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. 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 ‘‘Allergy Testing Access 4 Act of 2019’’. 5 SEC. 2. FINDINGS. 6 Congress finds the following: 7 VerDate Sep 11 2014 03:56 Jul 27, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2246.IS S2246 kjohnson on DSK79L0C42 with BILLS 2 •S 2246 IS (1) Allergies, when not properly diagnosed, can- 1 not be effectively treated. 2 (2) Allergies to food, inhaled particles, or other 3 sources can cause debilitating and, in some cases, 4 fatal reactions. 5 (3) Allergies can substantially compound other 6 illnesses, including asthma, emphysema, and adult 7 obstructive pulmonary diseases, leading to social and 8 economic costs for families and our Nation’s health 9 care system. 10 (4) According to clinical guidelines from the 11 National Institutes of Health and recommendations 12 from peer-reviewed literature, in vitro specific IgE 13 tests and percutaneous tests are considered equiva- 14 lent as confirmatory tests in terms of their sensi- 15 tivity and accuracy. 16 (5) Despite these recommendations, some cur- 17 rent Medicare local coverage determinations and 18 Medicaid coverage policies deny equal access to in 19 vitro specific IgE tests and percutaneous tests. 20 (6) In vitro specific IgE tests and percutaneous 21 tests must be equally accessible for clinicians and 22 patients to improve health outcomes, reduce system 23 costs, and reduce current health care disparities 24 caused by the lack of equal coverage. 25 VerDate Sep 11 2014 03:56 Jul 27, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2246.IS S2246 kjohnson on DSK79L0C42 with BILLS 3 •S 2246 IS SEC. 3. MEDICAID COVERAGE FOR ALLERGY DIAGNOSTIC 1 TESTING SERVICES. 2 (a) IN GENERAL.—Title XIX of the Social Security 3 Act (42 U.S.C. 1396 et seq.) is amended— 4 (1) in section 1902(a)— 5 (A) in paragraph (85), by striking ‘‘and’’ 6 at the end; 7 (B) in paragraph (86), by striking the pe- 8 riod at the end and inserting ‘‘; and’’; and 9 (C) by inserting after paragraph (86) the 10 following new paragraph: 11 ‘‘(87) provide, with respect to the provision of 12 allergy diagnostic testing services (as defined in sec- 13 tion 1905(ff)) under the State plan, for equality in 14 the treatment of in vitro specific IgE tests and 15 percutaneous tests with respect to— 16 ‘‘(A) any medical necessity or other cov- 17 erage requirements established for such in vitro 18 specific IgE and percutaneous tests; 19 ‘‘(B) any frequency limits established for 20 such tests; and 21 ‘‘(C) any allergen unit limits established 22 for such tests.’’; and 23 (2) in section 1905— 24 (A) in subsection (r)— 25 VerDate Sep 11 2014 03:56 Jul 27, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2246.IS S2246 kjohnson on DSK79L0C42 with BILLS 4 •S 2246 IS (i) by redesignating paragraph (5) as 1 paragraph (6); and 2 (ii) by inserting after paragraph (4) 3 the following new paragraph: 4 ‘‘(5) Allergy diagnostic testing services (as de- 5 fined in subsection (ff)).’’; and 6 (B) by adding at the end the following new 7 subsection: 8 ‘‘(ff) ALLERGY DIAGNOSTIC TESTING SERVICES DE- 9 FINED.—The term ‘allergy diagnostic testing services’ 10 means in vitro specific IgE tests and percutaneous tests 11 that— 12 ‘‘(1) have been cleared under section 501(k), 13 classified under section 513(f)(2), or approved under 14 section 515 of the Federal Food, Drug, and Cos- 15 metic Act; and 16 ‘‘(2) are provided to individuals for the purpose 17 of evaluating immunologic response to certain anti- 18 gens.’’. 19 (b) EFFECTIVE DATE.— 20 (1) IN GENERAL.—Subject to paragraph (2), 21 the amendments made by this section shall apply 22 with respect to items and services provided on or 23 after January 1, 2021. 24 VerDate Sep 11 2014 03:56 Jul 27, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2246.IS S2246 kjohnson on DSK79L0C42 with BILLS 5 •S 2246 IS (2) EXCEPTION FOR STATE LEGISLATION.—In 1 the case of a State plan under title XIX of the So- 2 cial Security Act (42 U.S.C. 1396 et seq.) that the 3 Secretary of Health and Human Services determines 4 requires State legislation in order for the respective 5 plan to meet any requirement imposed by amend- 6 ments made by this section, the respective plan shall 7 not be regarded as failing to comply with the re- 8 quirements of such title solely on the basis of its 9 failure to meet such an additional requirement be- 10 fore the first day of the first calendar quarter begin- 11 ning after the close of the first regular session of the 12 State legislature that begins after the date of the en- 13 actment of this Act. For purposes of the previous 14 sentence, in the case of a State that has a 2-year 15 legislative session, each year of the session shall be 16 considered to be a separate regular session of the 17 State legislature. 18 SEC. 4. MEDICARE COVERAGE FOR ALLERGY DIAGNOSTIC 19 TESTING SERVICES. 20 (a) COVERAGE.—Section 1861 of the Social Security 21 Act (42 U.S.C. 1395x) is amended— 22 (1) in subsection (s)(2)— 23 (A) in subparagraph (GG), by striking 24 ‘‘and’’ at the end; 25 VerDate Sep 11 2014 03:56 Jul 27, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2246.IS S2246 kjohnson on DSK79L0C42 with BILLS 6 •S 2246 IS (B) in subparagraph (HH), by striking the 1 period at the end and inserting ‘‘; and’’; and 2 (C) by adding at the end the following new 3 subparagraph: 4 ‘‘(II) allergy diagnostic testing services (as de- 5 fined in subsection (kkk));’’; and 6 (2) by adding at the end the following new sub- 7 section: 8 ‘‘(kkk) ALLERGY DIAGNOSTIC TESTING SERVICES.— 9 ‘‘(1) IN GENERAL.—The term ‘allergy diag- 10 nostic testing services’ means in vitro specific IgE 11 tests and percutaneous tests— 12 ‘‘(A) that have been cleared under section 13 501(k), classified under section 513(f)(2), or 14 approved under section 515 of the Federal 15 Food, Drug, and Cosmetic Act; and 16 ‘‘(B) which are furnished to individuals for 17 the purpose of evaluating immunologic response 18 to certain antigens, as determined appropriate 19 by the practitioner ordering such test. 20 ‘‘(2) EQUAL ACCESS TO TESTING METHODS.— 21 The Secretary shall ensure equality in the treatment 22 of in vitro specific IgE tests and percutaneous tests 23 described in paragraph (1) with respect to— 24 VerDate Sep 11 2014 03:56 Jul 27, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S2246.IS S2246 kjohnson on DSK79L0C42 with BILLS 7 •S 2246 IS ‘‘(A) any medical necessity or other cov- 1 erage requirements established for such in vitro 2 specific IgE and percutaneous tests; 3 ‘‘(B) any frequency limits established for 4 such tests; and 5 ‘‘(C) any allergen unit limits established 6 for a year for such tests.’’. 7 (b) PAYMENT.—Section 1834 of the Social Security 8 Act (42 U.S.C. 1395m) is amended by adding at the end 9 the following new subsection: 10 ‘‘(x) ALLERGY DIAGNOSTIC TESTING SERVICES.— 11 For purposes of payment only, in the case of allergy diag- 12 nostic testing services (as defined in section 1861(kkk))— 13 ‘‘(1) in vitro specific IgE tests shall be treated 14 as clinical diagnostic laboratory tests; and 15 ‘‘(2) percutaneous tests shall be treated as phy- 16 sicians’ services.’’. 17 (c) EFFECTIVE DATE.—The amendments made by 18 this section shall apply with respect to items and services 19 furnished on or after January 1, 2021. 20 Æ VerDate Sep 11 2014 03:56 Jul 27, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\S2246.IS S2246 kjohnson on DSK79L0C42 with BILLS