Substantial, if not fundamental, changes to health-care fraud and abuse laws appear on the horizon in light of the U.S. Department of Human Services “Regulatory Sprint to Coordinated Care.” If proposed changes submitted by key stakeholders come to fruition, a sizable swath of health law regulatory practice may be replaced, if not largely disappear. That is, the need to fit a wide range of innovative provider arrangements into complex and confusing Stark exceptions and Anti‑Kickback Safe Harbors may become largely obsolete,
Earlier this year, two federal agencies, the Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector General (OIG) within the Department of Health and Human Services (HHS), issued formal requests for information to seek input to further the “Regulatory Spring to Coordinated Care” launched by HHS. Published responses from a wide range of affected constituents (e.g., numerous hospital associations, physician societies and associations, and trade groups) reveal numerous common threads that portend potentially fundamental change to fraud and abuse laws.
The Problem
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