Allergy Testing Access Act of 2021
Bill: H.R.4114 | Sponsor: Rep. Clarke, Yvette D. (D-NY)
Policy area: Health

Summary:
Allergy Testing Access Act of 2021
This bill requires equal coverage of two types of allergy tests under Medicaid and Medicare.
Specifically, in vitro specific IgE tests (blood tests) and percutaneous tests (skin tests) must be treated equally with respect to (1) medical necessity or other coverage requirements, (2) frequency limits, and (3) allergen unit limits.

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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Allergy Testing Access Act of 
2021''.

SEC. 2. 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.

SEC. 3. MEDICARE COVERAGE FOR ALLERGY DIAGNOSTIC TESTING SERVICES.

    (a) Coverage.--Section 1861 of the Social Security Act (42 U.S.C. 
1395x) is amended--
            (1) in subsection (s)(2)--
                    (A) in subparagraph (GG), by striking ``and'' at 
                the end;
                    (B) in subparagraph (HH), by striking the period at 
                the end and inserting ``; and''; and
                    (C) by adding at the end the following new 
                subparagraph:
            ``(B) allergy diagnostic testing services (as defined in 
        subsection (lll));''; and
            (2) by adding at the end the following new subsection:
    ``(lll) 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.''.
    (b) Payment.--Section 1834 of the Social Security Act (42 U.S.C. 
1395m) is amended by adding at the end the following new subsection:
    ``(z) Allergy Diagnostic Testing Services.--For purposes of payment 
only, in the case of allergy diagnostic testing services (as defined in 
section 1861(lll))--
            ``(1) in vitro specific IgE tests shall be treated as 
        clinical diagnostic laboratory tests; and
            ``(2) percutaneous tests shall be treated as physicians' 
        services.''.
    (c) Effective Date.--The amendments made by this section shall 
apply with respect to items and services furnished on or after January 
1, 2022.

SEC. 4. MEDICAID COVERAGE FOR ALLERGY DIAGNOSTIC TESTING SERVICES.

    (a) In General.--Title XIX of the Social Security Act (42 U.S.C. 
1396 et seq.) is amended--
            (1) in section 1902(a)--
                    (A) in paragraph (86), by striking ``and'' at the 
                end;
                    (B) in paragraph (87), by striking the period at 
                the end and inserting ``; and''; and
                    (C) by inserting after paragraph (87) the following 
                new paragraph:
            ``(88) provide, with respect to the provision of allergy 
        diagnostic testing services (as defined in section 1905(hh)) 
        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
            (2) in section 1905--
                    (A) 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 (hh)).''; and
                    (B) by adding at the end the following new 
                subsection:
    ``(hh) 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.''.
    (b) Effective Date.--
            (1) In general.--Subject to paragraph (2), the amendments 
        made by this section shall apply with respect to items and 
        services provided on or after January 1, 2022.
            (2) 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 section, 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 Act. 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.
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