S 249
Access to Pediatric Technologies Act of 2025
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Bill overview
This bill aims to improve access to pediatric medical technologies by establishing a process for the Centers for Medicare & Medicaid Services (CMS) to determine appropriate payment rates for these devices. Specifically, it requires CMS to create national relative value units under the physician fee schedule when requested by manufacturers of qualifying pediatric technologies, which are medical devices covered by Medicare, FDA-approved, using a temporary billing code, and primarily used with pediatric patients. The bill outlines a timeline and data requirements for manufacturers to submit requests to CMS.
Key provisions
- CMS must establish national relative value units for qualifying pediatric technologies upon manufacturer request.
- Manufacturers must provide data like pricing, claims data, and time/motion studies to CMS for payment methodology development.
- Qualifying pediatric technologies are defined by Medicare coverage, FDA approval, use of a temporary HCPCS code, and primary use in pediatric patients.
- CMS will establish these units through an annual rulemaking process, with deadlines for manufacturer requests.
- The process prioritizes requests received by May 1st of a given year for rulemaking in that year.
- Requests must include information verifying the technology's qualification and relevant data.
- The bill does not require coverage of the technology under Medicare.
- It references specific FDA approval pathways (510(k), 513(f)(2), and 515).
Who is affected
- Manufacturers of pediatric medical technologies
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119th CONGRESS — 1st Session
S. 249
IN THE SENATE OF THE UNITED STATES
A BILL
To amend title XVIII of the Social Security Act to facilitate patient access to certain pediatric technologies.
This Act may be cited as the Access to Pediatric Technologies Act of 2025
.
Section 1848 of the Social Security Act (42 U.S.C. 1395w–4) is amended by adding at the end the following new subsection:
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.
The Secretary shall establish national relative value units for a qualifying pediatric technology under this subsection—
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).
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.
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.
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.
In this subsection, the term qualifying pediatric technology means a medical device that is—
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).