(a) The Secretary shall make every use of his or her power to ensure that the Medicaid Public Agency notifies the manufacturer, no later than sixty days after the last day of each remittance period, of the discount invoice (CMS-R-144) or the minimum usage information described in Point II. (f) this Agreement, i.e. information relating to Medicaid`s use of covered outpatient medicines, which have been dispensed and/or, where applicable, paid for during the remission period. In addition, the Secretary will expect that any changes to the State`s previous quarterly drug use data will be reported simultaneously. Commentators also noted that cmS should use the term “shall” because it complies with legal requirements, and not the more revised NDRA language “Employ best efforts”. Commentators consider that the revised “employ best efforts” text is open to broad interpretation and, as such, constitutes considerable uncertainty as to the precise activities of CMS undertaken to ensure the State`s compliance with the obligations to report discount invoices. Commentators have noted that the CMS should strengthen the language to reflect our responsibility to ensure the state`s compliance with the legal provisions in force. However, while CMS continues to use “best efforts” language in the updated NDRA, commentators have asked CMS to develop, in parallel with the completion of the NDRA, draft guidelines to give manufacturers a clearer definition of how the Agency will meet existing legal obligations. Answer: While we appreciate the comment, we do not believe that the NDRA is the appropriate vehicle to transmit such operating instructions. However, we make it clear that the legal requirements have not changed, nor has the language of the current rebate agreement with respect to the manufacturer`s rebate payment in the proposed NDRA.
Operational guidelines for applying for interest rates after the 37th day following the date of the postmark of the invoice are available in various program releases, including state releases #29 and #166, as well as release publications #7. The program`s publications are available on www.Medicaid.gov. Home Print Page 12777 Comment: One commenter stated that CMS should revise the definition of State Drug Utilization Data to specifically refer to the legal prohibition of double discounts in Section 340B(a)(5)(A) of the PHSA. The commentator also recommended that CMS in any event refer to the double ban on discounts in the revised NDRA in which it is involved and stressed the need for states to request discounts only for outpatient medicines covered by ffS and MCO that were not purchased under the 340B programme. Reply: We understand the commentator`s concerns and have revised the language in Section VII. (d) to establish two sentences that are now worded: if the reduction agreement is terminated, the manufacturer is prohibited from entering into another rebate agreement in accordance with section 1927 (b) (4) (C) of the Act for at least one discount period from the effective date of termination. The manufacturer shall also, to the satisfaction of CMS, address all outstanding infringements under previous rebate agreements, including but not limited to the payment of outstanding rebates, and make good faith efforts to challenge or resolve outstanding issues before the OIG regarding the MDRP or the exclusion provided for in subsection (c) of this section. unless the secretary finds a good reason to reinstate earlier.. . .