In the December 30, 2014 Federal Register, the OIG solicited comments on potential new or modified safe harbors under the federal Anti-Kickback Statute. Comments are due by March 2, 2015, and the OIG requested that any suggested safe harbor be accompanied by logical justifications and empirical data.

The OIG must annually solicit proposals to modify and create new safe harbors to identify new potential areas of fraud and abuse, and this solicitation is in fulfillment of that obligation. The OIG is also requesting suggestions on new “Special Fraud Alerts,” which the OIG uses to provide general guidance to practitioners on potential fraudulent arrangements that are considered to be widespread.

In considering suggestions for both safe harbors and Special Fraud Alerts, the OIG will specifically assess whether the proposals increase or decrease:

  • Access to healthcare services;
  • Quality of healthcare services;
  • Patient freedom of choice among healthcare providers;
  • Competition among healthcare providers;
  • Cost to federal healthcare programs;
  • Potential overutilization of healthcare services; and
  • The ability of healthcare facilities to provide services in medically underserved areas or medically underserved populations.

Furthermore, the OIG will consider factors including the existence of financial benefits that may affect a provider’s decision to order a healthcare item or services or arrange for a referral.

The Federal Register announcement is available here.

The OIG responded to proposals received last year in its October 2014 Semi-Annual Report to Congress, available here (Appendix F). The OIG stated that it does not want feedback on the proposals discussed in that report at this time.