Domain dossier
Shared background for a clinical problem, keyed by domain rather
than by candidate, so the second idea in an area starts from the first one's research.
A dossier carries no confidence tags. A line here has to be copied into a
candidate's claims as unverified before anything can check or score it.
Used by: idea-008
Research reports behind it: care-pathway · clinical-evidence · epidemiology · market-players · reference-products · reimbursement · technology · user-groups
Internal hemorrhoids are graded I-IV by degree of prolapse; grade II-III disease is the band where conservative management has failed but full surgical hemorrhoidectomy is not yet required, and where an in-office procedural device competes directly against rubber band ligation, infrared coagulation, and sclerotherapy — all cheap, established, already-owned instruments. State the thinness up front: this pass ran a broad literature sweep and a real CMS payment-file retrieval (a genuine first for this repo's reimbursement work — see §6) but did not touch epidemiology beyond one review-article prevalence figure, did not search user groups/incentives at all, and could not retrieve full text of either ASCRS clinical practice guideline (paywalled). A later reader should treat sections 2, 3, and the grade-specific epidemiology row in §1 as effectively unwritten.
This file carries no confidence tags. Every line below is context with a source attached. To affect a score, a line must be copied into a candidate's ## Claims as unverified and pass the Verifier or the Corroborator. See README.md in this directory.
CPT descriptors are AMA-licensed and are never reproduced here, in whole or in short-descriptor form — §6 scopes strictly to code numbers and CMS administrative-file fields (RVUs, global-day indicator, conversion factor), never to the codes' descriptive text.
as_of: 2026-08-27 · sources searched: connectors literature ("prevalence hemorrhoids United States" — too broad to be useful, and "hemorrhoids grade distribution" was not separately run), literature-detail on the two review articles below · not searched: incidence, demographic/racial/regional concentration, trend direction, and — the gap that matters most for this domain — what share of symptomatic patients present at grade II-III specifically rather than grade I or IV
| Fact | Quantity (n, population, date) | Source |
|---|---|---|
| Prevalence, US | "affects approximately 10 million individuals in the US" | JAMA narrative review, 2025 [1] |
| Pregnancy subgroup | hemorrhoids occur in "up to two-thirds of women during pregnancy" | AGA Clinical Practice Update, 2026 [2] |
| Incidence | not found — not separately searched | — |
| Grade II-III share of presentations | not found — not searched | — |
| Trend direction | not found — not searched | — |
Verbatim:
"Hemorrhoidal disease, pathology of the tissue lining of the anal canal, affects approximately 10 million individuals in the US." — [1]
Read this narrowly: [1] is a JAMA narrative review (tertiary source, no methods section, no stated primary source for the 10-million figure itself), not a US surveillance study. It is the only US population-level prevalence figure this pass located, and it is not grade-stratified.
Gaps: grade-specific prevalence (the number that would size this candidate's actual addressable population) is not found, not merely not searched hard enough — one broad query returned 3,749 matches dominated by unrelated colorectal-surgery topics and was not narrowed further this pass. Incidence, demographic concentration, and trend direction were not searched at all.
as_of: 2026-08-27 · sources searched: the two guideline-adjacent abstracts in §4; one literature query for "hemorrhoids primary care referral colorectal surgery office procedure" (0 results) · not searched: anything about primary care as an entry point, throughput, staffing, or equipment already in the room
| Step in the pathway | Setting / site of service | Who performs it | What equipment is already there | Source |
|---|---|---|---|---|
| Diagnosis / grading | Office, on history and exam | Not established which specialty sees the patient first | Anoscope ("should be performed, whenever possible, on every new patient with suspected hemorrhoids... prior to treatment") | [2] |
| First-line procedural treatment (grade I-III) | Office, no sedation | Both gastroenterology and colorectal surgery claim this scope (see below) | Banding device, IRC unit, or sclerosant + anoscope | [1][2] |
| Escalation to surgery (grade III failing banding, or grade IV) | Facility / OR | Colorectal surgeon | Standard surgical suite | [1][2] |
Two societies claim overlapping ownership of this pathway, and this dossier does not resolve which one sees a given patient first. AGA's own guideline states outright: "The diagnosis and treatment of hemorrhoids is within the purview of the gastroenterologist" — [2]. ASCRS separately maintains its own hemorrhoid guideline (2018 [3], updated 2024 [4]) as the colorectal-surgery society's counterpart document. Neither source in this pass states what fraction of grade II-III patients enter through primary care, gastroenterology, or colorectal surgery directly — that split is not found.
Verbatim:
"BPA 4: Anoscopy should be performed, whenever possible, on every new patient with suspected hemorrhoids, prior to treatment, to ensure accurate diagnosis." — [2]
Gaps: the entire primary-care-to-specialist referral question; staffing and throughput in the office setting; whether the procedure is typically done at initial consultation or a follow-up visit.
as_of: 2026-08-27
Not searched. No source has been queried for this section. Recorded so the shape is visible: prescriber/decider (whichever specialty sees the patient — see §2's unresolved split), operator (the same physician, since this is a same-visit office procedure, not a device handed to ancillary staff), purchaser (the practice), payer (Medicare and commercial, with the site-of-service economics turning on the non-facility payment — see §6), and patient are at minimum five parties. None of their incentives are evidenced here.
Gaps: the entire section.
as_of: 2026-08-27 · sources searched: connectors literature ("ASCRS clinical practice guideline hemorrhoids", "clinical practice guideline management of hemorrhoids Davis", "rubber band ligation internal hemorrhoids recurrence", "infrared coagulation hemorrhoids recurrence"), literature-detail on 10 PMIDs, one attempted WebFetch of the ASCRS 2018 guideline's paywalled full text (HTTP 402) and one of its free-toolkit PDF mirror (retrieved 947.7KB of binary PDF content that this pass's tools could not render to text — pdftoppm/ poppler-utils is not installed in this environment) · not searched: CLSI/KDIGO-equivalent formal evidence grading tables, the ASCRS document's own cited evidence base
The ASCRS guideline's existence is established; its content is not retrievable this pass, and that is a stated access limitation, not a finding about its content. Two versions are registered in PubMed — the original 2018 guideline [3] and a 2024 update [4] — and neither PubMed record carries an abstract (common for this journal's practice guidelines). The full-text host (journals.lww.com) returned HTTP 402 Payment Required to a direct fetch, and a free-toolkit PDF mirror was retrieved as bytes but could not be rendered to text by the tools available this pass. A future pass should retry the PDF render (poppler-utils would need to be available) before concluding the guideline is unreachable.
In its place, the AGA's 2026 Clinical Practice Update [2] — a comparable US society-level guideline covering the identical treatment ladder — was fully retrievable with a structured, quotable abstract, and is used below as the guideline-quality source for this section.
| Item | What it establishes | Evidence quality (design, n, endpoint) | Source |
|---|---|---|---|
| Guideline position, treatment ladder | Office banding/IRC before surgical hemorrhoidectomy for grades 1-3; grade 3 failing banding referred to a surgeon; grade 4 requires surgery | AGA Clinical Practice Update — "Best Practice Advice" statements drawn from literature review and expert opinion, explicitly not a formal systematic review ("these BPA statements do not carry formal ratings regarding the quality of evidence") | [2] |
| Effect size vs. comparator, grade II-III specifically | Network meta-analysis ranking 14 treatments by recurrence, pain, bleeding, urinary retention, and incontinence | 79 RCTs, n=9,232, RCTs published 1980-2020, Bayesian network meta-analysis; 73% of included RCTs judged high risk of bias by the authors' own assessment | [5] |
| RBL vs. coagulation (IRC and non-IRC), direct comparison | No significant difference in efficacy, recurrence, or urinary retention between RBL and coagulation; RBL had higher post-op pain, lower post-op bleeding | Meta-analysis of 9 RCTs (of 59 screened), "moderate methodological quality" per the authors | [6] |
| Known negative/equivocal finding — RBL durability at grade III specifically | RBL was not noninferior to hemorrhoidectomy on 12-month quality-adjusted life years in grade III disease; recurrence "worse in the rubber band ligation group (47.5% vs 6.1%)" | Multicenter (10 Dutch hospitals), open-label, randomized, noninferiority trial, n=87 (47 RBL / 40 hemorrhoidectomy), 12-month follow-up, NCT04621695, early-terminated for funding — authors' own stated limitation: "relatively small sample size and limited statistical power" | [7] |
Verbatim:
"Both hemorrhoid banding and infrared coagulation are safe, effective, and easy to perform in the office setting. Infrared coagulation and rubber band ligation have similar benefits in the short term. Rubber band ligation has longer-term benefits for treatment of prolapsing hemorrhoids and recurrent bleeding. Hemorrhoid banding or infrared coagulation should be employed prior to surgical hemorrhoidectomy for grades 1 to 3 hemorrhoids." — [2]
"Consultation with a surgeon should be offered to patients with grade 3 internal hemorrhoids who fail banding procedures or have associated external hemorrhoids... Grade 4 internal hemorrhoids require surgical hemorrhoidectomy." — [2]
"Open and closed haemorrhoidectomy, and stapled haemorrhoidopexy were associated with worse pain, and more postprocedural bleeding, urinary retention, and bowel incontinence, but had the lowest rates of symptom recurrence." — [5]
"Recurrence rate was worse in the rubber band ligation group (47.5% vs 6.1%), with an absolute risk difference of 41% (95% CI, 24%-59%)." — [7]
Read [5] and [7] together, carefully, because they frame this candidate's entire regulatory-strategy question. The standing guideline advice [2] treats office banding/IRC as adequate first-line therapy through grade III. The best-controlled single RCT that isolated grade III specifically [7] found RBL's own durability at that grade substantially worse than surgery, on a primary endpoint the trial was explicitly designed (if underpowered) to test. Neither finding contradicts the other — a treatment can be guideline-endorsed as first-line and still show a real recurrence gap versus surgery at the higher grade — but a candidate proposing to out-perform RBL specifically at grade III should read [7] as the evidence bar its own mechanism-and-clinical-risk claim needs to clear, not [2]'s general endorsement.
Gaps: no formal evidence-graded ASCRS position was retrieved (see access-limitation note above); no US-specific comparative trial was located — [7] is Dutch, and the balance of the comparative literature found this pass (§5) is Chinese; no data located on how often grade III patients are in practice treated in-office versus referred directly to surgery.
as_of: 2026-08-27 · sources searched: connectors literature + literature-detail (14 PMIDs read at abstract depth across four searches), connectors clearances/510k/ clearance-summary/recalls/classification (device- and firm-scoped), connectors trials/trial-detail · not searched: MAUDE (no connector in this repo), any US-specific RBL/IRC/sclerotherapy cohort (everything comparative located this pass is Dutch or Chinese)
This is the load-bearing section for this domain, and the direct comparator class is well populated: three non-surgical office modalities the incumbent literature treats as roughly interchangeable first-line options, plus a cleared RF/electrosurgical device landscape more extensive than a device-name search alone would surface.
| Signal | Quantity (n, population, date) | Source |
|---|---|---|
| Resolution rate, general (tertiary-source figure, not primary-study) | "resolves symptoms in 89% of patients" | [1] |
| Repeat banding needed | "in up to 20%" of patients | [1] |
| Recurrence at grade III specifically, vs. hemorrhoidectomy, 12 months | 47.5% (RBL) vs 6.1% (hemorrhoidectomy), n=87 (47/40), 10 Dutch hospitals, RCT, NCT04621695 | [7] |
| Recurrence, mixed grades I-III, >3-month follow-up (contrast with the row above) | 9.7% (11/113), n=253 total across three arms, single Chinese hospital, retrospective | [8] |
| Recurrence, grade III vs grade I-II, multi-band single-session RBL, median 14.3-month follow-up | 32.8% (grade III) vs 14.6% (grade I-II), n=120 patients, single-centre, unspecified national origin (journal: Irish Journal of Medical Science) | [9] |
| Major complication — delayed massive bleeding from premature band slippage | 5 cases in conventional-RBL arm (n=125) vs 0 in a modified-technique arm (n=149) | [10] |
| Recurrence, modified vs. conventional RBL, grade II/III, 3-month follow-up | 5.4% (modified) vs 13.6% (conventional) | [10] |
"Recurrence rate was worse in the rubber band ligation group (47.5% vs 6.1%), with an absolute risk difference of 41% (95% CI, 24%-59%)." — [7]
"Massive, delayed bleeding (DB) is the most common major complication of Rubber Band Ligation (RBL) for internal hemorrhoids caused by premature band slippage." — [10]
Read the recurrence numbers in this table as four different questions, not four estimates of the same fact — this dossier does not reconcile them, and neither should a later reader without going back to methods. [7]'s 47.5% is grade-III-only, 12-month, RCT-controlled, non-US. [8]'s 9.7% pools grades I-III, uses a >3-month recurrence definition, and is a single-centre retrospective series. [9]'s 32.8%-vs-14.6% split is the one result here that isolates grade as the variable within a single cohort and design, and it is the most directly relevant single number to this candidate's own scope note (durability specifically "at grade III"): recurrence roughly doubles or more from grade I-II to grade III in the same series. No US-population recurrence figure for RBL at any grade was located.
| Signal | Quantity (n, population, date) | Source |
|---|---|---|
| Success rate reducing bleeding/prolapse (tertiary-source figure) | "70% to 80% success" | [1] |
| Head-to-head vs. RBL, efficacy/recurrence | "No significant difference... in terms of efficacy rate, postoperative prolapse rate, recurrence rate" | [6] |
| Head-to-head vs. RBL, pain | RBL patients had "a higher postoperative pain rate than patients undergoing infrared coagulation" | [6] |
| Pain ranking across 11 treatments, network meta-analysis | IRC among the treatments yielding "the lowest pain scores," alongside direct-current electrotherapy and DG-HAL with mucopexy | [5] |
"Infrared coagulation uses heat to coagulate hemorrhoidal tissue, yielding 70% to 80% success in reducing bleeding and prolapse." — [1]
Gaps: no grade-III-isolated IRC recurrence figure comparable to [7]'s RBL number was located; no cleared IRC device was individually traced to a K-number this pass (a device-name search for "infrared coagulat*" was not run).
| Signal | Quantity (n, population, date) | Source |
|---|---|---|
| Short-term efficacy (tertiary-source figure) | "efficacious in the short term (weeks to months) among 70% to 85% of patients" | [1] |
| Long-term remission (tertiary-source figure) | "long-term remission occurs in only one-third of patients" | [1] |
| Recurrence, direct comparison to RBL and combined therapy, grades I-III, >3-month follow-up | 11.6% (11/95) sclerotherapy vs 9.7% (11/113) RBL vs 4.3% (1/23) combined, n=253 total, single Chinese hospital, retrospective | [8] |
| Recurrence, foam sclerotherapy + banding combined vs. banding alone, grade II-III, 12 months | 11.2% (combined) vs 21.6% (RBL alone), n=195, 4 tertiary hospitals, prospective multicenter RCT | [11] |
"Sclerotherapy, which induces fibrosis with a sclerosant injection, is efficacious in the short term (weeks to months) among 70% to 85% of patients, but long-term remission occurs in only one-third of patients." — [1]
Read this the same way as the RBL table: [1]'s "one-third long-term remission" figure is a tertiary-source claim with no primary study cited in the retrieved abstract text; [8] and [11] are the two primary comparative figures located, and both used sclerotherapy in combination with or against RBL rather than as monotherapy grade III data in isolation. No sclerotherapy-alone grade-III-isolated recurrence figure comparable to [7]'s RBL number was found.
This is the section most relevant to this candidate specifically, and it is more extensive than a device-name search for "radiofrequency" or "hemorrhoid" alone would surface — the cleared devices below carry internal-hemorrhoid or anal-canal indications while several carry neither word in FDA's device-name field.
"The Barrx Anorectal RFA Wand is indicated for use in the coagulation of bleeding and non-bleeding sites in the anal canal and rectum including, but not limited to, arteriovenous malformations, angiomata, angiodysplasia, radiation proctitis (RP), and anal intraepithelial neoplasia (AIN)" — [18]. Hemorrhoids are not named.
Gaps: no US-population abandonment/discontinuation figure for any of these three office modalities was located (everything comparative is Dutch or Chinese); MAUDE has no connector in this repo, so device-level complaint/failure-mode data for any named device above is unsearched; no device price for RBL bands, IRC units, sclerosant, or any cleared RF console/probe was located.
as_of: 2026-08-27 · sources searched: connectors payment/coverage/procedures/hcpcs (all four, code 46930/46945/46946 — no local data/ cache present, confirmed distinct from "not found"); pfs.data.cms.gov's public metastore API, fetched directly this pass — the first successful primary-source retrieval of CMS Physician Fee Schedule RVU data in this repo · not searched: the CMS NCCI PTP quarterly edit-pair file (public, code-number-keyed, not fetched this pass); Medicare NCD/LCD text for office hemorrhoid destruction
| Item | Detail | Source |
|---|---|---|
| Codes in use | 46930, 46945, 46946 exist as billing codes in the CMS Physician Fee Schedule (code numbers only — descriptor text is AMA-licensed and not reproduced) | [24] |
| Payment rate / fee schedule | See table and caveats below | [24] |
| Coverage policy (NCD/LCD) | Not located this pass — connectors coverage 46930 returns unconfirmed, no local cache | connector attempt, no cache |
| Site-of-service differential | Confirmed to exist and quantified below — non-facility (office) pays materially more per unit than facility, for 46930 | [24] |
| Whose budget it comes out of | Medicare Part B / commercial physician fee schedules; not independently traced further | — |
A CMS administrative data file for the CY2026 Physician Fee Schedule was located, is directly downloadable, and was fetched this pass — pfs.data.cms.gov's public metastore lists an "Indicators for 2026" dataset (identifier 7c7df311-5315-4f38-b9ed-fd62f8bebe11, distribution URL https://pfs.data.cms.gov/sites/default/files/data/indicators2026-07-01-2026.csv). This is a government-published RVU/indicator file (columns include hcpc, rvu_work, full_nfac_total, full_fac_total, global, conv_fact), not an aggregator table, and it resolves several items this repo's candidate file for this domain (idea-008) had flagged as blocked only by a missing local cache:
| HCPCS code | Total RVU, non-facility | Total RVU, facility | Global days | Computed payment, non-facility (two CY2026 conversion factors found in the same file: 33.4009 and 33.5675) | Computed payment, facility |
|---|---|---|---|---|---|
| 46930 | 7.42 | 4.72 | 090 | $247.83 – $249.07 | $157.65 – $158.44 |
| 46945 | 10.49 | 10.49 (no separate non-facility PE priced) | 090 | $350.39 – $352.12 | $350.39 – $352.12 |
| 46946 | 11.49 | 11.49 (no separate non-facility PE priced) | 090 | $383.78 – $385.69 | $383.78 – $385.69 |
Payment = total RVU (work + practice expense + malpractice, national unadjusted, GPCI not applied) × conversion factor. Two conversion factors (33.4009 and 33.5675) are both present in the same 2026 file with no distinguishing date/quarter column — this pass could not establish which billing scenario each applies to (a plausible but unconfirmed explanation is the Qualifying-APM vs non-Qualifying-APM conversion-factor split CMS has applied in recent years) and reports both rather than picking one. Locality-adjusted (GPCI-applied) local Medicare Administrative Contractor payment will differ from this national-unadjusted figure in either direction depending on locality.
This resolves one item and reframes another that this domain's existing candidate file (idea-008) had recorded. The 90-day global period claim is independently confirmed by this file's public global column (090 for all three codes) — a CMS administrative field, not AMA-licensed descriptor text, so this was checkable all along without a licensed CPT source. Separately, and worth flagging explicitly for a Verifier rather than resolved here: the non-facility figure computed from this primary CMS file (~$248-249) is the higher of the two 46930 settings, and the facility figure (~$158) is the lower one — the reverse pairing of "~$248 facility / ~$158 non-facility" that idea-008's claims section currently carries, sourced there to two commercial aggregator sites. This dossier does not resolve which pairing is correct; it records that a primary CMS source and the aggregator-sourced claim disagree on which setting gets which number, which is exactly the kind of label-inversion aggregator data is prone to.
Gaps: the CMS NCCI PTP quarterly edit-pair file (the source that would settle the CCI bundling-into-46945 claim) was not fetched this pass, though it is public and code-number-keyed, same as this section's other gaps. No NCD/LCD text was located for office hemorrhoid destruction. hcpcs, payment, coverage, and procedures connector calls all still return unconfirmed for lack of a local data/ cache — this is a missing input, not a finding, and is now a narrower gap than before this pass, since the actual source file (pfs.data.cms.gov) is not on engine/scripts/fetch_data_file.py's host allowlist (only www.cms.gov, cms.gov, data.cms.gov, and the two accessdata.fda.gov variants are allowed) — loading it into data/hcpcs_payment_rates.csv would need either a hand-attached file or an allowlist change, neither of which is this pass's call to make.
as_of: 2026-08-27
| Change | When | What it enabled | Source |
|---|---|---|---|
| Bipolar RF electrocautery cleared for internal hemorrhoids (grade I-II) | 2011-2020, four clearances, most recent held by a large strategic (Covidien/Medtronic) | An active, maintained office RF product line in this exact modality, capped at grade II | [12][13][14][25] |
| Anorectal RFA cleared for non-hemorrhoid anal-canal lesions | 2015, 2017 (Covidien) | Establishes RF energy delivery inside the anal canal as cleared-device territory generally, on the same product code as the hemorrhoid-indicated devices above | [18][19] |
| Disposable single-use anoscope class, active and commoditizing | 3 clearances in 5 years (2021, 2023, 2025) | A cleared, disposable delivery vehicle already indicated through grade III hemorrhoids exists before this candidate does | [17][25] |
| CMS Physician Fee Schedule RVU/indicator data confirmed directly downloadable | this pass, 2026-08-27 | The first time this repo's own reimbursement gap for this domain was closed with a primary source rather than left as "no local cache" | [24] |
A counted series — clearances per year, entrants per year — cannot carry a confidence tag anywhere in this repo; the counts above are context, not a scored trend.
Gaps: no search was run for newer non-RF energy modalities (laser hemorrhoidoplasty, Doppler-guided hemorrhoidal artery ligation devices, direct-current coagulation beyond Ultroid); no search for impedance-based dosimetry or automatic-cutoff feature precedent in any cleared electrosurgical device, which is this candidate's own specific differentiator.
as_of: 2026-08-27
| Player | Position | Entered / exited | Recent activity | Source |
|---|---|---|---|---|
| HET Systems, LLC → Covidien, LLC (now Medtronic) | Bipolar RF hemorrhoid coagulation, grade I-II indication | Entered 2011; most recent clearance under Covidien ownership 2020 | K200146 (2020) is the most recent clearance in this domain found this pass under any name | [12][13][14] |
| Ultroid Technologies, Inc. (formerly Ultroid, LLC) | DC/thermal coagulation, grade I-IV indication, console + disposable-probe model | Cleared 2003; nationwide QSR recall 2016 (Terminated) | Recall covered the console, mobile unit, procedure pack, and disposable probes sold individually | [15][16][23] |
| Covidien, LLC (now Medtronic) | Anorectal RFA (non-hemorrhoid anal-canal lesions), same product code as the HET line | Entered 2015 | Second clearance 2017 | [18][19] |
| Haemoband Surgical, Ltd. | Disposable anoscope, hemorrhoid-indicated through grade III | Entered 2025 | Most recent clearance found in this domain (2025-10-09) | [17] |
| F Care Systems (Belgium) / F Care Systems USA, LLC | Venous/aesthetic RF thermocoagulation — no anorectal indication in any of 3 US clearances | Entered US market 2013 (K130283); most recent US clearance 2026 | Checked and ruled out as an anorectal competitor on the US registry this pass | [20] |
| Well Care (Wuhan) Medical Technology; Applied Medical Resources | Disposable/reusable anoscope class, no thermal/RF indication | 2021, 2023 | Establishes the anoscope class is multi-entrant, not a single-firm position | [25] |
Gaps: no funding, revenue, or installed-base data for any player above was searched; no search was run for entrants using non-RF modalities (Doppler-guided ligation device makers, laser hemorrhoidoplasty device makers); MAUDE (complaint-level market signal) has no connector in this repo.
| Question | Class | What would settle it | Reachable by? |
|---|---|---|---|
| What share of US symptomatic hemorrhoid patients present at grade II-III specifically? | 1/2 | A US claims-based or registry study stratifying hemorrhoid disease by Goligher grade | Not found this pass; narrower literature queries than the one run here |
| What does the full-text ASCRS 2018/2024 guideline say about the grade II-III treatment ladder and its evidence grading? | 1 | Full-text retrieval of PMID 29420423 / 38294832 | Blocked this pass by paywall (HTTP 402) and an unrenderable PDF (missing poppler-utils); retriable with different tooling |
| Does RBL's grade-III-specific recurrence rate replicate in a US population? | 2 | A US cohort or trial isolating grade III RBL recurrence, comparable in design to [7] | Not found — [7] is Dutch; no US-specific figure located |
| What is the CMS non-facility payment for 46930, resolved against the CY2026 PFS RVU file rather than aggregator sources? | 1 | pfs.data.cms.gov's Indicators file, already retrieved this pass (§6) — the remaining step is reconciling which of the two conversion factors applies and loading the file into this repo's connector-readable cache | Reachable; partially done this pass (computed both values, did not resolve the CF ambiguity or load the cache — host not on fetch_data_file.py's allowlist) |
| What does the CMS NCCI PTP edit-pair file say about 46930 bundling into 46945/46946? | 1 | The public NCCI PTP quarterly file, code-number-keyed | Not fetched this pass; no licensing obstacle |
| Would proceduralists switch from an owned reusable instrument (banding forceps, IRC unit) to a per-case disposable RF/anoscope combination? | 3 | Nothing directly answers this. Its twin — what proceduralists have actually done when RBL recurs at grade III (continued banding vs. escalated to surgery vs. adopted a different office device) — is not established either; [7], [9] show recurrence rates but not what clinicians did next | Nobody, for the stated question; its twin is itself only partially reachable and was not further pursued this pass |
| Would patients accept an office RF procedure without sedation at the same rate they accept RBL/IRC? | 3 | Nothing directly answers this. Its twin — documented acceptance/completion rates for existing office procedures — was not searched this pass | Nobody, for the stated question; the twin is a literature question not yet run |
| Is a European RF hemorrhoid device ("Rafaelo"/"CRA probe") referenced in international literature cleared in the US under a different corporate or product name? | 1 | An assignee/applicant sweep beyond device-name string matching, or an FTO-style patent search identifying the underlying manufacturer | Device-name search returned null this pass (not evidence of non-clearance under a different name); not pursued further |
Class-3 questions are recorded here and never answered here.
| Section | as_of | How it was gathered | Never checked |
|---|---|---|---|
| 1 Epidemiology | 2026-08-27 | connectors literature (2 queries) + literature-detail on the review articles cited in §4/§5 | Incidence; grade-specific prevalence; demographic concentration; trend direction |
| 2 Care pathway | 2026-08-27 | AGA/ASCRS guideline abstracts; one empty literature query | Primary-care referral patterns; throughput; staffing |
| 3 User groups | 2026-08-27 | — | everything |
| 4 Clinical evidence | 2026-08-27 | connectors literature (4 queries) + literature-detail on 10 PMIDs; one WebFetch to a paywalled guideline (402) and one WebFetch of a PDF this pass's tools could not render | Formal ASCRS evidence grading; any US-specific comparative trial |
| 5 Reference products | 2026-08-27 | connectors literature + literature-detail (14 PMIDs); clearances/510k/clearance-summary/recalls/classification; trials/trial-detail | MAUDE (no connector); device pricing; US-population abandonment data for any of the three office modalities |
| 6 Reimbursement | 2026-08-27 | connectors payment/coverage/procedures/hcpcs (all unconfirmed, no cache); direct fetch of pfs.data.cms.gov's public metastore and CY2026 Indicators CSV | NCCI PTP edit-pair file; NCD/LCD text; which of two conversion factors applies to which billing scenario |
| 7 Technology | 2026-08-27 | Clearance counts drawn from §5's device-level searches | Non-RF/non-anoscope technology trajectory (laser, DG-HAL devices, DC coagulation beyond Ultroid) |
| 8 Market players | 2026-08-27 | Firm-scoped recalls and device-scoped clearances/510k calls from §5 | Funding, revenue, installed base; non-RF entrants |
What this dossier has never looked at: grade-specific epidemiology and any US-population abandonment/recurrence figure for RBL, IRC, or sclerotherapy (everything comparative located is Dutch or Chinese); the full text of either ASCRS guideline (paywalled/unrenderable this pass); MAUDE narratives for any device named here (no connector exists); the CMS NCCI PTP edit-pair file (public, not yet fetched); device or consumable pricing for any of the five reference products in §5; user groups and incentives (§3, entirely unsearched); and any non-RF, non-anoscope competitive technology (laser hemorrhoidoplasty, Doppler-guided ligation systems). Absence of scanning is not absence of change — this file is a starting point for further research passes, not the output of one.
pfs.data.cms.gov, HCPCS 46930 / 46945 / 46946.