Insights
Regenerative and stem cell
PRP, exosomes and stem cell work are three different risks that get spoken about as one. The evidence each needs is different too.
Three risks, not one
They are grouped together and they do not belong together
PRP
Autologous, drawn and returned to the same patient in the same visit. The most straightforward of the three, and the one with the longest track record in a submission.
Exosomes
Not autologous. Sourcing, processing and the supplier's own regulatory standing all enter the file, and they are the whole of the question.
Stem cell
The narrowest market of the three and the one where the regulatory line matters most. Submissions are read closely and a thin one does not get far.
The line that matters
361 and 351 are not a technicality
Whether a product is regulated as a 361 HCT/P or requires approval as a 351 biologic is the single most consequential fact about regenerative work in a submission.
The distinction turns on minimal manipulation and homologous use. A product that meets both can be handled under section 361. One that does not is a drug or biologic and sits in a different regulatory position entirely.
Enforcement activity in this area has been consistent and public. Underwriters read it, and they ask practices to show which side of the line their product sits on and on what basis.
If a supplier tells you their product is exempt, the useful follow up is to ask them to put the basis for that in writing, naming the manipulation and the intended use. A supplier who will not is telling you something.
What a submission needs
Produce these and the file moves
The regenerative pack
- The specific product and supplier, named, for each service offered.
- The supplier's documentation of regulatory position, in writing.
- Chain of custody and storage protocol, including temperature handling.
- Who performs the procedure, their credential, and their training record.
- Consent specific to regenerative work, which states what the product is and what it is not approved for.
- What the practice tells patients about expected outcomes, and where that is recorded.
Where the market is
Plainly
PRP is written routinely. Exosomes are written with underwriting scrutiny and depend heavily on sourcing documentation. Stem cell work is a referral conversation and the answer depends on the specific product and the specific protocol.
That is a description of appetite as we observe it across the submissions and renewals we handle. It is not a statement about what any policy does, and it is not a prediction about where the market goes next.
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