Automated Documentation, Coding & Reimbursement Optimization

● What Solaris is (operation‑ready snapshot for reimbursement planning). Product type. SOLARIS Self‑Expandable Nitinol PTFE‑Covered Stent (base platform), with an in‑development drug‑eluting (DE) version. Exhibits from distributor contracts specify Ø 5–9 mm with lengths 40/60/80 mm (and 100 mm for Ø 6–9 mm), sheath compatibility 8/9F; list/EXW pricing shown at $950–$1,000 (Colombia) and €1,100 (EU) for the base device.

Clinical setting. Endovascular maintenance of the hemodialysis access circuit (peripheral & central segments). ● How it is billed today (U.S.) — Base platform (non‑drug) fits existing hemodialysis‑circuit codes: Physician: CPT 36903 (peripheral stent; includes angioplasty), optional +36908 (central stent add‑on) when treated centrally in the same session. Facilities (HOPD/ASC) are paid under OPPS/ASC with device‑intensive APCs; example 2025 OPPS national payment for the most intensive dialysis‑circuit interventions (APC 5194) is ≈$17,957.

Devices: hospitals typically report C1874 (stent, coated/covered, with delivery system); depending on CMS packaging and pass‑through status, device cost may be packaged or separately paid (see §4). ● Drug‑eluting (DE) variant—expected pathways.

FDA Breakthrough Device can unlock expedited coverage/payment levers:

• IPPS/NTAP alternative pathway for FDA Breakthrough Devices (3‑year, cost‑based

add‑on during inpatient stays), and

• OPPS device pass‑through (TPT) for outpatient HOPD/ASC when CMS grants

pass‑through to a new device category. Merit Medical+1

Separately, CMS’ TCET (Transitional Coverage for Emerging Technologies) can accelerate

national coverage for Breakthrough devices via an NCD + Coverage with Evidence

Development. CMS+1

● Market need remains large and procedure‑rich. Roughly ~808k+ people live with ESRD in the U.S.; ~68% are on dialysis—creating large, recurring volumes of access‑circuit interventions. NIDDK

• What Randy asked and why it matters (verbatim insights

+ reality checks) From your CEO conversation:

• Competitor precedent & add‑on payment. “Rhapsody… got Breakthrough designation… now

received an NTAP… $5,700 additional reimbursement on top of $17,000… good for 3 years.”【WEBVTT†00:35:50–00:36:10】 What CMS shows now: Merit’s WRAPSODY™ Endoprosthesis has IPPS NTAP status with a max add‑on ≈$3,770 (subject to case‑mix and cost tests), not $5,700. The ≈$17k figure aligns with OPPS APC 5194 hospital‑outpatient payment levels—not IPPS. In other words, Randy’s strategic takeaway is right (add‑on boosts economics), but the inpatient/outpatient programs differ (NTAP vs. OPPS device pass‑through). Venture Med Group

• Investor questions to answer every time.

○ Current codes & payments in hospital vs ASC; facility vs physician profitability. ○ Will Solaris fit into existing DRGs/CPTs/ICD‑10 immediately or need new codes? ○ For new technology, what’s the path & timing for NTAP/TPT/TCET, and what happens after 3 years?【WEBVTT†00:39:17–00:41:16】【

WEBVTT†00:40:00–00:41:01】

• Business impact. Early‑year revenue slope dominates acquisition value; reimbursement

frictions flatten that slope and depress NPV/DCF.【WEBVTT†00:41:34–00:42:23】

• Execution wish list. Build an AI reimbursement module that pulls from CMS/FDA +

competitor guides, surfaces specific codes & rates by site of service, and keeps everything current.【WEBVTT†00:37:52–00:39:10】【WEBVTT†00:43:06–00:44:02】 These points are incorporated throughout this whitepaper and mapped to Module 6 (see §9).

• FDA device classification & regulatory signals (why they

matter to payment) ● Base platform (covered stent for AV access) aligns with FDA product code PFV – “System, endovascular graft, AV dialysis access circuit stenosis treatment”—a Class III PMA space (e.g., Bard FLUENCY PLUS PMA P130029). Class III status is consistent with high‑impact, “new” device claims under CMS. FDA Access Data+1 ● Central venous/iliac venous applications appear under venous stent product codes such as QKJ (central venous stent) or QAN (iliac vein), both Class III—useful if Solaris later expands indications. FDA Access Data ● Why this matters: Breakthrough Device designation (especially for the DE variant) unlocks IPPS NTAP alternative pathway and strengthens your case for OPPS device pass‑through and TCET national coverage. Merit Medical+1

• Outpatient/HOPD & ASC coding and payment (current

state for Solaris base platform)

Physician coding (professional fees)

For hemodialysis access circuit work, use the dedicated dialysis‑circuit code family (36901–36909). Core Solaris scenarios: ● 36903 – Dialysis circuit intervention with stent placement in the peripheral segment (includes any angioplasty within that segment).

● +36908 – Add‑on for stent placement in the central segment (report once per session, in addition to a base code 36901–36906). ● +36907 – Add‑on for angioplasty in the central segment (if performed). Authoritative policies summarize billing conventions (single base code per session; +36907/+36908 typically once per session). AAPC+1 When to consider non‑dialysis venous stent codes (37238/37239). If a case is not a dialysis‑circuit service (e.g., stand‑alone iliac/central venous stent unrelated to circuit maintenance), 37238 (initial vein) / 37239 (each additional vein) may apply. Check MAC policies and documentation. www.bostonscientific.com Coding caution. CPT content is AMA IP; verify exact descriptors and NCCI edits with your coding lead.

HOPD (hospital outpatient) payment

● Dialysis‑circuit interventions map to Endovascular Procedure APCs. 2025 national average OPPS rates commonly referenced by vascular‑access vendors are: APC 5192 ≈ $5,701, APC 5193 ≈ $11,340, APC 5194 ≈ $17,956.72 (national unadjusted; device‑intensive packaging rules apply). Venture Med Group ● Device reporting. Hospitals typically report C1874 (stent, coated/covered, w/ delivery system). Payment for the device is packaged unless the device has OPPS pass‑through

(TPT) status. Merit Medical

● Pass‑through example (how it works in dialysis codes). CMS granted OPPS/ASC TPT for HCPCS C1600 (a vessel preparation device) and explicitly paired it with dialysis‑circuit codes 36902/36903/36905/36906—a clean exemplar of how pass‑through overlays procedural APCs in Solaris’ service family. CMS Implication for Solaris DE. If the DE stent earns a new device category and pass‑through, the stent cost can be separately paid (beyond the APC), improving HOPD/ASC economics during the pass‑through window (typically 2–3 years) before the cost is packaged into APC rates. CMS

ASC payment

● ASC rates exist for dialysis‑circuit interventions, and CMS/contractor tables confirm ongoing file updates. Manufacturers’ 2025 compliance guides show example national average ASC rates for 36902–36906 and note that ASCs may receive TPT payments for eligible devices (e.g., C1600) in addition to the procedural payment. CMS+1

• Inpatient coding & payment (IPPS) and NTAP strategy

● ICD‑10‑PCS: stent placement in upper‑extremity/central veins is typically coded to “Insertion of Intraluminal Device … Percutaneous Approach”, e.g., 05HY3DZ (upper vein) or specific central‑vein body parts (e.g., 06H03DZ for IVC). Dilation codes (067…) describe angioplasty, and are distinct from “Insertion.” icd10data.com+1 ● MS‑DRG assignment: Vascular access stent/graft procedures commonly group to MS‑DRGs 252–254 (“Other Vascular Procedures” w/ MCC; w/ CC; w/o CC/MCC) when performed inpatient. CMS ● NTAP (New Technology Add‑On Payment): ○ Alternative Breakthrough pathway reduces the “substantial clinical improvement” bar for FDA Breakthrough devices; newness and cost tests still apply. NTAP lasts up to 3 years. Merit Medical ○ Current benchmark: WRAPSODY™ has NTAP with max add‑on ≈$3,770 per case for FY 2025–2026 (Merit’s official guide & earnings disclosures). This validates add‑on feasibility for Solaris, while highlighting that add‑on amounts are capped by CMS formulas—not a flat $5,700. CMS

• Coverage acceleration: TCET and coding logistics for

Solaris DE

● TCET (Transitional Coverage for Emerging Technologies) is now final: CMS will accept up to ~5 FDA Breakthrough devices/year, target an NCD within ~6 months of FDA authorization, and often require Coverage with Evidence Development (CED). For Solaris DE, TCET offers predictable national Medicare coverage during initial data accrual. CMS+1 ● Coding steps you’ll likely need for DE

• HCPCS device code request if no existing code accurately identifies a drug‑eluting

covered stent for AV access (separate from the CPT procedure code).

• OPPS device pass‑through application (if eligible), enabling separate payment in

HOPD/ASC for ~2–3 years. CMS

• NTAP for IPPS if you expect inpatient utilization (rare for dialysis maintenance but

relevant for select admissions). Merit Medical

• Consider TCET nomination pre‑authorization to align FDA and CMS clocks,

especially if DE claims imply substantial clinical improvement over covered stents.

CMS

• Competitor & analog coding signals you can leverage

● Covered stents with AV‑access labels (e.g., Covera™; Fluency Plus PMA history) are Class III stent grafts used in this circuit; their guides use the same dialysis‑circuit CPT family and standard venous stent device codes—there is no special CPT for “drug‑eluting” in AV access today. BD+1 ● Reference OPPS/ASC payment levels published by neutral or competitor sources (Boston Scientific, Medtronic, VentureMed) consistently show APC 5192/5193/5194 tiers and ASC rates for 36902–36906; these are useful benchmarks for Solaris’ base platform economics and for forecasting DE uplift with pass‑through. www.bostonscientific.com+2Medtronic+2

• Market research snapshot (for top‑down TAM and

site‑of‑service mix) ● ESRD prevalence & dialysis split. ~808k people in the U.S. live with ESRD; about ~68% receive dialysis. This supports a >500k dialysis‑patient base generating high annual volumes of access interventions (AVF/AVG creation, maturation, maintenance). NIDDK ● Vascular‑access burden & repeat interventions. USRDS vascular‑access chapters document persistent re‑intervention needs for AVFs/AVGs over one and two years, explaining why hemodialysis circuit maintenance is a large, repetitive procedure market.

(See USRDS 2024 Ch. 4.) USRDS

Implication: Because most maintenance occurs outpatient, OPPS/ASC economics dominate Solaris’ P&L, while NTAP is strategically valuable for DE if/when inpatients are treated or if CMS needs inpatient cost evidence.

• Module 6: How to operationalize (automated

documentation, coding & reimbursement optimization) Anchored to your Module‑6 vision (NLP extraction → AI pre‑submission checks → revenue optimization), here’s a Solaris‑specific blueprint:

• NLP autocode (physician & facility).

○ Train on Solaris‑specific operative notes and your dialysis‑circuit code policy: prioritize 36901–36906 base‑code selection rules; surface +36907/+36908 add‑on indications when central work is documented; flag when the service is not dialysis‑circuit (suggest 37238/37239 alternative). Encode NCCI/MUE checks from MAC policies (e.g., Novitas LCD coding points) to prevent denials. AAPC

• Device coding guardrails.

○ Default C1874 for covered stent in HOPD/ASC unless/ until a new pass‑through code is assigned to Solaris DE. If a case uses a TPT‑eligible device, auto‑pair the correct device HCPCS with eligible CPTs (CMS has explicitly shown such pairing with

C1600 ↔ 36902/36903/36905/36906). Merit Medical+1

• AI pre‑submission claim validation.

○ Check site of service (HOPD vs. ASC vs. inpatient) → apply OPPS/ASC status indicators, APC mapping and device‑intensive logic. Validate that all required device codes and revenue codes are present for device‑intensive procedures. (See

OPPS tiers and ASC indicators for 36902–36906.) Venture Med Group+1

• Revenue optimization dashboards.

○ Surface expected APC/ASC payment by CPT combination and overlay any pass‑through add‑on detected (e.g., device cost line for DE once granted). ○ Where cases are admitted, project MS‑DRG 252–254 base payment and any NTAP add‑on if applicable. CMS+1

• Regulatory “fast‑track” checklist for DE.

○ Breakthrough → TCET nomination (pre‑auth dialogue with CMS). ○ OPPS pass‑through application (separate payment; 2–3 years). ○ IPPS NTAP application (cost & newness tests; 3 years). ○ Plan for “after 3 years”: model with/without device packaging—APC re‑calibration and potential DRG weight updates based on claims data trajectory.

CMS+1

• Governance & “single source of truth.”

○ Keep CMS Addenda (OPPS/ASC), MAC LCDs, and FDA PMA updates synced into the Module‑6 knowledge base so your AI always answers with current sources—exactly what Randy requested.【WEBVTT†00:54:50–01:00:04】

• “What to bill” quick‑reference (planning view)

Final coding must follow operative detail and payer policy; this table is a starter for your internal guide. Clinical scenario Physician

CPT (pro

HOPD/ASC

(facility) Device coding Notes Peripheral dialysis‑segment stent (with adjunct angioplasty)

(base) OPPS APC

5193–5194 tiering by intensity; ASC rates available C1874 (covered stent) today; new pass‑through HCPCS likely for DE Add +36907/+36908 if central segment treated in the same session (once per session). AAPC+1 Central dialysis‑segment stent (during same session) Add +36908 Same as above Same Follow LCD/CCI edits; imaging is bundled in dialysis‑circuit codes. AAPC Non‑dialysis venous stent (e.g., iliac/central vein unrelated to circuit) 37238 (initial) /

(add’l)

OPPS venous endovascular

APCs; ASC

allowed C1874 / C1876 as applicable Use only when the service is outside dialysis‑circuit definitions. www.bostonscientific.com Inpatient stent placement

ICD‑10‑PCS

Insertion (e.g., 05HY3DZ upper vein) ± angioplasty codes

MS‑DRG

252–254 (Other Vascular Procedures) Device on

UB‑04; NTAP

applies if approved (DE or other breakthrough) NTAP add‑on is time‑limited (up to 3 years) and capped by CMS formulas. icd10data.com+2CMS+2

• Risk controls & denial‑prevention tips

● Dialysis‑circuit coding is “all‑inclusive” for access/diagnostic imaging/maneuvers; avoid unbundled S&I codes that trigger edits. (See major vendor coding guides & MAC LCD). Medtronic+1 ● Add‑on codes (+36907, +36908) are once per session rules; exceeding MUEs invites denials. Medtronic ● Device‑intensive procedures require that appropriate device HCPCS and revenue codes appear on the claim (e.g., pass‑through devices like C1600 paired to 3690x). Use Module‑6 pre‑submission checks to enforce this automatically. CMS

• Roadmap for Solaris (base platform → DE) with explicit

• Are hospitals/ASCs “whole” on these procedures today?

○ Yes, under existing APC/ASC rates for dialysis‑circuit interventions; national OPPS references show APC 5194 ≈ $17.96k for the highest tier, with device packaging unless pass‑through applies. Venture Med Group

• Do existing codes cover Solaris base platform?

○ Yes: 36903 ± +36908 (and related family) for the dialysis circuit; 37238/37239 if not a dialysis‑circuit service. ICD‑10‑PCS “Insertion…Intraluminal Device” codes cover inpatient. AAPC+2www.bostonscientific.com+2

• What’s the DE reimbursement path?

○ Target FDA Breakthrough, then apply for OPPS TPT (HOPD/ASC separate device payment) and IPPS NTAP (if inpatient use) and nominate for TCET to secure predictable Medicare coverage while evidence matures. Plan now for the post‑pass‑through period (packaging and DRG/APC recalibration). CMS+2Merit Medical+2

• What happens “after 3 years”?

○ NTAP expires; APC and DRG weights absorb real‑world costs over time; OPPS TPT similarly sunsets and device costs are packaged—hence the importance of early volume/cost data to influence recalibration. CMS

• Appendices

A. Product details from executed agreements (useful for code mapping & supply chain) ● Colombia distribution exhibit lists SOLARIS Self‑Expandable Nitinol PTFE Covered Stent, Ø 5–9 mm × 40/60/80/100 mm, EXW price $950–$1,000 (8/9F sheath).

● EU distribution agreement shows €1,100 unit price for the Solaris Self‑Expandable Covered Stent. (These details help revenue‑cycle teams validate supply/device lines against C‑codes.) B. Code references & sources ● Dialysis‑circuit CPT family (36901–36909) usage rules, add‑on limits, and central/peripheral segmentation: MAC LCDs and major vendor guides. AAPC+1 ● OPPS APCs & 2025 rates (5192–5194) used by vascular‑access manufacturers referencing

CMS Addenda. Venture Med Group

● Device HCPCS: C1874 (stent, coated/covered, with delivery system). Merit Medical ● OPPS/ASC pass‑through mechanics and example pairing to dialysis codes (C1600 →

36902/36903/36905/36906). CMS

● ICD‑10‑PCS examples for venous stent insertion (05HY3DZ, 06H03DZ). icd10data.com+1 ● MS‑DRGs 252–254 for inpatient vascular procedures. CMS ● Breakthrough → NTAP alternative pathway and TCET final notice. Merit Medical+1 ● Market size: NIDDK ESRD fact sheet (~808k; ~68% dialysis). NIDDK

• What to do next (checklist you can assign this week)
• Lock base‑platform coding policy. Publish a one‑page coder sheet: default 36903

(peripheral stent) ± +36908 (central), C1874 device; include “when non‑dialysis → 37238/37239” rules and sample op‑note phrases to trigger add‑ons. (Wire this into

Module‑6 NLP.)

• Stand up Module‑6 claim validation. Turn on device‑intensive checks, MUE limits for

+36907/+36908, and site‑of‑service payment previews (OPPS APC & ASC). (Flag missing device HCPCS and revenue code pairings automatically.) CMS

• DE reimbursement program. Start Breakthrough strategy → TCET nomination; draft

OPPS pass‑through and NTAP application shells now so they’re ready at ID/IDE milestones. CMS

• Investor packet. Recast the section Randy described into a 2‑page “Reimbursement at a

Glance”: site‑of‑service codes & payments, DE add‑on pathways, and a 3‑year post‑launch revenue curve with and without pass‑through/NTAP.

• Where Randy’s remarks appear in this paper (for

traceability) ● Rhapsody/NTAP and “$5,700 on $17,000” example; 3‑year term discussion: 【

WEBVTT†00:35:50–00:36:40】

● Investor questions: HOPD vs ASC, facility vs physician, existing DRGs/CPT/ICD‑10 vs new codes: 【WEBVTT†00:39:17–00:41:16】 ● New‑tech reimbursement risk → early revenue slope → NPV/DCF: 【

WEBVTT†00:41:34–00:42:23】

● Need for an AI reimbursement module pulling CMS/FDA + competitor guides and keeping current: 【WEBVTT†00:37:52–00:39:10】 ● Request to keep the bot connected to the internet & synced to the latest data room: 【

WEBVTT†00:54:50–01:00:04】

Note: Where Randy’s numbers conflict with current CMS sources (e.g., the exact NTAP amount for WRAPSODY), I left his strategic point intact but corrected the figure using current manufacturer/CMS references.

• Disclaimers

CPT® codes, descriptions and other data are © 2024–2025 American Medical Association. All rights reserved. This document is informational and not billing advice. Coverage/payment decisions are payer‑ and locality‑specific and change over time; always verify with current CMS Addenda, MAC policies, and AMA CPT publications.

Sources (select, load‑bearing) ● Dialysis‑circuit coding rules (36901–36909): MAC/Novitas LCD summary; vendor coding guides. AAPC+1 ● OPPS/ASC payment tiers & examples (APC 5192–5194): 2025 manufacturer reimbursement guide synthesizing CMS Addendum B. Venture Med Group ● Device HCPCS: C1874 descriptor (stent, coated/covered). Merit Medical ● OPPS/ASC pass‑through mechanics & dialysis‑code pairing (C1600): CMS transmittal and table. CMS ● ICD‑10‑PCS examples (05HY3DZ; 06H03DZ): ICD10data & CMS ICD‑10-PCS manual page.

● MS‑DRGs 252–254 (Other Vascular Procedures). CMS

● NTAP breakthrough alternative pathway (policy basis). Merit Medical ● WRAPSODY NTAP specifics (cap ≈$3,770). CMS ● TCET final notice & pathway characteristics. CMS+1 ● ESRD prevalence (~808k; 68% dialysis): NIDDK. NIDDK ● Product details and pricing snapshots from Solaris distributor agreements (for device & supply chain context).