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What We Do Advisory Services Market Access & Reimbursement

Market Access & Reimbursement

When payor expectations are more demanding than ever, success requires more than expertise; it requires a champion. Avania delivers comprehensive market access and reimbursement strategies designed to accelerate your path to commercial readiness and patient impact worldwide.

Key Differentiators:

  • 25+ years of market access specialization with deep technical knowledge and in-country relationships
  • 450+ clients served including 90% of the top 50 MedTech companies
  • Global expertise across all therapeutic areas and device types
  • Integrated approach linking coverage, coding, and payment strategies
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Global market access

Navigating the Complexities

Understanding Your Challenges

The path to reimbursement is complex and constantly evolving. MedTech innovators face mounting challenges, including:

  • Navigating diverse global regulations across markets
  • Balancing funding pressures with robust evidence generation
  • Managing time-to-market demands and payor expectations
  • Avoiding costly missteps that can delay access or limit adoption

What’s at Stake

Market access is mission-critical. A weak reimbursement strategy can mean delayed market entry, limited patient access, and lost revenue. In a competitive and cost-conscious landscape, having a specialized partner to guide your strategy from the start is essential to ensure commercial success.

Is Now the Right Time for Market Access?

Early market access planning shapes reimbursement, adoption, and commercial performance. Engaging this work during — or before — clinical development ensures the evidence you generate supports both regulatory approval and payment. Avania provides the strategic direction needed to align clinical, regulatory, and commercial goals from the outset.

Preclinical and Clinical Stage Market Access Strategy

Effective market access starts with the right evidence strategy. Avania embeds PRO development, HTA-aligned endpoints, and reimbursement requirements into study design, ensuring trials support both approval and payment. Our pre-market work includes CPT code strategy, payor advisory input, and health-economic modeling to define the value proposition early. The result is a clear reimbursement pathway that supports launch readiness.

Commercial Stage Market Access Solutions and Services

Commercial success requires structured payor engagement and proactive coverage management. Avania supports coverage determination, Medical Director outreach, and prior authorization strategy while guiding CPT and PLA code applications. We also develop value frameworks and real-world evidence programs to reinforce clinical and economic performance. As policies and competitors shift, we refine access plans to sustain coverage and strengthen pricing.

Why Avania: Your Strategic Partner in Access and Impact

Our Experts

Market Access Strategy Minds Behind Your Success

Speak with our Experts
Eric Lam

SVP Market Access & Reimbursement

Eric Lam, PhD

  • 20+ years of global healthcare experience
  • Doctorate Degree in Pharmacology
  • NIH-sponsored post-doctoral fellowship in Pharmacology and Medicine
  • Specialized expertise in IVD market access
stephen hull

SVP Market Access & Reimbursement

Stephen Hull

  • 25+ years of market access expertise
  • Committee chair experience for ISPOR
  • Advanced degree in health policy from Johns Hopkins
  • Bloomberg School of Public Health
  • Bachelor’s degree in international relations and French from Colgate University
Meike bomhof

VP Market Access & Reimbursement

Meike Bomhof

  • 30+ years of global medical technology experience
  • Masters Degree in Healthcare Assessment and Market Access
  • International postgraduate diploma in health economics and business administration
  • Deep expertise in European market access strategies

Our Operational Leaders

Partnering for Commercial Success

Speak with our Experts
jennifer varela

Director of Reimbursement Services

Jennifer Varela

  • 25+ years experience in medical coding and billing operations in medical devices
  • Experienced patient advocate with expertise liasoning with healthcare providers and payors
  • AAPC/Certified Professional Coder, Certified Outpatient Coder, and ICD-10-CM Certified International postgraduate diploma in health economics and business administration
  • Specialized deep expertise in medical coding and billing operations in medtech

Continuum of Expertise

Market access is a single milestone in the broader MedTech journey. Avania integrates regulatory insights, clinical evidence development, and commercial considerations to build smarter, faster reimbursement strategies from day one. This continuity means you can jump in anywhere in the development process and receive tailored expertise that aligns with your overall product strategy.

MedTech Focus, Purpose-Built

Unlike generalist CROs or pharma-first organizations, Avania was designed primarily for MedTech. Our experts understand the unique clinical, regulatory, and economic nuances of devices, diagnostics, and combination products, ensuring every strategy is tailored to your technology and target markets.

Comprehensive Market Access & Reimbursement Capabilities

Detailed Service Offerings

  • Market access and reimbursement assessments
  • Evidence planning and health economic studies
  • Data analytics and health economics
  • Pricing studies and assessment validation
  • In-country reimbursement strategy and support
  • Coverage and coding support across 22 global markets
  • Post-launch claim processing
  • Billing code guidance and denied claims appeals
  • Certified clinical coders with unmatched hotline proficiency
  • U.S. Market Access: Medicare, Medicaid, and commercial payor strategies, CPT and HCPCS code applications, Medicare payment setting, and payor outreach
  • Australia: PLAC applications and MBS item number strategies
  • Brazil: ROL private sector and CBHPM coding processes
  • China: Provincial Greenbook coding and payment support
  • Europe: Comprehensive coverage across major markets including Germany, France, Italy, Spain, Netherlands, and UK
  • Japan: MHLW reimbursement strategy and STM pathway expertise

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Technology Expertise

Our regulatory expertise spans all critical medical device technology segments where specialized expertise drives competitive advantage:

  • Active Implantable Devices – Coding strategy and payor evidence for premium implant reimbursement
  • Minimally Invasive Surgery Instruments – Procedure code optimization and economic rationale for advanced surgical tools
  • SaMD & AI/ML – Coverage pathways and evidence needs for digital and algorithm-driven products
  • Wearables & Remote Monitoring – RPM coding, payment alignment, and value demonstration for remote models
  • Robotics & Surgical Systems – Reimbursement positioning for robotic procedures and capital-related cost structures
  • Interventional Devices – Procedure coding and payor-required outcomes for high-acuity interventions
  • In Vitro Diagnostics (IVD) – Coding and clinical utility support for complex and next-gen diagnostic assays
  • Medical Imaging Equipment – Payment strategy and value justification for advanced imaging technologies
  • Emerging Technologies – Market access pathways for novel devices requiring new codes or evidence models
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Therapeutic Focus

Our market access expertise spans all major therapeutic areas where Avania excels:

  • Cardiovascular – Deep expertise in complex, high-risk device trials from structural heart to electrophysiology
  • Neurology & Neurovascular – Specialized in adaptive, multi-site studies for neurological and cerebrovascular interventions
  • Musculoskeletal & Orthopedics – Proven partner for surgical, regenerative, and real-world evidence studies
  • Aesthetics & Dermatology – Focused on advancing aesthetic and regenerative innovations with tailored strategies
  • Endocrinology, Gastroenterology & Urology – Broad experience in metabolic, gastrointestinal, and urologic device development
  • Medical Oncology & Radiology – Expertise in diagnostic and interventional oncology and imaging technologies
  • Other Expertise – Supporting a wide range of MedTech innovations across emerging and specialized fields

We serve all device types and technologies, including implantable devices, IVD diagnostics, SaMD/AI solutions, and combination products.

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Client Success & Impact:

Proof of Our Partnership

“Eric Lam is the best consultant we have ever worked with…We came to Avania because we didn’t understand the nuances of coding, coverage, and payment—much less how to develop a reimbursement pathway for a medical diagnostic in the US market. Eric Lam and team didn’t just hand us a strategy; they educated us, nurtured our team through the process, and helped us internalize the knowledge to build our own program. The result was a clear, succinct tactical strategy we could present to our board with confidence. After 20+ years in diagnostics, I can say without hesitation: Eric is forthright, logical, deeply knowledgeable in his trade—he listens, he cares, and he makes every effort to help us succeed. The investment in these consulting services exceeded our expectations.”

Collin Shaw, CEO
US IVD Medical Diagnostic Company

“Avania’s rare expertise tripled our projected market size and accelerated our path to FDA submission…SIME Diagnostics is developing a first-to-market technology addressing an unmet need in neonatology—no predicate devices, no existing payment codes, no established pathways. Very few consultancies have meaningful expertise in NICU point-of-care diagnostics. We selected Avania specifically because of their rare combination of medtech regulatory depth and market access expertise in this specialized space. The results have been significant: we identified clear US pricing strategy, uncovered new clinical use cases that tripled our projected market size, and seamlessly transitioned into FDA submission support with a team that already understood our technology. Our development speed has increased dramatically because Avania anticipates our needs and moves decisively where others would struggle. They’re uniquely equipped for medtech—not biotech—and that distinction matters enormously. We thoroughly recommend Avania as a partner for any medtech company seeking expert, end-to-end support.”

Povl Verder, Founder & CEO
SIME Diagnostics
sime diagnostics logo

Case Study

Securing Premium CPT Reimbursement to Accelerate Robotic Surgery Adoption

Challenge:

A robotic surgical device manufacturer faced limited reimbursement under existing bundled procedure codes, preventing adoption despite superior clinical outcomes. Competitive systems had secured dedicated CPT codes with 40% higher reimbursement rates.

Avania’s Approach:

We developed a comprehensive AMA CPT Editorial Panel strategy, coordinating clinical evidence collection, health economic modeling, and specialty society endorsements. Our team guided the client through the rigorous application process, including physician time studies, resource utilization analysis, and comparative effectiveness documentation required for successful code applications.

Outcome:

The AMA CPT Editorial Panel approved a CPT code with significantly higher reimbursement than bundled alternatives. The new code drove an increase in procedure volume within months, establishing market leadership in the segment.

Strategic reimbursement positioning transforms innovative devices from cost centers into profit drivers for healthcare systems.

Case Study

Establishing a High-Value PLA Code to Unlock National Diagnostic Expansion

Challenge:

A novel assay lacked appropriate CPT codes, forcing laboratories to use generic molecular pathology codes with inadequate reimbursement that didn’t reflect the assay’s clinical complexity or value.

Avania’s Approach:

We orchestrated a multi-year CPT code development strategy, coordinating clinical utility studies, health economic analyses demonstrating cost-effectiveness versus standard imaging surveillance, and securing key oncology society endorsements. Our team guided the laboratory through AMA CPT Editorial Panel submissions, including detailed workflow documentation and physician survey data on clinical decision-making impact.

Outcome:

The AMA approved a proprietary laboratory assay (PLA) code with reimbursement rates higher than generic molecular codes. The improved coverage facilitated national laboratory partnerships and drove increase in test utilization.

Strategic CPT positioning transforms innovative diagnostics from laboratory cost burdens into clinically integrated, financially sustainable testing platforms.

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our approach

Avania’s Integrated Approach to Market Access & Reimbursement

Avania operates as a true extension of your team, combining transparency, communication, and shared purpose in every engagement. Our market access expertise combines regulatory knowledge, health economics, and commercial insights to ensure sound strategic direction and implementation.

Whether you need comprehensive end-to-end market access support or targeted assistance with specific challenges, we adapt to your evolving needs — filling capability gaps, scaling with your innovation, and maintaining the highest standards of quality, compliance, and operational excellence across every project.

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Ready to Advance Your Market Access & Reimbursement

Strategy?

Your innovation deserves a clear path to patients. Partner with Avania to unlock market potential with the strategic insight, local expertise, and global reach that only MedTech’s trusted champion can deliver.

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