Health, Education & Government Life Sciences & Pharma Connected Medical Devices

Digital Health

Regulated development and commercialization journeys where clinical, quality, and market access align.

Livongo (Teladoc) Omada Health Hims & Hers Noom
Inside this journey
  1. Customer Discovery

    Align on target clinical and financial outcomes, target populations, stakeholders (clinical, actuarial, legal), required evidence, and success criteria for coverage and procurement.

    Discovery Questions

    Start Here: Tell Us Who You're Trying to Protect

    • Who are you representing for this initiative (select all that apply)? Options: Regional health plan CMO/Medical leadership, National health plan CMO/Medical leadership, Benefits director at a self‑insured employer, Population health VP at a health system, Care management/Value‑based contracting lead, Other (please specify)
    • How many covered lives are in scope for this program? Options: 10,000–49,999, 50,000–199,999, 200,000–499,999, 500,000+, Unsure / gathering data
    • Which clinical areas are highest priority for you right now? Options: Type 2 diabetes prevention/A1C reduction, Chronic musculoskeletal pain/opioid reduction, Depression/anxiety and PHQ‑9 follow‑up, Multiple of the above, Other
    • Have you previously evaluated or deployed any FDA‑authorized digital therapeutics? Options: Yes — currently deployed, Yes — evaluated but not deployed, No — first evaluation, Unsure
    • Tell us in a few sentences about one previous pilot or vendor decision that felt like a success — what made it work?

    Are You Settling for Small Wins?

    • When it comes to diabetes, pain, and depression, have you accepted incremental improvements as 'good enough'? Options: Yes — incremental gains are our realistic target, We expect clinically meaningful change, We want transformational outcomes but aren’t sure how to get there, Other
    • Which specific HEDIS or quality measures are you under the most pressure to improve? Options: HEDIS diabetes measures (e.g., A1C control), HEDIS depression follow‑up after hospitalization, Musculoskeletal quality/care gap measures, Risk adjustment/PCMH metrics, Not tracked via HEDIS, Other
    • What impact have existing programs produced in the last 12–24 months (be as specific as you can: % change, absolute numbers, cost savings)?
    • What would it feel like internally to move from 'incremental' to 'clinically significant' results for one of these conditions?
    • How do you weigh short‑term engagement metrics (e.g., 2‑week retention) against long‑term clinical outcomes when deciding to add a vendor? Options: Engagement first, then outcomes, Clinical outcomes are primary, We require both simultaneously, Depends on program/condition

    What Keeps You Up at Night?

    • Which operational blind spot, if left unaddressed, would cause the most clinical or financial harm to your organization? Options: Undetected high A1C patients, Rising opioid prescriptions for MSK pain, Inadequate follow‑up after positive depression screens, Poor member identity/eligibility matching, Other
    • How often do you discover gaps between member eligibility/claims data and who actually needs outreach? Options: Frequently, Occasionally, Rarely, We don't know — no baseline
    • Tell us about a recent case where a data or workflow gap caused a missed opportunity to engage a member — what happened and how did it feel to the team?
    • Which of these internal capacities are most constrained right now? Options: Care management staffing, Data engineering for feeds and matching, Actuarial analytics, Legal/BAA review bandwidth, Provider outreach/prescribing workflows, Other
    • Which regulatory or compliance concern would make you pause a deal (select top two)? Options: BAA/data security, FDA claims and representations, State telehealth/privacy laws, Patient consent/eligibility, Data residency

    Where the Numbers Don’t Match the Feelings

    • Are your actuarial savings projections and front‑line clinicians telling different stories about what’s working? Options: Yes — clinicians see more benefit than actuaries model, Yes — actuaries project savings clinicians don’t observe, No — both align, Unsure
    • Please share your most recent baseline metrics we should know when modeling impact (A1C distribution, average PHQ‑9, MSK utilization/opioid rates, or a summary if numbers aren't available).
    • What attribution window do you typically use to validate outcomes for behavioral or chronic disease programs? Options: 3 months, 6 months, 12 months, Variable by contract, Unsure
    • How comfortable would your finance/actuarial team be with a small‑scale outcomes pilot (pay‑for‑performance) versus a PMPM approach? Options: Prefer outcomes‑based pilot, Prefer PMPM first then outcomes, Only PMPM, Open to either with guarantees
    • What minimum engagement and clinical thresholds would you require before releasing full payment or expanding coverage? Options: % engaged at 12 weeks, Average A1C reduction, PHQ‑9 change, Opioid prescription reduction, Other — please specify

    If Coverage Could Move the Needle

    • Imagine your formulary included an FDA‑authorized DTx that replicated trial results — what would change inside your organization in 12 months?
    • Which decision criteria must be satisfied for you to recommend coverage to the clinical committee (pick top three)? Options: Peer‑reviewed RCT evidence, Real‑world effectiveness in similar population, Clear actuarial savings model, Seamless claims/eligibility integration, BAA and security terms signed, Provider prescription workflow integration
    • How do you prefer clinical evidence be presented to your committee? Options: Peer‑reviewed publications and meta‑analysis, De‑identified RWE dashboards and case studies, Actuarial models tied to claims data, Live presentations from clinical investigators, Combination of the above
    • What reporting cadence would satisfy both clinical review and actuarial oversight? Options: Weekly dashboard + monthly summary, Monthly detailed report, Quarterly outcomes and financial reconciliation, Custom cadence per pilot
    • Which KPIs would be deal‑breaking if not demonstrably improved? Options: A1C reduction among enrolled members, PHQ‑9 remission or meaningful decrease, Reduction in opioid or high‑risk analgesic prescriptions, Reduction in inpatient or ED utilization, Enrollment and sustained engagement rates

    How Decisions Really Get Made (and Who Slows It Down)

    • When a promising clinical solution stalls here, who do people usually point to as the blocker? Options: Actuarial team, Legal/compliance, Procurement, IT/security, Clinicals/CMO, Budget owner/Finance
    • Which stakeholder group requires the most convincing evidence or guardrails before signing on? Options: Clinical leadership, Actuarial/Finance, Legal/Compliance, IT/Security, Provider relations
    • What are your typical procurement and contracting timeframes for new clinical vendors? Options: Under 3 months, 3–6 months, 6–12 months, 12+ months
    • Which legal milestones are non‑negotiable before pilot launch? Options: BAA executed, Data security questionnaire completed, Business associate assessments, Regulatory representations documented, None required for pilot
    • Describe a past contracting conversation that derailed a deal — what phrase or item triggered the stall?

    What Would Make Us Irresistible?

    • If you could require one contractual guarantee that would turn a skeptical committee into advocates, what would it be? Options: Outcomes guarantee tied to A1C/PHQ‑9, Financial clawback if targets not met, Strict data security/BAA terms, Pilot-to-scale fast‑track clause, Provider adoption commitments
    • Between PMPM pricing and outcomes‑based pricing, which structure would your team be most likely to pilot and why? Options: PMPM first for predictability, Outcomes‑based for alignment, Hybrid (PMPM + bonus), Depends on condition and population
    • What minimum sample size or enrollment would make the pilot statistically or operationally meaningful for you? Options: <500 members, 500–2,000 members, 2,000–10,000 members, 10,000+ members, Unsure — need actuarial input
    • How important is EHR prescription workflow integration to your clinicians for adoption? Options: Critical — must be in EHR, Important but not required initially, Nice to have, Not important
    • What member outreach channels have worked best for you and which would you want the vendor to own? Options: Claims‑driven outreach (vendor), Clinician referral (provider), Member portal/email (vendor), Care management outreach (shared), Other

    Practical Roadblocks to Go‑Live

    • What internal bottleneck will most likely delay deployment beyond your target date? Options: Data feeds and identity matching, IT/security approvals, Provider onboarding/prescribing workflows, Legal/contracting timeline, Member outreach capabilities
    • Do you currently have eligibility and claims feeds we can ingest for matching and outcomes measurement? Options: Yes — live feeds available, Partially — some feeds available, No — would need to set up, Unsure — need to confirm
    • Which technical capability is unavailable today but required for the pilot? Options: Real‑time eligibility API, Claims historical data extract, SFTP for de‑identified data, EHR prescription endpoint, None — capabilities ready
    • Who would own day‑to‑day integration work internally (role or team)?
    • How long does your IT/security review typically take once documentation is submitted? Options: Under 2 weeks, 2–6 weeks, 6–12 weeks, 12+ weeks, Unsure

    Commitment & Next Small Step

    • What one deliverable from us this week would move you to a technical deep‑dive with your team? Options: Sample actuarial model tailored to our baseline, De‑identified RWE dashboard for a similar population, Draft pilot scope and success criteria, BAA template and security documentation, Clinical evidence packet (publications)
    • Who are the three internal stakeholders we should include in the next conversation and their preferred roles (name + function)?
    • Realistically, when could your organization start a 6‑month pilot if approvals and feeds were in place? Options: Immediately (0–4 weeks), Within 1–3 months, 3–6 months, 6+ months
    • Are you open to a staged pilot (technical integration → enrollment burst → outcomes measurement) that ties payments to milestones? Options: Yes — staged pilot preferred, Maybe — need details, No — prefer single contract
    • Is there anything we have not asked that would materially affect your decision to move forward?
  2. Solution Experience

    Apply the customer’s real scenarios to show how FDA‑authorized programs drive measurable A1C, pain, and PHQ‑9 improvements and integrate with claims and EHR workflows.

    Experience Meetings

    • Solution Experience Prep & Alignment (Prework Review)
    • Current State & Consequence Workshop (Executive + Actuarial)
    • Scenario Walkthrough — Diabetes (A1C) Using Customer Data
    • Scenario Walkthrough — Pain & Behavioral Health (Pain scores, PHQ‑9)
    • Integration Proof & Outcomes Validation (Decision & Next Steps)
    • Obtain customer validation that these scenario outcomes meet the clinical committee's evidentiary standards.
    • Reiterate the Problem Statement for Diabetes Cohort
    • Prove that the program generates measurable A1C reductions for the customer's cohort and that those results are trackable in their data systems.
    • Validate that the demonstrated referral and reporting flows align with the customer's EHR and claims processes.
    • Agree on the specific KPIs and dashboard extracts the customer requires for ongoing monitoring and actuarial validation.
    • Seller to provide a sample outcomes dashboard export mapped to the customer's member IDs and KPI definitions.
    • Customer IT to confirm EHR referral API endpoints and timelines for any sandbox access needed.
    • Both parties to sign off on the A1C measurement cadence and allowable lab sources.
    • Problem & Impact Statement for Pain + BH
    • Demonstrate measurable pain and PHQ‑9 score improvements in the customer's context and show downstream utilization reductions.
    • Confirm integration touchpoints for care teams and the claims reporting needed for actuarial sign‑off.
    • Introductions & Meeting Objectives
    • Seller to provide a cohort-level outcomes summary (pain score deltas, PHQ‑9 deltas, opioid fill changes) for the customer's selected populations.
    • Customer to nominate a clinician and care manager to be the point people for workflow integration testing.
    • Both parties to agree on an acceptance threshold for engagement and clinical change that triggers performance guarantee conversations.
    • End‑to‑End Flow Recap
    • Validate that integrations and outcome measurement function end‑to‑end in the customer's environment or sandbox.
    • Agree on the commercial pricing path (PMPM vs outcomes) and the performance guarantees tied to the demonstrated metrics.
    • Define the decision deliverables and timeline required to move to the Mutual Commit stage, with named owners.
    • Seller to deliver final actuarial model files and a redline of proposed performance guarantees within 3 business days.
    • Customer legal and security to provide required BAA and compliance checklist items and confirm any outstanding risk items.
    • Both parties to agree on a Mutual Commit target date and list of milestones required to meet that date.
    • Customer and seller agree on a crystal clear current state statement validated by customer leadership.
    • Consequence is quantified and linked to measurable KPIs the customer cares about (cost, utilization, HEDIS, etc.).
    • Future state and success criteria are defined in operational terms and sign‑off obtained to proceed with scenario walkthroughs.
    • All required de‑identified data & stakeholder attendees are confirmed for subsequent meetings.
    • Customer to provide de‑identified eligibility + 12 months claims extract and 6 months EHR referral examples in agreed schema.
    • Seller to prepare one‑sentence current state, consequence, and future state statements and circulate for sign‑off.
    • Schedule scenario walkthrough meetings and assign validation owners from both sides.
    • Current Clinical Pathways Review
    • Create a shared, data‑backed quantification of the cost and clinical consequences of the current state.
    • Agree on 1–2 priority patient populations (e.g., prediabetes with A1C 5.7–6.4; chronic low back pain high utilizers) to use in scenario walkthroughs.
    • Obtain actuarial agreement on baseline assumptions to be used in the outcomes model delivered in later meetings.
    • Actuarial team to deliver sensitivity ranges for cost savings per avoided admission/A1C point change.
    • Customer clinical leads to confirm the two priority cohorts for scenario walkthroughs.
    • Seller to run an initial ROI model using agreed assumptions and prepare slides for scenario sessions.
    • Preconditions Check: Current State
    • Live Integration Checks
    • Dual‑Condition Member Walkthrough
    • Member Journey Mapping
    • Gap & Failure Modes
    • Live Dashboard & Evidence Proof
    • Clinical Evidence & Real‑World Results
    • Actuarial Savings Model & Pricing Options
    • Quantify Consequences (Actuarial Inputs)
    • Preconditions Check: Consequence
    • Performance Guarantees & Contractual Triggers
    • Preconditions Check: Future State & Success Criteria
    • Claims/EHR Integration Demonstration
    • Prioritization for Impact
    • Care Team Integration
    • Validation Checkpoint
    • Data & Artifacts Confirmation
    • Validation & Acceptance Criteria
    • Tieback & Validation
    • Decision & Next Steps
    • Logistics & Validation Rules
  3. Solution Scope

    Define selected program(s), enrollment pathway, eligibility and claims integrations, coaching model, reporting cadence, measurable success metrics, and pricing option (PMPM vs outcomes‑based).

    Scope Configuration

    • Deploy FDA-authorized mobile therapeutic app to members
    • Provision certified health coach messaging support
    • Deliver one-on-one video coaching sessions
    • Deploy 12-week structured CBT curriculum in-app
    • Activate claims and eligibility data integration
    • Integrate prescribing workflow within EHR
    • Provision connected glucometers and wearable devices
    • Enable outcomes reporting dashboard with clinical metrics
    • Provide de-identified claims-linked outcomes data export
    • Operate opioid-reduction clinical pathway module
    • Launch musculoskeletal guided exercise and PT program
    • Enable performance-based billing and reconciliation

    Scope Questions

    Deploy FDA-authorized mobile therapeutic app to members

    • Which of our programs should be included in the app rollout for this population? Options: Type 2 diabetes prevention, Chronic musculoskeletal pain, Behavioral health (anxiety/depression), All of the above, Other
    • What enrollment pathway do you prefer for members? Options: Auto-enroll via eligibility feed, Opt-in via outreach campaign, Clinician-prescribed via EHR, Self-enroll through portal, Other
    • What geographic scope and regulatory constraints apply (states, territories, special rules)?
    • Do you require custom branding or co-branding of the app for members? Options: Yes, No
    • Which languages must the app support at launch? Options: English, Spanish, Chinese (Mandarin), Other
    • Are there accessibility or enterprise device-management requirements (e.g., 508, MDM)? Options: Yes, No
    • What member device types/platforms must be supported (smartphone OS, tablet, web)? Options: iOS, Android, Web browser, Tablet, Other

    Provision certified health coach messaging support

    • What hours of coach availability do you expect (timezone reference)? Options: Business hours (M-F), Extended hours (including evenings), 24/7, Other
    • What languages and cultural competencies are required for coaches? Options: English, Spanish, Other
    • What is the desired coach-to-member caseload or ratio at steady state? Options: 1:25, 1:50, 1:75, Custom
    • Should coaches be able to escalate clinical concerns to plan clinicians or care managers? Options: Yes, with defined escalation pathways, No, coaching only
    • Which messaging channels should coaches use with members? Options: In-app messaging, Secure SMS, Email, Phone
    • Do you require coach notes to be written back into the EHR or care management platform? Options: Yes — writeback to EHR, Yes — export to care management system, No
    • Are there special qualification or certification requirements for coaches (e.g., licensed clinicians, certified diabetes educators)? Options: Yes, No

    Deliver one-on-one video coaching sessions

    • What is the expected session cadence and duration per member? Options: Weekly (30 min), Biweekly (30 min), Monthly (30 min), Ad hoc as needed
    • Will video sessions be scheduled by members, coaches, or via clinician referral? Options: Member-scheduled, Coach-scheduled, Clinician-referral scheduled, Hybrid
    • Which video platform integration do you prefer for clinician workflows? Options: In-app native video, Zoom, Microsoft Teams, Other
    • Do you require video session recording, storage, or transcription (consent and retention policies apply)? Options: Yes, No
    • Should video visits create clinical documentation that flows into the EHR or care management tooling? Options: Yes — full writeback, Yes — summary only, No
    • Are there payer or employer limits on session counts per member we must enforce? Options: Yes, No
    • Do you require clinician co-attendance or supervision for certain member presentations? Options: Yes — for high-risk members, No

    Deploy 12-week structured CBT curriculum in-app

    • Which condition-specific CBT tracks should be enabled? Options: Depression (PHQ-9 focused), Anxiety, Chronic pain CBT, Diabetes self-management, Other
    • Do you need content customization (employer/plan-specific messages, branding, policies)? Options: Yes — content customization, No — standard curriculum
    • What assessment cadence do you want embedded (baseline, mid, end; e.g., PHQ-9 weekly)? Options: Baseline + weekly, Baseline + midpoint + end, Baseline + end only, Custom
    • Should completion criteria trigger outcomes payments or clinical escalation? Options: Yes — triggers both, Triggers outcomes payment only, Triggers clinical escalation only, No triggers
    • Do you require clinician review or sign-off on curriculum completion for certain members? Options: Yes, No
    • Are translations or literacy-level adjustments required for the curriculum? Options: Yes, No
    • Do you want integration of device-collected measures (PHQ-9, pain scores, glucose) into progress modules? Options: Yes, No

    Activate claims and eligibility data integration

    • What data feeds do you want integrated? Options: Eligibility (member roster), Medical claims, Pharmacy claims, Lab results, Other
    • What frequency and latency are acceptable for each feed? Options: Real-time/near-real-time, Daily batch, Weekly batch, Other
    • What identifier(s) will be available for member matching (e.g., Member ID, MBI, DOB+Name)? Options: Member ID, MBI/Policy number, SSN (limited), DOB + Name, Other
    • Do you require data transformation/mapping templates or will you provide mapped files? Options: We will provide mapped files, We need mapping assistance
    • What secure transfer method is preferred for data exchange? Options: SFTP, API (FHIR/other), Secure cloud drop, Other
    • Are there specific PHI/PII encryption or residency requirements we must meet? Options: Yes, No
    • What is the target go-live timeline for data integrations? Options: <4 weeks, 4-8 weeks, 8-12 weeks, >12 weeks

    Integrate prescribing workflow within EHR

    • Which EHR(s) must be supported for prescribing/workflow integration? Options: Epic, Cerner/Oracle, athenahealth, Allscripts, Other
    • Which integration method is preferred for clinician ordering? Options: SMART on FHIR app, Orderable in EHR (CPT/Service code), API integration, Referral workflow
    • Do you require embedded clinical decision support or order prompts at point-of-care? Options: Yes — CDS required, No — simple order only
    • Will clinicians prescribe via medication-like order, referral order, or e-prescribe equivalent? Options: Referral order, Orderable/medication-like, E-prescribe equivalent, Other
    • Do you need audit trails and clinician attribution for referrals/prescriptions? Options: Yes, No
    • Are there specific credentialing or training requirements for prescribers to add to their workflow? Options: Yes, No
    • Do you require staging/test environments and FHIR sandboxes for validation? Options: Yes, No

    Provision connected glucometers and wearable devices

    • Which device types must be supported at launch? Options: Bluetooth glucometers, Cellular glucometers, Wearable activity trackers, Other
    • Do you have preferred device manufacturers or procurement agreements? Options: Yes — list will be provided, No — vendor suggested devices OK
    • What distribution model do you prefer for devices? Options: Ship direct to member, Ship to employer/clinic for distribution, Clinic pick-up, Other
    • What provisioning and onboarding support is required for members (phone setup, in-app pairing, live help)? Options: Full provisioning support, Self-setup with guides, Hybrid
    • Do you require inventory tracking, replacements, and warranty handling through the vendor? Options: Yes, No
    • Estimate number of devices to provision initially and monthly (free response)

    Enable outcomes reporting dashboard with clinical metrics

    • Which KPIs must be included on the dashboard? Options: A1C reduction, PHQ-9 score change, Pain score improvement, Engagement/retention, Utilization impact, Other
    • What report cadence do you require (real-time, daily, weekly, monthly)? Options: Real-time, Daily, Weekly, Monthly, Quarterly
    • Which user roles should have dashboard access and what permission levels? Options: Clinical team (view/write), Actuarial/analytics (view/export), Executive (summary), Other
    • Do you need patient-level drilldown versus aggregated/population views? Options: Patient-level (PHI) with BAAs, Aggregated only (no PHI)
    • Which delivery formats do you require for exports (CSV, SFTP, API, PDF)? Options: CSV, SFTP, API, PDF, Other
    • Are there custom KPI calculations or actuarial-adjusted metrics you want pre-calculated? Options: Yes, No

    Provide de-identified claims-linked outcomes data export

    • Which de-identification standard is required for exports? Options: HIPAA Expert Determination, HIPAA Safe Harbor, Pseudonymized linkable identifiers, Other
    • Which linkage approach should be used to connect claims to app outcomes? Options: Deterministic (member ID), Probabilistic (DOB + Name + ZIP), Pseudonymized token via hashing, Other
    • What variables must be included in the export (diagnoses, procedures, Rx, enrollment dates, costs)?
    • What export cadence and delivery method do you require? Options: Monthly via SFTP, Quarterly via API, Ad hoc on request, Other
    • Do you require validation samples or parallel runs before full production handoff? Options: Yes, No
    • Are legal/IRB or data governance approvals needed before exports begin? Options: Yes, No
  4. Mutual Commit

    Finalize commercial terms, performance guarantees, actuarial assumptions, BAA/data security terms, regulatory representations, and legal milestones required for contracting.

    Agreement Modules

    • Statement of Work (SOW)
    • Master Services Agreement (MSA)
    • Commercial Terms & Pricing Schedule
    • Performance Guarantee & Outcomes Addendum
    • Actuarial Assumptions & Savings Model
    • Business Associate Agreement (BAA) / Data Use Agreement (DUA)
    • Data Security & Compliance Attestations
    • Regulatory Representations & Warranties
    • Third‑Party Integrations & Subprocessor Schedule
    • Implementation Acceptance Criteria & Go‑Live Conditions
    • Legal Milestones & Contracting Timeline
    • Change Order & Amendment Process
    • Termination, Transition & Data Return Plan
    • Indemnification, Liability & Insurance Schedule
  5. Deployment

    Operationalize rollout with readiness checks, enablement, and outcome validation.

    1. Pre-Deployment Readiness

      Confirm data feeds, identity matching, BAAs executed, technical endpoints, clinician prescription workflows, and internal owners for integration workstreams.

      Readiness Questions

      Start Here: Quick Snapshot

      • Who are you and which role will own this evaluation (title and business unit)?
      • Which best describes your organization? Options: Regional health plan, National health plan, Self‑insured employer (10k+ lives), Health system / provider organization, Other
      • Roughly how many covered lives or employees would this program scope include? Options: 10k–25k, 25k–100k, 100k–500k, 500k+, Unsure / need help estimating
      • Which of these clinical priorities are core to your decision right now? (select all that apply) Options: Diabetes prevention / A1C reduction, Chronic musculoskeletal pain, Depression / PHQ‑9 follow‑up, Opioid stewardship, HEDIS quality improvement, Other
      • What is your target timeline for a coverage decision or pilot launch? Options: 30–60 days, 2–3 months, 3–6 months, 6–12 months, No set timeline

      Are You Comfortable With 'Good Enough'?

      • When you look at current outcomes for diabetes, pain, or depression in your population, what keeps you up at night?
      • How far are you from the clinical benchmarks you care about (HEDIS targets, expected A1C reduction, pain score change, PHQ‑9 follow‑up)? Options: Meeting targets, Within 10% of targets, 20–30% gap, Significant gap (>30%), Unknown / data needed
      • Give a recent example where a program or vendor failed to deliver the clinical or financial result you expected—what happened and what was most frustrating?
      • If this area improved meaningfully in the next 12 months, how would that change how clinicians, members, or finance leaders talk about care in your organization?
      • Which consequence would be most important to avoid: stagnant quality scores, rising medical spend, low member engagement, or regulatory/compliance risk? Options: Stagnant quality scores, Rising medical spend, Low member engagement, Regulatory/compliance risk, All equally important

      Who's In The Room—and Who's Silent But Critical?

      • Who will have final sign‑off on a new digital therapeutic—clinical committee, medical director, procurement, CFO, or someone else? Options: Clinical committee / CMO, Procurement / Vendor management, Actuarial / Finance, Legal / Compliance, CEO / Executive sponsor, Other
      • Which groups tend to slow decisions down in your organization and why (clinical concerns, actuarial skepticism, legal/BAA issues, IT integration)? Options: Clinical concerns, Actuarial skepticism, Legal/BAA issues, IT/integration capacity, Vendor security review, Other
      • Describe the last procurement where cross‑functional alignment went well—what enabled it? Conversely, what typical meeting or data gap breaks alignment?
      • Are there external constraints (state regs, union contracts, PBM arrangements) that often limit what you can implement? Options: Yes — several, Yes — a few, No, Unsure / need to check
      • Who outside your core team should we proactively bring into early demos to accelerate trust and shorten the review cycle?

      How Will We Know It Worked?

      • If you had to pick one outcome to prove value within 12 months, which would force a yes from finance or the CMO? Options: HEDIS improvement, A1C mean reduction, PHQ‑9 improvement, Reduced opioid prescriptions / utilization, Per‑member medical cost reduction, Engagement thresholds met
      • What minimum clinical effect size (e.g., absolute A1C reduction, pain score points, PHQ‑9 change) would you require to consider the program successful?
      • What engagement metrics do you view as prerequisites for clinical impact (first‑30‑day active use, 3‑month retention, coach interactions per member)? Options: 30‑day active use, 3‑month retention, Coach interactions per member, Completion of program modules, Other
      • What reporting cadence and level of granularity do your clinical and actuarial teams need (weekly patient lists, monthly aggregated outcomes, raw claims linkages)? Options: Weekly operational lists, Monthly aggregated dashboards, Quarterly actuarial packages, Raw claims+EHR exports, Ad hoc deep dives
      • Do you have existing baselines (claims, A1C distributions, PHQ‑9, pain scores) we can use for power calculations and target setting? If yes, how accessible are those datasets? Options: Yes — readily accessible, Yes — accessible with support, Partial / fragmented, No

      What Evidence Will Make You Say Yes?

      • How essential is FDA authorization compared to peer‑reviewed RCTs or real‑world evidence when evaluating a digital therapeutic? Options: FDA authorization is essential, Peer‑reviewed RCTs are essential, Real‑world evidence is equally important, All three are required, Unsure
      • Which types of evidence convince your actuaries most: published RCTs, large RWE cohorts, claims‑linked economic models, or vendor‑provided case studies? Options: Published RCTs, Large real‑world cohorts, Claims‑linked economic models, Vendor case studies, Regulatory approvals
      • What minimum sample size, follow‑up duration, or effect stability do you expect to consider outcomes credible?
      • Are there external thresholds (peer plan benchmarks, CMS/HEDIS targets) you need vendors to demonstrate relative to your population? Options: Yes — specific benchmarks, Yes — general comparators, No specific benchmarks, Unsure
      • Would a neutral third‑party actuarial validation or an independent EHR/claims reconciliation materially change your confidence? If so, who would you trust to do it? Options: Yes — actuarial validation, Yes — EHR/claims reconciliation, No — vendor data sufficient, Unsure

      What Keeps Integrations From Being 'Done'?

      • Which integration has historically been the hardest—eligibility feeds, claims ingestion, identity matching, EHR prescription/writing, or BAAs and data security? Options: Eligibility feeds, Claims ingestion, Identity matching, EHR prescription workflows, BAA / data security, Other
      • Do you currently have technical owners and bandwidth to support API work, SFTP feeds, or EHR build tasks—yes, limited, or no? Options: Yes — dedicated team, Limited capacity, No — need vendor-led support, Unsure
      • What identity‑matching accuracy or turnaround time do you require for enrollment to avoid clinical workflow friction?
      • Which security or compliance hurdles typically delay contracting—technical security assessment, BAA negotiation, penetration testing, or privacy impact assessments? Options: Security assessment, BAA negotiation, Penetration testing, Privacy impact assessment, Other
      • If we were to run a pilot, what minimum technical scope would you accept before live member outreach (e.g., eligibility + claims sync, one‑way referral, full two‑way EHR prescription)? Options: Eligibility + claims sync, One‑way referral, Two‑way EHR prescription, Manual enrollment with data exports, Other

      If We Move Forward, What Would Winning Look Like—and Who Owns It?

      • Imagine it’s 12 months after go‑live: what concrete signs make you say this was worth it (specific HEDIS/clinical/financial milestones)?
      • Which enrollment pathway do you prefer for your members—clinician prescription through EHR, care manager referral, claims‑triggered outreach, or self‑directed opt‑in? Options: Clinician prescription (EHR), Care manager referral, Claims‑triggered outreach, Self‑directed opt‑in, Hybrid approach
      • What outreach channels and messaging have historically achieved the best activation in your population (phone, SMS, mailed letter, portal message, employer communications)? Options: Phone outreach, SMS/text, Mailed letter, Member portal message, Employer communications, Other
      • Which pricing model is more acceptable to your procurement and finance teams: PMPM with volume commitments or outcomes‑based with guarantees and shared savings? Options: PMPM with commitments, Outcomes‑based with guarantees, Hybrid, Unsure / need modeling
      • Who will be the internal day‑to‑day owner for operations, clinical escalation, and vendor coordination after contracting?
      • What would you need from us next to advance—an actuarial model, pilot proposal, security package, or clinical steering session? Options: Actuarial model, Pilot proposal, Security and privacy package, Clinical steering session / demo, All of the above
    2. Deployment Enablement

      Coordinate integration sprints, onboarding for clinicians and coaches, member outreach and enrollment sequencing, training, and Gantt milestones with clear owners and escalation paths.

    3. Validation Checklist

      Execute acceptance tests for data synchronization, referral/prescription flows, engagement tracking, and baseline outcome measurement to verify go‑live criteria.

      Validation Questions

      Tell Us Who You’re Fighting For

      • Who are the primary member populations you most want to move the needle for this year? Options: Members with prediabetes, Members with diagnosed type 2 diabetes, Chronic low back pain patients, Knee/hip osteoarthritis patients, Members with depression, Members with anxiety, High opioid utilizers, Other
      • Roughly how large is the target population you’re considering (covered lives or monthly eligible members)? Please provide numbers or ranges.
      • Which clinical measures or quality programs do you personally feel most accountable for improving (select up to three)? Options: HEDIS: Diabetes measures (e.g., A1C control), HEDIS: Behavioral health follow-up/PHQ-9 screening, HEDIS: Medication adherence, Reduction in opioid prescribing, Avoidable inpatient admissions, Total cost of care per member, Other
      • What current programs or vendors do you have in place for these populations today? Options: Disease management telephonic coaching, Digital wellness apps (non-FDA), EAP / mental health platform, Pain physical therapy vendors, No current program, Other
      • When you think about those existing programs, what feels most lacking or frustrating?

      Are We Settling for Incremental Wins Instead of Meaningful Change?

      • If a vendor delivered modest engagement but no meaningful A1C/PHQ‑9/pain improvements, would you view that as success or a missed opportunity? Options: Success — engagement is the leading indicator, Missed opportunity — clinical impact matters most, Depends on cost, Unsure
      • What minimum clinical thresholds would you require to consider a program clinically successful (for example: average A1C reduction, PHQ‑9 point change, pain scale improvement)? Please be specific.
      • How do you currently validate that a program’s reported outcomes are real (e.g., claims adjudication, lab pulls, independent actuarial review)? Options: Claims-based analysis, EHR clinical data, Third‑party actuarial validation, Peer‑reviewed publications, We rarely validate, Other
      • Tell us about one recent example where a program met initial expectations — what made it real to you (data source, timeframe, stakeholder buy‑in)?
      • How important is regulatory status (e.g., FDA De Novo authorization) in moving a digital therapeutic onto your formulary or benefits list? Options: Critical — non‑negotiable, Very important, Nice to have, Not important

      What Would It Mean (and Cost) If We Were Wrong?

      • What financial metrics do your actuaries use to judge a vendor—ROI, PMPM impact, trend reduction over X years, or something else? Options: ROI over multi‑year horizon, PMPM budget impact, Claims trend reduction, Avoided inpatient/ED days, Other
      • What is your current annual spend (or percent of total medical spend) for diabetes, musculoskeletal, and behavioral health combined? Please estimate.
      • How comfortable are you with outcomes‑based pricing versus a straight PMPM? What risk split would your team consider reasonable? Options: Prefer PMPM, Prefer outcomes‑based, Hybrid (PMPM + upside/downside), Depends on guarantee size
      • Have you previously negotiated performance guarantees with a digital health vendor? If yes, what worked and what failed? Options: Yes — worked well, Yes — failed to meet expectations, No
      • What’s an acceptable downside protection (cap or holdback) if clinical targets aren’t met? Options: Full refund guarantee, Partial refund/holdback, No downside — only upside, Undecided

      Who Holds the Keys — Champions, Skeptics, and Silent Blockers

      • Who are the internal stakeholders that must be convinced for program approval (list roles and names where possible)?
      • Which committee or forum makes the final clinical formulary decision (e.g., Pharmacy & Therapeutics, Clinical Review Committee, Value Assessment)? Options: Pharmacy & Therapeutics, Clinical Review Committee, Value Assessment Committee, Executive Steering Committee, Other
      • What are the top three concerns you expect from legal/security, procurement, and actuarial reviewers respectively?
      • Who will be the ultimate contract signatory and what approvals must precede their signature? Options: CMO, CFO, General Counsel, Head of Procurement, Other
      • Thinking about past procurements, who tended to slow approvals down the most and why?

      Is Your Data Plumbing Ready to Prove Results — Or a Mile Away?

      • How frequently do you receive claims and eligibility feeds that are usable for near‑real‑time measurement (daily, weekly, monthly)? Options: Daily, Weekly, Bi‑weekly, Monthly, Less than monthly, No automated feed
      • Do you have existing connectors to EHR(s) for clinician prescription/referral and outcomes retrieval? If so, which systems? Options: Epic, Cerner/Oracle, Allscripts, Athenahealth, Other, No EHR connector
      • What percent of members have reliable lab data available (e.g., A1C values) in your data lake/EHR for measuring outcomes? Options: >75%, 50–75%, 25–50%, <25%, Unknown
      • Describe your identity matching expectations for linking app engagement to claims/EHR outcomes (deterministic match, probabilistic, member ID mapping). Options: Deterministic (exact member ID), Probabilistic match, Member ID mapping via vendor, We need vendor to propose approach, Other
      • Are BAAs and data transfer agreements already standardized, or do they require lengthy bespoke negotiation? Options: Standard templates ready, Minor edits expected, Significant negotiation required, Unsure

      How Do You Separate Early Hype from Clinically Meaningful Programs?

      • What types of evidence are non‑negotiable to you (e.g., RCTs, peer‑reviewed publications, real‑world evidence, FDA authorization)? Options: Randomized controlled trials, Peer‑reviewed real‑world studies, FDA authorization/clearance, Independent actuarial analysis, None required
      • Would an FDA De Novo authorization be sufficient to fast‑track clinical review, or do you still require independent RCTs in your population? Options: Sufficient, Prefer RCTs in our population, Need both, Unsure
      • What engagement benchmarks must a digital therapeutic meet to earn continued coverage (e.g., 30‑day active use, 90‑day retention, coach response times)? Options: 30‑day active use, 60‑day retention, 90‑day retention, Coach response <24 hours, Other
      • When you read vendor claims, what’s the single piece of evidence that immediately earns your trust? Options: Peer‑reviewed publication, Third‑party actuarial report, Health system pilot data, FDA regulatory letter, Real‑world outcomes dashboard
      • Describe a time you rejected a vendor for insufficient evidence—what was missing and how would your evaluation have changed if it had been present?

      How Will Clinicians Actually Prescribe This—and What Keeps Them From?

      • What does a clinician referral/prescription workflow need to look like for adoption to be realistic in your org (one‑click order, referral via care manager, inbox message, etc.)? Options: One‑click order in EHR, Referral by care manager, Automated best‑practice alert, Manual referral form, Other
      • Which clinician groups are highest priority to engage (PCPs, endocrinologists, behavioral health clinicians, care managers)? Options: Primary care, Endocrinology, Behavioral health, Care management teams, Specialty pain clinics, Other
      • How do clinicians in your system typically respond to digital therapeutics—enthusiastic, skeptical, indifferent? Please give an example. Options: Enthusiastic, Skeptical, Indifferent, Varies widely
      • What training, clinical decision support, or incentives would move clinicians from passive to active prescribers? Options: Live training sessions, EHR prompts and order sets, Performance incentives, Clinical evidence summaries, Other
      • Who would be responsible for clinician onboarding and ongoing adoption monitoring on your side?

      If We Could Launch Tomorrow, What Would ‘Go/No‑Go’ Look Like?

      • What specific acceptance tests would you require before declaring a pilot successful (data sync, referral delivery, coach engagement, baseline outcome capture)? Options: Claims data sync verified, Eligibility feed validated, Referrals appear in EHR workflow, Coach communication validated, Baseline clinical measures captured
      • Who on your team signs off on each acceptance test (name/role for data, clinical, legal, procurement)?
      • What sample size or pilot duration would you consider adequate to make a coverage decision (e.g., 500 members for 6 months)? Options: Small pilot (<500 members), Medium pilot (500–2,000), Large pilot (>2,000), Timebound pilot (3/6/12 months), Undecided
      • What are your non‑negotiable go‑live blockers that would pause deployment regardless of promises (e.g., unresolved BAA, identity match failure, clinician workflow broken)?
      • How quickly can your technical team engage in integration sprints once contracts are executed? Options: Immediately, Within 2–4 weeks, 1–2 months, 3+ months, Need internal approval

      Your Ideal Next Step — What Would Make This Easy to Say Yes To?

      • Which commercial model would most likely clear internal review for you: PMPM, outcomes‑based, or a hybrid? Why? Options: PMPM, Outcomes‑based, Hybrid (PMPM + outcomes), Undecided
      • If we proposed a pilot, what pilot size, duration, and success thresholds would make you confident to expand?
      • What are the top three residual risks that would stop you from moving forward today?
      • Who should join a short technical and clinical kickoff if we agree to pilot (roles and names preferred)?
      • Realistically, what is your internal timeline for a procurement decision (select the closest range)? Options: 0–3 months, 3–6 months, 6–9 months, 9–12 months, 12+ months
      • Finally, what would you most want from us in the next 7 days to help you make progress (data sample, actuarial model, clinician demo, security docs)? Options: Data sample, Actuarial model, Clinician workflow demo, Security/BAA templates, Peer health plan reference, Other
  6. Success

    Review outcomes against HEDIS and actuarial targets, report real‑world engagement and clinical results, and maintain a shared backlog for issues and enhancements.

    Success Reviews

    • Quarterly Outcomes Review — HEDIS & Clinical Results
    • Actuarial Reconciliation & ROI Validation
    • Engagement & Real-World Evidence Deep Dive
    • Shared Backlog & Continuous Improvement Prioritization — Working Session
    • Regulatory, Data Security & Reporting Compliance Review

    Issues & Enhancements

    • Establish a recurring backlog review cadence and escalation path for high-risk items.
    • Assign clinical lead to implement two remediation actions for underperforming cohorts and report interim metrics in 4 weeks.
    • Document any data quality issues and schedule a data-engineering fix with target resolution date.
    • Meeting Objectives & Pre-Reads
    • Reach consensus on the validated savings number and the actuarial methodology used.
    • Decide on amounts due (payments/credits) under contractual guarantees and the timeline for settlement.
    • Identify and assign ownership for any disputed items requiring further audit or data pulls.
    • Establish repeatable reconciliation cadence and artifacts for future quarters.
    • Produce a signed reconciliation workbook with line-item support and distribute to attendees within 7 business days.
    • Schedule a claims audit for flagged discrepancies and assign external/internal audit owner.
    • Update actuarial assumptions in the shared model and version-control the file for future reconciliations.
    • Purpose & Key Questions
    • Identify 2–3 high-impact, measurable interventions to improve engagement that are likely to move clinical outcomes.
    • Agree on metrics and timeframe to evaluate each experiment and link results back to actuarial impact.
    • Surface demographic or channel-specific opportunities to re-target outreach for better ROI.
    • Launch prioritized A/B test for outreach messaging with agreed sample sizes and KPI targets within 14 days.
    • Deliver a cohort-level report tying engagement changes to clinical outcomes after the next 60-day window.
    • Implement one operational change (e.g., enrollment pathway tweak) and monitor its effect for 30 days.
    • Prework Review & Rules of Engagement
    • Agree on a prioritized backlog for the next 1–3 sprints with clear owners and timelines.
    • Define acceptance criteria and measurement plans for each prioritized item to ensure value delivery.
    • Welcome & Objectives
    • Publish the prioritized backlog into the shared project board and notify owners within 48 hours.
    • Owners to deliver implementation outlines and QA plans for their items 5 business days before sprint start.
    • Schedule a follow-up checkpoint in 4 weeks to review progress and early metrics.
    • Objectives & Required Approvals
    • Confirm that all compliance controls and BAAs are current and acceptable for ongoing data sharing.
    • Validate that data feeds meet quality thresholds required for HEDIS measurement and reporting.
    • Agree on deliverables and dates for any outstanding security or reporting items prior to HEDIS submission.
    • Remediate identified data quality gaps and certify feed health in writing before the next reporting window.
    • Complete any outstanding penetration test remediation and provide attestation to the payer security team.
    • Deliver finalized HEDIS reporting package and sign-off checklist by the agreed submission date.
    • Confirm whether the deployed programs met the agreed HEDIS and clinical targets for the review period.
    • Validate the integrity of the outcomes dataset and document any limitations for actuarial use.
    • Agree on remediation steps and owners where outcomes fall short, including timeline for re-measurement.
    • Capture clinical insights and success patterns to replicate across other cohorts.
    • Deliver a reconciled outcomes report (raw claims + DTx data + methodology) within 10 business days.
    • Restate Current State & Targets
    • Compliance Posture Overview
    • Methodology Review
    • Current State Statement & Consequences
    • Funnel Performance Snapshot
    • Claims Reconciliation Findings
    • Data Validation Summary
    • Top Backlog Items Presentation
    • Data Feed & Quality Health
    • Engagement-to-Outcome Correlation
    • Impact Voting & Prioritization
    • Reporting Artifacts & Cadence
    • Outcomes Dashboard Walkthrough
    • Segment Analysis
    • Sensitivity & Scenario Analysis
    • Performance Guarantee Adjudication
    • Open Security/Privacy Issues
    • Member Feedback & Qualitative Insights
    • Resource & Timeline Allocation
    • Variance & Root-Cause Analysis
    • Clinical Success Stories & Edge Cases
    • Experimentation Roadmap
    • Define Acceptance Criteria & Success Metrics
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