DarshanTalks Podcast

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In this conversation, Edye Edens with Nyssa Towsley from UNLV, examine how today’s shifting funding landscape is reshaping IRB operations. Historically, IRBs were built around the assumption that most research would be government-funded. That assumption is being challenged, with changes in funding priorities and availability beginning to influence the volume and nature of submissions.

At UNLV, for example, faculty research submissions show a slight dip in volume and a change in character. With fewer grants available, complex multi-site or multi-cohort studies may give way to more pilot projects and smaller-scale research that can be conducted without significant external funding. This could, in turn, influence IRB turnaround times, since less complex projects may be easier to review. Faculty remain passionate and committed to their research agendas, but the pressures of funding may shape what kinds of studies they are able to pursue.

Despite these shifts, one area that seems more stable is student research submissions. Because students need to complete projects to graduate—and these projects are rarely dependent on outside funding—the volume of student submissions to IRBs is expected to remain consistent. Seasonal surges are still anticipated, particularly around semester deadlines when students are racing to complete their work.

Turnaround times remain a perennial issue. IRBs are constantly balancing faculty and student urgency with the reality of limited staffing and resources. Researchers expect efficiency, while administrators need to ensure compliance and quality. This tension makes turnaround time a critical metric of IRB performance, one that institutions monitor closely and researchers feel directly.

Ultimately, while the character of faculty research may evolve, and funding pressures may drive more modest study designs, student research activity is unlikely to change significantly. IRBs will continue to navigate these competing demands, balancing speed, compliance, and the needs of researchers.

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In this video, Darshan discusses recent enforcement trends show three weak spots to watch:

1. Encounter Quality – If prescribers are just checking boxes without real patient relationships, it’s not care—it’s exposure. Demand documented standards, ID proofing, intake, decision support, and supervision. Don’t take claims at face value—audit them.
   
   
2. Cash Flow Logic – Murky subscription fees, misuse of facility fees, or volume-driven compensation are red flags. Require transparent fee schedules, fair market value memos, and ongoing monitoring.
   
   
3. Referral Data Architecture – Patient steering crosses compliance lines. Keep education, navigation, and clinical decisions separate from marketing. Document clear pathways.

Due Diligence Toolkit: credentialing, exclusion checks, state coverage policies, encounter blueprints, billing guardrails, HIPAA/data-sharing mapping, anti-kickback controls, escalation and audit playbooks.

Takeaway Question: Where is your telemedicine workflow weakest—encounter quality, cash flow, or referral steering?

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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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The FDA has recently stepped up its enforcement of pharmaceutical advertising rules, issuing 100 cease-and-desist notices and thousands of letters. These notices were largely non-personalized and intended as general guidance, emphasizing that drug advertisements must not create misleading impressions. While such enforcement has always been possible, this renewed effort signals increased regulatory attention, particularly on direct-to-consumer marketing.

Historically, FDA enforcement letters have trended downward, partly due to stronger First Amendment protections for off-label promotion. The Trump administration highlighted this issue through a presidential memorandum calling for a step-up in enforcement, though some observers see this as more of a political statement than a substantive change in authority. Nonetheless, it has drawn attention to ongoing concerns about the proliferation of drug ads and compliance with existing rules.

Future oversight may extend beyond drug manufacturers to pharmacies, online platforms, and social media influencers. Both Congress and the FDA have expressed concern about influencer-driven advertising, and questions remain about whether celebrities with significant social media followings fall under these rules. Coordination with the FTC may also be needed, as the agency regulates certain advertising claims, especially in digital spaces.

Another area of focus is closing loopholes that allow companies to refer patients to websites for side-effect information. This is likely to shift more promotional activity online, reducing costly TV advertising while keeping companies compliant. Overall, the renewed enforcement effort reflects growing scrutiny of pharmaceutical marketing, though the practical impact will depend on how agencies implement and coordinate these policies.

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Darshan Kulkarni and Edye Edens launch an exciting new episode, focusing on the unique challenges academic medical centers (AMCs) face in securing funding in an ever-changing political and regulatory environment. Unlike independent or commercial sites, AMCs operate at a different scale, often managing millions of dollars in government-funded research while navigating complex administrative structures, compliance layers, and internal politics. Edye, drawing from her 10 years inside a major AMC, shares firsthand insights into the heightened sensitivity surrounding controversial research topics, the impact of presidential and state-level funding shifts, and the pressures of maintaining compliance and operational efficiency under intense scrutiny.

The episode explores the top five factors that can determine funding success for AMCs:

1. Research topics – Certain areas may be restricted or politically sensitive.
   
   
2. DEI stances and organizational culture – Internal positions can influence perceptions and funding opportunities.
   
   
3. Key opinion leaders – Their political positions and reputations can affect institutional funding.
   
   
4. State government relationships – AMCs’ alignment with state priorities can be critical for state-funded research.
   
   
5. Regulatory efficiency – Streamlining IRB, HRPP, and other compliance processes can create operational advantages.
   
   

Darshan and Edye emphasize that understanding these factors directly from AMC administrators is invaluable. By listening to those navigating funding, compliance, and research operations in real time, AMCs and sponsors alike can better position themselves to maximize resources, maintain compliance, and continue driving innovation and patient impact.

Future episodes will expand on additional considerations, featuring industry experts and administrators sharing their perspectives and practical strategies. The series aims to provide actionable insights for AMCs, sponsors, and CROs who want to understand the realities of high-volume, high-stakes academic research.

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Darshan Kulkarni and Edye Edens are kicking off a brand-new video series diving into the unique world of academic medical centers (AMCs) in clinical research.

While KLF has long worked with sponsors, CROs, and independent sites, AMCs bring their own challenges: complex operations, unique funding models, layers of compliance, and requirements like investigator-initiated trials that don’t exist elsewhere. As Edye—drawing from 10 years inside a major AMC—explains, these environments operate at a different pace and scale, and often face resource strains even as they generate critical innovation and patient impact.

Darshan highlights how AMCs are often left out of mainstream site or sponsor conversations, despite managing volumes of research that pressure-test the entire system. Their experiences can offer invaluable lessons for industry players who want to understand how research actually succeeds—or fails—at scale.

This series will explore:
 ✅ How AMC operations differ from other sites
 ✅ Why compliance, contracts, and budgeting look different in academia
 ✅ What industry can learn from high-volume academic centers
 ✅ The regulatory and funding pressures shaping AMC research today

We haven’t picked a name yet—so we’d love your input! Drop your ideas in the comments, and stay tuned as Edye leads us through this deep dive.

Questions or suggestions? Reach out anytime at www.kulkarnilawfirm.com or connect with Darshan and Edye on LinkedIn.

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Edye Edens and Darshan Kulkarni share the origin story of KLF and explain what makes working with licensed attorneys different from hiring non-legal consultants. They highlight three key advantages:

1. Privilege & Confidentiality: Legal privilege means attorneys must keep client information confidential indefinitely—offering stronger protections than standard NDAs.
   
   
2. Broader Strategic Scope: Lawyers approach problems with a strategic lens, integrating legal, operational, and regulatory considerations before offering advice, often working alongside consultants for execution.
   
   
3. Duty to Client’s Best Interests: Attorneys are legally bound to prioritize the client’s best interests, even when it conflicts with their own financial gain.
   
   

They emphasize that while consultants and contractors bring valuable skills, legal licensing carries unique obligations and analytical approaches that can be a “game changer” for clients.

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Telehealth and pharma are facing some of their biggest compliance challenges yet—and the latest enforcement actions prove regulators aren’t slowing down.

On one side, the FTC is investigating Hims & Hers, a popular telehealth company, over allegations of misleading advertising and unfair cancellation practices. This case highlights how patient-facing companies must tread carefully when making claims about access, outcomes, or subscription services. The FTC’s involvement signals that “growth hacking” in healthcare has limits—and consumer protection laws apply just as strongly in digital health as anywhere else.

On the other side, Texas has filed a lawsuit against Eli Lilly, accusing the pharma giant of using financial incentives to improperly influence providers. This shows that traditional pharma companies aren’t immune from state-level scrutiny, particularly around patient support programs and alleged inducements. It also underscores how states are stepping up enforcement even as federal agencies tighten their own oversight.

Together, these cases send a clear message: direct-to-patient (DTP) programs are not risk-free. Whether you’re a telehealth startup or a multinational pharma, you’re operating in the same regulatory ecosystem. Advertising claims, patient subscriptions, support programs, and even reimbursement structures are now under the microscope.

In this episode, Darshan breaks down the compliance red flags exposed by both cases and shares key strategies every company should adopt to reduce risk while building sustainable DTP programs. The big takeaway? Compliance isn’t a barrier to growth—it’s the only way to ensure your innovations survive regulatory scrutiny and protect patient trust.

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