Taking a Closer Look at Less Expensive CTPs

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• Wound care products (US Medicare setting): Price is foundational—products costing >$127 per square centimeter lead to financial loss; clinicians should prioritize lower-priced options that at least break even before clinical selection.
• FDA regulatory pathways (devices vs human tissue): Lower-priced options fall into FDA-exempt human tissue products (e.g., cadaver skin, some amnions) or medical devices—PMA devices (e.g., Apligraf, Integra) with prospective FDA trials may claim healing; 510(k) devices cannot.
• Clinical documentation & compliance: Only PMA-approved products can use healing or infection-reduction claims; inappropriate wording in notes is a Medicare audit risk.

Please note: This content is a direct transcript, capturing the authentic conversation without edits. Some language may reflect the flow of live discussion rather than polished text. 

With regard to the big price change and CTPs, there is an algorithm, a mental approach to looking at these other products, and of course, it begins with price. Because if you purchase a product for more than $127 per square centimeter, you'll lose money. That is a reality. 
 
But beyond that, this is an opportunity for clinicians to look at those lower priced products, everything that is going to at least involve breaking even or better from the standpoint of the pricing, and then ask yourself which ones of these do I want to choose? 
 
And now's a good time for clinicians to be aware that those lower-priced products are in one of three sort of groups. The two big groups are, are they a device or are they a human tissue product that's exempt from the requirement for FDA? And there are lots of great human tissue products. They're cadaver skin. Some amnions are below that price point, many others will probably change their price. So that's the one group, the human tissues that are exempt. 
 
The others are medical devices. And medical devices come in two categories. One is the PMA categories, like PMA category like Apligraf and Integra that have gone through prospective clinical trials with the FDA and can make a very specific claim of healing. The other are the 510K medical devices that are on the market because they're similar to some other product. The only products that can make healing claims are products that have gone through the PMA process. 
 
This may seem like a very esoteric discussion, but it gets down to what a clinician can say in their note about why they picked a product. Each of these products has its own unique potential value. So it's not that one category is better than another. You just need to know what it is. So just realize that there are certain words that you shouldn't use with a product that is not allowed to say “We heal wounds, we reduce infection.” There are some claims that are only able to be used by a product that's gone through PMA. So just be aware that this is a trap that the Medicare auditors look for to see if you picked a reason for selecting a product that is wording that is beyond the bounds of what that particular category is able to say. Just be careful. Those are pitfalls. 

Dr. Fife is the Chief Medical Officer of Intellicure, LLC.