PSYCHEDELICS STRATEGY INTEL
Regulatory trajectory ร Stratum positioning analysis
WINDOW SIGNAL
May 4, 2026
๐ข
VERDICT: NOT A PIVOT โ A SEQUENCED EXTENSION
The psychedelic therapy RCM market is 18โ36 months from being real. The corpus can't be built yet because insurance claims don't exist yet. But the window to establish first-mover positioning is open now. The move is Spravato corpus (near-term revenue) + clinical necessity framework participation (zero-cost positioning) + psilocybin corpus intake at FDA approval (2026โ2027). Stratum's thesis โ high-variability clinical scenarios that volume-optimized RCM AI fails at โ fits psychedelic therapy better than anything else in behavioral health.
The most complex denial patterns in behavioral health history are 18 months away. Stratum should be the infrastructure they run on.
EO Signed
Apr 18
Trump fast-track EO, 2026
Est. FDA Approval
Q1 '27
COMPASS psilocybin TRD
Coverage Opens
2028
Commercial payer est.
Market 2026
$5.5B
โ $26.4B by 2035
Corpus White Space
0
Competitors in denial intel
NOW โ Spravato Wedge
EXECUTE
Esketamine (Spravato) is FDA-approved, has Category I CPT codes, is covered by all major commercial payers with complex PA requirements. Same clinical population as psilocybin (TRD). Every Spravato denial precedent is a psilocybin template. Build the corpus now; generate revenue now.
NOW โ Positioning Signal
PUBLISH
No RCM company is publishing on psychedelic denial intelligence. The clinical necessity frameworks are being written now by working groups (NNDC, AMA CPT panel). Publish white paper. Enter those rooms. Oregon/Colorado operators will need RCM infrastructure in 18 months โ be the company they know before they need you.
2027 โ Corpus Intake
MONITOR
At COMPASS NDA filing (Q4 2026), activate beta corpus partner relationships with clinic operators. First psilocybin coverage denials emerge 2027โ2028. Stratum enters with 12+ months of precedent intelligence vs. zero for any competitor entering at that moment.
The Signal โ What Just Happened
Political Context
The April 18, 2026 EO is bipartisan-flavored: veterans + PTSD is the political hook, RFK Jr. is the HHS champion, and Marty Makary (FDA Commissioner) is implementing. This combination โ veteran advocacy + MAHA movement + bipartisan mental health urgency โ gives this more political durability than typical psychedelic legislation. Ibogaine for veteran PTSD is the explicit policy rationale; that framing is nearly impossible to defund.
EO Actions (April 18โ24, 2026)
Apr 18
Trump signs EO "Accelerating Medical Treatments for Serious Mental Illness"
Directs FDA to fast-track psychedelics with Breakthrough Therapy designation. Mandates $50M ARPA-H funding to states developing psychedelic programs.
Apr 24
FDA issues Commissioner's National Priority Vouchers to 3 companies
COMPASS (psilocybin/TRD), second company (psilocybin/MDD), third company (methylone/PTSD). Vouchers compress FDA review to ~1โ2 months post-NDA filing.
Apr 24
COMPASS receives NDA rolling review acceptance simultaneously
FDA grants rolling NDA review request for COMP360 TRD. Q4 2026 submission target with final 26-week durability data expected early Q3 2026.
2025 (prior)
HALT Fentanyl Act reformed Schedule I research process
Significantly streamlined DEA research authorization for controlled substances, enabling faster clinical trial initiation for psychedelics.
Regulatory Timeline โ Compound Status
| Compound | Company / Program | Status | Earliest FDA Decision | Coverage Implication |
|---|---|---|---|---|
| Psilocybin (TRD) | COMPASS Pathways (COMP360) | Phase 3 complete โ 2 positive trials | Late 2026 / Q1 2027 | First commercial coverage decisions 2027โ2028 |
| Psilocybin (MDD) | Usona + others | Phase 3 ongoing | 2027โ2028 | Broader coverage follows COMPASS precedent |
| Methylone (PTSD) | MAPS successor entity | Priority voucher issued | 2027+ | Uncertain โ MDMA rejection casts shadow |
| MDMA | Lykos Therapeutics | Complete Response Letter (rejected 2024) | Unknown โ resubmission pending | Not imminent |
| Ibogaine | Various | Phase 1 trial approved | 2029+ | Cardiac safety concerns; distant |
| Esketamine (Spravato) | Janssen / J&J | FDA approved 2019 | Live โ Category I CPT codes exist | Covered now with PA at UHC, Cigna, Anthem, Horizon |
| Ketamine (IV) | Various clinics | Legal / no FDA psychiatric approval | None pending | Mostly self-pay; some off-label coverage |
Key Insight: MDMA Rejection Is a Feature, Not a Bug
FDA's 2024 rejection of MDMA-assisted therapy proves the agency will hold the line on safety and efficacy. Every approval that does happen carries clinical legitimacy โ which means payer coverage will follow with clear medical necessity criteria, not vague "we'll see." The MDMA rejection gives payers a template for what they'll demand before covering any psychedelic: robust Phase 3 data, REMS-equivalent safety monitoring, contraindication documentation. Psilocybin's two consecutive Phase 3 successes are meaningful precisely because MDMA failed the same bar.
The RCM Problem Forming in Real Time
Why Psychedelic Therapy Will Be the Hardest RCM Billing in Behavioral Health History
6โ8 hour dosing sessions already exceed Medically Unlikely Edits (MUEs) for standard psychotherapy CPT codes. Category III codes (0820Tโ0823T) exist but are tracking codes only โ not reimbursable under Medicare, Medicaid, or commercial insurance. No Category I CPT status until 18โ24 months post-FDA approval at minimum. "Investigational," "no medical necessity," and "protocol non-adherence" will be the dominant denial vectors. Payers are already building internal task forces โ prior authorization will be their first instrument, and it will be more complex than any existing BH PA schema.
Structural Complexity Drivers
6โ8 hour session duration
Exceeds MUE limits for all existing psychotherapy CPT codes โ no clean billing pathway exists without Category I codes
Category III codes (tracking only)
0820Tโ0823T introduced by AMA โ zero reimbursability, but required for tracking. Category I upgrade: 18โ24 months post-approval
No standard of care comparators
Payers have no internal medical necessity criteria to reference โ they'll write them from scratch, with maximum conservatism
Concurrent psychotherapy mandates
Integration therapy (before + after dosing) requires separate billing โ payers will audit session bundling, split billing, and care coordination
REMS-equivalent safety monitoring
Will require facility certification, prescriber registration, patient monitoring documentation โ each a denial vector if documentation is incomplete
The Spravato Analog โ What Psilocybin Will Look Like
Spravato (esketamine) received FDA approval in 2019. In 2026 โ 7 years later โ it still faces:
Step therapy mandates at all major payers
Must document failure of โฅ2 antidepressants โ same step-therapy logic will govern psilocybin
Prior authorization at every commercial payer
UHC effective 5/1/2025, Cigna, Anthem, Horizon, Florida Blue all require active PA โ and have distinct criteria
High initial denial โ appeal success pattern
"Many approvals happen on appeal once the plan sees a complete file" โ J&J publishes a dedicated Exceptions & Appeals Guide
REMS program compliance as denial vector
Sessions must occur in certified healthcare settings with 2-hour post-dose monitoring โ non-compliance = automatic denial
BH Denial Baseline Stratum Already Operates In
| Metric | Current (2025โ2026) | Psychedelic Trajectory |
|---|---|---|
| BH claims growth | +17% in 2025 โ payer scrutiny accelerating | Add psychedelic claims volume post-approval: further acceleration |
| Top denial code | CO-197 โ no authorization on file | Psychedelics will generate CO-197 at far higher initial rates โ novel modality, payers unfamiliar |
| Revenue leakage | 15โ30% of collectible revenue lost annually | Psychedelic practices (higher per-session cost) will face proportionally larger dollar losses |
| Primary challenge | Prior auth denials for residential + PHP/IOP | Prior auth for novel 6-hour dosing sessions will be the hardest PA scenario in BH |
Market Data
Market Size 2026
$5.5B
Global psychedelic therapeutics
Projected 2035
$26.4B
18.9% CAGR (Business Research Insights)
Cumulative Investment
$3.8B+
VC + public markets through 2025
North America Share
43%
FDA designations + Medicare pilots
Oregon Psilocybin Program (State of Play)
| Clients served (Q1 2025) | 1,500+ per quarter |
| Session cost | $1,200 โ $3,000 |
| Group sessions | $300 โ $500 |
| Insurance coverage | None โ 100% self-pay |
| Income skew | Majority >$95K/yr |
| Why no coverage | Federally Schedule I; payers await FDA approval + CMS precedent |
Colorado has a parallel program. Combined: the largest real-world psychedelic therapy dataset outside of clinical trials. Zero insurance billing โ zero denial corpus. This is Stratum's window.
Federal Funding Deployed
| ARPA-H allocation (EO-directed) | $50M minimum |
| Target | States with active psychedelic programs |
| HALT Fentanyl Act (2025) | Streamlined Schedule I research authorization |
| Priority voucher benefit | FDA review compressed to ~1โ2 months post-NDA |
| Political champions | Trump (EO), RFK Jr. (HHS), Makary (FDA) |
| Durability driver | Ibogaine for veteran PTSD โ bipartisan, un-defundable |
Critical Analysis โ The Honest Read
The Case Against โ What You Need to Hear First
The corpus doesn't exist yet and can't be built. Stratum's thesis is precedent-based intelligence โ actual denial decisions and clinical necessity reasoning encoded across thousands of cases. For psychedelic therapy, those cases don't exist. Oregon is 100% self-pay. No insurance claims means no denials means no corpus. "First corpus in psychedelic denial intelligence" is a category error โ you'd be building documentation infrastructure for a market that has generated zero insurance documentation.
Stratum has no revenue yet. H1 (knowledge asymmetry proves real) is unvalidated. Adding an 18-month speculative extension before locking paying customers in the primary BH market is how founders lose focus at exactly the wrong moment.
The timeline risk is real. MDMA got rejected. Ibogaine has cardiac risk concerns. If COMPASS hits a manufacturing issue or safety signal, NDA approval slips to 2028. Commercial coverage follows 12โ18 months after that. Medicaid coverage (the dominant BH payer) could be 5+ years from now in most states.
Stratum has no revenue yet. H1 (knowledge asymmetry proves real) is unvalidated. Adding an 18-month speculative extension before locking paying customers in the primary BH market is how founders lose focus at exactly the wrong moment.
The timeline risk is real. MDMA got rejected. Ibogaine has cardiac risk concerns. If COMPASS hits a manufacturing issue or safety signal, NDA approval slips to 2028. Commercial coverage follows 12โ18 months after that. Medicaid coverage (the dominant BH payer) could be 5+ years from now in most states.
The Competitive Threat You Need to Take Seriously
Large AI RCM platforms already have an implicit corpus. Waystar, Availity, Cohere, and R1 have processed tens of millions of claims. At that volume, pattern-level denial intelligence is a statistical byproduct โ they don't need a curated corpus because the signal emerges from volume alone. If they've processed enough Spravato and Auvelity claims, they effectively already have what Stratum is planning to build.
Their data has two structural weaknesses Stratum can exploit. First, BH claims have historically been processed through carved-out managed behavioral health organizations (MBHOs) with separate data architectures โ the large RCM platforms have meaningfully worse BH data than their general medical data. Second, their implicit corpus degrades at low volume and high complexity: novel treatment categories, new drug approvals, cases where n is small. For COMP360 at launch, nobody will have the pattern data โ and whoever builds it first has an 18-month lead before the volume players catch up.
The real H3 hypothesis refinement. The original H3 (corpus depth creates compounding returns) needs a sharper assumption: that a curated, structured, precedent-annotated corpus produces better outcomes than a statistically-derived one at the same volume. In BH specifically, this is a reasonable bet โ clinical necessity logic is more narrative and less codifiable than medical. But it needs to be true, not just assumed. The Spravato corpus is where you validate this.
Their data has two structural weaknesses Stratum can exploit. First, BH claims have historically been processed through carved-out managed behavioral health organizations (MBHOs) with separate data architectures โ the large RCM platforms have meaningfully worse BH data than their general medical data. Second, their implicit corpus degrades at low volume and high complexity: novel treatment categories, new drug approvals, cases where n is small. For COMP360 at launch, nobody will have the pattern data โ and whoever builds it first has an 18-month lead before the volume players catch up.
The real H3 hypothesis refinement. The original H3 (corpus depth creates compounding returns) needs a sharper assumption: that a curated, structured, precedent-annotated corpus produces better outcomes than a statistically-derived one at the same volume. In BH specifically, this is a reasonable bet โ clinical necessity logic is more narrative and less codifiable than medical. But it needs to be true, not just assumed. The Spravato corpus is where you validate this.
The Real Window โ It's Not Just About COMP360 Approval
The competitive clock runs faster than the approval clock. The window isn't "get there before psilocybin approval in 2027โ28." It's "get there before Waystar processes enough Spravato and Auvelity claims to make their implicit corpus good enough." That clock is already running and has a shorter fuse than the FDA timeline.
The SUD + psychedelic LOC intersection identified separately (PHP/IOP authorization for patients who received ketamine or psilocybin as part of SUD treatment) is a genuinely new denial category where this dynamic is most visible. No volume player has pattern data here yet. The category is forming now. This is the highest-leverage surface for Stratum to plant a flag โ not because the market is biggest, but because the lead time against implicit corpus competition is longest.
The SUD + psychedelic LOC intersection identified separately (PHP/IOP authorization for patients who received ketamine or psilocybin as part of SUD treatment) is a genuinely new denial category where this dynamic is most visible. No volume player has pattern data here yet. The category is forming now. This is the highest-leverage surface for Stratum to plant a flag โ not because the market is biggest, but because the lead time against implicit corpus competition is longest.
The Reframe That Changes the Math
The real opportunity isn't the psychedelic corpus. It's the clinical necessity framework โ and the corpus is what makes any upstream prevention product defensible.
By the time psilocybin coverage begins, payers will have already written their medical necessity criteria. The organizations writing those criteria now โ NNDC, AMA CPT Editorial Panel, OHA Psilocybin Services Division โ are drafting the policy that will generate Stratum's future corpus. If Stratum is a participant in that process, you're not waiting for the corpus to appear โ you're helping write the criteria the corpus will be scored against.
On the upstream prevention question: moving into claim submission assistance is a different product (closer to Cohere Health) that requires EHR integration, payer criteria mapping, and significant capital. The better path is to remain the intelligence layer that upstream tools need to license. Without Stratum's corpus, a PA automation tool is just applying generic InterQual criteria. With it, you know that Cigna denies PHP post-ketamine on criterion X 73% of the time, and successful appeals cite document Y. Stay in the intelligence layer. Let the workflow tools come to you.
By the time psilocybin coverage begins, payers will have already written their medical necessity criteria. The organizations writing those criteria now โ NNDC, AMA CPT Editorial Panel, OHA Psilocybin Services Division โ are drafting the policy that will generate Stratum's future corpus. If Stratum is a participant in that process, you're not waiting for the corpus to appear โ you're helping write the criteria the corpus will be scored against.
On the upstream prevention question: moving into claim submission assistance is a different product (closer to Cohere Health) that requires EHR integration, payer criteria mapping, and significant capital. The better path is to remain the intelligence layer that upstream tools need to license. Without Stratum's corpus, a PA automation tool is just applying generic InterQual criteria. With it, you know that Cigna denies PHP post-ketamine on criterion X 73% of the time, and successful appeals cite document Y. Stay in the intelligence layer. Let the workflow tools come to you.
| Move | Horizon | What It Requires | Revenue | Risk |
|---|---|---|---|---|
| Spravato denial corpus | Now | Existing claims data + payer PA policies (public) | Yes โ near-term | Low โ market exists |
| Clinical necessity framework positioning | Now โ 6 months | White paper + working group participation | No โ brand/inbound | Very low โ zero cost |
| Psilocybin corpus intake | 2027โ2028 | FDA approval + coverage decisions to exist | Yes โ longer-term | Medium โ timeline dependent |
Strategic Moves โ Insertion Points
MOVE 01 ยท EXECUTE NOW
Spravato Corpus โ Near-Term Revenue + Psychedelic Proof of Concept
Build Spravato (esketamine) denial pattern corpus: step-therapy failure documentation requirements, TRD diagnostic criteria payers require, concurrent psychotherapy mandates, REMS program compliance denials. J&J publishes a Prior Authorization Toolkit and an Exceptions & Appeals Guide โ these are public documents that encode the appeal logic Stratum should systematize. Map clinical necessity criteria across all major payers (UHC effective 5/1/2025, Cigna, Anthem, Horizon, Florida Blue โ all public).
Why it matters strategically: When psilocybin coverage begins, it will mirror Spravato's pathway exactly. Every Spravato denial precedent is a psilocybin precedent template. Target: 300โ400 specialized psychiatric and TRD clinics that administer Spravato โ the same clinics that will be first movers on psilocybin.
Why it matters strategically: When psilocybin coverage begins, it will mirror Spravato's pathway exactly. Every Spravato denial precedent is a psilocybin precedent template. Target: 300โ400 specialized psychiatric and TRD clinics that administer Spravato โ the same clinics that will be first movers on psilocybin.
โฑ Horizon: Now ยท Revenue: Yes ยท Risk: Low
MOVE 02 ยท PUBLISH NOW
White Paper: "Before the Precedents Exist: Building Clinical Necessity Infrastructure for Psychedelic-Assisted Therapy"
Audience: BH RCM directors, psychedelic clinic operators, payer medical policy teams, healthcare investors. Argument: (1) The PA system for novel BH modalities is broken by design โ Spravato is the proof. (2) Psychedelic therapy will face a more complex denial landscape than any prior BH innovation. (3) Clinical necessity criteria are being written now, before any payer has covered a single session โ this is the leverage point. (4) Stratum's corpus architecture is the infrastructure this market needs.
Distribution: Psychedelic Alpha (industry trade publication), MAPS network, ASKPยณ (American Society of Ketamine Physicians), behavioral health VC networks.
Distribution: Psychedelic Alpha (industry trade publication), MAPS network, ASKPยณ (American Society of Ketamine Physicians), behavioral health VC networks.
โฑ Horizon: 60 days ยท Revenue: No (inbound) ยท Risk: Very low
MOVE 03 ยท ENTER NOW
Clinical Necessity Working Groups โ Be in the Room Where Criteria Are Written
| Organization | What They're Doing | Stratum's Entry Point |
|---|---|---|
| NNDC | Published psilocybin consensus statement (Lancet eClinicalMedicine, 2025) | Submit commentary; request working group participation |
| AMA CPT Editorial Panel | Will vote on 0820Tโ0823T Category I promotion post-approval | Monitor comment period; submit provider impact testimony |
| Oregon Health Authority | Running first-in-nation psilocybin program; publishing quarterly data | Build relationship with OHA data team; position as billing infrastructure |
| MACPAC / CMS | Will write Medicare coverage determination post-approval | Track NCD timeline; submit comment on medical necessity standards |
โฑ Horizon: 90 days ยท Revenue: No (positioning) ยท Risk: Very low
MOVE 04 ยท CULTIVATE NOW
Oregon/Colorado Operator Relationships โ Be the Company They Call in 18 Months
Oregon: 1,500+ clients per quarter, growing. Every one of those clients is self-pay today. Every one becomes a billable claim the moment coverage begins. The pitch: "You're building a practice on a self-pay model that will transition to insurance reimbursement within 24 months. The denial patterns that emerge will define your revenue for the next decade. Stratum is building the precedent intelligence infrastructure so you learn from everyone's denials, not just your own." They don't need RCM today โ they need to know who they're calling in 18 months.
โฑ Horizon: Ongoing ยท Revenue: No (pipeline) ยท Risk: Very low
MOVE 05 ยท EXECUTE THIS WEEK
Evidence Registry Extension โ Add Psychedelic-Adjacent Clinical Necessity Evidence
Add a new category to the Stratum Evidence Registry: Psychedelic-Adjacent Clinical Necessity Evidence. Seed with: (1) Spravato clinical necessity criteria across 5 major payers โ all published, all public. (2) AMA Category III code definitions (0820Tโ0823T) and documentation requirements. (3) NNDC consensus statement clinical criteria for appropriate psilocybin candidates. (4) Oregon OHA facilitator service protocols (de facto clinical necessity framework for state-regulated access). (5) MDMA rejection CRL โ FDA stated concerns become the clinical necessity contraindications payers will adopt.
None of this requires waiting for insurance claims. It's the framework documentation that will structure the corpus when claims begin.
None of this requires waiting for insurance claims. It's the framework documentation that will structure the corpus when claims begin.
โฑ Horizon: This week ยท Revenue: No (corpus readiness) ยท Risk: None
MOVE 06 ยท TRACK NOW
SUD + Psychedelic LOC Intersection โ The Highest-Leverage New Category
A genuinely new denial category is forming: payers denying PHP/IOP authorization for patients who received ketamine or psilocybin as part of their SUD treatment โ on grounds that the treatment was experimental, or that the LOC isn't supported post-infusion. This sits at the intersection of a drug PA decision and a level-of-care authorization decision, which is unusual leverage terrain.
Why this category matters more than most: No volume player has pattern data here yet. The category is too new and too small for statistical corpus approaches to work. Stratum's curated, structured approach is the only viable methodology at current n. First-mover precedent corpus in this category could be built now, at low cost, before any competitor recognizes it exists.
Note: The clinical necessity logic does NOT transfer between drug PA and LOC frameworks โ these are separate adjudication tracks. The opportunity is mapping the intersection cases, not conflating the criteria sets. Drug PA denials and PHP/IOP authorization denials in the same episode are the corpus unit, not a unified framework.
Why this category matters more than most: No volume player has pattern data here yet. The category is too new and too small for statistical corpus approaches to work. Stratum's curated, structured approach is the only viable methodology at current n. First-mover precedent corpus in this category could be built now, at low cost, before any competitor recognizes it exists.
Note: The clinical necessity logic does NOT transfer between drug PA and LOC frameworks โ these are separate adjudication tracks. The opportunity is mapping the intersection cases, not conflating the criteria sets. Drug PA denials and PHP/IOP authorization denials in the same episode are the corpus unit, not a unified framework.
โฑ Horizon: Track now, build as cases emerge ยท Revenue: Future ยท Risk: Very low โ zero cost to track
The Three-Move Sequence
| NOW | Spravato + Position | Spravato corpus (revenue-generating) + white paper + working group entry + Oregon/Colorado relationship building | Revenue | Low cost |
| Q4 2026 | Activate | COMPASS NDA filing triggers active monitoring. Position Stratum to intake first psilocybin coverage denials as beta corpus partner with clinic operators built over prior 12 months | Pre-revenue | Timeline |
| 2027โ28 | Corpus Intake | Real coverage, real denials, real corpus. Stratum enters with 12+ months of precedent intelligence vs. zero for any competitor entering at this moment | Revenue | Market proven |
Risk Factors โ Track These
RISK 01 ยท HIGH ยท MONITOR MONTHLY
FDA Timeline Slippage
COMPASS targets late 2026 NDA submission. Any manufacturing issue, safety signal, or CMC (Chemistry, Manufacturing, Controls) gap delays approval to 2028+. Coverage follows 12โ18 months after approval. Market could open 3+ years later than expected. Monitor: COMPASS quarterly filings, COMP006 Part B durability data (expected early Q3 2026).
RISK 02 ยท MEDIUM ยท STRUCTURAL
Payer Blanket Exclusions โ Standard Playbook for Novel Therapeutics
Standard payer playbook: approve in principle, exclude in practice via step-therapy and medical necessity criteria that few patients can meet. MDMA's rejection gives payers cover to be maximally conservative. Even with FDA approval, psilocybin could face 2โ3 years of "non-covered โ investigational" determinations before commercial coverage becomes routine. The Spravato 7-year timeline is the precedent. Implication: This risk is actually bullish for Stratum โ the more complex the payer environment, the more Stratum's corpus matters.
RISK 03 ยท LOW ยท POLITICAL
Federal Policy Reversibility
The EO was signed April 2026. A political shift or RFK Jr. departure could stall implementation. However: the veteran/PTSD framing is the most politically durable in healthcare policy. Ibogaine for veterans has explicit cross-aisle support. The FDA actions (priority vouchers, rolling NDA review) are now institutional โ harder to reverse than executive orders. Risk rated low, not zero. Monitor: RFK Jr. tenure, midterm political landscape, DOD/VA psychedelic research funding.
RISK 04 ยท HIGH ยท COMPETITIVE
AI RCM Platform Implicit Corpus โ The Volume Player Threat
Large AI RCM platforms (Waystar, Availity, Cohere, R1) have processed tens of millions of claims. Pattern-level denial intelligence is a statistical byproduct at that volume โ they don't need a curated corpus. For Spravato today, Waystar likely has meaningful signal already. The competitive window for Stratum is not "before FDA approval" โ it's "before these platforms process enough novel-mechanism antidepressant claims to make their implicit corpus good enough." That window is open now but has a shorter fuse than the regulatory timeline suggests.
Stratum's structural advantages: BH claims historically flow through MBHOs with separate data architectures โ large RCM platforms have weaker BH data specifically. Implicit corpora degrade at low volume / high complexity; novel categories like SUD + psychedelic LOC intersection have near-zero signal anywhere. Curated + annotated > statistically-derived in narrative clinical necessity logic (the H3 bet).
Monitor: Waystar/Cohere product announcements for BH-specific PA intelligence features. Any signal they're investing here compresses Stratum's window. Implication: The Spravato corpus is time-sensitive. Don't treat it as "we'll get to it." Start now.
Stratum's structural advantages: BH claims historically flow through MBHOs with separate data architectures โ large RCM platforms have weaker BH data specifically. Implicit corpora degrade at low volume / high complexity; novel categories like SUD + psychedelic LOC intersection have near-zero signal anywhere. Curated + annotated > statistically-derived in narrative clinical necessity logic (the H3 bet).
Monitor: Waystar/Cohere product announcements for BH-specific PA intelligence features. Any signal they're investing here compresses Stratum's window. Implication: The Spravato corpus is time-sensitive. Don't treat it as "we'll get to it." Start now.
RISK 05 ยท MEDIUM ยท FOCUS
Stratum Pre-Revenue Position โ Focus Dilution
Adding a speculative 18-month horizon positioning play before H1 (knowledge asymmetry) is validated risks diluting focus at the worst possible time. The Spravato wedge mitigates this โ it's not speculative, it's an adjacent market that exists today. White paper and working group participation are low-cost. The risk is if Stratum treats psychedelics as a primary market strategy before proving the core BH denial market. Guardrail: Psychedelics positioning is a parallel track at <15% of time allocation until H1 is validated.
Sources
GOV
Accelerating Medical Treatments for Serious Mental Illness โ White House EO
White House ยท April 18, 2026
GOV
FDA Accelerates Action on Treatments for Serious Mental Illness
FDA ยท April 24, 2026
CORP
COMPASS Pathways: FDA granted NDA rolling review + Priority Voucher
COMPASS Pathways IR ยท April 2026
LEGAL
Psychedelics and the Executive Order: From Schedule I to Treatment Priority
Foley & Lardner ยท April 2026
LEGAL
CLINICAL
Consensus statement: Clinical considerations for psilocybin integration โ NNDC Task Group
Lancet eClinicalMedicine ยท 2025
CLINICAL
BILLING
Future of Psychedelic Therapy Billing in 2025
MedStates ยท 2025
BILLING
Spravato Exceptions and Appeals Guide
Janssen / J&J ยท 2025
MARKET
Record Venture Funding Elevates Psychedelic Therapies in Mental Health Trials
GlobeNewswire ยท January 2026
MARKET
Psilocybin FDA Approval Status Tracker
Psychedelic Beacon ยท Updated April 2026
MARKET
STATE
Oregon Psilocybin Services Tracker
Psychedelic Alpha ยท Ongoing
STATE
Oregon psilocybin therapy clients tend to be wealthier
OPB ยท July 2025