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docs: add Research section to Docusaurus with skin substitutes pages

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New sidebar section "Research" with skin substitutes sub-pages:
- Overview: hypothesis, background, key cases, data sources, phase status
- Literature Methods: search queries, PRISMA flow, grey lit catalogue
- Evidence Base: tag schema, collection hierarchy, COI enrichment, querying

Moves documentation from dev/docs/ into the Docusaurus site where it
belongs. Research section follows existing autogenerated sidebar pattern.
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kert
2026-03-25 11:43:18 -04:00
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# Skin Substitutes Literature Review: Methods
## Search Strategy
### Databases
- **PubMed** (MEDLINE) via NCBI E-utilities (esearch + efetch XML)
- **Grey literature**: OIG, CMS, GAO, MedPAC, DOJ, court filings, MAC LCDs, industry
### Date Range
- PubMed: inception through 2026-03-25
- Grey literature: 2015-current (enforcement), 2012-current (CMS rules)
### Search Date
2026-03-25
## PubMed Search Queries
### Domain 1: Clinical Efficacy
```
("skin substitutes"[MeSH] OR "biological dressings"[MeSH]
OR "tissue scaffolds"[MeSH] OR "bioengineered skin"[tiab]
OR "cellular tissue product"[tiab] OR "wound matrix"[tiab]
OR "skin substitute"[tiab] OR "skin substitutes"[tiab]
OR "Apligraf"[tiab] OR "EpiFix"[tiab] OR "Grafix"[tiab]
OR "DermACELL"[tiab] OR "Dermagraft"[tiab])
AND ("wound healing"[MeSH] OR "treatment outcome"[MeSH]
OR "clinical trial"[pt] OR "randomized controlled trial"[pt]
OR "systematic review"[pt] OR "meta-analysis"[pt]
OR "efficacy"[tiab] OR "effectiveness"[tiab])
```
**Result: 7,448 records**
### Domain 2: Cost-Effectiveness
```
("skin substitutes"[MeSH] OR "biological dressings"[MeSH]
OR "skin substitute"[tiab] OR "skin substitutes"[tiab]
OR "cellular tissue product"[tiab])
AND ("costs and cost analysis"[MeSH]
OR "cost-benefit analysis"[MeSH]
OR "health care costs"[MeSH] OR "medicare"[MeSH]
OR "reimbursement"[tiab] OR "cost-effectiveness"[tiab]
OR "economic"[tiab] OR "spending"[tiab]
OR "average sales price"[tiab] OR "ASP"[tiab])
```
**Result: 123 records**
### Domain 3: Fraud, Waste, and Abuse
```
("skin substitutes"[MeSH] OR "biological dressings"[MeSH]
OR "skin substitute"[tiab] OR "skin substitutes"[tiab]
OR "cellular tissue product"[tiab] OR "wound care"[tiab])
AND ("fraud"[MeSH] OR "waste"[tiab] OR "abuse"[tiab]
OR "inappropriate"[tiab] OR "overutilization"[tiab]
OR "billing"[tiab] OR "enforcement"[tiab]
OR "compliance"[tiab] OR "medically unnecessary"[tiab]
OR "upcoding"[tiab] OR "kickback"[tiab])
```
**Result: 358 records**
## PRISMA Flow
```
Records identified through PubMed:
Clinical efficacy: 7,448
Cost-effectiveness: 123
Fraud/waste/abuse: 358
─────────────────────────────
TOTAL identified: 7,929
Duplicates removed: 112
Unique articles: 7,817
By publication type:
Meta-analyses: 85
Systematic reviews: 1,395
RCTs: 455
Other (observational,
case reports, etc.): 5,882
```
## Grey Literature Sources (20 documents)
| Source | Count | Description |
|-----------|------:|------------------------------------------------------|
| OIG | 3 | Sept 2025 payment trends, SAB, audit reports |
| CMS | 4 | OPPS/PFS final rules (2024-2026), Benefit Policy |
| DOJ | 1 | National healthcare fraud enforcement action |
| Court | 3 | Jenson (S.D. Tex.), Gehrke/King (D. Ariz.), Vohra |
| GAO | 1 | Part B biologicals spending (GAO-23-105537) |
| MedPAC | 2 | June 2024, March 2025 Reports to Congress |
| MAC LCD | 4 | Noridian, CGS, First Coast, Palmetto |
| Industry | 2 | Alliance position statement, WHS guidelines |
## Conflict of Interest / Stance Enrichment
PubMed articles were enriched with automated COI and stance detection:
| Tag | Count | Method |
|-----------------------|------:|-------------------------------------------------|
| coi:single-product | 2,003 | Only one brand name mentioned in title/abstract |
| stance:skeptical | 598 | Negative outcome language in abstract |
| stance:favorable | 510 | Positive outcome language in title |
| coi:industry-linked | 11 | Funding/employment patterns in extra metadata |
**Enrichment coverage:** 2,862 / 7,817 PubMed articles (36.6%)
## Tag Schema
All items tagged with `module:skin-subs` plus:
- **Source tags:** `source:pubmed`, `source:oig`, `source:cms`, `source:court`,
`source:doj`, `source:gao`, `source:medpac`, `source:mac-lcd`, `source:industry`
- **Type tags:** `type:clinical`, `type:economic`, `type:fraud`, `type:rct`,
`type:review`, `type:meta-analysis`, `type:report`, `type:rule`, `type:filing`,
`type:lcd`, `type:position`, `type:press-release`, `type:manual`
- **Year tags:** `year:YYYY`
- **COI tags:** `coi:industry-linked`, `coi:single-product`
- **Stance tags:** `stance:skeptical`, `stance:favorable`
- **Entity tags:** `entity:oig`, `entity:doj`, `entity:gao`, `entity:medpac`,
`entity:noridian`, `entity:cgs`, `entity:first-coast`, `entity:palmetto`
- **Case tags:** `case:jenson`, `case:gehrke-king`, `case:vohra`
- **Rule tags:** `rule:cy2026-opps`, `rule:cy2025-opps`, `rule:cy2024-pfs`
## Collection Hierarchy
```
Skin Substitutes/
Clinical Evidence/
RCTs (455 items)
Systematic Reviews (1,395 items)
Meta-Analyses (85 items)
Observational Studies (5,547 items)
CMS Policy/
Final Rules (OPPS/PFS) (3 items)
Benefit Policy Manuals (1 item)
ASP Pricing Files
OIG Reports (3 items)
GAO & MedPAC (3 items)
Enforcement/
DOJ Press Releases (1 item)
Court Filings (3 items)
MAC LCDs (4 items)
Market Data
Industry & Societies (2 items)
Cost-Effectiveness (70 items)
Fraud & Abuse Literature (265 items)
```
## Scripts
| Script | Purpose |
|--------|---------|
| `dev/scripts/search_pubmed_skin_subs.py` | PubMed E-utilities search, XML parsing, bib.sqlite storage |
| `dev/scripts/collect_grey_lit_skin_subs.py` | Curated grey literature catalogue, bib.sqlite storage |
| `dev/scripts/build_skin_subs_evidence_base.py` | Collection hierarchy, COI enrichment, verification |
## Limitations
1. **No full-text screening**: Articles included based on PubMed metadata only; no manual
title/abstract screening for relevance (full PRISMA would require human review)
2. **COI detection is heuristic**: Based on keyword patterns in abstracts and metadata,
not full-text disclosure sections
3. **Grey literature is curated, not systematic**: Known key documents captured; no
systematic search of OIG/GAO/PACER databases
4. **No Cochrane Library**: Only PubMed searched for journal literature
5. **No citation network analysis**: Forward/backward snowball not yet performed (#237)
6. **No quantitative meta-analysis**: Study data extraction and pooling not yet done (#237)

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{"label": "Research", "position": 13}

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---
title: Research
sidebar_position: 1
---
# Research
Analytical use of the Stack platform for healthcare policy research.
Each research project uses the platform's data infrastructure (DuckDB, pipeline runner, bibliography system) to investigate a specific question. Evidence is stored in `bib.sqlite` with structured tags and collections; analysis is reproducible via scripts in `dev/scripts/` and interactive notebooks in `notebooks/`.
## Active Projects
| Project | Status | Evidence | Milestone |
|---------|--------|----------|-----------|
| [Skin Substitutes](skin-substitutes/) | In progress | 7,837 items | P29 |
## Methodology
All research projects follow a common workflow:
1. **Data acquisition** -- ingest administrative data (HCPCS codes, ASP pricing, claims)
2. **Literature search** -- systematic PubMed search + curated grey literature
3. **Evidence base** -- structured tagging and collection hierarchy in `bib.sqlite`
4. **Analysis** -- narwhals/DuckDB pipelines, marimo notebooks
5. **Documentation** -- methods, PRISMA flow, limitations documented in Docusaurus

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{"label": "Skin Substitutes", "position": 1}

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---
title: Evidence Base
sidebar_position: 3
---
# Evidence Base
All evidence for the skin substitutes analysis is stored in `bib.sqlite` with structured tags and organized into collections. The evidence base currently contains **7,837 items**.
## Tag Schema
All items carry `module:skin-subs` plus additional tags from these namespaces:
### Source Tags
| Tag | Count | Description |
|-----|------:|-------------|
| `source:pubmed` | 7,817 | PubMed journal articles |
| `source:oig` | 3 | HHS Office of Inspector General reports |
| `source:cms` | 4 | CMS rules and manuals |
| `source:court` | 3 | Court filings and settlements |
| `source:doj` | 1 | DOJ press releases |
| `source:gao` | 1 | Government Accountability Office |
| `source:medpac` | 2 | Medicare Payment Advisory Commission |
| `source:mac-lcd` | 4 | Medicare Administrative Contractor LCDs |
| `source:industry` | 2 | Industry and professional society documents |
### Type Tags
| Tag | Count | Description |
|-----|------:|-------------|
| `type:clinical` | 7,445 | Clinical efficacy domain |
| `type:review` | 1,395 | Systematic reviews |
| `type:rct` | 455 | Randomized controlled trials |
| `type:fraud` | 356 | Fraud/waste/abuse domain |
| `type:economic` | 123 | Cost-effectiveness domain |
| `type:meta-analysis` | 85 | Meta-analyses |
| `type:report` | 6 | Government reports |
| `type:lcd` | 4 | Local Coverage Determinations |
| `type:rule` | 3 | Federal Register rules |
| `type:filing` | 3 | Court filings |
| `type:position` | 2 | Position statements |
| `type:press-release` | 1 | DOJ press release |
| `type:manual` | 1 | CMS manual chapter |
### Enrichment Tags
COI and stance tags are applied via automated heuristic analysis of PubMed article metadata.
| Tag | Count | Method |
|-----|------:|--------|
| `coi:single-product` | 2,003 | Only one brand name in title/abstract |
| `stance:skeptical` | 598 | Negative outcome language in abstract |
| `stance:favorable` | 510 | Positive outcome language in title |
| `coi:industry-linked` | 11 | Funding/employment patterns in metadata |
**Enrichment coverage:** 2,862 / 7,817 PubMed articles (36.6%)
### Other Tags
- **Year:** `year:YYYY` on all items
- **Entity:** `entity:oig`, `entity:doj`, `entity:gao`, `entity:medpac`, `entity:noridian`, `entity:cgs`, `entity:first-coast`, `entity:palmetto`
- **Case:** `case:jenson`, `case:gehrke-king`, `case:vohra`
- **Rule:** `rule:cy2026-opps`, `rule:cy2025-opps`, `rule:cy2024-pfs`
## Collection Hierarchy
```
Skin Substitutes/
Clinical Evidence/
RCTs (455)
Systematic Reviews (1,395)
Meta-Analyses (85)
Observational Studies (5,547)
CMS Policy/
Final Rules (OPPS/PFS) (3)
Benefit Policy Manuals (1)
ASP Pricing Files
OIG Reports (3)
GAO & MedPAC (3)
Enforcement/
DOJ Press Releases (1)
Court Filings (3)
MAC LCDs (4)
Market Data
Industry & Societies (2)
Cost-Effectiveness (70)
Fraud & Abuse Literature (265)
```
## Querying the Evidence Base
```python
from bib.store import Store
store = Store()
# All skin-subs items
items = store.list_items(tag="module:skin-subs")
# Only RCTs
rcts = store.list_items(tag="type:rct")
# Industry-linked studies
coi = store.list_items(tag="coi:industry-linked")
# Export to DataFrame
df = store.to_dataframe(tag="module:skin-subs")
```
## Remaining Work
- Cochrane Library search for existing systematic reviews
- Forward/backward snowball citation chasing from included studies
- Quantitative meta-analysis where RCTs report comparable outcomes
- Additional court filings from PACER
- Additional MAC LCDs from remaining jurisdictions
- GRADE assessment of evidence quality per product category

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---
title: Overview
sidebar_position: 1
---
# Skin Substitutes
Predatory pricing, distribution, and utilization analysis of skin substitute / cellular tissue products (CTPs) in the Medicare program.
## Hypothesis
Certain distributors, products, geographies, and care settings are softer or harder targets for predatory use, distribution, and pricing of skin substitutes.
## Background
Medicare spending on skin substitutes grew from $256M in 2019 to over $10B by 2024. The DOJ's 2025 National Health Care Fraud Enforcement Action charged 324 defendants across $14.6B in alleged fraud, with skin substitutes as a primary target area. CMS responded with a January 2026 reclassification from drugs/biologicals (ASP+6%) to incident-to supplies (flat $127.28/cm^2), projecting $9.4B in savings over 10 years.
## Key Cases
| Case | Venue | Billed | Paid | Allegation |
|------|-------|--------|------|------------|
| USA v. Jenson et al. | S.D. Tex. (4:25-cr-00271) | $90M | $45M | Podiatry clinic, medically unnecessary applications |
| USA v. Gehrke & King | D. Ariz. | $1.2B | $615M | Mobile wound care, nationwide kickback network |
| Vohra Wound Physicians | S.D. Fla. | -- | $45M settlement | EMR auto-upcoding of wound care services |
## Data Sources
| Source | Records | Script |
|--------|---------|--------|
| HCPCS code universe | 286 products + 34 reference codes | `dev/scripts/generate_skin_sub_claims.py` |
| ASP quarterly pricing | 1,974 rows (2009-Q1 to present) | `dev/scripts/ingest_asp.py` |
| Synthetic claims | 4,257 encounter lines | `dev/scripts/generate_skin_sub_claims.py` |
| PubMed articles | 7,817 unique | `dev/scripts/search_pubmed_skin_subs.py` |
| Grey literature | 20 curated documents | `dev/scripts/collect_grey_lit_skin_subs.py` |
## Phases
| Phase | Issues | Status |
|-------|--------|--------|
| 1. Data acquisition | #232-#234 | Complete |
| 2. Literature search | #235-#237 | ~75% |
| 3. Market segmentation | #238-#239 | Not started |
| 4. Geographic/setting analysis | #240-#241 | Not started |
| 5. Hypothesis testing | #242-#243 | Not started |
| 6. Deliverables | #244-#246 | ~75% (#244) |
## Pages
- [Literature Methods](literature-methods) -- search strategy, PRISMA flow, tag schema
- [Evidence Base](evidence-base) -- collection hierarchy, COI enrichment, verification

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---
title: Literature Methods
sidebar_position: 2
---
# Literature Review Methods
Systematic literature search covering clinical efficacy, cost-effectiveness, and fraud/waste/abuse domains for skin substitutes and cellular tissue products.
## Databases
- **PubMed** (MEDLINE) via NCBI E-utilities (esearch + efetch XML)
- **Grey literature**: OIG, CMS, GAO, MedPAC, DOJ, court filings, MAC LCDs, industry
**Search date:** 2026-03-25
**Date range:** PubMed inception through search date; grey literature 2012--current (CMS rules), 2015--current (enforcement)
## PubMed Search Queries
### Domain 1: Clinical Efficacy
```
("skin substitutes"[MeSH] OR "biological dressings"[MeSH]
OR "tissue scaffolds"[MeSH] OR "bioengineered skin"[tiab]
OR "cellular tissue product"[tiab] OR "wound matrix"[tiab]
OR "skin substitute"[tiab] OR "skin substitutes"[tiab]
OR "Apligraf"[tiab] OR "EpiFix"[tiab] OR "Grafix"[tiab]
OR "DermACELL"[tiab] OR "Dermagraft"[tiab])
AND ("wound healing"[MeSH] OR "treatment outcome"[MeSH]
OR "clinical trial"[pt] OR "randomized controlled trial"[pt]
OR "systematic review"[pt] OR "meta-analysis"[pt]
OR "efficacy"[tiab] OR "effectiveness"[tiab])
```
**Result: 7,448 records**
### Domain 2: Cost-Effectiveness
```
("skin substitutes"[MeSH] OR "biological dressings"[MeSH]
OR "skin substitute"[tiab] OR "skin substitutes"[tiab]
OR "cellular tissue product"[tiab])
AND ("costs and cost analysis"[MeSH]
OR "cost-benefit analysis"[MeSH]
OR "health care costs"[MeSH] OR "medicare"[MeSH]
OR "reimbursement"[tiab] OR "cost-effectiveness"[tiab]
OR "economic"[tiab] OR "spending"[tiab]
OR "average sales price"[tiab] OR "ASP"[tiab])
```
**Result: 123 records**
### Domain 3: Fraud, Waste, and Abuse
```
("skin substitutes"[MeSH] OR "biological dressings"[MeSH]
OR "skin substitute"[tiab] OR "skin substitutes"[tiab]
OR "cellular tissue product"[tiab] OR "wound care"[tiab])
AND ("fraud"[MeSH] OR "waste"[tiab] OR "abuse"[tiab]
OR "inappropriate"[tiab] OR "overutilization"[tiab]
OR "billing"[tiab] OR "enforcement"[tiab]
OR "compliance"[tiab] OR "medically unnecessary"[tiab]
OR "upcoding"[tiab] OR "kickback"[tiab])
```
**Result: 358 records**
## PRISMA Flow
### Identification
| Domain | Records |
|--------|--------:|
| Clinical efficacy | 7,448 |
| Cost-effectiveness | 123 |
| Fraud/waste/abuse | 358 |
| **Total identified** | **7,929** |
### Deduplication
| Step | Records |
|------|--------:|
| Duplicates removed | 112 |
| **Unique articles** | **7,817** |
### By Publication Type
| Type | Count |
|------|------:|
| Meta-analyses | 85 |
| Systematic reviews | 1,395 |
| RCTs | 455 |
| Other (observational, case reports, etc.) | 5,882 |
## Grey Literature
20 curated documents across 8 source categories.
| Source | Count | Key Documents |
|--------|------:|---------------|
| OIG | 3 | Sept 2025 payment trends report, Special Advisory Bulletin, audit |
| CMS | 4 | OPPS/PFS final rules (CY2024--2026), Benefit Policy Manual ch.15 |
| DOJ | 1 | National healthcare fraud enforcement action (2025) |
| Court | 3 | Jenson (S.D. Tex.), Gehrke/King (D. Ariz.), Vohra (S.D. Fla.) |
| GAO | 1 | GAO-23-105537: Part B biologicals spending |
| MedPAC | 2 | June 2024 and March 2025 Reports to Congress |
| MAC LCD | 4 | Noridian L39831, CGS L38916, First Coast L36498, Palmetto L35041 |
| Industry | 2 | Alliance of Wound Care Stakeholders position, WHS guidelines |
## Scripts
| Script | Purpose |
|--------|---------|
| `dev/scripts/search_pubmed_skin_subs.py` | PubMed E-utilities search, XML parsing, bib.sqlite storage |
| `dev/scripts/collect_grey_lit_skin_subs.py` | Curated grey literature catalogue |
| `dev/scripts/build_skin_subs_evidence_base.py` | Collection hierarchy, COI enrichment, verification |
## Limitations
1. **No full-text screening** -- articles included based on PubMed metadata only; full PRISMA would require human title/abstract review
2. **No Cochrane Library** -- only PubMed searched for journal literature
3. **Grey literature is curated, not systematic** -- known key documents captured; no systematic PACER/OIG/GAO database search
4. **No citation network analysis** -- forward/backward snowball not yet performed
5. **No quantitative meta-analysis** -- study data extraction and pooling not yet done

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type: "autogenerated", type: "autogenerated",
dirName: "pipelines", dirName: "pipelines",
}, },
{
type: "autogenerated",
dirName: "research",
},
"dag", "dag",
], ],
}; };