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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