Project Background
Akros is supporting an early-stage medical device company developing a respiratory therapy product for young pediatric patients with sleep-disordered breathing or sleep apnea.
The product may include a primary device, accessories, replacement components, and consumable elements. The company is evaluating its U.S. commercialization strategy and needs to understand whether the product can be reimbursed within existing coding and benefit-category frameworks.
Consultant will serve as Akros’ medical coding and reimbursement subject-matter expert for this assignment.
Key Questions
The engagement will answer the following questions:
Do any existing CPT, HCPCS, ICD-10, revenue, or related codes apply to the product, its accessories, or the associated service?
If an existing code may apply, what conditions must the product satisfy to use it appropriately?
Would the product, accessory configuration, intended use, documentation, care setting, supplier model, or distribution strategy need to change to improve coding eligibility?
If no existing code is appropriate, what are the practical options for billing during early commercialization?
Should the company consider a new HCPCS code or other formal coding pathway, and what would need to occur before pursuing it?
Are the available coding pathways commercially workable, or would they create material limitations involving payment, coverage, provider adoption, or scalability?
Scope of Work
Consultant will review the available product, regulatory, clinical, and commercialization materials and identify any information gaps that materially affect the analysis.
Consultant will research potentially applicable codes, benefit categories, coding guidance, payer policies, and relevant comparable products. The research should address both the primary device and its accessories or replacement components.
The analysis must go beyond identifying codes that appear similar. Consultant will assess whether each potential pathway is technically supportable, operationally usable, and commercially relevant.
Where an existing code does not clearly fit, Consultant will evaluate the implications of using a miscellaneous or unlisted code and whether a new-code pathway may eventually be warranted.
Consultant will also identify product, documentation, workflow, supplier, or distribution changes that may improve reimbursement feasibility.
Deliverable
Consultant will prepare a concise Coding and Reimbursement Assessment that includes:
The recommended coding and benefit-category pathway
Other plausible pathways considered
The reasoning supporting or limiting each option
Product or commercialization changes that may be required
Implications if no existing code fits
Preliminary considerations for a new-code application
Material risks, assumptions, and open questions
Recommended next steps
The assessment should be written for startup executives and non-coding stakeholders. It should translate the coding findings into clear product-development and commercialization implications rather than simply restating code descriptions.
Consultant will provide citations or links for material sources and clearly distinguish confirmed guidance from professional judgment or assumptions.
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 will provide the draft assessment within approximately two weeks after the kickoff meeting and receipt of the required materials.
Final timing may be adjusted by mutual agreement if material information is unavailable or the research identifies an unexpected issue requiring additional analysis.
Consultant Responsibilities
Consultant will personally perform the work unless Akros approves another individual in writing. The Consultant will maintain confidentiality, use authoritative and traceable research sources, disclose any conflicts of interest, and promptly flag findings that could materially change the project’s assumptions.
Consultant may not contact the client or other third parties without Akros’ prior written authorization.
Exclusions
Unless separately authorized, this engagement does not include submission of a CPT, HCPCS, or PDAC application; payer outreach; claims submission; appeals; provider enrollment; legal advice; regulatory advice; clinical-trial design; or implementation of a billing program.
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’ 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.