BioInsights LLC

BioInsights LLCBioInsights LLCBioInsights LLC
Home
Services Offered
  • CLIA Laboratory Services
  • Reimbursement Consulting
  • LDT Product Development
  • Med Device Approval
  • Go to Market Strategies
  • Our Team
  • Our Mission
  • Contact US

BioInsights LLC

BioInsights LLCBioInsights LLCBioInsights LLC
Home
Services Offered
  • CLIA Laboratory Services
  • Reimbursement Consulting
  • LDT Product Development
  • Med Device Approval
  • Go to Market Strategies
  • Our Team
  • Our Mission
  • Contact US
More
  • Home
  • Services Offered
    • CLIA Laboratory Services
    • Reimbursement Consulting
    • LDT Product Development
    • Med Device Approval
    • Go to Market Strategies
    • Our Team
    • Our Mission
    • Contact US
  • Home
  • Services Offered
    • CLIA Laboratory Services
    • Reimbursement Consulting
    • LDT Product Development
    • Med Device Approval
    • Go to Market Strategies
    • Our Team
    • Our Mission
    • Contact US

Market access and Reimbursement

AMA-CPT Coding

         1. Code Selection Support

  • Help providers choose the most accurate and compliant codes for the services performed.
  • Clarify correct use of Category I, II, and III codes, modifiers, and guidelines.


          2. Coding Audits & Reviews

  • Review existing coding practices to ensure accuracy and compliance.
  • Identify undercoding (missed revenue) or overcoding (compliance risk).


          3. Documentation Improvement

  • Advise on clinical documentation so it fully supports the selected CPT codes.
  • Teach providers how to document services clearly and completely.


          4. Regulatory Compliance

  • Ensure alignment with CMS, payer policies, and AMA guidelines.
  • Mitigate risk of audits, denials, or penalties (especially important with Medicare/Medicaid).


           5. Training & Education

  • Provide customized training to clinicians, coders, and billing staff.
  • Cover coding updates (CPT changes annually), complex scenarios, and payer-specific nuances.


           6. New Technology Coding (including Category III codes)

  • Assist with correct coding for emerging procedures and technologies — crucial in fields like telemedicine, genomics, or AI-based diagnostics.


           7. CPT Code Proposal Assistance

  • Some consultants help organizations develop and submit applications for new CPT codes — especially relevant for medical device companies, biotech firms, or research teams introducing novel services.

Reimbursement Strategy Development

Reimbursement strategy: Mapping out whether existing codes can apply to your technology — or if you’ll need a new CPT code, HCPCS code, or other pathway


Code gap analysis: Assessing current CPT code sets to see if your product fits within existing codes or if coding gaps exist. 


CPT code application support: Assisting with AMA CPT Editorial Panel submissions for new Category I or III codes — including evidence gathering, preparing proposals, and navigating the approval process. 


Clinical evidence guidance: Advising on what clinical data you need to support a new CPT code application (e.g., efficacy, widespread use, FDA status).


Advising on Category III (emerging tech) vs. Category I (established) pathways: Guiding you on the best route depending on your product’s maturity and adoption.


Stakeholder engagement: Helping with specialty society endorsements, payer discussions, and other advocacy needed to back your CPT application.


Coding education for Clients: Training the clinicians, coders, and billing departments who will be using your product — so they know how to code and get reimbursed for it correctly.|

Value Based Contracting and Analysis

Define the clinical outcome / decision the test impacts (e.g., reduces unnecessary biopsies, guides drug choice, predicts recurrence)


Model economic impact (e.g., cost avoided, hospital days saved, drugs avoided)


Design measurable performance metrics (e.g., % decision change, adverse event reduction rate, diagnostic accuracy)


Engage payers early Co-design contract terms they value → reduces coverage friction


Collect real-world evidence (RWE) To support ongoing utility and refine contract


Build operational infrastructure Track outcomes, adjudicate metrics, ensure compliance (may need IT, analytics)

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