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Recalculating: Major Stark, Anti-Kickback and CMP Final Rule Changes Are Taking Us in a New Direction


CMS and OIG recently finalized the most significant changes to the Stark Law rules, the Anti-Kickback Statute (AKS) safe harbors and the Beneficiary Inducements CMP regulations that the agencies have adopted in recent years. The final rules address value-based arrangements, introduce major changes to other key Stark Law concepts and definitions, address the donation of cybersecurity technology and services, and create flexibility to provide patient incentives in value-based arrangements and with respect to telehealth. Click here to read King & Spalding’s Client Alert highlighting the key proposals.

We are hosting a three-part webinar series to discuss these changes in greater detail, described below. We will cover new flexibilities and limitations created by these final rules, as well as how they may impact enterprise risk and future enforcement actions.

  • In Part One, we will discuss the changes to fundamental Stark Law concepts such as taking into account the volume or value of referrals or other business generated, fair market value, commercial reasonableness and the definition of indirect compensation arrangements. We also will address changes to the definition of “group practice,” writing requirements, changes to several commonly used compensation exceptions and new provisions related to cybersecurity technology and related services.
  • In Part Two, we will discuss changes related to value-based arrangements and patient incentives. This will include the new AKS safe harbors and Stark Law exception for value-based arrangements, modifications to existing AKS safe harbors and Stark Law exceptions to address value-based arrangements, new AKS safe harbors for patient incentives, revisions to the local transportation safe harbor and the warranties safe harbor and a new telehealth exception to the Beneficiary Inducements CMP.
  • In Part Three, we will explore how future enforcement theories and litigation of False Claims Act cases with Relators and the Department of Justice may evolve based primarily on changes to the Stark Law concepts of indirect compensation arrangements, taking into account the volume or value of referrals, fair market value, and commercial reasonableness.

Part One
Thursday, January 7, 2021
1:00 P.M. – 2:30 P.M. ET

Part Two
Thursday, January 14, 2021
1:00 P.M. – 2:30 P.M. ET

Part Three
Thursday, January 21, 2021
1:00 P.M. – 2:00 P.M. ET

Your registration will allow you to attend Part One, Part Two and Part Three.

CLE

King & Spalding is an accredited provider of CLE credit in California, Georgia, Illinois, New York and Texas. We can issue reciprocal credit for attorneys licensed in Connecticut, Florida, and New Jersey. We will apply for credit in Colorado, North Carolina and Virginia (subject to MCLE Board approval). For jurisdictions not listed, attendees are provided with a Universal Certificate of Attendance. New York licensed attorneys: Transitional/Appropriate for newly-admitted and experienced attorneys. Financial aid is available for qualifying lawyers. For CLE-related questions, please contact Gisel Arias, garias@kslaw.com. King & Spalding, 1180 Peachtree Street NE, Atlanta, GA 30309. CA Provider #10947.

If you have questions concerning this roundtable webinar, email lifesciences-healthcare@kslaw.com.

Event Details

Date: January 7, 2021

Time: 1:00 pm (ET)

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Please register soon. You do not have to be a client to attend, and there is no charge.