Answer: We do not believe that revisions are necessary, as we believe Section V. (b). The updated NDRA addresses these concerns and corrects these issues. As noted above, in response to the comments, we have updated the language in Section II. (f) with respect to increases and decreases in the amount of the rebate, and believe that this provides sufficient information on the increase and decrease in salary rebates. The mandatory discount is calculated as a basic discount plus a discount on inflation. The basic discount is the largest 23.1% of the PMT per unit or the difference between the PMT and the “best price”, which is defined as the best price for most commercial insurers. The inflation discount, the difference between the PMT on the launch date compared to the current quarter and the U.S. Urban Consumer Price Index. Some policy proposals focus on increasing purchasing power in order to negotiate additional rebates. For example, even the PDLs via FFS and MCO can give more leverage to a state that negotiates with a producer. Starting in fiscal year 2019, at least 17 states have adopted a single LDP for one or more classes of drugs.49 California has proposed: Negotiate rebates on all government programs, not just Medicaid.50 (b) Starting with the quarter in which the National Rebate Drug Agreement is signed for all ambulatory drugs covered by all manufacturer labelling codes.
, calculate and disclose all necessary price data for each outpatient drug covered nDC in accordance with Section 1927 of the Act and transposed into 42 CFR 447.510. In addition, except as provided in Section V.b. of the agreement, manufacturers are required to charge an ARU and pay a rebate to each government agency Medicaid, in accordance with each calculated ARU, for outpatient drugs of the manufacturer, paid by the state during a period of rebate, for outpatient drugs of the manufacturer, paid by the state. CMS can calculate an ARU based on product and price data provided by the manufacturer and make the ARU available to states to facilitate the counting of rebates. However, the calculation of the CMS ARU does not absone the manufacturer of responsibility in calculating the ARU. Comment: A commentator asked CMS to review the new language in Section III. (a) to eliminate any perception that the terms of maturity apply only to FFS rebate applications, since the new language refers to information about Medicaid`s use of covered outpatient drugs that were “paid” during the rebate period. The commentator noted that CMS distinguished the obligations of the manufacturer Start Printed Page 12778, which apply to FFS units on the basis of the payment date for pharmacies and MCO units based on the date of the transfer to Medicaid participants. The commentator also indicated that the status refers to the number of “ceded units” . . . payment was made under the plan during the period, including information reported by McOs.