On Aug. 24, 2018, the Office of Inspector General (OIG) issued a request for information (RFI) regarding the Anti-Kickback Statute (AKS) and Beneficiary Inducement provisions of the Civil Monetary Penalty (CMP) law.

The RFI notes that the Department of Health and Human Services (HHS) is working to transform the healthcare system into a system that better pays for value. One method of achieving this transformation is to remove unnecessary government obstacles through HHS’s “Regulatory Sprint to Coordinated Care” initiative. This initiative is intended to identify regulatory provisions that act as barriers to coordinated care and to issue guidance and revise regulations to address such obstacles. The ultimate goal is to encourage and incentivize coordinated care while protecting against harms caused by fraud and abuse.

The RFI specifically seeks public input on a number of topics, including but not limited to, the following:

  • Promoting Care Coordination and Value-Based Care. The OIG is requesting additional information regarding potentially beneficial arrangements, including which safe harbors, if any, should be added or modified to protect such arrangements.
  • Beneficiary Incentives. Specifically, the OIG is seeking guidance as to which types of incentives providers, suppliers and others are interested in providing, including incentives connected to medication adherence. The OIG is also soliciting comments as to whether the definition of “nominal value” should be increased from no more than $15 per item and $75 in the aggregate per patient on an annual basis.
  • Beneficiary Cost-Sharing Obligations. The OIG is requesting input regarding how reducing or eliminating cost-sharing obligations may improve care delivery, enhance value-based arrangements, and promote quality of care.
  • Intersection with the Stark Law. On Aug. 24, 2018, the comment period relating to the request for information published by Centers for Medicare and Medicaid Services (CMS) relating to the physician self-referral law (the Stark Law) closed. Although many of the comments submitted in response to Stark Law request may overlap with issues identified in the OIG’s request, the OIG is specifically requesting that such comments be resubmitted for consideration by the OIG. Specifically, the OIG is requesting feedback regarding which exceptions to Stark Law and which safe harbors to the AKS should align with respect to the OIG’s RFI.
  • Other Topics of Interest. The OIG is also seeking comments regarding (i) the current fraud and abuse waivers, (ii) donation of cybersecurity-related items and services to providers, (iii) incentive payments under the Accountable Care Organization (ACO) Beneficiary Incentive Program, and (iv) exceptions for telehealth technologies provided to end-stage renal disease (ESRD) patients.

All comments related to the RFI must be received by Oct. 26, 2018.