§ 447.511 Requirements for States. ( a ) *Invoices submitted to participating drug manufacturers.* Within 60 days of the end of each quarter, the State must bill participating drug manufacturers an invoice which includes, at a minimum, all of the following data and any subsequent changes to the data fields on the CMS-R-144 Medicaid Drug Rebate Invoice form: ( 1 ) The State code.
( 2 ) National Drug Code.
( 3 ) Period covered.
( 4 ) Product FDA list name.
( 5 ) Unit rebate amount.
( 6 ) Units reimbursed.
( 7 ) Rebate amount claimed.
( 8 ) Number of prescriptions.
( 9 ) Medicaid amount reimbursed.
( 10 ) Non-Medicaid amount reimbursed.
( 11 ) Total amount reimbursed.
( b ) *Data submitted to CMS.* On a quarterly basis, the State must submit drug utilization data to CMS, which will be the same information as submitted to the manufacturers on the CMS-R-144, as specified in paragraph (a) of this section. The state data submission will be due no later than 60 days after the end of each rebate period. In the event that a due date falls on a weekend or Federal holiday, the submission will be due on the first business day following that weekend or Federal holiday. Any adjustments to previously submitted data will be transmitted to the manufacturer and CMS in the same reporting period.
( c ) *State that has participating Medicaid Managed care organizations (MCO).* A State that has participating Medicaid managed care organizations (MCO) which includes covered outpatient drugs in its contracts with the MCOs, must report data described in paragraph (a) of this section for covered outpatient drugs dispensed to individuals eligible for medical assistance who are enrolled with the MCO and for which the MCO is required under contract for coverage of such drugs under section 1903 of the Act. These data must be identified separately from the data pertaining to drugs that the State reimburses on a fee-for-service basis.
( d ) *State data certification.* Each data submission in this section must be certified by one of the following: ( 1 ) The State Medicaid Director (SMD);
( 2 ) The Deputy State Medicaid Director (DSMD);
( 3 ) An individual other than the SMD or DSMD, who has authority equivalent to an SMD or DSMD; or
( 4 ) An individual with the directly delegated authority to perform the certification on behalf of an individual described in paragraphs (d)(1) through (3) of this section.
( e ) *State data certification language.* Each data submission by a state must include the following certification language: “I hereby certify, to the best of my knowledge, that the state's data submission is complete and accurate at the time of this submission, and was prepared in accordance with the state's good faith, reasonable efforts based on existing guidance from CMS, section 1927 of the Act and applicable Federal regulations. I further certify that the state has transmitted data to CMS, including any adjustments to previous rebate periods, in the same reporting period as provided to the manufacturer. Further, the state certifies that it has applied any necessary edits to the data for both CMS and the manufacturer to avoid inaccuracies at both the NDC/line item and file/aggregate level. Such edits are to be applied in the same manner and in the same reporting period to both CMS and the manufacturer.”
[43 FR 45253, Sept. 29, 1978, as amended at 85 FR 87103, Dec. 31, 2020]