Ensuring HRSA has adequate resources to oversee the program

(a) In general Section 340B(a) of the Public Health Service Act (42 U.S.C. 256b(a)), as amended by the preceding sections, is further amended by adding at the end the following: (17) User fee program (A) In general Beginning in fiscal year 2027, the Secretary shall assess and collect fees from covered entities participating in the program under this section, in accordance with this paragraph. (B) Fee amounts The fees described in subparagraph (A) shall be assessed and collected from each covered entity on an annual basis, in an amount determined by the Secretary through procedures established through notice and comment rulemaking. In general, the fee shall be 0.1 percent of the dollar amount paid by the covered entity for covered outpatient drugs under this section in the previous year. (C) Use of fees Any fees collected under this paragraph from covered entities shall be used by the Secretary for purposes of administering this section and enhancing program integrity and oversight activities under this section, including— (i) the development of a multi-functional web-based system to collect fees under this paragraph; (ii) the establishment, use, and maintenance of the data clearinghouse under section 1150D of the Social Security Act; (iii) the improvement of the integrity, transparency, security, searchability, and reliability of the 340B Office of Pharmacy Affairs Information System (or a successor to such system), including to ensure that such system continues to meet the needs of external stakeholders; (iv) improvements to the compliance tool used to integrate all information related to manufacturers that have entered into agreements with the Secretary under paragraph (1) and covered entities; (v) audits under this section of covered entities and such manufacturers; and (vi) any other uses for the purposes of program integrity, as the Secretary determines appropriate. (D) Supplement not supplant Any fees collected under this paragraph shall be used to supplement and not supplant amounts otherwise provided in appropriations Acts to carry out this section. (E) Regulations The Secretary shall promulgate regulations as necessary to implement the user fee program under this paragraph, which shall include establishment of a process to provide for exceptions to the fee amount under subparagraph (B), including the circumstances under which such exceptions may apply to certain covered entities. (F) Oversight of user fee program The Inspector General of the Department of Health and Human Services shall— (i) conduct an annual review of the user fee program under this paragraph for the first 5 years of such program; and (ii) not later than September 30 of each year for which a review is required under clause (i), submit to Congress a report on the review conducted under clause (i), together with such recommendations as the Inspector General determines appropriate.. (b) Conforming amendment Section 340B(a)(4) of the Public Health Service Act (42 U.S.C. 256b(a)(4)) is amended, in the matter preceding subparagraph (A), by inserting, has submitted user fees to the Secretary in the amount assessed under paragraph (17) for the current year, after paragraph (5). Section 340B(a)(1) of the Public Health Service Act (42 U.S.C. 256b(a)(1)) is further amended by inserting, and has submitted user fees to the Secretary in the amount assessed under paragraph (17) for the current year, after the first reference to agreement in such paragraph. (c) Funding Section 340B of the Public Health Service Act (42 U.S.C. 256b) is amended by adding at the end the following new subsection: (j) Authorizations of appropriations (1) Authorization of appropriations for audits, investigations, and other oversight and enforcement activities In addition to amounts made available under subsection (d)(4), there are authorized to be appropriated $3,000,000 for each of fiscal years 2027 through 2031, for purposes of conducting audits, investigations, and other oversight and enforcement activities with respect to the drug discount program under this section, including audits of covered entities and manufacturers. (2) Authorization of appropriation for general purposes In addition to amounts made available under paragraph (1) and subsection (d)(4), there are authorized to be appropriated $9,000,000 for each of fiscal years 2028 through 2031, for purposes of implementing the activities under this section, including audits of covered entities and manufacturers.. (d) Direct hire authority Section 340B(d) of the Public Health Service Act (42 U.S.C. 256b(d)) is amended by adding at the end the following new paragraph: (6) Direct-hire authority Notwithstanding section 3304(a)(3) of title 5, United States Code, and sections 3309 through 3318 of such title, and section 337 of title 5 of the Code of Federal Regulations (or any successor regulations), the Secretary may, beginning on the date of the enactment of this paragraph, exercise direct-hire authority to appoint a minimum of twenty qualified candidates to permanent positions within the competitive service in order to carry out management and oversight activities under this section, with respect to covered entities and manufacturers participating in the drug discount program under this section..