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Safe Harbor Regulations

The "safe harbor" regulations describe various payment and business practices that, although they potentially implicate the Federal anti-kickback statute, are not treated as offenses under the statute.

The safe harbor regulations, in their entirety, can be found here.

Links to Federal Register notices containing preambles to the safe harbor regulations appear below.

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2013

12-27-2013
Final Rule: Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute
Solicitation of New Safe Harbors and Special Fraud Alerts
04-10-2013
Proposed Rule: Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute (78 Fed. Reg. 21314; April 10, 2013)

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2007

10-04-2007
Final Rule: Safe Harbor for Federally Qualified Health Centers Arrangements Under the Anti-Kickback Statute (72 Fed. Reg. 56632; October 4, 2007)

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2006

08-08-2006
Final Rule: Safe Harbors for Certain Electronic Prescribing and Electronic Health Records Arrangements Under the Anti-Kickback Statute (71 Fed. Reg. 45110; August 8, 2006)
Final Rule: CMS Physician Self-Referral Electronic Prescribing and Electronic Health Records Exceptions (71 Fed. Reg. 45140; August 8, 2006)
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2005

10-11-2005
Proposed Rule: Safe Harbor for Certain Electronic Prescribing Arrangements Under the Anti-Kickback Statute (70 Fed. Reg. 59015; October 11, 2005)
07-01-2005
Proposed Rule: Safe Harbor for Federally Qualified Health Centers Under the Anti-Kickback Statute (70 Fed. Reg. 38081; July 1, 2005)

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2002

09-25-2002
Proposed Rule: Safe Harbor Under the Anti-Kickback Statute for the Waiver of Medicare SELECT Beneficiary Coinsurance and Deductible Amounts (67 Fed. Reg. 60202; September 25, 2002)

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2001

12-04-2001
Final Rule: Ambulance Replenishing Safe Harbor Under the Anti-Kickback Statute (66 Fed. Reg. 62979; December 4, 2001)

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2000

05-22-2000
Proposed Rule: Ambulance Restocking Safe Harbor under the Anti-Kickback Statute (65 Fed. Reg. 32060; May 22, 2000)

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1999

11-19-1999
Interim Final Rule: Federal Health Care Programs, Fraud and Abuse, Statutory Exception to the Anti-Kickback Statute for Shared Risk Arrangements (64 Fed. Reg. 63504; November 19, 1999)
Final Rule: Clarification of the Initial OIG Safe Harbor Provisions and Establishment of Additional Safe Harbor Provisions under the Anti-Kickback Statute (64 Fed. Reg. 63518; November 19, 1999)
11-18-1999
Fact Sheet: Federal Anti-kickback Law and Regulatory Safe Harbors
Press Release: Inspector General Announces Eight New Anti-kickback Statute Safe Harbors

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1996

01-25-1996
Final Rule: Safe Harbors for Protecting Health Plans (61 Fed. Reg. 2122; January 25, 1996): Revised final rule addressing the three managed care safe harbors originally promulgated in the 11-05-1992 interim final rule.

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1994

07-21-1994
Proposed Rule: Safe Harbor Anti-Kickback Provisions (59 Fed. Reg. 37202; July 21, 1994): Proposed clarifications to the original safe harbor provisions published on 07-29-1991.

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1993

09-21-1993
Proposed Rule: Additional Safe Harbor Provisions Under the Anti-Kickback Statute (58 Fed. Reg. 49008; September 21, 1993): Proposed rule designed to incorporate seven additional safe harbor provisions.

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1992

11-05-1992
Interim Final Rule: Safe Harbors for Protecting Health Plans (57 Fed. Reg. 52723; November 5, 1992): Sets forth three new safe harbors addressing managed care plans through interim final rulemaking.

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1991

07-29-1991
Final Rule: OIG Anti-Kickback Provisions (56 Fed. Reg. 35952; July 29, 1991): Final rulemaking promulgating the 10 original safe harbor provisions.

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1989

01-23-1989
Proposed Rule: OIG Anti-Kickback Provisions (54 Fed. Reg. 3088; January 23, 1989): Proposed original 10 safe harbor provisions.

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