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This proposed rule amends the safe harbors to the anti-kickback statute and the civil monetary penalty rules under the authority of the Office of Inspector General (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 Affordable Care Act of 2010 (Patient Protection and Affordable Care Act), (Pub. L. 111-148), 124 Stat. 119 (2010), as amended by the Health Care and Education Reconciliation Act of 2010, (Pub. L. 111-152), 124 Stat. 1029 (2010), (hereafter "ACA"), and all of which would protect certain payment practices and business arrangements from criminal prosecution and civil sanctions under the anti-kickback provisions of the statute. We also propose to codify ACA's revised definition of "remuneration" and add a gainsharing civil monetary penalty (CMP or penalty) provision in 42 CFR part 1003.