What is a safe harbor under the Anti-Kickback Statute?
The safe harbor regulations define payment and business practices that will not be considered kickbacks, bribes, or rebates that unlawfully induce payment by Medicare or Medicaid programs. The regulations specify allowable financial and referral relationships between physicians or other providers and suppliers.
How many anti-Kickback is safe harbors?
19, 1999, Federal Register. After publication of the two new rules, there will be a total of 23 anti-kickback safe harbors consolidated in the Code of Federal Regulations in 21 subparagraphs.
What is a safe harbor OIG?
The new safe harbors reduce the need for the OIG to issue separate fraud and abuse waivers for each CMS-sponsored model and is designed to provide greater uniformity across models. The participants must satisfy such other programmatic requirements as may be imposed by CMS in connection with the use of the safe harbor.
Is compliance with safe harbors voluntary?
Compliance with a safe harbor is voluntary. Failing to structure an arrangement to meet a safe harbor does not necessarily mean that the parties have violated the law. However, when an arrangement satisfies each and every element of a regulatory safe harbor, the parties are shielded from liability.
What are the three new safe harbors of the OIG?
New Safe Harbors Value-Based Arrangements With Full Financial Risk (§ 1001.952 (gg)). Under the three new safe harbors, the OIG requires fewer regulatory safeguards as the parties assume greater levels of financial risk. All three value-based safe harbors offer protection for in-kind remuneration, such as technology donations or services.
Where can I find the safe harbor regulations?
HHS Office of Inspector General. 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.
Is there a safe harbor from the AKS for VBAs?
The OIG finalizes a safe harbor from the AKS for VBAs between participants in VBEs that assume substantial downside financial risk that protects monetary and in-kind remuneration.
What was the final rule for safe harbors?
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.
