410-121-0157 Participation in the Medicaid Drug Rebate Program (1) The Oregon Medicaid Pharmaceutical Services Program is a participant in the Centers for Medicare and Medicaid Services (CMS) Medicaid Drug Rebate Program, created by the Omnibus Budget Reconciliation Act (OBRA) of 1990. The Patient Protection and Affordable Care Act (PPACA) enacted on March 23,2010 and the Health Care and Education Reconciliation Act of 2010, (HCERA) enacted on March 30, 2010, together called the Affordable Care Act, requires the Division to collect drug rebates for covered outpatient drugs dispensed to enrollees of Medicaid managed care organizations, (MCOs). The Medicaid Drug Rebate Program requires a drug manufacturer to enter into and have in effect a national rebate agreement with the Secretary of the Department of Health and Human Services for States to receive federal funding for outpatient drugs dispensed to Medicaid patients. The drug rebate program is administered by CMS's Center for Medicaid and State Operations (CMSO). Pharmaceutical companies participating in this program have signed agreements with CMS to provide rebates to the Division of Medical Assistance Programs (Division) on all their drug products. The Division will reimburse providers only for outpatient drug products manufactured or labeled by companies participating in this program. (2) Documents in rule by reference: Names and Labeler Code numbers for participants in the Medicaid Drug Rebate Program are the responsibility of and maintained by CMS. The Division receives this information from CMS in the form of numbered and dated Releases. The Division includes in rule by reference, the CMS Releases online at: https://www.medicaid.gov/medicaid/prescription-drugs/program-releases/index.html . (3) Retroactive effective dates: The CMS Medicaid Drug Rebate Program experiences frequent changes in participation and often this information is submitted to the Division after the effective date(s) of some changes. Therefore, certain participant additions and deletions may be effective retroactively. See specific instructions in the CMS Releases for appropriate effective date(s) of changes. (4) The Division contracts with a Pharmacy Benefit Manager (PBM) to manage the Medicaid Rebate Dispute Resolution program. Pharmacy providers must verify the accuracy of their Medicaid pharmacy claims with the PBM within 30 days of request in instances where drug manufacturers dispute their claim information. Verification can be photocopies of drug invoices showing that the billed products were in stock during the time of the date of service. (5) The actual National Drug Code (NDC) dispensed and the actual metric decimal quantity dispensed, must be billed. Statutory/Other Authority: ORS 413.042 & 414.065 Statutes/Other Implemented: ORS 414.065 History: DMAP 36-2018, minor correction filed 05/25/2018, effective 05/25/2018 DMAP 14-2011, f. 6-29-11, cert. ef. 7-1-11 DMAP 34-2008, f. 11-26-08, cert. ef. 12-1-08 DMAP 16-2008, f. 6-13-08, cert. ef. 7-1-08 OMAP 49-2006, f. 12-28-06, cert. ef. 1-1-07 OMAP 12-2006, f. 5-26-06, cert. ef. 6-1-06 OMAP 7-2006(Temp), f. 3-29-06, cert. ef. 4-1-06 thru 9-15-06 OMAP 5-2006, f. 3-22-06, cert. ef. 4-1-06 OMAP 55-2005, f. 10-25-05, cert. ef. 11-1-05 OMAP 30-2005, f. & cert. ef. 6-6-05 OMAP 7-2005(Temp), f. 3-1-05, cert. ef. 4-1-05 thru 8-1-05 OMAP 6-2005, f. 3-1-05, cert. ef. 3-31-05 OMAP 1-2005(Temp), f. & cert. ef. 1-14-05 thru 6-1-05 OMAP 82-2004, f. 10-29-04, cert. ef. 11-1-04 OMAP 53-2004(Temp), f. & cert. ef. 9-10-04 thru 2-15-05 OMAP 42-2004, f. 6-24-04 cert. ef. 7-1-04 OMAP 31-2004(Temp), f. & cert. ef. 5-14-04 thru 10-15-04 OMAP 24-2004, f. & cert. ef. 3-30-04 OMAP 5-2004(Temp), f. & cert. ef. 2-4-04 thru 6-15-04 OMAP 74-2003, f. & cert. ef. 10-1-03 OMAP 74-2003, f. & cert. ef. 10-1-03 OMAP 48-2003, f. & cert. ef. 7-7-03 OMAP 39-2003(Temp), f. & cert. ef. 5-15-03 OMAP 38-2003, f. & cert. ef. 5-9-03 OMAP 6-2003(Temp), f. & cert. ef. 2-14-03 thru 7-1-03 OMAP 67-2002(Temp), f. & cert. ef. 11-1-02 thru 3-15-03 OMAP 34-2002(Temp), f. & cert. ef. 8-14-02 thru 1-15-03 OMAP 20-2002(Temp), f. & cert. ef. 5-15-02 thru 10-1-02 OMAP 16-2002(Temp), f. & cert. ef. 4-12-02 thru 9-1-02 OMAP 4-2002(Temp), f. & cert. ef. 3-5-02 thru 8-1-02 OMAP 66-2001(Temp), f. 12-28-01, cert. ef. 1-1-02 thru 5-15-02 OMAP 57-2001(Temp), f. 11-28-01, cert. ef. 12-1-01 thru 4-15-02 OMAP 56-2001(Temp), f. & cert. ef. 11-1-01 thru 4-15-02 OMAP 48-2001(Temp), f. 9-28-01, cert. ef. 10-1-01 thru 3-1-02 OMAP 27-2001(Temp), f. 7-30-01, cert. ef. 8-1-01 thru 1-26-02 OMAP 25-2001(Temp), f. 6-28-01, cert. ef. 7-1-01 thru 12-1-01 OMAP 24-2001(Temp), f. 5-9-01, cert. ef. 5-10-01 thru 11-1-01 OMAP 3-2001, f. & cert. ef. 3-16-01 OMAP 43-2000(Temp), f. 12-29-00, cert. ef. 1-1-01 thru 5-1-01 OMAP 29-2000, f. 9-29-00, cert. ef. 10-1-00 OMAP 2-1998, f. 1-30-98, cert. ef. 2-1-98 HR 27-1997, f. & cert. ef. 12-1-97 HR 22-1997, f. & cert. ef. 10-1-97 HR 23-1995, f. 12-29-95, cert. ef. 1-1-96 HR 14-1995, f. 6-29-95, cert. ef. 7-1-95 HR 6-1995, f. 3-31-95, cert. ef. 4-1-95 HR 2-1995, f. & cert. ef. 2-1-95 HR 25-1994, f. & cert. ef. 7-1-94 HR 17-1994, f. & cert. ef. 4-1-94 HR 24-1993, f. & cert. ef. 10-1-93 HR 14-1993, f. & cert. ef. 7-2-93 HR 7-1993 (Temp), f. & cert. ef. 4-1-93 HR 4-1993, f. 3-10-93, cert. ef. 3-11-93 HR 34-1992, f. & cert. ef. 12-1-92 HR 31-1992, f. & cert. ef. 10-1-92 HR 21-1992, f. 7-31-92, cert. ef. 8-1-92 HR 13-1992, f. & cert. ef. 6-1-92 HR 1-1992, f. & cert. ef. 1-2-92 HR 50-1991(Temp), f. & cert. ef. 10-29-91 HR 45-1992, f. & cert. ef. 10-16-91 HR 36-1991(Temp), f. 9-16-91, cert. ef. 10-1-91 HR 31-1991, f. & cert. ef. 7-16-91 HR 23-1991(Temp), f. 6-14-91, cert. ef. 6-17-91 HR 22-1991, f. & cert. ef. 5-16-91 HR 16-1991(Temp), f. 4-12-91, cert. ef. 4-15-91