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skin-subs: grey literature — OIG reports, CMS rules, GAO, MedPAC, court filings #236

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opened 2026-03-25 05:34:29 +00:00 by kert · 3 comments
kert commented 2026-03-25 05:34:29 +00:00
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Objective

Capture all non-journal evidence: regulatory, enforcement, and policy documents.

Tasks

  • OIG reports on skin substitutes (2015–current), especially Sept 2025 payment trends report
  • CMS final rules: OPPS, PFS, MPFS that define/modify skin substitute payment (2012–2026)
  • CMS Jan 2026 reclassification rule (drugs/biologicals → incident-to supplies, flat $127.28/cm²)
  • GAO reports on wound care/biologicals spending
  • MedPAC reports and testimony on Part B drug/biological spending
  • DOJ press releases: Jenson (S.D. Tex.), Gehrke/King (D. Ariz.), Vohra (S.D. Fla.)
  • Court filings: superseding indictment (4:25-cr-00271), plea agreements, sentencing memos
  • MAC Local Coverage Determinations (LCDs) for skin substitutes — all jurisdictions
  • Industry white papers, wound care society position statements
  • All captured in Zotero with tags: source:oig|cms|gao|medpac|court|mac-lcd|industry
## Objective Capture all non-journal evidence: regulatory, enforcement, and policy documents. ## Tasks - [ ] OIG reports on skin substitutes (2015–current), especially Sept 2025 payment trends report - [ ] CMS final rules: OPPS, PFS, MPFS that define/modify skin substitute payment (2012–2026) - [ ] CMS Jan 2026 reclassification rule (drugs/biologicals → incident-to supplies, flat $127.28/cm²) - [ ] GAO reports on wound care/biologicals spending - [ ] MedPAC reports and testimony on Part B drug/biological spending - [ ] DOJ press releases: Jenson (S.D. Tex.), Gehrke/King (D. Ariz.), Vohra (S.D. Fla.) - [ ] Court filings: superseding indictment (4:25-cr-00271), plea agreements, sentencing memos - [ ] MAC Local Coverage Determinations (LCDs) for skin substitutes — all jurisdictions - [ ] Industry white papers, wound care society position statements - [ ] All captured in Zotero with tags: `source:oig|cms|gao|medpac|court|mac-lcd|industry`
kert added this to the P29: Skin Substitutes — predatory pricing, distribution, and utilization analysis milestone 2026-03-25 05:34:29 +00:00
kert commented 2026-03-25 14:07:18 +00:00
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Additional source identified: CMS Town Hall meetings.

CMS conducts public town hall calls when proposing major payment changes. The skin substitute reclassification (CY 2025/2026 OPPS) generated significant town hall activity:

  • CMS OPPS Town Hall transcripts (2024-2025) — industry testimony on reclassification impact
  • Stakeholder comment letters on proposed rule CMS-1809-P and final rule CMS-1834-FC
  • CMS responses to public comments in the final rule preamble
  • These document: manufacturer lobbying positions, provider impact estimates, CMS policy rationale

These are critical for the predatory pattern analysis because they reveal:

  1. Which manufacturers argued hardest against reclassification (potential conflict of interest indicator)
  2. CMS quantitative estimates of spending impact ($9.4B savings)
  3. Industry claims about clinical necessity vs CMS findings on waste

Need to be captured as Zotero items with tags: source:cms-townhall, source:cms-comment-letter, module:skin-subs

**Additional source identified: CMS Town Hall meetings.** CMS conducts public town hall calls when proposing major payment changes. The skin substitute reclassification (CY 2025/2026 OPPS) generated significant town hall activity: - CMS OPPS Town Hall transcripts (2024-2025) — industry testimony on reclassification impact - Stakeholder comment letters on proposed rule CMS-1809-P and final rule CMS-1834-FC - CMS responses to public comments in the final rule preamble - These document: manufacturer lobbying positions, provider impact estimates, CMS policy rationale These are critical for the predatory pattern analysis because they reveal: 1. Which manufacturers argued hardest against reclassification (potential conflict of interest indicator) 2. CMS quantitative estimates of spending impact ($9.4B savings) 3. Industry claims about clinical necessity vs CMS findings on waste Need to be captured as Zotero items with tags: `source:cms-townhall`, `source:cms-comment-letter`, `module:skin-subs`
kert commented 2026-03-25 15:39:39 +00:00
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~75% complete. PubMed search done (7,817 articles), grey lit catalogue done (20 docs), evidence base built with collections + COI enrichment. Remaining: PRISMA screening, snowball citation chasing, quantitative meta-analysis, Cochrane search, additional court filings/LCDs.

~75% complete. PubMed search done (7,817 articles), grey lit catalogue done (20 docs), evidence base built with collections + COI enrichment. Remaining: PRISMA screening, snowball citation chasing, quantitative meta-analysis, Cochrane search, additional court filings/LCDs.
kert commented 2026-03-25 15:59:40 +00:00
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~90% complete. Added: study characteristics table (7,817 rows, product/sample size extraction), forward snowball (2,415 new articles), entity tags (2,130 items), expanded grey lit (30 docs: +4 CMS rules, +3 LCDs, +2 court filings, +1 OIG). Evidence base in DuckDB (10,262 rows). Remaining: Cochrane, quantitative meta-analysis, GRADE assessment.

~90% complete. Added: study characteristics table (7,817 rows, product/sample size extraction), forward snowball (2,415 new articles), entity tags (2,130 items), expanded grey lit (30 docs: +4 CMS rules, +3 LCDs, +2 court filings, +1 OIG). Evidence base in DuckDB (10,262 rows). Remaining: Cochrane, quantitative meta-analysis, GRADE assessment.
kert closed this issue 2026-03-26 06:14:38 +00:00
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