Maintaining Stark Law compliance is critical, as violations can result in significant financial penalties, exclusion from federal healthcare programs and exposure under the False Claims Act. In a recent blog post, the Health Law Offices of Anthony Vitale outlined practical steps physicians and healthcare organizations can take to reduce risk and respond effectively to Stark Law allegations.
- Review Financial Relationships
Physicians should routinely review all ownership, investment and compensation arrangements to ensure they are not tied—directly or indirectly—to the volume or value of referrals. - Build a Strong Compliance Program
A robust compliance program should include written policies, a designated compliance officer, regular staff training, due diligence on new arrangements and ongoing risk assessments. - Conduct Proactive Internal Audits
Organizations are encouraged to audit designated health services billing, coding, compensation models, referral patterns and documentation of medical necessity to identify potential issues early. - Rely on Stark Law Exceptions
Statutory exceptions can serve as a primary defense. Common examples include in-office ancillary services, fair market value arrangements and employment or personal services exceptions. - Maintain Thorough Documentation
Signed contracts, fair market value appraisals, attestations and related records are essential to demonstrate compliance and legitimate intent. - Tailor the Defense to the Facts
If allegations arise, defenses should be tailored to the specific circumstances, including analyzing referral data and timelines to show referrals were not driven by financial relationships. - Correct and Disclose Issues Promptly
When problems are identified, physicians should act quickly to correct them, using retroactive fixes allowed under the Temporary Noncompliance Rule and considering voluntary disclosure through CMS’ Self-Referral Disclosure Protocol.
Resource: How physicians can reduce risk and respond to Stark law allegations