Maintaining Stark law compliance is critical as violations could trigger major fines, exclusion from federal healthcare programs, and False Claims Act exposure, according to a November blog post from Health Law Offices of Anthony Vitale.
Here are seven tips the law firm lays out to defend against Stark law allegations:
1. Review all ownership, investment and compensation relationships for prohibited ties to referral volume or value, including direct and indirect arrangements.
2. According to the report, it is important to build a robust compliance program with written policies, a compliance officer, routine training, due diligence on new arrangements and recurring risk assessments.
3. Conduct proactive internal audits of DHS billing, coding, compensation models, referral patterns and documentation of medical necessity to identify risks early.
4. Rely on statutory exceptions as a primary defense, showing that each arrangement fits an exception such as in-office ancillary services, fair market value or employment/personal services.
5. Compile airtight documentation, including signed contracts, appraisals, attestations and related records, to show exception compliance and legitimate intent.
6. If allegations arise “tailor your defense to the facts” by challenging causation and timing, according to the report, including using referral analytics and testimony to show referrals weren’t driven by financial ties or occurred outside contract terms.
7. Correct and disclose problems quickly when they’re found, using retroactive fixes allowed under the Temporary Noncompliance Rule and considering voluntary disclosure through the CMS Self-Referral Disclosure Protocol.
