Manufacturers currently participating in the Medicaid Program have until October 1, 2018, to sign the new Agreement. Failure to enter into a new Agreement by October 1, will result in termination of a manufacturer’s existing Agreement.
While the new Agreement does not contain significant changes from the existing Agreement, several changes are worth noting and repeating:
- Manufacturers must calculate and report pricing data for all covered outpatient drugs for all labeler codes of a manufacturer. In other words, a manufacturer cannot pick and choose for which drugs it will report pricing data.
- Although CMS may calculate the unit rebate amount (“URA”) for a covered drug based upon manufacturer reported pricing and provide the URA to the States, manufacturers are still required to calculate the URA.
- Manufacturers are permitted to identify one main contact (a total of three contacts) for Legal, Invoice, and Technical issues. These contacts must have an address in the United States.
- CMS uses drug information (i.e., Marketing Category and Drug Type) listed with the Food and Drug Administration (“FDA”) to verify that a National Drug Code (“NDC”) meets the definition of a covered outpatient drug. Manufacturers must electronically list their NDCs with the FDA in order to be able to certify their product data in the Medicaid Drug Data Reporting System (“DDR”).
- Manufacturers on the Inspector General’s Exclusion List will be immediately terminated from the Medicaid Program.
Remember, in order for outpatient drugs to be covered under Medicaid and Medicare Part B, a drug manufacturer must enter into a National Drug Rebate Agreement. So put a reminder in your calendar 30 days prior to October 1, 2018 to make sure your company has entered into a new Agreement.