On June 17, 2015, the Health Resources and Services Administration (HRSA) issued a proposed rule to implement civil money penalty (CMP) provisions added to section 340B of the Public Health Service Act as part of the Affordable Care Act (ACA). The proposed rule addresses three primary issues: (i) the calculation of the 340B “ceiling price” that may be charged to covered entities; (ii) the substantive standards applicable to CMPs; and (iii) the procedures applicable to the imposition of CMPs. Although the proposed rule is relatively limited in scope, and additional 340B program subregulatory guidance is anticipated from HRSA in the future the proposed rule contains several noteworthy elements that may warrant public comment, as discussed in our Reed Smith Client Alert. HRSA will accept public comments submitted on or before August 17, 2015.