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AAMC Submits Comments on OIG Beneficiary Inducements, Gainsharing Proposals

December 12, 2014—The AAMC Dec. 2 submitted comments  in response to the Department of Health and Human Services (HHS) Office of Inspector General (OIG) Oct. 3 proposed rule, Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements and Gainsharing.

The letter urges the OIG to accommodate “changes in the health care system [that] are intended to improve patient care, reduce costs, and increase patient satisfaction,” although it recognizes the challenges faced by the OIG in enforcing certain laws. 

The AAMC also asks that HHS not consider paying for costs in clinical trials as beneficiary inducements if the following criteria are met:

  • The research is approved by an institutional review board (IRB).

  • The IRB determines that expenses themselves must be incurred because the expenses are directly related to the research.

  • All research subjects are given information about covered costs.

  • There are no alternatives for the subject to participate in research where he/she would not incur these expenses.

The letter notes the absence of proposed regulatory language regarding gainsharing except for language related to the imposition of penalties, which the AAMC supports.

It further states, “In this rapidly moving environment, it is essential to avoid definitions or criteria that will soon be out of date. The AAMC suggests that the OIG not attempt to define the term ‘reduce or limit services.’ Instead, there should be strong support for programs that encourage better patient care, report metrics, and work for continuous quality improvement, along with a recognition that attempts at too tightly defining the criteria for these activities may inadvertently impede them.”


Ivy Baer, J.D., M.P.H.
Senior Director and Regulatory Counsel
Telephone: 202-828-0499


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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806