Page:United States Statutes at Large Volume 124.djvu/851

 124 STAT. 825 PUBLIC LAW 111–148—MAR. 23, 2010 ‘‘(vi) The imposition of sanctions in the form of civil monetary penalties, which— ‘‘(I) shall be assessed according to standards established in regulations to be promulgated by the Secretary not later than 180 days after the date of enactment of the Patient Protection and Affordable Care Act; ‘‘(II) shall not exceed $5,000 for each instance of overcharging a covered entity that may have occurred; and ‘‘(III) shall apply to any manufacturer with an agreement under this section that knowingly and intentionally charges a covered entity a price for purchase of a drug that exceeds the maximum applicable price under subsection (a)(1). ‘‘(2) COVERED ENTITY COMPLIANCE.— ‘‘(A) IN GENERAL.—From amounts appropriated under paragraph (4), the Secretary shall provide for improve- ments in compliance by covered entities with the require- ments of this section in order to prevent diversion and violations of the duplicate discount provision and other requirements specified under subsection (a)(5). ‘‘(B) IMPROVEMENTS.—The improvements described in subparagraph (A) shall include the following: ‘‘(i) The development of procedures to enable and require covered entities to regularly update (at least annually) the information on the Internet website of the Department of Health and Human Services relating to this section. ‘‘(ii) The development of a system for the Secretary to verify the accuracy of information regarding covered entities that is listed on the website described in clause (i). ‘‘(iii) The development of more detailed guidance describing methodologies and options available to cov- ered entities for billing covered drugs to State Medicaid agencies in a manner that avoids duplicate discounts pursuant to subsection (a)(5)(A). ‘‘(iv) The establishment of a single, universal, and standardized identification system by which each cov- ered entity site can be identified by manufacturers, distributors, covered entities, and the Secretary for purposes of facilitating the ordering, purchasing, and delivery of covered drugs under this section, including the processing of chargebacks for such drugs. ‘‘(v) The imposition of sanctions, in appropriate cases as determined by the Secretary, additional to those to which covered entities are subject under sub- section (a)(5)(E), through one or more of the following actions: ‘‘(I) Where a covered entity knowingly and intentionally violates subsection (a)(5)(B), the cov- ered entity shall be required to pay a monetary penalty to a manufacturer or manufacturers in the form of interest on sums for which the covered entity is found liable under subsection (a)(5)(E), such interest to be compounded monthly and equal Sanctions. Determination. Guidance. Procedures. Applicability.