119-s249

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 249 Introduced in Senate

    (IS) ]

<DOC>

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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