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As healthcare moves increasingly from fee for service model to one focused on outcomes and value-based payments, the traditional fraud and abuse laws, such as the Anti-Kickback Statute and the Stark Law, pose obstacles to this transition. As a result, the Department of Health and Human Services (HHS) issued a proposed rule to make changes to these statutes’ regulations as part of its Regulatory Sprint to Coordinated Care. These changes both address facilitating the transition to value-based payments and also reduce regulatory burden by proposing new or amending safe harbors and exceptions. The Stark Law proposed rule also includes new or revised definitions of key terms, such as fair market value, the “volume or value of referrals,” and commercial reasonableness.
In this podcast, Katherine Bowles, a registered nurse and healthcare attorney at Nelson Hardiman and Tony Maida a partner at McDermott Will & Emery explain these proposed changes and how to consider preparing for a final rule. This preparation could include exploring potential partnerships to create a value-based enterprise.
Even if the proposed rules are finalized, compliance with the Anti-Kickback Statute and Stark Law will remain an important part of an organization’s compliance program. The panelists discuss ways for compliance programs to address these issues, such as having a sound approval process and monitoring contract performance.
Finally, our panelists also discuss how the COVID-19 pandemic has impacted compliance with these laws, including the rise of telemedicine and the Stark waivers and Anti-Kickback policy statements.
Listen in to learn more.