The Hillman Letter
Zero Was True. The Claim Was Still False.
Six SNG dialysis centers pay about $2 million after reporting zero revenue to HRSA without disclosing a pre-arranged sale or closure. A true number in a misleading context still supports a False Claims Act theory.
1.25-1.6x Beats Treble: The Six-Month FCA Self-Disclosure Window
DOJ and HHS just put a price tag on coming forward: a 1.25 to 1.6x repayment for disclosing previously unknown civil False Claims Act issues. The clock runs to April 22, 2027.
The Spreadsheet Knew
Two September and October settlements show how a stalled internal review turns into a False Claims Act case. The 60-day overpayment clock is the reason.
The Same Surgical Procedure Loophole Is Closed. Here Is What the Cell Surgical Network Injunction Means for Everyone Building a Cell or Exosome Product.
Eight years, one reversal, and a nine-page order that ends the argument.
Why family offices beat venture capital on early biotech. And where venture still wins.
On where family offices outperform venture capital on early biotech, and where venture still wins.
The hard road. Building a biotech of real value without operating in the gray market.
Issue No. 3 of The Hillman Letter, on building a biotech of real value without operating in the gray market.
Full archive on thehillmanletter.substack.com.
351(a) or 361. The pathway question that determines whether your biologic ever sees a BLA.
The fastest way to lose two years and four million dollars in early biotech is to pick the wrong pathway.
The Specific Pattern That Killed Five Biotech Programs I Personally Watched
The pattern was the same across five programs. In case you are running one of the next ones.
Why Dallas Is Quietly Becoming the Right Place to Build FDA-Regulated Biotech
The Dallas-Fort Worth biotech ecosystem has been compounding for three decades.
The 351 vs 361 Decision That Kills Most Exosome Programs
Why most exosome programs pick the wrong FDA pathway, and what the BLA route actually demands.
Why Family Office Capital Fits FDA-Regulated Biotech Better Than Venture Money
A ten-year venture fund has to return capital on a schedule. The FDA does not care about your schedule.
The Six Documentation Patterns That Show Up Before Federal Healthcare Enforcement
Every enforcement action I have served on involved a pattern visible eighteen to thirty-six months before.
What Thirty Years of Operating in FDA-Regulated Healthcare Actually Taught Me
Five lessons I would tell my younger self if I could.
The Silent Killer of Biotech Startups: Ignoring the Full Legal Landscape
Argues that many biotech founders underestimate healthcare regulation and wrongly assume basic HIPAA or Anti-Kickback Statute awareness is good enough.