I 

116TH CONGRESS 

1ST SESSION H. R. 2009 

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 

APRIL 1, 2019 

Ms. CLARKE of New York (for herself and Mr. UPTON) 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 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 ‘‘Removing Barriers to 

5 Allergy Diagnostic Testing Act of 2019’’. 


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1 SEC. 2. FINDINGS. 

2 Congress finds the following: 

3 (1) Allergies, when not properly diagnosed, can4 not be effectively treated. 

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

6 sources can cause debilitating and, in some cases, 

7 fatal reactions. 

8 (3) Allergies can substantially compound other 

9 illnesses, including asthma, emphysema, and adult 

10 obstructive pulmonary diseases, leading to social and 

11 economic costs for families and our Nation’s health 

12 care system. 

13 (4) According to clinical guidelines from the 

14 National Institutes of Health and recommendations 

15 from peer-reviewed literature, in vitro specific IgE 

16 tests and percutaneous tests are considered equiva17 lent as confirmatory tests in terms of their sensi18 tivity and accuracy. 

19 (5) Despite these recommendations, some cur20 rent Medicare local coverage determinations and 

21 Medicaid coverage policies deny equal access to in 

22 vitro specific IgE tests and percutaneous tests. 

23 (6) In vitro specific IgE tests and percutaneous 

24 tests must be equally accessible for clinicians and 

25 patients to improve health outcomes, reduce system 


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1 costs, and reduce current health care disparities 

2 caused by the lack of equal coverage. 

3 SEC. 3. MEDICAID COVERAGE FOR ALLERGY DIAGNOSTIC 

4 TESTING SERVICES. 

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

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

7 (1) in section 1902(a)— 

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

9 at the end; 

10 (B) in paragraph (86), by striking the pe11 riod at the end and inserting ‘‘; and’’; and 

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

13 following new paragraph: 

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

15 allergy diagnostic testing services (as defined in sec16 tion 1905(ee)) under the State plan, for equality in 

17 the treatment of in vitro specific IgE tests and 

18 percutaneous tests with respect to— 

19 ‘‘(A) any medical necessity or other cov20 erage requirements established for such in vitro 

21 specific IgE and percutaneous tests; 

22 ‘‘(B) any frequency limits established for 

23 such tests; and 

24 ‘‘(C) any allergen unit limits established 

25 for such tests.’’; and 


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1 (2) in section 1905— 

2 (A) in subsection (r)— 

3 (i) by redesignating paragraph (5) as 

4 paragraph (6); and 

5 (ii) by inserting after paragraph (4) 

6 the following new paragraph: 

7 ‘‘(5) Allergy diagnostic testing services (as de8 fined in subsection (ff)).’’; and 

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

10 subsection: 

11 ‘‘(ff) ALLERGY DIAGNOSTIC TESTING SERVICES DE12 FINED.—The term ‘allergy diagnostic testing services’ 

13 means in vitro specific IgE tests and percutaneous tests 

14 that— 

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

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

17 section 515 of the Federal Food, Drug, and Cos18 metic Act; and 

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

20 of evaluating immunologic response to certain anti21 gens.’’. 

22 (b) EFFECTIVE DATE.— 

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

24 the amendments made by this section shall apply 


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1 with respect to items and services provided on or 

2 after January 1, 2021. 

3 (2) EXCEPTION FOR STATE LEGISLATION.—In 

4 the case of a State plan under title XIX of the So5 cial Security Act (42 U.S.C. 1396 et seq.) that the 

6 Secretary of Health and Human Services determines 

7 requires State legislation in order for the respective 

8 plan to meet any requirement imposed by amend9 ments made by this section, the respective plan shall 

10 not be regarded as failing to comply with the re11 quirements of such title solely on the basis of its 

12 failure to meet such an additional requirement be13 fore the first day of the first calendar quarter begin14 ning after the close of the first regular session of the 

15 State legislature that begins after the date of the en16 actment of this Act. For purposes of the previous 

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

18 legislative session, each year of the session shall be 

19 considered to be a separate regular session of the 

20 State legislature. 

21 SEC. 4. MEDICARE COVERAGE FOR ALLERGY DIAGNOSTIC 

22 TESTING SERVICES. 

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

24 Act (42 U.S.C. 1395x) is amended— 

25 (1) in subsection (s)(2)— 


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

2 ‘‘and’’ at the end; 

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

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

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

6 subparagraph: 

7 ‘‘(II) allergy diagnostic testing services (as de8 fined in subsection (kkk));’’; and 

9 (2) by adding at the end the following new sub10 section: 

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

12 ‘‘(1) IN GENERAL.—The term ‘allergy diag13 nostic testing services’ means in vitro specific IgE 

14 tests and percutaneous tests— 

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

16 501(k), classified under section 513(f)(2), or 

17 approved under section 515 of the Federal 

18 Food, Drug, and Cosmetic Act; and 

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

20 the purpose of evaluating immunologic response 

21 to certain antigens, as determined appropriate 

22 by the practitioner ordering such test. 

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

24 The Secretary shall ensure equality in the treatment 


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1 of in vitro specific IgE tests and percutaneous tests 

2 described in paragraph (1) with respect to— 

3 ‘‘(A) any medical necessity or other cov4 erage requirements established for such in vitro 

5 specific IgE and percutaneous tests; 

6 ‘‘(B) any frequency limits established for 

7 such tests; and 

8 ‘‘(C) any allergen unit limits established 

9 for a year for such tests.’’. 

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

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

12 the following new subsection: 

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

14 For purposes of payment only, in the case of allergy diag15 nostic testing services (as defined in section 1861(jjj))— 

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

17 as clinical diagnostic laboratory tests; and 

18 ‘‘(2) percutaneous tests shall be treated as phy19 sicians’ services.’’. 

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

21 this section shall apply with respect to items and services 

22 furnished on or after January 1, 2021. 

Æ 


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