Allergy Testing Access Act of 2021

II 117TH CONGRESS 1ST SESSION S. 701 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 MARCH 11, 2021 Mr. MORAN (for himself, Mr. MURPHY, Mr. SCOTT of South Carolina, and Mr. BROWN) introduced the following bill; which was read twice and re- ferred 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 2021’’. 5 SEC. 2. FINDINGS. 6 Congress finds the following: 7 VerDate Sep 11 2014 18:50 Apr 07, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S701.IS S701 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 701 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 18:50 Apr 07, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S701.IS S701 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 701 IS SEC. 3. MEDICARE COVERAGE FOR ALLERGY DIAGNOSTIC 1 TESTING SERVICES. 2 (a) COVERAGE.—Section 1861 of the Social Security 3 Act (42 U.S.C. 1395x) is amended— 4 (1) in subsection (s)(2)— 5 (A) in subparagraph (GG), by striking 6 ‘‘and’’ at the end; 7 (B) in subparagraph (HH), by striking the 8 period at the end and inserting ‘‘; and’’; and 9 (C) by adding at the end the following new 10 subparagraph: 11 ‘‘(B) allergy diagnostic testing services (as de- 12 fined in subsection (lll));’’; and 13 (2) by adding at the end the following new sub- 14 section: 15 ‘‘(lll) ALLERGY DIAGNOSTIC TESTING SERVICES.— 16 ‘‘(1) IN GENERAL.—The term ‘allergy diag- 17 nostic testing services’ means in vitro specific IgE 18 tests and percutaneous tests— 19 ‘‘(A) that have been cleared under section 20 501(k), classified under section 513(f)(2), or 21 approved under section 515 of the Federal 22 Food, Drug, and Cosmetic Act; and 23 ‘‘(B) which are furnished to individuals for 24 the purpose of evaluating immunologic response 25 VerDate Sep 11 2014 18:50 Apr 07, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S701.IS S701 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 701 IS to certain antigens, as determined appropriate 1 by the practitioner ordering such test. 2 ‘‘(2) EQUAL ACCESS TO TESTING METHODS.— 3 The Secretary shall ensure equality in the treatment 4 of in vitro specific IgE tests and percutaneous tests 5 described in paragraph (1) with respect to— 6 ‘‘(A) any medical necessity or other cov- 7 erage requirements established for such in vitro 8 specific IgE and percutaneous tests; 9 ‘‘(B) any frequency limits established for 10 such tests; and 11 ‘‘(C) any allergen unit limits established 12 for a year for such tests.’’. 13 (b) PAYMENT.—Section 1834 of the Social Security 14 Act (42 U.S.C. 1395m) is amended by adding at the end 15 the following new subsection: 16 ‘‘(z) ALLERGY DIAGNOSTIC TESTING SERVICES.— 17 For purposes of payment only, in the case of allergy diag- 18 nostic testing services (as defined in section 1861(lll))— 19 ‘‘(1) in vitro specific IgE tests shall be treated 20 as clinical diagnostic laboratory tests; and 21 ‘‘(2) percutaneous tests shall be treated as phy- 22 sicians’ services.’’. 23 VerDate Sep 11 2014 18:50 Apr 07, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S701.IS S701 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 701 IS (c) EFFECTIVE DATE.—The amendments made by 1 this section shall apply with respect to items and services 2 furnished on or after January 1, 2022. 3 SEC. 4. 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 (86), by striking ‘‘and’’ 9 at the end; 10 (B) in paragraph (87), by striking the pe- 11 riod at the end and inserting ‘‘; and’’; and 12 (C) by inserting after paragraph (87) the 13 following new paragraph: 14 ‘‘(88) provide, with respect to the provision of 15 allergy diagnostic testing services (as defined in sec- 16 tion 1905(hh)) 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 cov- 20 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 VerDate Sep 11 2014 18:50 Apr 07, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S701.IS S701 pamtmann on DSKBC07HB2PROD with BILLS 6 •S 701 IS ‘‘(C) any allergen unit limits established 1 for such tests.’’; and 2 (2) in section 1905— 3 (A) in subsection (r)— 4 (i) by redesignating paragraph (5) as 5 paragraph (6); and 6 (ii) by inserting after paragraph (4) 7 the following new paragraph: 8 ‘‘(5) Allergy diagnostic testing services (as de- 9 fined in subsection (hh)).’’; and 10 (B) by adding at the end the following new 11 subsection: 12 ‘‘(hh) ALLERGY DIAGNOSTIC TESTING SERVICES DE- 13 FINED.—The term ‘allergy diagnostic testing services’ 14 means in vitro specific IgE tests and percutaneous tests 15 that— 16 ‘‘(1) have been cleared under section 501(k), 17 classified under section 513(f)(2), or approved under 18 section 515 of the Federal Food, Drug, and Cos- 19 metic Act; and 20 ‘‘(2) are provided to individuals for the purpose 21 of evaluating immunologic response to certain anti- 22 gens.’’. 23 (b) EFFECTIVE DATE.— 24 VerDate Sep 11 2014 18:50 Apr 07, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S701.IS S701 pamtmann on DSKBC07HB2PROD with BILLS 7 •S 701 IS (1) IN GENERAL.—Subject to paragraph (2), 1 the amendments made by this section shall apply 2 with respect to items and services provided on or 3 after January 1, 2022. 4 (2) EXCEPTION FOR STATE LEGISLATION.—In 5 the case of a State plan under title XIX of the So- 6 cial Security Act (42 U.S.C. 1396 et seq.) that the 7 Secretary of Health and Human Services determines 8 requires State legislation in order for the respective 9 plan to meet any requirement imposed by amend- 10 ments made by this section, the respective plan shall 11 not be regarded as failing to comply with the re- 12 quirements of such title solely on the basis of its 13 failure to meet such an additional requirement be- 14 fore the first day of the first calendar quarter begin- 15 ning after the close of the first regular session of the 16 State legislature that begins after the date of the en- 17 actment of this Act. For purposes of the previous 18 sentence, in the case of a State that has a 2-year 19 legislative session, each year of the session shall be 20 considered to be a separate regular session of the 21 State legislature. 22 Æ VerDate Sep 11 2014 18:50 Apr 07, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\S701.IS S701 pamtmann on DSKBC07HB2PROD with BILLS