124 STAT. 824 PUBLIC LAW 111–148—MAR. 23, 2010 ‘‘(i) The development of a system to enable the Secretary to verify the accuracy of ceiling prices cal- culated by manufacturers under subsection (a)(1) and charged to covered entities, which shall include the following: ‘‘(I) Developing and publishing through an appropriate policy or regulatory issuance, precisely defined standards and methodology for the calcula- tion of ceiling prices under such subsection. ‘‘(II) Comparing regularly the ceiling prices calculated by the Secretary with the quarterly pricing data that is reported by manufacturers to the Secretary. ‘‘(III) Performing spot checks of sales trans- actions by covered entities. ‘‘(IV) Inquiring into the cause of any pricing discrepancies that may be identified and either taking, or requiring manufacturers to take, such corrective action as is appropriate in response to such price discrepancies. ‘‘(ii) The establishment of procedures for manufac- turers to issue refunds to covered entities in the event that there is an overcharge by the manufacturers, including the following: ‘‘(I) Providing the Secretary with an expla- nation of why and how the overcharge occurred, how the refunds will be calculated, and to whom the refunds will be issued. ‘‘(II) Oversight by the Secretary to ensure that the refunds are issued accurately and within a reasonable period of time, both in routine instances of retroactive adjustment to relevant pricing data and exceptional circumstances such as erroneous or intentional overcharging for covered drugs. ‘‘(iii) The provision of access through the Internet website of the Department of Health and Human Serv- ices to the applicable ceiling prices for covered drugs as calculated and verified by the Secretary in accord- ance with this section, in a manner (such as through the use of password protection) that limits such access to covered entities and adequately assures security and protection of privileged pricing data from unauthorized re-disclosure. ‘‘(iv) The development of a mechanism by which— ‘‘(I) rebates and other discounts provided by manufacturers to other purchasers subsequent to the sale of covered drugs to covered entities are reported to the Secretary; and ‘‘(II) appropriate credits and refunds are issued to covered entities if such discounts or rebates have the effect of lowering the applicable ceiling price for the relevant quarter for the drugs involved. ‘‘(v) Selective auditing of manufacturers and whole- salers to ensure the integrity of the drug discount program under this section. Procedures.
