Wade’s Health Law Highlights for August 11, 2026
Read the issue: Wade’s Health Law Highlights for August 11, 2026False Claims Act settlements and judgments announced in the first half of 2026 total more than $1.8 billion The total includes two nine-figure Medicare Advantage resolutions and a customs duties settlement exceeding half a billion dollars, the largest of its kind. As…
Recent issues
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Revisions to Stark Law Rules Covering Physician Profit Sharing and Bonuses
CMS also clarified that if a group has five or fewer physicians, overall profits means the profits from DHS from the entire group; but if a…
