Safeguarding Patients and Taxpayers Act

II 118TH CONGRESS 1ST SESSION S. 1589 To provide for transparency of funds appropriated for purposes of implementing part E of title XI of the Social Security Act. IN THE SENATE OF THE UNITED STATES MAY 11, 2023 Mr. TILLIS (for himself, Mr. MCCONNELL, Mr. CRAPO, Mr. DAINES, and Mrs. BLACKBURN) introduced the following bill; which was read twice and re- ferred to the Committee on Finance A BILL To provide for transparency of funds appropriated for pur- poses of implementing part E of title XI of the Social Security Act. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Safeguarding Patients 4 and Taxpayers Act’’. 5 VerDate Sep 11 2014 20:30 May 24, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1589.IS S1589 TKELLEY on DSK125TN23PROD with BILLS 2 •S 1589 IS SEC. 2. OVERSIGHT OF USE OF IMPLEMENTATION FUNDING 1 FOR DRUG PRICE NEGOTIATION PROGRAM. 2 Part E of title XI of the Social Security Act (42 3 U.S.C. 1320f) is amended by adding at the end the fol- 4 lowing new section: 5 ‘‘SEC. 1199. REPORTS ON USE OF IMPLEMENTATION FUND- 6 ING. 7 ‘‘(a) REPORTS.— 8 ‘‘(1) IN GENERAL.—Not later than 180 days 9 after the date of enactment of this section and not 10 less frequently than annually thereafter for as long 11 as funding is available under section 11004 of Pub- 12 lic Law 117–169, the Secretary shall submit to the 13 Committees on Energy and Commerce, Ways and 14 Means, and Appropriations of the House of Rep- 15 resentatives and the Committees on Finance and 16 Appropriations of the Senate a comprehensive report 17 on the amounts expended, the use of such funds, 18 and the projected and actual unused funds, from 19 amounts appropriated under such section 11004 20 during the preceding year. Each report under this 21 subsection shall include— 22 ‘‘(A) any relevant information with respect 23 to contracting relationships and entities, includ- 24 ing associated contracts, criteria for selection of 25 contracts, and procedures for monitoring the 26 VerDate Sep 11 2014 03:35 May 24, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1589.IS S1589 TKELLEY on DSK125TN23PROD with BILLS 3 •S 1589 IS use of funds and compliance with program re- 1 quirements by contractors and subcontractors; 2 ‘‘(B) a description of efforts the Secretary 3 has undertaken to prevent fraud, waste, and 4 abuse related to accessing maximum fair prices, 5 including any violations involving entities or in- 6 dividuals not eligible to have access to the max- 7 imum fair price for a selected drug, violations 8 related to dispensing or administering a se- 9 lected drug to an individual who is not a max- 10 imum fair price eligible individual, and viola- 11 tions of duplicate discounts such as the non- 12 duplication provisions under section 1193(d); 13 ‘‘(C) the identification of any entity the 14 Secretary is contracting with to implement the 15 program, the extent to which contractors con- 16 duct health technology assessments, the types 17 of clinical and economic outcomes and stand- 18 ards used in such assessments, and the use of 19 such assessments by the Secretary; 20 ‘‘(D) a description of the average amount 21 of funds, full-time equivalent employees, and 22 contractor staffing and support expended under 23 the program for negotiation of the final max- 24 imum fair price established for a selected drug, 25 VerDate Sep 11 2014 03:35 May 24, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1589.IS S1589 TKELLEY on DSK125TN23PROD with BILLS 4 •S 1589 IS including a breakdown of expenditures dedi- 1 cated to employees as well as to contractors, 2 and how those expenditures are apportioned 3 across various activities; 4 ‘‘(E) the amount expended on development 5 and maintenance of a data confidentiality policy 6 for proprietary data as required under section 7 1193(c); 8 ‘‘(F) the amount expended on conducting 9 research and analysis or evaluating data and re- 10 search from external sources, including external 11 stakeholders; 12 ‘‘(G) the amount expended to establish and 13 maintain safeguards to prevent fraud, waste, 14 and abuse in the program as described in para- 15 graph (B); and 16 ‘‘(H) the amount of staff time and funds 17 expended under the program on resolving dis- 18 putes with manufacturers or other stakeholders 19 over the accuracy of data used by the Secretary 20 and how such data is interpreted by the Sec- 21 retary. 22 ‘‘(2) LIMITATION.—The Secretary shall ensure 23 that reports under paragraph (1) do not disclose 24 trade secrets or other proprietary information. 25 VerDate Sep 11 2014 03:35 May 24, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1589.IS S1589 TKELLEY on DSK125TN23PROD with BILLS 5 •S 1589 IS ‘‘(b) LIMITATION ON USE OF FUNDING.—Except as 1 otherwise provided in this part, none of the funds provided 2 under section 11004 of Public Law 117–169 shall be 3 available for obligation or expenditure through a re- 4 programming or transfer of funds that— 5 ‘‘(1) creates a new program; 6 ‘‘(2) eliminates a program, project, or activity; 7 ‘‘(3) increases funds or personnel for any pro- 8 gram, project, or activity for which funds have been 9 denied or restricted by the Congress; 10 ‘‘(4) proposes to use funds directed for a spe- 11 cific activity by this part for a different purpose; 12 ‘‘(5) creates or reorganizes offices, programs, or 13 activities not otherwise authorized under such sec- 14 tion 11004; or 15 ‘‘(6) tests a model under section 1115A. 16 ‘‘(c) USE OF EXISTING FUNDING FOR REPORTS.— 17 The Secretary shall use funds appropriated under section 18 11004 of Public Law 117–169 to carry out subsection 19 (a).’’. 20 Æ VerDate Sep 11 2014 03:35 May 24, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\S1589.IS S1589 TKELLEY on DSK125TN23PROD with BILLS