In this second installment of the Healthcare Enforcement Quarterly Roundup for 2019, we cover several topics that have persisted over the past few years and identify new issues that will shape the scope of enforcement efforts for the remainder of this year and beyond. In this Quarterly Roundup, we discuss DOJ’s guidance on compliance programs and cooperation credit, new US Department of Health and Human Services (HHS) rules and enforcement activity on provider religious/conscience opt-out rights, enforcement activity against home health agencies and telemedicine providers, continued federal action to combat the opioid crisis, and resolution of ambiguity in the False Claims Act (FCA) statute of limitations.

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

Click here to download a PDF of the issue.  

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Photo of David Quinn Gacioch David Quinn Gacioch

 

Dave Gacioch counsels clients across the health care industry and beyond on compliance and risk management issues. He also assists clients in conducting internal investigations and represents them in matters involving government investigations, enforcement actions and civil litigation. Read David Gacioch’s full bio.

Photo of Tony Maida 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…

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.

Photo of Laura McLane 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…

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.

Photo of Amandeep S. Sidhu 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…

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.

Photo of Paul M. Thompson 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…

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.

Photo of Edward G. Zacharias Edward G. Zacharias

 

Edward (Ed) G. Zacharias focuses his practice on complex transactions and regulatory compliance matters. He represents hospitals and health systems, academic medical centers, physician group practices, post-acute care providers, health information technology vendors, biotech companies, insurers, pharmaceutical companies and a variety of…

 

Edward (Ed) G. Zacharias focuses his practice on complex transactions and regulatory compliance matters. He represents hospitals and health systems, academic medical centers, physician group practices, post-acute care providers, health information technology vendors, biotech companies, insurers, pharmaceutical companies and a variety of other health care entities. Read Edward Zacharias’ full bio.

Photo of Theodore Alexander 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. 

Photo of Jennifer Aronoff Jennifer Aronoff

Jennifer (Jen) Aronoff focuses her practice on white-collar and securities defense matters. Previously, Jen served as law clerk to the Honorable Thomas M. Hardiman of the US Court of Appeals for the Third Circuit. While in law school, she was an articles editor…

Jennifer (Jen) Aronoff focuses her practice on white-collar and securities defense matters. Previously, Jen served as law clerk to the Honorable Thomas M. Hardiman of the US Court of Appeals for the Third Circuit. While in law school, she was an articles editor for the Northwestern University Law Review. Jen is also a former reporter for the Charlotte Observer. Read Jen Aronoff’s full bio.

Photo of Lauren Evans Lauren Evans

Lauren H. Evans advises clients on litigation matters, with a particular focus on commercial disputes.  She has experience in a broad range of litigation matters in both state and federal courts. Read Lauren’s full biography. 

Photo of Irene A. Firippis 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…

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.  

Photo of Marshall E. Jackson, Jr. Marshall E. Jackson, Jr.

Marshall E. Jackson, Jr. focuses his practice on transactional and regulatory counseling for clients in the health care industry, as well as advises clients on the legal, regulatory and compliance aspects of digital health. Marshall provides counseling and advice to hospitals and health…

Marshall E. Jackson, Jr. focuses his practice on transactional and regulatory counseling for clients in the health care industry, as well as advises clients on the legal, regulatory and compliance aspects of digital health. Marshall provides counseling and advice to hospitals and health systems, private equity firms and their portfolio companies, post/sub-acute providers, physician practices, and other public and private health care companies in a variety of complex transactions and health regulatory compliance matters. Read Marshall Jackson’s full bio.

Photo of Sophia A. Luby Sophia A. Luby

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

Photo of Drew Elizabeth McCormick 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…

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.

Photo of Katrina Rogachevsky Katrina Rogachevsky

Katrina Rogachevsky represents clients in litigation before state and federal courts across the country. Read Katrina’s full bio. 

Photo of Jennifer B. Routh 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…

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.