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HHS/OS RIN: 0991-AB72 Publication ID: Fall 2010 
Title: ●Safe Harbors to the Anti-Kickback Statute for Certain Arrangements 
Abstract: This proposed rule would add safe harbors under the anti-kickback statute addressing arrangements in the following areas (subject to certain conditions): waivers of Federal health care program beneficiary cost-sharing amounts in the context of certain government sponsored clinical trials and in the context of certain emergency medical services furnished by suppliers owned or operated by States or municipalities; certain local transportation provided to Federal health care program beneficiaries; certain waived or reduced cost-sharing amounts under Medicare Part D (codifying in regulations section 101(e) of the Medicare Prescription Drug Improvement and Modernization Act of 2003); and certain discounts in the price of “applicable drugs” of manufacturers furnished to “applicable beneficiaries” under the Medicare Coverage Gap Discount Program (pursuant to section 3301 of the Affordable Care Act of 2010). In addition, this rule would re-propose expanding the existing safe harbor for certain waivers of beneficiary co-insurance and deductible amounts for Part A or Part B services for Medicare SELECT policyholders in accordance with an agreement between the Medicare SELECT issuer and a provider or supplier, in certain contexts. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 42 CFR 1001.952   
Legal Authority: PL 100–93, sec 14(a)    PL 111–148, sec 3301    PL 108–173, sec 101(e)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  04/00/2011    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: Undetermined 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
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