Insights

Washington – November 9, 2023: Michael Shaheen, former trial attorney in the U.S. Department of Justice Commercial Litigation Branch’s Fraud Section, has rejoined Crowell & Moring. Shaheen returns as a partner in the firm’s Health Care Group where he will focus on False Claims Act cases and healthcare fraud and abuse. He will also work closely with members of the firm’s White Collar and Regulatory Enforcement Group.

The Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) published the General Compliance Program Guidance (GCPG) on November 6, 2023. The GCPG provides updated descriptions of the seven elements of an effective compliance program that health care entities have long relied upon. The new guidance also includes recommendations to conduct annual internal risk assessments, to consider quality of care as a component of the compliance program, and to emphasize the importance of a board’s and executive leadership’s oversight of compliance.

In a prime example of the significant interplay between the Anti-Kickback Statute (“AKS”) and the False Claims Act (“FCA”), a federal jury has returned a verdict of more than $43 million in damages against Cameron-Ehlen Group, Inc., which does business as “Precision Lens,” and its owner.  The verdict in this long-running and closely watched fraud case out of the U.S. District Court for the District of Minnesota comes after a six-week trial, with the jury ultimately finding that the defendants paid kickbacks to ophthalmic surgeons to induce their use of defendants’ products in cataract surgeries reimbursed by Medicare, resulting in the submission of 64,575 false claims between 2006 and 2015.  While the jury calculated damages at the massive sum of $43 million, that number may grow exponentially after the court applies the FCA’s treble-damages calculation (increasing the liability to $129 million) and statutory penalties of between $5,500 and $11,000 for each of the 64,575 claims (resulting in additional penalties of $355 million to $710 million).  All told, the total FCA liability is expected to range between $485 million and $839 million.

Section 230 of the Communications Decency Act (CDA, codified at 47 U.S.C. § 230) and Section 512 of the Digital Millennium Copyright Act (DMCA, codified at 17 U.S.C. § 512) are separate legal structures that work together to uphold certain protections for online service providers against claims arising out user-generated content.

A panel of attorneys representing government agencies, relators, and defendants discuss developing precedent surrounding the element of scienter in False Claims Act litigation. Topics of discussion will include recent circuit court precedents such as the AseraCare, Supervalu, and Allergan Sales decisions, and the impact these decisions have on how civil fraud claims are alleged, investigated, and defended.

Join us for this year’s Health Care Ounce of Prevention Seminar (HOOPS), a webinar series where our experienced practitioners will provide insight into a number of exciting topics. This year’s seminar will focus on topics such as Remote Health Care and Telemedicine, Mental Health Parity, Health Care Litigation, and Health Care Trends for 2022. 

Please Join Crowell & Moring for a Webinar on COVID-19 and the False Claims Act: What to Expect and How to Defend Investigations, Audits, and Qui Tam Actions in a Post-Pandemic World.

In this episode, hosts Michael Shaheen and Jason Crawford discuss the Department of Justice’s recently announced False Claims Act (FCA) recovery statistics for fiscal year 2022. The podcast breaks down last year’s FCA activity—which included a record number of new matters—and considers what the trends could portend for fraud enforcement in the year to come. "Let's Talk FCA" is Crowell & Moring’s podcast covering the latest developments with the False Claims Act.

In this episode, hosts Michael Shaheen and Tully McLaughlin cover part one of a discussion about the Department of Justice’s authority to dismiss qui tam complaints brought by relators.  The podcast: (1) outlines the government’s authority under the statute and the caselaw; (2) discusses how the Department of Justice wields that authority; and (3) describes the false controversy between the Department and Senator Grassley on the scope of that authority. "Let's Talk FCA" is Crowell & Moring’s podcast covering the latest developments with the False Claims Act.

In this episode, hosts Payal Nanavati and Joe Records talk to partner Michael Shaheen, who recently served as a Trial Attorney with the Fraud Section of the DOJ. Michael sheds some light on what potential FCA targets can do to understand and rebut DOJ’s use of data analytics to pursue FCA investigations. Payers, Providers, and Patients – Oh My! is Crowell & Moring’s biweekly health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.