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.

In addition, the annual inflation updates to the annual cap on patient engagement tools and supports under 42 CFR § 1001.952(hh) can be found here.

2020

11-20-2020

• Final Rule: Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements
  • Fact Sheet-Final Rule

11-20-2020

• Final Rule: Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees
  • On March 22, 2021, OIG issued a notification of the court-ordered delay of the effective date of this final rule. End of
    Translation That notification stated that the effective date of the amendments to 42 C.F.R. § 1001.952(h)(6) through (9), (cc), and (dd) is delayed until January 1, 2023. The notification also stated that the effective date of the corrections published at 86 Fed. Reg. 7815 (Feb. 2, 2021), is delayed from March 22, 2021, to January 1, 2023. See 86 Fed. Reg. 15,132 (Mar. 22, 2021).
  • On November 15, 2021, the Infrastructure Investment and Jobs Act, Public Law 117-58, became law. Section 90006 of Public Law 117-58 states that:
    
    • Notwithstanding any other provision of law, the Secretary of Health and Human Services shall not, prior to January 1, 2026, implement, administer, or enforce the provisions of the final rule published by the Office of the Inspector General of the Department of Health and Human Services on November 30, 2020, and titled "Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees" (85 Fed. Reg. 76666).
      
  • On June 25, 2022, the Bipartisan Safer Communities Act, Public Law 117–159, became law. Section 13101 of the Bipartisan Safer Communities Act amends section 90006 of Public Law 117-58 by striking “January 1, 2026” and inserting “January 1, 2027”. Consequently, the amendments to 42 C.F.R. § 1001.952(h)(5) and 42 C.F.R. § 1001.952(h)(6) through (9), (cc), and (dd) will not be implemented, administered, or enforced prior to January 1, 2027.
  • On August 16, 2022, the Inflation Reduction Act of 2022, Public Law 117-169, became law. Section 11301 of the Inflation Reduction Act of 2022 extends the moratorium on implementation, administration, or enforcement of this final rule until January 1, 2032.
  • On December 29, 2023, in response to the moratoria enacted by Congress on implementation of the 2020 Final Rule, most recently in section 11301 of the Inflation Reduction Act of 2022, OIG issued a final rule to stay the amendments to the safe harbors to the Federal anti-kickback statute that were promulgated in the 2020 Final Rule until January 1, 2032.

2019

10-09-2019

• Proposed Rule: Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements
  • Fact Sheet: Notice of Proposed Rulemaking OIG-0936-AA10-P

01-31-2019

• Proposed Rule: Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees

2018

08-27-2018

• Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti- Kickback Statute and Beneficiary Inducements CMP

2016

12-06-2016

• Final Rule: Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements

2014

10-02-2014

• Proposed Rule: Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements and Gainsharing

2013

12-27-2013

• Final Rule: Medicare Program; Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships: Exception for Certain Electronic Health Record Arrangements (78 Fed. Reg. 78751; Dec. 27, 2013)
• Final Rule: Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute

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)

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)

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)

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)

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)

2001

12-04-2001

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

2000

05-22-2000

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

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

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.

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.

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.

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.

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.

1989

01-23-1989

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