The HHS Office of Inspector General (OIG) has issued its annual solicitation of recommendations for new or revised Anti-kickback Statute (AKS) safe harbors and new Special Fraud Alerts. In reviewing proposed safe harbor changes, the OIG will consider the extent to which the proposals would increase or decrease:

  • Access to health care services
  • Quality of health care services
  • Patient freedom of choice among health care providers
  • Competition among health care providers
  • Costs to federal health care programs
  • Potential overutilization of health care services
  • The ability of health care facilities to provide services in medically underserved areas or to medically underserved populations.

The OIG also will consider factors such as whether the proposal would provide potential financial benefits to health care providers that may influence decisions to order or refer health care services.

Comments will be accepted until March 2, 2020. The OIG notes that this solicitation is separate from both: (1) its August 27, 2018 request for information (RFI) on the AKS and the beneficiary inducement provisions of the Civil Monetary Penalty (CMP) statute; and (2) its October 17, 2019 proposed rule that would align the AKS and CMP Law regulations with value-based health care arrangements (the comment period on that rulemaking closed on December 31, 2019). The OIG states that commenters need not duplicate comments previously submitted in response to the RFI or proposed rule.