Healthcare Update: OIG Proposed Rule Would Amend Anti-Kickback Statute Safe Harbors and Civil Monetary Penalty Rules; CMS Launches Open Payments Database

OIG Proposed Rule Would Amend Anti-Kickback Statute Safe Harbors and Civil Monetary Penalty Rules

On October 3, 2014, the U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) published a proposed rule that would amend the safe harbors to the anti-kickback statute (“AKS”) and the civil monetary penalty (“CMP”) rules under the authority of the OIG.

The proposed rule would add the following AKS safe harbors (note: the first three codify already existing statutory exceptions):

• Part D Cost-Sharing Waivers by Pharmacies. This exception would protect the waiver or reduction of a Medicare beneficiary’s Part D cost-sharing amounts by a pharmacy if the following conditions are met: (1) the waiver or reduction is not advertised as part of a solicitation; (2) the pharmacy does not routinely waive the cost-sharing; and (3) before waiving the cost-sharing, the pharmacy either determines in good faith that the beneficiary has a financial need or the pharmacy fails to collect the cost-sharing amount after making a reasonable effort to do so. (Read more)