Haynes Boone attorneys Jennifer Kreick and Thomas Tanabe explore key fraud and abuse concerns for healthcare tech companies in DBA Headnotes, highlighting recent DOJ enforcement actions and best practices for structuring compliant arrangements. Read an excerpt below:
Healthcare providers, payors, and healthcare technology companies are seeking innovative alignment strategies and partnerships to reduce costs and provide high quality care, but the healthcare industry is heavily regulated and participants in these arrangements should be mindful of healthcare fraud and abuse laws when structuring and implementing such arrangements. Navigating this complex healthcare regulatory landscape involves a thorough understanding of state and federal laws and regulations, such as anti-kickback statutes, fee splitting laws, false claims act statutes, self-referral laws, and beneficiary inducement laws.
Failure to comply with healthcare fraud and abuse regulations can lead to significant consequences, as demonstrated by various enforcement actions by the U.S. Department of Justice (DOJ) against electronic health records (EHR) software companies. For example, a health information technology developer paid $145 million to resolve criminal and civil investigations related to its arrangement with a sponsoring pharmaceutical manufacturer. The arrangement involved creating and embedding an alert in the EHR software that suggested certain treatments to clinicians, including opioids manufactured by the sponsor. The DOJ alleged that the purpose of the alert was to increase sales of the sponsor’s products, based on certain factors including that (i) the decision-support tool suggested treatments that were not consistent with evidence-based medical guidelines from the U.S. Department of Health and Human Services and other agencies, (ii) the tool was sold to the sponsor based on anticipated return on investment (ROI) calculations, and (iii) the payment was financed by and designed with input from the sponsor’s marketing department.
Read the full article in the April edition of Headnotes, on page six.
