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HHS/CMS RIN: 0938-AT09 Publication ID: Fall 2018 
Title: Covered Outpatient Drug; Line Extension Definition and Delay in Including U.S. Territories in Definitions of States and U.S.; Changes to the Rebate Calculation for Line Extension Drugs (CMS-2345-F2) 

This rule will respond to comments on the interim final rule that  1) finalized the definition of line extension in the Medicaid Drug Rebate Program (MDRP) and 2) delayed including the U.S. Territories in the definitions of states and United States.  Additionally, this would include interim final changes to the rebate calculation for line extension drugs to be consistent with the changes that were made through the Bipartisan Budget Act (BBA) of 2018.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Other 
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  01/00/2019 
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