the Federal Supplementary Medical Insurance Trust Fund established under section 1841.
“(7) Civil money penalty.—If a manufacturer of a part B rebatable drug has failed to comply with the requirements under paragraph (1)(B) for such drug for a calendar quarter, the manufacturer shall be subject to, in accordance with a process established by the Secretary pursuant to regulations, a civil money penalty in an amount equal to at least 125 percent of the amount specified in paragraph (3) for such drug for such calendar quarter. The provisions of section 1128A (other than subsections (a) (with respect to amounts of penalties or additional assessments) and (b)) shall apply to a civil money penalty under this paragraph in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a).
“(8) Study and report.—
“(A) Study.—The Secretary shall conduct a study of the feasibility of and operational issues involved with the following:
“(i) Including multiple source drugs (as defined in section 1847A(c)(6)(C)) in the rebate system under this subsection.
·HR 4663 TH
