Under changes announced on 9 October by the US Health and Human Services Office of Inspector General (HHS OIG) and the Centers for Medicare and Medicaid Services (CMS), new so-called "safe harbors" to the anti-kickback statute and planned changes to the physician self-referral statute (Stark Law) would shelter health-care providers – including device-makers – who enter into value-based care arrangements for services paid for by Medicare. Such changes have been promoted by medtech firms.
Three new so-called "safe harbors" proposed by the US Department of Health and Human Services Office of Inspector General (HHS 0IG) on 9 October would allow health-care providers to enter into more value-based care arrangements without triggering anti-kickback statute (AKS) violations.
The same day, the Centers for Medicare and Medicaid Services (CMS) proposed changes to physician self-referral regulations under the Stark Law that would “unleash innovation by prompting physicians and...