Government Investigations

The digital health sector has seen tremendous growth and innovation over the past few years. This momentum introduces new complexities within the legal and regulatory landscape that is trying to
Continue Reading Top 5 Legal Issues in Digital Health to Watch for in 2022

U.S. Attorney’s Offices (“USAOs”) across the country are issuing warning letters to physicians and other prescribers (collectively, “Prescribers”) cautioning them about their opioid prescribing practices (the “Warning Letters”). In just the last week, the USAO for the Eastern District of Wisconsin sent warning letters to over 180 prescribers identified by Drug Enforcement Administration (“DEA”) data as prescribing opioids at relatively high levels. The Food and Drug Administration and the Federal Trade Commission have also been issuing their own warning letters to opioid marketers and distributors over the past several months, evidencing a concerted effort to combat the opioid epidemic on a number of fronts through various federal enforcement and regulatory efforts.
Continue Reading Compliance Risk Alert: Opioid Warning Letters issued by the U.S. Department of Justice Target Prescribers

Healthcare joint ventures are nothing new.  Since the mid-2000’s, physician-hospital ventures have been resurgent, notwithstanding the Office of Inspector General’s skepticism regarding the risk of fraud and abuse when investors are sources of referrals and the filing of numerous whistleblower actions under the False Claims Act (e.g., the nine cases filed against Health Management Associates, Inc., which have been transferred to the District of District of Columbia for consolidated and coordinated proceedings).  More recently, a new kind of joint venture has come on the scene: partnerships between insurance companies and healthcare systems.  Partly in response to healthcare reform, these ventures seek to “align incentives” between these traditional adversaries.  Since 2010, a number of health systems have either acquired or decided to form their own insurance companies.  Partnering with insurance companies, however, may be the more practical approach, since health systems can take advantage of insurance companies’ information technology and expertise, while avoiding the cost, time and regulatory approvals required to build an insurance plan from scratch.  In 2013, Florida Hospital was among the first to go down this path, announcing a joint venture with Health First Health Plans.  More recently, in April 2014 Independence Blue Cross and DaVita HealthCare Partners announced the creation of Tandigm Health, touted as a “unique joint venture” using a coordinated care model to deliver higher quality care at lower cost.
Continue Reading Potential Risks of Healthcare Joint Ventures Between Insurance Companies and Hospitals

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

By Karie Rego
 

Private or government investigations usually start with a request for records. In more egregious situations, the FBI or other state or federal agency could show up and take records pursuant to a search warrant.
 

If state or federal agents arrive with a “search warrant” it will allow the agents the right to enter and seize documents identified in the warrant. It is crucial to contact your legal counsel immediately and have them come over. You can ask the agents to wait until your legal counsel arrives.
 

Continue Reading How to Be Prepared for a Search Warrant