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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.

2021

10-20-2021


2020

11-20-2020

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. 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, 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).

      Consequently, there is a three-year moratorium on implementation of 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).

2019

10-09-2019

01-31-2019


2018

08-27-2018


2016

12-06-2016


2014

10-02-2014


2013

12-27-2013

04-10-2013


2007

10-04-2007


2006

08-08-2006


2005

10-11-2005

07-01-2005


2002

09-25-2002


2001

12-04-2001


2000

05-22-2000


1999

11-19-1999

11-18-1999


1996

01-25-1996


1994

07-21-1994


1993

09-21-1993


1992

11-05-1992


1991

07-29-1991


1989

01-23-1989