(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 (ff)).’’; and 
(B) by adding at the end the following new 
subsection: 
‘‘(ff) 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.— 
(1) IN GENERAL.—Subject to paragraph (2), 
the amendments made by this section shall apply 
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with respect to items and services provided on or 
after January 1, 2021. 
(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. 
SEC. 4. 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)— 
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(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: 
‘‘(II) allergy diagnostic testing services (as de-
fined in subsection (kkk));’’; and 
(2) by adding at the end the following new sub-
section: 
‘‘(kkk) 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 
‘‘(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 
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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: 
‘‘(x) ALLERGY DIAGNOSTIC TESTING SERVICES.— 
For purposes of payment only, in the case of allergy diag-
nostic testing services (as defined in section 1861(jjj))— 
‘‘(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.’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply with respect to items and services 
furnished on or after January 1, 2021. 
Æ 
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