[Congressional Record Volume 166, Number 54 (Friday, March 20, 2020)]
[Senate]
[Page S1876]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 1561. Mr. MORAN submitted an amendment intended to be proposed by 
him to the bill S. 3548, to provide emergency assistance and health 
care response for individuals, families, and businesses affected by the 
2020 coronavirus pandemic; which was referred to the Committee on 
Finance; as follows:

       At the appropriate place, insert the following:

     SEC. __. COVERAGE FOR ALLERGY DIAGNOSTIC TESTING SERVICES 
                   UNDER MEDICARE AND MEDICAID.

       (a) Findings.--Congress finds the following:
       (1) Allergies, when not properly diagnosed, cannot be 
     effectively treated.
       (2) Allergies to food, inhaled particles, or other sources 
     can cause debilitating and, in some cases, fatal reactions.
       (3) Allergies can substantially compound other illnesses, 
     including asthma, emphysema, and adult obstructive pulmonary 
     diseases, leading to social and economic costs for families 
     and our Nation's health care system.
       (4) According to clinical guidelines from the National 
     Institutes of Health and recommendations from peer-reviewed 
     literature, in vitro specific IgE tests and percutaneous 
     tests are considered equivalent as confirmatory tests in 
     terms of their sensitivity and accuracy.
       (5) Despite these recommendations, some current Medicare 
     local coverage determinations and Medicaid coverage policies 
     deny equal access to in vitro specific IgE tests and 
     percutaneous tests.
       (6) In vitro specific IgE tests and percutaneous tests must 
     be equally accessible for clinicians and patients to improve 
     health outcomes, reduce system costs, and reduce current 
     health care disparities caused by the lack of equal coverage.
       (b) Medicaid Coverage for Allergy Diagnostic Testing 
     Services.--
       (1) In general.--Title XIX of the Social Security Act (42 
     U.S.C. 1396 et seq.) is amended--
       (A) in section 1902(a)--
       (i) in paragraph (85), by striking ``and'' at the end;
       (ii) in paragraph (86), by striking the period at the end 
     and inserting ``; and''; and
       (iii) by inserting after paragraph (86) the following new 
     paragraph:
       ``(87) provide, with respect to the provision of allergy 
     diagnostic testing services (as defined in section 1905(gg)) 
     under the State plan, for equality in the treatment of in 
     vitro specific IgE tests and percutaneous tests with respect 
     to--
       ``(A) any medical necessity or other coverage requirements 
     established for such in vitro specific IgE and percutaneous 
     tests;
       ``(B) any frequency limits established for such tests; and
       ``(C) any allergen unit limits established for such 
     tests.''; and
       (B) in section 1905--
       (i) in subsection (r)--

       (I) by redesignating paragraph (5) as paragraph (6); and
       (II) by inserting after paragraph (4) the following new 
     paragraph:

       ``(5) Allergy diagnostic testing services (as defined in 
     subsection (gg)).''; and
       (ii) by adding at the end the following new subsection:
       ``(gg) Allergy Diagnostic Testing Services Defined.--The 
     term `allergy diagnostic testing services' means in vitro 
     specific IgE tests and percutaneous tests that--
       ``(1) have been cleared under section 501(k), classified 
     under section 513(f)(2), or approved under section 515 of the 
     Federal Food, Drug, and Cosmetic Act; and
       ``(2) are provided to individuals for the purpose of 
     evaluating immunologic response to certain antigens.''.
       (2) Effective date.--
       (A) In general.--Subject to subparagraph (B), the 
     amendments made by this subsection shall apply with respect 
     to items and services provided on or after January 1, 2021.
       (B) Exception for state legislation.--In the case of a 
     State plan under title XIX of the Social Security Act (42 
     U.S.C. 1396 et seq.) that the Secretary of Health and Human 
     Services determines requires State legislation in order for 
     the respective plan to meet any requirement imposed by 
     amendments made by this subsection, the respective plan shall 
     not be regarded as failing to comply with the requirements of 
     such title solely on the basis of its failure to meet such an 
     additional requirement before the first day of the first 
     calendar quarter beginning after the close of the first 
     regular session of the State legislature that begins after 
     the date of the enactment of this subsection. For purposes of 
     the previous sentence, in the case of a State that has a 2-
     year legislative session, each year of the session shall be 
     considered to be a separate regular session of the State 
     legislature.
       (c) Medicare Coverage for Allergy Diagnostic Testing 
     Services.--
       (1) Coverage.--Section 1861 of the Social Security Act (42 
     U.S.C. 1395x) is amended--
       (A) in subsection (s)(2)--
       (i) in subparagraph (GG), by striking ``and'' at the end;
       (ii) in subparagraph (HH), by striking the period at the 
     end and inserting ``; and''; and
       (iii) by adding at the end the following new subparagraph:
       ``(II) allergy diagnostic testing services (as defined in 
     subsection (kkk));''; and
       (B) by adding at the end the following new subsection:
       ``(kkk) Allergy Diagnostic Testing Services.--
       ``(1) In general.--The term `allergy diagnostic testing 
     services' means in vitro specific IgE tests and percutaneous 
     tests--
       ``(A) that have been cleared under section 501(k), 
     classified under section 513(f)(2), or approved under section 
     515 of the Federal Food, Drug, and Cosmetic Act; and
       ``(B) which are furnished to individuals for the purpose of 
     evaluating immunologic response to certain antigens, as 
     determined appropriate by the practitioner ordering such 
     test.
       ``(2) Equal access to testing methods.--The Secretary shall 
     ensure equality in the treatment of in vitro specific IgE 
     tests and percutaneous tests described in paragraph (1) with 
     respect to--
       ``(A) any medical necessity or other coverage requirements 
     established for such in vitro specific IgE and percutaneous 
     tests;
       ``(B) any frequency limits established for such tests; and
       ``(C) any allergen unit limits established for a year for 
     such tests.''.
       (2) Payment.--Section 1834 of the Social Security Act (42 
     U.S.C. 1395m) is amended by adding at the end the following 
     new subsection:
       ``(x) Allergy Diagnostic Testing Services.--For purposes of 
     payment only, in the case of allergy diagnostic testing 
     services (as defined in section 1861(kkk))--
       ``(1) in vitro specific IgE tests shall be treated as 
     clinical diagnostic laboratory tests; and
       ``(2) percutaneous tests shall be treated as physicians' 
     services.''.
       (3) Effective date.--The amendments made by this subsection 
     shall apply with respect to items and services furnished on 
     or after January 1, 2021.

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