Page:United States Statutes at Large Volume 124.djvu/852

 124 STAT. 826 PUBLIC LAW 111–148—MAR. 23, 2010 to the current short term interest rate as deter- mined by the Federal Reserve for the time period for which the covered entity is liable. ‘‘(II) Where the Secretary determines a viola- tion of subsection (a)(5)(B) was systematic and egregious as well as knowing and intentional, removing the covered entity from the drug discount program under this section and disqualifying the entity from re-entry into such program for a reasonable period of time to be determined by the Secretary. ‘‘(III) Referring matters to appropriate Federal authorities within the Food and Drug Administra- tion, the Office of Inspector General of Department of Health and Human Services, or other Federal agencies for consideration of appropriate action under other Federal statutes, such as the Prescrip- tion Drug Marketing Act (21 U.S.C. 353). ‘‘(3) ADMINISTRATIVE DISPUTE RESOLUTION PROCESS.— ‘‘(A) IN GENERAL.—Not later than 180 days after the date of enactment of the Patient Protection and Affordable Care Act, the Secretary shall promulgate regulations to establish and implement an administrative process for the resolution of claims by covered entities that they have been overcharged for drugs purchased under this section, and claims by manufacturers, after the conduct of audits as authorized by subsection (a)(5)(D), of violations of sub- sections (a)(5)(A) or (a)(5)(B), including appropriate proce- dures for the provision of remedies and enforcement of determinations made pursuant to such process through mechanisms and sanctions described in paragraphs (1)(B) and (2)(B). ‘‘(B) DEADLINES AND PROCEDURES.—Regulations promulgated by the Secretary under subparagraph (A) shall— ‘‘(i) designate or establish a decision-making offi- cial or decision-making body within the Department of Health and Human Services to be responsible for reviewing and finally resolving claims by covered enti- ties that they have been charged prices for covered drugs in excess of the ceiling price described in sub- section (a)(1), and claims by manufacturers that viola- tions of subsection (a)(5)(A) or (a)(5)(B) have occurred; ‘‘(ii) establish such deadlines and procedures as may be necessary to ensure that claims shall be resolved fairly, efficiently, and expeditiously; ‘‘(iii) establish procedures by which a covered entity may discover and obtain such information and documents from manufacturers and third parties as may be relevant to demonstrate the merits of a claim that charges for a manufacturer’s product have exceeded the applicable ceiling price under this section, and may submit such documents and information to the administrative official or body responsible for adju- dicating such claim; ‘‘(iv) require that a manufacturer conduct an audit of a covered entity pursuant to subsection (a)(5)(D) Audits. Deadline. Regulations.