[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 249 Introduced in Senate (IS)]
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119th CONGRESS
1st Session
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
January 24, 2025
Mrs. Blackburn (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 Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Access to Pediatric Technologies Act
of 2025''.
SEC. 2. FACILITATING ACCESS TO PEDIATRIC TECHNOLOGIES.
(a) In General.--Section 1848 of the Social Security Act (42 U.S.C.
1395w-4) is amended by adding at the end the following new subsection:
``(u) Facilitating Access to Pediatric Technologies.--
``(1) In general.--For each qualifying pediatric technology
(as defined in paragraph (4)) furnished on or after January 1,
2026, the Secretary shall, upon receipt of a manufacturer
request under paragraph (3), establish national relative value
units under the physician fee schedule established under this
section, to the extent no such national relative value units
have been established for such qualifying pediatric technology
under such fee schedule.
``(2) Payment methodology.--The Secretary shall establish
national relative value units for a qualifying pediatric
technology under this subsection--
``(A) in accordance with the payment methodology
established under this section and applicable
regulations; and
``(B) using available data related to the
qualifying pediatric technology, which may include
applicable contractor pricing information, claims data,
time and motion studies, invoice information, or other
information used by the Secretary in establishing
payment rates.
``(3) Implementation.--
``(A) In general.--Upon written request to the
Secretary from the manufacturer of a qualifying
pediatric technology, the Secretary shall establish
national relative value units under paragraph (1)
through the annual rulemaking process for the physician
fee schedule established under this section, in
accordance with the timeline described in subparagraph
(B).
``(B) Timeline.--
``(i) In the case where the Secretary
receives a request under this paragraph on or
before May 1 of a given year from a
manufacturer with respect to a qualifying
pediatric technology of the manufacturer, the
Secretary shall establish national relative
value units for the qualifying pediatric
technology in the rulemaking process during
that year for the physician fee schedule
established under this section.
``(ii) In the case where the Secretary
receives a request under this paragraph after
May 1 of a given year from a manufacturer with
respect to a qualifying pediatric technology of
the manufacturer, the Secretary shall establish
national relative value units for the
qualifying pediatric technology in the
rulemaking process during the following year
for the physician fee schedule established
under this section.
``(C) Content of manufacturer requests.--A
manufacturer submitting a request under this paragraph
with respect to a qualifying pediatric technology of
the manufacturer shall include in such request
information to verify that the technology is a
qualifying pediatric technology and to allow the
Secretary to establish national relative value units
for such technology, including (to the extent
available) contractor pricing information, claims data,
time and motion studies, invoice information, or other
relevant information.
``(4) Qualifying pediatric technology defined.--In this
subsection, the term `qualifying pediatric technology' means a
medical device that is--
``(A) covered under this title;
``(B) approved, cleared, or authorized under
section 510(k), 513(f)(2), or 515 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360(k), 360c(f)(2),
360e);
``(C) described by a temporary Level I HCPCS Code
intended for emerging technologies, services, or
procedures; and
``(D)(i) used as part of a procedure predominantly
performed on pediatric patients; or
``(ii) has otherwise been specifically designed for
safe and effective use in pediatric populations.
``(5) Rule of construction.--Nothing in this subsection
shall be construed to require coverage of a qualifying
pediatric technology under this title or alter the requirements
of section 1862(a)(1)(A).''.
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