At the Save Our Sites (SOS) conference, many site owners expressed excitement over finally having a space to openly discuss real challenges—budgets, pricing, contracting, and the isolation of being a site owner. While the intent was mutual support, concerns quickly arose when some attendees began advocating for standardized pricing across sites (e.g., "$200 for an X-ray")—a move that borders on illegal price fixing.

Darshan raised red flags, emphasizing that while site collaboration is valuable, actions like setting uniform pricing or paying for patient referrals can violate antitrust and anti-kickback laws. Edye pointed out that many site owners, especially those without traditional academic or regulatory backgrounds, may genuinely not know these rules.

They agreed: sites need spaces for community and education, but must distinguish between support networks and collective negotiation efforts—especially since the latter may trigger legal concerns such as RICO violations or be misinterpreted as forming a union. The bottom line? Intent isn’t enough. Awareness and compliance matter.

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The recent conviction of a Michigan pharmacist and his brother in a $15 million healthcare fraud scheme highlights the growing crackdown on pharmacy-related fraud. The scheme involved billing for medications that were never dispensed, targeting Medicare, Medicaid, and private insurance. This pattern of fraud is not new, as the Department of Justice (DOJ) recently charged nearly 200 individuals in similar cases amounting to $2.75 billion in fraud claims. Pharmacies, both large and small, are increasingly under scrutiny as enforcement agencies widen their focus.

For pharmacists, compliance officers, and legal professionals working with pharmacies, this trend serves as a reminder that even small lapses in billing, documentation, or deadlines can lead to major legal consequences. The DOJ is committed to ensuring the integrity of taxpayer-funded healthcare programs, meaning minor non-compliance could result in severe penalties. With large corporations like Walgreens paying millions to settle fraud claims, it's clear that all pharmacies are at risk. To protect your business, it's crucial to implement a strong compliance program, conduct thorough audits, and train your team on the latest regulations.

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Pharma is finally catching up to the on-demand world—offering direct-to-patient (DTP) services that promise convenience, faster delivery, and a more personalized experience. Major players like Pfizer, Lilly, and Novo Nordisk are leading the way, cutting out intermediaries like pharmacists, PBMs, and even traditional physicians.

But convenience comes at a cost.

By removing these safeguards, companies take on massive compliance liabilities. Telehealth prescribing raises serious questions around physician independence and anti-kickback regulations. Fulfillment introduces risks tied to product integrity, recalls, and data privacy. Even cash-based payments can trigger transparency violations and pricing scrutiny.

The risks are real: HIPAA breaches, malpractice claims, and federal investigations can derail even the most well-meaning DTP strategies. That’s why pharmaceutical companies must treat compliance as foundational—not an afterthought.

The path forward? Define clear boundaries between pharma, prescribers, and delivery partners. Invest in internal audits. Build scenario-based risk plans. And most importantly, bring legal and compliance professionals to the table from day one.

At Kulkarni Law Firm, we specialize in helping pharma companies innovate without compromising compliance. If your organization is exploring or expanding its DTP strategy, let’s make sure you’re protected—before risks become reality.

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