New CMS Code Prompts an Old FDA Question
CMS just proposed billing codes for a product the FDA says requires a drug license. For more than a decade, the FDA has maintained that injectable and micronized amniotic tissue belongs on the drug pathway. CMS has now proposed Medicare billing codes for that same product form.
Both positions exist at the same time.
One federal agency says these products require a Biologics License Application before they can be marketed. The other has proposed HCPCS codes describing how they could be billed. Providers now find themselves between two agencies applying different frameworks to the same category, and that uncertainty reaches well beyond coding.
Two Agencies, Two Different Frameworks
The FDA's position has remained remarkably consistent.
Under 21 CFR 1271.10, human tissue products qualify for regulation as a 361 HCT/P only if they meet specific criteria, including minimal manipulation. Sheet-form amniotic membrane generally satisfies that standard because its structural characteristics remain intact. Once that same tissue is processed into a micronized powder or injectable flowable, the FDA has consistently concluded the product exceeds minimal manipulation and belongs under the 351 biologic pathway, requiring a Biologics License Application.
That position first appeared in agency correspondence more than a decade ago and has been reaffirmed through enforcement actions following the close of the FDA's enforcement discretion period in 2021.
Few manufacturers chose the BLA pathway. Most products simply never entered the market through that route.
CMS Just Introduced a Different Conversation
The CY2027 OPPS proposed rule introduces new HCPCS codes that deserve close attention.
Several new Q-code descriptors reference flow products, while new application codes—G0681 through G0684—are written specifically for non-sheet skin substitute forms. Unlike traditional sheet products that remain tied to product volume, the proposed application codes reimburse according to wound size and the application itself.
Whether those codes ultimately survive the rulemaking process remains to be seen. Their inclusion alone signals that CMS is thinking about this category differently than the FDA has.
Providers Are Standing Between the Two
The FDA regulates whether a product belongs on the market.
CMS determines how Medicare pays for services involving that product.
Those responsibilities are different, but providers operate where they intersect.
A physician billing one of the proposed non-sheet application codes may eventually have a Medicare payment pathway for a product form that continues to carry significant FDA regulatory questions. That does not automatically create a compliance conflict, but it does create uncertainty that practices will need to understand before changing how they treat patients.
Why This Matters
Regulatory uncertainty rarely stays inside Washington.
It influences product availability, reimbursement strategy, manufacturer investment, and ultimately the choices physicians have when treating patients.
That is why Bionavix approaches these developments differently. Our role extends beyond product access. We help practices understand how evolving regulation, Medicare policy, documentation expectations, and product selection fit together before those questions reach the treatment room.
The CY2027 proposed rule is still open for comment, and the final rule may look different. This week, ask your billing team one question: are we coding, or planning to code, any non-sheet skin substitute claims under G0681 through G0684, and can we show medical necessity that holds up regardless of which pathway CMS or the FDA ultimately recognizes for that product?
If the answer isn't a clear yes, that is the gap Bionavix exists to close. Call us before you build billing or treatment decisions around codes that haven't been finalized. We'll walk through what's confirmed, what's still in flux, and what that means for your documentation.
URL slug: /cms-fda-skin-substitute-billing-codes