# CGM DMEPOS Market Research Synthesis — v1
Date: 2026-05-01
Source: Perplexity Deep Research (10 queries), internal review

## Purpose
Reference document for the Signal build-out. Corrects claims in existing
materials and establishes verified facts for all future copy, pitch docs,
and product positioning.

---

## Terminology (Confirmed)

Use "resupply" not "refill" in all materials.
CGM supply allowances (A4238/A4239) are exempt from Medicare refill
rules. DMEPOS suppliers process resupply orders, not prescriptions.
This distinction affects how Signal describes its workflow and how
supplier staff understands their obligations.

---

## Documentation Requirements (Confirmed)

Governing LCD: L33822 (Joint LCD — applies uniformly across all MACs)

Required for each CGM resupply claim:
- Valid order/prescription on file
- Face-to-face or telehealth qualifying visit within 6 months of
  resupply (measured from last qualifying visit, not supply date)
- Supplier PECOS enrollment active and current
- SWO (Statement of Medical Necessity / Written Order) complete
- Proof of delivery (POD) on file

Note: POD is a top denial reason not in Signal's v1 scope.
Flag as a future module.

---

## Prior Authorization Status — April 2026

CGM HCPCS codes (A4238, A4239, K0553, K0554) are on the CMS Master
List of items requiring prior authorization consideration.

They are NOT on the Required Prior Authorization List as of April 2026.

Implication for Signal copy: do not frame PA as a current mandatory
burden for CGM. Frame it as a known future risk as CMS expands the
Required PA List. This is a compliance horizon item, not a present
obstacle.

---

## Verified Statistics (Use These. Retire the Others.)

| Claim | Status | Replace With |
|-------|--------|-------------|
| "94.2% of CGM denials are documentation failures" | NOT VERIFIABLE. Do not use. | See CERT data below |
| "35-45% of CGM claims denied" | Scenario-based, not universal. Qualify if used. | "first-pass denial rates vary significantly by supplier documentation maturity" |
| CERT 2019: 32.8% error rate for glucose monitors | Verified, CMS-sourced | Use with citation year |
| CERT 2019: 68.6% of those errors from insufficient documentation | Verified, CMS-sourced | Pair with above |

Recommended framing for Signal materials:
"CMS CERT data shows 32.8% of glucose monitor claims had errors,
with insufficient documentation driving over two-thirds of those
failures."

---

## Competitive Bidding 2028 (Confirmed)

Final rule: CMS-1828-F
Effective: January 1, 2028
CGMs explicitly included in the competitive bidding program.

Implication: small and mid-size suppliers face margin compression
and potential market exit if they cannot demonstrate clean claim rates
and operational efficiency before the bid cycle. This is Signal's
existential urgency driver for the 2026-2027 sales window.

---

## PECOS Validation — Genuine Signal Differentiator

Most billing platforms validate PECOS enrollment at intake (one time).
NikoHealth performs monthly automated PECOS checks per patient.
Most platforms do not.

Signal's per-resupply PECOS validation (each CSV import cycle) is
a differentiator. Suppliers whose PECOS lapses mid-cycle generate
denials with no warning under current workflows. Signal flags this
before the claim is submitted.

---

## Competitive Landscape — Key Finding

NikoHealth (~$3.5M revenue, independent): integration partner,
not competitor. Operates an AI-friendly billing hub with Tennr,
CompliantRx, and Notable. Signal complements this stack by
providing upstream documentation readiness that feeds cleaner
data into billing workflows.

Do not position Signal against NikoHealth. Position Signal as
what makes NikoHealth's workflow cleaner on the front end.

---

## HIPAA-Compliant Outreach Resources for Suppliers

Suppliers conducting outreach to prescribers and patients have
access to:
- Secure fax (still dominant in prescriber communication)
- HIPAA-compliant messaging platforms (Spruce Health, RingCentral
  for Healthcare, Updox)
- EHR messaging via integration (limited by prescriber EHR access)
- Phone outreach with HIPAA-compliant call logging

Signal's role: identify who needs outreach and what is missing.
Selection of outreach channel remains with the supplier.
Signal does not recommend or integrate a specific outreach tool
in v1 scope.

---

## What This Changes in Existing Materials

| Document | Required Change |
|----------|----------------|
| pitch/master-summary.md | Replace 94.2% with CERT stat; qualify denial rate |
| pitch/signal-pitch-v1-plain.md | Same stat corrections; update product name |
| pitch/signal-pitch-v2-professional.md | Same stat corrections; update product name |
| sttil-website/signal-cgm.html | Same stat corrections; update product framing |
| pitch/signal-business-model-v1.md | PA section: reframe as future risk |
| KG: denial_root_cause | Correct "94 percent" fact (pending approval) |
