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Fraud, Abuse, and the Latest Stark Law Developments with the American Health Law Association

February 15, 2022

Stark Law Changes 2021  

In November 2020, sweeping new regulations were enacted to implement the Physician Self-Referral Law, more commonly referred to as the Stark Law. Experts have reason to believe 2022 will bring even more developments. 

In a podcast from the American Health Law Association (AHLA) Fraud and Abuse Practice Group, Matthew Wetzel (AHLA Member and Partner at Goodwin Procter) speaks to Charles B. Oppenheim (AHLA Member and Partner at Hooper Lundy) about recent developments in interpreting the Stark Law. 

Oppenheim, co-author of the brand-new Seventh Edition of AHLA's The Stark Law: Comprehensive Analysis and Practical Guide, discusses new issues in the healthcare delivery system that remain unaddressed by the new Stark Law regulations, the challenges clients are facing related to COVID-19 waivers, and how clients are navigating the new value-based arrangement exception. 

Listen to the full conversation here on Buzzsprout, or wherever you get your podcasts.

To go beyond the basics, check out the brand-new Seventh Edition of AHLA's The Stark Law: Comprehensive Analysis and Practical Guide. Get an exclusive look inside the book to explore the expanded table of contents and a sneak peek at the first chapter. 

What is Stark Law? 

In short, the Stark Law prohibits physicians from referring patients to receive "designated health services,” or DHS, payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship (some exceptions apply).  

Financial relationships include both ownership/investment interests and compensation arrangements. For example, if investing in an imaging center, the Stark Law requires the resulting financial relationship to fit within an exception or you may not refer patients to the facility and the entity may not bill for the referred imaging services. 

What are Designated Health Services? 

Designated Health Services include a range of medical services, supplies, and prescription drugslisted under the Stark Law. Below is a list of such designated health services.  

  • Clinical laboratory services. 
  • Physical therapy services. 
  • Occupational therapy services. 
  • Outpatient speech-language pathology services. 
  • Radiology and certain other imaging services. 
  • Radiation therapy services and supplies. 
  • Durable medical equipment and supplies. 
  • Parenteral and enteral nutrients, equipment, and supplies. 
  • Prosthetics, orthotics, and prosthetic devices and supplies. 
  • Home health services. 
  • Outpatient prescription drugs. 
  • Inpatient and outpatient hospital services. 

The Stark Law is a liability statute, which means proof of specific intent to violate the law is not required. The Stark Law also prohibits the submission, or causing the submission, of claims in violation of the law's restrictions on referrals. Penalties for physicians who violate the Stark Law include fines as well as exclusion from participation in the Federal health care programs.  

For a more a more in-depth look at the Stark Law and recent developments check out the brand-new Seventh Edition of AHLA's The Stark Law: Comprehensive Analysis and Practical Guide.