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Insights

Our experts provide real world insights to help you navigate the market access maze


Beyond Cash-Pay: How Wellness Devices Can Obtain Medical Billing Codes

Wellness device companies can make significant revenue from cash payments. But depending on such payments

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Why “Close Enough” Coding is a Compliance Nightmare

We sometimes hear from medical device companies that they have a medical code because there

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The Complexities of Navigating the FDA Breakthrough Devices Program

Devices that qualify for Breakthrough Device designation often involve an ambitious clinical claim, a novel

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A Category III Code Can Mean Automatically Denied

Getting a Category III code is often considered a milestone on the path to reimbursement.

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Breakthrough Isn’t Enough: The Real Challenge of Getting Devices to Patients

Securing a Breakthrough Device designation from the FDA is significant, but it is only the

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Unlocking New Revenue: How the NOPAIN Act Creates a Reimbursement Advantage for Non-Opioid Device Makers 

Medicare’s traditional approach to reimbursement makes it difficult for hospitals and physicians to use innovative

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Opaque, Unregulated AI Algorithms Deny Patient Care

If prior authorization is making it hard to get your medical innovation to patients, you’re not alone.

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Getting Physician Feedback That Matters

For medical device, test, and technology innovators, one of the earliest and most important questions

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What to Expect When You Hire a Market Access Consulting Firm

Bringing a new medical device, test, or technology to market is no small feat. Between

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Don’t Wait to Get Paid: Building a Compliant Path to Early Reimbursement

Bringing a medical device or diagnostic test to market is no small feat—but getting reimbursed

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