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Course Details

Course Information
  • smart_display Format

    On-Demand

  • signal_cellular_alt Difficulty Level

    Intermediate

  • work Practice Area

    Health

Date & Time
  • event Date

    Wednesday, May 31, 2023

  • schedule Time

    1:00 p.m. ET./10:00 a.m. PT

  • timer Program Length

    90 minutes

Credit Information

  • This 90-minute webinar is eligible in most states for 1.5 CLE credits.

$297.00
CLE
ALL

This CLE course will guide healthcare counsel on ensuring compliance with the Anti-Kickback Statute (AKS) and Stark law in managed care contracting and downstream provider arrangements. The panel will also provide best practices for counsel on structuring arrangements to fit within the AKS safe harbors and Stark exceptions and the applicable physician incentive plan rules.

Faculty

Alexandra B. Shalom
Attorney
Foley & Lardner LLP

Ms. Shalom focuses on counseling clients in the health care, pharmacy, and medical device industries with respect to a wide range of regulatory and compliance matters. Her experience includes advising clients on Medicare and Medicaid reimbursement; internal investigations; managed care and value based payment arrangements; self-disclosures; federal and state fraud and abuse compliance; and state licensure issues. She also assists health care clients with a broad range of transactional matters, including mergers and acquisitions and formation of friendly professional corporations.

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Torrey K. Young
Partner
Mukasey Frenchman, LLP

Ms. Young represents clients in the health care and life sciences industries. A leader in her field, she has a wealth of experience defending clients in civil and criminal government enforcement actions and cases arising out of the False Claims Act. She conducts internal investigations, provides fraud and abuse analyses, and advises her clients on Medicare/Medicaid reimbursement issues. She also implements compliance programs and assesses their effectiveness, as well as counsels clients on clinical research, research misconduct, and grant fraud. Her versatility is reflected in her representation of many different types of entities, including health systems, universities, laboratories, home health agencies, hospices, telehealth companies, pharmacy benefit managers, pharmaceutical companies, and DMEPOS companies.

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Description

As providers enter into new payment models, it is important to remember that payment models need to remain compliant with the fraud and abuse laws, including the AKS and Stark laws. The AKS and Stark laws provide several safe harbors and exceptions that shield certain alternative payment arrangements from the prohibitions outlined by the AKS and Stark. These safe harbors, such as those for eligible managed care organizations, create flexibility in managed care contracting and allow payment arrangements that could otherwise present a risk of violating the AKS.

Counsel for healthcare providers and payers must consider the AKS and Stark law requirements and the safe harbors and exceptions when contracting with managed care companies and when structuring downstream arrangements with providers. Counsel must also understand when physician incentive payments are subject to Civil Monetary Penalty (CMP) Statute liability, or conversely, are protected under the PIP rules.

Listen as our authoritative panel of health law counsel reviews the various AKS safe harbors potentially applicable to managed care arrangements and downstream provider arrangements. The presenters will address situations that trigger Stark concerns, examine the Stark exceptions for managed care arrangements and safe harbors, and discuss the CMP Statute and the PIP rules. The panel will also outline guidance for counsel to healthcare providers and payers on structuring arrangements to fit within the AKS safe harbors and Stark exceptions and the PIP rules for managed care contracting.

Outline

  1. Application of the AKS, Stark laws, and applicable safe harbors and exceptions
  2. Physician incentive plan rules
  3. Civil monetary penalty exposure

Benefits

The panel will review these and other key issues:

  • When does a risk-sharing arrangement between a managed care organization and a physician constitute a financial arrangement under Stark?
  • What rules are applicable when structuring downstream provider arrangements?
  • What is the scope of the AKS and Stark safe harbors and exceptions?
  • What are the exceptions and safe harbors in AKS and Stark that create flexibility for managed care contracts and downstream provider arrangements?