New rules loosen safe harbors but increase penalties for non-compliance

Why This Topic Matters

These updates affect how health care entities structure patient-facing benefits and compliance programs, and they expand the range of conduct that can trigger federal penalties or exclusion. Practices that work with referrals, patient support, or financial assistance policies may need to review operations against the updated federal standards.

Article Sections

1. Compliance

   An overview of the federal rule changes and the general compliance context for providers and organizations.

2. Gainsharing dropped in final rule

   A discussion of the proposed gainsharing change and why it was not carried forward in the final rule.

3. OIG expands ability to impose CMPs

   A summary of the additional conduct that can now lead to penalties, assessments, or exclusion under federal law.

4. Nominal gift amounts increase 50%

   A brief note on the updated nominal value policy and its timing.