Issues RFI Regarding the Anti-Kickback Statute and Beneficiary Inducements

On August 20, 2018, Inspector General Daniel R. Levinson, from the Office of Inspector General (OIG), HHS issued a request for information (RFI) seeking input from the public on how to address any regulatory provisions that may act as barriers to coordinated care or value-based care.

The OIG is seeking to identify ways in which it might modify safe harbors to the anti-kickback statute and exceptions to the beneficiary inducements civil monetary penalty (CMP) definition of remuneration to support arrangements promoting care coordination, advance the delivery of value-based care, and protect against harms caused by fraud and abuse. The RFI reports that the 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.

In particular, the OIG has issued a detailed RFI which includes specific questions in several areas such as Value-Based Care arrangements, Safe harbors to the anti-kickback statute or exceptions to the definition of “remuneration” under the beneficiary inducements CMP may be necessary to protect such arrangements and how “value” should 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, among others.

Comments must be submitted no later than 5 p.m. on October 26, 2018, and must refer to file code OIG-0803-N. Comments may be submitted in one of three ways:

1. Electronically. You may submit electronic comments on this regulation to http://
www.regulations.gov. Follow the “Submit a comment” instructions.

2. By regular, express, or overnight mail. You may send written comments to the following address: Susan Edwards, Office of Inspector General, Department of Health and Human Services, Attention: OIG-0803-N, Room 5513, Cohen Building, 330 Independence Avenue SW, Washington, DC 20201.

3. By hand or courier. If you prefer, you may deliver your written comments by hand or courier before the close of the comment period to: Susan Edwards, Office of Inspector General, Department of Health and Human Services, Attention: OIG-0803-N, Room 5513, Cohen Building, 330 Independence Avenue SW, Washington, DC 20201.

For more information on Medicare issues, please contact Linda at 781-272-8001.