Project Background
Akros is supporting an early-stage medical device company developing a non-invasive ultrasound platform intended to diagnose, confirm, and therapeutically ablate peripheral neural tissue associated with chronic facet-mediated low-back pain.
The technology is intended to replace or modify elements of the current interventional pain pathway, which may include diagnostic medial branch blocks followed by radiofrequency ablation under fluoroscopic or CT guidance.
The proposed technology may combine diagnostic and therapeutic functions, reduce the number of procedures required, eliminate radiation exposure, and shorten the overall treatment pathway.
Consultant will serve as Akros’ medical coding and reimbursement subject-matter expert for this assignment.
Key Questions
The engagement will answer the following questions:
Can the proposed procedure appropriately use existing codes for facet-joint nerve ablation or related interventional pain services?
Does the change in energy source, imaging modality, invasiveness, diagnostic functionality, or procedure workflow affect code applicability?
Do existing Medicare, Medicaid, or commercial payer policies permit the proposed treatment pathway?
Could the company eliminate or combine elements of the current pathway—such as diagnostic blocks—without undermining coverage eligibility?
Would existing reimbursement support the proposed product configuration, disposable pricing, provider workflow, and site of service?
How would the proposed pathway affect provider economics, including revenue from procedures that may be replaced or eliminated?
What changes to the product, intended use, clinical workflow, documentation, evidence plan, or commercialization model would improve reimbursement feasibility?
If existing codes are not suitable, should the company use an unlisted code, pursue a new or revised code, or commercialize through another revenue pathway?
Scope of Work
Consultant will review the available product, regulatory, clinical, workflow, pricing, and commercialization materials.
Consultant will compare the proposed procedure with the current standard of care and identify the coding and billing implications of the differences between them.
The assessment will consider potentially applicable procedure and diagnosis codes, relevant billing instructions, bundled services, imaging requirements, modifiers, anatomical-level rules, provider requirements, and site-of-service considerations.
Consultant will review relevant Medicare guidance and a focused selection of Medicaid and commercial payer policies to determine whether existing coverage criteria are compatible with the proposed treatment pathway.
The analysis must distinguish between:
A code that appears technically similar
A code that can reasonably and compliantly be used
A covered service
A commercially workable reimbursement pathway
Consultant will assess whether existing payment supports the proposed procedure and product model, including the relative role of capital equipment, reusable components, and procedure-specific disposables.
Where existing coding or coverage is insufficient, Consultant will evaluate the practical implications of an unlisted-code strategy, a new or revised coding pathway, or an alternative commercialization model.
Deliverable
Consultant will prepare a concise Coding and Reimbursement Strategy Assessment that includes:
The recommended coding pathway
The rationale for whether existing ablation codes do or do not fit
Relevant coverage-policy requirements
Material professional and facility payment considerations
Implications for provider workflow and economics
Product, documentation, or evidence changes that may be required
Options if existing codes are not viable
Key risks, assumptions, and unresolved questions
Recommended next steps
The deliverable should connect reimbursement findings directly to product design, clinical workflow, pricing, evidence, and commercialization decisions.
Consultant will provide citations or links for material sources and identify where conclusions reflect professional judgment rather than settled coding or payer guidance.
Meetings and Collaboration
The engagement includes:
One kickoff meeting
Reasonable written follow-up questions
One draft review with Akros
One findings discussion, which may include the client
Reasonable revisions necessary to finalize the assessment
Akros will lead the broader commercialization strategy and maintain responsibility for the client relationship and final client-facing recommendations.
Timeline
Consultant will provide the draft assessment within approximately three weeks after the kickoff meeting and receipt of the required materials.
Any expected delay caused by missing product information, unresolved regulatory assumptions, or unusually complex payer research must be raised promptly.
Consultant Responsibilities
Consultant will personally perform the work unless Akros approves another individual in writing. The Consultant will use current, authoritative, and traceable sources; maintain confidentiality; disclose conflicts; and clearly communicate uncertainty.
Consultant may not contact the client or other outside parties without Akros’ prior written authorization.
Exclusions
Unless separately authorized, this engagement does not include preparing or submitting a CPT or HCPCS application; conducting RUC or valuation work; formal regulatory advice; payer interviews; claims testing; prior authorization; appeals; full health-economic modeling; clinical protocol development; 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. Additional work requires prior written approval from Akros.
Acceptance
The engagement will be considered complete when the final assessment has been delivered, material findings are supported by traceable sources, and reasonable comments from Akros have been addressed.