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HHS/CMS RIN: 0938-AT09 Publication ID: Fall 2017 
Title: 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.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Not subject to, not significant 
CFR Citation: 42 CFR 447   
Legal Authority: Pub. L. 111-148   
Legal Deadline:  None
Action Date FR Cite
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  02/00/2018 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: State 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Related RINs: Related to 0938-AQ41 
Agency Contact:
Wendy Tuttle
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S1-01-16, Center for Medicaid and CHIP Services, MS: S2-14-26, 7500 Security Boulevard,
Baltimore, MD 21244
Phone:410 786-8690