In this episode, Darshan Kulkarni talks with Thomas Siepka about the 340B program, rebates, and the crucial role of pharmacy benefit managers (PBMs) in today’s healthcare system. Siepka, a pharmacist and CEO of HCI Healthcare Consultants, shared his extensive experience working across health systems, community health centers, and tribal healthcare organizations.

They break down the complex healthcare landscape, explaining the distinction between health insurance companies and PBMs. PBMs specialize in managing the medication component of insurance programs, handling everything from claims processing and formulary management to manufacturer negotiations and rebate administration. Initially, PBMs were simply transactional processors of claims, but over time, they became key players in controlling medication costs, developing formularies, and creating step therapy protocols to ensure appropriate prescribing.

The discussion highlights how PBMs evolved in response to pharmaceutical influence on prescribers, which sometimes led to inappropriate drug use and rising healthcare costs. While PBMs help manage this, their practices—such as retaining rebates, fees, or reclassifying discounts—can sometimes increase costs for employers or patients. Siepka also underscores the influence of direct-to-consumer advertising, which further pressures providers and patients in drug selection.

Ultimately, PBMs serve as intermediaries trying to balance patient care, cost management, and insurer obligations, but their opaque financial practices make transparency critical.

For more information, reach out to us on www.kulkarnilawfirm.com

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In the episode of a new series on academic medical centers, Edye Edens of Kulkarni Law Firm sits down with Cortni Romaine of Florida Atlantic University (FAU) to explore how compliance offices in academia create programs that others aspire to emulate.

Cortni explains FAU’s proactive approach to compliance, emphasizing the importance of partnerships both within the university and across the state. At FAU, new federal, state, or institutional requirements are reviewed collaboratively by compliance, research integrity, sponsored programs, general counsel, and other key offices to ensure smooth implementation. Beyond the campus, FAU participates in the Compliance Alliance, a statewide network that brings together universities to openly share policies, training opportunities, and solutions to emerging challenges.

Unlike industry, where competitive pressures and proprietary concerns often limit collaboration, academia thrives on an environment of trust and knowledge-sharing. Cortni highlights how colleagues across institutions freely exchange policies, training materials, and even failures—acknowledging when a particular initiative did not succeed so others can learn and avoid the same mistakes. This willingness to collaborate builds what she and Edye describe as an “ethical ecosystem,” where compliance professionals collectively raise standards, foster mentorship, and support the broader research community.

The conversation also touches on the unique advantages of the academic setting:

• The ability to crowdsource ideas across institutions.
  
  
• The openness to borrow and adapt policies while giving credit.
  
  
• The culture of mentorship, with senior professionals guiding others through publishing, policy development, and training design.
  
  
• The freedom for compliance professionals to share broadly without being bound by the “publish or perish” pressures faced by faculty researchers.
  
  

Through real-world examples, Cortni illustrates how this cooperative approach not only strengthens institutional compliance but also creates aspirational programs that other universities look to model. The episode closes with the reminder that while every institution’s culture and resources differ, the regulatory floor is the same for all. How each university builds upon that foundation—through trust, openness, and collaboration—determines whether its program becomes one that others want to follow.

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In one of the largest recent Medicare fraud cases, Peter Roussonicolos, a Florida durable medical equipment (DME) company owner, was sentenced to 12 years in federal prison for orchestrating a scheme that defrauded Medicare of more than $61 million.

Here’s how the scheme worked:

• Hidden Ownership: Roussonicolos used straw owners to disguise his true role in several DME companies, evading disclosure requirements and regulatory oversight.
  
  
• Illegal Kickbacks: He arranged payments to marketers and telemedicine providers in exchange for patient referrals, blatantly violating federal Anti-Kickback Statute provisions.
  
  
• False Documentation: Physicians and other medical providers were incentivized to generate fraudulent prescriptions and medical necessity documentation, creating a paper trail that made the claims appear legitimate.
  
  
• Excessive Billing: Using this structure, the companies submitted tens of millions in false claims to Medicare for equipment patients didn’t need—or never even received.
  
  

The Department of Justice and HHS-OIG highlighted this case as part of their ongoing crackdown on healthcare fraud, waste, and abuse, emphasizing the importance of transparency, compliance, and strong internal controls.

Compliance Takeaways:

1. Ownership transparency matters. Hidden or straw ownership arrangements are a red flag that regulators actively investigate.
   
   
2. Kickback-free operations are critical. Even “creative marketing arrangements” can be viewed as inducements if tied to patient referrals
   
   
3. Medical necessity must be genuine. Documentation is not just paperwork—it’s evidence, and falsification leads directly to liability.
   
   
4. Internal oversight saves businesses. Routine compliance audits, robust training, and third-party reviews can prevent practices from drifting into legally risky territory.
   
   

The Roussonicolos case is a cautionary tale: shortcuts and “workarounds” to grow revenue may look profitable in the short term, but in regulated industries like healthcare, they often end in criminal convictions, reputational collapse, and financial ruin.

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