I 

118TH CONGRESS 

1ST SESSION H. R. 5389 

To amend title XVIII of the Social Security Act to ensure transparency 

in the national coverage determination process under the Medicare program. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 12, 2023 

Mr. GUTHRIE (for himself and Mr. KELLY of Pennsylvania) introduced the 

following bill; which was referred to the Committee on Ways and Means, 

and in addition to the Committee on Energy and Commerce, 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 ensure 

transparency in the national coverage determination 

process under the Medicare program. 

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 ‘‘National Coverage De5 termination Transparency Act’’. 


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1 SEC. 2. ENSURING TRANSPARENCY IN THE NATIONAL COV2 ERAGE DETERMINATION PROCESS UNDER 

3 THE MEDICARE PROGRAM. 

4 (a) IN GENERAL.—Section 1862(l) of the Social Se5 curity Act (42 U.S.C. 1395y(l)) is amended by adding at 

6 the end the following new paragraphs: 

7 ‘‘(7) TRANSPARENCY IN NATIONAL COVERAGE

8 DETERMINATIONS.— 

9 ‘‘(A) IN GENERAL.—With respect to each 

10 document (whether physical or electronic) re11 ceived by the Secretary on or after the date 

12 that is 30 days after the date of the enactment 

13 of this paragraph that identifies itself as a re14 quest for a national coverage determination, the 

15 Secretary shall, not later than 30 calendar days 

16 after receipt of such document— 

17 ‘‘(i) determine whether such document 

18 is a complete, formal request for a national 

19 coverage determination (as described in the 

20 rule entitled ‘Medicare Program; Revised 

21 Process for Making National Coverage De22 terminations’ (78 Fed. Reg. 48164) or a 

23 successor regulation); and 

24 ‘‘(ii) in the case that the Secretary 

25 finds that such document is not a com26 plete, formal request for a national covVerDate Sep 11 2014 02:47 Sep 13, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5389.IH H5389

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1 erage determination, directly transmit to 

2 the entity submitting such document an 

3 explanation of such finding that includes a 

4 specification of each item of additional in5 formation needed to make such document 

6 a complete, formal request for a national 

7 coverage determination. 

8 ‘‘(B) RESUBMISSION OF DOCUMENT.— 

9 ‘‘(i) IN GENERAL.—In the case of a 

10 document described in subparagraph (A) 

11 with respect to which the Secretary has 

12 made a finding described in clause (ii) of 

13 such subparagraph, the entity submitting 

14 such document may submit to the Sec15 retary a revised document that includes the 

16 additional information specified in such 

17 clause with respect to such document. 

18 Such revised document shall be treated as 

19 a newly-received document for purposes of 

20 subparagraph (A). 

21 ‘‘(ii) TECHNICAL ASSISTANCE.—The 

22 Secretary shall provide such technical as23 sistance as is practicable in order to assist 

24 entities in submitting revised documents 

25 under clause (i). 


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1 ‘‘(C) PUBLICATION.—The Secretary shall 

2 make available on a publicly accessible website 

3 of the Centers for Medicare & Medicaid Serv4 ices or other appropriate means each document 

5 that the Secretary has determined is a com6 plete, formal request for a national coverage de7 termination (as described in subparagraph 

8 (A)(i)) not later than 2 business days after the 

9 date of such determination. 

10 ‘‘(8) CLARIFICATION ON TIMING REQUIRE11 MENTS FOR NATIONAL COVERAGE DETERMINA12 TIONS.—For purposes of paragraphs (2) and (3) 

13 and with respect to a request for a national coverage 

14 determination received on or after the date that is 

15 30 days after the date of the enactment of this para16 graph, the references to ‘the date of the request’ and 

17 ‘the date the request is made’ shall be treated as ref18 erences to the date the request was received by the 

19 Secretary, regardless of whether the Secretary had 

20 determined that such request was a complete, formal 

21 request (as described in paragraph (7)(B)(i)) as of 

22 such date.’’. 

23 (b) INCLUSION OF CERTAIN TIME PERIODS IN AN24 NUAL REPORTS.—Section 1869(f)(7)(A) of the Social Se25 curity Act (42 U.S.C. 1395ff(f)(7)(A)) is amended by addVerDate Sep 11 2014 02:47 Sep 13, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5389.IH H5389

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1 ing at the end the following new sentence: ‘‘Each such re2 port submitted on or after the date that is 30 days after 

3 the date of the enactment of this sentence shall include 

4 in such actual time periods with respect to such a request 

5 any intervening time between the receipt of such request 

6 by the Secretary and the Secretary’s determination that 

7 such request was a complete, formal request (as described 

8 in section 1861(l)(7)(B)(i)).’’. 

Æ 


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