Essays · The Hillman Letter
Operator notes from inside regulated medicine.
Essays that walk through FDA regulatory strategy, frontier therapeutics, family office capital, and healthcare compliance. Thirty years of operating experience, written to read in twenty minutes each. Seven essays published. New essays weekly.
Essays
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 60-Day Overpayment Rule: When a Kept Overpayment Becomes a False Claim
How the Medicare and Medicaid 60-day overpayment rule works, what changed in 2025, and why an unfinished internal review can turn a kept overpayment into reverse False Claims Act liability.
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.
How to Build a Brand People Remember
An eight-step operator checklist for distinctive, consistent brands in regulated healthcare and biotech.
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.
MSC Exosomes and Extracellular Vesicles: A Structured Review of Published Studies
How published preclinical and early-phase MSC-EV studies were designed, administered and reported, with every result attributed to its original authors. Education only.
Exosome and mesenchymal stem cell-derived extracellular vesicle products are not approved by the FDA for any indication. The work referenced here describes published scientific literature. It does not describe an available treatment.
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.
On Medium
Your AI Billing Audit Tool Just Started the 60-Day Clock
Federal rules now tie the overpayment deadline to the False Claims Act knowledge standard. An AI flag that nobody reviews is the kind of record that reads as reckless disregard.
The AI Scribe Wrote the Note. Your Signature Owns It.
CMS says the clinician who signs an AI-drafted note affirms it. In a records review, that signature is the first thing an expert reads.
The Biology Is Rarely What Stalls a Biotech’s First FDA Filing. The Chemistry Is.
What CBER looks for in a Pre-IND package, and why chemistry, manufacturing and controls deserves more of the prep than the science deck.
Your State Said Yes to Stem Cells. The FDA Did Not.
A wave of 2025 and 2026 state laws permits unapproved regenerative therapies, while federal law did not move and the Supreme Court let the Ninth Circuit ruling stand.
Lawyers Know the Statute. They Hire an Operator to Explain How the Business Actually Ran.
What a healthcare operator expert witness does, why the 2023 change to Rule 702 raised the bar, and the eight things counsel should send first.
1,297 Whistleblower Cases in One Year. The Next One May Already Be on Your Payroll.
How qui tam works, why it now drives False Claims Act enforcement, and what a healthcare operator should build before a sealed complaint exists.
The Most Dangerous Document in Healthcare Is an Audit Nobody Finished
Two 2026 Justice Department settlements show how the 60-day overpayment rule can turn a stalled internal review into a False Claims Act case.
The Hillman Letter archive
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.
More essays on Medium
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.
Science notes on Medium
The Biotech Revolution in Limb Salvage
An overview of how biological agents, cellular approaches and bioengineered scaffolds are shifting reconstructive medicine research from amputation toward limb preservation.
Single-Cell Sequencing Frameworks Unlocking Complex Genomic Mechanisms
Explains how single-cell sequencing moves past the averaging of bulk tissue analysis to show cellular differences in complex biological systems.
Recombinant DNA Innovations Driving Next-Generation Biopharmaceutical Production
How genetic engineering and molecular techniques support biopharmaceutical production as demand grows for targeted therapies, vaccines and personalized medicine.
How to Start a Career in Agricultural Biotechnology
A guide to entering agricultural biotechnology, a field focused on crop yields, nutrition and sustainable farming amid food security and climate pressures.
5 Breakthrough Cancer Therapies Approved by the FDA
Reviews five FDA-approved cancer therapies that reflect oncology's shift from broad toxic treatments toward precision medicine.
Decentralized Bio-Networks: Blockchain Integration in Global Clinical Trials
Examines how blockchain-based decentralized networks could address data fragmentation and administrative inefficiency in global clinical trials.
Proteomics and the Dark Genome: Unveiling Novel Therapeutic Targets Through High-Throughput…
How advances in proteomics and high-throughput sequencing are used to explore the dark genome for possible new therapeutic targets.
Organ-on-a-Chip 2.0: Scaling Microfluidic Platforms for Accelerated Preclinical Drug Discovery
Looks at scaling microfluidic organ-on-a-chip platforms as an alternative to animal models in preclinical drug discovery.
Understanding Biopharmaceuticals: From Lab to Patient
An introduction to biologically derived therapies, from monoclonal antibodies to gene therapies, and their path from research lab to patient.
The Transformative Power of AI and Data Science in Biotechnology
On how artificial intelligence and data science help researchers analyze large, complex datasets in genomics, proteomics and synthetic biology.
Documents
AI Governance Rules
A document setting out AI governance rules.
Andrew Jonathan Hillman
Dallas senior paralegal and healthcare compliance expert witness. Not an attorney.
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