II
119THCONGRESS
1
STSESSION S. 249
To amend title XVIII of the Social Security Act to facilitate patient access
to certain pediatric technologies.
IN THE SENATE OF THE UNITED STATES
JANUARY24, 2025
Mrs. B
LACKBURN(for herself and Mr. LANKFORD) introduced the following
bill; which was read twice and referred to the Committee on Finance
A BILL
To amend title XVIII of the Social Security Act to facilitate
patient access to certain pediatric technologies.
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 ‘‘Access to Pediatric 4
Technologies Act of 2025’’. 5
SEC. 2. FACILITATING ACCESS TO PEDIATRIC TECH-6
NOLOGIES. 7
(a) I
NGENERAL.—Section 1848 of the Social Secu-8
rity Act (42 U.S.C. 1395w–4) is amended by adding at 9
the end the following new subsection: 10
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‘‘(u) FACILITATINGACCESS TOPEDIATRICTECH-1
NOLOGIES.— 2
‘‘(1) I
N GENERAL.—For each qualifying pedi-3
atric technology (as defined in paragraph (4)) fur-4
nished on or after January 1, 2026, the Secretary 5
shall, upon receipt of a manufacturer request under 6
paragraph (3), establish national relative value units 7
under the physician fee schedule established under 8
this section, to the extent no such national relative 9
value units have been established for such qualifying 10
pediatric technology under such fee schedule. 11
‘‘(2) P
AYMENT METHODOLOGY .—The Secretary 12
shall establish national relative value units for a 13
qualifying pediatric technology under this sub-14
section— 15
‘‘(A) in accordance with the payment 16
methodology established under this section and 17
applicable regulations; and 18
‘‘(B) using available data related to the 19
qualifying pediatric technology, which may in-20
clude applicable contractor pricing information, 21
claims data, time and motion studies, invoice 22
information, or other information used by the 23
Secretary in establishing payment rates. 24
‘‘(3) I
MPLEMENTATION.— 25
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‘‘(A) IN GENERAL.—Upon written request 1
to the Secretary from the manufacturer of a 2
qualifying pediatric technology, the Secretary 3
shall establish national relative value units 4
under paragraph (1) through the annual rule-5
making process for the physician fee schedule 6
established under this section, in accordance 7
with the timeline described in subparagraph 8
(B). 9
‘‘(B) T
IMELINE.— 10
‘‘(i) In the case where the Secretary 11
receives a request under this paragraph on 12
or before May 1 of a given year from a 13
manufacturer with respect to a qualifying 14
pediatric technology of the manufacturer, 15
the Secretary shall establish national rel-16
ative value units for the qualifying pedi-17
atric technology in the rulemaking process 18
during that year for the physician fee 19
schedule established under this section. 20
‘‘(ii) In the case where the Secretary 21
receives a request under this paragraph 22
after May 1 of a given year from a manu-23
facturer with respect to a qualifying pedi-24
atric technology of the manufacturer, the 25
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Secretary shall establish national relative 1
value units for the qualifying pediatric 2
technology in the rulemaking process dur-3
ing the following year for the physician fee 4
schedule established under this section. 5
‘‘(C) C
ONTENT OF MANUFACTURER RE -6
QUESTS.—A manufacturer submitting a request 7
under this paragraph with respect to a quali-8
fying pediatric technology of the manufacturer 9
shall include in such request information to 10
verify that the technology is a qualifying pedi-11
atric technology and to allow the Secretary to 12
establish national relative value units for such 13
technology, including (to the extent available) 14
contractor pricing information, claims data, 15
time and motion studies, invoice information, or 16
other relevant information. 17
‘‘(4) Q
UALIFYING PEDIATRIC TECHNOLOGY DE -18
FINED.—In this subsection, the term ‘qualifying pe-19
diatric technology’ means a medical device that is— 20
‘‘(A) covered under this title; 21
‘‘(B) approved, cleared, or authorized 22
under section 510(k), 513(f)(2), or 515 of the 23
Federal Food, Drug, and Cosmetic Act (21 24
U.S.C. 360(k), 360c(f)(2), 360e); 25
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‘‘(C) described by a temporary Level I 1
HCPCS Code intended for emerging tech-2
nologies, services, or procedures; and 3
‘‘(D)(i) used as part of a procedure pre-4
dominantly performed on pediatric patients; or 5
‘‘(ii) has otherwise been specifically de-6
signed for safe and effective use in pediatric 7
populations. 8
‘‘(5) R
ULE OF CONSTRUCTION .—Nothing in 9
this subsection shall be construed to require cov-10
erage of a qualifying pediatric technology under this 11
title or alter the requirements of section 12
1862(a)(1)(A).’’. 13
Æ
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