research use' means, 
with respect to a laboratory developed test, that the 
test's purpose is solely for analytical development or 
scientific research, and not for use in making clinical 
decisions for individual patients.'';
(2) by adding at the end:
``(r) Laboratory Developed Tests.--
``(1) Reasonable assurance of analytical and clinical 
validity of laboratory developed tests.--
``(A) Standard.--Beginning 2 years after enactment 
of the Enhancing CLIA Act of 2026, no laboratory may 
perform a laboratory developed test unless the test 
meets the applicable standard.
``(B) Analytical validity.--For purposes of meeting 
the applicable standard under this section, a 
laboratory developed test has a reasonable assurance of 
analytical validity if--
``(i) the laboratory that develops the test 
establishes performance specifications that 
support the ability of the test to identify, 
measure, detect, calculate, or analyze 1 or 
more analytes, biomarkers, substances, or other 
targets intended to be identified, measured, 
detected, calculated, or analyzed by the test; 
and
``(ii) the laboratory that performs the 
test, if different than the laboratory that 
develops the test, verifies such performance 
specifications prior to use.
``(C) Clinical validity.--For purposes of meeting 
the applicable standard under this section, a 
laboratory developed test has a reasonable assurance of 
clinical validity if the laboratory that develops the 
test has documented evidence, which may include 1 or 
more of the following that supports the ability of the 
laboratory developed test to reliably and accurately 
achieve its stated purpose--
``(i) peer-reviewed literature;
``(ii) clinical guidelines;
``(iii) bench studies;
``(iv) case studies or histories;
``(v) consensus standards;
``(vi) reference standards;
``(vii) data registries;
``(viii) postmarket data;
``(ix) real world data;
``(x) 1 or more clinical validation 
studies; or
``(xi) other evidence deemed appropriate by 
the Secretary.
``(D) Supplemental affirmation that standard has 
been met.--
``(i) At any time, a laboratory may, but is 
not required to, obtain 1 or more supplemental 
affirmations that the laboratory developed test 
meets the applicable standard from a third 
party approved under subparagraph (E), pursuant 
to the process in subparagraph (F). Subject to 
clause (ii) of this subparagraph, such 
supplemental affirmation does not expire.
``(ii) If a third party approved under 
subparagraph (E) has its approval withdrawn by 
the Secretary, a supplemental affirmation that 
a laboratory developed test meets the 
applicable standard issued by that third party 
shall remain in effect for no longer than the 
later of--
``(I) 90 days after the date that a 
third party notifies a laboratory under 
subparagraph (E)(iv) that its approval 
has been withdrawn; or
``(II) if within 60 days of 
receiving the notification under 
subparagraph (E)(iv) the laboratory 
submits information to a different 
third party requesting a supplemental 
affirmation that the laboratory 
developed test meets the applicable 
standard, the date on which such 
approved third party determines whether 
the laboratory developed test meets the 
applicable standard under subparagraph 
(F)(i)(II).
``(E) Approved third parties.--Beginning 2 years 
after enactment of the Enhancing CLIA Act of 2026, the 
Secretary shall approve third parties to provide a 
supplemental affirmation that a laboratory developed 
test meets the applicable standard if--
``(i) the standards and procedures applied 
by the third party in determining whether the 
laboratory developed test meets the applicable 
standard are determined by the Secretary to be 
sufficiently risk-based, rigorous, and not 
overly burdensome;
``(ii) in the case that the third party 
determines under subparagraph (F)(ii)(III)(cc) 
that the data and information provided by the 
laboratory demonstrates that the laboratory 
developed test does not meet the applicable 
standard, the laboratory developed test is 
being offered with false or deceptive claims, 
or that it is probable that the test will cause 
serious adverse health consequences, the third 
party agrees to notify the Secretary within 10 
days of such determination unless the 
laboratory stops offering, and notifies the 
third party that it no longer offers, the 
laboratory developed test;
``(iii) the third party agrees to notify 
the Secretary at least 30 days before it 
changes its standards and procedures for 
determining that a laboratory developed test 
meets the applicable standard; and
``(iv) if the third party has its approval 
withdrawn by the Secretary, the third party 
agrees to notify each laboratory that obtained 
a supplemental affirmation that the applicable 
standard was met for any laboratory developed 
test of the withdrawal within 10 days of the 
withdrawal.
``(F) Process for supplemental affirmation by 
approved third party.--
``(i) If a laboratory submits information 
to a third party approved by the Secretary 
under subparagraph (E) requesting a 
supplemental affirmation that a laboratory 
developed test meets the applicable standard, 
the approved third party shall within 60 
calendar days of receipt of the submitted 
information--
``(I) review the submitted 
information, which may include 
communication with the laboratory; and
``(II) determine whether the 
laboratory developed test meets the 
applicable standard and communicate 
such determination with the laboratory 
as described in clause (ii).
``(ii) The approved third party shall 
provide written notice to the laboratory of the 
approved third party's determination under 
clause (i)(II) as follows:
``(I) The approved third party 
shall notify the laboratory if the 
approved third party determines that 
the laboratory developed test--
``(aa) meets the applicable 
standard; or
``(bb) does not meet the 
applicable standard and 
subclauses (II) and (III) do 
not apply.
``(II) If the approved third party 
determines that the laboratory 
developed test does not meet the 
applicable standard but that such 
determination may be resolved within a 
reasonable time--
``(aa) the approved third 
party shall notify the 
laboratory of such 
determination and the reasons 
therefore, and allow the 
laboratory to seek a 
teleconference to discuss the 
finding;
``(bb) the laboratory shall 
submit information 
demonstrating resolution of the 
determination within 60 days of 
receiving such notification; 
and
``(cc) the approved third 
party shall make a 
determination within 30 days of 
the receipt of such submission 
of information as to whether 
the laboratory developed test 
continues not to meet the 
applicable standard.
``(III) If the approved third party 
determines that there is a lack of 
credible and verifiable information 
supporting that the laboratory 
developed test meets the applicable 
standard, the laboratory developed test 
is being offered with false or 
deceptive claims, or that it is 
probable that the test will cause 
serious adverse health consequences--
``(aa) the approved third 
party shall notify the 
laboratory of such 
determination and the reasons 
therefore, and allow the 
laboratory to seek a 
teleconference to discuss the 
finding;
``(bb) the laboratory shall 
submit information 
demonstrating resolution of the 
determination within 60 days of 
receiving such notification; 
and
``(cc) the approved third 
party shall make a 
determination within 30 days of 
the receipt of such submission 
of information as to whether 
such determination continues to 
apply.
``(iii) In the case that the third party 
determines under subparagraph (F)(ii)(I)(bb) 
that a laboratory developed test does not meet 
the applicable standard, the laboratory may 
resubmit a request for supplemental affirmation 
by the same or different third party for review 
without prejudice at any time.
``(iv) In the case that the third party 
determines under subparagraph (F)(ii)(III)(cc) 
that there is a lack of credible and verifiable 
information supporting the analytical or 
clinical validity of the laboratory developed 
test, the laboratory developed test is being 
offered with false or deceptive claims, or that 
it is probable that the test will cause serious 
adverse health consequences--
``(I) the third party will not 
notify the Secretary of such 
determination if the laboratory stops 
performing such laboratory developed 
test, and notifies the third party that 
it has stopped performing such 
laboratory test, within 10 days; and
``(II) the laboratory may resubmit 
a request for supplemental affirmation 
by the same or different third party 
for review without prejudice at any 
time.
``(G) Deemed supplemental affirmation.--A 
laboratory developed test shall be deemed to have 
obtained a supplemental affirmation that it meets the 
applicable standard under subparagraph (D) if it is--
``(i) approved by the New York State 
Department of Health;
``(ii) determined to be reasonable and 
necessary under Medicare pursuant to a 
favorable review of a technical assessment 
under the MolDX Program;
``(iii) within a category of tests 
identified by the Secretary in regulation that 
shall be deemed to have obtained a supplemental 
approval.
``(H) Food and drug administration an approved 
third party.--
``(i) The Food and Drug Administration 
shall be deemed an approved third party under 
subparagraph (E).
``(ii) Beginning 2 years after enactment of 
the Enhancing CLIA Act of 2026, a laboratory 
may request a supplemental affirmation from the 
Food and Drug Administration that a laboratory 
developed test for clinical use meets the 
applicable standard.
``(iii) Any laboratory seeking supplemental 
affirmation from the Food and Drug 
Administration under clause (ii) shall pay a 
fee for such review that is no greater than the 
applicable user fee for a premarket 
notification submission under section 738 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379j).
``(iv) If a laboratory seeks supplemental 
affirmation from the Food and Drug 
Administration under clause (ii) and pays the 
fee under clause (iii), the Food and Drug 
Administration--
``(I) shall review the information 
for the laboratory developed test only 
in accordance with the standards 
applied by the Secretary under 
subparagraph (A) and the procedure 
applied by approved third parties under 
subparagraph (F); and
``(II) shall not apply to the 
laboratory developed test the standards 
or other requirements that apply to 
devices or any other product regulated 
under the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.).
``(2) Centralized database for laboratory developed tests 
for clinical use.--Beginning 2 years after enactment of the 
Enhancing CLIA Act of 2026, each laboratory performing 1 or 
more laboratory developed tests for clinical use shall submit 
to the Secretary the information described in subparagraph (A) 
in accordance with the applicable schedule described in 
subparagraph (B). Such information shall be submitted 
electronically to the centralized database established by the 
Secretary under subparagraph (C). If multiple laboratories 
within the same corporate organization and with common 
ownership by the same parent corporation perform the same 
laboratory developed test, a corporate entity with common 
ownership of such laboratories may submit the information 
described in subparagraph (A) on behalf of such laboratories, 
provided that each laboratory performing a laboratory developed 
test is separately identified with respect to each laboratory 
developed test it performs.
``(A) Submission.--For each laboratory developed 
test performed for clinical use by the laboratory, the 
laboratory shall submit the following information, as 
applicable:
``(i) Name and certificate number of the 
laboratory.
``(ii) Name and certificate number of the 
laboratory that developed the laboratory 
developed test, if different than the 
laboratory performing the laboratory developed 
test.
``(iii) Name of the laboratory developed 
test.
``(iv) Purpose of the laboratory developed 
test, including--
``(I) analyte(s) measured;
``(II) disease(s), impairment(s) or 
assessment(s) of the health of human 
beings for which the laboratory 
developed test is used; and
``(III) for what purpose(s) the 
information from the laboratory 
developed test will be used, such as 
for the screening, diagnosis, 
prognosis, or other type of assessment.
``(v) Specimen type(s) used with the 
laboratory developed test, which may include 
digital laboratory data.
``(vi) Type of examination, such as 
biological, microbiological, serological, 
chemical, immuno-hematological, hematological, 
biophysical, cytological, pathological, flow 
cytometric, molecular, genomic, or other type 
of examination.
``(vii) Summary of performance 
specifications for the laboratory developed 
test.
``(viii) Whether the laboratory developed 
test modifies the use of a device that is 
lawfully marketed under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.) and, 
if applicable, information identifying the 
specific device that is modified.
``(ix) Whether the test is deemed to have a 
supplemental affirmation under regulations 
issued by the Secretary or an approved third 
party has supplementally affirmed that the 
laboratory developed test meets the applicable 
standard and, if the latter, the name of such 
approved third party.
``(x) If the laboratory developed test is 
first performed for clinical use by the 
laboratory 2 or more years after enactment of 
the Enhancing CLIA Act of 2026, is not deemed 
to have a supplemental affirmation under 
regulations issued by the Secretary, and an 
approved third party has not supplementally 
affirmed that the test meets the applicable 
standard, a brief summary of the information in 
paragraph (1)(B)(c) that supports that the 
laboratory developed test has a reasonable 
assurance of clinical validity.
``(B) Submission schedule.--
``(i) Tests offered 2 or more years after 
enactment of the enhancing clia act of 2026.--
If the laboratory developed test is first 
performed for clinical use by the laboratory 2 
or more years after the date of enactment of 
the Enhancing CLIA Act of 2026, the laboratory 
must submit the information in subparagraph (A) 
for the laboratory developed test by the later 
of--
``(I) 30 days after such laboratory 
developed test is first performed for 
clinical use; or
``(II) 60 days after the 
centralized database described in 
subparagraph (C) is established.
``(ii) Tests offered prior to the date that 
is 2 years after enactment of the enhancing 
clia act of 2026.--If the laboratory developed 
test is first performed for clinical use by the 
laboratory prior to the date that is 2 years 
after enactment of the Enhancing CLIA Act of 
2026, the laboratory must submit the 
information in subparagraph (A) for the 
laboratory developed test by the later of--
``(I) 3 years after enactment of 
the Enhancing CLIA Act of 2026; or
``(II) 60 days after the 
centralized database described in 
subparagraph (C) is established.
``(C) Establishment of centralized database.--Not 
later than 2 years after enactment of the Enhancing 
CLIA Act of 2026, the Secretary shall make available a 
centralized database that is designed to--
``(i) provide a transparent interface on 
the website of the Centers for Medicare and 
Medicaid Services for stakeholders, to the 
extent permitted by applicable laws, which may 
include access to--
``(I) information submitted by 
laboratories under subparagraph (A); 
and
``(II) information about test 
errors submitted under paragraph (3); 
and
``(ii) provide a secure portal for 
electronic submission of information under 
subparagraph (A) and reports of test errors 
under paragraph (3), which provides protections 
from unauthorized disclosure of information, 
including of--
``(I) trade secret or confidential 
commercial financial information;
``(II) information that could 
compromise national security; and
``(III) identifiable patient data.
``(D) Updates and corrections.--
``(i) A laboratory must update or correct 
the information submitted under this paragraph 
for a laboratory developed test within 30 days 
of--
``(I) determining that an update or 
correction is necessary to maintain the 
accuracy of the previously submitted 
information; or
``(II) a request from the Secretary 
to make a specific correction, unless 
the laboratory demonstrates within 21 
days of such request that a correction 
is not necessary.
``(ii) A laboratory may supplement or 
modify the information submitted under this 
paragraph for a laboratory developed test when 
new information becomes available.
``(3) Test error reporting.--
``(A) Definitions.--In this section:
``(i) Serious harm.--The term `serious 
harm' means a misdiagnosis or failure to 
diagnose that results in the absence, delay, or 
discontinuation of critical medical treatment, 
or administration of unnecessary medical 
treatment, that causes death or serious injury 
to the patient.
``(ii) Serious injury.--The term `serious 
injury' means an injury that--
``(I) is life threatening;
``(II) results in permanent 
impairment of a body function or 
permanent damage to a body structure; 
or
``(III) necessitates further 
medical or surgical intervention to 
preclude permanent impairment of a body 
function or permanent damage to a body 
structure.
``(B) Submission of individual reports.--Beginning 
2 years after enactment of the Enhancing CLIA Act of 
2026, a laboratory shall submit a report not later than 
5 calendar days after becoming aware of an undetected 
inaccurate result for a laboratory developed test for 
clinical use that reasonably suggests--
``(i) that a laboratory developed test 
caused serious harm that resulted in death; or
``(ii) an imminent threat to public health.
``(C) Submission of quarterly reports.--Beginning 2 
years after enactment of the Enhancing CLIA Act of 
2026, a laboratory shall submit quarterly reports that 
include any undetected inaccurate results of which the 
laboratory becomes aware for laboratory developed tests 
for clinical use that reasonably suggest that the 
laboratory developed test caused serious harm other 
than death. Such quarterly reports shall be submitted 
not later than the end of the quarter following the 
quarter in which the laboratory becomes aware of such 
undetected inaccurate results.
``(D) Report not an admission.--A report submitted 
by a laboratory under this paragraph and the 
Secretary's release of such report or information does 
not constitute an admission by the laboratory that the 
laboratory developed test caused or contributed to 
serious harm.
``(4) Review of analytical and clinical validity.--
``(A) The criteria described in this subparagraph 
are that a laboratory developed test in clinical use--
``(i) does not have a supplemental 
affirmation under paragraph (1)(D) that the 
applicable standard is met, and the test does 
not meet the applicable standard; or
``(ii) has a supplemental affirmation under 
subparagraph (1)(D) that the applicable 
standard is met, and the test--
``(I) is represented for a purpose 
that is not supported by the 
supplemental affirmation; and
``(II) does not meet the applicable 
standard for such purpose.
``(B) Beginning 2 years after enactment of the 
Enhancing CLIA Act of 2026, the Secretary may issue to 
the developing laboratory of a laboratory developed 
test a written request for information that--
``(i) identifies specific scientific 
concerns, based on credible and verifiable 
information, which indicate that 1 or more of 
the criteria described in subparagraph (A) 
apply to the laboratory developed test; and
``(ii) requesting information that would 
resolve such concern.
``(C) Not later than 45 days after receiving a 
request for information under subparagraph (B)--
``(i) the laboratory--
``(I) may seek a teleconference 
prior to the submission of information 
under subclause (II) to discuss the 
Secretary's request; and
``(II) shall submit the information 
requested pursuant to subparagraph (B), 
and may include in such submission a 
request for a teleconference; and
``(ii) the Secretary shall--
``(I) schedule a teleconference 
requested under clause (i)(I); and
``(II) hold a teleconference if 
requested within 10 days of the 
Secretary's receipt of the information 
submitted under clause (i)(II).
``(D) Upon receiving a submission under 
subparagraph (C), the Secretary shall--
``(i) review the submitted information 
within 45 calendar days of such receipt, which 
may include communication with the laboratory; 
and
``(ii) determine whether the criteria 
listed in subparagraph (A) apply to the 
laboratory developed test and communicate such 
determination with the laboratory as described 
in subparagraph (E).
``(E) The Secretary shall provide written notice to 
the laboratory of the Secretary's determination under 
subparagraph (D) as follows:
``(i) The Secretary shall notify the 
laboratory if the Secretary determines that the 
criteria in subparagraph (A)--
``(I) do not apply to the 
laboratory developed test; or
``(II) apply to the laboratory 
developed test and clause (ii) does not 
apply.
``(ii) If the Secretary determines that the 
criteria in subparagraph (A) apply to the 
laboratory developed test but that such 
determination may be resolved within a 
reasonable time, and the laboratory developed 
test has not previously been subject to this 
paragraph on the basis of the same or 
substantially similar concerns identified in 
the written request issued under subparagraph 
(B)--
``(I) the Secretary shall notify 
the laboratory of such a determination 
and allow the laboratory to seek a 
teleconference to discuss the finding;
``(II) the laboratory shall submit 
information demonstrating resolution of 
the determination within 60 days of 
receiving such notification; and
``(III) the Secretary shall make a 
determination within 30 days of the 
receipt of such submission of 
information as to whether the criteria 
in subparagraph (A) continue to apply 
to the laboratory developed test.
``(F) If the Secretary notifies the laboratory 
under subparagraph (E)(i)(II) or (E)(ii)(III) that the 
criteria in subparagraph (A) apply to the laboratory 
developed test, the laboratory must--
``(i) cease performing the laboratory 
developed test until the laboratory obtains a 
confirmation from the Secretary under 
subparagraph (G) that the criteria under 
subparagraph (A) no longer apply to the 
laboratory developed test; and
``(ii) instruct all laboratories within the 
same corporate organization and under common 
ownership by the same parent corporation to 
cease performing the laboratory developed test 
until the developing laboratory obtains the 
confirmation described in clause (i).
``(G) The Secretary shall, within 30 days of 
receiving the information described in this 
subparagraph, provide a confirmation that the criteria 
in subparagraph (A) no longer apply to a laboratory 
developed test that was previously issued a 
notification under subparagraph (F) if the laboratory 
that developed the test submits evidence that--
``(i) it has obtained a supplemental 
affirmation from an approved third party under 
paragraph (1)(D) that the test meets the 
applicable standard; and
``(ii) the criteria in subparagraph (A) no 
longer apply to the test.
``(5) Investigational use.--Beginning 2 years after 
enactment of the Enhancing CLIA Act of 2026, a laboratory 
developed test may not be offered for investigational use 
unless it meets the applicable standard for such use and the 
test report and all other advertising and promotional materials 
for the test clearly state, `For investigational use only'. 
Clinical validity has not yet been established.'';
(3) in subsection (e)(2)(A)(ii) by adding at the end 
``except that such standards shall not require that laboratory 
developed tests offered by the laboratory have a supplemental 
affirmation from any approved third party that the applicable 
standard has been met,'';
(4) in subsection (i)(1)(C) by inserting ``or (r)'' after 
``subsection (d)''; and
(5) in subsection (o) by striking the period and inserting 
``, except that the Secretary may not delegate to the Food and 
Drug Administration the responsibility or authority for 
determining whether any laboratory developed test meets the 
applicable standard under subsection (r)(4) of this section. 
Notwithstanding the prior sentence, the Food and Drug 
Administration may provide a supplemental affirmation that a 
laboratory developed test meets the applicable standard 
pursuant to subsection (r)(4)(F).''.
(b) Amendments to the Federal Food, Drug, and Cosmetic Act.--The 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is 
amended--
(1) in section 201(h)(1) by striking the period after 
``pursuant to section 520(o)'' and inserting ``or laboratory 
developed tests as defined in the Enhancing CLIA Act of 2026. 
For clarity, the term `device' does not include articles 
intended solely for medical and scientific research using 
materials derived from the body of man or other animals, which 
are not intended for any use described in subparagraphs (A) 
through (C).''.
(2) in section 501(f)(1)(C) by striking the period at the 
end and inserting ``, except that this paragraph does not apply 
to a device that is distributed for use with a laboratory 
developed test as defined under the Enhancing CLIA Act of 2026 
if the device could otherwise be lawfully distributed under 
this Act.''.
(3) in section 502(o) by striking the period at the end and 
inserting, ``except that this subsection does not apply to a 
device that is distributed for use with a laboratory developed 
test as defined under the Enhancing CLIA Act of 2026 if the 
device could otherwise be lawfully distributed under this 
Act.''.
(c) National Coverage Determinations for Laboratory Developed 
Tests.--Section 1862(l)(1) of the Social Security Act (42 U.S.C. 
1395y(l)(1)) is amended by adding at the end, ``For purposes of all 
existing and future national coverage determinations for a clinical 
laboratory diagnostic test, a supplemental affirmation from any 
approved third party that the applicable standard has been met under 
section 353 of the Public Health Services Act (42 U.S.C. 263a et seq.), 
as amended by the Enhancing CLIA Act of 2026 shall be considered 
equivalent to an approval or clearance under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.).''.
(d) Companion Diagnostics.--If a diagnostic test result is required 
for the approval of a drug under section 505 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355) or the licensure of a biologic under 
section 351 of the Public Health Service Act (42 U.S.C. 262), such test 
result may be determined by use of a device regulated under the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or based on a 
laboratory developed test with a supplemental affirmation from any 
approved third party under section 353 of the Public Health Services 
Act (42 U.S.C. 263a et seq.) as amended by this Act.

SEC. 3. TRANSITION.

(a) Effective Date.--Except as otherwise provided in this section, 
the amendments made by this Act shall take effect immediately upon 
enactment.
(b) Transition and Regulations.--
(1) The Secretary of Health and Human Services (in this 
subsection referred to as the ``Secretary'') shall take the 
following actions, and may expend such funds as the Secretary 
determines necessary to ensure an orderly transition--
(A) within 180 days of enactment, promulgate 
proposed regulations required under the amendments made 
by this Act;
(B) within 2 years of enactment, establish the 
centralized database for laboratory developed tests 
under section 353(r)(2) of the Public Health Service 
Act, as added by section 2(a) of this Act;
(C) within 2 years of enactment, promulgate final 
regulations to mitigate potential conflict of interest 
by organizations that provide multiple oversight 
services under section 353 of the Public Health 
Services Act (42 U.S.C. 263a), including accreditation 
of laboratories, proficiency testing, and supplemental 
affirmation for laboratory developed tests; and
(D) within 30 days of enactment, revise the 
definition of ``in vitro diagnostic products'' at 
section 809.3 of Title 21 of the Code of Federal 
Regulations, effective immediately, to clarify that 
such term--
(i) does not include laboratory developed 
tests as defined in subsection (a) of section 2 
of this Act; and
(ii) includes protocols for use in the 
diagnosis of disease or other conditions, 
including a determination of the state of 
health, in order to cure, mitigate, treat, or 
prevent disease or its sequelae when such 
protocols are--
(I) commercially distributed for 
performance in laboratories not under 
common ownership by the same parent 
corporation as the laboratory that 
developed the protocol; or
(II) commercially distributed by an 
entity or individual that is not a 
laboratory;
except that such protocols are not commercially 
distributed solely because they are published, 
including in public or scientific 
presentations, or patented.
(2) Applicability of regulations.--Notwithstanding the date 
on which regulations are issued under paragraph (1), no 
regulations issued pursuant to the amendments made by this Act 
shall be implemented or take effect until 2 years after 
enactment, except as otherwise specified in this section.
(c) Conversion.--
(1) This subsection applies to a laboratory developed test 
as defined in subsection (a) of section 2 of this Act that 
has--
(A) a premarket approval under section 515 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e), 
an approved humanitarian device exemption under section 
520(m) of such Act (21 U.S.C. 360j(m)), a clearance 
under section 510(k) of such Act (21 U.S.C. 360(k)), an 
authorization under section 513(f)(2) of such Act (21 
U.S.C. 370c(f)(2)), an investigational device exemption 
under section 520(g) of such Act (21 U.S.C. 360j(g)), 
or a licensure under section 351 of the Public Health 
Service Act (42 U.S.C. 262); or
(B) a premarket approval application under section 
515 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360e), an application for humanitarian device 
exemption under section 520(m) of such Act (21 U.S.C. 
360j(m)), a premarket notification under section 510(k) 
of such Act (21 U.S.C. 360(k)), a de novo 
classification request under section 513(f)(2) of such 
Act (21 U.S.C. 370c(f)(2)), an investigational device 
exemption under section 520(g) of such Act (21 U.S.C. 
360j(g)), or an application for licensure under section 
351 of the Public Health Service Act (42 U.S.C. 262) 
pending on the date of enactment.
(2) Notwithstanding any other provision of this Act, a 
laboratory developed test under paragraph (1) shall be a device 
under section 201(h)(1) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321(h)(1)) until--
(A) if a notification is submitted under paragraph 
(3)(A), the date of such notification; or
(B) if a notification is submitted under paragraph 
(3)(B), the earlier of--
(i) approval, clearance, authorization, 
exemption, or licensure of a modification to 
such test such that it meets the definition of 
device under section 201(h)(1) of such Act (21 
U.S.C. 321(h)(1));
(ii) 2 years after enactment;
(iii) the date a subsequent notification is 
submitted under paragraph (3)(A); or
(iv) 60 days after enactment if no 
notification is submitted under paragraph (3).
(3) For a laboratory developed test under paragraph (1), 
within 60 days of enactment, a laboratory may submit to the 
Food and Drug Administration a notification that the 
laboratory--
(A) does not intend to modify the test to meet the 
definition of a device under section 201(h)(1) of the 
Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)(1)); or
(B) intends to modify the test to meet the 
definition of a device under section 201(h)(1) of the 
Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)(1)).
(4) For a laboratory developed test under paragraph (1)(A), 
upon the applicable date in paragraph (2) that such test is no 
longer a device, such test is deemed to have a supplemental 
affirmation from the Food and Drug Administration under section 
353(r)(1)(D) of the Public Health Service Act (42 U.S.C. 
263a(r)(1)(D)), as added by section 2(a) of this Act, that the 
laboratory developed test meets the applicable standard.

SEC. 4. CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) UPDATES.

(a) CLIA Specialties.--No later than 180 days after enactment, the 
Secretary shall issue a proposed regulation to establish new types of 
examinations that may be performed by laboratories under section 353 of 
the Public Health Service Act (42 U.S.C. 263a) consistent with the 
current state of clinical laboratory science and technology, including 
the advancements with respect to molecular diagnostics, digital 
pathology, and next generation sequencing. Within 1 year of finalizing 
such regulations, the Secretary must evaluate whether additional 
proficiency testing programs should be approved for these new 
specialties under section 353(f)(3)(C) of such Act (42 U.S.C. 
263a(f)(3)(C)).
(b) Notice of Subregulatory Changes.--If the Centers for Medicare 
and Medicaid Services intend to issue new or revised sub-regulatory 
guidance and policies related to the regulation of laboratories under 
section 353 of the Public Health Service Act (42 U.S.C. 263a), 
including new or revised State operations manuals applicable to the 
regulation of laboratories, it must describe such proposed action in a 
public report at least 90 days prior to taking such action and allow an 
opportunity for public comment.
(c) Engagement With Laboratories.--The Centers for Medicare and 
Medicaid Services must hold regular open door forums with clinical 
laboratories, no less frequently than annually, to discuss issues 
related to the regulation of laboratories under section 353 of the 
Public Health Service Act (42 U.S.C. 263a).
(d) Regulation Updates.--At least once every 5 years, the Centers 
for Medicare and Medicaid Services must review the regulations 
promulgated under section 353 of the Public Health Service Act (42 
U.S.C. 263a), and--
(1) issue a request for information in the Federal Register 
regarding whether updates to such regulations are necessary to 
reflect advancements in laboratory science and technology; and
(2) establish a public docket, to remain open for no less 
than 180 days, to solicit public comments on the request for 
information issued under paragraph (1).
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