Removing Barriers to Allergy Diagnostic Testing Act of 2019

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 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- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Removing Barriers to 4 Allergy Diagnostic Testing Act of 2019’’. 5 VerDate Sep 11 2014 18:35 Apr 09, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2009.IH H2009 pamtmann on DSKBFK8HB2PROD with BILLS 2 •HR 2009 IH SEC. 2. FINDINGS. 1 Congress finds the following: 2 (1) Allergies, when not properly diagnosed, can- 3 not be effectively treated. 4 (2) Allergies to food, inhaled particles, or other 5 sources can cause debilitating and, in some cases, 6 fatal reactions. 7 (3) Allergies can substantially compound other 8 illnesses, including asthma, emphysema, and adult 9 obstructive pulmonary diseases, leading to social and 10 economic costs for families and our Nation’s health 11 care system. 12 (4) According to clinical guidelines from the 13 National Institutes of Health and recommendations 14 from peer-reviewed literature, in vitro specific IgE 15 tests and percutaneous tests are considered equiva- 16 lent as confirmatory tests in terms of their sensi- 17 tivity and accuracy. 18 (5) Despite these recommendations, some cur- 19 rent Medicare local coverage determinations and 20 Medicaid coverage policies deny equal access to in 21 vitro specific IgE tests and percutaneous tests. 22 (6) In vitro specific IgE tests and percutaneous 23 tests must be equally accessible for clinicians and 24 patients to improve health outcomes, reduce system 25 VerDate Sep 11 2014 18:35 Apr 09, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2009.IH H2009 pamtmann on DSKBFK8HB2PROD with BILLS 3 •HR 2009 IH costs, and reduce current health care disparities 1 caused by the lack of equal coverage. 2 SEC. 3. MEDICAID COVERAGE FOR ALLERGY DIAGNOSTIC 3 TESTING SERVICES. 4 (a) IN GENERAL.—Title XIX of the Social Security 5 Act (42 U.S.C. 1396 et seq.) is amended— 6 (1) in section 1902(a)— 7 (A) in paragraph (85), by striking ‘‘and’’ 8 at the end; 9 (B) in paragraph (86), by striking the pe- 10 riod at the end and inserting ‘‘; and’’; and 11 (C) by inserting after paragraph (86) the 12 following new paragraph: 13 ‘‘(87) provide, with respect to the provision of 14 allergy diagnostic testing services (as defined in sec- 15 tion 1905(ee)) under the State plan, for equality in 16 the treatment of in vitro specific IgE tests and 17 percutaneous tests with respect to— 18 ‘‘(A) any medical necessity or other cov- 19 erage requirements established for such in vitro 20 specific IgE and percutaneous tests; 21 ‘‘(B) any frequency limits established for 22 such tests; and 23 ‘‘(C) any allergen unit limits established 24 for such tests.’’; and 25 VerDate Sep 11 2014 18:35 Apr 09, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2009.IH H2009 pamtmann on DSKBFK8HB2PROD with BILLS 4 •HR 2009 IH (2) in section 1905— 1 (A) in subsection (r)— 2 (i) by redesignating paragraph (5) as 3 paragraph (6); and 4 (ii) by inserting after paragraph (4) 5 the following new paragraph: 6 ‘‘(5) Allergy diagnostic testing services (as de- 7 fined in subsection (ff)).’’; and 8 (B) by adding at the end the following new 9 subsection: 10 ‘‘(ff) ALLERGY DIAGNOSTIC TESTING SERVICES DE- 11 FINED.—The term ‘allergy diagnostic testing services’ 12 means in vitro specific IgE tests and percutaneous tests 13 that— 14 ‘‘(1) have been cleared under section 501(k), 15 classified under section 513(f)(2), or approved under 16 section 515 of the Federal Food, Drug, and Cos- 17 metic Act; and 18 ‘‘(2) are provided to individuals for the purpose 19 of evaluating immunologic response to certain anti- 20 gens.’’. 21 (b) EFFECTIVE DATE.— 22 (1) IN GENERAL.—Subject to paragraph (2), 23 the amendments made by this section shall apply 24 VerDate Sep 11 2014 18:35 Apr 09, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2009.IH H2009 pamtmann on DSKBFK8HB2PROD with BILLS 5 •HR 2009 IH with respect to items and services provided on or 1 after January 1, 2021. 2 (2) EXCEPTION FOR STATE LEGISLATION.—In 3 the case of a State plan under title XIX of the So- 4 cial Security Act (42 U.S.C. 1396 et seq.) that the 5 Secretary of Health and Human Services determines 6 requires State legislation in order for the respective 7 plan to meet any requirement imposed by amend- 8 ments made by this section, the respective plan shall 9 not be regarded as failing to comply with the re- 10 quirements of such title solely on the basis of its 11 failure to meet such an additional requirement be- 12 fore the first day of the first calendar quarter begin- 13 ning after the close of the first regular session of the 14 State legislature that begins after the date of the en- 15 actment of this Act. For purposes of the previous 16 sentence, in the case of a State that has a 2-year 17 legislative session, each year of the session shall be 18 considered to be a separate regular session of the 19 State legislature. 20 SEC. 4. MEDICARE COVERAGE FOR ALLERGY DIAGNOSTIC 21 TESTING SERVICES. 22 (a) COVERAGE.—Section 1861 of the Social Security 23 Act (42 U.S.C. 1395x) is amended— 24 (1) in subsection (s)(2)— 25 VerDate Sep 11 2014 18:35 Apr 09, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2009.IH H2009 pamtmann on DSKBFK8HB2PROD with BILLS 6 •HR 2009 IH (A) in subparagraph (GG), by striking 1 ‘‘and’’ at the end; 2 (B) in subparagraph (HH), by striking the 3 period at the end and inserting ‘‘; and’’; and 4 (C) by adding at the end the following new 5 subparagraph: 6 ‘‘(II) allergy diagnostic testing services (as de- 7 fined in subsection (kkk));’’; and 8 (2) by adding at the end the following new sub- 9 section: 10 ‘‘(kkk) ALLERGY DIAGNOSTIC TESTING SERVICES.— 11 ‘‘(1) IN GENERAL.—The term ‘allergy diag- 12 nostic testing services’ means in vitro specific IgE 13 tests and percutaneous tests— 14 ‘‘(A) that have been cleared under section 15 501(k), classified under section 513(f)(2), or 16 approved under section 515 of the Federal 17 Food, Drug, and Cosmetic Act; and 18 ‘‘(B) which are furnished to individuals for 19 the purpose of evaluating immunologic response 20 to certain antigens, as determined appropriate 21 by the practitioner ordering such test. 22 ‘‘(2) EQUAL ACCESS TO TESTING METHODS.— 23 The Secretary shall ensure equality in the treatment 24 VerDate Sep 11 2014 18:35 Apr 09, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2009.IH H2009 pamtmann on DSKBFK8HB2PROD with BILLS 7 •HR 2009 IH of in vitro specific IgE tests and percutaneous tests 1 described in paragraph (1) with respect to— 2 ‘‘(A) any medical necessity or other cov- 3 erage requirements established for such in vitro 4 specific IgE and percutaneous tests; 5 ‘‘(B) any frequency limits established for 6 such tests; and 7 ‘‘(C) any allergen unit limits established 8 for a year for such tests.’’. 9 (b) PAYMENT.—Section 1834 of the Social Security 10 Act (42 U.S.C. 1395m) is amended by adding at the end 11 the following new subsection: 12 ‘‘(x) ALLERGY DIAGNOSTIC TESTING SERVICES.— 13 For purposes of payment only, in the case of allergy diag- 14 nostic testing services (as defined in section 1861(jjj))— 15 ‘‘(1) in vitro specific IgE tests shall be treated 16 as clinical diagnostic laboratory tests; and 17 ‘‘(2) percutaneous tests shall be treated as phy- 18 sicians’ services.’’. 19 (c) EFFECTIVE DATE.—The amendments made by 20 this section shall apply with respect to items and services 21 furnished on or after January 1, 2021. 22 Æ VerDate Sep 11 2014 18:35 Apr 09, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\H2009.IH H2009 pamtmann on DSKBFK8HB2PROD with BILLS