OIG Seeks Comments to Update the Anti-Kickback Statute and Civil Monetary Penalty Law

The Centers for Medicare & Medicaid Services (CMS) recently closed its public comment period on August 24, 2018, for a Request for Information (RFI) regarding possible changes to the Stark Law. The RFI sought public input to address the undue regulatory impact and burden of the physician self-referral law. This RFI arose from the realization that the existing law was likely impeding value-based care. As the CMS RFI’s public comment period approached its deadline, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published its own RFI on August 27, 2018. The OIG RFI sought public feedback on potential new safe harbors to the Anti-Kickback Statute (AKS) and exceptions to the beneficiary inducement prohibition in the Civil Monetary Penalty (CMP) Law. Similar to the CMS RFI, the OIG RFI was in response to a perceived notion that these laws were impeding care coordination and value-based care. Both RFIs are a result of new and anticipated regulatory reforms in the healthcare industry. For example, HHS has developed the “Regulatory Sprint to Coordinated Care” (Regulatory Sprint) to help accelerate the transformation to a value-based system of healthcare. The Regulatory Sprint is designed to address regulatory obstacles to coordinated care and provide guidance or revise regulations to address such obstacles.

The OIG RFI includes requested public comments for the following general categories:

1. 1. Promoting Care Coordination and Value-Based Care
      • Information about potential arrangements the industry is interested in pursuing that may implicate the AKS or beneficiary inducements CMP;
      • Identification of any new or modified safe harbors to the AKS or exceptions to the definition of “remuneration” under the beneficiary inducements CMP necessary to protect arrangements;
      • Explanations for how ”value” could be defined and used in a safe harbor or exception;
      • Thoughts on definitions for critical terminology for such arrangements; and
      • Suggestions of any opportunities where the OIG can clarify its position through guidance as opposed to regulation.
   2. Beneficiary Engagement
      • Feedback regarding types of beneficiary incentives and how such incentives could contribute to or improve quality of care, care coordination, and patient engagement; and
      • Input about how relieving or eliminating beneficiary cost-sharing obligations may improve care delivery, value-based arrangements, and quality of care.
   3. Other Related Topics of Interest
      • Feedback on current fraud and abuse waivers developed for CMS testing models and the Medicare Shared Savings Program;
      • Information about cybersecurity-related items or services that organizations wish to donate or subsidize and potential barriers current fraud and abuse laws may be causing;
      • Input regarding “other conditions” the ACO Beneficiary Incentive Program, (Section 50341(b) of the Bipartisan Budget Act of 2018), could include as protections or safeguards; and
      • Thoughts on how “telehealth technologies” should be defined under Section 50302(c) of the Bipartisan Budget Act of 2018, which creates a new exception to the definition of “remuneration in the beneficiary inducements CMP.
   4. Alignment of the Stark Law and AKS
      • Feedback regarding circumstances where exceptions to the Stark Law and safe harbors to AKS should align.

Comments for the OIG RFI are due by October 26, 2018.