(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:

(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.

(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.