II 

116TH CONGRESS 

1ST SESSION S. 2246 

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 SENATE OF THE UNITED STATES 

JULY 24, 2019 

Mr. MORAN introduced the following bill; which was read twice and referred 

to the Committee on Finance 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Allergy Testing Access 

5 Act of 2019’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 


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1 (1) Allergies, when not properly diagnosed, can2 not be effectively treated. 

3 (2) Allergies to food, inhaled particles, or other 

4 sources can cause debilitating and, in some cases, 

5 fatal reactions. 

6 (3) Allergies can substantially compound other 

7 illnesses, including asthma, emphysema, and adult 

8 obstructive pulmonary diseases, leading to social and 

9 economic costs for families and our Nation’s health 

10 care system. 

11 (4) According to clinical guidelines from the 

12 National Institutes of Health and recommendations 

13 from peer-reviewed literature, in vitro specific IgE 

14 tests and percutaneous tests are considered equiva15 lent as confirmatory tests in terms of their sensi16 tivity and accuracy. 

17 (5) Despite these recommendations, some cur18 rent Medicare local coverage determinations and 

19 Medicaid coverage policies deny equal access to in 

20 vitro specific IgE tests and percutaneous tests. 

21 (6) In vitro specific IgE tests and percutaneous 

22 tests must be equally accessible for clinicians and 

23 patients to improve health outcomes, reduce system 

24 costs, and reduce current health care disparities 

25 caused by the lack of equal coverage. 


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1 SEC. 3. MEDICAID COVERAGE FOR ALLERGY DIAGNOSTIC 

2 TESTING SERVICES. 

3 (a) IN GENERAL.—Title XIX of the Social Security 

4 Act (42 U.S.C. 1396 et seq.) is amended— 

5 (1) in section 1902(a)— 

6 (A) in paragraph (85), by striking ‘‘and’’ 

7 at the end; 

8 (B) in paragraph (86), by striking the pe9 riod at the end and inserting ‘‘; and’’; and 

10 (C) by inserting after paragraph (86) the 

11 following new paragraph: 

12 ‘‘(87) provide, with respect to the provision of 

13 allergy diagnostic testing services (as defined in sec14 tion 1905(ff)) under the State plan, for equality in 

15 the treatment of in vitro specific IgE tests and 

16 percutaneous tests with respect to— 

17 ‘‘(A) any medical necessity or other cov18 erage requirements established for such in vitro 

19 specific IgE and percutaneous tests; 

20 ‘‘(B) any frequency limits established for 

21 such tests; and 

22 ‘‘(C) any allergen unit limits established 

23 for such tests.’’; and 

24 (2) in section 1905— 

25 (A) in subsection (r)— 


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1 (i) by redesignating paragraph (5) as 

2 paragraph (6); and 

3 (ii) by inserting after paragraph (4) 

4 the following new paragraph: 

5 ‘‘(5) Allergy diagnostic testing services (as de6 fined in subsection (ff)).’’; and 

7 (B) by adding at the end the following new 

8 subsection: 

9 ‘‘(ff) ALLERGY DIAGNOSTIC TESTING SERVICES DE10 FINED.—The term ‘allergy diagnostic testing services’ 

11 means in vitro specific IgE tests and percutaneous tests 

12 that— 

13 ‘‘(1) have been cleared under section 501(k), 

14 classified under section 513(f)(2), or approved under 

15 section 515 of the Federal Food, Drug, and Cos16 metic Act; and 

17 ‘‘(2) are provided to individuals for the purpose 

18 of evaluating immunologic response to certain anti19 gens.’’. 

20 (b) EFFECTIVE DATE.— 

21 (1) IN GENERAL.—Subject to paragraph (2), 

22 the amendments made by this section shall apply 

23 with respect to items and services provided on or 

24 after January 1, 2021. 


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1 (2) EXCEPTION FOR STATE LEGISLATION.—In 

2 the case of a State plan under title XIX of the So3 cial Security Act (42 U.S.C. 1396 et seq.) that the 

4 Secretary of Health and Human Services determines 

5 requires State legislation in order for the respective 

6 plan to meet any requirement imposed by amend7 ments made by this section, the respective plan shall 

8 not be regarded as failing to comply with the re9 quirements of such title solely on the basis of its 

10 failure to meet such an additional requirement be11 fore the first day of the first calendar quarter begin12 ning after the close of the first regular session of the 

13 State legislature that begins after the date of the en14 actment of this Act. For purposes of the previous 

15 sentence, in the case of a State that has a 2-year 

16 legislative session, each year of the session shall be 

17 considered to be a separate regular session of the 

18 State legislature. 

19 SEC. 4. MEDICARE COVERAGE FOR ALLERGY DIAGNOSTIC 

20 TESTING SERVICES. 

21 (a) COVERAGE.—Section 1861 of the Social Security 

22 Act (42 U.S.C. 1395x) is amended— 

23 (1) in subsection (s)(2)— 

24 (A) in subparagraph (GG), by striking 

25 ‘‘and’’ at the end; 


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1 (B) in subparagraph (HH), by striking the 

2 period at the end and inserting ‘‘; and’’; and 

3 (C) by adding at the end the following new 

4 subparagraph: 

5 ‘‘(II) allergy diagnostic testing services (as de6 fined in subsection (kkk));’’; and 

7 (2) by adding at the end the following new sub8 section: 

9 ‘‘(kkk) ALLERGY DIAGNOSTIC TESTING SERVICES.— 

10 ‘‘(1) IN GENERAL.—The term ‘allergy diag11 nostic testing services’ means in vitro specific IgE 

12 tests and percutaneous tests— 

13 ‘‘(A) that have been cleared under section 

14 501(k), classified under section 513(f)(2), or 

15 approved under section 515 of the Federal 

16 Food, Drug, and Cosmetic Act; and 

17 ‘‘(B) which are furnished to individuals for 

18 the purpose of evaluating immunologic response 

19 to certain antigens, as determined appropriate 

20 by the practitioner ordering such test. 

21 ‘‘(2) EQUAL ACCESS TO TESTING METHODS.— 

22 The Secretary shall ensure equality in the treatment 

23 of in vitro specific IgE tests and percutaneous tests 

24 described in paragraph (1) with respect to— 


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1 ‘‘(A) any medical necessity or other cov2 erage requirements established for such in vitro 

3 specific IgE and percutaneous tests; 

4 ‘‘(B) any frequency limits established for 

5 such tests; and 

6 ‘‘(C) any allergen unit limits established 

7 for a year for such tests.’’. 

8 (b) PAYMENT.—Section 1834 of the Social Security 

9 Act (42 U.S.C. 1395m) is amended by adding at the end 

10 the following new subsection: 

11 ‘‘(x) ALLERGY DIAGNOSTIC TESTING SERVICES.— 

12 For purposes of payment only, in the case of allergy diag13 nostic testing services (as defined in section 1861(kkk))— 

14 ‘‘(1) in vitro specific IgE tests shall be treated 

15 as clinical diagnostic laboratory tests; and 

16 ‘‘(2) percutaneous tests shall be treated as phy17 sicians’ services.’’. 

18 (c) EFFECTIVE DATE.—The amendments made by 

19 this section shall apply with respect to items and services 

20 furnished on or after January 1, 2021. 

Æ 


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