I 
117TH CONGRESS 
1ST SESSION H. R. 4114 
To amend titles XVIII and XIX of the Social Security Act to provide equal 
coverage of in vitro specific IgE tests and percutaneous tests for allergies 
under the Medicare and Medicaid programs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 24, 2021 
Ms. CLARKE of New York (for herself and Mr. UPTON) introduced the fol-
lowing bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committee on Ways and Means, for a pe-
riod to be subsequently determined by the Speaker, in each case for con-
sideration of such provisions as fall within the jurisdiction of the com-
mittee concerned 
A BILL 
To amend titles XVIII and XIX of the Social Security Act 
to provide equal coverage of in vitro specific IgE tests 
and percutaneous tests for allergies under the Medicare 
and Medicaid programs, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Allergy Testing Access 
Act of 2021’’. 
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SEC. 2. FINDINGS. 
Congress finds the following: 
(1) Allergies, when not properly diagnosed, can-
not be effectively treated. 
(2) Allergies to food, inhaled particles, or other 
sources can cause debilitating and, in some cases, 
fatal reactions. 
(3) Allergies can substantially compound other 
illnesses, including asthma, emphysema, and adult 
obstructive pulmonary diseases, leading to social and 
economic costs for families and our Nation’s health 
care system. 
(4) According to clinical guidelines from the 
National Institutes of Health and recommendations 
from peer-reviewed literature, in vitro specific IgE 
tests and percutaneous tests are considered equiva-
lent as confirmatory tests in terms of their sensi-
tivity and accuracy. 
(5) Despite these recommendations, some cur-
rent Medicare local coverage determinations and 
Medicaid coverage policies deny equal access to in 
vitro specific IgE tests and percutaneous tests. 
(6) In vitro specific IgE tests and percutaneous 
tests must be equally accessible for clinicians and 
patients to improve health outcomes, reduce system 
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costs, and reduce current health care disparities 
caused by the lack of equal coverage. 
SEC. 3. MEDICARE COVERAGE FOR ALLERGY DIAGNOSTIC 
TESTING SERVICES. 
(a) COVERAGE.—Section 1861 of the Social Security 
Act (42 U.S.C. 1395x) is amended— 
(1) in subsection (s)(2)— 
(A) in subparagraph (GG), by striking 
‘‘and’’ at the end; 
(B) in subparagraph (HH), by striking the 
period at the end and inserting ‘‘; and’’; and 
(C) by adding at the end the following new 
subparagraph: 
‘‘(B) allergy diagnostic testing services (as de-
fined in subsection (lll));’’; and 
(2) by adding at the end the following new sub-
section: 
‘‘(lll) ALLERGY DIAGNOSTIC TESTING SERVICES.— 
‘‘(1) IN
GENERAL.—The term ‘allergy diag-
nostic testing services’ means in vitro specific IgE 
tests and percutaneous tests— 
‘‘(A) that have been cleared under section 
501(k), classified under section 513(f)(2), or 
approved under section 515 of the Federal 
Food, Drug, and Cosmetic Act; and 
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‘‘(B) which are furnished to individuals for 
the purpose of evaluating immunologic response 
to certain antigens, as determined appropriate 
by the practitioner ordering such test. 
‘‘(2) EQUAL ACCESS TO TESTING METHODS.— 
The Secretary shall ensure equality in the treatment 
of in vitro specific IgE tests and percutaneous tests 
described in paragraph (1) with respect to— 
‘‘(A) any medical necessity or other cov-
erage requirements established for such in vitro 
specific IgE and percutaneous tests; 
‘‘(B) any frequency limits established for 
such tests; and 
‘‘(C) any allergen unit limits established 
for a year for such tests.’’. 
(b) PAYMENT.—Section 1834 of the Social Security 
Act (42 U.S.C. 1395m) is amended by adding at the end 
the following new subsection: 
‘‘(z) ALLERGY DIAGNOSTIC TESTING SERVICES.— 
For purposes of payment only, in the case of allergy diag-
nostic testing services (as defined in section 1861(lll))— 
‘‘(1) in vitro specific IgE tests shall be treated 
as clinical diagnostic laboratory tests; and 
‘‘(2) percutaneous tests shall be treated as phy-
sicians’ services.’’. 
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(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply with respect to items and services 
furnished on or after January 1, 2022. 
SEC. 4. MEDICAID COVERAGE FOR ALLERGY DIAGNOSTIC 
TESTING SERVICES. 
(a) IN GENERAL.—Title XIX of the Social Security 
Act (42 U.S.C. 1396 et seq.) is amended— 
(1) in section 1902(a)— 
(A) in paragraph (86), by striking ‘‘and’’ 
at the end; 
(B) in paragraph (87), by striking the pe-
riod at the end and inserting ‘‘; and’’; and 
(C) by inserting after paragraph (87) the 
following new paragraph: 
‘‘(88) provide, with respect to the provision of 
allergy diagnostic testing services (as defined in sec-
tion 1905(hh)) under the State plan, for equality in 
the treatment of in vitro specific IgE tests and 
percutaneous tests with respect to— 
‘‘(A) any medical necessity or other cov-
erage requirements established for such in vitro 
specific IgE and percutaneous tests; 
‘‘(B) any frequency limits established for 
such tests; and 
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‘‘(C) any allergen unit limits established 
for such tests.’’; and 
(2) in section 1905— 
(A) in subsection (r)— 
(i) by redesignating paragraph (5) as 
paragraph (6); and 
(ii) by inserting after paragraph (4) 
the following new paragraph: 
‘‘(5) Allergy diagnostic testing services (as de-
fined in subsection (hh)).’’; and 
(B) by adding at the end the following new 
subsection: 
‘‘(hh) ALLERGY DIAGNOSTIC TESTING SERVICES DE-
FINED.—The term ‘allergy diagnostic testing services’ 
means in vitro specific IgE tests and percutaneous tests 
that— 
‘‘(1) have been cleared under section 501(k), 
classified under section 513(f)(2), or approved under 
section 515 of the Federal Food, Drug, and Cos-
metic Act; and 
‘‘(2) are provided to individuals for the purpose 
of evaluating immunologic response to certain anti-
gens.’’. 
(b) EFFECTIVE DATE.— 
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(1) IN GENERAL.—Subject to paragraph (2), 
the amendments made by this section shall apply 
with respect to items and services provided on or 
after January 1, 2022. 
(2) EXCEPTION FOR STATE LEGISLATION.—In 
the case of a State plan under title XIX of the So-
cial Security Act (42 U.S.C. 1396 et seq.) that the 
Secretary of Health and Human Services determines 
requires State legislation in order for the respective 
plan to meet any requirement imposed by amend-
ments made by this section, the respective plan shall 
not be regarded as failing to comply with the re-
quirements of such title solely on the basis of its 
failure to meet such an additional requirement be-
fore the first day of the first calendar quarter begin-
ning after the close of the first regular session of the 
State legislature that begins after the date of the en-
actment of this Act. For purposes of the previous 
sentence, in the case of a State that has a 2-year 
legislative session, each year of the session shall be 
considered to be a separate regular session of the 
State legislature. 
Æ 
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