Dear State Technical and Rebate Contacts,
This is a follow-up to the April 3, 2019 email reminder to states regarding preparation for the upcoming 2018 Branded Prescription Drug (BPD) Fee Year.
Reporting of State Drug Utilization Data for Branded Drug Fee Calculation
In accordance with section 1927(b)(2)(A) of the Social Security Act (the Act), states are required to submit all Medicaid drug rebate utilization data, including physician administered drug utilization and managed care organization (MCO) drug utilization, to CMS within 60 days of the end of each quarter. CMS maintains this utilization data in the Medicaid Drug Rebate (MDR) system and also performs nightly updates of this data in the Drug Data Reporting for Medicaid (DDR) system. All states should be able to access DDR, and are able to view their most recent utilization data by accessing the “Utilization Summary” feature within the “Utilization Data” tab. Any state that does not currently have access should contact DDR@cms.hhs.gov to request access.
State utilization data continues to be used as part of the methodology for establishing an annual fee on branded prescription drug manufacturers that was enacted by section 9008 of the Affordable Care Act on March 23, 2010. While the Department of Treasury is responsible for imposing these fees, the government drug programs specified in section 9008 (e.g., Medicaid, Medicare Part B and Medicare Part D) are required to report drug sales information to the Department of the Treasury each year so that the fees can be accurately calculated. For purposes of the Medicaid data, CMS does not want to impose a new reporting requirement on the states as part of this process; therefore, the state utilization data that are currently reported under section 1927(b)(2)(A) of the Act are being provided to the Department of Treasury as one element of Medicaid’s drug sales information. However, if a state has not reported its utilization data, these new fees cannot be appropriately calculated; therefore, timely and complete reporting of state utilization data is essential to this process.
We will be reviewing your state’s utilization file submissions for all quarters of 2018 to ensure that CMS has received the data, and that the state has responded to any utilization emails or reports that it has received from CMS. Please review the utilization data that has been submitted for 2018 to determine whether any additional submissions or corrections are necessary. If so, please submit the additional data/corrections by December 15, 2019, via the normal drug rebate utilization data transmission process.
Importance of Submitting Correct Data
Over the past few years, it has come to our attention that some states are not submitting the same utilization on the rebate invoice to the labeler as are being reported to CMS. In many such cases, it appears the state is either applying different edits to the individual rebate invoice than they do to the quarterly utilization file they send to CMS. Other states are not sending changes to CMS in a timely manner (i.e., with the next quarterly reporting from the unit adjustment with the labeler, if not sooner). Many states are not applying necessary drug unit conversion factors prior to billing the labeler correctly, and are submitting the erroneous utilization to CMS, causing disputes on the calculated BPD fee. Such states are not in compliance with their utilization data reporting requirements. It is imperative that states and labelers work together to correct these data inconsistencies. Please note that if states fail to update or correct overstated or understated state utilization data reported to CMS, it may result in a compliance action to recover the amount the erroneous data submission caused to be calculated or omitted from the calculation of sales owed to the federal government under the branded prescription drug fee program. For additional information, please refer to State Release No’s 163 & 166 located on Medicaid.gov or the BPD webpage.
Thank you for your cooperation with this effort. If you have any questions, please feel free to contact us via this email resource box, MedicaidBPD@cms.hhs.gov.
CMS Medicaid BPD Team