
HeartFlow
B2B per-analysis service, not a subscription. A site sends a coronary CTA; HeartFlow returns an FFRCT Analysis or Plaque Analysis and recognises revenue on delivery to the physician. Critically, HeartFlow does not bill Medicare: the hospital outpatient department or practice bills CPT 75580 (FFRCT) or 75577 (plaque) and pays HeartFlow a per-analysis fee out of what it collects. CMS says so outright — status indicator O1 pays the hospital OPD, not the algorithm vendor (canon REG-CMS-012). The CMS rate is therefore not HeartFlow's price; it is the ceiling above which HeartFlow's price cannot go, because it is the customer's entire recovery. That distinction is the business.
The thesis on this name
State of AI for Healthcare
The board's existence proof that a CPT code can produce software margin in healthcare, and simultaneously the name most exposed to the ceiling that proof implies. Q1 2026 revenue was $52.6M (+41.3%) at an 80.2% GAAP gross margin, and HeartFlow holds 7 of the 1,524 authorisations on FDA's AI list. But its payer is CMS's fee schedule, the one payer the corrected thesis says never sustains margin, and the rule is moving against it. CPT 75580 (FFR-CT) has gone $1,017.39 (CY2025) → $877.34 (CY2026, −13.8% in one year) → a proposed $850.50 for CY2027 (−3.1%), which also moves it out of clinical APC 5724 into New Technology APC 1510 — a bucket CMS itself calls an 'interim policy' and a 'transitional period', with standard ratesetting suspended under discretionary equitable-adjustment authority, one year at a time. Exclusivity is decaying in Addendum B rather than in the preamble: CPT 0623T–0626T were deleted and replaced by a single shared Category I code, 75577, flat at $950.50 across four vintages and billable by Cleerly or any future entrant; three new Category III placeholders (X567T, X668T, X669T) land in the same APC 1510 at the same $850.50; and KeyaMed holds a second FDA clearance under 75580's own product code. Trailing growth of ~41% is already guided down to +29–32% for FY2026 ($228–232M), against a TTM net loss of $111.8M at $25.23 / $2.18B (31 Jul 2026), 52-week range $20.13–$41.22. Avoid as the reimbursement-moat expression — the rent is being levelled across everyone who clears the gate.
State of AI for Healthcare
Consensus reads a Category I CPT code as a moat and carries a Strong Buy with a $36.63 average target; CMS-1850-P reads it as a ceiling — moving CPT 75580 out of clinical APC 5724 at $877.34 into New Technology APC 1510 at $850.50, and seating three new algorithmic Category III placeholders in that same APC at the identical price.
State of AI for Healthcare
Consensus reads a Category I CPT code as a moat and carries a Strong Buy with a $36.63 average target; the CY2027 OPPS proposed rule reads it as a ceiling. ~$25.23 (31 Jul 2026 close), $2.18B market cap on $191.42M of TTM revenue (+40.6%) — ~11.4x trailing sales, but ~9.4–9.6x on the company's own raised FY2026 guide of $228–232M (+29–32%) at approximately 81% non-GAAP gross margin; TTM net loss $111.83M; 52-week range $20.13–$41.22. The mechanism is in Addendum B, not the preamble: CPT 75580 ran $997.22 (CY2024) to $1,017.39 (CY2025) to $877.34 (CY2026, a 13.8% cut in one year) and is proposed at $850.50 for CY2027 in New Technology APC 1510 — a further $26.84, or 3.1% — while three new algorithmic Category III placeholders (X567T, X668T, X669T) are seated in that same APC at the identical price. The adjacent plaque code 75577 is a category code, not a company code: HeartFlow and Cleerly both bill it at $950.50 in APC 1511, and any future entrant would too, so vendors compete inside a price the payer sets. Deliberately small: the prob-weighted edge is ~+6%, the proposed rate move is only −3.1%, revenue compounds above 40%, sell-side consensus is Strong Buy and the float is a 2025 IPO with squeeze risk. This is the cheapest price at which the CMS-payer view can be expressed, not a standalone bear case, and it covers on the rule text rather than on price.
Earnings, margins, COGS & capex
HeartFlow is the cleanest listed test of a proposition the rest of the board tests and declines: that a Category I CPT code is a moat. The operating business works — revenue grew 40% in FY2025 to $176.0M and 41.3% in Q1 2026 to $52.587M, GAAP gross margin moved 75.1% to 80.2% year over year, guidance was raised in May rather than cut, and the adjusted EBITDA loss narrowed to $(14.0)M. Nothing in the P&L is broken. The problem is in Addendum B. CPT 75580, the FFRCT code carrying the bulk of revenue, paid $997.22 in CY2024, rose to $1,017.39 in CY2025, then fell to $877.34 in CY2026 — a 13.77% cut in one year — and CMS proposes $850.50 for CY2027, a further $26.84 or 3.06%, cumulatively -16.40% from the peak (canon REG-CPT-001/002). In the same proposal 75580 leaves clinical APC 5724 for New Technology APC 1510, and three new algorithmic Category III placeholders (X567T, X668T, X669T) are seated in that same APC at exactly $850.50 (REG-CPT-004). The second code is worse for the moat story: 75577 is flat at $950.50 across four vintages and is a CATEGORY code HeartFlow, Cleerly and any entrant bill identically (REG-CPT-003). The honest frame is a fast-compounding, high-gross-margin business whose unit price is published annually by a payer that has already cut it, and whose newest code is shared with the rival it is suing.
Income statement — where each revenue dollar goes
% of revenueOf every $1 of revenue, ~20¢ is cost of goods and ~80¢ operating expense, and the remainder is an operating loss.
Revenue trend
Margins
up ~500bp YoY; consolidated across FFRCT and Plaque, not code-level
rising; guide raised alongside revenue 14 May 2026
improving through FY2025, then distorted by the Q1 charge
loss narrowing in dollars against a growing base
FY2025's net loss far exceeded the $64.1M operating loss on pre-IPO capital-structure items; Q1 2026's is smaller than its operating loss, on interest income from IPO proceeds
COGS structure
Per analysis, not per seat, and heavier than pure SaaS. Each study consumes GPU inference over a multi-hundred-slice CT volume — segmentation, centreline and lumen extraction, then a computational-fluid-dynamics simulation for FFRCT or a plaque quantification — plus PHI-compliant transfer and storage, plus a human quality step on output a cardiologist will act on. That human step does not fall with GPU prices, which is why ~80% is impressive rather than automatic: it was earned by moving 75.1% to 80.2% in a year, most plausibly by automating exactly that step. The asymmetry: cost improvements accrue to HeartFlow, price improvements do not — the ceiling is what the site collects, and CMS has lowered it. CMS has also noticed the model, naming 'per-use or per-click fees' in its program-integrity discussion, verbatim the mechanism HeartFlow discloses (canon REG-CMS-011).
Capex
Not separately disclosed; structurally immaterial. No scanner fleet, no disclosed owned data centres, compute as cloud opex — the capital-intensive asset belongs to the CT OEMs and sits in the customer's building. The only fixed-asset event visible is the $7.482M non-cash impairment in Q1 2026, a write-down rather than an investment, and one canon requires be named whenever the Q1 loss is quoted (CF-HTFL-10).
Latest earnings
Beat — $52.6M against consensus near $50.7M — and the company RAISED FY2026 guidance in the same release, on both revenue and non-GAAP gross margin. For any thesis built on administrative price compression, this is the fact that must be stated first.
FY2026 revenue $228-232M (+29-32%) and non-GAAP gross margin approximately 81% (+400bp), both raised 14 May 2026 from $218-222M and 80-81%. Canon is explicit that this guide IS assertable and must not be bundled with the unknowable CY2027 final-rule outcome (CF-HTFL-06, PB-021). Next print: Q2 2026 after the close on 13 Aug 2026.
- CPT 75580 (FFRCT) OPPS rate ladder
- $997.22 CY2024 (APC 5724, RW 11.4122) -> $1,017.39 CY2025 (RW 11.4097) -> $877.34 CY2026 (RW 9.5973) -> $850.50 CY2027 proposed (New Technology APC 1510, SI O1). Canon REG-CPT-001, from CMS Addendum B each year
- CPT 75580 deltas
- -13.77% CY2025->CY2026; -3.06% CY2026->CY2027 proposed; -16.40% cumulative from the CY2025 peak (canon REG-CPT-002)
- CPT 75577 (plaque)
- $950.50 flat across CY2024/CY2025 (as 0625T), CY2026 and CY2027 proposed, APC 1511 — delta $0.00. A SHARED category code: HeartFlow, Cleerly and any entrant bill it identically (canon REG-CPT-003)
- CPT 75574 (the CCTA the algorithm rides on)
- $175.24 -> $357.13 -> $356.43 -> $398.54 proposed. The scan is paid more while the algorithm on it is paid less (canon REG-CPT-010)
- Estimated MPPR on 75577
- An ESTIMATED 50% multiple-procedure reduction when 75577 is billed in the same session as 75574 — the only session it is used in — implying realised payment below $500. NOT VERIFIED at any CMS primary; carry as an estimate, never as a CMS fact (canon REG-CPT-013)
- Rate versus CMS-measured cost
- AI-QCT paid $950.50 against a CY2023 geometric mean of ~$180, a four-year arithmetic mean of $243 and a CY2024 geometric mean of ~$496 (canon REG-CPT-008). CY2028 is the first cycle with real 75577 claims data
- Cash and investments
- $254.9M at 31 Mar 2026 from $280.2M at 31 Dec 2025 — a derived $25.3M sequential decline
- Shares and float
- 86.24M outstanding; 85.6M weighted-average Q1 2026; ~25% float from the 21.67M-share Aug 2025 IPO — the board's named squeeze risk (canon CF-HTFL-12)
- Sell-side consensus
- Strong Buy, $36.63 average target at the 31 Jul 2026 vintage (canon CF-HTFL-11) — an aggregate of third-party estimates with no primary source, quoted as the view the board's short disagrees with
- FDA authorisations
- 7 on the FDA AI-Enabled Medical Device List corporate-family roll-up, vintage 2026-06-16 (canon REG-FDA-018 — quote only on that basis)
Growth drivers
- Category I CPT 75580 for FFRCT, effective 1 Jan 2024, with the company disclosing payor coverage policies reaching approximately 99% of US covered lives (FY2025 10-K — a disclosure about coverage breadth, not about the rate)
- The Plaque Analysis ramp on the second Category I code, 75577, effective 1 Jan 2026 at $950.50 in APC 1511, with five of seven MACs at final LCD and the rest case-by-case; management said at the Q1 print that Plaque adoption is 'ramping ahead of schedule'
- CCTA-first evaluation of stable chest pain displacing functional stress testing — the secular driver, independent of HeartFlow's execution. CMS is paying MORE for the underlying scan: CPT 75574 went $175.24 (CY2024) to $357.13 (CY2025) to $356.43 (CY2026) to $398.54 proposed (canon REG-CPT-010)
- Installed-base depth — 1,800+ healthcare institutions, 650,000 patients served globally and 200 million annotated CCTA images as of the Q1 2026 print
- Evidence with real duration — the PRECISE randomised trial (2,103 participants, 65 sites) and ADVANCE-DK, whose seven-year follow-up shows 5.7% adverse events with a normal FFRCT against 16.2% abnormal
- International, small and under-penetrated at $15.4M in FY2025 (+26%): the UK, Japan and Canada run their own pathways with no OPPS exposure, making it the only growth vector genuinely uncorrelated with the CY2027 final rule
Reported financials — SEC EDGAR
Audited GAAP figures pulled from SEC filings · latest filing 2026-03-18. The audited primary-source spine — not financial advice.
Revenue — annual (GAAP)
Margins & balance sheet — FY’25
Bull & bear
A 41%-growing, 80%-gross-margin software business that beat and raised in its most recent quarter, holds two Category I CPT codes, sits in 1,800+ institutions with coverage policies at approximately 99% of US covered lives, and carries $254.9M of cash. The bear case is about a proposed 3.1% rate cut. On the company's own raised guide the stock trades at 9.4-9.6x forward sales, not the 11.4x trailing headline, and consensus at the vintage was Strong Buy with a $36.63 target. Volume growth of this magnitude absorbs a low-single-digit price move several times over.
- The proposed cut is small and the growth is not: -$26.84 or -3.06% on 75580, against guided revenue growth of +29-32% and trailing growth of +40.6%. CMS's own aggregate effect across the 30 SI-O1 codes that already had a CY2026 rate is +0.53%, not a cut (canon REG-CMS-005)
- CMS has demonstrated inside this very rule that it will protect software rates by hand — holding Optellum at $650.50 against data implying an approximate 90 percent reduction, and holding 75577 at $950.50 against a CY2023 geometric mean near $180. The authority that could cut 75580 is currently holding a whole cohort above measured cost (canon REG-CPT-006/008)
- The margin compounds independently of the rate: 75.1% to 80.2% GAAP in a year, ~81% non-GAAP guided. Because the ceiling is administrative, every dollar of automation in the over-read and inference stack is retained rather than competed away on price
- Two codes are ramping at once and the second is early. FFRCT is the durable core; Plaque only became Category I on 1 Jan 2026, has five of seven MACs finalised, and is ramping ahead of schedule. The base that must absorb any rate move is growing from two engines
- The evidence and installed base are the actual moat and CMS does not price them: PRECISE, seven-year ADVANCE-DK outcomes, 650,000 patients, 200 million annotated images, 1,800+ institutions. A shared code lets a rival bill; it does not hand over the corpus, the LCDs, the sales force or the seven-year data
- The structural exit is now priced. Medtronic paid up to $585M for CathWorks on 20 Apr 2026, putting AI-derived FFR inside a cath-lab sales force. HeartFlow at ~$2.2-2.3B with two Category I codes is the obvious next asset — and a 25% float means any bid, or any covering into one, moves violently
Strip the growth rate away and the question is what a company is worth when one government agency publishes the ceiling on its selling price once a year, has already lowered it 13.8% in a single cut, proposes to lower it again, and calls the regime holding the rate up 'interim'. HeartFlow does not bill CMS — the hospital does — so its per-analysis fee is bounded by what the customer collects. The 80.2% gross margin is real on the cost side and rented on the price side, and the second code is shared with the rival HeartFlow is suing.
- The rate has already moved, and not by a rounding amount: $1,017.39 (CY2025) to $877.34 (CY2026) is a 13.77% cut in one year, before this proposal; with the proposed -3.06% the cumulative move is -16.40%. A realised price cut with a second on the table (canon REG-CPT-001/002)
- The move from clinical APC 5724 into New Technology APC 1510 matters more than the dollars. CMS calls the SaMS regime interim and CY2027 transitional — six occurrences — maintains rates by hand under section 1833(t)(2)(E) instead of standard rate-setting, and gets real 75577 claims data for CY2028. It has published the gap it will eventually close: $950.50 paid against a CY2024 geometric mean of ~$496 (canon REG-CPT-007/008)
- Exclusivity is decaying in the addenda, in writing: X567T, X668T and X669T seated in APC 1510 at exactly $850.50; vMap crosswalked to 75580 to be priced; KeyaMed's DEEPVESSEL FFR cleared since 2022 under HeartFlow's own product code PJA. The classification HeartFlow's De Novo created is the door its competitors walk through (canon REG-CPT-004/011/012)
- The plaque code is not a second moat but a shared toll — $950.50 to HeartFlow, Cleerly and Elucid alike, $0.00 of movement across four vintages. On top of that canon carries an ESTIMATED 50% multiple-procedure reduction when 75577 is billed with the CTA it rides on, implying realised payment below $500. That estimate is explicitly NOT verified at a CMS primary and must be labelled so — but if real, the second growth engine realises roughly half its headline rate (canon REG-CPT-003/013)
- CMS has named this revenue model as a program-integrity problem, flagging 'subscription- or license-based arrangements, as well as per-use or per-click fees' and adding that the cost-based system 'may not effectively constrain pricing' — while separately soliciting comment on status-indicator-T discounting. The regulator is describing the mechanism and floating the tool (canon REG-CMS-011/009)
- And the business still loses money at scale: TTM net loss $111.83M, operating expenses at 136% of revenue, $25.3M of cash consumed in a quarter, no guided path to profitability. At 11.4x trailing sales the equity is priced for the volume ramp to continue undisturbed through a rate the payer is actively re-basing — with a ~25% float to amplify the re-rating either way
What it is worth
Sales multiples on both bases, anchored to a price the company does not set. At the board's 31 Jul 2026 vintage: $2.18B market cap on $191.42M TTM revenue = 11.39x TRAILING sales, but 9.40-9.56x on the raised FY2026 guide of $228-232M. Canon requires both be carried — quoting only the trailing multiple omits the issuer's forward guide, quoting only the forward one flatters it (canon CF-HTFL-05/06, PB-020). There is no P/E: TTM net income is -$111.83M. On the post-vintage 6 Aug 2026 close of $27.19 ($2.34B) the same figures are 12.2x trailing and 10.1-10.3x forward. The ladder below is the board's, at its ~$25.23 spot, with its published probabilities — and the LABELS ARE FLIPPED relative to the board's position sheet, which writes them short-relative: the board's 'bull' (short right, $15) is this dossier's BEAR, its 'bear' (short wrong, $37) is this dossier's BULL (canon PB-019).
$15 (board probability 28%
the board files this as its short being RIGHT, tied to roughly 7x trailing sales — $191.42M x 7 = $15.54, rounded to $15). The final rule confirms APC 1510 at $850.50 and the market re-prices the payment pathway as a levelled toll rather than a rent: the plaque code is shared with the rival HeartFlow is suing, three Category III placeholders already sit at the identical rate, a second cleared device holds 75580's own product code, CMS has crosswalked other algorithms to 75580 as a public benchmark, and CMS has floated multiple-procedure discounting for exactly this class of service. If the ESTIMATED — and primary-UNVERIFIED (canon REG-CPT-013) — 50% MPPR on 75577 with 75574 is real, the second growth engine realises under $500 a study rather than $950.50. On that reading, 11.4x trailing sales on a business losing $111.83M compresses toward 7x, and the gap CMS has already published between the paid rate and measured cost — $950.50 against a CY2024 geometric mean of ~$496 — becomes the CY2028 conversation.
$22 (board probability 47%)
The final rule lands roughly as proposed: 75580 at $850.50 in New Technology APC 1510, a $26.84 or 3.06% cut no model breaks on. Volume keeps compounding at the guided +29-32% and defends most of the price, but the multiple drifts as investors re-read the code as a ceiling rather than a moat — the shared 75577, three placeholders at 75580's exact proposed rate, and CMS's interim-and-transitional language make the terminal rent harder to underwrite than it looked at IPO. The stock underperforms without breaking, and the argument moves to CY2028, the first cycle in which CMS has real 75577 claims data to set a rate from.
$37 (board probability 25%
the board files this as its short being WRONG). CMS uses its section 1833(t)(2)(E) equitable-adjustment authority to hold or restore 75580 — exactly what it does elsewhere in the same rule, holding 75577 at $950.50 against a CY2023 geometric mean near $180 and Optellum's 0721T/0722T at $650.50 where the data implied an approximate 90 percent reduction. With the ceiling intact, a business growing 29-32% at approximately 81% non-GAAP gross margin, ramping a second Category I code ahead of schedule and beating and raising each quarter, re-rates toward the $36.63 consensus; a ~25% float turns that into a squeeze rather than a drift. The optional kicker is structural — Medtronic just paid up to $585M for CathWorks, and a strategic bid for two Category I codes plus 1,800 institutions would settle the argument outright.
Framing, not a recommendation, and not investment advice. The QAI board is SHORT HeartFlow at 2% of NAV ($200,000 notional on a $10M illustrative book), collateralised out of the T-bill sleeve. It is explicitly a catalyst-dated hedge — the board's single expression of the CMS-fee-schedule payer, which its payer test places on the wrong side — and NOT a standalone bear case on the company. The honest prob-weighted edge is only ~+6% (0.28 x $15 + 0.47 x $22 + 0.25 x $37 = $23.79 against a $25.23 spot), which is exactly why the size is small: the proposed rate move is just -3.1%, the company raised its own revenue and gross-margin guidance, consensus is Strong Buy at $36.63, and a ~25% float carries squeeze risk (canon PB-006, PB-019, PB-030). Three dated events sit inside the window: Q2 2026 earnings after the close on 13 Aug 2026; the CMS-1850-P comment period closing 31 Aug 2026, open at 7 August 2026; and the CY2027 OPPS final rule, expected around 1 Nov 2026 and effective 1 Jan 2027 — expected on CMS's annual cadence, not a published date (canon PB-022, REG-CMS-014). The published falsifier is written on the rule, not the tape: a final rule restoring 75580 to a clinical APC, or granting FFRCT an equitable adjustment above the CY2026 $877.34 level, covers the short immediately.
SWOT
Strengths
- The category's founding regulatory position plus a decade of evidence: FFRCT was granted through the De Novo pathway on 1 Dec 2014 (DEN130045), creating 21 CFR 870.1415 Class II product code PJA, then extended by 510(k) clearances for Plaque and Roadmap (Oct 2022) and Next Gen Plaque (Sep 2025). PRECISE (2,103 participants, 65 sites) and seven-year ADVANCE-DK outcomes (5.7% vs 16.2% adverse events) are data no console feature has
- Software economics improving fast — 80.2% GAAP gross margin from 75.1% a year earlier, ~81% non-GAAP guided. The gain is earned cost improvement and it is retained, because the sell-side price is fixed
- Growth that is fast, broad and beating — +41.3% in Q1 2026 on a +40% FY2025, a revenue beat, and guidance RAISED on both the top line and gross margin in the same release. Two Category I codes are ramping at once
- Distribution depth that is slow to rebuild — 1,800+ institutions, 650,000 patients served, 200 million annotated CCTA images, and company-disclosed FFRCT coverage policies at approximately 99% of US covered lives
- A funded balance sheet and an offensive legal posture — $254.9M of cash after a $364.2M gross IPO, funding both the operating loss and a six-patent suit against its closest private rival that the defendant must fund out of venture equity
Weaknesses
- The selling price is not the company's to set — 75580 fell 13.77% in one year and is proposed down a further 3.06%, cumulatively -16.40% from the CY2025 peak, in a rule HeartFlow can comment on but not control
- The second code is shared, not owned. 75577 pays $950.50 flat across four vintages and Cleerly and any entrant bill it identically — the plaque ramp is a volume race inside a price CMS sets, with zero pricing exclusivity
- Persistently loss-making with no dated path to profit — FY2025 net loss $116.8M on $176.0M, TTM net loss $111.83M, Q1 2026 operating expenses at 136% of revenue, $25.3M of cash consumed in the quarter
- Concentration of the purest kind — essentially all revenue on two CPT codes, one payer's annual rulemaking cycle, one modality, and one country for over 91% of it. International grew slower (+26%) than the US (+41%) in FY2025
- A ~25% float from a 2025 IPO makes the equity mechanically volatile in both directions: the 52-week range spans 2.0x on a business whose fundamentals moved in one direction all year
Opportunities
- The plaque ramp itself — 75577 became Category I on 1 Jan 2026 with five of seven MACs at final LCD, and management says adoption is ahead of schedule. If the code is a volume permit rather than a rent, the vendor with the largest installed base and deepest image corpus wins the race
- CMS's equitable-adjustment authority cuts both ways, with a live precedent in the same rule: it held Optellum's 0721T/0722T at $650.50 where claims data implied APC 1502 and, verbatim, 'the resulting approximate 90 percent reduction in payment', overriding under section 1833(t)(2)(E) (canon REG-CPT-006)
- The base procedure is being paid more — CPT 75574 rises to a proposed $398.54 from $356.43, +11.8%. A payer expanding the scan is expanding HeartFlow's addressable study volume even while trimming the algorithm's rate
- Non-OPPS revenue the CY2027 rule does not touch — the UK, Japan and Canada run separate pathways, and US office and imaging-centre volume falls under the Physician Fee Schedule, a separate rule (CMS-1848-P, 91 FR 43842, comments close 14 Sep 2026; canon REG-CMS-013)
- Consolidation optionality now that the comparable has priced — Medtronic completed its CathWorks acquisition on 20 Apr 2026 for up to $585M. A ~$2.2-2.3B listed asset with two Category I codes and 1,800 institutions is a legible target for an imaging OEM or cardiovascular strategic
Threats
- The CY2027 OPPS final rule, EXPECTED on public display around 1 Nov 2026 and effective 1 Jan 2027 — an expectation from CMS's annual cadence, not a published date (canon REG-CMS-014). It decides whether 75580 lands at $850.50 in APC 1510
- Exclusivity decaying inside Addendum B rather than the preamble — X567T, X668T and X669T sit in APC 1510 at exactly $850.50, and CMS already used 75580 as a public crosswalk benchmark to price Vektor Medical's vMap (0897T) in the CY2026 final rule (canon REG-CPT-004, REG-CPT-011)
- CMS calls the whole regime temporary in its own words — 'this is an interim policy', 'we propose to use CY 2027 as a transitional period', six occurrences — with rates maintained by hand under section 1833(t)(2)(E) rather than standard rate-setting, and CY2028 the first cycle with real 75577 claims data (canon REG-CPT-007). A rate held by fiat can be released by fiat
- In the same section that creates the category, CMS solicits comment on 'whether a new status indicator with the same specification as status indicator T (Procedure or service subject to multiple procedure discounting) would provide more appropriate payment' — a discount floated at exactly the multi-algorithm session HeartFlow's two products create (canon REG-CMS-009)
- Non-exclusivity at the device level — KeyaMed NA's DEEPVESSEL FFR was cleared 1 Apr 2022 (K213657) under HeartFlow's own product code PJA — the classification HeartFlow's De Novo created became a competitor's on-ramp (canon REG-CPT-012). Add Medtronic-owned CathWorks in the cath lab, Cleerly and Elucid on the plaque code, and the OEMs at the console
- A published gap between paid rate and measured cost — $950.50 against a CY2024 geometric mean of ~$496 and a CY2023 mean of ~$180. When CMS applies standard rate-setting, the arithmetic does not point up
Moats, dependencies & bottlenecks
Moats
Strong as a barrier to entry, weak as pricing power Low-medium on price, medium-high on access — the code is permanent, the RATE is annual Unlike the shared plaque code, 75580 describes the service HeartFlow pioneered, with company-disclosed coverage policies at approximately 99% of US covered lives. But the descriptor names a service, not a company, and a second FDA-cleared device already holds its product code. The rate is 16.40% below its CY2025 peak on the proposal (canon REG-CPT-001/002/012).
Zero as exclusivity; real as a category permit $950.50 flat across four Addendum B vintages, APC 1511, moving to SI O1 for CY2027. HeartFlow, Cleerly and any entrant bill it identically, so vendors compete on service inside a price the payer sets. Carry the ESTIMATED, primary-UNVERIFIED 50% MPPR against 75574 as a risk to realised rate (canon REG-CPT-003/013).
the asset a rate cut cannot take away The De Novo rested on HeartFlowNXT; PRECISE randomised 2,103 participants at 65 sites; ADVANCE-DK shows 5.7% seven-year adverse events with a normal FFRCT against 16.2% abnormal. A decade of prospective and registry data is the one competitive asset neither a shared code nor a console bundle replicates on a product cycle.
1,800+ institutions, 650,000 patients served, 200 million annotated CCTA images. Real friction in protocols, PACS integration and cardiologist habit — but a per-study send-out is easier to re-route than an EHR-embedded platform, and the site's economics are set by the code, not the vendor.
Company-disclosed FFRCT policies at approximately 99% of US covered lives, and five of seven MACs at final LCD on plaque. Contracting takes years — but coverage attaches to the CODE and the service, so a rival billing 75577 inherits much of the work without repeating it.
but HeartFlow is the plaintiff litigated Six patents with 2012-2018 priority dates asserted against Cleerly's ISCHEMIA and Plaque Analysis in the Eastern District of Texas on 13 Apr 2026, seeking permanent injunctive relief; the complaint alleges a former consultant founded the rival. Cleerly's 17 Apr 2026 statement calls the claims baseless. Reaching for patents where the code is shared and the price is fixed is itself the tell about how much the code is worth.
Dependencies
Ceiling-setter for the core service The dependency that defines the name. 75580: $997.22 -> $1,017.39 -> $877.34 -> $850.50 proposed, moving from clinical APC 5724 to New Technology APC 1510; 75577 flat at $950.50. CMS calls the regime interim, holds rates by hand under section 1833(t)(2)(E), and gets its first real 75577 claims data for CY2028. Rate risk is not a sensitivity here — it is the business (canon REG-CPT-001/003/007).
Customer AND the party CMS actually pays Approximately 3,500 OPDs are paid under OPPS, and CMS's O1 pays the OPD, not the algorithm vendor (canon REG-CMS-012). HeartFlow's fee comes out of what the site collects, so a cut to the site's rate compresses willingness to pay before it appears in any document about HeartFlow. It also means OPPS does not govern office-based or imaging-centre volume at all.
Coverage gatekeepers A priced code with no coverage determination pays nothing. FFRCT coverage is mature (approximately 99% of US covered lives per the company); on plaque, five of seven MACs have final LCDs with the rest case-by-case. Utilisation management and prior authorisation move addressable volume independently of the published rate.
Siemens Healthineers, Canon Medical, Philips) no scan, no product Every unit of revenue requires a CTA already acquired on hardware HeartFlow does not own, making these four simultaneously the supply of studies and the most credible bundlers of competing console analytics at a near-zero marginal price. On canon's single FDA-list basis they also dominate authorisation stock — GE 130, Siemens 95, Philips 45, Canon Medical 43, against HeartFlow's 7 (REG-FDA-018).
Cardiology practice pattern and guideline bodies (ACC / AHA / SCCT) Demand generation The CCTA-first chest-pain pathway is set by guidelines and referring-physician habit, not by HeartFlow. Favourable that CMS is paying more for the scan; unfavourable that the same pathway feeds every rival analysing the same study.
Per-study inference plus a CFD simulation for FFRCT, and a human quality step on cardiologist-facing output. That step does not fall with GPU prices — and the 500bp of margin gain in a year suggests it is being automated. Falling compute cost is retained because the price side is capped.
Financing and legal $254.9M of cash against a $25.3M sequential decline and no guided profitability date — roughly ten quarters on that burn, which makes the November final rule a financing-conditions event as well as a revenue event. On the suit HeartFlow is the plaintiff, so the exposure is spend and an adverse ruling rather than an injunction against its own products; invalidity on the 2012-2018 patents would remove the last exclusion mechanism available where the code is shared.
Advantages
- The founding regulatory position — a De Novo grant (DEN130045, 1 Dec 2014) that created the Coronary Physiologic Simulation Software Device classification itself, extended by 510(k) clearances in Oct 2022 and Sep 2025
- Two Category I CPT codes ramping simultaneously — 75580 for FFRCT (1 Jan 2024) and 75577 for plaque (1 Jan 2026)
- Software economics improving fast — 75.1% to 80.2% GAAP gross margin in a year, ~81% non-GAAP guided for FY2026
- Depth no code confers — PRECISE, seven-year ADVANCE-DK outcomes, 650,000 patients served, 200 million annotated CCTA images, 1,800+ institutions
- Company-disclosed FFRCT coverage at approximately 99% of US covered lives, and five of seven MACs at final LCD on plaque
- A funded balance sheet ($254.9M) and a plaintiff's position in the category's defining patent suit
Weaknesses
- The price is administratively set and has already been cut — -13.77% in one year, -16.40% cumulative on the CY2027 proposal
- The plaque code is shared with Cleerly and Elucid at an identical $950.50 — no pricing exclusivity in the second growth engine
- Deeply loss-making: TTM net loss $111.83M, Q1 2026 opex at 136% of revenue, no guided path to profitability
- Extreme concentration — two CPT codes, one payer's annual rule, one modality, one country for over 91% of revenue
- CMS has named 'per-use or per-click fees' as a program-integrity concern, verbatim the disclosed revenue mechanism
- A ~25% float from the August 2025 IPO makes the equity structurally volatile, with a 52-week range spanning 2.0x
Bottlenecks
- The published ceiling — HeartFlow's per-analysis price cannot durably exceed what the site collects, and that number is set in OPPS Addendum B once a year — $877.34 today on 75580, $850.50 proposed
- CCTA capacity and scheduling — scanner time, protocol standardisation and image quality gate every downstream analysis, and none of that capacity is HeartFlow's to add
- Prior authorisation and utilisation management on the underlying scan, which throttles volume upstream of any code or coverage decision
- Per-study human over-read and QA, the COGS line that does not fall with GPU prices and caps gross margin below classic SaaS even at 80%
- The ESTIMATED 50% multiple-procedure reduction on 75577 with 75574 — UNVERIFIED at any CMS primary (canon REG-CPT-013) — an unquantified haircut on realised plaque rate rather than a known cost
- Operating leverage that has not arrived — Q1 2026 operating expenses at 136% of revenue, so the ramp must run substantially further before the P&L inflects
- International expansion gated country-by-country by reimbursement rather than by product — under 9% of revenue and growing slower than the US
- A ~25% float, which limits institutional sizing and makes the equity a poor instrument for expressing a slow regulatory thesis in either direction
Top signals & trends
Top signals
The issuer's most recent disclosure moved forward expectations up, not down. For any thesis built on price compression, this has to be stated first (canon PB-021).
Parsed from CMS's own Addendum B across four vintages (canon REG-CPT-001/002). A realised cut, not a projected one — and the reclassification from clinical APC 5724 to New Technology APC 1510 travels with it.
Exclusivity decaying in the addenda rather than the preamble (canon REG-CPT-004). CMS also crosswalked Vektor Medical's vMap to 75580 in the CY2026 final rule, making the code a public benchmark for pricing other algorithms (REG-CPT-011).
Roughly 500bp of earned cost improvement, and because the sell-side price is administratively fixed the saving is retained rather than competed away — the one asymmetry that works for the vendor.
Canon REG-CPT-006 — the clearest evidence CMS will use section 1833(t)(2)(E) to protect a software rate by hand. The same authority applied to 75580 would immediately falsify the bear case.
Canon REG-CMS-009/011: a cut floated in the same section that creates the category, aimed at exactly the multi-algorithm session HeartFlow's two products produce — and the named billing model is verbatim HeartFlow's disclosed mechanism. Counterweight: CMS wrote no SaMS impact estimate at all, zero occurrences in the Regulatory Impact Analysis (REG-CMS-008).
Canon REG-CPT-010. Bullish on volume — a better-paid base procedure gets ordered more — bearish on the rent split, with CMS moving money toward the scan and away from the analysis.
A strategic just paid for AI-derived FFR and put it inside a cath-lab sales force — validating the category and pricing a comparable, while making the invasive-adjacent competitor materially better distributed.
Offensively, the listed plaintiff can outspend a private defendant. Structurally, reaching for patents where the code is shared and the price is fixed admits the code is not the exclusion mechanism. Cleerly called the claims baseless on 17 Apr 2026.
Canon REG-CMS-001 / REG-CMS-014. The window is OPEN at 7 August 2026 — write it as open, not spent. The ~1 Nov date is an EXPECTATION from CMS's annual cadence, not a published date, and it is the primary falsifier date for the whole reimbursement thesis.
Trends
The most important secular driver for the category and independent of HeartFlow's execution. CMS is reinforcing it by paying more for the underlying scan — 75574 proposed at $398.54 for CY2027, up from $175.24 in CY2024.
Four vendor-specific Category III plaque codes collapsed into one shared Category I code; three new placeholders seated at 75580's proposed rate; 75580 itself used as a crosswalk benchmark. Exclusivity decays in the addenda, quietly, one line at a time.
CMS designates 36 HCPCS codes as SaMS (21 reassigned from clinical APCs) while exactly 50 codes carry proposed SI O1 in Addendum B — different sets that must never be joined. The aggregate effect across the 30 O1 codes with a CY2026 rate is +0.53%, so the regime is not uniformly a cut. But CMS calls it interim six times, suspends standard rate-setting for CY2027, and gets real data for CY2028 (canon REG-CMS-004/005, REG-CPT-007).
GE HealthCare (130 FDA AI authorisations on canon's single basis), Siemens (95), Philips (45) and Canon Medical (43) control the acquisition point. A 'good enough, already paid for' console feature pressures willingness to pay for a third-party per-study send-out regardless of what the code pays.
Medtronic's completed CathWorks acquisition (20 Apr 2026, up to $585M) is the template: the algorithm is worth more attached to a sales force with a catheter bag than standing alone. It prices the category and raises the competitive bar at once.
Where the code is shared and the price is fixed, patents are the only remaining exclusion mechanism — and the newly listed party with public-market capital is the one able to use them. Accretive if the patents hold, destructive as a signal about where the moat actually sits.
FFRCT policies at approximately 99% of US covered lives per the company, and five of seven MACs at final LCD on plaque within the first year of the Category I code. Coverage normalisation is the precondition for volume, even where the benefit attaches to the code rather than the vendor.
Ecosystem & competitor graph
Suppliers feed the company; customers pull from it. Line thickness shows the strength of each tie (supply-chain dependency, customer earnings contribution). Hover to isolate a tie.
GE HealthCare / Siemens Healthineers / Canon Medical / Philips The CT installed base. Every analysis requires a coronary CTA already acquired on OEM hardware HeartFlow does not own, making these four simultaneously the supply of studies and the most credible bundlers of a competing console feature. Canon FDA-list counts on one basis: GE 130, Siemens 95, Philips 45, Canon Medical 43 (REG-FDA-018).
GPU compute for per-study inference and the computational-fluid-dynamics simulation behind FFRCT. Falling compute cost is retained margin because the sell-side ceiling is administratively fixed.
PHI-compliant image transfer, storage and hosting, consumed as opex rather than capex. Azure = MSFT, GCP = GOOGL.
The human quality step on cardiologist-facing output — the COGS line that does not fall with GPU prices, and the most likely source of the 500bp of gross-margin gain in the year to Q1 2026.
Study routing, DICOM transfer and results return into the reading environment. Integration depth is real switching friction and also a surface an enterprise-imaging incumbent can occupy.
The largest channel and the one the board's short is dated to. Approximately 3,500 OPDs are paid under OPPS; they bill 75580 at $877.34 (CY2026, $850.50 proposed) and 75577 at $950.50, and pay HeartFlow per analysis out of that collection. CMS pays the OPD, not HeartFlow (canon REG-CMS-012).
Cardiology practices and freestanding imaging centres Governed by the Physician Fee Schedule, a separate rule (CMS-1848-P, 91 FR 43842, comments close 14 Sep 2026), not by OPPS — so this channel is not exposed to the CY2027 OPPS rate change. The two settings must never be compared as one number.
Integrated delivery networks and cardiovascular service lines Buy on pathway economics — avoided invasive angiograms, avoided negative caths, throughput — rather than on the code alone. Most of the 1,800+ institutions sit here.
Japan, Canada) $15.4M of FY2025 revenue (+26%), under 9% of the total, reimbursed through national pathways with no OPPS exposure — the only revenue uncorrelated with the November final rule, and the smallest.
Private. The direct plaque rival, billing the same shared 75577 at the same $950.50 in APC 1511, with a Category I code effective 1 Jan 2026, five of seven MACs finalised and seven commercial payers covering '86+ million Americans'. Also HeartFlow's litigation defendant since 13 Apr 2026 — six patents, 2012-2018 priority, permanent injunction sought against ISCHEMIA and Plaque Analysis; Cleerly denies infringement. No post-money was disclosed at its $106M Series C extension (4 Dec 2024) and none should be inferred (canon CM-PRIV-CL-01, PB-039).
Private. Plaque-characterisation rival that can bill the shared 75577, and holder of the one AI imaging code in the cohort whose rate is RISING: 0712T at $88.05 (CY2025) -> $220.60 (CY2026) -> $250.50 proposed (canon REG-CPT-009). The cleanest evidence that HeartFlow's rate compression is a code-specific CMS judgement rather than a sector-wide posture.
FFRangio derives fractional flow reserve from routine X-ray angiography in the cath lab without a pressure wire. Medtronic announced its intent to exercise its option on 3 Feb 2026 and completed the deal on 20 Apr 2026 for up to $585M plus undisclosed earn-outs, following a 2022 partnership with a $75M investment and co-promotion rights. The most consequential competitive change of the period: an adjacent-modality FFR competitor now carried by one of the largest cardiovascular sales forces in the world.
The incumbent standard of care FFRCT displaces rather than a software rival — PressureWire X and the invasive FFR/iFR franchise. Every FFRCT analysis is a wire study that did not happen, so Abbott is both the substitute and the benchmark HeartFlow's evidence is measured against, with cath-lab contracting leverage a per-study send-out vendor cannot match.
The other invasive-physiology incumbent, with the COMET pressure guidewire inside a broad interventional portfolio. Same substitution dynamic as Abbott and the same structural advantage: physiology sold as part of a procedural bundle under an existing cath-lab contract rather than as a separately reimbursed analysis.
Private. Holds DEEPVESSEL FFR, cleared 1 Apr 2022 (K213657) under HeartFlow's own FDA product code PJA — a second authorised device inside the classification HeartFlow's De Novo created, and the load-bearing proof that 75580's pathway is non-exclusive at the device level, not merely the code level (canon REG-CPT-012). US commercial presence is limited; noted as a competitive fact only, with no listing implied or recommended.
95 FDA AI authorisations on canon's single corporate-family roll-up basis (90 Siemens-named plus Varian 5, vintage 2026-06-16). Controls the CT acquisition point with long-running coronary-physiology research; console-seated analytics carry a near-zero marginal price for a customer that already owns the scanner.
130 FDA AI authorisations, the leaderboard top on the same canon basis, plus a cardiology software franchise and demonstrated appetite for imaging-software M&A. The QAI board separately excludes GEHC at 0% NAV on its clearance-stock test — the largest AI-clearance stock in the world, whose Advanced Imaging Solutions (AIS) segment earned 13.9% EBIT in Q2 2026 — the clearest available statement that clearance stock is a barrier to entry, not a margin pool.
ASX-listed Australian AI-QCT vendor with FDA clearance for CCTA coronary plaque assessment, positioned on vulnerable-plaque detection. Smaller clinical and payer footprint than Cleerly or HeartFlow, but listed, funded, and able to bill the same shared category code once US coverage is in place.
Private (Netherlands). Angiography-derived physiology software — Medis's QAngio XA 3D quantitative flow ratio and Pie Medical's CAAS vFFR — competing for the same clinical decision from a different image source and with no CT dependency. Individually small; collectively evidence that the physiology read is being commoditised across modalities.