[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 701 Introduced in Senate (IS)]
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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
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 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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