Bill Details

HR.1931 - 119th Congress

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Status
  1. Introduced
  2. Passed House
  3. Passed Senate
  4. To President
  5. Law
Latest action
2025-03-06 - Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Introduced Date
2025-03-06
Policy Area
Health
6
0

AI Summary This summary was generated by AI from the bill text. AI can get information wrong.

This bill would make it easier for some pediatric medical devices to be paid for under Medicare’s doctor payment system. Starting January 1, 2026, if a device meets the bill’s definition of a “qualifying pediatric technology,” the Health and Human Services Secretary would have to set national payment values for it when the device’s manufacturer asks for it. The goal is to help newer child-focused technologies get recognized in the Medicare payment schedule using available pricing and use data, which could make payment decisions clearer and faster. The bill does not require Medicare to cover any device, and it does not change the rules for what Medicare can or cannot cover.

  • The bill applies to certain medical devices that are already covered by Medicare and have been approved, cleared, or authorized by the FDA.
  • To qualify, the device must have a temporary Level I HCPCS code and either be used mainly in procedures for children or be specially designed for safe and effective use in pediatric patients.
  • Manufacturers would need to send a written request and include information that helps prove the device qualifies and helps set payment values, such as pricing, claims data, study data, or invoices if available.
  • If the request is received by May 1, the payment values would be set in that year’s rulemaking process; if it comes after May 1, the values would be set the following year.

Official Summaries

Access to Pediatric Technologies Act of 2025

This bill requires the Centers for Medicare & Medicaid Services (CMS) to establish, upon request, specific payment methodologies for qualifying pediatric technologies under the Medicare physician fee schedule. Qualifying pediatric technologies are medical devices that are (1) covered under Medicare, (2) approved by the Food and Drug Administration, (3) currently billed using a specified temporary billing code for emerging technologies, and (4) predominantly used or specifically designated for pediatric patients.

The CMS must develop a payment methodology for a qualifying pediatric technology upon request from the manufacturer and based on available data, including pricing information and claims data. Manufacturers must include relevant information in their requests to enable the CMS to develop the corresponding methodologies.

Current Full Text

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1931 Introduced in House (IH)]

<DOC>






119th CONGRESS
  1st Session
                                H. R. 1931

 To amend title XVIII of the Social Security Act to facilitate patient 
               access to certain pediatric technologies.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 6, 2025

Mr. Joyce of Pennsylvania (for himself and Mrs. Trahan) introduced the 
   following bill; which was referred to the Committee on Energy and 
  Commerce, and in addition to the Committee on Ways and Means, for a 
 period to be subsequently determined by the Speaker, in each case for 
consideration of such provisions as fall within the jurisdiction of the 
                          committee concerned

_______________________________________________________________________

                                 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 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>