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-004
Research reports behind it: care-pathway · clinical-evidence · epidemiology · market-players · reference-products · reimbursement · technology · user-groups
Neonatal hyperbilirubinemia is one of the most common reasons for a birth-hospital admission or readmission in the first week of life. Phototherapy is the established first-line treatment; the clinical question this domain is about is not whether phototherapy works (it does, robustly) but where it is delivered — inpatient bassinet/ overhead units versus a fiberoptic blanket or wearable garment used at home — and what happens to newborns treated at home. State up front what this file is thin on: almost all of the controlled clinical literature on home phototherapy outcomes is non-US (Sweden, the Netherlands, Canada, Bangladesh), the full text of the 2022 AAP clinical practice guideline could not be retrieved (publications.aap.org returned HTTP 403 to an automated fetch, both for the PDF and the HTML article page), and the national CMS DMEPOS payment cache this domain needs (data/hcpcs_payment_rates.csv, data/hcpcs_level_ii.csv, data/medicare_coverage_policies.csv) is still absent from data/ — only one state Medicaid fee schedule (Louisiana) was located and read directly.
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.
as_of: 2026-08-27 · sources searched: CDC/NCHS data brief search, literature connector (PubMed) for US cohort studies, HCUP/KID-based literature · not searched: CDC WONDER natality microdata directly (no connector reaches it); state-by-state birth volumes; incidence of hyperbilirubinemia broken out by race/ethnicity (a documented risk concentration in the condition that this pass did not pursue)
| Fact | Quantity (n, population, date) | Source |
|---|---|---|
| US annual births (denominator for any TAM) | 3,628,934 births registered in the US, 2024 (up 1% from 2023's 3,596,017) | [1] |
| Hospitalizations with hyperbilirubinemia diagnosis, US trend | Proportion of term infant discharges carrying a hyperbilirubinemia diagnosis rose 65% (9.4% to 15.5%, p<.001) and preterm rose 34.5% (33.5% to 45%, p<.001), 1997-2012, HCUP Kids' Inpatient Database, ICD-9 774.2/774.6 | [2] |
| Phototherapy use, US trend (birth hospitalization) | Phototherapy use increased 83% over the same 1997-2012 window (exchange transfusion fell 67%; kernicterus discharges fell from 7 to 1.9 per 100,000 newborns) | [2] |
| Post-discharge phototherapy need, US cohort | Of 148,162 infants ≥35 weeks gestation born 2012-2017 at 11 Kaiser Permanente Northern California facilities who did not receive phototherapy during the birth hospitalization, 1.8% (2,623) exceeded the AAP phototherapy threshold after discharge | [3] |
| Readmission rate for hyperbilirubinemia, US birth-hospital baseline | In a US retrospective cohort of 359 newborns at 9 pediatric clinics with discharge TSB 0.1-3 mg/dL below the inpatient phototherapy threshold, 9% overall were readmitted for hyperbilirubinemia | [4] |
| Trend direction after the 2022 AAP threshold revision | At one US birth hospital (John H. Stroger, Jr. Hospital of Cook County, level III NICU), comparing the year before vs. after 2022 AAP guideline implementation (n=1,577 infants ≥35 weeks, 763 vs. 814): hyperbilirubinemia diagnosis fell 6.6%, pre-discharge phototherapy use fell 8.4%, first-week TSB checks fell ~4%, with no increase in readmission rate or post-discharge clinic visits | [5] |
Verbatim, for anything load-bearing:
"The number of births in the United States increased 1% from 2023 to 2024, to 3,628,934 births." — [1]
"Implementation of the 2022 revised AAP guidelines for neonatal hyperbilirubinemia led to reduced diagnosis, phototherapy use during birth hospitalization and fewer TSB checks in the first week of life, without increasing readmission rates or post-discharge clinic visits for jaundice." — [5]
Gaps: No US population-level source in this pass reports the fraction of newborns ≥35 weeks who receive phototherapy at all (the "8-12%" figure idea-004 uses is a Generator guess, not sourced here either) — [2] and [3] are the closest US proxies located and neither answers that directly. Not searched: race/ethnicity risk concentration (G6PD deficiency prevalence, a recognized risk factor, appears repeatedly in the non-US literature scanned but a US-specific prevalence/incidence figure was not pursued this pass); state-level birth volume distribution, relevant to which state Medicaid programs would carry the most volume.
as_of: 2026-08-27
| Step in the pathway | Setting / site of service | Who performs it | What equipment is already there | Source |
|---|---|---|---|---|
| Universal pre-discharge bilirubin screening | Newborn nursery, birth hospital | Nursing staff draw/measure, per hospital protocol; 76% of surveyed US hospitals screen between 24-48h of age per AAP guideline | Bilirubinometer (transcutaneous) or lab TSB draw | [6] |
| Phototherapy initiation decision | Birth hospital nursery or NICU, or outpatient follow-up visit | Attending neonatologist / pediatrician, against AAP threshold graphs (Bhutani nomogram / ΔTSB) | Overhead or bassinet phototherapy unit (LBI product code) | [3] |
| Discharge with borderline bilirubin | Birth hospital | Discharging pediatrician/neonatologist decides follow-up timing and whether to start home phototherapy prophylactically | — | [3] |
| Post-discharge follow-up bilirubin check | Outpatient pediatric clinic or home-visit nurse | Ordering pediatrician / general pediatrician, not necessarily the birth-hospital team | Transcutaneous or lab bilirubin | (pathway step; no US-specific timing source retrieved this pass — AAP guideline full text not retrieved, see gaps) |
| Home phototherapy administration, once ordered | Home | Parent/caregiver operates device; degree of nursing oversight varies by program | Fiberoptic blanket or (newly) wearable LED garment | idea-004 candidate claims (SnugLit/BiliWrap IFUs) |
| Guideline adherence to post-phototherapy monitoring | Birth hospital / outpatient | Practice varies: in a 2026 survey of US "BORN" network hospitals (67 of 123 contacted, 55% response), 76% followed the guideline's phototherapy-discontinuation threshold, but only 24% obtained a transcutaneous bilirubin measurement ≥24h after stopping phototherapy as the guideline recommends | [6] |
Gaps: The AAP guideline's own stated conditions for home phototherapy (monitoring frequency, admission triggers) could not be retrieved from the primary document — publications.aap.org returned HTTP 403 to both the PDF and HTML article URLs on this pass, for both the 2022 CPG (e2022058859) and the companion 2024 technical report on phototherapy. What is on record here (from the technical-report abstract, a PubMed scan pointer, not independently verified) is that the guideline "narrowly" raised phototherapy initiation thresholds relative to 2004 — see idea-004's Claims for the exact pointer (PMID 35927519). Who specifically orders and titrates home phototherapy (birth-hospital team vs. handoff to a general pediatrician) is not established from a US source in this pass; [6]'s practice-variability finding is the closest proxy and it argues the pathway is not standardized.
as_of: 2026-08-27
| Role | Who they are | What they gain | What they lose / what it costs them | Whose budget | Source |
|---|---|---|---|---|---|
| Prescriber / decider | Discharging birth-hospital neonatologist/pediatrician, or the ordering outpatient pediatrician | Avoids a readmission on their service; a documented dose/adherence record (this candidate's differentiator) if it exists | Clinical liability if bilirubin trajectory is missed at home | N/A (clinical decision) | reasoning from pathway above, not a sourced quantity |
| Operator / daily user | Parent/caregiver | Keeps the family together; reported net-positive experience in the one qualitative source located | Learning to operate/monitor a medical device on a newborn with no bedside nurse | Family (device rental cost, if any out-of-pocket share) | [7] (positive experience); [8] (barriers/facilitators, HCP+parent perspective) |
| Purchaser | Not established from a source in this pass — idea-004 carries the assumption that a DME supplier purchases/stocks the fleet and bills the payer, which is unverified and unresourced here | — | — | — | idea-004 Claims (deck-surfaced assumption, unverified, no source) |
| Payer | State Medicaid programs (newborns are not Medicare beneficiaries) and commercial insurers | Lower total cost of care if home phototherapy substitutes for an inpatient stay (see Section 6/cost source) | Reimbursement uncertainty was named directly as an implementation barrier in one source | State Medicaid / commercial plan | [8] ("Barriers concerned the lack of reimbursement options") |
| Patient / newborn | Newborn ≥35 weeks with uncomplicated hyperbilirubinemia | Avoids hospitalization/separation from parents | Under-dosing risk with no bedside nurse to catch a rising trajectory | N/A | reasoning; see Section 5 for the concrete wearable-device failure-mode evidence |
Gaps: [8] is a Dutch/European-context implementation study (Midwifery journal, CFIR framework), not a US study — its finding that reimbursement uncertainty is a barrier to clinician adoption is recorded here as directional evidence from a non-US health system, not evidence about US clinician incentives specifically; the same caution idea-004 already applies to its own clinician-substitution claim. No source located names the actual purchaser of a home phototherapy unit in the US market (hospital, DME supplier, or family) — this remains an assumption, not a finding, in every candidate file that touches it.
as_of: 2026-08-27
| Item | What it establishes | Evidence quality (design, n, endpoint) | Source |
|---|---|---|---|
| Guideline position | 2022 AAP CPG revision raised phototherapy-initiation thresholds relative to 2004, described by its own technical report as a "narrow" change | Guideline text itself not retrieved (403); only the companion technical-report abstract read | idea-004 Claims, PMID 35927519 (pointer only) |
| Pivotal comparative evidence, home vs. inpatient phototherapy | 2024 systematic review/meta-analysis: 9 studies (4 RCTs + 5 cohort studies), 998 patients total | Overall evidence quality rated "very low." RCT subgroup found no significant difference in phototherapy duration (SMD -0.04, 95% CI -0.15 to 0.08); cohort-study subgroup found longer duration with home phototherapy (SMD 0.90, 95% CI 0.69-1.11) | [9] |
| Effect size vs. comparator — readmission | Same 2024 meta-analysis: hospital readmission was higher with home phototherapy than inpatient (RR 4.61, 95% CI 1.43-14.86, p=.01) | Pooled across the 9 included studies; none of the 3 studies reporting on exchange transfusion found any cases | [9] |
| Effect size vs. comparator — parental stress | Same 2024 meta-analysis: home phototherapy associated with lower parental stress (SMD -0.44, 95% CI -0.71 to -0.16, p=.002) | Same evidence base | [9] |
| Known negative / equivocal finding | The meta-analysis's own conclusion: "The current evidence does not strongly support HPT efficacy for neonatal hyperbilirubinemia, as high-quality data on long-term outcomes are scarce." | Authors' own stated limitation, not this dossier's paraphrase | [9], verbatim below |
| Second, larger meta-analysis (2026) | 31 included studies, mixed-methods systematic review; pooled hospital (re)admission after home phototherapy = 3.5% (95% CI 2.2-5.3%); no difference in treatment duration or daily bilirubin decline vs. inpatient reported; quality of evidence rated low for all outcomes; no studies evaluated cost-effectiveness | Evidence base geography not reported in the structured abstract — cannot be established as US | [10] (also recorded as a Stage 0 scan pointer in idea-004) |
Record the negative findings with the same weight as the positive ones: [9]'s pooled result is that home phototherapy took longer in cohort studies and was associated with a higher readmission rate than inpatient treatment, on evidence its own authors call very low quality — this cuts directly against this candidate's premise and is recorded here at full weight rather than folded into a generally positive summary.
Verbatim, for anything load-bearing:
"HPT was associated with longer phototherapy duration (SMD = 0.55, 95% CI: 0.06-1.04, P = 0.03)... Hospital readmission was higher with HPT (RR = 4.61; 95% CI: 1.43-14.86, P = 0.01)... The evidence quality was very low... The current evidence does not strongly support HPT efficacy for neonatal hyperbilirubinemia, as high-quality data on long-term outcomes are scarce." — [9]
"No studies evaluated cost-effectiveness... Quality of evidence was rated low for all outcomes." — [10]
Gaps: No RCT in this evidence base was conducted in the US (the one RCT with a published cost-effectiveness analysis, [11] below, is Swedish — NCT03536078, Region Örebro County). No US-specific readmission-rate comparison of home vs. inpatient phototherapy was located in this pass. The AAP guideline's own graded evidence tables (which almost certainly exist, since the technical report describes updating "the evidence base") were not retrieved — a 403 from publications.aap.org, not a negative finding.
as_of: 2026-08-27 · this is the section worked hardest, per the research-lane spec
predicate_or_analog:
field.
| Signal | Quantity (n, population, date) | Source |
|---|---|---|
| Discontinuation / dropout — reflected as readmission | 4.61x higher readmission risk with home vs. inpatient phototherapy, pooled across 9 studies (998 patients), 2024 meta-analysis | [9] |
| Discontinuation / dropout — home-phototherapy-specific pooled rate | 3.5% (95% CI 2.2-5.3%) hospital (re)admission after home phototherapy initiation, pooled across 31 studies, 2026 meta-analysis | [10] |
| Stated reasons for discontinuation | Home biliblanket use (not discontinuation specifically) was associated with fewer readmissions than not using one in a US cohort: 4% readmitted with biliblanket vs. 13% without (n=359, OR 0.16, 95% CI 0.06-0.44) — i.e., where biliblankets were used at all, readmission was lower, which argues the failure mode is non-use/non-selection rather than the device itself | [4] |
| Adherence / implementation barriers | Qualitative study (21 healthcare professionals, 10 parents, non-US/European CFIR study): "Barriers concerned the lack of reimbursement options and the challenge to reach all the different healthcare professionals for education" | [8] |
| Recurring complaint or failure mode | Two FDA recalls on the Natus neoBLUE blanket LED system (K103589) for discoloration/degradation of the fiberoptic bundle at the connection of the pad and box, both terminated | [12] |
| Recalls / enforcement (broader LBI product-code window, 2016-2020) | 5 total recalls in a 10-year scan window (2016-08 to 2026-08): 2 on the Natus neoBLUE blanket (fiberoptic bundle degradation), 1 on a Lumitex Giraffe Blue Spot PT Lite (light output below minimum due to light-pipe overheating), 1 on an Ohmeda/GE Giraffe Spot PT Lite (power-cord overheating, fire/thermal-injury risk). None of the 5 fall within the most recent 5 years (last was 2019-12-11) — idea-004's own 5-year recall scan correctly found none, and both windows are recorded here so a reader does not mistake the 5-year "none" for "never" | [12] |
| Withdrawn from commercial distribution | Not established from a source in this pass | — |
"neoBLUE blanket LED Phototherapy System distributed since release of the product in 2011 is recalled due to customer complaints regarding discoloration/ degradation of fiberoptic bundle at connection of pad and box." — [12] (Z-0770-2017)
"We found that home biliblanket use was associated with lower odds of hospital readmission for newborn jaundice." — [4]
| Signal | Quantity (n, population, date) | Source |
|---|---|---|
| Device-specific failure mode (wearable form factor generally, not a named cleared product) | First-in-human pilot, 12 near-term/term neonates (Rotterdam, Netherlands, non-US), single-arm: phototherapy completed within 48h in 83% (10/12); 2 of 12 (17%) were switched to conventional intensive phototherapy because bilirubin kept rising despite wearable treatment — the concrete instance of the "under-dosing at home" risk idea-004's own Claims already name as unresolved | [13] |
| Safety endpoints tracked but not yet reported | A US randomized trial (NCT03599258, HonorHealth Research Institute, Arizona, enrollment 72 actual) compared Neolight Skylife phototherapy to standardized phototherapy, tracking skin irritation/ulceration and body-temperature maintenance as safety endpoints; completed 2021-05-27, hasResults=false — no outcome, positive or negative, is available from the registry | [14] |
| Stated reasons for not using home phototherapy at all (population-based, non-US) | In a Swedish population-based study of 492 term newborns receiving phototherapy, 48% received it exclusively in hospital; the most common reasons for not using home phototherapy were haemolytic disease (35%) and need for multiple simultaneous phototherapy devices (26%) | [15] |
| Adverse-event surveillance (non-US) | One-time Canadian Paediatric Surveillance Program survey: 58 of 497 responding centres (12%) offer home phototherapy; 15 of 497 physicians (3%) reported an adverse event in the preceding 12 months, 21 cases total, "most... resulted in admissions or readmissions to the hospital for inpatient phototherapy," no serious AEs reported | [16] |
"Two neonates were switched to conventional intensive phototherapy due to the ongoing rise of bilirubin levels despite wearable phototherapy treatment. No safety issues were recorded." — [13]
"AEs were reported by 15 (3%) physicians with 21 cases of AEs associated with HP in the preceding 12 months. Most AEs resulted in admissions or readmissions to the hospital for inpatient phototherapy. No serious AEs or long-term consequences were reported." — [16]
Gaps: No US-specific readmission-rate comparison exists between home and inpatient phototherapy in this evidence base — every readmission-rate figure above with a design and n attached ([9], [10], [15], [16]) is non-US or pooled across mostly non-US studies, with [4]'s biliblanket-use comparison the sole US-population figure. Price and unit economics for any named product were not located. The "not a differentiator" reading idea-004 already gives SnugLit is unchanged and, if anything, reinforced: no cleared wearable's own record claims a dosimetry/adherence feature, so a dosimetry-equipped entrant would be first, not following, on that specific axis — but the field's one wearable outcome study to date ([13], on an unnamed device) shows the exact failure mode a dose record is meant to catch.
as_of: 2026-08-27
| Item | Detail | Source |
|---|---|---|
| Codes in use (HCPCS; CPT only if licensed) | HCPCS E0202. National descriptor text could not be confirmed this pass — data/hcpcs_level_ii.csv is still absent, so hcpcs E0202 returns a missing-cache result, unchanged from idea-004's own prior finding | idea-004 Claims; connector run this pass reproduced the same "No local cache" result |
| Payment rate / fee schedule — national | No CMS DMEPOS fee-schedule cache exists in data/ (data/hcpcs_payment_rates.csv absent); payment E0202 returns the same missing-cache result on this pass as on idea-004's prior pass | connector run, this pass |
| Payment rate / fee schedule — one state located | Louisiana Medicaid DMEPOS Fee Schedule carries two E0202 line items: a "type of service" 07 entry at $30.90 (rate effective 2012-07-01) and a "type of service" 09 entry at $33.71 (rate effective 2021-09-01), both still listed as active in the schedule effective for dates of service 2024-10-01 and forward. The description field truncated in extraction reads "PHOTOTHERAPY (BILIRUBIN) LIGHT" (TOS 07) and "PHOTOTHERAPY (BILIRUBIN) LIGHT WITH..." (TOS 09) — consistent with, but not a verbatim confirmation of, a "with photometer" descriptor; the full descriptor string was not reproduced because the table-column extraction truncated it and this dossier will not guess the missing words | [17] |
| Coverage policy (NCD/LCD, commercial) | Not located. No Medicaid LCD or commercial medical policy for home phototherapy was read this pass beyond the fee-schedule line item above, which is a payment amount, not a coverage criterion document | not searched beyond [17] |
| Site-of-service differential | Not established | — |
| Whose budget it comes out of | Newborns are not Medicare beneficiaries. [17] establishes that at least one state Medicaid program pays for E0202 today, which is the first primary confirmation in either this dossier or idea-004 that any payer actually reimburses this code, as distinct from the code merely existing in HCPCS. Commercial-payer coverage and the ~40%+ Medicaid-birth-share figure idea-004 cites remain unconfirmed by a primary source in this pass | [17]; idea-004 Claims |
Gaps: This is one state's fee schedule, is not the national CMS DMEPOS rate, and two line items at different rates under different "type of service" modifiers were found without an explanation of which modifier a DME supplier would actually bill under for a rental (vs. purchase) episode — that distinction was not resolved. The CMS national files remain fetchable in principle (engine/scripts/fetch_data_file.py allows cms.gov/data.cms.gov hosts) but were not fetched this pass; a live URL for the current-quarter HCPCS Alpha-Numeric file and the DMEPOS fee schedule would need to be located and validated before an agent fetch, which is future work rather than a negative finding.
as_of: 2026-08-27
| Change | When | What it enabled | Source |
|---|---|---|---|
| LED replacing fiberoptic-halogen light sources in the LBI class | Visible across the whole 2016-2026 clearance window (neoBLUE, Lullaby, BiliLux, Bilicocoon, Skylife all LED-based) | Lower heat generation at the light source, a precondition for a wearable/garment form factor | [12] clearance listing (Stage 0 scan, not independently graded here) |
| First wrap/wearable-garment clearances under LBI | BiliWrap, K243372, decided 2025-05-29; SnugLit, K251308, decided 2026-01-15 | A form factor distinct from both the rigid bassinet unit and the fiberoptic blanket — closer to a garment than either | [12] |
| First-in-human wearable outcome data (non-US) | Published 2025-06-09 | The first published clinical outcome data (n=12) on any wearable phototherapy device, showing both the completion-rate promise and the under-dosing failure mode in the same small cohort | [13] |
| A registered US comparative trial of a named commercial device (Neolight Skylife) | Completed 2021-05-27, no results posted | Establishes at least one US sponsor (HonorHealth Research Institute) ran a head-to-head trial against standardized phototherapy; the trial's own safety endpoints (skin irritation, temperature control) are exactly the wearable-specific risks a dosimetry/garment design would need to answer, and they remain unanswered in public data | [14] |
Gaps: No count of clearances per year should be read as a trend without a caveat — this is a bounded Stage 0 scan window (10 years back from today), not an audited enumeration of the full LBI history (docs/backlog.md 1.10's point about counted series applies directly). Rate of new entry outside the US (CE-marked wearables, for instance) was not searched.
as_of: 2026-08-27
| Player | Position | Entered / exited | Recent activity (funding, launch, recall) | Source |
|---|---|---|---|---|
| Natus Medical Incorporated | Incumbent, fiberoptic blanket + rigid units | Multiple clearances since at least 2016 (K160745, K182178; earlier K103589, K022196 also on record) | Two recalls on the neoBLUE blanket for fiberoptic-bundle degradation (2016-2017); one recall on an earlier neoBLUE generation (2017) | [12] |
| Neolight, LLC | Entrant, LED bassinet unit (Skylife) | Cleared 2017 (K170585) | Sponsored a US RCT (NCT03599258) against standardized phototherapy; no results posted | [12], [14] |
| Draeger Medical Systems, Inc. | Incumbent, BiliLux | Cleared 2018 (K172656) | Also sponsor of an unrelated transcutaneous bilirubinometer trial (NCT02774434, Draeger Jaundice Meter JM-105) — a measurement-side product, not phototherapy | [12] |
| Little Sparrows Technologies, Inc. | Entrant, bili-hut (tent/incubator form factor) | Cleared 2019 (K190899) | Not researched beyond the 510(k) listing this pass | [12] |
| Avalon Biomedical (Shenzhen) Limited | Entrant | Cleared 2020 (K200031) | Not researched | [12] |
| Bistos Co., Ltd. | Entrant | Cleared 2021 (K210289) | Not researched | [12] |
| Gerium Medical, Ltd. | Entrant, BiliWrap (wrap/wearable form factor) | Cleared 2025 (K243372) | See Section 5 | [12] |
| Thera B Medical Products | Entrant, SnugLit (wearable form factor) | Cleared 2026 (K251308) | See Section 5; closest current analog to this domain's candidate device | [12] |
| Lumitex Inc. | Incumbent-adjacent, Giraffe Blue Spot PT Lite | — | Recalled 2019 for light output below minimum spec (light-pipe overheating) | [12] |
| Ohmeda Medical / GE | Incumbent, Giraffe Spot PT Lite | — | Recalled 2016 for power-cord overheating (fire/thermal-injury risk) | [12] |
| Wipro GE Healthcare | Incumbent, Lullaby LED | Cleared prior to this window (K120168, per idea-004's own Claims) | Not researched further this pass | idea-004 Claims |
Gaps: No funding, launch, or company-financial data (PitchBook/Crunchbase-type sources) were sought — idea-004's Scores table already names this as a licensed-source gap with no connector in this repo, and that stands unchanged here.
| Question | Class (1 registry / 2 published / 3 stakeholder-future) | What would settle it | Reachable by? |
|---|---|---|---|
| Would parents prefer home phototherapy over inpatient admission/readmission? | 3 | Nothing settles a stakeholder-future question. Its revealed-behaviour twin was researched instead: pooled home-phototherapy (re)admission rates ([9] 4.61x RR vs. inpatient; [10] 3.5% pooled) and one US biliblanket-use readmission comparison ([4], 4% vs. 13%) — i.e., what fraction of families who started home phototherapy ended up readmitted anyway, and under what device | Already done, this pass, see Section 5 |
| Would clinicians substitute home phototherapy for inpatient treatment without an added home bilirubin measurement? | 3 | Twin already researched: [8] names "lack of reimbursement options" and difficulty reaching all relevant healthcare professionals for education as the concrete, stated barriers a non-US cohort of clinicians reported, and [6]'s US practice-variability survey shows guideline-adherence to post-phototherapy monitoring is itself inconsistent (24% obtained the recommended post-discontinuation TcB check) | Already done, this pass; a US-specific clinician survey on this exact question was not located and may not exist |
| What fraction of US newborns ≥35 weeks who receive phototherapy could be treated at home? | 2 | A US population-based study analogous to [15] (Örebro, Sweden: 52% received at least partial home phototherapy) has not been located for a US population | literature with narrower US-hospital-system search terms; a Kaiser Permanente or HCUP-based follow-up study is the likeliest candidate source |
| Does CMS publish a national DMEPOS payment rate for E0202, and does it require a photometer to bill it? | 1 | The CMS HCPCS Level II Alpha-Numeric quarterly file and DMEPOS fee schedule, neither yet in data/ | engine/scripts/fetch_data_file.py against a validated cms.gov/data.cms.gov URL, then hcpcs/payment connectors |
| What does the 2022 AAP guideline itself (not a secondary technical-report abstract) say about home-phototherapy conditions and monitoring? | 1 (a named guideline document) | The full guideline text at publications.aap.org, currently returning HTTP 403 to automated fetches | A human-supplied copy, or a mirror host if one becomes identified; not currently reachable by this pipeline's tooling |
| Is there a US population-level readmission-rate comparison of home vs. inpatient phototherapy? | 2 | A US cohort or claims-based study directly comparable to [9]/[10] but restricted to US sites | literature search did not surface one this pass; may not exist yet in the published literature |
Class-3 questions are recorded here and never answered here. If one looks answerable, it has a revealed-behaviour twin — find it and record the twin instead (docs/research-lane-spec.md §3.1).
| Section | as_of | How it was gathered | Never checked |
|---|---|---|---|
| 1 Epidemiology | 2026-08-27 | literature/literature-detail (PubMed), one direct fetch of a CDC/NCHS data-brief web page | CDC WONDER natality microdata directly; race/ethnicity risk concentration |
| 2 Care pathway | 2026-08-27 | literature-detail; AAP guideline full text attempted and refused (403) | Who specifically hands off home-phototherapy titration between birth-hospital team and outpatient pediatrician |
| 3 User groups | 2026-08-27 | literature-detail (qualitative/implementation studies), reasoning from the pathway | The actual US purchaser of a home phototherapy unit (hospital, DME supplier, or family) — no source located |
| 4 Clinical evidence | 2026-08-27 | literature-detail, two systematic reviews/meta-analyses read at abstract depth | AAP guideline's own graded evidence tables (403); a US-specific home-vs-inpatient RCT |
| 5 Reference products | 2026-08-27 | clearances, recalls, trial-detail, literature-detail; reused idea-004's own IFU reads rather than re-fetching the same PDFs | bili-hut (K190899) abandonment record; pricing for any named product |
| 6 Reimbursement | 2026-08-27 | hcpcs/payment/coverage connectors (all missing-cache, reproduced from idea-004); one state Medicaid fee-schedule PDF fetched directly and read | National CMS DMEPOS rate; any coverage policy document; commercial-payer policy |
| 7 Technology | 2026-08-27 | Same clearances scan as Section 5, plus [13]/[14] | Non-US technology entrants; a validated per-year clearance count |
| 8 Market players | 2026-08-27 | Same clearances/recalls scan | Funding/financial data (no connector; licensed-source gap, unchanged from idea-004) |
What this dossier has never looked at: MAUDE adverse-event narratives for any named device in this class (only the enforcement/recall side was pulled, not individual event reports); veterinary or non-US regulatory pathways (out of scope by design, per docs/research-lane-spec.md); CPT-coded professional-service billing around home phototherapy setup/training (CPT is AMA-licensed and out of reach here regardless); any primary interview or survey of US parents or US clinicians specifically (every qualitative source located in this pass is non-US); and the bili-hut (Little Sparrows Technologies, K190899) product line beyond its bare 510(k) listing.
and python3 -m connectors recalls --product-code LBI --since 10y`
(window 2016-08-29 to 2026-08-27, run 2026-08-27). 510(k)s: K160745, K163526, K170585,
K172656, K182178, K190899, K200031, K210289, K243372, K251308. Recalls:
Z-0923-2020 (Lumitex), Z-1924-2017 (Natus), Z-1503-2017 (Ohmeda/GE), Z-0770-2017
(Natus), Z-0769-2017 (Natus). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm
python3 -m connectors trial-detail NCT03599258.
https://clinicaltrials.gov/study/NCT03599258