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Physician Office Laboratories: Stark, AKS, Fee-Splitting Prohibitions, Medical Necessity, and Other Legal Issues

Recording of a 90-minute CLE video webinar with Q&A

This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

Conducted on Wednesday, April 10, 2024

Recorded event now available

or call 1-800-926-7926

This CLE webinar will guide healthcare counsel on legal issues with physician office laboratories (POLs). The panel will address Stark, AKS, fee-splitting prohibitions, medical necessity, and other legal issues. The panel will offer best practices for mitigating risks and ensuring compliance with the regulatory requirements.

Description

Many physician practices or physician groups maintain POLs, which perform common lab tests. Like most aspects of the healthcare industry, POLs are highly regulated and face numerous federal and state requirements including licensing and reimbursement, as well as fraud and abuse laws.

The Stark law prohibits referrals by physicians to an entity in which they have a financial interest absent an exception. There are several Stark exceptions that may apply, including the In-Office Ancillary Services Exception, which allows a physician or group practice to refer and provide clinical laboratory services within the practice. Beyond Stark, POL arrangements must be analyzed under the Anti-Kickback Statute and the Eliminating Kickbacks in Recovery Act.

In addition to being concerned about Stark and AKS, physicians and physician groups must be careful to not run afoul of other regulatory issues, including fee-splitting prohibitions and medical necessity requirements.

Listen as our authoritative panel of healthcare attorneys examines POLs and the legal issues they face. The panel will address Stark, AKS, fee-splitting prohibitions, medical necessity, and other legal issues. The panel will offer best practices for mitigating risks and ensuring compliance with the regulatory requirements.

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Outline

  1. POLs
  2. Legal/regulatory challenges
    1. Stark and exceptions
    2. AKS and safe harbors
    3. Fee-splitting
    4. Medical necessity
    5. EKRA
    6. PAMA
    7. Others
  3. Best practices
    1. Risk mitigation
    2. Regulatory compliance

Benefits

The panel will review these and other key issues:

  • What problematic POL models potentially trigger Stark and AKS violations?
  • What Stark exceptions can physician practices apply in order to provide laboratory services?
  • What steps can healthcare counsel and their clients take to mitigate the risks associated with POLs?

Faculty

Countryman, Clay
Clay J. Countryman

Partner
Breazeale Sachse & Wilson

Mr. Countryman represents clients in all areas of the healthcare industry, with a focus on healthcare corporate...  |  Read More

Dresevic, Adrienne
Adrienne Dresevic

Founding Partner
The Health Law Partners

Ms. Dresevic practices in all areas of healthcare law and devotes a substantial portion of her practice to providing...  |  Read More

Dunham, Charles
Charles C. Dunham, IV

Shareholder
Greenberg Traurig

Mr. Dunham is a corporate healthcare attorney providing counsel in business, regulatory, compliance, reimbursement, and...  |  Read More

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