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

Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
Intermediate
- work Practice Area
Health
- event Date
Wednesday, April 10, 2024
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
-
This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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.
Faculty

Mr. Dunham is a corporate healthcare attorney providing counsel in business, regulatory, compliance, reimbursement, and white-collar defense matters. He represents an array of healthcare providers, suppliers, and other health-related entities with a distinct focus on the laboratory and telehealth industries. Mr. Dunham also advises private equity firms and venture capital groups on their investments in the healthcare industry, including due diligence reviews of target acquisitions, negotiated contracts, and health regulatory compliance by such investments post-closing.

Ms. Dresevic practices in all areas of healthcare law and devotes a substantial portion of her practice to providing clients with counsel and analysis regarding Stark and fraud and abuse. She also regularly assists clients with compliance issues, reimbursement issues, and payor audits. She has written extensively on subjects across the spectrum of health care law, including, co-authoring a monthly column in the Association for Medical Imaging Management's (AHRA) publication, Link, regarding up-to-date legal issues relevant to imaging providers and suppliers.

Mr. Countryman represents clients in all areas of the healthcare industry, with a focus on healthcare corporate transactions, fraud and abuse compliance, development of healthcare provider networks and alternative healthcare payment approaches. He has primarily served as legal counsel to several different types of healthcare providers and provider organizations, ranging from national and regional hospital systems, physician organizations, specialty physician groups, clinically integrated networks, physician-owned hospitals, diagnostic imaging facilities, ambulatory surgical centers, pharmacies, health care management companies, and health care trade associations. Mr. Countryman has been an active member of the ABA for over 20 years, including several leadership positions in the Health Law Section, the ABA Veterans Legal Services Commission, Medical-Legal Partnerships and the ABA Young Lawyers Division.
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.
Outline
- POLs
- Legal/regulatory challenges
- Stark and exceptions
- AKS and safe harbors
- Fee-splitting
- Medical necessity
- EKRA
- PAMA
- Others
- Best practices
- Risk mitigation
- 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?
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