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Access to Pediatric Technologies Act of 2025
To amend title XVIII of the Social Security Act to facilitate patient access to certain pediatric technologies.
Summary
This bill directs the Secretary of Health and Human Services to establish Medicare pricing (national relative value units under the physician fee schedule) for qualifying pediatric medical devices upon manufacturer request, beginning January 1, 2026. A qualifying pediatric technology must be FDA-approved/cleared, covered under Medicare, have a temporary Level I HCPCS code for emerging technologies, and either be used predominantly on children or be specifically designed for pediatric use. Manufacturers can request pricing by May 1 for that year's pricing cycle, or after May 1 for the following year, and must provide supporting data such as pricing information, claims data, and time/motion studies. The bill does not require Medicare coverage of these devices or change existing coverage rules; it only establishes a process for pricing devices that are already covered.
AI-generated plain-language summary of the bill text — neutral, and may be imperfect. See the full text below for the exact wording.
Sponsor (1)
1 cosponsor
- Sen. Lankford, James [R-OK] (R-OK)
Actions (2)
- Jan 24, 2025 Read twice and referred to the Committee on Finance. · senate
- Jan 24, 2025 Introduced in Senate
Similar bills (6)
Bills with similar text or summary — includes reintroductions across Congresses. Ranked by semantic similarity of the bill text (computed locally); a neutral discovery aid, not a claim the bills are duplicates.
Full text
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).”. <all>
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