317:2-1-10. Drug Rebate appeal process
The purpose of this Section is to afford a process to both the manufacturer and the state to administratively resolve drug rebate discrepancies. These rules anticipate discrepancies between the manufacturer and the Oklahoma Health Care Authority (OHCA) which would require the manufacturer to pay a higher rebate or a lower rebate. These regulations provide a mechanism for both informal dispute resolution of drug rebate discrepancies between the manufacturer and OHCA and a mechanism for appeals of drug rebate discrepancies between the manufacturer and OHCA.
(1) The process begins at the end of each calendar quarter when the OHCA mails a copy of the State's past quarter's utilization data to the manufacturer. Utilization data and a billing for rebates will be mailed to the manufacturer within sixty (60) days after the end of each quarter. It is this data which dictates the application of the federal drug rebate formula.
(2) Within thirty (30) days from the date utilization data is sent to the manufacturer, the manufacturer may edit state data and resolve data inconsistencies with the state. The manufacturer may utilize telephone conferences, letters and any other mechanism to resolve data inconsistencies in mutual agreement with the state.
(3) Within thirty (30) days after the utilization data is mailed to the manufacturer, the manufacturer may:
(A) pay the same amount as billed by the state with the quarterly utilization date;
(B) pay an amount which differs from the amount billed by the state with the utilization data and send disputed data information;
(C) pay nothing and send no disputed data information;
(D) pay nothing and send disputed data information.
(4) In the event the state receives the rebate amount billed by the 30th day, the dispute ends.
(5) If after thirty (30) days one of the following events occurs, the state will acknowledge the receipt of the correspondence and review the disputed data:
(A) the receipt of an amount lower than that billed to the manufacturer;
(B) the receipt of disputed data.
(6) In the event no disputed data is received and no payment is received, interest will be computed in accordance with the provisions of federal law found at 42 United States Code (U.S.C.) ' 1396b(d)(5) and will be compounded upon the amount billed from thirty-eight days after the date utilization data is sent.
(7) In the event a lower amount than billed is paid or in the event disputed data is sent, and no money is received, interest will be computed in accordance with 42 U.S.C. Section 1396b(d)(5) and will be computed from thirty-eight days from the date utilization data is sent to the manufacturer.
(8) Within seventy (70) days from the date utilization data is sent to the manufacturer, the state will make its final informal review of the disputed data. OHCA will mail a second notice to the manufacturer which will include:
(A) receipt of the rebate, if any;
(B) receipt of the dispute;
(C) a statement regarding the interest amount; and
(D) a statement regarding the appeal rights of the manufacturer with a copy of the appeal form.
(9) Within ninety (90) days of the date utilization data is sent to the manufacturer or within thirty (30) days of the date a second notice is mailed to the manufacturer, whichever is sooner, the state or the manufacturer may request a hearing to administratively resolve the matter.
(10) The administrative appeal of drug rebate discrepancies includes:
(A) The appeal process will begin by the filing of a form LD-2 by the manufacturer or OHCA.
(B) The process afforded the parties will be the process found at OAC 317:2-1-2(c) and (d).
(C) With respect to the computation of interest, interest will continue to be computed from the thirty-eight (38) day based upon the policy contained in the informal dispute resolution rules above.
(D) The Administrative Law Judge's (ALJ) decision will constitute the final administrative decision of the OHCA.
(E) If the decision of the ALJ affirms the decision of OHCA in whole or in part, payment from the manufacturer must be made within thirty (30) days of the decision. If the decision of the ALJ reverses the decision of the OHCA, the OHCA will make such credit or action within (30) days of the decision of the ALJ.
(F) The nonpayment of the rebate by the manufacturer within thirty (30) days after the ALJ's decision will be reported to the Centers for Medicare and Medicaid Services and may be the basis of an exclusion action by the OHCA.