ARKA regulatory standing
How ARKA operates on a first-party AIIE standard, tracks the CMS Appropriate Use Criteria Program, and positions for reinstatement — with cited federal sources.
Licensing posture
ARKA operates on a first-party AIIE standard with no third-party criteria license in the live data path. Scoring draws on peer-reviewed clinical literature, the CMS Appropriate Use Criteria Program structure established by PAMA §218(b), and the RAND/UCLA Appropriateness Method for the 1–9 scale semantics — not on embedded or transcribed proprietary criteria tables.
ARKA's AIIE engine is designed to operate independently of any single criteria licensor — drawing on peer-reviewed clinical literature, CMS Appropriate Use Criteria Program standards (PAMA §218(b)), and first-party machine-learning validation.
Methodology detail: AIIE Methodology & Evidence Basis · Evidence Methodology Dossier
CMS Appropriate Use Criteria Program — current status
The posture below reflects the latest human- or system-confirmed snapshot from CMS and Federal Register sources. Automated monitoring may propose changes; an admin confirms reinstatement or activation with a citation.
What this means for buyers
- No CDSM consultation is required on Medicare fee-for-service claims while the program is paused.
- ARKA already meets the program's clinical-standard intent via the first-party AIIE engine and peer-reviewed evidence register.
- If CMS reinstates the mandate, ARKA is positioned to re-qualify as a CDSM-aligned mechanism at point of order.
Honest regulatory band
Three dated facts. None of the business case depends on any of them.
- WISeR (1 January 2026) — CMS's Wasteful and Inappropriate Service Reduction model pairs AI with licensed clinical review on the denial path for select services.
- CMS-0057-F (8 February 2024) — Impacted payers publish machine-executable prior-authorisation rules; ARKA executes whichever rules apply rather than authoring its own.
- Imaging AUC (1 January 2024) — The programme ARKA was originally aligned to was withdrawn, and the post-mortem is why ARKA no longer treats a regulation as demand.
Congress's own proposed correction to the imaging AUC programme removes the real-time claims-reporting requirement and keeps consultation at the point of care. That is the failure mode ARKA rules out by construction rather than by promise. It is not a reason to buy ARKA.
What we will not touch
The two concepts share a word and nothing else. Beneficiary assignment is set by programme rule, not by us. Contribution measurement is the product. The commitments below are generated from the never-do catalog — the same artefact CI checksums — with the named enforcement mechanism on each row.
| Axis | Beneficiary attribution | Contribution attribution |
|---|---|---|
| What it answers | Which patients belong to which clinician or ACO | Which clinician's ordering behaviour changed |
| Who sets it | CMS programme rule, or the customer's own model | ARKA's measurement, against a locked pre-period |
| ARKA's posture | Read-only. Never written. Never influenced. | This is the product. |
| Financial effect | Determines who is at risk for a population, and the benchmark | Determines who gets credit for a measured reduction |
| Enforcement | CHECK-ATTR-1, the ingest allowlist, Clause 6 | CHECK-INC-* (Prompt 25.3), Clause 8 |
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ARKA does not compute, influence, or recommend changes to beneficiary attribution or to risk-adjustment coding. Attribution and risk scores are read-only inputs supplied by your organisation. We measure avoided utilisation against the attribution and risk model you give us, and we publish the specification of how we use them.
Coding firewall — the note is invisible to measurement surfaces
Whether a considered-and-deferred note exists is invisible to measurement, comparison, attribution, incentive and sales surfaces. It is a clinical artefact and nothing else. The commitments below are generated from the never-do catalog — the same artefact CI checksums — with the named enforcement mechanism on each row.
- 01
No ARKA surface, artefact, metric, export, contract clause or piece of marketing may reference evaluation-and-management coding, billing level, code selection or reimbursement in connection with the considered-and-deferred note — and the build fails if one does.
contractualObjection: The write-back is a coding-intensity tool, and you will teach my clinicians to document for level.
lint · CHECK-CF-1 in scripts/lint-coding-firewall.ts; docs/coding-firewall.json computed disjointness; Clause 10 in docs/arka-aj/DEPLOYMENT_AGREEMENT_CLAUSES.md
Proves: No write-back-touching module or copy may carry banned coding lexicon (CPT, E/M, level of service, MDM, data/risk element, complexity, documentation improvement, capture, uplift, reimbursement); clinical-note and billing-relevant field sets are a computed set-difference
- 02
Whether a considered-and-deferred note was written may not enter the attribution ledger, the peer-comparison packet, the contribution export, or any incentive computation. The write-back module graph is unreachable from attribution, ledger and incentive, and the build proves it.
contractualObjection: Clinicians who write the note will look better on the measure than clinicians who do not — you built a documentation incentive by accident.
lint · CHECK-CF-2 / CHECK-CF-3 in scripts/lint-scope-boundary.ts; CHECK-CF-4 / CHECK-CF-5 in scripts/lint-coding-firewall.ts and scripts/lint-tcoc.ts; Clause 10 in docs/arka-aj/DEPLOYMENT_AGREEMENT_CLAUSES.md
Write-back brief — why the note is not a billing feature
v1.0.0 · 22 August 2026 · one page for a compliance officer
ARKA does not write notes. ARKA offers your clinician a structured way to record a decision they already made, in their own words, under their own attestation — and ARKA never sees, counts, reports or is paid for what that does to a billing code. That last clause is in your contract, it is enforced by a check in our build, and it is published on our never-do list.
What the note is
The considered-and-deferred note is a record of a clinical decision: alternatives the clinician considered and the alternative they selected, written into the patient chart under attestation.
Check: CHECK-ATT-1 / CHECK-ATT-2 / CHECK-ATT-3
Who authors it
The physician authors it. ARKA may compose a draft from clinician selections; ARKA never invents clinical assertions and never writes into the chart without attestation.
Check: CHECK-ATT-1 / CHECK-ATT-2 / CHECK-ATT-3
What ARKA never sees, counts, or is paid for
ARKA never sees, counts, reports, or is paid for what the considered-and-deferred note does to a billing code.
Never-do: no-billing-language-in-clinical-writeback · Check: docs/coding-firewall.json (disjoint: true)
Five rules
Rule 1. The physician authors it; ARKA never does
Nothing enters the patient record from the considered-and-deferred path that the clinician did not select or type and then explicitly attest. ARKA may compose a draft from clinician inputs; ARKA may not invent clinical assertions.
Check: CHECK-ATT-1 / CHECK-ATT-2 / CHECK-ATT-3
ARKA-PROTO — Non-Device Clinical Decision Support position
v1.0.0 · 25 August 2026 · ARKA's reasoning for this module only
This section states ARKA's reasoning for why ARKA-PROTO is designed to meet the four Non-Device Clinical Decision Support criteria under FD&C Act §520(o)(1)(E), as interpreted in FDA's January 2026 final guidance on Clinical Decision Support Software (Docket FDA-2017-D-6569). It is ARKA's own analysis of this module only. It is not a legal opinion, not a regulatory conclusion, and does not apply to any other ARKA product unless that product publishes its own position.
Statute and January 2026 guidance
FD&C Act §520(o)(1)(E) excludes software functions from the device definition when four criteria are met. FDA's January 2026 final guidance supersedes the September 2022 version. The four criteria are unchanged in substance; the January 2026 revision sharpens explainability and automation-bias expectations under criterion 4.
Four criteria — how ARKA-PROTO meets each
Criterion 1. Not acquire, process, or analyze medical images or signals
The software function does not acquire, process, or analyze medical images or signals from in vitro diagnostic devices.
ARKA-PROTO assembles structured chart facts, report text, and device records. It does not read DICOM pixels, waveforms, or acquisition frames. A reachability test fails the build if a Criterion-1 surface becomes callable from lib/proto/.
Check: CHECK-PROTO-8
Criterion 2. Display, analyze, or print medical information
The software function is intended for displaying, analyzing, or printing medical information about a patient or other medical information.
Appropriateness is not coverage
We do not author coverage criteria and our clinical engine cannot read them. Appropriateness cites evidence; coverage cites the specific policy paragraph. Where they disagree we report the disagreement rather than resolving it.
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A payer-authored or utilisation-management source may inform a coverage determination and may never inform clinical appropriateness. The two field sets are disjoint and the build proves it.
contractualObjection: Your clinical score is the payer's criteria with a white coat on.
lint · CHECK-APPR-1 in scripts/lint-tcoc.ts; CHECK-FW-1..3 in lint:sources / lint:coverage / lint:scope; the disjoint-input proof in docs/appropriateness-firewall.json; Clause 9 in docs/arka-aj/DEPLOYMENT_AGREEMENT_CLAUSES.md
Proves: No payer-authored or utilisation-management source may inform a clinical appropriateness rating. Verdict A (score.ts and the knowledge matrix) and Verdict B (lib/coverage) are computed from disjoint field sets in docs/appropriateness-firewall.json; the clinical engine cannot reach lib/coverage, lib/pa, lib/davinci or lib/ins even transitively; no ModalityRating carries a payer_um / payer_utilization anchor.
Enforcement artefact: docs/appropriateness-firewall.json. The two field sets are a computed set-difference; the build fails if they overlap.
How to challenge a contribution figure
A vendor publishing how to challenge its own numbers is unusual. It is the reason a physician group will accept the module at all.
- Generation. A figure is computed against a locked pre-period. For 14 days it is provisional and cannot enter any pay export.
- Dispute. A clinician files a dispute with a reason. The record moves to disputed and is excluded from export until resolved.
- Resolution. Resolutions are appended, never overwritten. Only after the window has closed and no open dispute remains is the figure exportable.
- Attenuation. Where the interval includes zero, the exported figure is attenuated toward zero rather than the point estimate, and the attenuation is stated. Paying on a figure statistically indistinguishable from no change is refused.
There is no override that exports a provisional or disputed figure. The pressure to use one arrives at payroll deadline; the type system refuses it.
Policy-trigger watchlist
Section 25 item 39. Each row is a dated answer — yes, no, or unchecked — with a Source Register id and a retrieval date. Legislative triggers also carry a staged history (introduced → … → enacted); a recent stage move shortens the re-check interval (CHECK-WL-4). A recorded negative is kept because it was tested. Re-check intervals are enforced by CHECK-WL-2 in the lint; CHECK-WL-3 fails if any row is still unchecked. This page prints the stored retrieval date only.
| Trigger | Answer | Source | Retrieved | Re-check | If the answer flips |
|---|---|---|---|---|---|
| any imaging operator, PACS/RIS vendor or radiology-AI vendor has announced protocol automation, protocol-variance measurement or scanner-minute recovery as a named product feature. Vol XI §16 risk 6. | no | Competitive scan of public product pages — protocol automation / protocol-variance measurement / scanner-minute recovery as named featurescompetitor-protocol-automation-scan-2026-08 | 2026-08-24 | 30 days | Product copy and the protocol-variance census would be reviewed against the named feature. The business case does not depend on competitor product pages. |
| CY2027 OPPS has finalized site-neutral (PFS-equivalent) payment for imaging without contrast in excepted off-campus provider-based departments. | no | CMS CY2027 OPPS/ASC proposed rule fact sheet (CMS-1850-P) |
Official references
Federal and CMS primary sources for the AUC program and related interoperability rules. All links open in a new tab.