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MOTIV™ – the MSK real-world evidence collaboration between RegenMed and OREF – is off to a strong start. The initial MOTIV™ Observational Protocol (OP) is based upon the mandated CMS TKA PRO PM, but also collects product, surgical technique, pain management, and other real-world data. The OREF expert-reviewed OP was co-authored by Doctors Andrew Wickline and John Mercuri. WCG Clinical Services has issued its Certificate of Action confirming that the generation of Circle Datasets pursuant to that OP is exempt under 45 CFR 46.104(d)(4). Orthopedic surgeons from around the country, and representing over 2,000 TKAs annually, have already joined as Circle Members and begun enrolling Cases. Many more have indicated their intention to join. Last week’s initial Circle Hour brought together current and interested Circle Members. Topics included positive feedback on clinician and patient experience, benefits of national collaboration on TKA topics of common interest, and the opportunities for publication and Circle Dataset licensing. RegenMed and OREF will be hosting another Circle Hour at the Academy meeting in New Orleans in early March. The FDA TEMPO and CMS ACCESS programs are prioritizing fit-for-purpose, verifiable real-world evidence for several major therapeutic areas, including MSK. Circle Datasets not only meet these requirements, they do so with excellent physician UX, collaboration and ethical financial participation. Please contact Alyssa Johncola or Erika Deleon to learn more.

Executive Summary: The End of the Proxy EraAs of early 2026, the American healthcare system has reached a critical inflection point in the validation of clinical efficacy and safety. For decades, the industry relied on "administrative proxies"—billing codes, claims data, and retrospective audits—to approximate population health and provider performance. However, a structural transition toward Proven Medical Accuracy is underway, derived directly from the point of care. This shift represents a fundamental realignment of the healthcare economy, where the data generated by a clinical encounter is as vital an asset as the treatment itself.The Systemic Failure of Legacy CodingThe reliance on legacy fee-for-service (FFS) reimbursement models and administrative data architecture has historically created a significant "veracity gap."Limitations of ICD-10 and HCPCS: While ICD-10-CM codes provide classification, they often act as mere proxies for a patient’s actual clinical state. The 2026 updates to ICD-10-CM, including nearly 75,000 codes, highlight an increasing but often overwhelming granularity that still struggles to capture real-time clinical nuances without high-fidelity documentation [1].Coding Discrepancies: These codes are frequently influenced by documentation nuances and financial incentives rather than pure clinical signals. Common errors such as unbundling or upcoding continue to distort the accuracy of claims-based data [2].The "Veracity Gap" in Audits: Traditional administrative datasets often lack the granularity required for high-stakes clinical decision-making or rigorous federal audits. Historical reliance on these proxies has led to compliance risks when documentation does not perfectly align with the reported codes [1, 3].Administrative Bottlenecks: Legacy systems require vast volumes of manual paperwork, deterring the collection of high-fidelity, longitudinal data and creating a bottleneck that AI agents are now being deployed to solve [4].The CMS Shift: Data Accuracy as Revenue DefenseIn 2026, the Centers for Medicare & Medicaid Services (CMS) has altered its enforcement stance, shifting from a focus on "effort" to a focus on "proof."The Removal of Traditional Audit ScoringCMS is moving toward binary standards focused on immediate impact and remediation. If internal data does not reconcile with federal "sources of truth," such as the Provider Enrollment, Chain, and Ownership System (PECOS), organizations face immediate revenue consequences rather than incremental score deductions [1, 5].Automated Oversight and AIThe agency is increasingly utilizing advanced analytics and artificial intelligence to identify safety and efficacy signals in real-time. This proactive approach allows auditors to identify non-compliance and data anomalies before a provider even recognizes the error [1, 4].Outcome-Aligned Payments (OAP)Central to this mandate is the launch of the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model. Scheduled to begin July 1, 2026, this 10-year national test focuses on beneficiaries with chronic conditions like hypertension, diabetes, and chronic musculoskeletal pain [6]. Unlike traditional FFS, ACCESS provides recurring payments explicitly tied to achieving measurable, guideline-informed health outcomes against each patient's own baseline [7].From Billing Codes to Proven Medical AccuracyThe transition to Proven Medical Accuracy requires capturing high-trust evidence as a byproduct of care rather than as an administrative afterthought.Point-of-Care Data Integrity: High-fidelity datasets must meet new regulatory and reimbursement requirements for medical accuracy. This is particularly vital in new models where payment is tied directly to clinical results rather than service volume [6, 7].Role of Interoperability: Mandates for FHIR®-based APIs ensure that high-accuracy data flows seamlessly between participants, reducing the friction previously inherent in data exchange [8].Audit-Ready Ground Truth: To survive in a binary audit environment, organizations must maintain an "audit-ready" ground truth that is verifiable and free from the artifacts of legacy coding practices [1, 5].Strategic Implications for Healthcare ExecutivesThe 2026 Veracity Mandate demands a total re-evaluation of data strategy and operational governance.Reclassify as a Tech-Enabled Asset: Organizations that can provide verified clinical veracity can shift from "service business" valuations to higher tech-enabled asset multiples by proving outcomes with data-driven precision [7, 8].Establish Strict Internal Reporting: Compliance is no longer a soft target; practice locations, ownership, and clinical outcomes must be reconciled within strict non-negotiable windows to avoid revenue stoppages [1, 5].Invest in Explainable AI: As AI becomes integrated into operations, executives must demand "explainability" to defend decisions during federal scrutiny and mitigate liability risks [4].Prioritize Quality Over Volume: ACCESS incentives reward specialists who detect worsening conditions early and use technology to prove functional recovery rather than those who simply increase procedural volume [6, 7].ConclusionThe 2026 Veracity Mandate is an opportunity for the medical profession to re-establish primary authority through verifiable proof. By moving beyond administrative proxies and embracing proven medical accuracy, leaders can safeguard revenue, reduce liability, and drive higher business valuations in an increasingly transparent global market.

The PremiseModern biomedicine is awash in correlations. High-throughput assays, EHR exhaust, and observational registries generate torrents of associations linking exposures to outcomes. These signals are cheap to produce and easy to publish. Yet clinical action requires something harder: causal understanding. When we mistake correlation for cause, we translate statistical noise into medical advice, inflate hope, and waste scarce clinical attention. The problem is not that correlations are useless; it is that they are increasingly treated as sufficient.The DistortionCorrelation masquerades as causation through three recurrent pathways:Confounding and selection. Patients self-select into treatments; clinicians allocate therapies based on prognosis; healthier people seek screening. Unmeasured factors drive both exposure and outcome, creating spurious links. Without a causal design—clear counterfactuals, exchangeability, and temporality—associations reflect the clinic’s sorting mechanism more than biology.Surrogate bias. We optimize for variables that are measurable (biomarkers, intermediate endpoints) rather than variables that matter (morbidity, mortality, function). Surrogates correlate with outcomes in one context and fail in another, inviting ineffective or harmful interventions that “improve the number” while leaving patients unchanged.Flexible analysis and garden-of-forking-paths. When thousands of features meet dozens of modeling choices, some association will appear significant. Absent prespecified analyses, causal graphs, and sensitivity checks, correlation is a by-product of researcher degrees of freedom, not the world.Together, these distortions reward speed over design. They generate publishable patterns that crumble at the bedside because they never answered a causal question in the first place. The ConsequenceThe mirage of correlation has practical and moral costs:Therapeutic misdirection. Interventions built on non-causal signals underperform in trials or succeed on surrogates while failing on outcomes, exposing patients to cost and risk without benefit.Policy volatility. Public guidance oscillates with each new association study, eroding trust among clinicians and citizens who experience “whiplash science.”Equity harms. Spurious correlations often encode structural confounding (access, environment, bias). Acting on them can amplify disparities by directing resources toward populations easiest to measure rather than those most likely to benefit.Epistemic stagnation. When correlations are treated as answers, we stop asking mechanistic questions. Biology becomes a backdrop for analytics rather than the governor of inference.In short, correlation without design produces abundant signals but little understanding—a surplus of claims and a deficit of care.The Way ForwardRestoring causation requires redesign, not rhetoric:Start with a target trial. In observational settings, explicitly specify the randomized trial you wish you could run: eligibility, treatment strategies, time zero, assignment, outcomes, follow-up, and causal contrasts. Then emulate it with appropriate data and methods.Draw the causal graph. Make assumptions visible with directed acyclic graphs (DAGs). Identify confounders to adjust, colliders to avoid, mediators to preserve, and instruments to employ. Method follows model.Commit to temporality and specification. Define exposures and outcomes prospectively where possible; preregister analytic plans; limit researcher degrees of freedom; conduct sensitivity analyses (negative controls, E-values, falsification endpoints).Retire weak surrogates. Tie intermediate markers to outcomes through validated causal pathways—or prioritize trials and longitudinal endpoints that capture what patients value.Report counterfactuals, not just correlations. Express results as effects under interventions (“If assigned strategy A vs B…”) and disclose the assumptions under which these effects are identified.Integrate mechanism. Let biology constrain models. Use causal reasoning to decide what must be true for an effect to exist, and design studies that could prove it false.Correlation is a starting line, not a finish. Medicine earns trust when we move from signals to causes—because only causes tell us what to do.

The Old Asymmetry For generations, medicine has depended on the generosity of its subjects and the ambition of its scientists. Patients provide their stories and samples; researchers extract discoveries. Yet when value emerges — in patents, data sales, or institutional prestige — the contributors of truth are absent from the ledger.This asymmetry is not accidental; it is architectural. Systems that cannot trace consent cannot distribute benefit.Circle’s model rewrites this architecture. It restores value to its rightful origin — to the individuals whose verifiable experiences sustain the science itself.The Economics of AcknowledgmentOwnership begins with recognition. Without acknowledgment, participation becomes exploitation disguised as progress.In the Circle ecosystem, every patient’s verified contribution is recorded, preserved, and auditable. Each act of consent, each update of data, generates a measurable stake in the moral economy of truth. This is not symbolic gratitude; it is computable recognition.The data contributor becomes a partner, not a product.Value as ReciprocityIn moral philosophy, reciprocity sustains justice: one good act should invite another. Circle turns this into mechanism. Each verified dataset generates a return proportional to its integrity, depth, and longevity. The more completely and ethically one participates, the greater the reward.This is not charity but reciprocal economics — a system where moral equity yields material equity.From Subjects to StakeholdersTraditional research treats patients as data sources, dissolving their agency at the moment of contribution. Circle’s token model ensures that agency persists. Participants remain visible in every subsequent use of their data through immutable provenance. Their involvement continues not as memory, but as stake.This transforms medicine from extractive industry to collaborative commons. The patient is no longer observed but represented.The Moral DividendIn financial markets, dividends measure productive participation. In moral markets, they measure remembered integrity. Circle introduces a new kind of yield — the dividend of dignity — distributed to all who contribute verified truth to the collective record.It closes the loop between ethics and economy: dignity itself becomes a source of liquidity.The Moral Outcome Value, in the Circle model, is not created by possession or production, but by participation. It is the birthright of those who lend their lived experience to the growth of honest knowledge.Each patient, clinician, and researcher who contributes verifiable truth owns a fraction of its continuing worth. Not by favor, but by design.In this architecture, justice is no longer retrospective — it is programmed into the system.The birth of moral value is the birth of shared ownership in the future of truth.

Dear colleagues,Peptide‑based therapies are rapidly expanding in clinical practice, yet many physicians report difficulty finding reliable, unbiased, and peer‑reviewed information amid growing commercial noise.The Canadian Peptide Research Society (CPRS) is reaching out to share new clinician-oriented resources designed to support safe, compliant, and evidence-based peptide use in patient care.Why This Matters for Your PracticeWith patient interest rising and regulations evolving, physicians are seeking::Clear, clinically validated guidanceUp‑to‑date safety and regulatory insightsPractical education that supports responsible clinical decision‑makingA trusted, non-commercial source of evidenceOur programs are designed to meet exactly these needs.What CPRS OffersOur clinical resources are designed to support safe implementation and informed decision‑making:‍Expert-led clinical webinars and workshops‍Peer‑reviewed white papers, therapeutic guidelines, and safety reviewsRegulatory and compliance updates for practitioners from Canada and USA‍Opportunities for clinical collaboration, case sharing, and research participationAbout CPRS MembershipMembership provides access to our full clinical library and physician‑only opportunities, including:Full access to our growing education libraryInvitations to member-only workshops and research initiativesA network of experts driving progress in peptide sciencePriority updates on new guidelines, regulatory changes, and clinical developmentsIf you’re exploring peptide-based therapies—or simply want unbiased, scientifically rigorous guidance—we’d be glad to support you.Best regards,Dr. Grant PagdinCanadian Peptide Research Society‍