Medical device makers get more flexibility with value-based care in Stark, anti-kickback final rules

Healthcare DIVE November 25, 2020
Ricky Zipp

Dive Brief:

• As part of the Trump administration’s overhaul of the Stark Law and Anti-Kickback Statute — rules meant to prevent fraud and abuse among physicians and other healthcare providers — medical device manufacturers can take part in certain value-based arrangements with providers with less legal risk than before.
• In particular, device or supply manufacturers are eligible to participate in the arrangements under two safe harbor pathways but only for what HHS calls digital health technologies, among other requirements, according to a final rule out Friday from the HHS Office of Inspector General.
• Industry lobby AdvaMed has not yet commented on the final rules, but has backed revamping the decades-old laws to allow more participation in flexible payment models.
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