In recent years, we’ve seen a dramatic rise in the use of Medicare Advantage (MA) plans, now covering over half of all Medicare beneficiaries. But with this shift has come a critical access challenge for medical device innovators.
In 2024 alone, over 50 million prior authorization requests were submitted to MA plans, according to the Kaiser Family Foundation. That’s more than 4 million authorization reviews per month — and many of them result in denials, even for devices that are FDA-approved and covered under traditional Medicare.
What’s Being Denied?
Medical device manufacturers are encountering barriers even when their products:
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Are FDA cleared or approved
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Are covered under National or Local Coverage Determinations (NCDs or LCDs)
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Meet medical necessity criteria under Medicare
Despite meeting these conditions, many devices are denied coverage by MA plans due to their own internal utilization management practices — creating a major disconnect between regulatory approval, CMS coverage, and payer access.
Why It Matters
These MA denials can seriously impact commercialization strategies and patient access:
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⏱ Delays in treatment for patients who need timely intervention
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📉 Reduced clinical uptake, especially in high-MA penetration markets
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🧑⚕️ Increased provider burden, discouraging use of innovative devices
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💸 Lost revenue and slowed market growth for manufacturers
This is not just a reimbursement issue — it’s a strategic challenge affecting pipeline planning, launch readiness, and long-term adoption.
The Market Access Experts Approach
At Market Access Experts, we specialize in helping medical device companies overcome these obstacles with targeted, strategic support. Our team has decades of experience navigating Medicare Advantage plans, payer criteria, and the evolving regulatory environment.
We offer:
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✅ Pre-launch planning that accounts for MA-specific hurdles
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📄 Documentation and appeals strategy tailored to payer expectations
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🤝 Direct engagement with MA plans to support clinical and economic alignment
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📊 Data-driven positioning to demonstrate value and necessity
Whether you’re preparing for market entry or facing repeated MA denials, we help ensure your innovation reaches the patients who need it — without delay or unnecessary friction.
Need help navigating Medicare Advantage access?
Contact us to discuss how we can support your device through successful coverage and adoption.