Project Background
Akros is supporting an early-stage neurotechnology company developing software that analyzes functional MRI (fMRI) data to identify patient-specific brain targets used to guide transcranial magnetic stimulation (TMS) treatment for depression.
The company is evaluating U.S. market entry and needs to understand whether its software-only targeting and treatment-planning functionality can fit within existing coding, billing, coverage, and payment pathways. A central question is whether the targeting component may be separately reportable and reimbursable when used with TMS, rather than sold only as part of an integrated hardware-and-software system.
Key Questions
The engagement will answer the following questions:
Which existing CPT, HCPCS, revenue, diagnosis, or related coding pathways may apply to the software, fMRI analysis, TMS targeting or treatment planning, and the associated TMS treatment workflow?
Can a software-only targeting or treatment-planning component be separately reported and reimbursed, or would it generally be considered bundled, incidental, or included within MRI interpretation, TMS treatment, or another service?
If separate reporting may be supportable, who may appropriately bill for the service, in which care settings, and subject to what documentation, professional/technical component, supervision, modifier, code-pairing, or bundling requirements?
How do Medicare and a focused selection of commercial or Medicaid payer policies address TMS for depression and any related imaging, targeting, planning, or navigation services that could affect coverage or payment?
Do FDA pathway, labeling, indication, or product-classification assumptions materially affect the coding or coverage analysis, and what questions should be resolved with regulatory counsel before relying on a reimbursement pathway?
If no existing code cleanly supports the proposed software-only model, what are the practical alternatives - including unlisted or miscellaneous coding, a new or revised coding pathway, bundling with another service, or a different commercialization model - and what product, evidence, workflow, or documentation changes would improve feasibility?
Scope of Work
Consultant will research applicable coding pathways and authoritative coding guidance, including relevant bundling or code-pairing rules, professional and technical component considerations, provider eligibility, documentation requirements, and site-of-service implications.
Consultant will compare the proposed software-enabled workflow with the current TMS treatment pathway and selected comparable neurostimulation, neuroimaging, targeting, or navigation solutions. Comparable-product research should inform the analysis but should not assume that observed billing practices establish a compliant pathway for this product.
Consultant will review relevant Medicare guidance and a focused selection of commercial and Medicaid payer policies to evaluate whether existing coverage criteria for TMS and related services are compatible with the proposed workflow. Where publicly available and meaningful, the assessment should also note material professional or facility payment considerations.
The analysis must distinguish between a code that appears technically similar, a code that can reasonably and compliantly be reported, a service that is covered, a service that receives separate payment, and a reimbursement pathway that is commercially workable for a software-only product. Where existing pathways are insufficient, Consultant will evaluate practical alternatives and the implications for product design, workflow, documentation, evidence, and commercialization.
Deliverable
Consultant will prepare a concise Coding and Reimbursement Assessment that includes:
The recommended coding and billing pathway for the software-enabled targeting or treatment-planning service
A concise matrix of plausible coding options, potential biller, care setting, key reporting requirements, bundling or separate-payment considerations, and material limitations
The rationale for whether the software functionality can or cannot be separately reported from MRI interpretation and/or TMS treatment
Relevant Medicare and selected payer coverage-policy requirements for TMS depression treatment and any related services
Material professional and facility payment considerations, including whether separate reimbursement for the targeting component appears commercially plausible
Comparable-product or analogous-service findings that materially inform the coding strategy
Product, labeling, workflow, documentation, evidence, or commercialization changes that may be required to improve reimbursement feasibility
Options if existing codes are not viable, key risks and assumptions, unresolved questions, and recommended next steps
The assessment should be written for startup executives and non-coding stakeholders. It should translate coding findings into clear product-development, regulatory-coordination, pricing, workflow, and commercialization implications rather than simply restating code descriptions.
Consultant will provide citations or links for material sources and clearly distinguish confirmed coding or payer guidance from professional judgment, assumptions, or areas that require regulatory or legal confirmation.
Meetings and Collaboration
The engagement includes:
One kickoff meeting
Reasonable written follow-up questions during the assessment
One draft review with Akros
One findings discussion, which may include the client
Reasonable revisions necessary to finalize the deliverable
Akros will manage all client communications unless the Consultant is expressly invited to participate.
Timeline
Consultant should indicate the earliest feasible turnaround. Akros currently anticipates a draft assessment within approximately three weeks after the kickoff meeting and receipt of the required materials.
Because the client is working under an accelerated planning timeline, any expected delay caused by missing product information, unresolved regulatory assumptions, or unusually complex coding or payer research must be raised promptly.
Consultant Responsibilities
Consultant will personally perform the work unless Akros approves another individual in writing. The Consultant will maintain strict confidentiality, use current and traceable research sources, disclose any conflicts of interest, and clearly communicate uncertainty or issues that could materially change the project assumptions.
Consultant may not identify or contact the client, comparable companies, payers, providers, or other outside parties regarding this project without Akros' prior written authorization. Project information may not be shared, reused, published, or referenced in marketing materials without Akros' written approval.
Exclusions
Unless separately authorized, this engagement does not include preparing or submitting a CPT, HCPCS, or other coding application; regulatory or legal advice; payer interviews or outreach; claims testing or submission; prior authorization or appeals; provider enrollment; full health-economic modeling; clinical-trial design; or implementation of provider billing processes.
Fees
Consultant will complete the engagement for the fees and payment terms stated in the applicable work order or contractor agreement.
Work beyond this scope requires Akros' prior written approval.
Acceptance
The engagement will be considered complete when the final assessment has been delivered, its material conclusions are supported by traceable sources, and reasonable comments from Akros have been addressed.