The exclusion of makers of devices and drugs from a proposed overhaul of the Anti-Kickback Statute (AKS) probably took many in industry by surprise, but Premier Inc., of Charlotte, N.C., argued that this approach fails to capitalize on an opportunity to hold manufacturers accountable for clinical outcomes in value-based arrangements.
Device makers have been scrambling for space in value-based care arrangements even though the pace of adoption of those arrangements has been somewhat tepid. While device makers are not explicitly included in a proposed overhaul of the Stark and Anti-Kickback Statute (AKS) regulations, providers may soon be more engaged in these arrangements, thus providing device makers with more opportunities even if they are not included in the rewrite of the related regulatory provisions.
Despite a substantial build-up of expectations, the U.S. federal government has excluded device makers from a proposal to provide safe harbors under the anti-kickback statutes for value-based arrangements between providers and medical device makers. The news comes as a blow to device makers, who have argued for some time that value-based arrangements between industry and hospitals could save the taxpayer millions each year in Medicare spending, but the draft rule made note of concern that such arrangements might reduce competition among device makers.
