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HHS/OS RIN: 0991-AA91 Publication ID: Spring 2011 
Title: Shared Risk Exception to the Safe Harbor Provisions 
Abstract: This final rule establishes a new safe harbor for risk-sharing arrangements under the Federal health care programs' anti-kickback provisions. The rule sets forth an exception from liability for remuneration between an eligible organization and an individual or entity providing items or services in accordance with a written agreement between these parties. The rule allows remuneration between an organization and an individual or entity if a written agreement places the individual or entity at "substantial financial risk" for the cost or utilization of the items or services that the individual or entity is obligated to provide. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 42 CFR 1001   
Legal Authority: 42 USC 1302    42 USC 1320a-7b    42 USC 1395hh    PL 104-191, sec 216(b)   
Legal Deadline:
Action Source Description Date
Final  Statutory    01/01/1997 
Timetable:
Action Date FR Cite
ANPRM  05/23/1997  62 FR 28410   
ANPRM Comment Period End  06/09/1997    
Interim Final Rule  11/19/1999  64 FR 63504   
Interim Final Rule Comment Period End  01/18/2000    
Final Action  To Be Determined    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Related RINs: Related to 0991-AB06 
Agency Contact:
Patrice S. Drew
Regulations Analyst
Department of Health and Human Services
330 Independence Avenue SW,
Washington, DC 20201
Phone:202 619-1368
Email: patrice.drew@hhs.gov