The healthcare industry has been under increased SEC and DOJ scrutiny lately for potential FCPA violations. What has been described as an “industry sweep,” has focused primarily on medical device and pharmaceutical companies. These companies are particularly vulnerable to FCPA violations because the DOJ and the SEC have taken the stance that employees of state-owned and state-controlled hospitals or health care providers are considered “foreign officials” under the FCPA. For example, in 2012, enforcement actions against Smith & Nephew, Biomet, Orthofix, and Pfizer were all partly based on this enforcement theory. Enforcement actions such as these typically arise from the efforts of a company, its subsidiaries, or its distributors to influence doctors and other officials to purchase, prescribe, or obtain government regulatory approvals and registrations for a company’s products.
Continue Reading Pfizer FCPA Settlement Emphasizes the Importance of Robust Compliance Programs for the Healthcare Industry

By David R. Garcia

California’s Attorney General has recently launched a broad investigation into whether increasing consolidation among hospitals and physician groups may be resulting in supra-competitive prices for medical care, according to several media sources. This investigation reflects increased scrutiny by antitrust regulators on a nationwide basis of rapid consolidation among the healthcare industry, which in large part has recently been motivated by the federal Affordable Care Act which encourages efficiency and higher quality through coordination of care among different groups of providers.Continue Reading California AG Becomes the Latest Antitrust Enforcer to Investigate Hospital/Doctor Group Combinations

By Karie Rego

Internal investigations of billing issues usually involve audits. It is important to approach an audit carefully or the auditors can create more risk for the organization by misinterpreting the standards.

Thus, it is very important to know what you are auditing before you audit. It seems simple but this is often overlooked. Fully researching all the issues involved with a critical eye is key. There may be subtle changes in coding, billing or coverage policy or guidance that caused confusion. There actually may be little reimbursement impact from the error.Continue Reading Managing an Internal Audit

By Karie Rego

A compliance program sends an important message to employees that mistakes will occur and that employees have an affirmative duty to report those mistakes so that they may be corrected. A compliance plan discourages employees from turning to the government or a payer to resolve issues or, what is worse, to one of the many attorneys advertising on the internet that promise whistleblowers large recoveries.Continue Reading How Compliance Programs Can Really Reduce Risk