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Current Legal Challenges
for Laboratory Professionals

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In recent years, the Centers for Medicare & Medicaid Services (CMS) was concerned about fraud and abuse. It wanted to rein in revenue-driven arrangements that facilitate over utilization of diagnostic services. In response to these regulations urology and gastroenterologists are now establishing in-house anatomic laboratories. They often contract with local pathology practices for assistance in setting up these labs, as well as providing ongoing technical and professional services.

Both business models are designed to provide referring physician practices a share of revenues from anatomical diagnostic service orders and are permitted under exceptions to the Stark self-referral law, noted Jane Pine Wood, attorney in the National Health Care Practice Group of the Cleveland-based law firm of McDonald Hopkins. She was addressing laboratory professionals participating in an audio conference, sponsored by THE DARK REPORT, on current legal issues confronting lab professionals. “I wish I could give you a lot of reasons why these arrangements are illegal,” she said, “Although there have been some changes in Medicare rules that have limited the availability of these options, unfortunately they still are available to referring physician groups if properly structured.”

Jane Pine Wood, along with Attorney Richard Cooper, who heads up the National Health Care Practice Group, explained how these physician-owned laboratories must be structured to comply with CMS regulations. They pointed out contractual pitfalls for lab professionals, and offered advice on the best way to handle these arrangements.

The Dark Report is happy to offer our readers a chance to download our recently published FREE White Paper “Current Legal Challenges for Laboratory Professionals” at absolutely no charge. This free download will provide readers with a detailed overview of current legal challenges that your lab may encounter in the near future.

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Here is just some of what you will take away…

  1. Types of In-Sourcing Structures Used by Physicians
  2. Exclusive or Limited Payer Panels
  3. Outsourcing Pathology and Laboratory Services
  4. For more about HIPAA Breach Notifications, please CLICK HERE

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Table of Contents

IntroductionPage 3

Chapter 1. In-sourcing Laboratory Services – Page 7
Chapter 2.
Exclusive or Limited Payer Panels – Page 20
Chapter 3. Outsourcing Pathology and Laboratory Services – Page 24
Chapter 4. EMR Donations – Page 27
Chapter 5.
HIPAA Breach Notifications – Page 32
Chapter 6. Regulation of Laboratory Developed Tests – Page 37

Appendices

A-1 About Jane Pine Wood – Page 41
A-2 About Richard Cooper – Page 43

A-3 About Elizabeth Sullivan – Page 42
A-4 About DARK DAILY – Page 44
A-5 About The Dark Intelligence Group, Inc., and The Dark Report – Page 45
A-6 About the Executive War College on Laboratory and Pathology Management – Page 46
A-7 About The Editor – Page  48

Terms of Use – Page 52

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In recent years, the Centers for Medicare & Medicaid Services
(CMS) was concerned about fraud and abuse. It wanted to rein
in revenue-driven arrangements that facilitate over utilization
of diagnostic services. In response to these regulations urology
and gastroenterologists are now establishing in-house anatomic
laboratories. They often contract with local pathology practices for
assistance in setting up these labs, as well as providing ongoing
technical and professional services.Both business models are designed to provide referring physician
practices a share of revenues from anatomical diagnostic service
orders and are permitted under exceptions to the Stark self-referral
law, noted Jane Pine Wood, attorney in the National Health Care
Practice Group of the Cleveland-based law firm of McDonald
Hopkins. She was addressing laboratory professionals participating in
an audio conference, sponsored by THE DARK REPORT, on current legal issues confronting lab professionals. “I wish I could give you a
lot of reasons why these arrangements are illegal,” she said, “Although
there have been some changes in Medicare rules that have limited the
availability of these options, unfortunately they still are available to
referring physician groups if properly structured.”

Wood, along with Attorney Richard Cooper, who heads up the
National Health Care Practice Group, explained how these physician-owned
laboratories must be structured to comply with CMS
regulations. They pointed out contractual pitfalls for lab professionals,
and offered advice on the best way to handle these arrangements.

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