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Industry Relations · Briefing Series

The Ledger.

Industry built modern podiatric surgery. It also bent it. A data-first reckoning with what gets recorded, what doesn't, and the price of partnership.

Ortho Research $ (2017–24)
$395.7M
Industry-sponsored research to ortho surgeon PIs
+8 yrs
Skin Substitute Spending
40×
Medicare Part B, 2019 → 2024
↑ HIGH RISK
Discrepancy Rate
~35%
AAOS authors, self-report vs. Open Payments (2019)
GAP
CMS 2026 Cut
$19.6B
Projected skin-substitute savings, single year
PFS RULE
§ 01

Two things are true.

THE FRAME

Every implant in a podiatric surgeon's hand was designed, manufactured, marketed, and — usually — first taught by industry. Every cadaver lab the resident scrubs in for is paid for, in part, by industry. Every conference where techniques are debated runs on industry exhibitor revenue. Every fellowship in foot and ankle exists in some financial proximity to it. The relationship is not incidental. It is the substrate of modern practice.

That is the first true thing. The second is harder. The same relationship that produces the locking plate, the headless compression screw, the PEEK fixation, the 3D bunion correction system has also produced a Medicare wound-care fraud docket so dense the DOJ now runs a dedicated Wound Care Initiative — and disclosure-discrepancy literature so consistent across orthopedic subspecialties that one third of authors at major meetings routinely fail to report what industry has already told the federal government about them.

The question is not whether to engage industry. The question is whether the profession's instruments of self-governance are equal to the relationship it has already built. — Editorial premise
§ 02

The case for     /     the case against.

THE DUALITY
+
What Industry Builds

The case for partnership.

  • $395.7M in research funding To orthopedic surgeon PIs, 2017–2024. Roughly 956 investigators per year. ~20% supports registered clinical trials.
  • Cadaver lab access The closest analog to flight simulation. Lapidus, TAA, hindfoot fusion, MIS courses — most operationally depend on industry partnership.
  • 200+ APMA partners Tier sponsorships from $2,500 to $125,000+ underwrite CME, residency education, regional lectures, and annual scientific meetings.
  • 91% of teaching hospitals Received industry payments in 2018, totaling $832M. The institutions that train residents are themselves industry-partnered.
!
What Goes Wrong

The case against complacency.

  • $10B+ skin substitute market Medicare Part B spending in 2024 — up from $256M in 2019. Patient volume only doubled.
  • ~35% AAOS disclosure discrepancy Senior authors at the largest orthopedic meeting fail to align self-disclosures with the federal Open Payments record.
  • Active DOJ Wound Care Initiative $1.1B+ takedown in 2025. Podiatrists, NPs, and embedded sales reps among defendants. Enforcement is accelerating.
  • 69% of payments are royalties The dominant ortho industry relationship is not dinners — it is long-term IP ties between surgeons and the implants they design and publish on.
§ 03

The Sunshine Act, in plain terms.

WHAT GETS RECORDED

The Physician Payments Sunshine Act, embedded in the 2010 Affordable Care Act, requires drug and device manufacturers to report any single payment over $10 — or any aggregate annual payment exceeding $100 — to physicians, including doctors of podiatric medicine. CMS publishes the data each June through the Open Payments database. Patients, journalists, and any podiatric resident with an internet connection can search any DPM by name.

69%
Royalties

Where the money sits.

Across the broader orthopedic profession, royalties and licensing alone account for roughly 69% of all device-company payments. The dominant financial relationship is not speaker fees or dinners — it is long-term IP arrangements between named surgeons and the implants they helped design.

  • Royalties & licensing69%
  • Consulting fees13%
  • Non-consulting / other18%
Foot & Ankle

$39M

To 802 ortho F&A surgeons across 29,442 transactions, 2014–2017.

Top 5% Earners

$158K

Average annual industry payment, foot & ankle subspecialty, 2018.

JFAS COIs

86.4%

Of disclosed conflicts in JFAS (2008–2020) were industry-related. ⚠ note

§ 04

The data exists. The use of it doesn't.

FAILURE MODE

Open Payments solved the problem of recording physician-industry transfers. It did not solve the problem of using that record to inform research, education, or guideline development. Multiple studies have compared physician-reported disclosures at meetings and in publications against the federal Open Payments record. The discrepancy rates are not encouraging.

Disclosure discrepancy across orthopedic literature
Self-reported COIs vs. Open Payments — multiple settings, multiple years
Discrepancy rate
AAOS Annual Meeting (2019)n = 1,380 authors
35%
FAI · Total ankle arthroplasty articles2015–2019, payment categories
~50%
AAOS membership (2011)Mandatory disclosure compliance
44%
Sports / spine literatureAggregate review, multiple journals
Up to 65%
AAOS CPGs & Appropriate Use CriteriaJBJS, 2018 — IOM standards not met
~42%

Most discrepancies fall below $1,000 per item. Most are likely careless rather than concealing. But "careless" is a structural problem, not an individual one. When a third of senior authors at the largest orthopedic meeting in the country fail to align their disclosures with what their own consulting agreements have already documented federally, the integrity of the resulting literature is exactly as good as the disclosure system. That is the system's floor, not a worst case.

Transparency without integration is performative. Open Payments did not fail. The professional culture around it did. — Editorial argument
§ 05

The skin substitute collapse.

CASE STUDY I

The clearest contemporary illustration of what industry-physician misalignment looks like at scale is the skin substitute market — cellular and tissue-based products applied to chronic wounds, including diabetic foot ulcers and venous leg ulcers. Roughly 75 products on the market. Many launched at high prices through 510(k) or §361 HCT/P pathways with thin or absent comparative-effectiveness data. The Average Sales Price + 6% reimbursement structure created an incentive aligned almost perfectly with using the highest-priced product available.

Medicare Part B spending: skin substitutes

2019 → 2024 · ~40× growth · patient volume only doubled
FRAUD RISK · CRITICAL
$10B $5B $2B $500M 2019 2020 2021 2022 2023 2024 $256M $10B+
2019 Spend
$256M
2024 Spend
$10B+
Multiplier
~40×
Patient Vol.
2× only
$45M
Alleged Medicare fraud
U.S. v. Jenson, DPM
Houston podiatrist indicted on 14 counts. Skin substitutes allegedly applied to patients without qualifying wounds; some told products were "stem cells" for body pain. Government claims warning issued early 2023; billing continued.
HOUSTON2025
$1.2B
Amniotic graft scheme
U.S. v. Gehrke / King
Apex Medical et al. Recruiters with no medical training located elderly hospice patients; ordered oversized grafts to maximize per-cm² billing. One organizer received $279M in alleged kickbacks alone.
ARIZONA2024
FCA
National scope
U.S. v. Vohra Wound Physicians
DOJ False Claims Act complaint against one of the country's largest wound-care providers. EMR allegedly designed to misclassify procedures as surgical; revenue-based debridement quotas; Modifier 25 applied to nearly all exams.
S.D. FLA.2025

In the CY 2026 Physician Fee Schedule final rule, CMS reclassified most skin substitutes from biologics (paid at ASP+6%) to "incident-to supplies" at a flat national rate of $127.28 per square centimeter. The agency projects roughly 90% reduction in skin substitute program spending — approximately $19.6B in savings for 2026 alone. ⚠ verify LCDs were withdrawn in late December 2025 even as the payment rule moved forward. The flat-rate fix may simply migrate the fraud risk from price arbitrage to overutilization.

§ 06

When innovation outpaces evidence.

CASE STUDY II · BUNION MARKET

The skin-substitute story is about fraud at the edges of the profession. The bunion story is about something different — what happens when a single company successfully redefines a procedure faster than the literature can keep up. Treace Medical Concepts, founded in 2014, built its identity around the Lapiplasty 3D Bunion Correction System. By 2021, Treace was a publicly traded company (NASDAQ: TMCI). Surgeon adoption was driven by industry-organized training, branded technique, and a coordinated marketing apparatus that few academic departments could rival.

Treace / Lapiplasty timeline
Founding · IPO · litigation · class action
NASDAQ: TMCI
2014
Treace Medical founded Lapiplasty patents filed; tri-planar Lapidus instrumentation suite developed.
2021
Treace IPO on NASDAQ Public market access enables marketing scale, surgeon training programs, DTC advertising.
2022
Suit vs. Fusion Orthopedics Patent and trademark dispute over LapiLock 4D system. Later resolved by mutual agreement.
Oct 2024
Treace sues Stryker / Wright Medical Nine-patent infringement claim plus unfair bundled-contract competition allegations in the bunion market.
May 2024
Stock falls ~63% overnight Q1 disclosure cites minimally-invasive osteotomy (MIS) competition; market reprices growth assumptions sharply.
Apr 2025
Securities class action filed M.D. Fla. Class period May 2023 – May 2024. Allegations of misleading statements on demand and competitive landscape.
Jun 2025
Treace sues Zimmer Biomet / Paragon 28 Four additional Lapiplasty-related patents asserted. Market consolidation continues.

The clinical question — whether tri-planar Lapidus bunionectomy outperforms appropriately-selected distal osteotomy or modified MIS techniques across age, deformity severity, and recurrence — remains genuinely open. The literature is improving but heavily populated by surgeons with industry relationships to one or another platform. ⚠ verify Long-term comparative outcome evidence is lower than the marketing positioning suggests, on every side of the question. The structural lesson: the speed of industry diffusion routinely outruns the speed of independent evaluation — and the profession's tools for that evaluation are themselves industry-funded more often than not.

§ 07

The choices were already made for you.

FOR THE TRAINEE
JAMA Network Open · 2023

65,992 residents studied.

Residents at privately-owned sponsoring institutions had elevated probability of accepting industry payments. Residents in surgical specialties had elevated probability across the board compared to internal medicine.

The supply chain is inherited.

F&A Fellowship Faculty

$1.5M+ avg.

Lifetime industry earnings reported among faculty at orthopedic foot-and-ankle fellowship programs (Open Payments, 2015–2021 cohort). Wide variability across programs; the relationships are inherited along with the technique.

Residents are not formally covered recipients under the Sunshine Act — but they enter a learning environment in which their attendings are. Mentor-to-trainee transmission of practice patterns is the entire point of residency. This is not framed as a critique. It is framed as a warning: the resident who never thinks about this is, by default, downstream of decisions made by people they have never met. The work for the trainee is to develop a stance — neither hostile to industry nor captured by it — early enough that it becomes a habit rather than a posture.

§ 08

Six discipline rules.

A WORKING STANCE
01
Audit your own Open Payments page annually. Once per year, before any conference disclosure or manuscript submission. The data exists. The discrepancy literature exists because physicians do not look at it.
02
Distinguish royalty from speaker fee. A royalty is a long-term IP relationship to a specific implant. A speaker fee is a transient consulting touch. Both must be disclosed. They mean different things for bias risk.
03
Read the primary literature on every device you use. If the only outcome data on an implant comes from authors with royalty relationships to that implant, name that fact in your own thinking. It calibrates the work; it does not invalidate it.
04
Know what the wound-care line looks like. If a sales rep offers to apply a product to a patient, that is the line. If a billing arrangement scales with product volume, that is the line. The DOJ knows what the line looks like.
05
Push your societies on disclosure rigor. ACFAS, APMA, AOFAS — the discrepancy gap is a society-level governance problem. The fix is mandatory cross-referencing of self-disclosure against Open Payments at submission. Technically trivial. Politically slow.
06
Refuse the false binary. Pretending you have no industry exposure is a fiction. Pretending industry exposure makes you compromised is a different fiction. Both end at the same place: a profession that cannot govern its own relationships.
§ 09

The genuine open questions.

HONEST BROKER
✓
Reasonably Established

What the data shows.

  • The Sunshine Act mechanism captures the data.
  • F&A industry payments are increasing— shifting toward education, royalties, consulting.
  • Disclosure-discrepancy rates are non-trivial— replicated across multiple orthopedic settings.
  • Skin substitute spending grew faster than population.
  • Industry-funded research correlates with positive findings on the funder's product.(Well-replicated across specialties.)
?
What We Do Not Know

Where the literature is thin.

  • Whether transparency itself changes prescribing.Some evidence suggests "moral licensing" partially offsets the transparency effect.
  • Whether industry-funded innovation outperforms unfunded alternatives.The counterfactual cannot be run.
  • Where the line sits between collaboration and capture— in any given subspecialty.
  • Whether the CMS rule fixes culture, or only pricing.
  • Whether DPM-specific patterns differ from orthopedic F&A data.Real research gap; very few published analyses use DPM as the unit of analysis.

This last point is worth dwelling on. Most published Open Payments analyses in foot and ankle have used orthopedic surgeons as the unit of analysis, not podiatric surgeons specifically. There is a real research gap here for any DPM analyst willing to do the work.

Confidence rating

8 / 10 · HIGH
Quant Data
Federal sources, peer-reviewed.
DOJ Cases
Public indictments & settlements.
CMS Policy
Final rule, current.
Treace Litig.
Public filings; outcome unsettled.
Discrepancy %
Multiple replications, ortho-weighted.
DPM-Specific
Limited; orthopedic data extrapolated.
§ 11

Primary sources.

REFERENCES

Cited in this briefing

  1. Casciato DJ, Brown J, Yancovitz S, Mendicino RW. Self-Reported COIs and Financial Disclosures in JFAS: A Systematic Review. J Foot Ankle Surg. 2022;61(5):1119–1123.
  2. Donoughe JS, Safavi KS, Rezvani A, et al. Industry Payments to Foot and Ankle Surgeons and Their Effect on Total Ankle Arthroplasty Outcomes. Foot Ankle Spec. 2021.
  3. Khan MM, et al. Industry Payments to Foot and Ankle-Trained Orthopedic Surgeons (Open Payments 2014–2019). Cureus. 2024.
  4. Tarazi JM, Frane N, Sherman AE, et al. Industry Payments to Orthopedic Surgeons Among All Subspecialties (2014–2019). Cureus. 2024;16(2):e54981.
  5. Anastasio AT, Baumann AN, Walley KC, Adams SB. Orthopaedic F&A Fellowship Characteristics and Industry Payments. Foot Ankle Orthop. 2023.
  6. AAOS Annual Meeting Disclosure Discrepancy Study (2019 cohort) — ~35% inconsistency rate. JAAOS. 2022.
  7. Hogan SO, Yamazaki K, Jing Y, et al. Industry Payments Received by Residents During Training. JAMA Netw Open. 2023;6(10):e2337904.
  8. King JS, Salama AH, Sanjay A, et al. Trends in Industry-Sponsored Research Funding to Orthopaedic Surgeons (2017–2024). medRxiv preprint 2025.
  9. CMS. CY 2026 Medicare Physician Fee Schedule Final Rule (CMS-1832-F). October 31, 2025.
  10. U.S. DOJ. 2025 National Health Care Fraud Takedown — Wound Care Initiative summaries (Apex Medical, Vohra Wound Physicians, Jenson DPM).
  11. HHS Office of Inspector General. Skin Substitute Spending Review. Cited in CY 2026 PFS final rule.
  12. Treace Medical Concepts, Inc. Public SEC filings & McCluney v. Treace Medical Concepts, Inc., No. 25-cv-00390 (M.D. Fla. 2025).
  13. APMA. Corporate Member Program; Industry Opportunities at The National.
  14. Physician Payments Sunshine Act, ACA 2010, 42 U.S.C. § 1320a-7h. openpaymentsdata.cms.gov

Editorial policy & disclosures

Source materials. Federal databases (CMS Open Payments, DOJ public charging documents, CMS rule-making), peer-reviewed orthopedic and podiatric literature, and public corporate filings. Quotation minimized; original sources cited.

AI use in production. Researched and drafted by Peter Sorensen, DPM, with a large language model used as a research-assistant tool for source synthesis and structural drafting. All source review, quantitative claims, framing, and editorial judgment are the author's.

Reader responsibility. Readers are responsible for verifying institutional access to peer-reviewed studies and reading the primary work. Statistical claims drawn from preprint or non-final regulatory documents are flagged inline with the ⚠ verify notation.

Author disclosures. The author has no royalty, consulting, speaker, equity, or research relationship with any of the device manufacturers or skin-substitute companies named. The author is a member of the APMA Emerging Leaders Program; editorial framing developed independently of that role.

General AI disclaimer. Editorial analysis intended for educational and journalistic purposes. Not legal, billing, regulatory, or clinical advice.