title 44, United States Code, shall not apply to any data collection undertaken by the Secretary under this paragraph. (11) Limiting cost-sharing to net price (A) In general For plan years beginning on or after January 1, 2028, the cost-sharing (for costs above the annual deductible specified in paragraph (1)) for a covered part D drug (other than a covered part D drug described in paragraph (8) or (9)) shall not exceed the negotiated price for such covered part D drug net of all price concessions (as defined in paragraph (10)(F)(v)), as reported in the Detailed DIR Report (or successor report) for the applicable plan year. (B) Enforcement (i) Monitoring compliance The Secretary shall monitor compliance with the requirements under subparagraph (A) on an ongoing basis, including through periodic audits. (ii) Retroactive penalties (I) In general A PDP sponsor or an MA organization that violates the requirements under subparagraph (A) may be subject to civil monetary penalties, consistent with sections 1857(g) and 1860D–12(b)(3)(E), as determined appropriate by the Secretary. The Secretary may impose such penalties retroactively upon review of the Detailed DIR Report (or any successor report) with respect to a given plan year. (II) Application The provisions of section 1128A (other than subsections (a) and (b)) shall apply to a civil monetary penalty under this clause in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a). (12) GAO study and report on implementation and effects of cost-sharing relief provisions (A) Study The Comptroller General of the United States (in this paragraph referred to as the Comptroller General ) shall conduct a study on certain effects of the implementation of the requirements specified under the provisions of paragraphs (10) and (11). (B) Report Once the data and information needed to conduct the study described in subparagraph (A) has become available and the Comptroller General has had sufficient opportunity to review and analyze such data and