HHS-OIG seeks input on Anti-Kickback Statute and other regulatory issues

Category: Stark Law, Anti-Kickback Statute, CMS, HHS, OIG

HHS-OIG seeks input on Anti-Kickback Statute and other regulatory issues


Two federal agencies say they are committed to transforming the healthcare system into one that pays for value. Care coordination is a key aspect of a value-based delivery system, and both agencies are looking for ways to reduce barriers for providers, patients and payors.

To that end, the Office of Inspector General (OIG) issued a new Request for Information (RFI) seeking public comment on the Anti-Kickback Statute (AKS) and certain alternative payment models. This follows an RFI issued by the Centers for Medicare and Medicaid Services (CMS) regarding the Stark Law in June.

 In particular, OIG is seeking to identify ways in which it might modify or add new safe harbors to the Anti-Kickback Statute. OIG is also considering whether to modify the definition of “remuneration” found in the civil monetary penalty law so that stakeholders could more easily shift costs and otherwise coordinate care. The RFI seeks comments on four broad issues:

1. Promoting Care Coordination and Value-Based Care

  • How certain safe harbors can be altered or amended to make value-based arrangements and alternative payment models more successful
  • Whether new safe harbors are needed to address care coordination service arrangements or arrangements which promote innovative technology
  • How certain terms – such as “gainsharing,” “incentive payments,” and “alternative payment model” – should be defined to achieve these policy objectives

2. Beneficiary Engagement

  • How providers are currently engaging with beneficiaries regarding beneficiary incentives and cost-sharing obligations, and whether new safe harbors should be added or existing safe harbors should be amended

3. Related Topics

  • How the current waivers developed for purposes of testing models by CMS are performing, specifically regarding:
    • Ease of compliance with waivers
    • Which structures work well
    • Which requirements are burdensome
    • Whether to allow an organization to donate cybersecurity-related items and services to certain providers
    • How to define the term “other conditions” with regard to the approval of beneficiary incentive programs in Accountable Care Organizations as outlined in the Bipartisan Budget Act of 2018 (BBA)
    • How to implement the telehealth technologies exception to the CMP established by the BBA

4. Intersection of Stark and AKS

  • Which exceptions to the Stark Law and safe harbors under AKS should be aligned to achieve the policy goals set forth in this RFI
  • Which exceptions to the Stark Law in furtherance of care coordination or value-based care which should not have a corresponding safe harbor to the AKS

The Requests for Information related to the Stark Law, Anti-Kickback Statute and Civil Monetary Penalties Law are part of the broader “Regulatory Sprint to Coordinated Care” previously announced by the U.S. Department of Health and Human Services. These initiatives represent an important step forward in the transition to a value-based reimbursement system.

Many participants in innovative payment programs are struggling with the economics around the changing reimbursement model. Part of the downside risk for these participants is the substantial investment that is required to participate in these data-driven pilot programs. If physicians and other stakeholders can effectively communicate these challenges and propose practical policy solutions, federal agencies may very well be receptive.

The period for public comment is open until 5 p.m. on October 26, 2018. Waller is available to assist stakeholders in preparing and filing comments related to this RFI and provide additional advocacy as needed.

Top of Page