0938-AT09 201804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0938 Centers for Medicare & Medicaid Services CMS 0900 Department of Health and Human Services HHS Covered Outpatient Drug; Finalization of Line Extension Definition and Delay in Including U.S. Territories in the Definitions of States and United States (CMS-2345-F2)

This final rule responds to comments on the definition and identification of line extension drugs for which we requested comments in the Covered Outpatient Drug final rule with comment published on February 1, 2016. This rule also finalizes the interim final rule with comment period published on November 15, 2016 that delayed the inclusion of the territories in the definitions of States and United States until April 1, 2020.

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage No No Other 42 CFR 447 Pub. L. 111-148 No Interim Final Rule 11/15/2016 81 FR 80003 Interim Final Rule Effective 11/15/2016 Interim Final Rule Comment Period End 01/17/2017 Final Action 11/00/2018 No State No No No 0938-AQ41 Related to Wendy Tuttle Health Insurance Specialist 0938 Centers for Medicare & Medicaid Services CMS 410 786-8690 wendy.tuttle@cms.hhs.gov S1-01-16, Center for Medicaid and CHIP Services, MS: S2-14-26, 7500 Security Boulevard, Baltimore MD 21244