FCA UPDATE
FCA UPDATE
Exploring Recent Developments in False Claims Act Litigation, Enforcement and Compliance
FCA UPDATE
Exploring Recent Developments in False Claims Act Litigation, Enforcement and Compliance

Health Care Enforcement Quarterly Roundup – Q1 2019

By , , , , , , , , , , , , and on April 26, 2019
Posted In Additional Compliance Resources, Other Notable Enforcement Actions, Pharmaceuticals

In this first installment of the Health Care Enforcement Quarterly Roundup for 2019, we continue to monitor trends we identified in 2018 and introduce new enforcement efforts that are expected to persist in the coming year. In this Roundup, we focus on increased enforcement activity against electronic health record (EHR) companies, enforcement against individuals (with an acute focus on the telemedicine industry), lower court interpretations of the landmark Escobar ruling, developments related to the Granston Memo and dismissal of False Claims Act (FCA) cases, potential changes to the FCA statute of limitations, and the current state of affairs in opioid litigations around the country.

Click here to read the full issue of the Health Care Enforcement Quarterly Roundup.

Click here to download a PDF of the issue.  

Tags: EHR, electronic health records, Escobar decision, False Claims Act, FCA, FCA statute of limitations, Granston Memo, US opioid crisis
McDermott Will & Emery





Amandeep S. Sidhu
Amandeep (Aman) S. Sidhu focuses his practice on complex commercial disputes with an emphasis on regulated industries, including health care-related investigations and litigation. He represents hospitals and health care companies in investigations and defense of qui tam whistleblower litigation involving federal False Claims Act (FCA), Stark Laws and Anti-Kickback Statute in federal district courts throughout the United States. Aman regularly supports settlement negotiations with the US Department of Justice for clients in multiple jurisdictions, including negotiation of corporate integrity agreements with the US Department of Health and Human Services Office of Inspector General. Aman also represents health care and life sciences companies in the navigation of state and federal investigations, including responding to congressional inquiries. Aman serves on the Firm's Diversity/Inclusion Committee, Pro Bono and Community Service Committee and Associate Development Committee. Read Amandeep Sidhu's full bio.

Drew Elizabeth McCormick
Drew Elizabeth McCormick maintains a general health industry and regulatory practice. Drew advises health care clients on a wide variety of health care regulatory issues, including Medicare and Medicaid regulations, the Federal Anti-Kickback Statute, Ethics in Patient Referral Law, False Claims Act and Health Insurance Portability and Accountability Act (HIPAA), as well as state fraud and abuse laws, privacy laws, licensure regulation, research regulation, and health care compliance matters. Drew also has experience counseling clients who are undergoing government audits and investigations. Read Drew Elizabeth McCormicks' full bio.

Irene A. Firippis
Irene A. Firippis focuses her practice on white-collar and securities defense matters, government investigations and anticorruption compliance. She has represented clients in investigations and enforcement matters involving the United States Securities and Exchange Commission (SEC), United States Department of Justice (DOJ), Financial Industry Regulatory Authority (FINRA) and state securities agencies. Read Irene A. Firippis' full bio.  

James A. Cannatti III
James A. Cannatti III* practices at the intersection of today's most pertinent health care issues, including digital health, health IT policy, and fraud and abuse, including Anti-Kickback Statute/Stark Law matters. With more than 10 years of experience in the US Department of Health & Human Services’ (HHS) Office of Inspector General (OIG), most recently as Senior Counselor for Health Information Technology, James is well-attuned to the regulatory issues impacting the rapidly evolving digital health landscape. Read James A. Cannatti III's full bio.  *Not admitted to practice in the District of Columbia; admitted only in Ohio. Supervised by principals of the Firm who are members of the District of Columbia Bar.

Jennifer B. Routh
Jennifer Routh focuses her practice on complex civil litigation. She has achieved notable successes for her clients including significant summary dispositions and through trial to final judgment. She recently tried three cases in the span of twelve months, all of which resulted in victories for her clients. Read Jennifer Routh's full bio. 

Laura McLane
Laura McLane serves as head of McDermott's Boston Litigation Practice Group. Laura represents national and international clients in health care, securities and other government enforcement matters, both civil and criminal. She also represents clients in professional and products liability cases and in complex commercial disputes. A significant part of Laura's practice is devoted to representing health care and other companies, as well as individuals, in government investigations and qui tam litigation based on the False Claims Act (FCA) and related statutes, including the Anti-Kickback Statute and the Stark Law. Read Laura McLane's full bio.

Matthew M. Girgenti
Matthew M. Girgenti focuses his practice on complex civil litigation and government investigations. He has experience in a broad range of litigation matters, including Fifth Amendment takings claims against the federal government Contract and tort disputes between commercial entities Americans with Disabilities Act claims defense False Claims Act litigation Administrative, state and federal motion and appellate practice Read Matthew Girgenti's full bio.

Paul M. Thompson
Paul M. Thompson focuses his practice on white-collar criminal defense, congressional investigations and appellate matters. He is a current member of the Firm-wide Management Committee and a former member of the Firm’s Executive Committee. From 2011 to 2015, Paul served as partner-in-charge of the Washington, DC office. Read Paul M. Thompson's full bio.

Sean Hennessy
Sean Hennessy focuses his practice on white-collar and securities defense matters, including the defense of criminal and civil investigations brought by the Department of Justice (DOJ), the Securities and Exchange Commission (SEC), and State Attorneys General. Sean defends individuals and public and private companies against governmental investigations involving allegations of antitrust violations, securities and investment adviser fraud, insider trading, financial market manipulation, tax crimes and violations of the False Claim Act. Read Sean Hennessy's full bio.

Sophia A. Luby
Sophia A. Luby focuses her practice on complex civil litigation. Read Sophia Luby's full bio.

Theodore Alexander
Theodore (Ted) Alexander focuses his practice on general litigation matters. He has experience in Americans with Disabilities Act (ADA) and white-collar cases. Ted also advises clients on federal health policy. Read Theodore Alexander's full bio. 

Tony Maida
Tony Maida counsels health care and life sciences clients on government investigations, regulatory compliance and compliance program development. Having served as a government official, Tony has extensive experience in health care fraud and abuse and compliance issues, including the federal and state Anti-Kickback and Stark Laws and Medicare and Medicaid coverage and payment rules. He represents clients in False Claims Act (FCA) qui tam matters, government audits, civil monetary penalty and exclusion investigations, and Centers for Medicare and Medicaid Services (CMS) suspension, and revocation actions, negotiating and implementing corporate integrity agreements, and making government self-disclosures. Read Tony Maida's full bio.

T. Reed Stephens
T. Reed Stephens represents clients in the life sciences industry, including pharmaceutical and biotech manufacturers, wholesalers and individuals, as well as health care systems and non-health care related companies in other global industries such as the defense and financial services/banking sectors. He also represents clients in matters involving state and federal government law enforcement, voluntary disclosures and congressional investigations. Read T. Reed Stephens' full bio.

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