[Congressional Record Volume 166, Number 52 (Wednesday, March 18, 2020)]
[Senate]
[Pages S1814-S1815]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 1560. Mr. MORAN submitted an amendment intended to be proposed by
him to the bill H.R. 6201, making emergency supplemental appropriations
for the fiscal year ending September 30, 2020, and for other purposes;
which was ordered to lie on the table; 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;
[[Page S1815]]
``(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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