OAR 410-121-0580: Oregon Medicaid and Pharmaceutical Manufacturers’ Dispute Resolution Procedures

(1) Within 60 days after the end of each calendar quarter, the Division of Medical Assistance Programs (Division) shall report the number of units dispensed for each drug National Drug Code (NDC) for which payment was made to the manufacturer of said product. Utilization reports to manufacturers shall follow this schedule: (a) The period from January 1 through March 31 will be Quarter 1. Quarter 1 invoices shall be due by May 30 of that same year; (b) The period from April 1 through June 30 will be Quarter 2. Quarter 2 invoices shall be due by August 29 of that same year; (c) The period from July 1 through September 30 will be Quarter 3. Quarter 3 invoices shall be due by November 29 of that same year; (d) The period from October 1 through December 31 will be Quarter 4. Quarter 4 invoices shall be due by February 29 of the following year. (2) A manufacturer must make payment within 30 days of receipt of utilization reports, i.e., rebate invoice. Using eight days as reasonable time for reports to reach the manufacturer, payment of the invoiced amount is due per the following schedule: (a) Rebate payment for Quarter 1 shall be due by July 7 of that same year; (b) Rebate payment for Quarter 2 shall be due by October 7 of that same year; (c) Rebate payment for Quarter 3 shall be due by January 6 of the following year; (d) Rebate payment for Quarter 4 shall be due by April 6 of the following year. (3) Division considers any failure to make timely payment in full of the amount due to be a dispute. Timely is defined by Division as 38 days after the postmarked date of the invoice. (4) If a manufacturer does not indicate in writing, by specific NDC number(s), the reason(s) for non-payment in full, a letter asking for clarification will be sent and interest will accrue as set forth in the Rebate Agreement, Section V, Dispute Resolution, beginning 38 days after the postmarked date of each invoice. (5) Utilization/unit disputes shall be handled by a careful examination of paid claims data to determine the reasonableness of the reported units of products provided to Oregon recipients. If it is determined that the manufacturer is in error a letter notifying the manufacturer of the completed review and findings will be mailed to the manufacturer and interest will accrue as set forth in the Rebate Agreement, Section V, Dispute Resolution. (6) If a manufacturer determines that incorrect information was sent to the Centers for Medicare and Medicaid Services (CMS), the manufacturer must still make payment in full to Oregon Medicaid for the invoiced rebate amount. Oregon Medicaid will credit the manufacturer's account through CMS’s prior period adjustment process. (7) Interest will accrue as set forth in the Rebate Agreement, Section V, Dispute Resolution, on the 31st day after a manufacturer receives information from Division on the number of units paid by NDC number (i.e., rebate invoice). (8) Manufacturer requests for audit information by product and zip codes will be acknowledged by Division in letter form. Each letter will include a Division Audit Request Form and instructions to the manufacturer on how to complete the form. The letter will also include a standard explanation of the audit process. (9) Days referred to in this process shall be considered calendar days. (10) Efforts should be made through an informal rebate resolution process as outlined in this rule before a hearing will be scheduled. Hearings will follow OAR 410-120-0760 through 410-120-1060 and be held in Marion County, OR. (11) Oregon Medicaid will notify CMS of all disputing manufacturers in writing.