HHS OIG Solicits Input on Changes in Anti-Kickback Safe Harbors for Value Based Care Models

The Department of Health and Human Services’ Office of Inspector General (OIG) on Friday announced a new request for information on the federal anti-kickback statute (AKS) safe harbors that would “balance additional flexibility for industry stakeholders to provide efficient, well-coordinated, patient-centered care with protections against the harms caused by fraud and abuse.” Comments to the OIG RFI are due by October 26, 2018.

RFI Specifics

According to the announcement of the RFI, the Office of Inspector General is seeking to identify ways in which it might modify or add new safe harbors to the anti-kickback statute and exceptions to the beneficiary inducements civil monetary penalty (CMP) definition of “remuneration” in order to foster arrangements that would promote care coordination and advance the delivery of value-based care, while also protecting against harms caused by fraud and abuse. Through internal discussion and with the benefit of facts and information received from external stakeholders, OIG has identified the broad reach of the anti-kickback statute and beneficiary inducements CMP as a potential impediment to beneficial arrangements that would advance coordinated care. To inform the OIG’s efforts, it welcomes public comment on the safe harbors to the anti-kickback statute and the exceptions to the beneficiary inducements CMP definition of “remuneration.”

The OIG RFI includes a series of detailed questions to inform potential updates to its AKS policies including:

• Scope of value-based models: Potential arrangements that the industry is interested in pursuing, such as care coordination, value-based arrangements, alternative payment models, arrangements involving innovative technology, and other novel financial arrangements that may implicate the anti-kickback statute or beneficiary inducements CMP;
• Safe Harbors: New or updates to safe harbors to the anti-kickback statute or exceptions to the definition of “remuneration” under the beneficiary inducements CMP;
• Value definition: How “value” could be defined and used in a safe harbor or exception such that OIG could evaluate “value” within an arrangement to determine compliance with the safe harbor or exception;
• Incentives: Feedback regarding the types of incentives providers, suppliers, and others are interested in providing to beneficiaries, how providing such incentives would contribute to or improve quality of care, care coordination, and patient engagement;
• Beneficiary Cost-sharing: Input about how relieving or eliminating beneficiary cost-sharing obligations might improve care delivery, enhance value-based arrangements, and promote quality of care;
• Cybersecurity: The types of cybersecurity-related items or services that entities wish to donate or subsidize, and how existing fraud and abuse laws may pose barriers to such arrangements; and
• Stark and AKS Alignment: Specific circumstances in which (i) exceptions to the physician self-referral law and safe harbors to the anti-kickback statute should align for purposes of the goals of this RFI; and (ii) exceptions to the physician self-referral law in furtherance of care coordination or value-based care should not have a corresponding safe harbor to the anti-kickback statute.

Several organizations have  added that this is a welcome proposal.   AdvaMed has already commented that ” the regulations under both the Stark Law and the AKS should contain parallel
safe harbors setting forth terms and conditions under which value-based price adjustments
and value-based services can be provided without violating the broad prohibitions of these
two statutes. Absent these changes, these laws create significant impediments to
implementation of measures needed to coordinate care, share risk, and otherwise improve
clinical outcomes while controlling costs. ”

American Hospital Association stated “We believe meaningful changes to the regulations can achieve significant improvements to patient care. We previously discussed the adverse impact the Stark
requirements have on patient care in AHA’s report, Legal (Fraud and Abuse) Barriers to
Care Transformation and How to Address Them…Wayne’s World. That is why we
recommend specific changes to the compensation regulations that will foster and
enable the relationships between hospitals and physicians necessary to achieve valuebased
care and a patient-centered system, and to remove unnecessary and
burdensome requirements that do not advance coordinated care.”

Comments can be submitted online through October 26, 2018at https://www.regulations.gov/docket?D=CMS-2018-0082