S1589-118

1. Short title This Act may be cited as the Safeguarding Patients and Taxpayers Act.

2. Oversight of use of implementation funding for drug price negotiation program Part E of title XI of the Social Security Act (42 U.S.C. 1320f) is amended by adding at the end the following new section: Not later than 180 days after the date of enactment of this section and not less frequently than annually thereafter for as long as funding is available under section 11004 of Public Law 117–169, the Secretary shall submit to the Committees on Energy and Commerce, Ways and Means, and Appropriations of the House of Representatives and the Committees on Finance and Appropriations of the Senate a comprehensive report on the amounts expended, the use of such funds, and the projected and actual unused funds, from amounts appropriated under such section 11004 during the preceding year. Each report under this subsection shall include— any relevant information with respect to contracting relationships and entities, including associated contracts, criteria for selection of contracts, and procedures for monitoring the use of funds and compliance with program requirements by contractors and subcontractors; a description of efforts the Secretary has undertaken to prevent fraud, waste, and abuse related to accessing maximum fair prices, including any violations involving entities or individuals not eligible to have access to the maximum fair price for a selected drug, violations related to dispensing or administering a selected drug to an individual who is not a maximum fair price eligible individual, and violations of duplicate discounts such as the nonduplication provisions under section 1193(d); the identification of any entity the Secretary is contracting with to implement the program, the extent to which contractors conduct health technology assessments, the types of clinical and economic outcomes and standards used in such assessments, and the use of such assessments by the Secretary; a description of the average amount of funds, full-time equivalent employees, and contractor staffing and support expended under the program for negotiation of the final maximum fair price established for a selected drug, including a breakdown of expenditures dedicated to employees as well as to contractors, and how those expenditures are apportioned across various activities; the amount expended on development and maintenance of a data confidentiality policy for proprietary data as required under section 1193(c); the amount expended on conducting research and analysis or evaluating data and research from external sources, including external stakeholders; the amount expended to establish and maintain safeguards to prevent fraud, waste, and abuse in the program as described in paragraph (B); and the amount of staff time and funds expended under the program on resolving disputes with manufacturers or other stakeholders over the accuracy of data used by the Secretary and how such data is interpreted by the Secretary. The Secretary shall ensure that reports under paragraph (1) do not disclose trade secrets or other proprietary information. Except as otherwise provided in this part, none of the funds provided under section 11004 of Public Law 117–169 shall be available for obligation or expenditure through a reprogramming or transfer of funds that— creates a new program; eliminates a program, project, or activity; increases funds or personnel for any program, project, or activity for which funds have been denied or restricted by the Congress; proposes to use funds directed for a specific activity by this part for a different purpose; creates or reorganizes offices, programs, or activities not otherwise authorized under such section 11004; or tests a model under section 1115A. The Secretary shall use funds appropriated under section 11004 of Public Law 117–169 to carry out subsection (a). 1199.Reports on use of implementation funding(a)Reports(1)In generalNot later than 180 days after the date of enactment of this section and not less frequently than annually thereafter for as long as funding is available under section 11004 of Public Law 117–169, the Secretary shall submit to the Committees on Energy and Commerce, Ways and Means, and Appropriations of the House of Representatives and the Committees on Finance and Appropriations of the Senate a comprehensive report on the amounts expended, the use of such funds, and the projected and actual unused funds, from amounts appropriated under such section 11004 during the preceding year. Each report under this subsection shall include—(A)any relevant information with respect to contracting relationships and entities, including associated contracts, criteria for selection of contracts, and procedures for monitoring the use of funds and compliance with program requirements by contractors and subcontractors;(B)a description of efforts the Secretary has undertaken to prevent fraud, waste, and abuse related to accessing maximum fair prices, including any violations involving entities or individuals not eligible to have access to the maximum fair price for a selected drug, violations related to dispensing or administering a selected drug to an individual who is not a maximum fair price eligible individual, and violations of duplicate discounts such as the nonduplication provisions under section 1193(d);(C)the identification of any entity the Secretary is contracting with to implement the program, the extent to which contractors conduct health technology assessments, the types of clinical and economic outcomes and standards used in such assessments, and the use of such assessments by the Secretary;(D)a description of the average amount of funds, full-time equivalent employees, and contractor staffing and support expended under the program for negotiation of the final maximum fair price established for a selected drug, including a breakdown of expenditures dedicated to employees as well as to contractors, and how those expenditures are apportioned across various activities;(E)the amount expended on development and maintenance of a data confidentiality policy for proprietary data as required under section 1193(c);(F)the amount expended on conducting research and analysis or evaluating data and research from external sources, including external stakeholders;(G)the amount expended to establish and maintain safeguards to prevent fraud, waste, and abuse in the program as described in paragraph (B); and(H)the amount of staff time and funds expended under the program on resolving disputes with manufacturers or other stakeholders over the accuracy of data used by the Secretary and how such data is interpreted by the Secretary. (2)LimitationThe Secretary shall ensure that reports under paragraph (1) do not disclose trade secrets or other proprietary information. (b)Limitation on use of fundingExcept as otherwise provided in this part, none of the funds provided under section 11004 of Public Law 117–169 shall be available for obligation or expenditure through a reprogramming or transfer of funds that—(1)creates a new program;(2)eliminates a program, project, or activity;(3)increases funds or personnel for any program, project, or activity for which funds have been denied or restricted by the Congress;(4)proposes to use funds directed for a specific activity by this part for a different purpose; (5)creates or reorganizes offices, programs, or activities not otherwise authorized under such section 11004; or(6)tests a model under section 1115A.(c)Use of existing funding for reportsThe Secretary shall use funds appropriated under section 11004 of Public Law 117–169 to carry out subsection (a)..

1199. Reports on use of implementation funding Not later than 180 days after the date of enactment of this section and not less frequently than annually thereafter for as long as funding is available under section 11004 of Public Law 117–169, the Secretary shall submit to the Committees on Energy and Commerce, Ways and Means, and Appropriations of the House of Representatives and the Committees on Finance and Appropriations of the Senate a comprehensive report on the amounts expended, the use of such funds, and the projected and actual unused funds, from amounts appropriated under such section 11004 during the preceding year. Each report under this subsection shall include— any relevant information with respect to contracting relationships and entities, including associated contracts, criteria for selection of contracts, and procedures for monitoring the use of funds and compliance with program requirements by contractors and subcontractors; a description of efforts the Secretary has undertaken to prevent fraud, waste, and abuse related to accessing maximum fair prices, including any violations involving entities or individuals not eligible to have access to the maximum fair price for a selected drug, violations related to dispensing or administering a selected drug to an individual who is not a maximum fair price eligible individual, and violations of duplicate discounts such as the nonduplication provisions under section 1193(d); the identification of any entity the Secretary is contracting with to implement the program, the extent to which contractors conduct health technology assessments, the types of clinical and economic outcomes and standards used in such assessments, and the use of such assessments by the Secretary; a description of the average amount of funds, full-time equivalent employees, and contractor staffing and support expended under the program for negotiation of the final maximum fair price established for a selected drug, including a breakdown of expenditures dedicated to employees as well as to contractors, and how those expenditures are apportioned across various activities; the amount expended on development and maintenance of a data confidentiality policy for proprietary data as required under section 1193(c); the amount expended on conducting research and analysis or evaluating data and research from external sources, including external stakeholders; the amount expended to establish and maintain safeguards to prevent fraud, waste, and abuse in the program as described in paragraph (B); and the amount of staff time and funds expended under the program on resolving disputes with manufacturers or other stakeholders over the accuracy of data used by the Secretary and how such data is interpreted by the Secretary. The Secretary shall ensure that reports under paragraph (1) do not disclose trade secrets or other proprietary information. Except as otherwise provided in this part, none of the funds provided under section 11004 of Public Law 117–169 shall be available for obligation or expenditure through a reprogramming or transfer of funds that— creates a new program; eliminates a program, project, or activity; increases funds or personnel for any program, project, or activity for which funds have been denied or restricted by the Congress; proposes to use funds directed for a specific activity by this part for a different purpose; creates or reorganizes offices, programs, or activities not otherwise authorized under such section 11004; or tests a model under section 1115A. The Secretary shall use funds appropriated under section 11004 of Public Law 117–169 to carry out subsection (a).