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HHS/CMS RIN: 0938-AT09 Publication ID: Spring 2019 
Title: Covered Outpatient Drug; Further Delay of Inclusion of Territories In Definitions of State and United States (CMS-2345-IFC3) 

These regulations address the definition of line extension in the Medicaid Drug Rebate Program and inclusion of the territories in the definition of States and United States.

Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  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 and Second Interim Final Rule  04/01/2019  84 FR 12130   
Second Interim Final Rule Comment Period End  05/31/2019 
Third Interim Final Rule  12/00/2019 
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