I 

115TH CONGRESS 

2D SESSION H. R. 5541 

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 17, 2018 

Mr. UPTON (for himself and Ms. CLARKE of New York) 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 2018’’. 


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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 (82), by striking ‘‘and’’ 

9 at the end; 

10 (B) in paragraph (83), by striking the pe11 riod at the end and inserting ‘‘; and’’; and 

12 (C) by inserting before the matter fol13 lowing paragraph (83) the following new para14 graph: 

15 ‘‘(84) provide, with respect to the provision of 

16 allergy diagnostic testing services (as defined in sec17 tion 1905(ee)) under the State plan, for equality in 

18 the treatment of in vitro specific IgE tests and 

19 percutaneous tests with respect to— 

20 ‘‘(A) any medical necessity or other cov21 erage requirements established for such in vitro 

22 specific IgE and percutaneous tests; 

23 ‘‘(B) any frequency limits established for 

24 such tests; and 


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1 ‘‘(C) any allergen unit limits established 

2 for such tests.’’; and 

3 (2) in section 1905— 

4 (A) in subsection (r)— 

5 (i) by redesignating paragraph (5) as 

6 paragraph (6); and 

7 (ii) by inserting after paragraph (4) 

8 the following new paragraph: 

9 ‘‘(5) Allergy diagnostic testing services (as de10 fined in subsection (ee)).’’; and 

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

12 subsection: 

13 ‘‘(ee) ALLERGY DIAGNOSTIC TESTING SERVICES DE14 FINED.—The term ‘allergy diagnostic testing services’ 

15 means in vitro specific IgE tests and percutaneous tests 

16 that— 

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

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

19 section 515 of the Federal Food, Drug, and Cos20 metic Act; and 

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

22 of evaluating immunologic response to certain anti23 gens.’’. 

24 (b) EFFECTIVE DATE.— 


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

2 the amendments made by this section shall apply 

3 with respect to items and services provided on or 

4 after January 1, 2019. 

5 (2) EXCEPTION FOR STATE LEGISLATION.—In 

6 the case of a State plan under title XIX of the So7 cial Security Act (42 U.S.C. 1396 et seq.) that the 

8 Secretary of Health and Human Services determines 

9 requires State legislation in order for the respective 

10 plan to meet any requirement imposed by amend11 ments made by this section, the respective plan shall 

12 not be regarded as failing to comply with the re13 quirements of such title solely on the basis of its 

14 failure to meet such an additional requirement be15 fore the first day of the first calendar quarter begin16 ning after the close of the first regular session of the 

17 State legislature that begins after the date of the en18 actment of this Act. For purposes of the previous 

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

20 legislative session, each year of the session shall be 

21 considered to be a separate regular session of the 

22 State legislature. 


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1 SEC. 4. MEDICARE COVERAGE FOR ALLERGY DIAGNOSTIC 

2 TESTING SERVICES. 

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

4 Act (42 U.S.C. 1395x) is amended— 

5 (1) in subsection (s)(2)— 

6 (A) in subparagraph (FF), by striking 

7 ‘‘and’’ at the end; 

8 (B) in subparagraph (GG), by striking the 

9 semicolon at the end and inserting ‘‘; and’’; and 

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

11 subparagraph: 

12 ‘‘(HH) allergy diagnostic testing services (as 

13 defined in subsection (jjj));’’; and 

14 (2) by adding at the end the following new sub15 section: 

16 ‘‘(jjj) ALLERGY DIAGNOSTIC TESTING SERVICES.— 

17 ‘‘(1) IN GENERAL.—The term ‘allergy diag18 nostic testing services’ means in vitro specific IgE 

19 tests and percutaneous tests— 

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

21 501(k), classified under section 513(f)(2), or 

22 approved under section 515 of the Federal 

23 Food, Drug, and Cosmetic Act; and 

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

25 the purpose of evaluating immunologic response 


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1 to certain antigens, as determined appropriate 

2 by the practitioner ordering such test. 

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

4 The Secretary shall ensure equality in the treatment 

5 of in vitro specific IgE tests and percutaneous tests 

6 described in paragraph (1) with respect to— 

7 ‘‘(A) any medical necessity or other cov8 erage requirements established for such in vitro 

9 specific IgE and percutaneous tests; 

10 ‘‘(B) any frequency limits established for 

11 such tests; and 

12 ‘‘(C) any allergen unit limits established 

13 for a year for such tests.’’. 

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

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

16 the following new subsection: 

17 ‘‘(v) ALLERGY DIAGNOSTIC TESTING SERVICES.— 

18 For purposes of payment only, in the case of allergy diag19 nostic testing services (as defined in section 1861(jjj))— 

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

21 as clinical diagnostic laboratory tests; and 

22 ‘‘(2) percutaneous tests shall be treated as phy23 sicians’ services.’’. 


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

2 this section shall apply with respect to items and services 

3 furnished on or after January 1, 2019. 

Æ 


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