In this episode, hosts Payal Nanavati and Joe Records talk to Troy Barsky and Roma Sharma about their reflections on the first year of implementation of new regulations implementing the major fraud and abuse statutes — the Stark Law and Anti-Kickback Statute (AKS) — including discussing challenges, opportunities, and outstanding questions about the new exceptions and safe harbors for value-based care.

For more information please see:

-"CMS Issues Sweeping Reform to Modernize the Stark Law: Part I," Health Care Alert (November 30, 2020). Contacts: Troy A. Barsky, John T. Brennan Jr., Lidia Niecko-Najjum, Roma Sharma. (https://www.crowell.com/NewsEvents/AlertsNewsletters/all/CMS-Issues-Sweeping-Reform-to-Modernize-the-Stark-Law-Part-I)

-"OIG Issues Final Rule to Update AKS Safe Harbors: Part II," Administrative Law Alert (February 25, 2021). Contacts: Troy A. Barsky, Jodi G. Daniel, Michael Shaheen, Lidia Niecko-Najjum, Joe Records, Matthew Vicinanzo. (https://www.crowell.com/NewsEvents/AlertsNewsletters/all/OIG-Issues-Final-Rule-to-Update-AKS-Safe-Harbors-Part-II)

Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.

Reflecting on the First Year of the 2020 Stark & AKS Regulations

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This podcast episode features the following speakers:

Linda Malek is a partner in Crowell & Moring's New York office, and is a member of our Health Care, Privacy & Cybersecurity, and Life Sciences practices. She advises a broad array of health care and life sciences clients on compliance with federal, state, and international law governing clinical research, data privacy, cybersecurity, and fraud and abuse. Linda also counsels digital health and biotech companies developing AI tools. She navigates the complex and evolving federal and state regulatory landscape, balancing the priorities of oversight authorities with issues related to data privacy and security as well as business goals.

Matthew F. Ferraro is a partner in Crowell & Moring's Washington, D.C. office and is a member of our Privacy and Cybersecurity Group, where he advises leading organizations on high-impact matters involving artificial intelligence (AI), cybersecurity, and emerging technologies. He previously served as Senior Counselor for Cybersecurity and Emerging Technology to the Secretary of Homeland Security, helping shape national AI and cyber policy and helping to establish and run the Artificial Intelligence Safety and Security Board.

Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.

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Crowell & Moring LLP is an international law firm with approximately 550 lawyers representing clients in high-stakes litigation and arbitration, regulatory, and transactional matters. The firm is internationally recognized for its representation of Fortune 500 and emerging companies as well as its ongoing commitment to pro bono service, diversity, value-based billing, and legal project management.

Reflecting on the First Year of the 2020 Stark & AKS Regulations

Crowell & Moring LLP

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