On September 27, 2018, the Department of Justice (“DOJ”) for the first time announced its own “road map” guiding voluntary self-disclosures and cooperation with government investigations of fraud and abuse in the healthcare industry. By encouraging self-disclosure, the government is incentivizing healthcare entities to come forward early with reports of violations in the hope of negotiating reasonable settlements, avoiding exclusion from Federal healthcare programs, and reducing the severe civil and criminal penalties that would otherwise be imposed for such violations.
Healthcare has now surpassed nuclear power and financial services as the most highly regulated industry in the U.S. - and for good reason. The health, safety, and privacy of individual patients and the public at large is at stake.
For better or for worse, there exists a complex web of local, state, and federal laws and regulations that govern the businesses of healthcare providers and healthcare companies - from patient safety and privacy protections, to corporate transactions and contractual relationships. Navigating this complicated landscape requires a deep understanding of the risks and opportunities inherent in the healthcare industry—namely, it requires an experienced healthcare attorney.
On May 31, 2017, the U.S. Department of Justice announced that electronic health records (EHR) vendor eClinicalWorks (ECW), along with certain individual officers and employees, have agreed to pay a total of $155 million to settle a lawsuit under the False Claims Act (FCA). In its Complaint-in- Intervention, the government alleged ECW falsified compliance with certification requirements for EHR under the Meaningful Use program. The programming shortcuts ECW allegedly took in developing its software, along with inadequate post-market support and patches, could expose providers to increased risk of errors and jeopardize patient care. If you or your practice uses the eClinicalWorks software, you should be aware of ECW’s obligations and your rights under the Corporate Integrity Agreement (CIA).
Five new safe harbors have been added to the Anti-Kickback Statute (AKS) in the final rule, issued on December 17, 2016 by the Health and Human Services Office of the Inspector General (OIG). In addition, existing safe harbors have been revised to grant further protections to providers from criminal prosecution and civil damages. What these changes mean for providers: The trend in healthcare is to move from volume-based care to value-based care.