Covered Outpatient Drugs Policy
Interim Final Rule with Comment Period
On November 14, 2016 the Centers for Medicare & Medicaid Services (CMS) issued the Covered Outpatient Drug; Delay in Change in Definitions of States and United States Interim Final Rule with Comment Period (CMS-2345-IFC) that delays the inclusion of the U.S. territories (American Samoa, the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, and the U.S. Virgin Islands) in the definitions of “States” and “United States” from April 1, 2017 until April 1, 2020 which is effective on November 15, 2016. There is a 60-day comment period for this interim final rule that will end on January 17, 2017.
National Drug Rebate Agreement
Proposed Notice Published - On November 7, 2016 the Centers for Medicare & Medicaid Services (CMS) issued a Proposed Notice with comment period announcing changes that would be made to the Medicaid National Drug Rebate Agreement (NDRA) for use by the Secretary of the Department of Health and Human Services and manufacturers under the Medicaid Drug Rebate Program. The NDRA is being updated to incorporate legislative and regulatory changes that have occurred since the agreement was published in February, 1991, as well as to make editorial and structural revisions, such as references to the updated Office of Management and Budget (OMB)-approved data collection forms and electronic data reporting. There is a 90-day comment period for this proposed notice that will end on February 7, 2017.
Affordable Care Act
Final Rule with Comments Published – On January 21, 2016 the Centers for Medicare & Medicaid Services (CMS) issued the Covered Outpatient Drugs final rule with comment that addresses key areas of Medicaid drug reimbursement and changes made to the Medicaid Drug Rebate Program by the Affordable Care Act. This final rule also requests additional comments on the definition of line extension, which has a 60 day public comment period which will end on April 1, 2016. View the Fact Sheet to learn how this final rule assists states and the federal government in managing drug costs, establishing the long term framework for implementation of the Medicaid drug rebate program, and creating a more fair reimbursement system for Medicaid programs and pharmacies.
- FAQs on the Covered Outpatient Drug Final Rule with Comment (CMS-2345-FC) Published on July 6, 2016
- SMD: Implementation of the Covered Outpatient Drug Final Regulation Provisions Regarding Reimbursement for Covered Outpatient Drugs in the Medicaid Program Published February 11, 2016
- CMS-2345-P Medicaid Program: Covered Outpatient Drugs NPRM February 2, 2012
- Guidance on List of Pediatric Drugs and Blood Clotting Factors
- Final Rule to Withdraw AMP and FUL November 15, 2010
- State Medicaid Director Letter on Medicaid Prescription Drug Rebates September 28, 2010
- Proposed Rule to Withdraw AMP and FUL September 3, 2010
- State Medicaid Director Letter on Medicaid Prescription Drug Rebates April 22, 2010
Deficit Reduction Act (DRA)
- Court Order to Vacate Preliminary Injunction December 15, 2010
- CMS-2238-F Medicaid Program: Multiple Source Drug Definition Published October 7, 2008
- CMS-2238-FC Medicaid Program: Prescription Drugs Published July 17, 2007