Seeking to “eliminate any confusion,” the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has formally withdrawn proposed civil money penalty (CMP) and anti-kickback (AKS) safe harbor regulations that it no longer intends to finalize. Specifically, the OIG is withdrawing:

  • A 1994 proposed rule that would have codified the OIG’s authority to levy CMPs when a hospital knowingly makes incentive payments to a physician as an inducement for reducing services to Medicare or Medicaid beneficiaries.
  • A 2002 proposed rule that would have expanded an AKS safe harbor regulation at 42 CFR 1001.952(k) to include waivers of cost sharing amounts for Part A and B services for holders of Medicare SELECT policies.

According to the notices, the OIG has neither applied nor enforced the positions stated in the rules, and it does not intend to do so. Moreover, to the OIG’s knowledge, the public is not currently relying on, and may be unaware of” the proposed rules. If OIG were to finalize either proposal, updated public comments would be required, “as reimbursement methods and other aspects of the healthcare industry have changed in the interim.”

OIG states that the regulatory housecleaning is intended to comply with the Trump Administration’s goal of identifying regulations that can be repealed, replaced, or modified. Nevertheless, the OIG also may be taking advantage of this opportunity to clear the decks of outdated policy proposals while the Office of Management and Budget (OMB) reviews a highly-anticipated OIG proposed rule to amend the AKS safe harbors and exceptions to the beneficiary inducement CMP provisions intended to support coordinated care.