The Hillman Letter Podcast

The Hillman Letter Podcast

By Andrew Jonathan HillmanBusinessEducationHow ToManagement
Download on the App Store

The Hillman Letter Podcast episodes

  • 1.25–1.6x Beats Treble: The Six-Month FCA Self-Disclosure Window
    On October 22, 2026, the Justice Department's Civil Division and HHS launched the Healthcare False Claims Act Self-Disclosure Pilot Program (FCA SDPP). It offers healthcare companies a coordinated civil release for disclosing potential FCA violations previously unknown to the government, at a repayment of 1.25 to 1.6 times a base amount instead of the FCA's treble damages. Andrew Hillman walks through what the protocol says, why the math matters and a nine-point operator checklist for the six-month window, which closes at 11:59 PM on April 22, 2027.
    Hosted by Andrew Jonathan Hillman, Dallas, Texas.
    Read the Letter: https://thehillmanletter.substack.com/p/fca-self-disclosure-pilot
    Main site: https://andrew-hillman.com/
    Takeaways:
    - Repayment is 1.25 to 1.6 times the Base Self-Disclosure Repayment. The FCA allows up to three times damages plus per-claim penalties.
    - The gate is "previously unknown to the federal government." If the government already knows, the pilot is off the table.
    - Civil only. Potential criminal conduct goes to DOJ's National Fraud Enforcement Division under a separate policy.
    - Submissions go to [email protected] by 11:59 PM on April 22, 2027. Late or partial submissions will not be accepted or reviewed.
    - The 60-day overpayment rule at 42 C.F.R. 401.305 keeps running.
    Chapters:
    0:00 Cold open
    0:27 What happened
    4:55 Why it matters
    7:57 Practical checklist
    10:13 My take
    10:48 Disclaimer and close
    Sources:
    DOJ/HHS FCA SDPP protocol (PDF): https://www.justice.gov/opa/media/1467546/dl
    DOJ press release, Oct 22, 2026: https://www.justice.gov/opa/pr/justice-departments-civil-division-and-department-health-human-services-announce-anti-fraud
    HHS press release, Oct 22, 2026: https://www.hhs.gov/press-room/hhs-doj-launch-healthcare-false-claims-act-self-disclosure-pilot.html
    This episode is educational commentary and is not legal advice. Andrew Hillman is not an attorney. Talk to qualified counsel about your specific situation.
    Narrated by an AI voice (synthetic narration). No real person's voice or likeness is used.
    Links and resources:
    The Letter: https://thehillmanletter.substack.com/p/fca-self-disclosure-pilot
    Podcast home: https://andrew-hillman.com/podcast/
    About the host: https://andrew-hillman.com/who-is-andrew-jonathan-hillman/
    LinkedIn: https://www.linkedin.com/in/andrew-hillman-dallas
    The Hillman Letter on Substack: https://thehillmanletter.substack.com
    Apple Podcasts: https://podcasts.apple.com/us/podcast/the-hillman-letter-podcast/id6825615190
    Spotify: https://open.spotify.com/show/2ZYUBaVrUxWDAhskCNTXzs
    YouTube episode: https://www.youtube.com/watch?v=G2yFNQTmNQA
    YouTube playlist: https://www.youtube.com/playlist?list=PLElpO9MC9VC4
    Academia.edu, SMU: https://smu.academia.edu/AndrewHillman
    ORCID: https://orcid.org/0009-0001-5396-321X
    Wikipedia: https://en.wikipedia.org/wiki/Andrew_Jonathan_Hillman
    Book a call: https://calendly.com/ajhusa
    Educational only. Not legal advice. Not an attorney.
    12 min
  • Glass, Cold Chain and the Law: The 351(a) Classification of Wharton's Jelly Exosomes
    Andrew Hillman's 2026 manuscript on why Wharton's jelly stem cell exosomes require BLA licensure under Section 351(a), and what that classification means for manufacturing. We cover the four-criteria test, cGMP and ISO and ICH quality systems, Type I glass, the minus 80 degree cold chain, and the labeling problems the paper sees in grey market products. Exosome products are not approved by the FDA for any indication.
    Hosted by Andrew Jonathan Hillman, Dallas, Texas.
    Permanent record (DOI): https://doi.org/10.5281/zenodo.21169929
    Main site: https://andrew-hillman.com/
    Publications: https://andrew-hillman.com/publications/
    This episode is educational and is not legal or medical advice. Andrew Hillman is not an attorney.
    Narrated by an AI voice (synthetic narration). No real person's voice or likeness is used.
    Links and resources:
    Companion paper: https://andrew-hillman.com/publications/whartons-jelly-msc-exosomes-351a-classification/
    Podcast home: https://andrew-hillman.com/podcast/
    About the host: https://andrew-hillman.com/who-is-andrew-jonathan-hillman/
    LinkedIn: https://www.linkedin.com/in/andrew-hillman-dallas
    The Hillman Letter on Substack: https://thehillmanletter.substack.com
    Apple Podcasts: https://podcasts.apple.com/us/podcast/the-hillman-letter-podcast/id6825615190
    Spotify: https://open.spotify.com/show/2ZYUBaVrUxWDAhskCNTXzs
    YouTube playlist: https://www.youtube.com/playlist?list=PLElpO9MC9VC4
    Academia.edu, SMU: https://smu.academia.edu/AndrewHillman
    ORCID: https://orcid.org/0009-0001-5396-321X
    Wikipedia: https://en.wikipedia.org/wiki/Andrew_Jonathan_Hillman
    Book a call: https://calendly.com/ajhusa
    Educational only. Not legal advice. Not an attorney.
    8 min
  • The Biologics Paradigm: Why Exosomes Are a 351(a) Drug, Not a 361 Tissue Product
    Andrew Hillman's 2026 paper on the line between Section 361 tissue products and Section 351(a) biologics, and why he argues Wharton's jelly exosomes belong on the 351(a) path. We cover the four criteria in 21 CFR 1271.10(a), the FDA's 2019 safety notification, the federal RMAT and Right to Try frameworks and their limits, and what manufacturing controls look like. Exosome products are not approved by the FDA for any indication.
    Hosted by Andrew Jonathan Hillman, Dallas, Texas.
    Permanent record (DOI): https://doi.org/10.5281/zenodo.21142612
    Main site: https://andrew-hillman.com/
    Publications: https://andrew-hillman.com/publications/
    This episode is educational and is not legal or medical advice. Andrew Hillman is not an attorney.
    Narrated by an AI voice (synthetic narration). No real person's voice or likeness is used.
    Links and resources:
    Companion paper: https://andrew-hillman.com/publications/biologics-paradigm-351a-vs-361-hctp/
    Podcast home: https://andrew-hillman.com/podcast/
    About the host: https://andrew-hillman.com/who-is-andrew-jonathan-hillman/
    LinkedIn: https://www.linkedin.com/in/andrew-hillman-dallas
    The Hillman Letter on Substack: https://thehillmanletter.substack.com
    Apple Podcasts: https://podcasts.apple.com/us/podcast/the-hillman-letter-podcast/id6825615190
    Spotify: https://open.spotify.com/show/2ZYUBaVrUxWDAhskCNTXzs
    YouTube playlist: https://www.youtube.com/playlist?list=PLElpO9MC9VC4
    Academia.edu, SMU: https://smu.academia.edu/AndrewHillman
    ORCID: https://orcid.org/0009-0001-5396-321X
    Wikipedia: https://en.wikipedia.org/wiki/Andrew_Jonathan_Hillman
    Book a call: https://calendly.com/ajhusa
    Educational only. Not legal advice. Not an attorney.
    7 min
  • What Compliant Should Mean for Wharton's Jelly Exosomes: Source, 351(a), Drug Master Files and the Cold Chain
    Andrew Hillman's 2026 white paper on the regulatory and manufacturing standard for Wharton's jelly stem cell exosomes. We cover why the source tissue matters, why these products fall under Section 351(a), how a Type II Drug Master File works, and what donor testing, lot release, glass vials and cold chain shipping involve. FDA has not approved any exosome product.
    Hosted by Andrew Jonathan Hillman, Dallas, Texas.
    Permanent record (DOI): https://doi.org/10.5281/zenodo.20974697
    Main site: https://andrew-hillman.com/
    Publications: https://andrew-hillman.com/publications/
    This episode is educational and is not legal or medical advice. Andrew Hillman is not an attorney.
    Narrated by an AI voice (synthetic narration). No real person's voice or likeness is used.
    Links and resources:
    Companion paper: https://andrew-hillman.com/publications/whartons-jelly-msc-exosomes-gold-standard/
    Podcast home: https://andrew-hillman.com/podcast/
    About the host: https://andrew-hillman.com/who-is-andrew-jonathan-hillman/
    LinkedIn: https://www.linkedin.com/in/andrew-hillman-dallas
    The Hillman Letter on Substack: https://thehillmanletter.substack.com
    Apple Podcasts: https://podcasts.apple.com/us/podcast/the-hillman-letter-podcast/id6825615190
    Spotify: https://open.spotify.com/show/2ZYUBaVrUxWDAhskCNTXzs
    YouTube playlist: https://www.youtube.com/playlist?list=PLElpO9MC9VC4
    Academia.edu, SMU: https://smu.academia.edu/AndrewHillman
    ORCID: https://orcid.org/0009-0001-5396-321X
    Wikipedia: https://en.wikipedia.org/wiki/Andrew_Jonathan_Hillman
    Book a call: https://calendly.com/ajhusa
    Educational only. Not legal advice. Not an attorney.
    8 min
  • Exosomes, Disc Repair and the Epidural Steroid Label: Research Questions from a 2026 Spine Paper
    A 2026 review Andrew Hillman co-authored on Wharton's jelly stem cell exosomes and the spine. We cover the FDA's 2014 label warning on epidural corticosteroids, what lab and animal studies report about disc biology, and the three research questions the paper proposes for controlled trials. No exosome product is FDA-approved for any indication, and nothing here describes an available treatment.
    Hosted by Andrew Jonathan Hillman, Dallas, Texas.
    Permanent record (DOI): https://doi.org/10.5281/zenodo.20978822
    Main site: https://andrew-hillman.com/
    Publications: https://andrew-hillman.com/publications/
    This episode is educational and is not legal or medical advice. Andrew Hillman is not an attorney.
    Narrated by an AI voice (synthetic narration). No real person's voice or likeness is used.
    Links and resources:
    Companion paper: https://andrew-hillman.com/publications/whartons-jelly-msc-exosomes-spinal-disc-repair/
    Podcast home: https://andrew-hillman.com/podcast/
    About the host: https://andrew-hillman.com/who-is-andrew-jonathan-hillman/
    LinkedIn: https://www.linkedin.com/in/andrew-hillman-dallas
    The Hillman Letter on Substack: https://thehillmanletter.substack.com
    Apple Podcasts: https://podcasts.apple.com/us/podcast/the-hillman-letter-podcast/id6825615190
    Spotify: https://open.spotify.com/show/2ZYUBaVrUxWDAhskCNTXzs
    YouTube playlist: https://www.youtube.com/playlist?list=PLElpO9MC9VC4
    Academia.edu, SMU: https://smu.academia.edu/AndrewHillman
    ORCID: https://orcid.org/0009-0001-5396-321X
    Wikipedia: https://en.wikipedia.org/wiki/Andrew_Jonathan_Hillman
    Book a call: https://calendly.com/ajhusa
    Educational only. Not legal advice. Not an attorney.
    7 min
  • Stem Cell Vesicles and Tissue Repair: 40 Studies Across Four Body Systems
    A plain English tour of a 2026 narrative review Andrew Hillman co-authored on 40 peer-reviewed studies of stem cell extracellular vesicles in bone and joint, nerve, heart and skin repair. We cover the shared patterns the cited studies reported, the heart meta-analysis, manufacturing advances, and the review's stated limits. No MSC-EV product is FDA approved for any use.
    Hosted by Andrew Jonathan Hillman, Dallas, Texas.
    Permanent record (DOI): https://doi.org/10.5281/zenodo.23574345
    Main site: https://andrew-hillman.com/
    Publications: https://andrew-hillman.com/publications/
    This episode is educational and is not legal or medical advice. Andrew Hillman is not an attorney.
    Narrated by an AI voice (synthetic narration). No real person's voice or likeness is used.
    Links and resources:
    Companion paper: https://andrew-hillman.com/publications/msc-evs-tissue-repair-narrative-review/
    Podcast home: https://andrew-hillman.com/podcast/
    About the host: https://andrew-hillman.com/who-is-andrew-jonathan-hillman/
    LinkedIn: https://www.linkedin.com/in/andrew-hillman-dallas
    The Hillman Letter on Substack: https://thehillmanletter.substack.com
    Apple Podcasts: https://podcasts.apple.com/us/podcast/the-hillman-letter-podcast/id6825615190
    Spotify: https://open.spotify.com/show/2ZYUBaVrUxWDAhskCNTXzs
    YouTube playlist: https://www.youtube.com/playlist?list=PLElpO9MC9VC4
    Academia.edu, SMU: https://smu.academia.edu/AndrewHillman
    ORCID: https://orcid.org/0009-0001-5396-321X
    Wikipedia: https://en.wikipedia.org/wiki/Andrew_Jonathan_Hillman
    Book a call: https://calendly.com/ajhusa
    Educational only. Not legal advice. Not an attorney.
    8 min
  • What the Exosome Research Actually Shows: A Structured Review, Area by Area
    Andrew Hillman's 2026 structured review of published studies on stem cell exosomes and extracellular vesicles across the spine, brain injury, lung disease, knee osteoarthritis and other areas. We cover how early the evidence still is, why dose is reported in units that cannot be compared, and what the field needs next. FDA has not approved any exosome or MSC-EV product, and human use requires an IND or BLA.
    Hosted by Andrew Jonathan Hillman, Dallas, Texas.
    Permanent record (DOI): https://doi.org/10.5281/zenodo.21209815
    Main site: https://andrew-hillman.com/
    Publications: https://andrew-hillman.com/publications/
    This episode is educational and is not legal or medical advice. Andrew Hillman is not an attorney.
    Narrated by an AI voice (synthetic narration). No real person's voice or likeness is used.
    Links and resources:
    Companion paper: https://andrew-hillman.com/publications/msc-exosomes-evs-structured-review/
    Podcast home: https://andrew-hillman.com/podcast/
    About the host: https://andrew-hillman.com/who-is-andrew-jonathan-hillman/
    LinkedIn: https://www.linkedin.com/in/andrew-hillman-dallas
    The Hillman Letter on Substack: https://thehillmanletter.substack.com
    Apple Podcasts: https://podcasts.apple.com/us/podcast/the-hillman-letter-podcast/id6825615190
    Spotify: https://open.spotify.com/show/2ZYUBaVrUxWDAhskCNTXzs
    YouTube playlist: https://www.youtube.com/playlist?list=PLElpO9MC9VC4
    Academia.edu, SMU: https://smu.academia.edu/AndrewHillman
    ORCID: https://orcid.org/0009-0001-5396-321X
    Wikipedia: https://en.wikipedia.org/wiki/Andrew_Jonathan_Hillman
    Book a call: https://calendly.com/ajhusa
    Educational only. Not legal advice. Not an attorney.
    9 min
  • Service Before Scale: The Giving Record of Andrew Hillman, Dallas
    Service before scale: the community and giving record of Andrew Hillman, Dallas. The Lamplighter School, Parish Episcopal School, KidSwing Dallas for Scottish Rite for Children, the Heroes for Israel Project, and two $1,000 awards for U.S. undergraduates.
    Main site: https://andrew-hillman.com/
    Giving record: https://andrewhillman.org/
    Educational only. Not legal advice. Andrew Hillman is not an attorney.
    Narrated by an AI voice (synthetic narration). No real person's voice or likeness is used.
    Links and resources:
    Podcast home: https://andrew-hillman.com/podcast/
    About the host: https://andrew-hillman.com/who-is-andrew-jonathan-hillman/
    LinkedIn: https://www.linkedin.com/in/andrew-hillman-dallas
    The Hillman Letter on Substack: https://thehillmanletter.substack.com
    Apple Podcasts: https://podcasts.apple.com/us/podcast/the-hillman-letter-podcast/id6825615190
    Spotify: https://open.spotify.com/show/2ZYUBaVrUxWDAhskCNTXzs
    YouTube playlist: https://www.youtube.com/playlist?list=PLElpO9MC9VC4
    Academia.edu, SMU: https://smu.academia.edu/AndrewHillman
    ORCID: https://orcid.org/0009-0001-5396-321X
    Wikipedia: https://en.wikipedia.org/wiki/Andrew_Jonathan_Hillman
    Book a call: https://calendly.com/ajhusa
    Educational only. Not legal advice. Not an attorney.
    5 min
  • The Published Work of Andrew Hillman, Dallas: A Book, Research, Essays and Press
    The published work of Andrew Hillman, Dallas: his 2026 book Last Part Standing, regulatory research on Zenodo with permanent DOIs, essays on his sites, Medium and The Hillman Letter, and press coverage of his student awards. Not medical advice.
    Main site: https://andrew-hillman.com/
    Publications: https://andrew-hillman.com/publications/
    Educational only. Not legal advice. Andrew Hillman is not an attorney.
    Narrated by an AI voice (synthetic narration). No real person's voice or likeness is used.
    Links and resources:
    Podcast home: https://andrew-hillman.com/podcast/
    About the host: https://andrew-hillman.com/who-is-andrew-jonathan-hillman/
    LinkedIn: https://www.linkedin.com/in/andrew-hillman-dallas
    The Hillman Letter on Substack: https://thehillmanletter.substack.com
    Apple Podcasts: https://podcasts.apple.com/us/podcast/the-hillman-letter-podcast/id6825615190
    Spotify: https://open.spotify.com/show/2ZYUBaVrUxWDAhskCNTXzs
    YouTube playlist: https://www.youtube.com/playlist?list=PLElpO9MC9VC4
    Academia.edu, SMU: https://smu.academia.edu/AndrewHillman
    ORCID: https://orcid.org/0009-0001-5396-321X
    Wikipedia: https://en.wikipedia.org/wiki/Andrew_Jonathan_Hillman
    Book a call: https://calendly.com/ajhusa
    Educational only. Not legal advice. Not an attorney.
    5 min
  • Inside The Hillman Letter: Healthcare Compliance and Expert Witness Insight from Dallas
    A tour of The Hillman Letter, the Substack newsletter by Andrew Hillman, Dallas, on healthcare compliance, expert witness insight and legal operations. We walk through recent issues on records retention, Rule 702 expert reports, FDA warning letters, the False Claims Act and FDA pathways.
    Main site: https://andrew-hillman.com/
    Healthcare compliance expert witness page: https://andrew-hillman.com/healthcare-compliance-expert-witness/
    Educational only. Not legal advice. Andrew Hillman is not an attorney.
    Narrated by an AI voice (synthetic narration). No real person's voice or likeness is used.
    Links and resources:
    Podcast home: https://andrew-hillman.com/podcast/
    About the host: https://andrew-hillman.com/who-is-andrew-jonathan-hillman/
    LinkedIn: https://www.linkedin.com/in/andrew-hillman-dallas
    The Hillman Letter on Substack: https://thehillmanletter.substack.com
    Apple Podcasts: https://podcasts.apple.com/us/podcast/the-hillman-letter-podcast/id6825615190
    Spotify: https://open.spotify.com/show/2ZYUBaVrUxWDAhskCNTXzs
    YouTube playlist: https://www.youtube.com/playlist?list=PLElpO9MC9VC4
    Academia.edu, SMU: https://smu.academia.edu/AndrewHillman
    ORCID: https://orcid.org/0009-0001-5396-321X
    Wikipedia: https://en.wikipedia.org/wiki/Andrew_Jonathan_Hillman
    Book a call: https://calendly.com/ajhusa
    Educational only. Not legal advice. Not an attorney.
    5 min

About The Hillman Letter Podcast

From the publisher's feed

Plain English episodes from Andrew Hillman, Dallas, a Senior Paralegal and healthcare compliance expert witness retained through counsel. Topics include healthcare fraud and abuse law, The Hillman Letter, his published work and his giving record. Educational only. Not legal advice. Andrew Hillman is not an attorney. Narrated by an AI voice (synthetic narration). No real person's voice or likeness is used.