II 

118TH CONGRESS 

2D SESSION S. 5275 

To amend title XVIII of the Social Security Act to facilitate patient access 

to certain pediatric technologies. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 25, 2024 

Mrs. BLACKBURN 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Access to Pediatric 

5 Technologies Act of 2024’’. 

6 SEC. 2. FACILITATING ACCESS TO PEDIATRIC TECH7 NOLOGIES. 

8 (a) IN GENERAL.—Section 1848 of the Social Secu9 rity Act (42 U.S.C. 1395w–4) is amended by adding at 

10 the end the following new subsection: 


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1 ‘‘(u) FACILITATING ACCESS TO PEDIATRIC TECH2 NOLOGIES.— 

3 ‘‘(1) IN GENERAL.—For each qualifying pedi4 atric technology (as defined in paragraph (4)) fur5 nished on or after January 1, 2026, the Secretary 

6 shall, upon receipt of a manufacturer request under 

7 paragraph (3), establish national relative value units 

8 under the physician fee schedule established under 

9 this section, to the extent no such national relative 

10 value units have been established for such qualifying 

11 pediatric technology under such fee schedule. 

12 ‘‘(2) PAYMENT METHODOLOGY.—The Secretary 

13 shall establish national relative value units for a 

14 qualifying pediatric technology under this sub15 section— 

16 ‘‘(A) in accordance with the payment 

17 methodology established under this section and 

18 applicable regulations; and 

19 ‘‘(B) using available data related to the 

20 qualifying pediatric technology, which may in21 clude applicable contractor pricing information, 

22 claims data, time and motion studies, invoice 

23 information, or other information used by the 

24 Secretary in establishing payment rates. 

25 ‘‘(3) IMPLEMENTATION.— 


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1 ‘‘(A) IN GENERAL.—Upon written request 

2 to the Secretary from the manufacturer of a 

3 qualifying pediatric technology, the Secretary 

4 shall establish national relative value units 

5 under paragraph (1) through the annual rule6 making process for the physician fee schedule 

7 established under this section, in accordance 

8 with the timeline described in subparagraph 

9 (B). 

10 ‘‘(B) TIMELINE.— 

11 ‘‘(i) In the case where the Secretary 

12 receives a request under this paragraph on 

13 or before May 1 of a given year from a 

14 manufacturer with respect to a qualifying 

15 pediatric technology of the manufacturer, 

16 the Secretary shall establish national rel17 ative value units for the qualifying pedi18 atric technology in the rulemaking process 

19 during that year for the physician fee 

20 schedule established under this section. 

21 ‘‘(ii) In the case where the Secretary 

22 receives a request under this paragraph 

23 after May 1 of a given year from a manu24 facturer with respect to a qualifying pedi25 atric technology of the manufacturer, the 


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1 Secretary shall establish national relative 

2 value units for the qualifying pediatric 

3 technology in the rulemaking process dur4 ing the following year for the physician fee 

5 schedule established under this section. 

6 ‘‘(C) CONTENT OF MANUFACTURER RE7 QUESTS.—A manufacturer submitting a request 

8 under paragraph with respect to a qualifying 

9 pediatric technology of the manufacturer shall 

10 include in such request information to verify 

11 that the technology is a qualifying pediatric 

12 technology and to allow the Secretary to estab13 lish national relative value units for such tech14 nology, including (to the extent available) con15 tractor pricing information, claims data, time 

16 and motion studies, invoice information, or 

17 other relevant information. 

18 ‘‘(4) QUALIFYING PEDIATRIC TECHNOLOGY DE19 FINED.—In this subsection, the term ‘qualifying pe20 diatric technology’ means a medical device that is— 

21 ‘‘(A) covered under this title; 

22 ‘‘(B) approved, cleared, or authorized 

23 under section 510(k), 513(f)(2), or 515 of the 

24 Federal Food, Drug, and Cosmetic Act (21 

25 U.S.C. 360(k), 360c(f)(2), 360e); 


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1 ‘‘(C) described by a temporary Level I 

2 HCPCS Code intended for emerging tech3 nologies, services, or procedures; and 

4 ‘‘(D)(i) used as part of a procedure pre5 dominantly performed on pediatric patients; or 

6 ‘‘(ii) has otherwise been specifically de7 signed for safe and effective use in pediatric 

8 populations. 

9 ‘‘(5) RULE OF CONSTRUCTION.—Nothing in 

10 this subsection shall be construed to require cov11 erage of a qualifying pediatric technology under this 

12 title or alter the requirements of section 

13 1862(a)(1)(A).’’. 

Æ 


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