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HHS/CMS RIN: 0938-AQ41 Publication ID: Fall 2015 
Title: Covered Outpatient Drugs (CMS-2345-F)(Section 610 Review) 

This final rule revises requirements pertaining to Medicaid reimbursement for covered outpatient drugs to implement provisions of the Affordable Care Act. This rule also revises other requirements related to covered outpatient drugs, including key aspects of Medicaid coverage, payment, and the drug rebate program.

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 
RFA Section 610 Review: Section 610 Review 
CFR Citation: 42 CFR 447   
Legal Authority: Pub. L. 111- 48, sec 2501    Pub. L. 111- 48, 2503    Pub. L. 111- 48, 3301(d)(2)    Pub. L. 111-152, sec 1206    Pub. L. 111-8, sec 221   
Legal Deadline:
Action Source Description Date
Final  Statutory    01/01/2010 
Action Date FR Cite
NPRM  02/02/2012  77 FR 5318   
NPRM Comment Period End  04/02/2012    
Final Action  11/00/2015 
Additional Information: Includes Retrospective Review under E.O. 13563.
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: State, Tribal 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Related RINs: Related to 0938-AP26, Related to 0938-AP67 
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