Kusserow’s Corner: OIG Sent a New Proposed “Safe Harbor” Rule to OMB

Following the publication of new proposed rules to expand exclusion and Civil Monetary Penalty (CMP) authorities, the HHS Office of Inspector General (OIG) sent the Office of Management and Budget (OMB) another proposed rule that would add new anti-kickback safe harbors to reflect statutory changes, codify the Affordable Care Act’s (ACA) definition of “remuneration,” and add a gain-sharing CMP regulation. The OIG will begin review of a proposed rule on “safe harbors” from health-care fraud prosecution. This proposed rule amends the safe harbors to the anti-kickback statute and the civil monetary penalty rules under the authority of the OIG. The proposed rule would add new safe harbors, some of which codify statutory changes set forth in the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA) and the ACA, that would protect certain payment practices and business arrangements from criminal prosecution and civil sanctions under the anti-kickback provisions of the statute. The proposed rules would be to codify the ACA’s revised definition of “remuneration” and add a gainsharing CMP provision in 42 CFR part 1003. Although the two pending proposed rules sent to the OMB by the OIG overlap one another, they are being treated as separate and unrelated.

A “Safe Harbor” is a provision of a law or a regulation that specifies that certain conduct will be deemed not to violate a given rule. The OIG has been granted authority under Public Law 100-93, the Medicare and Medicaid Patient and Program Protection Act of 1987, to provide clarification under the administrative provisions of the Anti-Kickback Statue, particularly where it defines conduct that would not cause enforcement action by the OIG. Over the years the OIG has created a number of Safe Harbors. It is now proposing new provisions to fall under that authority.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

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Copyright © 2014 Strategic Management Services, LLC. Published with permission.