User fee program

(a) In general Section 340B(a) of the Public Health Service Act (42 U.S.C. 256b(a)), as amended by section 6(a), is further amended by adding at the end the following: (15) User fee program (A) Establishment of quarterly fee Beginning in fiscal year 2031, the Secretary shall in accordance with this section assess user fees on, and collect such fees from, each covered entity participating in the program under this section. The fees shall be assessed for a fiscal year and collected quarterly during the last 3 quarters of such fiscal year and the first quarter of the subsequent fiscal year, and the total amount assessed and collected for a fiscal year shall be the amount specified in subparagraph (B)(i) for such year, subject to subparagraph (C). (B) Assessment of user fees (i) Amount of assessment The total amount of user fees authorized to be assessed and collected under subsection (a) for a fiscal year is— (I) $50,000,000 for fiscal year 2031; and (II) for fiscal year 2032 and each subsequent fiscal year, the amount authorized to be assessed and collected in the previous fiscal year adjusted by the average annual percent change that occurred in the Consumer Price Index for all urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All items; Annual Index) in the 12-month period ending June 30 preceding the fiscal year for which fees are being established. (ii) Allocations of assessment by covered entity (I) In general The total user fees assessed and collected under subparagraph (A) each fiscal year with respect to each covered entity shall be an amount that is equal to the applicable percentage of covered outpatient drugs dispensed by such covered entity for the fiscal year multiplied by the amount specified in clause (i) for the fiscal year. (II) Applicable percentage For purposes of subclause (I), the applicable percentage of each covered entity for a fiscal year shall be determined by— (aa) dividing— (AA) the number of prescriptions for covered outpatient drugs dispensed by the covered entity in the previous fiscal year; by (BB) the total number of prescriptions for covered outpatient drugs dispensed by all covered entities in such fiscal year; and (bb) multiplying the amount determined under item (aa) by 100. (iii) Timing of assessment The Secretary shall notify each covered entity subject to this section of the amount of the annual assessment imposed on such covered entity under this subsection not later than December 31 of the fiscal year for which such fees apply. Payments of such assessments shall be made in 4 equal installments, which shall be made by the last day of each quarter of the calendar year immediately following the notification. (C) Use of fees Any fee collected under this paragraph 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); (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 may promulgate rules through notice and comment rulemaking as necessary to carry out 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 (15) for the current year, after paragraph (5).